DIA 2024 Global Annual Meeting

Fun and spunky Regulatory Nurse Specialist AND Regulatory Project Manager with 15+ years of clinical research experience with NIH and FDA. Specialties include ICU, stem cell transplant, malignant hematology, multiple myeloma. And I like dogs and my vacations usually involve scuba diving.

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide... Read more

Linda C. Akunne is a Chief, Project Management Staff in the Division of Regulatory Operations for Infection Diseases in CDER's Office of New Drugs. In this role, Linda provides technical direction, oversight, and leadership to the DROID staff on the drug review process for antiviral products from pre-clinical to withdrawal from market. Prior to joining the FDA, Linda was a Research Associate at the Forum for Collaborative Research, where she worked on several infectious disease research projects and initiatives. She received her graduate training in health policy from the George Washington University... Read more

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 and device review offices in PMDA. Also she works for Office of Regulatory Science Coordination, the office which is responsible for the electronic study data submission in the PMDA. She is a member of Real World Data Working Group and Global Clinical Study Working Group that are projects across multi-offices in the... Read more

Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the protection and assurance of the rights and welfare of human research subjects. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is board certified in Pediatrics and Infectious Disease. Dr. Ayalew also works at Urgent Care where he provides clinical services to both pediatrics and adult... Read more

I am a Life Sciences industry veteran with 30+ years-experience in the development and successful commercialization of bio/pharmaceuticals as well as combination products. A person whose experience includes clinical development, regulatory affairs, go-to-market strategy/operations and product lifecycle management.
I consider myself to be an ethical and highly respected leader. Having a track record in multiple organizations of leading scientific teams to collaborate in development and eventual regulatory approval of nearing 100 applications worldwide, e.g., A/NDAs, 505(b)2, PAS, IND, etc.
After... Read more

I lead the UAT services delivery team at Poxy Clinical, which provides strategic and tactical support for UAT of IRT systems. By myself and my team have guided the continued success of 100+ clinical trials by ensuring their component IRT systems are fit for purpose.
My multi-disciplinary experiences in technical management, quality assurance, and engineering principles have enabled Poxy Clinical to continuously improve the UAT experience for vendors and sponsors.
I holds a BS in Chemical Engineering from Missouri University of Science and Technology and an MS in Technical Entrepreneurship and Ma... Read more

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of... Read more

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 of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Leader of a department with 30+ CMC Regulatory professionals located throughout North America and India.
Maintains knowledge of global pharmaceutical CMC regulations and guidance documents pertaining to products in clinical development through post marketing applications. 

With over 16 years of experience as the President and Founder of Vantage BioTrials, I lead an award-winning Canadian CRO that delivers high-quality clinical trial management services to international clients in the pharmaceutical, biotechnology, and medical device sectors. I have a strong drug development knowledge, gained from more than 24 years of industry experience, that enables me to provide innovative and cost-effective solutions for various phases and therapeutic areas of clinical research.

I am passionate about advancing the life sciences sector in Canada and globally, and I contribute my expertise and insights as an advisor, speaker, trainer, and lecturer for various organizations and institutions. I have received recognition and awards for my excellence, entrepreneurship, and social responsibility, such as the Emerging Pharma Leader, the Biotechnology CRO of the Year, and the Top 50 under 50 Who are Shaping Tomorrow. My mission is to continue to grow Vantage BioTrials as a trusted partner for clinical research and to make a positive impact on the health and well-being of people aroun... Read more

In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical team in the rare cardiovascular therapeutic area. Lynn is a transformative leader with proven excellence in building & developing high performing teams. Along with her leadership positions, Lynn is very active in growing/expanding the MSL profession across the industry and is a frequent invited speaker. She has also authored... Read more

Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in the Temple University RAQA graduate program since 1998. Linda attained Regulatory Affairs Certification for the US, Canada and Europe and was inducted into the 2011 Class of RAPS Fellows. Linda was honored with the RAPS 2020 Founder's Award and the DIA 2012, 2019, and 2022 Excellence in Volunteer Leadership Awards. She... Read more

Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global business process design and harmonization, global safety operating models, and benchmarking. In addition to a strong history of compliance and efficiency improvements, she has also led the delivery and realization of AI-enabled cognitive automation of adverse event case processing through ConvergeHEALTH Safety at multiple... Read more

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 benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80... Read more

Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years of experience in Human Resources, Finance and Accounting in Fortune 500 companies. Her extensive and diverse background, in the corporate world, as an entrepreneur and board member, provides her a realistic grounding in the opportunities and challenges facing individuals in corporate and community. Tywnia is a very... Read more

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC). He also is the working group co-coordinator for the NIH Common Fund program on Somatic Cell Genome Editing, one of the leaders of the Platform Vector Gene Therapy (PaVe-GT) pilot project and the co-chair of the Bespoke Gene Therapy Consortium.

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and Nuvelo. Dr. Buchanan next served at BioSoteria as the head of the medical and safety consulting group. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group Interactive Safety Graphics... Read more

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 trial approaches. Prior to his current roles, from May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed. He is also adjunct faculty at the George Washington University in the... Read more

Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 10 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of the Drug Information Association (DIA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Prior to joining CIRS, Magda carried out research spanning scientific, engineering and policy issues regarding the development of medicines. She received her Master of... Read more

Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 80 publications and two industry textbooks on ePRO. Bill serves on 2 ISPOR task forces, the C-Path working group on CHF, the DIA's working group on meaningful change, and is a member of the C-Path eCOA Consortium where he previously served as Industry Vice Director. Bill is an advisory board member of the LABDA research program on sensor-derived movement behavior analysis, and a Senior Visiting Professor within Nottingham... Read more

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 Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute. He has had a long and distinguished career as a physician, researcher... Read more

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously a reviewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is in patient-focused drug development and the use of patient experience data in the regulatory setting.

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 global annual conferences from 2019 to 2023. At his current capacity as a VP, Quality and Regulatory Compliance, Global Regulatory Affairs, Novo Nordisk, Inc., he provides strategic leadership on Regulatory and Quality related Policy, External Affairs, strategic advice and solutions to quality and regulatory related... Read more

Dr. Wendy Charles has been involved in clinical trials from every perspective for nearly 30 years with a strong background in operations and compliance of digital health technologies. She currently serves as Chief Scientific Officer for BurstIQ, a health IT company specializing in blockchain and AI. She is also an adjunct faculty member in the Health Administration program at the University of Colorado, Denver and in two departments at the University of Denver. Dr. Charles augments her blockchain healthcare experience by serving on the EU Blockchain Advisory Panel, Government Blockchain Association... Read more

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 Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

Joan Cheung received her Doctor of Pharmacy degree from St. John's University and has been recognized by her colleagues in developing a labeling solution with a Product Excellence Award in 2022. She leverages her pharmacy background and technical acumen as a Business Analyst and Project Manager in Regulatory Operations and Regulatory Information Management. With over five years of experience in pharmacy and the life sciences industry, Joan supports clients in system implementations from requirements gathering, process mapping, governance documentation updates, to validation activities. Outside... Read more

Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead the Life Sciences strategy and solutions approach to creating value for patients. Prior to ServiceNow Evi was VP Global Life Science & Healthcare at Appian, VP Global Innovation at Catalent and held roles in Legal Affairs, R&D, Clinical Operations, Quality, CSV, Regulatory Affairs, and Program Management. He holds... Read more

Mitch oversees Adaptive Clinical’s key partnerships and serves as lead contact for sales and business development. Mitch’s background includes general management, marketing and sales/business development. He has been a Business Advisor on digital health for the Philadelphia Science Center, and an Entrepreneur in Residence for the Science Center’s Phase I Ventures program. Mitch has an undergraduate degree from UC Berkeley and an MBA from Harvard University. Mitch brings a wealth of healthcare and technology knowledge alongside his hands-on experience of building long-term and meaningful...

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 skills to bridge gaps between scientists, medical providers, payers, governments, and patients. Deborah has vast research experience in translational, clinical, epidemiology, health outcomes, and health delivery fields while working with academia, federal agencies, companies, non-profits, and patient communities...

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 support the development and approval of safe and effective COVID-19 vaccines and treatments.” Doing precisely that has since earned her various accolades including an Honorary Doctorate for outstanding contribution to healthcare (RCSI - 2023) and the ‘European of the Year 2022’ title by European Movement Ireland...

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 Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI/IHI, and passionate about paediatric drug development, rare/ultra-rare diseases and drug development optimisation.

I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics and Statistics at the University of Strathclyde, Glasgow. During this time I ran the statistical consultancy unit for the Department. Before that I studied for a PhD in Mathematics and Statistics at Department of Mathematics and Statistics at the University of Strathclyde, Glasgow.

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, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public... Read more

Hello! I am CEO and founder of Clinically Media, an award-winning full-service agency specializing in patient recruitment in clinical trials. Ask me what my favorite patient recruitment method is.

Dr. James (Jay) Duhig, Ph.D., is Global Head of the Office of Health Literacy for AbbVie. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional materials for patients and healthcare professionals. Dr. Duhig works with physicians, nurses, pharmacists, engineers, and others in the evaluation of multiple sources of pre-market and post-marketing safety data. He is a passionate advocate for the use health literacy to problem-solve the needs of patients not just at the hospital and... Read more

Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much convinced that digital innovation and patient engagement are the key success factors in the drug development phase and will impact positively the medicinal product lifecycle. Thierry acts as a Strategic Leader for the Pistoia Alliance, a global, not-for-profit members’ organization collaborating to lower barriers to...

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 submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme... Read more

After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. As Senior Partner and CEO, she continues to bring her enthusiasm and experience to client projects. She has twice been President of the European Medical Writers Association (EMWA), is an experienced trainer of medical writers, and runs workshops for EMWA, AMWA, DIA, and pharma companies around the world.

I have over 30 years of experience in the pharmaceutical and other regulated products industry (pre- and post-approval) as a chemistry, manufacturing, and controls (CMC) and clinical Regulatory Affairs Professional.
As an Associate Director, Regulatory Writing, I have written various CMC and clinical regulatory documents. I have experience in documentation preparation for pre-regulatory meeting briefing documents, Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), New Drug Applications (NDAs), and Marketing Authorisation Applications (MAAs) for large and small molecules with emphasis on regulations and electronic Common Technical Document (eCTD) requirements. I also have experience in writing Clinical Study Protocols (CSPs) and amendments, Investigator’s Brochures... Read more

David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization. David has held a number of senior positions leading quality along the continuum of research, development, manufacturing, and distribution at AbbVie and Lilly. David earned his M.S. at Butler University College of Pharmacy and Health Sciences, Indianapolis where he majored in Pharmaceutics.

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 of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he... Read more

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s... Read more

Dr. Richard Gliklich is the CEO of OM1, Inc., a real-world data, outcomes and technology company focused on using data and AI to accelerate medical research and personalize medicine, especially in chronic conditions. OM1 develops extensive data networks of participating practices, centers and other partners in immunology, rheumatology, dermatology, cardiometabolic, respiratory, and CNS/behavioral health disorders. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and a former... Read more

Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.

Renmeet is a Division Director in the Office of Regulatory Operations within the Center of Drug Evaluation and Research in the Office of New Drugs. She develops policies and procedures and provides leadership for regulatory activities of the review and evaluation of New Drug applications (NDAs) and Biologics License Applications (BLAs), amendments and supplements to determine if drugs are safe and effective. She provides the appropriate guidance for review activities that are highly complex, challenging and possibly policy-setting in their regulatory nature.

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 positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition... Read more

Jonathan Helfgott is an FDA regulatory, clinical, and market access expert, specializing in medical products’ commercialization. He has overseen global clinical research & regulatory activities such as product development, approvals, clinical trial design & communications with health authorities. From 2006-2015, Jonathan worked at the FDA, most recently as Associate Director for Risk Science. He is Faculty, Senior Lecturer, and Coordinator for MS in Regulatory Science at Johns Hopkins University.

I'm currently the Director of Outreach, Engagement and Communications at Count Me In (CMI), a direct-to-patient cancer research initiative at the Broad Institute of MIT and Harvard, and I lead the development of comprehensive outreach strategies to effectively engage and communicate with patients and partners within the cancer communities that CMI is leading cancer research studies in. 

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 Human Research Protection Program and the Director, University of Michigan Institutional Review Board. Jan has also served as a Senior Grants and Contracts Officer at Georgetown University, and as Supervisor of Research Operations at the Lombardi Cancer Center. Trained as a registered nurse in her native Australia... Read more

Li Huang is a principal biostatistician in PHASTAR since 2020. She received Doctor of Dental Surgery (DDS) from Hubei Medical University (China), Master of Science in Dentistry from National University of Singapore (NUS), and Master of Science in Applied Statistics from California State University, Long Beach (CSULB). She has worked in projects related to genetics, clinical trial and real-word evidence data studies for more than ten years at UC Irvine and pharmaceutical companies. She published six papers in the past six years related with oncological clinical trial using survival analysis, cumulative... Read more

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 well as an influential pioneer in Patient Engagement. In Stacy's role as Chief Patient Officer, she commands a seat at the table on behalf of patients and caregivers to examine and reduce patient burden thus increasing participation and retention along the clinical trial patient odyssey. Stacy was named to the 2023 "Fierce... Read more

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training, and industry outreach. She is co-Chair of the FDA Data Standards Advisory Board and FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She developed CDER’s electronic submissions... Read more

Subject Matter Expert with passion for topics such as real world evidence, patient centricity and application of advance analytics/machine learning throughout the life sciences value chain

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications as a Quality Engineer and in Six Sigma. He is Chair of DIA's GCP-QA Community, on the Core Committee for NJ CDISC User Group, and former Chair of Statistical Taskforce for the Animal Health Institute. Terry recently... Read more

Aman Khera has earned her nickname: Rebel Regulator, a clinical research professional, with nearly 3 decades of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry, Aman looks at how regulatory, strategy and innovation are intersecting within healthcare. She is a 2021 PharmaVOICE 100 honoree, recognized as one of the most influential and inspiring people in the life sciences industry. An advisor, board member and mentor in industry, most importantly as a family member of the care... Read more

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 under the OCE across CDER, CBER and CDRH, including for Accelerated approval, breakthrough therapies, safety, expanded access, diversity in clinical trials, expedited reviews (Real-time oncology review (RTOR)), etc.

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Technology and domain experts, we are dedicated to ensuring governance and data integrity for regulated life science and healthcare organizations. Our innovative solutions drive operational efficiencies and mitigate risks across entire data workflows, optimizing and controlling existing clinical development workflows, as well as empowering sponsors to utilize real-world data and AI with confidence in regulatory submissions.

Our solutions leverage cryptographic certifications that forms an authenticated and interoperable data fabric over any workflow. By partnering with global platforms, RWD, and AI model providers, we deliver regulators undeniable proof of data quality and adherence to responsible processes at every stage—from data capture and programming to analysis and the use of AI or automated processes... Read more

Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the PhRMA BRAT Framework, the MDIC Patient-Centered B-R Framework, the IMI PREFER public-private partnership and ISPOR's Quantitative B-R Task Force. He serves on committees that inform B-R policy including MDIC's Science of Patient Input Project, the Brighton Collaboration BRAVATO Team and PhRMA's Patient-Focused... Read more