DIA 2026 Global Annual Meeting: Full Schedule

11:00am EDT

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

Monday June 15, 2026 11:00am - 12:15pm EDT

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P; CME 1.25; RN 1.25

Clinical Operations leaders today are navigating one of the most dynamic periods in recent history. From managing AI-driven transformation to rethinking global outsourcing models and rebuilding teams in a post-layoff landscape, the challenges facing clinical operations executives are unprecedented — and so are the opportunities. This session brings together senior leaders from large, mid-size, and emerging biopharma companies for an unscripted fireside conversation exploring how the role of Clinical Operations has evolved over the past decade and where it’s heading next. Panelists will share candid insights on leading change, balancing innovation with execution, and maintaining resilience in the face of shifting talent models and regulatory expectations.

Learning Objectives

Discuss current trends, pressures, and innovations shaping Clinical Operations directly from industry leaders; Recognize operational strategies using benchmark data through real-world examples of how organizations are adapting their models, technologies, and teams; Identify emerging roles, skill requirements, and leadership priorities within the evolving ClinOps landscape to guide personal career planning and organizational development.

Chair

Joseph Dustin

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Nikki Amaratunge, MA, PMP

Panelist
Rosalie Filing

Panelist
Emily Walker, MBA

Speakers

Joe Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →

Joseph Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Rosalie Filing

Vice President, Clinical Operations, Keenova Therapeutics, United States

Nikki Amaratunge, MA, PMP

Director Clinical Operations, Allergan, United States

Jennifer Sheller

Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc., United States

Jennifer Sheller is Senior Vice President and Head of Global Clinical Trial Operations at Merck, where she leads the global infrastructure responsible for the operational delivery of Merck’s clinical development portfolio. With more than 25 years of experience across pharma, biotech... Read More →

Emily Walker

Vice President, Study Management, Alnylam, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Project Management & Strategic Planning
Tags Session

11:00am EDT

#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical

Monday June 15, 2026 11:00am - 12:15pm EDT

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-517-L04-P; CME 1.25; PDU 1.25 PMI 216647VJP8; RN 1.25

What if every investment were assessed for impact - before committing resources? As portfolio decisions in R&D and Medical Affairs are becoming increasingly complex, leadership teams often struggle to link individual projects to overall portfolio performance. This makes it difficult to clearly articulate portfolio potential, compare alternative portfolio configurations, or understand the portfolio-level impact of adding, re-prioritizing, or stopping initiatives. This interactive workshop explores whether and how an impact-driven portfolio approach, using the efficient frontier as a practical example, can help bridge this gap and support more effective management decision-making. Through hands-on exercises and facilitated discussion, participants will work with realistic portfolio scenarios to visualize portfolio performance and examine how individual initiatives contribute to overall portfolio value. Participants will test different portfolio scenarios, discuss trade-offs, and explore how project-level decisions shift portfolio-level performance. Rather than optimizing projects in isolation, the workshop focuses on using the efficient frontier to enable management-ready conversations that explicitly connect project choices to portfolio impact, risk, and strategic alignment. The workshop also examines the evolving role of project and portfolio managers as strategic impact managers, supporting leadership teams by creating portfolio transparency, enabling informed trade-offs, and driving value realization across R&D and Medical portfolios. The session is designed for Medical and R&D leaders seeking to strengthen strategic decision-making, improve transparency, and elevate portfolio management to impact stewardship.

Learning Objectives

Explain how the efficient frontier clarifies portfolio performance and supports leadership discussions portfolio-level impact and value; Analyze how individual initiatives change portfolio performance by using the efficient frontier to simulate adding, re-prioritizing, or stopping projects and assessing each decision by its portfolio-level effect; Discuss ways portfolio managers are evolving into strategic impact leaders.

Chair

Robin Boss, MS

Speaker

Panelist
Jill Orosz

Speakers

Robin Boss

VP, Business Transformation, Campana & Schott, United States

Robin Boss is Vice President of Business Transformation Consulting at Campana & Schott, where he leads a U.S. team working with Life Sciences organizations on large-scale pharma transformation programs. His focus is on portfolio and project management as a core lever to implement... Read More →

Jill Orosz

Vice President, TKI Franchise Head, Bayer, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Tags Workshop

11:00am EDT

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI

Monday June 15, 2026 11:00am - 12:15pm EDT

203AB

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25

In this session, we will focus on the evolving role of the quality assurance professional, show you how to manage your professional development as a project, and build skills to deliver measurable outcomes in the age of AI.

Learning Objectives

Recognize the evolving role of the quality assurance professional in the age of AI and how to align with emerging expectation; Apply project management principles to strategically plan and execute your personal upskilling journey in AI; Discuss how to build a personalized career roadmap using practical tools and frameworks to stay relevant, resilient, and future-ready.

Chair

Michael Pelosi, MA, MBA

Speaker

Smarter Roles, Stronger Skills: AI in Workforce Evolution
Haleh Valian, PHD

Compliance to Competence: How AI and New Regulations Are Reshaping the Quality Professional
Jeremy Jones, MS

Quality in the Age of Agents: A Look Back From the AI-Driven Future
Roshan D'Souza

Speakers

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States

Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States

Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States

Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 09: RD-Quality-Compliance, Session

Audience Basic
Area Artificial Intelligence
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Artificial Intelligence
Interest Area Health Technology & AI,Quality Assurance / Control & CMC
Tags Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

Monday June 15, 2026 11:00am - 12:15pm EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.

Learning Objectives

Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.

Chair

Jeffrey Francer, JD, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD

Speakers

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States

Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States

Barrett Tenbarge

Partner, Faegre Drinker, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student and Early Career Pathway
Interest Area Regulatory,Project Management & Strategic Planning
Tags Forum

2:30pm EDT

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

Monday June 15, 2026 2:30pm - 3:30pm EDT

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00

This seminar shows how life sciences teams can align strategy with execution through integrated program plans, AI-enabled planning, and P3M practices to accelerate time to market, foster innovation, and drive organizational transformation.

Learning Objectives

Distinguish how to align strategy with execution by integrating program plans (IPPs) across R&D, Clinical, CMC, Regulatory, and Commercial Leverage AI-enabled planning and P3M practices to enhance visibility, decision-making, and risk management, accelerating time to market; Discuss ways to adapt leadership approaches to drive organizational transformation, innovation, and compliance in an evolving life sciences landscape.

Chair

Christine Mears, MBA, PMP

Speaker

Aligning Strategy with Execution: Leveraging Integrated Program, Project and Portfolio management with AI to advance drug development
Philip M Zack, DVM, PHD

Panelist
Erin Mulrooney, MSC, PMP

Speakers

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States

Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States

Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States

Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 07: RegCMC-Product Quality, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Cross-Functional Collaboration
Interest Area Project Management & Strategic Planning
Tags Session

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions

Monday June 15, 2026 4:00pm - 5:00pm EDT

202AB

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive, flexible, and sustainable mentoring practices.

Learning Objectives

Assess mentorship myths using interactive cases; Differentiate mentorship from management; Apply the REAL framework to build inclusive, flexible, lasting mentoring relationships.

Chair

Carol Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH

Speakers

Tywnia Brewton

Executive Director, Human Resources, United States

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... Read More →

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States

Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States

Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Basic
Area Student and Early Career Pathway
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Student and Early Career Pathway
Tags Session

1:45pm EDT

#534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks, Pitch Decks, and Any Talk of a Lifetime

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

103A

Component Type: Workshop
Level: Intermediate

In this interactive workshop, coach Jeff Smith shares essential building blocks – Prep as Empathy, the Impact Wave, Visuals on Purpose, and Dynamic Delivery – used to shape “talks of a lifetime,” from founding pitch decks to keynote and TED stages.

Learning Objectives

Use preparation as an empathy tool to align with enterprise/pharma stakeholders; Structure pitches using the “Impact Wave” to guide audiences from problem recognition to urgency to action; Design clear visuals that increase trust and decision velocity; Elevate delivery using the “Dynamism Checklist” to project confidence and persuasive presence.

Chair

Jeff Smith

Speakers

Jeff Smith

The Curator, Smith and Jones Innovation, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Workshop | 06: ProfDevelop-Program-PortfolioMgmt, Workshop | 18: Lift-Series, Workshop

Audience Intermediate
Area Biotech-ClinTech-Pathway
Level Intermediate
format csv
Feature Topics Biotech-ClinTech-Pathway
Interest Area Biotechnology & Investors
Tags Workshop

1:45pm EDT

#536: Project Management as a Catalyst for Enterprise Transformation

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-575-L04-P; CME 1.25; PDU 1.25 PMI 21662N25CW; RN 1.25

Project Management as a Catalyst for Enterprise Transformation explores how Project Management (PM) drives strategic alignment, organizational evolution, and long-term sustainment across the enterprise. This session will examine how PM-led governance and decision-making frameworks bring clarity to chaos and accelerate transformation, while positioning PM as a strategic engine regardless of company size. Participants will engage in a hands-on exercise that applies these concepts to realistic scenarios, enabling them to identify capability gaps and define scalable PM practices that support both the evolution and the sustained success of their organizations.

Learning Objectives

Explain how PM-led governance and decision-making frameworks act as catalysts for strategic alignment and enterprise-wide transformation; Describe how to position Project Management as a strategic driver of organizational transformation across companies of all sizes; Identify PM capability gaps and define scalable practices that accelerate transformation.

Chair

Elizabeth Somers, MS

Speaker

Project Management as a Catalyst for Enterprise Transformation
Joann O'Connor

Project Management as a Catalyst for Enterprise Transformation
Jayanthi Reddy, MBA, MS

Speakers

Joann O'Connor

Executive Director, Head of Pipeline Project Management for BD and Alliances, GSK, United States

Joann O’Connor is a pharmaceutical R&D leader with 20 years of drug development experience spanning research, development, and commercialization. She is Executive Director, Head of Pipeline Project Management for Business Development and Partnerships at GSK, where she leads a specialized... Read More →

Jayanthi Reddy

Eikon Therapeutics, Head of Project and Portfolio Management, United States

Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.

Elizabeth Somers

Associate Vice President, Global Project and Alliance Management, Merck & Co., Inc., United States

Liz is an Associate Vice President in Global Project and Alliance Management at Merck leading a large team that is focused on end to end drug development Project Management in the therapeutic areas of Imm, Neuro, CV, ID/Vaccines and Ophthalmology. She has direct experience managing... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Tags Workshop

4:15pm EDT

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

105AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P; CME 1.00; RN 1.00

This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.

Learning Objectives

Identify common misconceptions around regulatory reviewer preferences and practices in reviewing CSRs and Module 2 documents; Explain how to prepare well-informed and effective arguments to persuade cross-functional authoring teams to create leaner, more concise, user-focused, and automation-ready documents; Recognize how and when to implement successful change management practices at your own organization

Chair

Lauren Geary, PHD

Speaker

Panelist
Inger Oedum Nielsen, PHD, MS

Speakers

Lauren Geary

Senior Director, GSC, Regulatory Writing and Submission Capabilities, Eli Lilly and Company, United States

As the Sr. Director of Regulatory Capabilities and Submissions at Eli Lilly, I am responsible for ensuring functional proficiency in regulatory medical writing. Leveraging my medical training at the USC Keck School of Medicine, and regulatory training and experience in clinical trial... Read More →

Inger Nielsen

Associate Director, Novo Nordisk A/S, Denmark

Inger Ødum Nielsen is Associate Director in Content Innovation and Management, Clinical Reporting at Novo Nordisk, where she leads a team focused on driving digital transformation in clinical reporting. She has a strong track record of operationalising digital tools into the line... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication,Regulatory
Tags Session

4:15pm EDT

#554: Reverse Pitches: How Pharma Actually Buys

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

103A

Component Type: Session
Level: Advanced

Founders pitch to pharma expecting a straightforward evaluation, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders, this session flips the script—showing how pharma actually evaluates, negotiates, and commits to partnerships with innovative companies.

Learning Objectives

Identify the hidden criteria and decision-makers that determine whether a pharma deal moves forward; Understand MSAs, compliance requirements, and relationship dynamics that shape biopharma partnerships; Recognize common deal-stoppers and structure early conversations to align with how pharma actually evaluates and buys.

Chair

Ligia Kilinski Kilinski Cevasco

Speaker

Panelist
Mindy Gruba

Speakers

Ligia Kilinski Cevasco

BioPharma Consultant, Ligia Kilinski-Cevasco, Inc., United States

Mindy Gruba

Associate Director, Clinical Trial Digital Health, Moderna, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 18: Lift-Series, Session

Audience Advanced
Area Biotech-ClinTech-Pathway
Level Advanced
format csv
Feature Topics Biotech-ClinTech-Pathway
Interest Area Biotechnology & Investors
Tags 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

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 →

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 →

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 →

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

Audience Advanced
Area Biotech-ClinTech-Pathway
Level Advanced
format csv
Feature Topics Biotech-ClinTech-Pathway
Tags Session

10:15am EDT

#609: Decision Under Uncertainty

Wednesday June 17, 2026 10:15am - 11:30am EDT

203AB

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-603-L04-P; CME 1.25; PDU 1.25 PMI 2166LODLKY; RN 1.25

In this interactive workshop, participants will participate in an interactive, case-based racing simulation that places participants in a high-pressure “go/no-go” decision before the most important race of the season. This is one of Harvard's case studies most commonly used in business school programs. In this simulation, participants decide whether to race in a high-stakes event, balancing technical risks, financial pressures, and limited data, highlighting decision-making under uncertainty. The exercise addresses key issues in decision-making under uncertainty and bias without awareness under time and stakeholder pressure. Upon conclusion of the exercise, participants report increased awareness of decision drivers, stronger analytical skills, and strategies to mitigate bias.

Learning Objectives

Demonstrate teamwork and communication under time constraints; Identify biases when making decisions under financial pressure; Assess technical, financial, and reputational risks in complex business situations.

Chair

Valerie Huh, PHARMD, MBA

Speaker

Decision under uncertainty
Dave Bezick, RN

Speakers

Dave Bezick

Vice President, Medical Information, Propharma, United States

Dave brings over 17 years of Medical Information Contact Center Management and Operations experience. A licensed Registered Nurse, he began his career as a front-line Medical Information Specialist and has continually advanced into roles of increasing responsibility within the Medical... Read More →

Valerie Huh

Director, Global Innovation and Implementation, Propharma, United States

Valerie Huh has over 21 years of experience in the pharmaceutical, healthcare, and education sectors, with more than 11 years specializing in Contact Center and Medical Information Process Improvement. She holds a Pharm.D and an MBA and is passionate about leveraging advanced technology... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Tags Workshop

10:15am EDT

#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability

Wednesday June 17, 2026 10:15am - 11:30am EDT

105AB

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-604-L04-P; CME 1.25; PDU 1.25 PMI 2166GIDLXI; RN 1.25

Link common team dysfunction signals with a practical mapping method to uncover hidden beliefs and routines. Learn small, safe-to-learn experiments and simple indicators to build trust, enable healthy debate, and strengthen accountability.

Learning Objectives

Diagnose how common dysfunction signals relate to hidden beliefs and protective routines in team culture; Apply a step-by-step, unbranded mapping method to translate dynamics like low trust or weak accountability into testable insights; Design small, safe-to-learn experiments with lightweight indicators to build trust, productive debate, commitment, and accountability.

Chair

John Z. Sun, PHD, MBA, PMP

Speaker

Panelist
Jeremy Jokinen, MS

Panelist
Sarah Tremethick

Panelist
John Dobbins, MS

Panelist
Jessie Li

Speakers

John Dobbins

Senior Manager, External Engagement, TransCelerate BioPharma Inc., United States

John Dobbins is an experienced change management practitioner and former educator. John is currently a senior manager of external engagement at TransCelerate BioPharma Inc., a collaborative biopharma consortium. In his day-to-day role, John supports TransCelerate's portfolio in its... Read More →

Jeremy Jokinen

Vice President Global Patient Safety, Argenx, United States

Jeremy Jokinen is the Vice President and Head of Global Patient Safety at argenx. He has more than 25 years of experience in the pharmaceutical industry, having held roles at Abbott Laboratories, Johnson & Johnson, AbbVie, and Bristol Myers Squibb. Jeremy has led numerous cross-industry... Read More →

Jessie Li

Director of Project Delivery, Fifth Quadrant, United States

Jessie Li is the Director of Project Delivery at Fifth Quadrant, where she leads the design and execution of professional programs that foster collaboration, knowledge exchange, and innovative thinking among professionals and organizations. She brings extensive experience in clinical... Read More →

John Sun

Program Lead, Portfolio, Strategy & Operations, CRM DU, Development, Novartis, United States

John is a Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively volunteered... Read More →

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom

A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Tags Workshop

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

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 →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States

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

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Artificial Intelligence
Tags Workshop

1:45pm EDT

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-621-L04-P; CME 1.00; PDU 1.00 PMI 21663K6JS3; RN 1.00

This workshop helps break through habitual thinking and guide teams toward inventive, high-impact strategies. Participants will engage in activities to encourage team engagement, uncover hidden constraints, and practice leading with confidence.

Learning Objectives

Analyze psychological and organizational factors that inhibit idea generation; Explain how to adopt techniques for leading scenario exploration.

Chair

Larissa Wilsie, MBA, MS, PMP

Speaker

Workshop Exercise 2
Nathan Kreischer, MS, PMP

Workshop Exercise 1
Amanda Adamek, MBA, PMP

Speakers

Amanda Adamek

Organon, United States

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc., United States

Nathan is a Director within Global Project & Alliance Management at Merck. He has almost 20 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →

Larissa Wilsie

Sr. Director, PPM Business Development, GlaxoSmithKline, United States

A cell biologist by training, Larissa moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She has been able to apply PM skills in a variety of settings beyond drug development... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Workshop

1:45pm EDT

#632: Program Manager: Jack of All Trades, Master of None?

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

203AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-622-L04-P; CME 1.00; PDU 1.00 PMI 21668R8O1J ; RN 1.00

The program manager role can be found within many functional areas, including discovery research, manufacturing, regulatory, and, the ultimate jack of all trades, the global program manager.

Learning Objectives

Recognize the diversity of PM role with respect to technical expertise and background required; Describe the importance of explicit roles and responsibilities and recognize the importance of not leaving anything unspoken or assume anything.

Chair

Rosa Tarng, MA

Speaker

Panelist
Simina Grigoriu, PHD

Speakers

Simina Grigoriu

Director, R&D Operations, Accent Therapuetics, United States

Simina is an early-stage clinical program manager who draws on over a decade of experience spanning the continuum from drug discovery to early clinical development. Trained in structural biology and protein sciences, she led Protein & Structural Sciences teams before moving into program... Read More →

Rosa Tarng

Early Development Leader, GSK, United States

Rosa Tarng is a drug development professional with over 20 years of industry experience. Rosa is currently an Early Development Leader at GSK. Prior experience includes leading Research and Translational program management teams as well as managing drug development programs and portfolios... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Cross-Functional Collaboration
Interest Area Project Management & Strategic Planning
Tags Session

4:00pm EDT

#650: Leading for Growth: Unlocking Individual Potential in Your Team

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

202AB

Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-657-L04-P; CME 1.00; PDU 1.00 PMI 2166FWL0S0; RN 1.00

This workshop equips leaders at all levels with adaptable, evidence-based tools to meet diverse team needs, boost motivation and performance, and strengthen retention through interactive discussions and hands-on activities.

Learning Objectives

Identify and adapt leadership practices to different employee needs, backgrounds, and motivations; Discuss personalized growth opportunities that align with organizational goals; Demonstrate coaching and feedback skills that empower employees to own their growth journey.

Chair

Jennifer Kim, PHD

Speaker

Removing siloes and increasing information transparency in interdependent teams
Tamei Elliott, MS

Which inclusive leadership behavior matters the most for improving employee outcomes?
Elizabeth Lange, MPH, MS

Speakers

Tamei Elliott

Director, Global Scientific Content, DIA, United States

Tamei Elliott, MS, is the Director of Global Scientific Content at the Drug Information Association (DIA). She leads DIA’s global scientific content strategy, ensuring alignment with regulatory priorities, industry trends, and evolving stakeholder needs across regions. She also... Read More →

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States

I'm a Research Associate Professor and Behavioral Scientist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on addressing health and work disparities in drug development, examining strategies and interventions that can... Read More →

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States

Elizabeth Rosenkrands Lange is an experienced R&D policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency and... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Tags Workshop

8:00am EDT

#704: The View from the Top: What is the Future of Medical Writing?

Thursday June 18, 2026 8:00am - 9:00am EDT

105AB

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-646-L04-P; CME 1.00; RN 1.00

Senior regulatory writing leaders from top pharma companies will share a candid, strategic view of how medical/regulatory writing is evolving over the next 3–5 years. The panel will explore how technology (including AI and structured content), new regulatory pathways, and shifting operating models are redefining writer responsibilities, team structures, and the value writers bring to development programs. Attendees will leave with clear insights on future-ready skills and practical steps to position regulatory writing as a critical driver of regulatory and clinical success.

Learning Objectives

Describe leadership-level forecasts for the medical/regulatory writing function over the next 3–5 years, including key forces driving change; Identify how top pharma organizations are redefining the role and value of regulatory writers; Explain the implications of technology adoption on writer responsibilities, quality oversight, and team structures.

Chair

Robin Whitsell

Speaker

Panelist
Elizabeth Brown, MS, PMP

Panelist
Krista Crenshaw, MS

Panelist
Nancy Tam, MS

Panelist
Joanne Hilton, MBA

Speakers

Elizabeth Brown

Executive Director, Clinical & Regulatory Strategic Communications, Merck & Co., Inc., United States

Elizabeth Brown is the Executive Director, Head of Clinical Transparency Communications at Merck & Co, Inc., where she oversees clinical trial registration and results disclosure, as well as health literacy deliverables (ICF/PLS). She has led people, projects, and initiatives in biopharma... Read More →

Krista Crenshaw

Sr. Director, Clinical Content Operations, Alcon, United States

Krista is the Senior Director of Clinical Content Operations at Alcon, leading a global organization of medical writers, QC specialists, and publications leads responsible for clinical trial documentation, regulatory submissions, and publications for devices and pharmaceuticals. With... Read More →

Joanne Hilton

VP, Global Medical Writing, GlaxoSmithKline, United Kingdom

Joanne Hilton has over 25 years’ experience in medical communications across regulatory affairs, clinical development and medical affairs in large pharma as well as boutique agencies. She has a track record of building capabilities globally, delivering strategic growth, talent management... Read More →

Nancy Tam

Vice President and Head of Medical Writing, Pfizer, United States

Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy is passionate about the role of medical writers in clinical development and has been involved in a wide range of transformation... Read More →

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 →

Thursday June 18, 2026 8:00am - 9:00am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Forum | 06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Advanced
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication
Tags Forum

8:00am EDT

#705: Fighting Medical Disinformation (Without Actually Starting a Fight)

Thursday June 18, 2026 8:00am - 9:00am EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P; CME 1.00; PDU 1.00 PMI 2166KJ1ZXS; RN 1.00

We’ll discuss whether drug development professionals have an ethical obligation to confront misinformation, effective ways to approach these conversations without confrontation, and what techniques and messages work best in different settings.

Learning Objectives

Explain the ethical principles that underlie the obligation of drug development professionals to combat disinformation; Discuss best practices for successful encounters in combatting disinformation; Distinguish the application of different practices in their most appropriate settings

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Perspectives of a Science Reporter
Sydney Lupkin

Effective Messaging to Combat Scientific Mis/Disinformation
Joseph N Cappella, PHD

Speakers

Joseph Cappella

Gerald R. Miller Professor Emeritus of Communication, University of Pennsylvania, United States

Joseph N. Cappella is the Gerald R. Miller Emeritus Professor of Communication at the Annenberg School for Communication. His research has resulted in more than 225 articles and four co-authored books. His research has been supported by grants from NIMH, NIDA, NSF, NCI, NHGRI, and... Read More →

Sydney Lupkin

NPR Pharmaceutical Correspondent, National Public Radio (NPR), United States

Sydney Lupkin is the pharmaceuticals correspondent for NPR. Prior to NPR, she was a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies... Read More →

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States

Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Intermediate
Area Student and Early Career Pathway, Ethics, Trust and Responsible Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Student and Early Career Pathway,Ethics, Trust and Responsible Innovation
Interest Area Project Management & Strategic Planning
Tags Forum