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Monday, June 15
 

11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P; CME 1.25; RN 1.25

The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers, regulatory agencies, and industry representatives

Learning Objectives

Explain the value of regulatory collaboration and describe recent technological advancements that enable it; Identify key challenges and opportunities associated with integrating cloud technologies into regulatory processes; Examine perspectives from technology providers, regulators, and industry on the future of regulatory collaboration and outline ways to participate in these efforts.

Chair

Dominique Lagrave, PHARMD

Speaker

Panelist
Marko Eric

Panelist
Julie Lepin, MA

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Vada Perkins, MS


Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil
Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →
avatar for Marko Eric

Marko Eric

Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia
Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Julie Lepin

Julie Lepin

Senior Vice President & Chief Regulatory Officer, BeOne Medicines, United States
Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy
Monday June 15, 2026 11:00am - 12:15pm EDT
117
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25

This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.

Learning Objectives

Recognize CtQ factors using integrated QbD and RBQM in a collaborative, cross-functional setting; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle; Discuss regulatory expectations and industry best practices for a unified quality strategy; List practical strategies for implementing this approach within organizations.

Chair

Paula Walker, MA

Speaker

Panelist
Mandy Kaur Budwal-Jagait, MSC

Panelist
Paula Walker, MA

Panelist
Sumitra Sachidanandan

Panelist
Cheryl Grandinetti


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for sumitra_sachidanandan

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore
Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom
Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum |   02: ClinicalTrialOps-Innovation, 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
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

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 →
avatar for Erin Mulrooney

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 →
avatar for Philip Zack

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
 
Tuesday, June 16
 

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A
Component Type: Session
Level: Intermediate

Many clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.

Learning Objectives

Design and execute a streamlined customer discovery process to validate unmet needs, buying triggers, and budget ownership before finalizing a go-to-market strategy; Translate insights into a sales learning roadmap that tests positioning, pricing, compliance, and objections to reduce commercial risk before raising capital; Align GTM and fundraising with validated demand to present a credible revenue story.

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA


Speakers
LH

Laura Hilty

Principal, HealthX Ventures, United States
JL

Jeff Lee

Board Director, Medstar Health Research Institute, United States
Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →
PS

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States
Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →
DS

Dan Sndyer

The Playbook, United States
DS

Dan Sndyer

The Playbook, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   18: Lift-Series, Session
 
Wednesday, June 17
 

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
avatar for Simina Grigoriu

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 →
avatar for Rosa Tarng

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

1:45pm EDT

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00

Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.

Learning Objectives

Examine the dynamic collaboration between Regulatory Affairs, Medical Affairs, and Market Access to effectively address current regulatory and payor requirements; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.

Chair

Alison Maloney, MBA, MS

Speaker

An Academic Perspective
Sean D. Sullivan, PHD

A Medical Perspective
Emma Lee

A Regulatory Perspective
Todd Paporello, PHARMD, MBA


Speakers
EL

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
SS

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   04: MedAffairs-SciComm, Session
 
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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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  • Trust and Responsible Innovation