NEW EVENT (2/18): Assessing the Viability of FDA’s Biosimilar Pathway

16.02.18, FDA Biosimilars Pathway posterNEW EVENT: Assessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA

Description

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  Continue reading

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

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TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium


MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West AB 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

TOMORROW, 1/20! A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

UPDATED AGENDA: Fourth Annual Health Law Year in P/Review, January 29!


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

1/20/16: Register Now! A Conversation with Margaret Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of Law and Business about the failures of the patent system to support new therapeutics. The text is below:

Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine

Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Continue reading

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

Gallery

Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, … Continue reading

The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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The Common Rule NPRM: Biospecimens

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Continue reading

REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:30 AM – 5:00 PM
8:30am-12:40pm: Austin Hall North (100);
12:40-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.

Agenda

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10/14: Webcast on the NIH’s Efforts to Support Translational Science

This month’s Regulatory Science Series presentation features Dr. Keith Joiner, MD, MPH, the Director of the Center for Management Innovations in Health Care at the Eller College of Management, and former Dean of the University of Arizona College of Medicine. He will present on NIH Efforts to Support Translational Science and discuss the importance of government funding policy to the regulatory science endeavor.

This event will stream live at 12:00 PM MT on Wednesday, October 14, 2015, at:  https://streaming.biocom.arizona.edu/event/index.cfm?id=26072.

The University of Arizona Regulatory Science Program is a partnership with the James E. Rogers College of Law and University of Arizona Health Sciences.

Bioethicist Art Caplan: No time to waste – the ethical challenges created by CRISPR

Bill of Health Contributor Art Caplan has a new article in EMBO Reports:

The term “CRISPR” has gained a lot of attention recently as a result of a debate among scientists about the possibility of genetically modifying the human germ line and the ethical implications of doing so. However, CRISPR is not just a method to edit the genomes of embryonic cells, as the public discussion might have implied; it is a powerful, efficient, and reliable tool for editing genes in any organism, and it has garnered significant attention and use among biologists for a variety of purposes. Thus, in addition to the discussion about human germ line editing, CRISPR raises or revives many other ethical issues, not all of which concern only humans, but also other species and the environment.

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Panel Tomorrow (10/8), 4 PM: Synthetic Biology – Science, Policy, and Ethics

DNAdata_green_slideSynthetic Biology: Science, Policy, and Ethics
October 8, 2015 4:00 PM
Harkness South Dining Room (205), Casperson Student Center
Harvard Law School, Cambridge, MA [Map]

 

Description:

Synthetic biology, “which aims to apply standardized engineering techniques to biology and thereby create organisms or biological systems with novel or specialized functions to address countless needs,”* offers the potential for tremendous benefit, alongside a range of possible risks.  How should these benefits and risks be balanced, from a scientific, ethical, and policy perspective?  Please join us for a discussion of these issues with a leader in the field of synthetic biology and an expert in risk regulation and policy.

Panelists:

  • George ChurchProfessor of Genetics, Harvard Medical School and Director, org
  • Adam Finkel, Senior Fellow and Executive Director, Penn Program on Regulation, University of Pennsylvania Law School and Clinical Professor of Environmental Health Sciences, University of Michigan School of Public Health
  • Moderator: Holly Fernandez Lynch Executive Director, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

This event is free and open to the public.

A video recording will be posted after the event on our website.

Find out as soon as the video is available – subscribe to our newsletter!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Monday, 9/21, HLS Health Law Workshop with Jessica Roberts

HLS Health Law Workshop: Jessica Roberts

September 21, 2015 5:00 PM
Hauser Hall, Room 102
Harvard Law School, 1575 Massachusetts Ave, Cambridge MA

Download the paper: “Theories of Genetic Ownership”

Jessica L. Roberts is the Director of the Health Law and Policy Institute and an Associate Professor of Law at the University of Houston Law Center. She specializes in health law, disability law, and genetics and the law. Prior to UH, Professor Roberts was an Associate-in-Law at Columbia Law School and an Adjunct Professor of Disability Studies at the City University of New York. Immediately after law school, she clerked for the Honorable Dale Wainwright of the Texas Supreme Court and the Honorable Roger L. Gregory of the Fourth Circuit Court of Appeals.

Professor Roberts’ research operates at the intersection of health law and antidiscrimination law. Her scholarship has appeared, or is forthcoming, in the Indiana Law Journal, the William and Mary Law Review, the Iowa Law Review, the Minnesota Law Review, the University of Illinois Law Review, the Notre Dame Law Review, the Vanderbilt Law Review, the University of Colorado Law Review, the American Journal of Law and Medicine and the Journal of Law and the Biosciences, among others. Professor Roberts teaches, or has taught, Contracts, Disabilities and the Law, Genetics and the Law, and Health Law Survey. In 2015, she received the university-wide Teaching Excellence Award and the Provost’s Certificate of Excellence. Professor Roberts was named a 2018 Greenwall Faculty Scholar in Bioethics.

Managing Diabetes: Is Silicon Valley the Solution?

By Emma Sandoe

According to a new study in JAMA, half of American adults either have diabetes or are pre-diabetic. The chronic condition costs the nation $245 billion annually in health care costs and lost wages. The diabetes technology industry has grown exponentially over the last several years, as the use of measuring and regulating devices has become the norm for monitoring and treating diabetes.

Last week, NPR examined how Google’s Life Sciences division is investing in the management of diabetes. Google’s Life Sciences division is part of its renamed company, Alphabet, and stems out of Google X — the same side of the company working on technology such as driverless cars and tracking the spread of disease outbreaks.

One of Google’s most anticipated products coming out of the new diabetes campaign is a contact lens that would be able to monitor glucose levels from water in the eye. This joint venture with Novartis was announced in January 2014 and is currently slated for research and developmental reviews.

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Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Continue reading

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!