PORTAL: Program on Regulation, Therapeutics, and Law
  • About Us
    • What is PORTAL?
    • Core Faculty
    • Research Team
    • Affiliated Faculty & Researchers
    • Expert Roundtable
  • Our Work
    • Publications
    • Policy Action
    • Literature Scan
    • In the Press
    • Media Center
    • Teaching
    • CeBIL
    • Biomarkers >
      • About The Project
      • The PBRC Team
      • Our Collaborators
      • AERO Graph
      • Workshops
      • Biomarkers2018
    • FDA REMS
  • Blog
  • Events
    • #policyethx 2020-2021
    • Events Archive >
      • #policyethx 2019-2020
      • #policyethx 2018-2019
      • #policyethx 2017-2018
      • #policyethx 2016-2017
      • Biosimilar Insulin
      • Older Events
  • Join Us
    • PORTAL Fellowships
    • Program Coordinator
  • Contact
    • Inquiries
    • E-mail List
  • About Us
    • What is PORTAL?
    • Core Faculty
    • Research Team
    • Affiliated Faculty & Researchers
    • Expert Roundtable
  • Our Work
    • Publications
    • Policy Action
    • Literature Scan
    • In the Press
    • Media Center
    • Teaching
    • CeBIL
    • Biomarkers >
      • About The Project
      • The PBRC Team
      • Our Collaborators
      • AERO Graph
      • Workshops
      • Biomarkers2018
    • FDA REMS
  • Blog
  • Events
    • #policyethx 2020-2021
    • Events Archive >
      • #policyethx 2019-2020
      • #policyethx 2018-2019
      • #policyethx 2017-2018
      • #policyethx 2016-2017
      • Biosimilar Insulin
      • Older Events
  • Join Us
    • PORTAL Fellowships
    • Program Coordinator
  • Contact
    • Inquiries
    • E-mail List
Picture

Health Policy & Bioethics Consortia 2019-2020

PORTAL runs a monthly seminar series that convenes two experts from different fields or vantage points to discuss how various aspects of therapeutic development and use are affected by ethical norms, laws, and regulations. These are organized in conjunction with the HMS Center for Bioethics  supported by the Oswald DeN. Cammann Fund at Harvard University.

You may join the discussion on Twitter before, during, or after each event by following 
@PORTAL_Research and using the hashtag #policyethx.

PAST EVENTS

Addressing the Public Health Crisis at Border Detention Centers

May 8, 2020 | Harvard Medical School

In the last few years, the process through which refugees from other countries seek to gain asylum in the US has been characterized by family separation, extended detentions, and reports of dangerous conditions. What is the role of physicians and other health care providers in these environments, and what sort of ethical and clinical dilemmas do they face?  What are the ways out of this crisis?
EXPERTS:

​
George Annas, J.D., M.P.H.
William Fairfield Warren Distinguished Professor and ​Chair
​Department of Health Law, Bioethics & Human Rights,
​Boston University School of Public Health

​
Katherine McKenzie, M.D.
Director, Yale Center for Asylum Medicine
​Department of Internal Medicine, Yale School of Medicine

​
Katherine Peeler, M.D.
Medical Director, Harvard Medical School Asylum Clinic
​Division of Medical Critical Care, Boston Children's Hospital​

MODERATOR:


​J. Wesley Boyd, M.D., Ph.D.
Co-founder, Human Rights and Asylum Clinic, Cambridge Health Alliance
Associate Professor of Psychiatry,
Harvard Medical School

Addiction: A Paradigm Shift from Problem to Patient through Policy

April 10, 2020 | Harvard Medical School

Addiction is one of numerous public health crises facing the US today. Treatment for severe substance use disorders (i.e., addiction) has evolved over time as science has advanced to better understand addiction as a chronic disease, acceptance of evidence-based practice guidelines, and availability of safe and effective treatments. Patients, however, still face barriers to engaging treatment for a variety of reasons (e.g., cost, stigma, limited resources), some of which will be explored in greater depth in this session. Thus, efforts to craft better policies that improve access to and affordable care for substance use disorder treatments are important.
EXPERTS:

Joshua Sharfstein, M.D.
Vice Dean for Public Health Practice and  Community Engagement
​Johns Hopkins Bloomberg School of Public Health

​Brandon del Pozo, Ph.D., M.P.A., M.A.
Chief of Police
(Retired)
Burlington, Vermont

MODERATOR:

​
Rachel Barenie, Pharm.D., M.P.H., J.D.
Postdoctoral Fellow, Program On Regulation, Therapeutics, And Law (PORTAL)​
Picture

Private Funding of Drug Discovery: Ethical Issues, Practical Alternatives

March 13, 2020 | Harvard Medical School

The traditional model for drug development begins with publicly-funded science based in academic or government laboratories before private investors and for-profit pharmaceutical manufacturers become involved with their substantial expertise and resources. This for-profit drug development model has also been criticized for leaving certain public health issues unaddressed, particularly diseases prevalent in low-resource settings. What is the viability of other alternatives for funding drug discovery and development? 
EXPERTS:
MODERATOR:
Picture
Rachel Cohen, M.P.P.
Regional Director, Drugs for Neglected Diseases Initiative

Picture
Sergio Sismondo, Ph.D.
Professor of Philosophy and Sociology
Queen's University

Picture
Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor of Medicine, Harvard Medical School
Assistant Director, Program On Regulation, Therapeutics, And Law (PORTAL)
​


Soda Taxes and Other Policy Responses to the Obesity Epidemic

February 14, 2020 | Harvard Law School


In recent years, some cities have tried to impose soda taxes and other new policies to reduce the obesity epidemic in the US—particularly among children—and its critical impact on society and the health care system. How effective are these policies? What is blocking their uptake?  What alternatives should we consider?
EXPERTS:

Emily Broad Leib, J.D.
Assistant Clinical Professor of Law
Director
 Food Law and Policy Clinic
Deputy Director, Center for Health Law and Policy Innovation
Harvard Law School


Steven Gortmaker, Ph.D.
Professor of the Practice of Health Sociology
Harvard T.H. Chan School of Public Health

MODERATOR:

​​Carmel Shachar, J.D., M.P.H.
Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
Harvard Law School
Picture

Gun Violence: The Health Care System's Role in a Public Health Epidemic

December 13, 2019 | Harvard Medical School

There is an epidemic of gun violence in the United States. Physicians are often on the front-line, but what can the health care system do to stem the epidemic? What evidence do we have about various legal options? And how do we implement change?
Picture
EXPERTS:

Megan Ranney, MD, MPH   
Associate Professor of Emergency Medicine, Warren Alpert Medical School
Chief Research Officer, American Foundation for Firearm Injury Reduction in Medicine (AFFIRM)


Rep. Liz Miranda
Massachusetts State Representative
​5th Suffolk District

MODERATOR:
​

Chana Sacks, MD, MPH
General Internist, Massachusetts General Hospital
Instructor in Medicine, Harvard Medical School
Co-Director, Mass General Center for Gun Violence Prevention

Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges

November 15, 2019 | Harvard Medical School

The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us to rethink the design of clinical trials and raises challenges for the traditional FDA approval process.

What is the future of these so-called "tumor-agnostic" therapies, and how will they be translated into effective treatment options in cancer and other diseases?
EXPERTS:

Steven Lemery, MD, MHS   
Associate Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration ​

​
​Lisa McShane, PhD
Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute

​
Deborah Schrag, MD
Chief, Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School

MODERATOR:
​
​
Spencer Hey, PhD

Faculty &Co-Director of Research Ethics, Center for Bioethics, Harvard Medical School
Research Scientist, Brigham and Women's Hospital
Picture

The Past and Future of Tobacco Regulation

October 11, 2019 | Harvard Medical School

After decades of efforts to better regulate the sale of tobacco products, the US has finally seen reductions in overall smoking levels. However, new dangers emerging from growing use of electronic cigarettes have threatened some of these public health advances, leaving the FDA and legislators scrambling. What lessons can we learn from past efforts to market tobacco products and past efforts to regulate them that we can apply to the current challenges in this field? ​
Picture
EXPERTS:

​
Howard Koh, MD, MPH
Harvey V. Fineberg Professor of the Practice of Public Health Leadership
Harvard T.H. Chan School of Public Health

​
​Keith Wailoo, PhD
Henry Putnam University Professor of History and Public Affairs
Princeton University

MODERATOR:

Lois Sheng Liu, JD, MSc
Postdoctoral Fellow
Program On Regulation, 
Therapeutics And Law
Brigham and Women's Hospital

Playing Games in the Prescription Drug Market: Cost Implications and Legal Solutions

September 13, 2019 | Harvard Medical School

High drug prices increase health care spending and cause substantial stress on patients. An important antidote to high prices is the introduction of low-cost generic drugs. However, brand-name drug manufacturers have employed various strategies to delay generic entry and undermine price competition, from forcing patients to switch to new formulations to transferring their patents to Native American tribes. What are the ethical implications of these strategies?  What is their economic toll?  How can we change the law to ensure that the generic drug market remains effective in delivering low-cost options for drugs and biologics?
EXPERTS:

​
Stacie B. Dusetzina, Ph.D.
Associate Professor of Health Policy and Ingram Associate Professor of Cancer Research
Vanderbilt University School of Medicine

C. Scott Hemphill, J.D., Ph.D., M.Sc.
Professor of Law
NYU School of Law

MODERATOR:


Michael S. Sinha, M.D., J.D., M.P.H.

Research Fellow, Harvard-MIT Center for Regulatory Science
Affiliate Researcher, Program On Regulation, Therapeutics, And Law (PORTAL)
Harvard Medical School
Picture
Picture
Program On Regulation, Therapeutics And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
1620 Tremont Street, Suite 3030
Boston, MA 02120
CONTACT