10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Wasserstein Hall, Milstein East B, Harvard Law School, 1585 Massachusetts Ave.

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

10/20/14: Emerging Issues and New Frontiers for FDA Regulation

lab_colored_beakers_slideEmerging Issues and New Frontiers for FDA Regulation

October 20, 2014 8:00 AM – 5:00 PM

Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404

Symposium co-sponsored by the Food and Drug Law Institute (FDLI) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Please join the Food and Drug Law Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for an academic symposium on cutting-edge legal and regulatory issues facing FDA.  Leading academics will present papers on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.  Papers will be available to registered attendees in advance, and will be published in an upcoming issue of the Food and Drug Law Journal.

Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at petrie-flom@law.harvard.edu.

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HLS Health Law Workshop 9/22 – Thomas McGuire

September 22, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA

Download the Paper: Do ‘Reverse Payment’ Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitve Pay for Delay?

Thomas G. McGuire, PhD, is a professor of health economics in the Department of Health Care Policy at Harvard Medical School. His research focuses on the design and impact of health care payment systems, the economics of health care disparities, and the economics of mental health policy. Dr. McGuire has contributed to the theory of physician, hospital, and health plan payment. His research on health care disparities includes developing approaches to defining and measuring disparities, and study of the theory and measurement of provider discrimination. For more than 30 years, Dr. McGuire has conducted academic and policy research on the economics of mental health.

Live Blogging: Post-Trial Responsibilities Conference, Session 4

Panel Discussion: Christine Grady, Mitchell Warren, Richard Saver, Luann van Campen; Moderator: Mark Barnes

Session four of the Post-Trial Responsibilities conference featured a panel discussion of a complex hypothetical scenario. The hypothetical used in this session (available here) was made complex by design, to avoid the easy answers and to force readers to make difficult choices regarding both people and institutions.

In this hypothetical, the Ministry of Health in Angola begins a collaboration with a Belgian biotech company, BelgiqueTec. BelgiqueTec is not an established multinational pharmaceutical company, but is instead more like a start-up that’s been funded by some investment capital but which lacks deep pockets. BelgiqueTec has the rights to a diabetes drug and is interested in testing it in clinical trials. The Angolan government contributes $25 million to finance trials of the drug in Angola, due to the population’s burgeoning diabetes problem and concomitant development of wait times for treatment in the government’s diabetes clinics. In return, the Angolan government will take some ownership stake in the company and therefore in the outcome. There is an in-kind commitment of resources from Angola in terms of the study sites, which will be hospitals or clinics owned by the Angolan government or ministry of health (MOH). The agreement between BelgiqueTec and the government establishes that Phase I and II trials will be done in Angola, and any Phase III trials would feature a site in Angola (as well as elsewhere).

In the hypothetical, the Phase I trial was completed and showed no adverse effects. Now, a Phase II study has enrolled 200 treatment-naïve Angolan citizens with moderate to severe diabetes. Half showed improvement in the control of their diabetes, but three patients showed decreased cardiac function associated in time with drug administration, suggesting a potential causal link between administration of the drug and the observed cardiac side effect.

The first set of key questions for discussion was as follows: if drug development is halted at Phase II based on the adverse events, what are the obligations of BelgiqueTec and the MOH to continue to deliver diabetes treatments of any kind to the 200 Phase II subjects? Since a number of the patients showed improvement on the experimental drug, should the treatment be the experimental drug or the standard of care? For how long must the treatment continue?

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Live Blogging: Post-Trial Responsibilities Conference, Session 3

By Robin Pierce

Session 3 of the Post Trial Responsibilities Conference, Lessons Learned, featured four speakers who have been involved in the conduct of trials for which post trial access was an issue. Moderated by Petrie-Flom Executive Director, Holly Fernandez Lynch, the session aimed to better understand real world experiences implementing post-trial responsibilities, including both successes and failures, and to more clearly articulate and assess the complexities involved. To do this, the speakers used case studies drawn from actual trials conducted around the world.

The first case study, presented by Joseph Millum of NIH, dealt with NIH-funded global HIV research, covered by the NIH policy on post-trial access to ARVs. Confronting the tough issues at the outset, Millum stated plainly that if there were no post trial access in the study at hand, which aimed to evaluate third line treatment options for HIV patients failing other regimens, there would be no way for affected participants to obtain the drugs that they needed to stay alive after the study. Here, Millum identified two key challenges – 1) access to drugs and 2) obtaining clinical care.

Millum devoted the rest of the discussion to describing the creation and implementation of a two part solution in which the manufacturers negotiated an agreement to provide darunavir, etravirine, and raltegravir free of charge for two years after study participation. Another element of the solution was created out of a recognition that in order for drugs to be administered at study sites, they had to be part of a study. Therefore, a final step was added to the study in which participants taking the drugs were given the option of staying in the study for an additional 96 weeks. For this, researchers tailored the consent process to state that after the study, the participant and his or her doctor will decide what treatment the participant should have and that study staff would discuss how the participants may be able to obtain the drugs post-trial.

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Upcoming Event: Cutting-Edge Issues in the Ethics of Conducting Biomedical Research

DNAcode_slideCutting-Edge Issues in the Ethics of Conducting Biomedical Research

Thursday, October 9, 2014, 7:45 AM – 2:15 PM

Saul Farber Auditorium, Bellevue Hospital, 27th Street and First Ave (462 First Ave.), New York City

Registration is required for the conference.

Informed consent and Institutional Review Boards (IRBs) are the cornerstones of modern bioethical research but they do not solve all of the complicated issues of science, justice, and coercion that such studies raise.  The NYULMC Division of Medical Ethics invites you to a provocative program on cutting-edge issues in the ethics of conducting biomedical research.  Attendees will learn from leading experts and engage in discussions of current controversies, ranging from understanding ‘minimal risk’ in studies that involve socially vulnerable populations to the ethics of randomized controlled trials without consent.  Other topics to be covered include the contemporary implications of the U.S.-led sexually transmitted disease research conducted on Guatemalans during the 1940s; new strategies and technologies for improving informed consent; and the vexing issue of compassionate use.

For a list of speakers and conference agenda, click here [PDF].

Tomorrow: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

Upcoming Event: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment. Continue reading

10/8/14: A Conversation with Jim Doyle

A Conversation with Jim Doyle
October 8, 2014 12:00 PM – 1:00 PM
Wasserstein Hall, Room 2012, 1585 Massachusetts Ave.

JimDoyleJoin the Harvard Health Law Society for a lunch talk with former Attorney General and Governor of Wisconsin Jim Doyle. Come hear about the former governor’s experiences tackling public health issues through state politics and join us for a Q&A session about health policy, health law careers, and politics. Governor Jim Doyle served as the 44th governor of Wisconsin and is recognized as a national leader in health care, energy, biotechnology, and many other areas. He has worked closely with the White House, high-ranking officials, and other governors. He currently serves as counsel for Foley & Lardner and is teaching a class at the Harvard School of Public Health this fall entitled “Health Policy, Leadership, and Politics at the State.”

Co-sponsored by the Center for Health Law Policy and Innovation and the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.

9/30/14: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Harvard Effective Altruism: an event today, Michael Kremer on Sept. 10, and a fellowship opportunity

A message from Harvard Effective Altruism:

On Saturday, Sept. 6 at 3pm in Sever 111, we are holding a giving game / donation discussion and an information session for Harvard students interested in our organization. We’ll explain what effective altruism is and what HCEA does here on campus. If you’re new to HCEA, you should definitely check it out!

Wednesday, Sept. 10 at 4:30pm in Science Center Hall A: Prof. Michael Kremer – a development economist at Harvard – will give a talk entitled “How can individuals reduce global poverty?” He’ll discuss the ways that individuals can use both their money and their careers to contribute to poverty reduction and international development.

All semester long! HCEA is hosting its third Philanthropy Fellowship program for Harvard undergrads and graduate students. Fellows will attend talks from speakers like Harvard professor Steven Pinker, Rob Mather of the Against Malaria Foundation, and Center for Applied Rationality president Julia Galef; learn about effective altruism at weekly dinners with other fellows and speakers; get to know likeminded students at discussions and social events; and fundraise for effective charities! You can find more information and apply on our website before 11:59pm on Sunday, Sept. 14th.

We hope to see soon! Altruistically yours,
Ales and John

9/18/14: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

bioIP Junior Faculty Workshop: Call for Abstracts by Oct. 1

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioip), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson,   Posted in Biotechnology, Call for Abstracts, Events, FDA, Intellectual Property, Kevin Outterson

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

AALS Call for Papers for a special Works-in-Progress for New Law School Teachers Program

Call for Papers
 AALS Section on Law, Medicine & Health Care
Works-in-Progress for New Law School Teachers
AALS Annual Meeting, Washington, DC
Saturday, January 3, 2015

The AALS Section on Law, Medicine and Health Care is pleased to announce a Call for Papers for a special Works-in-Progress for New Law School Teachers Program. The Section will run the Program from 5:15 to 6:30 p.m. on Saturday, January 3, at the AALS 2015 Annual Meeting in Washington, DC.

This program will bring together junior and senior health law scholars for a lively discussion of the junior scholar’s’ works-in-progress. Junior health law scholars will submit papers that they expect to submit in the spring 2015 law review submission cycle. After they briefly present their papers in a concurrent roundtable setting, senior scholars will provide oral comments and critiques. This new program presents an opportunity for the audience to hear cutting edge health law scholarship by recent members of the academy.

We will limit our selection to two or three papers.  Continue reading

AALS Call for Papers on the Unbefriended Elderly

Call for Papers, AALS Joint Program
Section on Aging and the Law  ●  Section on Law, Medicine, and Health Care
2015 AALS Annual Meeting in Washington, D.C.
January 3, 2015 from 3:30 to 5:15 p.m.
Unbefriended Elderly: 
Making Medical Treatment Decisions for Patients without Surrogates

The AALS Section on Aging and the Law and the AALS Section on Law, Medicine, and Health Care are sponsoring a joint program at the January 2015 Annual Meeting.  The program will consider many of the issues faced by elders, doctors, and the health care and social services systems when making medical treatment decisions for those incapacitated patients and residents who have no reasonably available legally authorized decision maker.

There are three confirmed panelists for this program:

(1)  Ellen Fox, MD, former Chief Officer for Ethics in Health Care, U.S. Department of Veterans Affairs

(2) Professor Lawrence A. Frolik, University of Pittsburgh School of Law

(3) Erica Wood, JD, Assistant Director, ABA Commission on Law and Aging

Two additional panelists will be selected through this call for papers.  Either paper proposals or completed papers are acceptable for submission.  Selected panelists may receive an offer for publication from the Journal of International Aging, Law & Policy, a joint publication of Stetson University College of Law and AARP.  The Journal is interested in papers that have an international or comparative component.  Acceptance of a publication offer is not a condition for serving as a panelist.  There is no formal requirement as to length of the proposal or final paper.  Preference will be given to papers that offer novel scholarly insights on the panel topic.  A paper may have already been accepted for publication as long as it will not be published prior to the Annual Meeting.

A successful proposal may focus on the broader legal, medical, or social aspects of making medical treatment decisions for patients without surrogates.  Also welcome are proposals that focus on ways to prevent patients from becoming unbefriended in the first place.  This could include analysis of: (a) broader default surrogate laws, (b) better advance care planning, or (c) more effective public guardianship procedures.  Narrative pieces concerning the administrative and regulatory issues presented will also be considered.

Paper proposals will be reviewed by a committee of law professors from both AALS sections.

Please submit your paper or proposal by Friday, August 31, 2014 at 5:00 p.m.  Please send it BOTH to Mark Bauer (Chair, AALS Section on Aging and the Law), Stetson University College of Law, mbauer at law.stetson.edu; and to Thaddeus Pope (Chair-Elect, Section on Law, Medicine, and Health Care), Hamline University School of Law, tpope01 at hamline.edu.

Public health in the shadow of the First Amendment

The First Amendment has been repurposed as a powerful deregulatory tool, especially in health care (NEJM on data privacy) and public health (NEJM on smoking). Amy Kapczynski at YLS has put together a timely and powerful conference, Public Health In The Shadow of the First Amendment. October 17-18 in New Haven. Register here.

@koutterson

 

Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

HealthAffairsJournal

Register online now!

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, “Using Big Data To Transform Care,” examines this new era for research and patient care from every angle.

You are invited to join Health Affairs Editor-in-Chief Alan Weil on Wednesday, July 9, for an event at the National Press Club, when the issue will be unveiled and authors will present their work.  Panels will cover:

  • Using Big Data At The Point Of Care
  • Research Issues
  • The Role Of The Federal Government
  • Obstacles/Challenges Of Using Big Data

Among the confirmed speakers are:  Continue reading

REGISTRATION OPEN: 9/18 conference on post-trial access

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014

Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.

This event is free and open to the public, but due to limited seating registration is required. Please register online.

Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.  Areas that currently lack clarity include:

  • What types of interventions or resources should be included within post-trial responsibilities?
  • What is a reasonable duration for post-trial responsibilities to extend?
  • What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?

This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.

Continue reading