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
——————————— Draft Agenda ———————————-
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 Keynote. Yele Aluko, Chief Medical Officer, EY Americas
- Reaffirming its Social Contract: BioPharma’s Commitment to Transparency, Accountability and Public Trust
8:55-9:05 Setting the Stage. Jennifer Miller, Co-Director, Yale Program for Biomedical Ethics, Associate Professor, Yale School of Medicine; President, Bioethics International; Founder, Good Pharma Scorecard.
- Why we are here and what we hope to accomplish. The role of the Good Pharma Scorecard and this Forum in advancing metrics for trustworthiness and patient centricity in pharma.
9:05-10am Establishing a Global Industry Reporting Standard for Clinical Research Data: Public health, ethics, and business considerations in response to Declaration of Helsinki revisions
- Opening Remarks. Jennifer Miller, Yale, Expectations, 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
10-10:15 Break
10:15-10:35 Keynote: Janet Woodcock, MD – tbd – Adaptive clinical trial designs as a pathway for access and drug approval: Defining metrics for success TBD
10:35-11:45 Clinical Demographics in Research.
- Cris Woolston, Sanofi
- Melissa Penn, Director, Patient Engagement R&D, Bayer
- Ivy Kam, Director DEI Sciences, Regeneron
- Lorena Kuri, Global Clinical Trials Strategy and Operations, BMS
- Andrew Whitehead, BMS
- Osa Eisele, MD, MPH, Executive Director and Head, Representation in Clinical Research, Amgen
- Martin Mendoza, Director, Office of Minority Health, CMS
- Tricha Shivas, Chief of Staff and Strategy, Foundation for Sarcoidosis Research
- Cary Gross, Professor, Medicine and Public Health; Director, National Clinician Scholars Program; Director, COPPER; Yale School of Medicine
- Pierre Theodore, Executive Director Health Equity, Genentech
11:45-12:05 The Bioethics Leadership Forum
- Facilitator: Jeremy Abbate
- Greg Licholai, CMO, ICON
- Missy Heidelberg, Takeda
- Kimberly Sabelko, Susan G. Komen
- Meg McKenzie and Pierre Theodore, Roche
- Vibhooti Ashar, BMS
- Mark Wilenzick, Gilead
- David Leventhal, Former Pfizer
- Cris Woolston, Sanofi
12:05-12:35 Lunch
12:35-12:50 Keynote – Mark McClellan, Former FDA Commissioner, Duke-Margolis Institute for Health Policy
12:50-2pm 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)
- John Sargent-Founding Partner or Chris LeGrand-CEO, BroadReach
- Vibhooti Ashar, Global Market Access & Pricing, BMS
- Alex Schmidt, Head, Vaccine Development, Bill & Melinda Gates Medical Research Institute
2pm -3:10pm 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, Senior Director, Global Patient Focused Implementation Science, Gilead
- Sneha Dave, Generation Patient
- Alan Balch, CEO, Patient Advocate Foundation; National Patient Advocate Foundation
- Linda Kollmar, AVP Patient Innovation and Engagement, Merck
- 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
- Tré LaRosa, Associate Project Manager, Foundation for the National Institutes of Health
- Tanya Simoncelli, VP of Science in Society, Chan Zuckerberg Initiative
- Pam Gavin, CEO, NORD
3:10-3:25 Break
3:25-4pm Linking Bioethics and Patient Centricity Efforts w/ Sustainability, Corporate Social Responsibility, ESG, Impact + Communications Reporting in Life Science Companies: How are investors, companies and regulators thinking and communicating about these efforts?
- Moderator: Mohit, Partner, Climate Change and Sustainability, EY
- 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 to brainstorm projects, themes/topics, and metrics we should think about developing to advance bioethics, patient centricity, access, and trustworthiness in medicines development and delivery. 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, Advisor, Bioethics International
4:24-4:55 Full Roundtable Discussions: Where do we go from here? Next steps for advancing, tracking, and communicating patient centricity, trustworthiness, and bioethics progress in pharma.
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 Good Pharma Scorecard
5-6pm Networking and Drinks, with all Participants, sponsored by EY
6-7:30pm Dinner, for speakers and BLF members, sponsored by Bioethics International
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 a ranking and rating of 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.