Join us for Bioethics International & EY’s 16th Annual Pharmaceutical Executive Roundtable w/ Yale’s Program for Biomedical Ethics & Scientific American
Ethics, Trust + Patient Centricity in Pharma: Defining Metrics for Success
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This year’s roundtable will convene leaders across the healthcare sector to define meaningful metrics for advancing transparency, trustworthiness, and patient centricity in medicines development, focusing on the role of the pharmaceutical industry. Discussions will also spotlight and align participants’ ongoing efforts in these areas. Insights from the roundtable may shape future agenda-setting and metrics for the Good Pharma Scorecard.
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8-8:30am Breakfast + Registration
8:30-8:40 Welcome.
- Jeremy Abbate, Publisher, Scientific American
- Arda Ural, Head of Life Sciences, Americas, EY
- Lauren Rogge, Principle, Climate Change and Sustainability, EY
8:40-8:55 Yele Aluko, Chief Medical Officer, EY Americas
8:55-9:05m Jennifer Miller, Co-Director, Yale Program for Biomedical Ethics, Associate Professor, Yale School of Medicine; President, Bioethics International; Founder, Good Pharma Scorecard.
9:05-9:25 Robert Califf, Former FDA Commissioner, Duke Clinical Research Institute, Duke University School of Medicine, Advancing patient and population health responsibly: Essential commitments for BioPharma
9:25-10:30 Establishing a Global Industry Reporting Standard for Clinical Research Data: Public health, ethics, and business considerations in response to Declaration of Helsinki revisions
In October 2024, the World Medical Association adopted a comprehensive revision of the Declaration of Helsinki, reinforcing ethical standards in clinical research. The update mandates the public disclosure of all clinical trial results—across all phases and participant types, including healthy volunteers—aligning with World Health Organization guidance on trial transparency. This panel will delve into the multifaceted implications of these guidance, exploring ethical, public health, governance, and business perspectives. Discussions will highlight how pharmaceutical companies are adapting to enhanced transparency expectations and their current performance trends. Whether the Good Pharma Scorecard’s accountability metrics, on this topic, requires recalibration to effectively measure and promote ethical research practices, will also be discussed.
- Opening Remarks. Jennifer Miller, Yale, Expectations, performance trends, and the role of the Good Pharma Scorecard in advancing research transparency
- Moderator. David Leventhal
- Laura Pioppo, ACT EU Programme Manager, European Medicines Agency and Francesca Scotti,Clinical Trial Information System, Transparency Lead, EMA
- Vasee Moorthy, Senior Advisor, R&D, World Health Organization
- Arthur Caplan, NYU School of Medicine
- Ben Rotz, AVP, Global Medical Policy, Strategy & Operations, Eli Lilly
- Morgan Hanger, Executive Director, CTTI, Duke School of Medicine
10:30-10:45 Break
10:45-11:55 Enhancing Clinical Demographics in Research. This session will examine FDA expectations, stakeholder priorities, and industry performance trends related to demographic representation in clinical trial enrollment. Panelists will explore strategies linked to success in this area and consider whether incorporating leading indicators into the Good Pharma Scorecard could help recognize progress and accelerate further improvement.
Moderator. Cris Woolston, Sanofi
- Melissa Penn, Director, Patient Engagement R&D, Bayer *confirmed
- Ivy Kam, Director DEI Sciences, Regeneron
- Lorena Kuri, Global Clinical Trials Strategy and Operations, Bristol Myers Squibb
- Andrew Whitehead, BMS
- Osa Eisele, MD, MPH, Executive Director and Head, Representation in Clinical Research, Amgen
- Martin Mendoza, Chief Health Population Health Officer, CMS
- Tricha Shivas, Chief of Staff and Strategy, Foundation for Sarcoidosis Research
- Cary Gross, Professor of Medicine and Public Health, Director of the National Clinician Scholars Program, Director of COPPER, Yale School of Medicine
- Pierre Theodore, Executive Director Health Equity, Genentech
- Silke Schoch, Director, Research & Programs, National Health Council
11:55-12:15 The Bioethics Leadership Forum (BLF).
12:15-12:40 Lunch Break
12:40-12:55 Keynote – Mark McClellan, Former FDA Commissioner, Duke-Margolis Institute for Health Policy
12:55-2pm Access to medicines in LMICS: Ethical considerations, barriers, facilitators + global trends
- Opening comments: State of the industry performance on these issues: Jennifer Miller, Yale School of Medicine
- Moderator: Amy Israel, Senior Advisor, Access to Medicines, Union for International Cancer Control (UICC)
- Mary Ann Slack, Former Director, US FDA CDER
- Vibhooti Ashar, Global Market Access & Pricing, BMS
- Alex Schmidt, Head, Vaccine Development, Bill & Melinda Gates Medical Research Institute
2:05pm -3:15 Patient Centricity in the Pharma Sector: Identifying a Consistent Set of Metrics & the Role of the Good Pharma Scorecard
Opening Remarks: Review the results of a literature review on themes, barriers and facilitators, and strategies for implementing a patient-centered corporate strategy in pharma. Jennifer Miller
Moderator: Cosmina Hogea, Global Patient Focused Implementation Science, Gilead
- Alan Balch, CEO, Patient Advocate Foundation; National Patient Advocate Foundation
- Sneha Dave, Generation Patient
- Linda Kollmar, AVP Patient Innovation and Engagement, Merck
- Luther T. Clark, Executive Director, Patient Innovation & Engagement, V&I Global Medical and Scientific Affairs, Merck Research Laboratories
- Ronika Alexander-Parrish, Director, US Medical Affairs, Pfizer
- Mat Phillips, Associate Director, Patient View
- Pat Furlong, CEO, Parent Project Muscular Dystrophy
- Ellyn Getz, MPH, Director, R&D Patient Partnerships, CSL
- Pam Gavin, CEO, NORD
- Tré LaRosa, Associate Project Manager, Foundation for the National Institutes of Health
3:15-3:30 Break
3:30-4pm Linking Bioethics and Patient Centricity Efforts w/ Sustainability, Corporate Social Responsibility, ESG and Impact Reporting in Life Science Companies: How are and should investors, companies and regulators thinking and communicating about these efforts?
Moderator: Mohit, Partner/Principal, Climate Change and Sustainability Services, EY
- Hayley Chapman, Senior Program Director, The Synergist
- Jennifer Evans, Executive Director, Environmental Sustainability & Social Impact, BMS
- Smita Pillai, CDO, Regeneron
- Jessica Federer, Board Member, Angelini Ventures, Sage Therapuetics, Pluto Health, and Aspivix; Advisory Board, Yale Blavatnik Fund for Innovation; Member, Yale Institutional Review board
- William Stack, ESG, Gilead,
- Brian Reid, Pharma Pricing and Public Affairs.
4-4:25pm Small Group Brainstorming Sessions: We will break out into 6 small groups of 10 people each to brainstorm projects, themes/topics, and metrics we should think about collaborating on and developing with the good pharma scorecard to advance bioethics, patient centricity, access, and trustworthiness in medicines development and delivery. Group facilitators:
- Group 1: Chris Robertson, Boston University School of Law
- Group 2: Greg Licholai, CMO, ICON
- Group 3: Morgan Hanger, CTTI, Duke University
- Group 4: Lauren Rogge, EY
- Group 5: Marc Wilenzick, Gilead
- Group 6: David Leventhal
4:25-4:55pm Full Roundtable Discussions: Where do we go from here? Next steps for advancing, tracking, and communicating patient centricity, trustworthiness, and bioethics progress in pharma. Facilitator: Jennifer Miller
4:55-5pm Closing Remarks
- Jeremy Abbate, Publisher, Scientific American
- Lauren Rogge, Principle, Climate Change and Sustainability, EY
- Arda Ural, Head of Life Sciences, Americas, EY
- Jennifer E. Miller, Co-Director, Associate Professor, Yale School of Medicine, President Bioethics International, Interim-CEO GPS
5-6pm Networking and Drinks
Roundtable Sponsors + Hosts
- Bioethics International (BEI) is a 501c3 public charity, founded in 2005, to help advance ethics, trustworthiness, patient-centricity, and social responsibility in healthcare.
- EY. EY’s purpose is building a better working world. The insights and quality services EY provide help build trust and confidence in the capital markets and in economies the world over. They develop outstanding leaders who team to deliver on their promises to all our stakeholders. In so doing, EY plays a critical role in building a better working world for its people, for clients and communities.
- Scientific American. Scientific American is the authority on science and technology for a general audience, with coverage that explains how research changes our understanding of the world and shapes our lives. First published in 1845, Scientific American is the longest continuously published magazine in the US. The magazine has published articles by more than 150 Nobel Prize-winning scientists and built a loyal following of influential and forward thinking readers. The archives of Scientific American include articles penned by Albert Einstein, Thomas Edison, Jonas Salk, Marie Curie, Stephen Hawking, Franklin D. Roosevelt, Stephen Jay Gould, Bill Gates, and more.
- Yale Program for Biomedical Ethics. The Yale Program for Biomedical Ethics incorporates a diverse group that brings a wide range of experience and expertise to the table, including faculty and staff from the Schools of Medicine, Nursing, Law, Divinity, Public Health, as well as Yale New Haven Hospital staff, and others who share a common interest in education, research, and clinical practice in the field of medical ethics. Our program coordinates the ethics education of Yale medical students over the course of their four years, including assistance for those who choose to write their thesis in this area. In addition, educational programs are provided for other members of the Yale medical community, such as journal clubs, working groups and special conferences.
- Good Pharma Scorecard (GPS). The Good Pharma Scorecard is an index that ranks and rates pharmaceutical companies on their bioethics, social responsibility, and patient centricity performance. Through the Scorecard, we develop benchmarks for what constitutes ‘good’ socially responsible practices. We then use these benchmarks to measure and rate company performance annually, helping recognize best practices, catalyze reform where needed, and track progress on goals over time.
Tickets: https://www.eventbrite.com/e/ethics-trust-patient-centricity-in-pharma-defining-metrics-for-success-tickets-1359157981109?aff=oddtdtcreator