DIA 2024 Global Annual Meeting: Full Schedule

8:00am PDT

#100: Opening Plenary and Keynote Address

Component Type: Forum

Join our opening plenary session, Innovation: The Possibilities, The Boundaries: Charting New Horizons, led by Tom and Emily Whitehead, who will give the incredible journey of Emily Whitehead, the pioneering pediatric patient who defied the odds and became the first in the world to undergo CAR T-cell therapy. Tom and Emily will share their invaluable insights into the transformative power of CAR-T therapy, offering a unique perspective that promises to captivate and inspire. Dean Kamen will discuss the Future of Regenerative Therapies, How Public-Private Partnerships Can Impact Advancement. Following your keynotes, we will have a panel discussion. Attendees can expect a lively and engaging discussion, with a diverse range of perspectives and insights from panelists who are leaders and at the forefront of our industry; including panelists from the Gates Foundation, regulatory agencies, and the patient perspective.

Chair

Marwan Fathallah, MBA, MSc

Speaker

Developing Cell Therapies for Cancer Patients
Carsten Linnermann, PhD

Keynote Speaker: Insights into the Transformative Power of CAR-T Therapy
Tom Whitehead

Keynote Speaker: Insights into the Transformative Power of CAR-T Therapy
Emily Whitehead

Keynote Speaker: Future of Regenerative Therapies - How Public-Private Partnerships Can Impact Advancement
Dean Kamen

Plenary Panel: Innovation - The Possibilities, the Boundaries - Charting New Horizons
David Mukanga, PhD, MPH

Panelist: Innovation
Dean Kamen

Panelist: EMA Perspective
Emer Cooke, MBA, MSc

Panelist: FDA Perspective
Peter W. Marks, MD, PhD

Panelist: Patient Perspective
Stacy Hurt, MBA, MHA

Speakers

Marwan Fathallah

President & Chief Executive Officer, DIA, United States

Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho... Read More →

Dean Kamen

Founder, DEKA Research & Development Corp., United States

Serial inventor and the founder of the ARMI-Advance Regeneratve Manufacturing Institute

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

Emily Whitehead

Co-founder, Emily Whitehead Foundation, United States

Emily Whitehead was diagnosed with acute lymphoblastic leukemia (ALL) in May 2010 when she was five years old. Typically, children diagnosed with this type of leukemia have an 85% to 90% chance of being cured; however, she relapsed twice. The leukemia became resistant to treatment... Read More →

Tom Whitehead

Co-founder and President, Emily Whitehead Foundation, United States

Emily’s parents, Tom and Kari, were not willing to give up. They heard about an experimental treatment, called CAR T-cell therapy, that was available as a Phase I clinical trial at Children’s Hospital of Philadelphia (CHOP). In April 2012, they enrolled Emily in the clinical trial... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel , United States

Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →

Carsten Linnermann

Chief Executive Officer, Neogene Therapeutics, AstraZeneca Group, Netherlands

Co-founder and CEO of Neogene Therapeutics, AstraZeneca Group will speak about his experience in developing cell therapies for cancer patients and the importance of collaboration to transform innovative science into new medicines for patients.

Monday June 17, 2024 8:00am - 10:00am PDT
Ballroom San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

00: Plenary, Forum | 09: Regulatory, Forum | 06: TranslationalDelivery Tech-PrecMedicine, Forum

Featured Topics Artificial Intelligence (AI), Cell and Gene Therapy, Patient Focused, Regulator Perspectives
Feature Topics Artificial Intelligence (AI),Cell and Gene Therapy,Patient Focused,Regulator Perspectives
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11:00am PDT

#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-518-L04-P; CME 1.00; RN 1.00

Reporting of pre-market and post market safety reports to be submitted in ICH E2B (R3) format to FDA Adverse Event Reporting System (FAERS). The presenters will discuss system readiness, testing approach, challenges, and lesson learned for reporting premarket and post market safety reports, both from FDA’s and industry’s perspective.

Learning Objectives

Recognize that FDA will go live with E2B R3 standard early next year and will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal; Describe regional data elements, system readiness, testing approach, challenges and lesson learned that are key for post market, IND and IND-exempt BA/BE safety reporting, both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Sheila M Estela, BSN, RN

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Subhan Ahmed Sharief

Speakers

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →

Sheila M Estela

Regional Patient Safety Head US and Canada, Novartis Pharmaceuticals Corporation, United States

I am a Registered Nurse currently working as the Regional Patient Safety Head for US & Canada at Novartis Pharmaceuticals. In this role, I lead a team of almost 70 dedicated PV professionals in the region. Additionally, I hold the position of US Country Patient Safety Head (CPSH... Read More →

Subhan Ahmed Sharief

Director, ArisGlobal LLC, United States

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

11:00am PDT

#109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-523-L04-P; CME 1.00; RN 1.00

In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.

Learning Objectives

Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.

Chair

Junko Sato, PhD

Speaker

FDA Update
Kassa Ayalew, MD, MPH

EMA Update
Peter Twomey

PMDA Update
Yoshiaki Nodera, MPharm

Speakers

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →

Yoshiaki Nodera

Principal Inspector, Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Yoshiaki Nodera currently serves as a principal inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA). He joined PMDA in 2008 and had been working as a reviewer of biotechnological/biological products, medical devices... Read More →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation and policy development in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
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11:00am PDT

#110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-524-L04-P; CME 1.00; RN 1.00

In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.

Learning Objectives

Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of two NDRP workstreams: Advisory Committees and Investigational New Drugs

Chair

Yoni Tyberg, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Meghana Chalasani, MHA

Panelist
Michael Monteleone, MS, RAC

Panelist
Andrew Emmett, MPH

Speakers

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory... Read More →

Andrew Emmett

FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States

Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →

Michael Monteleone

Associate Director for Labeling, OND, CDER, FDA, United States

Mr. Michael Monteleone is currently an Associate Director for Labeling in the Office of New Drugs at CDER, FDA. Michael has also held positions in Regulatory Affairs and Project Management throughout his 15 year tenure at the FDA.

Yoni Tyberg

Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States

Yoni Tyberg is the Associate Director of Special Program Staff (SPS) at the Office of New Drugs within CDER. In this role, Yoni supports the strategic planning, project development and execution of the New Drug Regulatory Program Modernization efforts across OND and CDER. He had also... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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11:00am PDT

#111: China Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-525-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

Learning Objectives

Summarize the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speaker

Opening Remarks and Introductions
Lili Cao, MS

Initiatives to Bring More New Drugs to Patients, and Faster
Zhimin Yang, MD

Recent Developments in Regulatory Science and Regulation
Jiangyong Yu

Advancing Clinical Research in China: A Clinical Oncologist’s Perspective
Shun Lu

Speakers

Ling Su

Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China

Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →

Lili Cao

Deputy Director, China Center for Food and Drug International Exchange, National Medical Products, China

Lili Cao is the Deputy Director-General, China Center for Food & Drug Int’l Exchange (CCFDIE), National Medical Products Administration (NMPA). She received her bachelor degree at Nankai University, and master degree at London School of Economics and Political Science, majoring... Read More →

Shun Lu

Director, Center for Clinical Medicine of Lung Cancer, Shanghai Chest Hospital,, Shanghai Jiaotong University, China

Shun Lu, MD, PhD, is a Director of the Oncology Department and Professor at Shanghai Chest Hospital. Dr. Lu serves on the International Affairs Committee of the American Society of Clinical Oncology, and Multidisciplinary Cancer Management Courses Working Group. He is also a member... Read More →

Zhimin Yang

Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China

Dr. Yang is theDeputy Director-General ,Center for Drug Evaluation of the National Medical Products Administration. Graduated from Peking University Medical Center, majoring in clinical medicine. She used to be a known pediatrician working at Peking University People's Hospital. In... Read More →

Jiangyong Yu

Director, Department of Drug Registration, National Medical Products Administration (NMPA), China

Dr. Yu Jiangyong, Doctor of Science, Chief Pharmacist. Currently, he is the consultant and director of division of TCMs and Ethno-Medicines, Department of Drug Registration (Department of TCMs and Ethno-Medicines Regulation) of China's NMPA.

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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2:15pm PDT

#133: ICH M11 Protocol Template: A Global Solution for Global Drug Development

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-533-L04-P; CME 1.00; RN 1.00

This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.

Learning Objectives

Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Support of Digital Protocol Initiatives
Chris Decker, MS

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
Vada A. Perkins, DrSc, MSc

Speakers

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →

Chris Decker

President and Chief Executive Officer, CDISC, United States

Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
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2:15pm PDT

#139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-539-L04-P; CME 1.00; RN 1.00

Explore US and EU AI drug regulation with experts from regulator, industry, and academic perspectives. Learn about principles, data privacy, transparency, and real-world examples. Gain insights into vital regulatory nuances.

Learning Objectives

Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.

Chair

Jayne Ware, MPH, MSc

Speaker

EMA Update
Steffen Thirstrup, MD, PhD

FDA Update
Tala Fakhouri, PhD, MPH

Industry Perspective
Rose Purcell, JD, MA

Speakers

Jayne Ware

Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC , United States

Jayne Ware is a Director for Global Regulatory Policy at Merck. She joined Merck in 2012 after 15 years at the US FDA. Jayne is responsible for coordinating regulatory policy intelligence and advocacy activities for key topic areas at Merck such as digital health issues, safety/pharmacovigilance... Read More →

Tala Fakhouri

Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States

Rose Purcell

Director, Global Regulatory Policy and Innovation, Takeda, United States

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
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2:15pm PDT

#140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-540-L04-P; CME 1.00; RN 1.00

This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.

Learning Objectives

Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.

Chair

Charles Lee, MBA, MS

Speaker

FDA Update
Motiur Rahman, PhD, MPharm, MS

EMA Update
Sabine Haubenreisser, PhD, MSc

PMDA Update
Yuki Ando, PhD

Speakers

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →

Yuki Ando

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yuki Ando is a Principal Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug... Read More →

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States

Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
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2:15pm PDT

#141: Innovation in Manufacturing Globally

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

Learning Objectives

Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc

FDA Perspective on Advanced Manufacturing
Sau L Lee, PhD

Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD

Decentralized Manufacturing of ATMPs
Ursula Busse, PhD, MBA

Panelist
Benjamin Stevens, PhD, MPH

Speakers

Ursula Busse

Head of Regulatory Affairs, Tigen Pharma SA, Switzerland

Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma... Read More →

Marcel Hoefnagel

Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands

Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars... Read More →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States

Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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3:30pm PDT

#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

Learning Objectives

Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

Chair

Andrew Bate, PhD, MA

Speaker

Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD

Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States

Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives, Digital Technology
Level Intermediate
Feature Topics Regulator Perspectives,Digital Technology
Credit Type ACPE, CME, RN
Tags Session

3:30pm PDT

#152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.

Learning Objectives

Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.

Chair

Emily Gebbia, JD

Speaker

FDA Update
Ling Yang, MD, PhD, FAAFP

Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA

Health Canada Update
Jennifer Evans

Speakers

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom

Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →

Jennifer Evans

Compliance and Enforcement Specialist, Health Canada, Canada

Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a compliance... Read More →

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →

Ling Yang

Senior Physician, OSI, OC, CDER, FDA, United States

Ling Yang is a senior physician in the Office of Scientific Investigations in FDA’s Center for Drug Evaluation and Research. She has worked at FDA for over 15 years and has extensive experience in GCP compliance evaluation, clinical review and FDA regulation of new drugs, generic... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

3:30pm PDT

#155: Health Canada Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-554-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Speaker

Panelist
Sophie Sommerer

Speakers

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada

Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →

Sophie Sommerer

Director General, Health Canada, Canada

Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:30pm PDT

#146: Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-545-L04-P; CME 1.00; RN 1.00

This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.

Learning Objectives

Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.

Chair

Dylan Bechtle, MS

Speaker

Industry Update
Andrea Doyle

Industry Update
Del Smith, PhD, MS

Industry Update
Stacy Holdsworth, PharmD

FDA Update
Tamy Kim, PharmD

Speakers

Dylan Bechtle

Associate Director, Regulatory Policy Lead- US, Johnson & Johnson, United States

Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →

Andrea Doyle

Head, Global Regulatory Affairs, Neurology, Sanofi, United States

Stacy Holdsworth

Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company, United States

Stacy Holdsworth is the Associate Vice President for U.S. Regulatory Policy & Strategy at Eli Lilly and Company. Her primary responsibilities are to lead a team of regulator professionals in the development and implementation of an external regulatory policy agenda that encourages... Read More →

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States

Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Regulator Perspectives
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.

Learning Objectives

Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.

Chair

Steffen Thirstrup, MD, PhD

Speaker

US Patient Representative
Karin Hoelzer, DVM, PhD

Co-Chair
Robyn Bent, MS, RN

EMA Update
Juan Garcia-Burgos, MD, PhD

EMA Update
Rosa Gonzalez-Quevedo

US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh

EU Industry Representative
Solange Corriol-Rohou, DrMed, MD, PhD

Speakers

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →

Rosa Gonzalez-Quevedo

Scientific Research Officer, European Medicines Agency, Netherlands

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States

Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

Format Session
Level Intermediate
Featured Topics Patient Focused, Regulator Perspectives
Level Intermediate
Feature Topics Patient Focused,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#211: PMDA Town Hall

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Daisuke Tanaka, PhD

Speaker

PMDA Update
Daisuke Koga, MSc, RPh

Industry Update
Atsushi Tsukamoto, PhD, MSc

Panelist
Yoshiaki Uyama, PhD, RPh

Speakers

Daisuke Tanaka

Office Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines... Read More →

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan

Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →

Atsushi Tsukamoto

Head is Therapeutic Area Strategies, Daiichi Sankyo, United States

Atsushi is the Corporate Officer and Head of Therapeutic Area Strategy in Daiichi Sankyo, to manage multiple therapeutic area strategy. Prior to that, he was VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He has been global project manager for nearly 20 years (in JPN... Read More →

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →

Cynthia Verst

President, R&D Solutions D&DI; 2023 President, IQVIA, United States

Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

Learning Objectives

Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

Chair

Francesco Pignatti, MD

Speaker

Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc

External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc

The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine C. Lerro, PhD, MPH

Speakers

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States

Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands

Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Advanced
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

Learning Objectives

Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

Chair

Steven M. Weisman, PhD

Speaker

Panelist
Claudia A Salinas, PhD

Panelist
Naomi Boxall, PhD

Panelist
Vera Ehrenstein, DrSc, MPH

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Steven Weisman

Global President, Clinical and Regulatory, Lumanity Inc, United States

Over the years, Dr. Weisman has built a stellar reputation as a regulatory and medical affairs consultant helping clients achieve productive relationships with regulatory authorities in the United States and around the world. Dr. Weisman has played a pivotal role working on important... Read More →

Naomi Boxall

General Manager, PHARMO Institute, Netherlands

Naomi is General Manager at PHARMO and INSZO and is accountable for a portfolio of RWE projects using health data from various sources to support drug development and commercialization for global life science sector. With over 20yrs experience from a breadth of epidemiology topics... Read More →

Vera Ehrenstein

Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark

Vera Ehrenstein is professor of pharmacovigilance at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has more than 20 years' experience as an epidemiologist, including more than 15 years' experience leading multinational postauthorisation safety studies of... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Claudia Salinas

Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States

Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#225: Regulatory Guidance and Papers on Technology Innovations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

Learning Objectives

Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

Chair

David Meats

Speaker

AI and Technology Trends and Regulation Introduction
David Meats

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD

Regulation Guidance
Louise Lind Skov, PhD

Speakers

David Meats

Director, Regulatory Services Management, Certara, United States

David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly... Read More →

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark

Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives, Digital Technology
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives,Digital Technology
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speaker

FDA Update
Emily Gebbia, JD

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives
Level Advanced
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-579-L04-P; CME 1.00; RN 1.00

Results from international industry experience surveys on the Access Consortium and Project Orbis followed by a panel discussion, involving health authorities, to discuss recommendations and next steps to improve and promote these schemes.

Learning Objectives

Recognize the benefits and challenges of international collaborative initiatives from both the industry and regulatory authority perspectives; Discuss the recommendations to improve these schemes; Describe how to influence your own organization to adopt or increase usage of these schemes.

Chair

Sarah Powell, RAC

Speaker

Results of Industry Survey of Orbis Projects
Sarah Powell, RAC

Results of Industry Survey on Access Program
Tse Siang Kang, PhD

Speakers

Sarah Powell

President, Powell Regulatory Services, United States

Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients... Read More →

Tse Siang Kang

Head of Regulatory Affairs, North, East, West Asia, Global Regulatory, Pfizer Pte Ltd, Singapore

Dr. Tse Siang Kang is the Head of Regulatory Sciences in North, East and West Asia cluster, Pfizer Global Regulatory Sciences. In addition to his role in managing a diverse Asia team in Pfizer. Dr Kang also has a particular interest in publishing emerging Regulatory Sciences topics... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives, Regulatory Collaboration
Level Intermediate
Feature Topics Regulator Perspectives,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#230: International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-581-L04-P; CME 1.00; RN 1.00

Innovative approaches have the potential to create new opportunities for patients, but they also bring challenges to regulators, called to evaluate, and supervise products for which traditional regulatory approaches might not be appropriate. Global regulators will discuss how regulatory science is key to develop solutions and how regulators worldwide need to work together to overcome such challenges.

Learning Objectives

Explore how to make faster progress with translating regulatory science research outputs into practice, for accelerating and improving medicine development and use; Discuss generalizable success stories and examples with challenges to an efficient translation; Describe and critically review hurdles and success factors.

Chair

Antonio Barra Torres, MD

Speaker

Promoting International Regulatory Convergence Through Regulatory Science
Emer Cooke, MBA, MSc

Path for Future Collaboration Utilizing Regulatory Science
Yasuhiro Fujiwara, MD, PhD

Regulatory Science Impact Stories
Robert M. Califf, MD

ICMRA Summit 2023: Regulators Working Together Towards the Future
Anthony Lawler, MD, MBA

Panelist
Alison Cave, PhD

Panelist
Pamela Aung-Thin

Speakers

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.

Robert Califf

Commissioner, FDA, United States

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with... Read More →

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →

Antonio Barra Torres

President Director, ANVISA, Brazil

Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

14: DIAmond, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

Learning Objectives

Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

Chair

Hilmar Hamann, PhD

Speaker

EMA Update
Lorenzo De Angelis, PhD

Industry Update
Carlyn Crisostomo, MBA

Industry Update
Alexandra (Zan) Cha, PhD, MA

Industry Update
Timothe Menard, PharmD, MSc

Speakers

Lorenzo De Angelis

Platform Architect, European Medicines Agency, Netherlands

Lorenzo De Angelis studied Physics in Sapienza University of Rome, where he graduated cum laude in July 2014. He then moved to the Netherlands, where he obtained his physics PhD in December 2018, with a thesis entitled "The Singular Optics of Random Light". Afterwards, he joined the... Read More →

Alexandra (Zan) Cha

Principal, Chief Technology Office, Booz Allen Hamilton, United States

Zan brings 20+ years of experience in health AI / analytics, and IT /product / ops management, applied to medical devices, pharmaceuticals, supply chain, clinical trials, insurance tech, chronic disease management, and population health & wellness. She is currently focused on advancing... Read More →

Carlyn Crisostomo

Vice President, Head of R&D AI Strategy and Execution (RAISE), Amgen, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc

Speakers

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States

Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland

Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Ethics, Regulator Perspectives
Level Intermediate
Feature Topics Ethics,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#264: Enhancing Adoption of Innovative Approaches in Clinical Trials

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Learning Objectives

Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Ella Balasa

Panelist
Michelle Rohrer, PhD

Panelist
Allison Cuff Shimooka, MBA

Speakers

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech Roche, United States

Michelle Rohrer, PhD is Global Head of Product Development Regulatory and Policy. Michelle has worked at the company for 27 years, starting as a post-doctoral fellow. She has worked as a clinical scientist, team leader, and regulatory strategist. In 2013, Michelle was named by the... Read More →

Ella Balasa

Patient Advocate and Engagement Consultant, Balasa Consulting, United States

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information... Read More →

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States

Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Basic
Featured Topics Regulator Perspectives
Level Basic
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

Learning Objectives

Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

Chair

Leonardo Semprun Semprun, RPh

Speaker

Electonic Product Information Regulatory Evolution in Brazil
Nélio Cézar de Aquino, SR, MSc

Electronic Product Information in Low to Middle Income Countries
Rutendo Kuwana, RPh

Industry Outlook in Brazil: Exploring eLabeling Perspectives
Rosana M. Mastellaro, PharmD, RPh

Considerations for Implementation and Adoption of Digital Labels
Maria Cristina Mota Pina, MBA

Speakers

Leonardo Semprun

Global Regulatory Policy Lead-LatAm, MSD, Panama

Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with... Read More →

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →

Rosana Mastellaro

Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory... Read More →

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#274: Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-606-L04-P; CME 1.00; RN 1.00

Industry leaders will discuss how regulatory and industrial policy can support delivering quality-assured medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines especially in light of new analytical technologies, and how to evaluate potential threats to quality in the context of benefit-risk and patient access.

Learning Objectives

Define quality management maturity (QMM) and how the government is proposing to use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals; Understand the role of third parties like USP in defining quality standards; Comprehend policy ideas that enable earlier patient access to medicines without compromising quality

Chair

Aaron Josephson, MS

Speaker

How to Integrate Quality Management Maturity into Regulatory Assessment and Oversight
Aaron Josephson, MS

Panelist
Katherine Wilson, JD, MA

Quality Policy Priorities of the Canadian Generic Industry
Kristin Willemsen, MS

Panelist
Brett Howard, JD, PhD

Speakers

Aaron Josephson

Senior Director, Global Regulatory Policy, Teva Pharmaceuticals, United States

Aaron develops and advocates for policies that enable more efficient and predictable regulatory systems aligned with Teva’s development programs, business objectives, and patient needs. Prior to joining Teva, Aaron worked at FDA for more than a decade in positions at CDER, CBER... Read More →

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Kristin Willemsen

Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada

Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for the implementation of regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key... Read More →

Katherine Wilson

Head, Global Regulatory Policy and Intelligence, Viatris, United States

Katherine (Katie) Wilson, leads Global Regulatory Policy + Intelligence at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.

Learning Objectives

Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.

Chair

Sri Mantha, MBA, MS

Speaker

Industry Update
Sean Darcy

Industry Update
Andrew Bate, PhD, MA

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Sean Darcy

Principal, Darcy Consulting Group, United States

Sri Mantha

Director, Office of Strategic Programs, CDER, FDA, United States

Sridhar (Sri) Mantha is currently Director of the Office of Strategic Programs (OSP) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OSP, Sri leads center-wide strategic and operational planning, performance analysis, and... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

Learning Objectives

Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

Chair

Sophie Radicke, MSc

Speaker

FDA Update
Carolyn A Volpe, PharmD, MS

Update from Ghana
Adela Ashie

MHRA Update
Sarah Vaughan

Speakers

Adela Ashie

Principal Regulatory Officer, Food and Drugs Authority, Ghana

Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Carolyn Volpe

Team Leader, OSI, OC, CDER, FDA, United States

CAPT Carolyn Volpe is a licensed pharmacist and serves as the Team Leader for the Pharmacovigilance Compliance Team in FDA’s Center of Drug Evaluation and Research Office of Compliance Office of Scientific Investigations. She has over 14 years’ experience at FDA in post-marketing... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics Regulatory Collaboration, Regulator Perspectives
Level Advanced
Feature Topics Regulatory Collaboration,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

Learning Objectives

Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

Chair

Steffen Thirstrup, MD, PhD

Speaker

EMA Update
Sabine Haubenreisser, PhD, MSc

Industry Update
Laura T. Pizzi, PharmD, MPH

Patient Update
Dave deBronkart

Industry Update
Brian Bradbury, DrSc, MA

Speakers

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States

"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Laura Pizzi

Chief Science Officer, ISPOR, United States

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE), Regulator Perspectives
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-617-L04-P; CME 1.00; RN 1.00

This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program

Learning Objectives

Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.

Chair

Jan Hewett, BSN, JD

Speaker

FDA Update
Kavita C. Dada, PharmD

Industry Perspective on Remote Assessments
James Riddle

Health Canada Update
Jennifer Evans

Speakers

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States

Jennifer Evans

Compliance and Enforcement Specialist, Health Canada, Canada

Jan Hewett

Regulatory Counsel for Policy, OSI, CDER, FDA, United States

Jan Hewett joined the U.S. Food and Drug Administration's Center for Drug Evaluation and Research -Office of Compliance- Office of Scientific Investigations office as Regulatory Counsel (Policy) in February 2015. Prior to joining OSI, Jan served as the Director of the Yale University... Read More →

James Riddle

Senior Vice President, Global Review Operations, Advarra, United States

JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#287: ANVISA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-619-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator.

Chair

Cammilla Horta Gomes, MA, MPharm

Speaker

Panelist
Antonio Barra Torres, MD

Panelist
Patricia Oliveira Pereira Tagliari, LLM, MPH

Panelist
Bianca Zimon, LLM

Speakers

Antonio Barra Torres

President Director, ANVISA, Brazil

Cammilla Horta Gomes

LATAM Regulatory Policy Lead, Roche, Brazil

Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization... Read More →

Patricia Oliveira Pereira Tagliari

Associate Director, ANVISA, Brazil

Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#289: Post-COVID cGMP Inspections by Global Regulatory Authorities

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.

Learning Objectives

Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.

Chair

Lan Mu, PhD, RAC

Speaker

Industry Update
Karthik Iyer, MS

Panelist
Erica Franca Costa, RPh

Case Studies
Chiang Syin, PhD

Speakers

Lan Mu

Senior Vice President, Bio-Thera Solutions, United States

Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →

Erica Franca Costa

Health Regulation Specialist, ANVISA, Brazil

Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →

Karthik Iyer

Director, Global Quality, Merck & Co., Inc., United States

Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →

Chiang Syin

President, Meadows Biosolutions LLC, United States

Dr. Chiang Syin founded Meadows Biosolutions in 2021 and serves as its President. He retired from FDA in 2017 after 29 years of services including CBER, CDER and FDA China Office. He later joined WuXi Biologics as Chief Quality Office from 2018 to 2021 overseeing its Quality Department... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE

Patient Update
Regina Mariam Kamoga, MPA

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda

She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Regulator Perspectives
Level Intermediate
Feature Topics Risk Management,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-630-L04-P; CME 1.00; RN 1.00

The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.

Learning Objectives

Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.

Chair

Sabrina Girty, JD

Speaker

FDA Overview and Perspective on OCE Projects
Tamy Kim, PharmD

From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
Mark Stewart, PhD

Industry Case Study: Implementing OCE Projects in Drug Development
Vandana Pathak, MS, RAC

Speakers

Sabrina Girty

Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States

Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, her team secured global marketing authorizations... Read More →

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Vandana Pathak

Director Global Regulatory Affairs, Amgen, United States

Vandana Pathak, MS, RAC is a Director, Global Regulatory Affairs - Oncology at Amgen Inc. She leads global regulatory teams to drive global regulatory strategy and provides regulatory leadership to cross-functional teams to develop and execute global regulatory product strategies... Read More →

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States

Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives
Level Advanced
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-632-L04-P; CME 1.00; RN 1.00

Established in 2007, the Access Consortium brings together like-minded regulatory agencies to promote regulatory convergence and foster synergy to address scientific and regulatory issues. In this session, leaders from the Access Consortium will provide an update on achievements using work-sharing initiatives for timely medicines approvals for our populations, enabling industry to bring new, innovative products through Access pathways.

Learning Objectives

Discuss pathways and opportunities for industry to bring innovative products through Access; Describe new tools and methodologies to optimize regulatory collaboration under the Access Consortium to support access to medicines.

Chair

Pamela Aung-Thin

Speaker

Panelist
June Raine, MD, MSc, FRCP

Panelist
Anthony Lawler, MD, MBA

Panelist
Mimi May Ling Choong, DrMed, MD

Panelist
Jörg Schläpfer, PhD

Panelist
Eveline Trachsel

Speakers

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.

Mimi May Ling Choong

Chief Executive Officer, Health Sciences Authority (HSA), Singapore

Dr Choong was appointed as the Chief Executive Officer of the Health Sciences Authority (HSA) of Singapore on 1 July 2014. She oversees HSA’s wide-ranging public health responsibilities, comprising health products regulation, the national blood service, the national analytical and... Read More →

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

June Raine

Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of... Read More →

Jörg Schläpfer

Head of Management Services and International Affairs, Swissmedic, Switzerland

Dr. Jörg Schläpfer, PhD is the Head of Management Services & International Affairs and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine... Read More →

Eveline Trachsel

Head of Medicinal Product Authorisation and Vigilance, Swissmedic, Switzerland

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Regulatory Collaboration, Regulator Perspectives
Level Intermediate
Feature Topics Regulatory Collaboration,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

Learning Objectives

Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

Chair

Alison Cave, PhD

Speaker

From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
Sarah Vaughan

Patient Perspective
Christine Von Raesfeld

Industry Perspective
Gregory Powell, PharmD, MBA

Academic Perspective
Kathleen M. Giacomini, PhD

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Kathleen Giacomini

Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States

Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →

Christine Von Raesfeld

Founder/SME, Patient Experience, The Light Collective, United States

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Risk Management, Regulator Perspectives
Level Intermediate
Feature Topics Risk Management,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

Learning Objectives

Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

Chair

Yao-Yao Zhu, MD, PhD

Speaker

Panelist
Katherine A. High, MD

Panelist
Vaishali Popat, MD, MPH

Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD

Speakers

Yao-Yao Zhu

Regulatory Affairs Director, AstraZeneca, United States

Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →

Katherine High

Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States

Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →

Ke Liu

Chief Development Officer, Marengo Therapeutics, United States

As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →

Vaishali Popat

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States

Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum | 04: MedAffairs-SciComm, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Cell and Gene Therapy
Level Intermediate
Feature Topics Regulator Perspectives,Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

Learning Objectives

Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

Chair

Ethan Chen, MBA, MS, PMP

Speaker

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Nicole Mahoney, PhD

Speakers

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tala Fakhouri

Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#367: EMA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-667-L04-P; CME 1.00; RN 1.00

The European Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an Advanced Therapy Medicinal Product (ATMP).

Learning Objectives

Describe the assessment procedure and the role of CHMP and rappoteur; Describe platforms to support developers; Discuss a successful submission of an ATMP.

Chair

Steffen Thirstrup, MD, PhD

Speaker

Panelist
Sabine Haubenreisser, PhD, MSc

Panelist
Anabela Marcal, PharmD

Panelist
Evdokia Korakianiti, PhD, MSc

Speakers

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#363: Implementing Changes To Drug-Device Combination Products Globally

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-663-L04-P; CME 1.00; RN 1.00

Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.

Learning Objectives

Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, for management of post approval changes to combination products globally.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
Andrea Gray, PhD

Industry Perspective on the Latest ICH Q12 Training Module 8
Andrew Chang, PhD

Industry Perspective on Postmarket Changes to Combination Products: Global
Amy Wise, MBA

PMDA Update: Postmarket Changes to Combination Products in Japan
Keisuke Tanaka, PhD

Industry Perspective on Postmarket Changes to Combination Products: US
Lori-Anne Boville

Speakers

Chelsea O'Connell

Director, Global Regulatory and R&D Policy, Amgen, United States

Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →

Amy Wise

Associate Director, RA Device and Combination Products, AbbVie, United States

Amy Wise is an Associate Director Regulatory Affairs Device and Combination Products at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the... Read More →

Andrea Gray

Biomedical Engineer Advisor, CBER, FDA , United States

Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →

Keisuke Tanaka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Tanaka is Reviewer of the Office of Cellular and Tissue-based Products, PMDA. He received his Ph, D. from Osaka University in Bioorganic chemistry with emphasis in nucleic acid therapy. Since joining PMDA in 2021, he has worked in the Office of Cellular and Tissue-based Products... Read More →

Lori-Anne Boville

Group Director, Pharma Technical Regulatory, Device and Combination Products, Genentech, A Member of the Roche Group, United States

She is a Regulatory Affairs Expert in Biologics products, Medical Devices & Combination Products at Genentech. Lori has over 20 years of Biopharmaceutical product development, analytical testing, commercial quality, regulatory affairs and medical device experience. She has successfully... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

9:15am PDT

#415: EMA-FDA Question Time

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD
Katherine Tyner, PhD

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Adam C Fisher, PhD

Panelist
R. Angelo De Claro, MD

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Steffen Thirstrup, MD, PhD

Panelist
Francesco Pignatti, MD

Speakers

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Katherine Tyner

FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States

Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical... Read More →

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States

Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States

Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →

Adam Fisher

Director, Enterprise Project Staff, OQA, OPQ, CDER, FDA, United States

Adam Fisher, PhD., is the Director of Enterprise Project Staff in the Office of Pharmaceutical Quality and lead of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative at the U.S. FDA. He has been a primary and secondary reviewer of generic drug applications... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 14: DIAmond, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Regulatory Collaboration
Level Intermediate
Feature Topics Regulator Perspectives,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Forum

10:45am PDT

#416: FDA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-24-691-L04-P; CME 1.25; RN 1.25

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Kim Quaintance-Lunn

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Julia Tierney, JD

Panelist
Anindita Saha

Panelist
Tamy Kim, PharmD

Speakers

Kim Quaintance-Lunn

Vice President, Regulatory Affairs Americas, Bayer AG, United States

Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory... Read More →

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

Julia Tierney

Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States

JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Thursday June 20, 2024 10:45am - 12:00pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 14: DIAmond, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum