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Wednesday, June 17
 

10:15am EDT

#604: Counting the Cost: Translating Participant Burden into Fair Compensation
Wednesday June 17, 2026 10:15am - 11:30am EDT
108B
Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-599-L04-P; CME 1.25; RN 1.25

This interactive workshop moves beyond analysis to implementation—translating burden into cost and exploring fair compensation models to advance equity, access, and the participation experience

Learning Objectives

Examine how participant burdens translate into measurable costs and affect recruitment and retention; Apply fairness-based frameworks that align compensation with lived experience; Evaluate ethical, regulatory, and policy considerations to guide implementation models that improve equity and strengthen science through representative participation

Chair

Lani Hashimoto

Speaker

Panelist
Donna Libretti Cooke, JD

Panelist
Bernadette Tosti

Panelist
T.J. Sharpe, PMP

Panelist
Shay Webb


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
Donna Libretti Cooke, JD is Chief Impact Officer and Owner of ImpactSphere Clinical, LLC, advising pharma sponsors, CROs, and start-up vendors on participant payment strategy and clinical trial operations. She co-developed the Whole-Person Participant Support™ framework and led... Read More →
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States
T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →
BT

Bernadette Tosti

Partner, BGT Partners LLC, United States
Bernadette Tosti brings nearly 10 years of healthcare marketing, clinical trial recruitment and retention, and digital recruitment technology experience to her role at Quintiles. During her tenure at Quintiles, she has helped develop innovative technology solutions for recruitment... Read More →
SW

Shay Webb

Global Clinical Trials Operation, Emerging Talent Rotation, Merck & Co., Inc., United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Workshop

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25

In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.

Learning Objectives

Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials; Identify key factors driving burden in clinical trials; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.

Chair

Abigail Dirks, MS

Speaker

Panelist
Stephanie Christopher, MA

Panelist
Katrina Mateo, PHD, MPH


Speakers
avatar for Stephanie Christopher

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States
Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →
avatar for Abigail Dirks

Abigail Dirks

Senior Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →
avatar for Katrina Mateo

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States
Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

10:15am EDT

#601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets
Wednesday June 17, 2026 10:15am - 11:30am EDT
103A
Component Type: Session
Level: Advanced

This session takes participants inside the investor’s mind in today’s complex funding environment. Investors and financial leaders will discuss how they evaluate pipelines, platforms, and partnerships, where they look for differentiated deal flow, how valuation frameworks are changing, and what ultimately convinces them to lean in—or pass.

Learning Objectives

Explain how current biotech investors evaluate pipelines, platforms, and partnerships in today’s funding climate; Describe how valuation frameworks, risk appetite, and evidence expectations are evolving across stages and modalities; Identify what ultimately convinces investors to engage, lean in, or pass and how companies can position themselves accordingly.

Chair

Raju Kucherlapati

Speaker

Panelist
Jay Roberts, MBA

Panelist
Sahirzeeshan Ali

Panelist
Mey Boukenna, MD, PHD


Speakers
avatar for Sahirzeeshan Ali

Sahirzeeshan Ali

Founder and General Partner, Modi Ventures, United States
Sahir Ali is the founder of Modi Ventures, a venture capital firm at the forefront of investing in the convergence of biology and technology. With a focus on scientific superintelligence and the engineering of life, he has backed breakthrough companies advancing AI-driven drug discovery... Read More →
MB

Mey Boukenna

Partner, Life Sciences & Healthcare Investments, PagsGroup, United States
Mey Boukenna, M.D., Ph.D., leads Biotechnology and Healthcare Investments at PagsGroup, Steve Pagliuca’s family office. She transitioned to investments after starting her career in medicine and research at the University of Bern, Switzerland. There, she conducted a few years of... Read More →
avatar for Raju Kucherlapati

Raju Kucherlapati

Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School, United States
Since 2001 Dr. Kucherlapati is the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School and was the first Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG). He was a co-founder of several... Read More →
avatar for Jay Roberts

Jay Roberts

Partner, Ventac Partners, United States
Senior strategic executive in the biopharma industry for over 30 yrs. Serving as an Executive Advisor for Life365, a next generation AI platform connecting patients and providers. Also serves as a Partner with Ventac Partners, a global venture catalyst in life sciences and a Venture... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session |   18: Lift-Series, Session

10:15am EDT

#608: Can You Complete Your Submission in 10 Weeks?
Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB
Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-605-L04-P; CME 1.25; PDU 1.25 PMI 2166B0UIY1 ; RN 1.25

Drug development teams are being expected to deliver marketing applications in record time, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.

Learning Objectives

Recognize key factors that must be identified proactively to ensure creation of a submission timeline that is both expedited and feasible; Diagnose the critical path and rate-limiting components in the plan, and learn ways of mitigating the risks of those components; Demonstrate the ability to adjust to changes and embrace scenario-planning when faced with uncertainty.

Chair

Steve Sibley, MS

Speaker

Can You Complete Your Submission in 10 weeks!
Sharon Wolfe-Schwartz, MS


Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
SW

Sharon Wolfe-Schwartz

Executive Director, Regulatory Medical Writing, Harmony Biosciences Management, Inc., United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop |   08: RegPolicy-Strategy-GlobalCollaboration, Workshop |   04: MedAffairs-SciComm, Workshop

1:45pm EDT

#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-616-L04-P; CME 1.00; RN 1.00

Comprehensive benchmarking of four major LLMs across 100 FDA approval packages identifies optimal models for regulatory tasks. Study provides critical insights on accuracy, limitations, and implementation strategies for regulatory AI adoption.

Learning Objectives

Identify which LLM models demonstrated highest accuracy of generative AI for extracting critical regulatory data from FDA approval packages; Recognize key limitations and failure modes when using LLMs for regulatory intelligence, including hallucination rates and performance degradation patterns; Apply evidence-based benchmarking to select an LLM

Chair

Sam Kay, RAC

Speaker

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Cameron Kieffer, PHD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Jeff MacDonald, PHARMD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Aleksandr Merenkov


Speakers
avatar for skay8

skay8

VP of Pharmaceutical Strategy, Basil Systems, United States
Sam Kay is Vice President of Pharma at Basil Systems, where he leads AI-powered regulatory intelligence solutions for global pharmaceutical companies. A recognized authority in the field, Sam co-authored Chapter 6 of Regulatory Intelligence Reimagined (RAPS) and teaches Regulatory... Read More →
CK

Cameron Kieffer

Director, Global Regulatory Intelligence and Policy Research, Takeda, United States
avatar for Jeff MacDonald

Jeff MacDonald

Associate Director, Global Regulatory Policy and Intelligence, BeOne Medicines, United States
AM

Aleksandr Merenkov

Associate Director, Global Regulatory Intelligence, Genmab US, Inc., United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P; CME 1.00; RN 1.00

We’ll review the history, laws, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of pa

Learning Objectives

Describe the history of data sharing and the laws and policies that have informed it; Discuss the ethical considerations for shifting our mindset about data access permissions; Apply a patient-directed mindset to data access to unlock innovation and improve data utility

Chair

Karla Childers, MS

Speaker

Panelist
Mary Gray, PHD

Panelist
Aaron Leibtag

Panelist
Sarah Chamberlin


Speakers
avatar for Sarah Chamberlin

Sarah Chamberlin

Founder and Chief Program Officer, flok, United States
Sarah Chamberlin is Founder & Chief Program Officer of flok Health, a nonprofit advancing care and research for inherited metabolic disorders. She is a leader in patient-directed research and participatory data models, building community-powered data infrastructure that centers patient... Read More →
avatar for Karla Childers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States
Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →
avatar for Mary Gray

Mary Gray

Senior Principal Researcher, Microsoft Research, United States
Mary L. Gray is a Senior Principal Researcher at Microsoft Research and a leading scholar of the social and ethical dimensions of data-driven AI systems. Trained as an anthropologist, her research examines how digital infrastructures shape labor, identity, and human rights. She leads... Read More →
AL

Aaron Leibtag

CEO, Pentavere, Canada
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   02: ClinicalTrialOps-Innovation, Forum

1:45pm EDT

#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-619-L04-P; CME 1.00; RN 1.00

This session provides a framework and tools to adopt a business mindset, helping regulatory writing leaders and teams shift from document/submission execution to strategic influence.

Learning Objectives

Discuss building a business mindset; Identify practical methods to incorporate business thinking into day-to-day decision-making; Recognize how to apply frameworks to evaluate team influence and cross-functional collaboration.

Chair

Robin Whitsell

Speaker

Panelist
Tatyana Wanderer, PHD

Panelist
Angela Russell Winnier, PHD


Speakers
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTD, Moderna, United States
With over 10 years of experience in the pharmaceutical industry, Dr. Wanderer brings innovative thinking and lean process-focused approach. As the Head of Medical Writing at Syros Pharmaceuticals, Tatyana leverages experience in both biotech/pharma side and the vendor side. On the... Read More →
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTTD, Moderna, United States
Tatyana Wanderer, PhD, is Head of Medical Writing and Clinical Trial Transparency & Disclosure at Moderna, where she leads global teams focused on delivering high-quality clinical documentation and advancing transparency. With nearly two decades of experience across regulatory writing... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
avatar for Angela Winnier

Angela Winnier

Executive Director of Medical Writing, Pfizer, United States
Angela Winnier joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Advanced
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
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