BEI Patient Advocacy Roundtable

Background: This Roundtable convenes patient groups to discuss their key ethics concerns about the pharmaceutical industry and how they define patient-centricity and trustworthiness for the sector. We will aim to produce a catalogue of ethics concerns and corresponding standards that may help address perceived problems. Discussions topics may include (1) how clinical trials are designed, (2) inclusivity in trial enrollment, (3) transparency in clinical trials and data-sharing, (4) returning trial results to patients, (5) issues related to the globalization of trials and accessibility of medicines, and (6) the ethics of industry-patient engagement and public-private partnerships. Our ultimate goal will be to understand patient group perspectives on how the healthcare innovation sector can better serve the needs of patients and advance population health, responsibly.

Participating Groups: PCORI, Michael J. Fox Foundation, Research!America, FDA Office of Minority Health, National Hemophilia Foundation, National Multiple Sclerosis Society, Alliance for Aging Research, Patients for Affordable Drugs, Cures within Reach, HealthyWomen, National Breast Cancer Coalition, Gemini Group, Johnson & Johnson


11:00-11:10 am          Welcome and Opening Remarks by Meeting Chairs

  • Jennifer E. Miller, PhD, Founder and President, Bioethics International; Assistant Professor, NYU School of Medicine
  • Stephen Sammut, MBA, BEI Board of Directors; Wharton Business School


11:10-11:25 am          Introductions (All)

  • Everyone: Who you are, why you are here, what you hope to gain from participating?


11:25-11:45 am          Good Pharma Scorecard (GPS): We will review the history, aims, and scope of the Good Pharma Scorecard as well as the results of our first pilot, conducted at Harvard, which evaluated and ranked new drugs approved by the FDA and large drug companies on their clinical trial transparency. Potential next steps will also be discussed.

  • Presenter: Jennifer E. Miller, PhD


11:45-12:30 pm         Clinical Trial Transparency: We will discuss how we can improve the clinical trial transparency portion of the GPS to be more useful for patient groups as well as patients’ general perspectives on trial transparency, results reporting, data-sharing, providing lay summaries to research participants, etc.

  • Opening Comments: Joseph Ross, MD, Yale Medical School
  • Everyone Comments


12:30-12:45 pm*       Break: Grab Food for Working Lunch   (*Lunch served)


12:451:15 pm           Clinical Trial Design: Patient perspectives on clinical trial designs, inclusivity in clinical trial enrollment, the globalization of research sites, expanded access to experimental therapies and the like.

  • Opening Comments: Sarah Berk, Michael J. Fox Foundation (TBD)


1:15-2:20 pm             Trust, Ethics, Patient-Centricity, and Patient-Industry Partnerships: Studies show industry sponsors the majority of clinical research for new FDA approved products. Yet, patients don’t trust it and 90% think companies put profits before people. This discussion will focus on patients’ ethics concerns about pharmaceutical companies and ethics standards they’d like to see companies adopt to address concerns. We will also discuss the impact of distrust in pharma on patients (i.e. pharmaco-adherence challenges) and how patients define patient-centricity for pharma (i.e. what are the constituent elements they’d like to see implemented in a company). Lastly, should companies partner more with patients in drug development and other activities, if so, how and what are the promises and perils (i.e. conflicts of interest) of enhanced engagement? How can we partner with integrity?

  • Opening Comments: Joe Selby, President, PCORI
  • Wrap up comments: Michelle Mello, JD, Stanford Law (on trust study)


2:20-2:30 pm             Break


2:30-3:15 pm             Ethics Pledge: Can we draft an Ethics Wish List, Pharma Code of Ethics, Patient Bill of Rights, or Ethics Pledge that multiple stakeholders can support?  What are our ethics priorities?

  • Opening Comments: Evan Greenfield, Bioethics International
  • Secondary Comments: Sue Peschin, Alliance for Aging Research


3:15-3:40 pm             Next Steps: Where do we go from here?

  • Opening Comments: Evan Greenfield, Bioethics International


3:40-4:00 pm             Thank You and Closing Comments

  • Jennifer E. Miller, PhD, Founder and President, Bioethics International; Assistant Professor, NYU School of Medicine
  • Llew Keltner, MD, PhD, BEI Board of Advisors
  • Stephen Sammut, MBA, BEI Board of Directors; Wharton Business School
  • Everyone


4:00-4:30 pm             Cocktails / Networking *(RSVP required)