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Exhibit Hall Theater #1 [clear filter]
Monday, June 17
 

10:15am PDT

#101 IT: Taimei Technology Innovation Theater: Next-Gen Trials Platform: AI-Native, Collaboration-First, and Site Network
Component Type: Session

AI-Driven Study Building: Experience the revolution in EDC database creation with AI, streamlining study building efficiency. Strategic Orchestration: Explore Trials Brain, a system comprehending project strategies and orchestrating resources for trial management. Collaboration: Explore next-gen trials tech, merging Virtual Site Network (VSN), Remote Monitoring Network (RMN), and Participant Recruitment Network (PRN) for seamless communication, fostering innovation in clinical research.

Chair

Taimei Technology, Inc.

Speaker

Speaker
Shou Yuan

Speaker
Gary Ma


Speakers
avatar for Taimei Technology, Inc.
avatar for Shou Yuan

Shou Yuan

Product Innovation and Global Operations Representative, Taimei Technology Inc., United States
Over 10 years of extensive experience in clinical project and system management Successfully completed 40+ projects in System R&D, DM, and Solution Delivery Specialization in EDC, IWRS, eCOA, CTMS, eTMF, system integration, and migration Proven leadership as a Data Management and... Read More →
avatar for Gary Ma

Gary Ma

SVP, CPO of Taimei Group, General Manager of Overseas BU, Taimei Technology Inc., United States
Gary Ma, with over 10 years of experience in the biopharmaceutical industry, currently serves as the SVP, Chief Product Officer, and Head of the Overseas BU at Taimei Technology. Before joining Taimei, he worked at both sponsor and CRO companies, including Hengrui Pharmaceuticals... Read More →

Monday June 17, 2024 10:15am - 10:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:15pm PDT

#119 IT: RWS Innovation Theater: Accelerate Time-to-Market with Smart, Structured Content, Reuse, and AI
Component Type: Session

Accelerate time-to-market is getting more and more important to our customers in pharma and life sciences. With structured content, we see benefits in the areas of efficiency, speed and consistency. During this session, we will share the benefits that our launching customers experience with the Fonto Integrated Authoring Platform. How AI, structured data and smart reuse contribute to time-to-market acceleration and an increase in efficiency, speed and consistency.

Chair

RWS

Speaker

Speaker
Jan Benedictus, MS, MSc


Speakers
avatar for Jan Benedictus

Jan Benedictus

Managing Director, Fonto, RWS, Netherlands
Jan Benedictus is founder and managing director of Fonto - a user-friendly authoring tool for structured content. Fonto is widely used in content-intense industries such as Publishing, Aviation, Technical Documentation, and increasingly in Pharma and Life Sciences. Jan is actively... Read More →
avatar for RWS

RWS

United States

Monday June 17, 2024 12:15pm - 12:45pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:55pm PDT

#123 IT: IQVIA Innovation Theater: Evolving Clinical Development Approach Amidst a Digital Transformation Wave
Component Type: Session

The rapid transformation of digital edge technologies is fundamentally shifting the solution experience for trial participants, sites, sponsors and clinical research teams. In this presentation, we will share a vision for the future of clinical development processes, that can leverage and drive value generation by maximizing benefits of the ongoing digital transformation wave.

Chair

IQVIA

Speaker

Speaker
Rajneesh Patil, DDS, MBA

Speaker
George Wu


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Rajneesh Patil

Rajneesh Patil

Vice President, Clinical Operations, IQVIA, United States
Rajneesh serves Clinical Operations at IQVIA as Head of Digital Strategy and Analytics Innovation. He is a gold medalist in Dental Surgery from India with Foundations in Public health from Australia and Digital Strategy-Executive from Harvard Business School, USA. At IQVIA, he leads... Read More →
avatar for George Wu

George Wu

Director, Biostatistics, Gilead, United States
George Wu is a Statistical Advisor in Biostatistics at Gilead. He is passionate about developing innovative approaches to improve drug development using his clinical trial experience and statistical expertise. He works on cross-functional initiatives ranging from innovative trial... Read More →

Monday June 17, 2024 12:55pm - 1:25pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:35pm PDT

#127 IT: Deloitte Innovation Theater: Turning Vision into Reality - Realizing the Promise of Next-Gen Regulatory Intelligence
Component Type: Session

Regulatory Affairs has always had the potential to transform into an insights-driven function capable of enhancing operations and accelerating the approval process. And now, advanced technologies and AI have exponentially accelerated this transformation. How can the regulatory function best help drive your organization toward a future state? Discover real-life solutions and future possibilities enabled by Regulatory Intelligence during this Q&A-style session.

Chair

Deloitte

Speaker

Speaker
Mukesh Singhal, MBA

Speaker
Camille Chicklis


Speakers
avatar for Camille Chicklis

Camille Chicklis

AI Strategy & Delivery Lead, Deloitte, United States
Camille Chicklis is an Artificial Intelligence Leader in Deloitte's Life Sciences & Health Care practice. She spearheads AI strategy and has extensive experience in productionizing AI solutions, connecting business and technical objectives to help organizations realize the true value... Read More →
avatar for Deloitte

Deloitte

United States
avatar for Mukesh Singhal

Mukesh Singhal

Partner, Deloitte, United States
Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry... Read More →

Monday June 17, 2024 1:35pm - 2:05pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

4:45pm PDT

#158 IT: InSilicoTrials Technologies Innovation Theater: Are Human Patients Needed for Clinical Trials, Tomorrow?
Component Type: Session

Chart your new horizons by pioneering on the edge of Gen AI-powered In Silico Data Modeling. Proven case studies will be shared in a panel session from regulatory, sponsor and CRO perspectives. Learn how InSilicoTrials has enhanced drug dosing, trial performance, and patient safety across targeted populations. Discover significant reductions in time and costs—achieving up to a 90% efficiency in specific R&D activities—while upholding the highest standards of patient safety.

Don't miss the chance to receive an autographed complimentary copy of the publication "Toward Good Simulation Practice," co-authored by our CEO, Luca Emili, with the contribution of 13+ FDA leaders. This book is a cornerstone in promoting reliable and efficient In Silico Trials solutions, reflecting a major stride in medical research and development.

Chair

InSilicoTrials

Speakers
I

Monday June 17, 2024 4:45pm - 5:15pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session
 
Tuesday, June 18
 

9:15am PDT

#215 IT: Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities
Component Type: Session

AI can help optimize operations, strengthen patient privacy, and improve data quality while reducing risks of human error in clinical trials. However, AI must be used responsibly and governed by the highest ethical principles with regard for data privacy and reducing bias in algorithm performance. Delve into the transformative role of AI in clinical trials: current industry status, common misconceptions, proactively tackling bias and navigating the evolving regulatory landscape.

Chair

Clario

Speaker

Speaker
Todd Rudo, MD

Speaker
Gaurav Josan

Speaker
Lauren Misztal

Speaker
Brian Dolan


Speakers
avatar for Clario

Clario

United States
avatar for Gaurav Josan

Gaurav Josan

Senior Vice President, R&D, Clario, United States
Gaurav Josan leads the R&D team at Clario as Sr. Vice President focused on innovation and next generation technology solutions including AI capabilities. She has more than 2 decades of experience working in the Clinical Trials space leading strategic technology initiatives. She is... Read More →
avatar for Lauren Misztal

Lauren Misztal

SVP, General Counsel, Clario, United States
Lauren is a business-oriented and solutions-driven legal advisor who draws on close to two decades of experience successfully resolving complex legal and regulatory issues. As Clario’s General Counsel, Lauren focuses on setting the Company’s global legal strategy and leads teams... Read More →
avatar for Todd Rudo

Todd Rudo

EVP & Chief Medical Officer, Clario, United States
Dr. Rudo provides medical and scientific leadership at Clario. He is passionate about leveraging scientific resources to support customer success with focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting on scientific and... Read More →
avatar for Brian Dolan

Brian Dolan

Vice President Artificial Intelligence and Machine Learning, Fortrea, United States
Brian is a mathematician, inventor and cyberneticist with decades of experience building enterprise grade artificial intelligence products. Equally comfortable in product, sales and technology roles, he excels at translating complex business problems into tractable mathematical solutions... Read More →

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#235 IT: Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving?
Component Type: Session

Technologies such as AI, automation and GenAI have the capability to transform the Safety function. But adoption has been uneven so far. Dive into the issues and explore the “why” behind barriers to adoption. Discover where early adoption pioneers stand now and join a Q&A around what it will take to really move the needle on transformation in Safety.

Chair

Deloitte

Speaker

Speaker
Amanda Bowles, MS

Speaker
Kelly Traverso


Speakers
avatar for Amanda Kirby Bowles

Amanda Kirby Bowles

Managing Director, Deloitte, United States
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... Read More →
avatar for Deloitte

Deloitte

United States
avatar for Kelly Traverso

Kelly Traverso

R&D Business Development, Deloitte, United States
Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design... Read More →

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:55am PDT

#238 IT: IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload
Component Type: Session

With too many systems and not enough staff, research sites are turning down studies they find unworkable. How can we get the clinical trial ecosystem in balance so that everyone benefits, most importantly patients in need?

In this panel, leaders across the ecosystem will discuss viable strategies to make a real impact on site tech overload. Learn about One Home for Sites, an initiative that’s bringing the industry together to increase clinical trial capacity and help all stakeholders succeed.

Chair

IQVIA Technologies

Speaker

Speaker
Gareth Dabbs

Speaker
Michael Rosenblatt

Speaker
Aruna Adhikari-Thapa

Speaker
Brad Hightower

Speaker
Erik Johs


Speakers
avatar for IQVIA Technologies

IQVIA Technologies

United States
avatar for Gareth Dabbs

Gareth Dabbs

Vice President, Global Product Strategy, IQVIA, United States
avatar for Aruna Adhikari-Thapa

Aruna Adhikari-Thapa

Senior Director, Product Strategy, IQVIA Technologies, United States
Aruna Adhikari-Thapa is a seasoned technology strategist with 20+ years of experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges... Read More →
avatar for Brad Hightower

Brad Hightower

Chief Executive Officer, Hightower Clinical, United States
Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast — a... Read More →
avatar for Michael Rosenblatt

Michael Rosenblatt

Managing Director, Greenhouse Consulting, United States
avatar for Erik Johs

Erik Johs

Vice President, Platform Engineering, Medidata Solutions, United States
Erik Johs is the Vice President of Platform Engineering at Medidata Solutions. With over 15 years of hands-on experience, he has honed his expertise in scalable infrastructure, cloud-native architectures, and DevOps practices. Erik’s leadership is marked by a relentless focus on... Read More →

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:35pm PDT

#241.1 IT: Flatiron Health Innovation Theater: The Time is Now - Pragmatic Approaches to Prospective Evidence Generation
Component Type: Session

Flatiron Health and the Clinical Trials Transformation Initiative (CTTI) share a bold vision for a more streamlined approach to running clinical trials. Critical to this vision is developing trials that are patient-centered, integrated into current healthcare processes, and maximally leveraging all available data, among other imperatives. Join us for a practical discussion around how to implement these streamlined practices into your trials through a combination of data, technology, and services.

Chair

Flatiron Health

Speaker

Presenter
Sara Bristol Calvert, PharmD

Presenter
Joshua Buddle


Speakers
JB

Joshua Buddle

Director, Clinical Operations, Flatiron Health, United States
avatar for Sara Calvert

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 →
avatar for Flatiron Health

Flatiron Health

United States

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

2:30pm PDT

#260 IT: Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1…
Component Type: Session

Pre-screening trial participants is tough when you don’t have access to full medical records. Instead, collect a HIPAA authorization and let Milliman IntelliScript retrieve and interpret prescription and medical data. Just upload name, zip, and DOB to access our proprietary data on most US residents. Filter by customizable inclusion and exclusion criteria in seconds for easier, more accurate pre-screening. Randomize more participants, realize more revenue, and push more trials to completion.

Chair

Milliman IntelliScript

Speaker

Speaker
Alyssa Vincze


Speakers
avatar for Milliman IntelliScript
avatar for Alyssa Vincze

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript
Alyssa is an actuary serving as Principal and Director of R&D with Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She recently led product development for IntelliScript’s clinical trials solution, adapting... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session
 
Wednesday, June 19
 

9:15am PDT

#314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials
Component Type: Session

This session on Pre-Approval Access (PAA) will address key considerations and challenges for provision of investigational products to patients outside of clinical trials, and before these therapies are approved by regulators. We will focus on key decisions and success factors for organizations to consider when developing their company’s philosophy on this type of access. We will also highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs.

Chair

IQVIA

Speaker

Speaker
Barbara Isquith Arone, MS

Speaker
Ana Tediosi


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Barbara Isquith Arone

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
avatar for Ana Tediosi

Ana Tediosi

Head of Expanded Access Strategy, WEP Clinical, United Kingdom
With over 10 years of experience in the pharmaceutical industry, Ana is a recognized expert in the field of Expanded Access Programs (EAP). Her expertise lies in oncology, hematology, Rare Diseases, and she has held various roles in the big Pharma (BMS, Roche, Menarini-Stemline... Read More →

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#331.1 IT: Syneos Health Innovation Theater: From Formula One to Fortnite - Clinical Trials Fast-Track to Innovation
Component Type: Session

The world’s fastest time series database and analytics engine, and video game-style trainings are accelerating clinical trial efficiency, reducing costs, enhancing CRA performance, and speeding time to market in life-changing therapies. Learn how these technologies are being applied today to optimize site selection, predict enrollment rates, reduce environmental impact and identify trial risks earlier, and how future use cases will tackle patient selection and predicting drug efficacy.

Chair

Syneos Health

Speaker

Speaker
Bob Zambon, PhD

Speaker
Greg Christie


Speakers
avatar for Paula Bain

Paula Bain

President of Clinical Delivery Services, Syneos Health, United States
Leading Clinical Delivery Services, Ms. Bain oversees Biometrics, Global Regulatory Affairs Solutions, Regulatory Intelligence and Medical Writing at Syneos Health. She has more than 35 years of clinical development experience, with a passion for science and creating integrated technology... Read More →
avatar for Greg Christie

Greg Christie

Chief Product Officer, StudyKIK, a Syneos Health Company, United States
Greg Christie is a leader in human-centered product development and design, earning accolades for contributions to clinical research technology such as a SCOPE Award, a nomination for the Prix Galien UK 2023 Award for StudyKIK’s apps and a 2023 PM360 ELITE 100 Award in the Tech-Know... Read More →
avatar for Syneos Health

Syneos Health

United States
avatar for Bob Zambon

Bob Zambon

Vice President, Technology Strategy and Strategic Partnerships, Syneos Health, United States
Dr. Zambon is VP, Technology Strategy & Strategic Partnerships at Syneos Health. He leads the development and operationalization of strategic solutions for clients to help address their key R&D and commercial needs by integrating data, technology, analytics, and various partnerships... Read More →

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

2:30pm PDT

#358.1 IT: DIA Innovation Theater: The 2024 DIA Science Priorities - Inspired by the Original Olympic Games Motto "Faster, Higher, Stronger"
Component Type: Session

Discussion of the new DIA Science Priorities and our approach for establishing new avenues for collaborative research and regulatory harmonization through information sharing and multi-stakeholder consensus building, with patients in the center of our agenda.

Chair

Maria Vassileva, PhD

Speaker

Speaker
Chockalingam Palaniappan, PhD


Speakers
avatar for Chockalingam Palaniappan

Chockalingam Palaniappan

Life Sciences Innovation Executive, United States
Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare... Read More →
avatar for Maria Vassileva

Maria Vassileva

Global Head of Science and Scientific Strategy, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session
 
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USS Midway
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • Featured Topics
  • Artificial Intelligence (AI)
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Ethics
  • ICH
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Reliance
  • Risk Management
  • Special Populations
  • Student Programming