Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
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 discussin...

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REGISTER NOW!: Second Annual HLS-UCLA Food Law and Policy Conference:
Drugs, Animals, and Food: Law & Policy of Antibiotics in the Food System

Friday, October 23, 2015 8:30 AM - 5:00 PM
Conferences
2015-2016
Harvard Law School
Cambridge, MA

Description

The debate over antibiotic use in animal agriculture combines elements of science, eth...

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For a Rare Disease, Drug Trials Scramble for Patients:

Wall Street Journal, August 19, 2015
by Amy Docker Marcus

After years of effort, scientists and families of young patients with the genetic condition Niemann...

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Price Rises For Ticket To A Quicker Drug Review By FDA

NPR, August 19, 2015
by Scott Hensley

A deal struck between drugmakers AbbVie and United Therapeutics Wednesday set a record price for a...

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Price Rises For Ticket To A Quicker Drug Review By FDA

NPR, August 19, 2015
by Scott Hensley

A deal struck between drugmakers AbbVie and United Therapeutics Wednesday set a record price for a...

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The FDA just recalled Kim Kardashian’s Instagram post

Washington Post, August 11, 2015
by Carolyn Johnson

When Kim Kardashian tweeted and instagrammed her enthusiasm about a morning sickness treatment, her...

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Catching Up With a Childhood Killer, Diarrhea

New York Times, August 10, 2015
by Donald G. McNeil, Jr.

Far from the world’s fears about Ebola and MERS, a quiet revolution is taking place...

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Less-Addictive Opioids Could Boost Drug Firms’ Image

NPR, August 2, 2015
by Rachel Martin, interviewing David Crow

RACHEL MARTIN, HOST:

Every day, according to the Centers for Disease Control, 44 Americans die bec...

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‘Abortion pill’ legalised in Canada

BBC News, July 30, 2015

Canadian health authorities have approved the drug RU-486, commonly known as the abortion pill.

Th...

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Drug Prices Soar, Prompting Calls for Justification

New York Times, July 23, 2015
by Andrew Pollack

As complaints grow about exorbitant drug prices, pharmaceutical companies are coming under pressure...

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Daily H.I.V. Drug Regimen Is Effective in African Women, Study Says

New York Times, July 22, 2015
by Donald G. McNeil, Jr.

Taking an antiretroviral drug daily shielded 76 percent of young African women assigned the drug &m...

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Promising Alzheimer’s Drugs Disappoint With Incremental Data

Forbes, July 22, 2015
by Matthew Herper

New data being presented this morning on experimental Alzheimer’s drugs from Biogen and Eli L...

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Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the N...

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Mass. Child Advocates Want To Screen Every Public School Student For Substance Use

WBUR (NPR Boston), July 16, 2015
by Deborah Becker

BOSTON - Some advocates for children in Massachusetts are suggesting another way to help stem&...

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California, Oregon To Allow Hormonal Contraceptives Without A Doctor’s Prescription

Kaiser Health News, July 15, 2015
by Barbara Feder Ostrov

California and Oregon will be the first states in the nation to allow women to get birth control pi...

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Specialty Pharmacies Proliferate, Along With Questions

New York Times, July 15, 2015
by Katie Thomas and Andrew Pollack

[...] Ms. Short is not dealing with her corner drugstore but with a so-called specialty pharma...

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Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the&nb...

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New Drug Agency Chief To Revive Buy Back Program

NPR, July 13, 2015
by Carrie Johnson

When Chuck Rosenberg took the top job at the at the Drug Enforcement Agency two months ago, the lon...

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Bill To Speed Drug Approvals Process Passes House With Strong Bipartisan Vote

Kaiser Health News, July 13, 2015

KHN Morning Briefing: Summaries of health policy coverage from major news organizations.

The...

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More than meets the IRB: On human subjects research and regulation: perspectives on the future

More Than Meets the IRB Podcast , May 2015, No. 11
by Holly F. Lynch (Executive Director), I. Glenn Cohen (Faculty Director), Michael Leary

In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen...

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Fall 2015 Course: Drug Product Liability Litigation

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Fall 2015 Course: Drug Product Liability Litigation
Harvard Law School

Deadline: Waitlist processing will run from Monday, May 18, 2015 through Friday, June 26, 2015.

Drug Product Liability Litigation

Mr. Peter Grossi
Fall 2015 Course
Meets: T, W 5:00pm - 7:00..
.

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FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, 1525 Massachusetts Ave., Cambridge, MA

Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussed the balance between sp...

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“Ending Institutional Corruption” conference, May 1-2

Edmond J. Safra Center for Ethics at Harvard University, April 14, 2015

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in th...

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Health Law Workshop: Rachel E. Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "Rethinking the Incentives/Access Dichotomy: Prescription Drug Reimbursement as...

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Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

Iowa Law Review, Vol. 81, No. 4, 2016 Forthcoming
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Founding Faculty Director Einer Elhauge and four co-authors have just posted a new article&nbs...

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Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the Un...

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Robust Exclusion and Market Division Through Loyalty Discounts

Harvard Public Law Working Paper No. 14-12, April 2, 2015
by By Einer Elhauge (Founding Faculty Director) and Abe Wickelgren

Founding Faculty Director Einer Elhauge has coauthored an article Abe Wickelgren on loyalty discoun...

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Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,

Petrie-Flom Center, February 5, 2015

On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethic...

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Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Couldn't make it in person? Check out the individual sessions in the videos linked above!

The...

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Program Manager

...

Program Manager
Harvard Multi-Regional Clinical Trials Center

Deadline: Open until filled.

The mission of the MRCT Center at Harvard is to improve the design, conduct, and oversight of multi...

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First biosimilar drug set to enter US market:

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its...

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Houston doctor sued for trading prescriptions for sex

Houston Chronicle, December 12, 2014
by St. John Barned-Smith, quoting I. Glenn Cohen (Faculty Director)

[...] Legal experts who specialize in medical ethics said the allegations and actions captured on f...

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Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 8:00 AM - 5:00 PM
Conferences
2014-2015
Washington, DC

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law...

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​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumnus) and I. Glenn Cohen (Faculty Director)

From the article:

[...] The FDA’s regulation of drugs is frequently the subject of poli...

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Can Big Data Cure Cancer?

U.S. News, October 15, 2014
by Lindsey Cook, quoting I. Glenn Cohen (Faculty Director)

From the article: 

In some ways, the learning health system has been around since the beginni...

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Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 7:30 AM - 5:30 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Conference Description 

Who:

Clinical research sponsors, investigators, funders, regulators...

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An Interview with I. Glenn Cohen on Controversial Health Issues

PBS.org, September 9, 2014
by Tavis Smiley, interviewing I. Glenn Cohen (Faculty Director)

In an interview with PBS.org, Faculty Director I. Glenn Cohen, sat down with Tavis Smiley to d...

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Ebola Crisis and Rationing

CCTV Mandarin, August 13, 2014
by CCTV Broadcaster, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV Mandarin to discuss the ration...

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article:

One of the largest big-data experiments in health care has set its first researc...

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article:

One of the largest big-data experiments in health care has set its first researc...

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How patent reform’s fraught politics have left USPTO still without a boss

The Washington Post, July 30, 2014
by Nancy Scola, quoting W. Nicholson Price II (Affiliated Faculty)

From the article:

[...] The controversy began in late June when rumors started to trickle out that...

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Clinical Trials and the Right to Remain Silent

JAMA, July 21, 2014
by Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial da...

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Call for Submissions: Journal of Law and the Biosciences

...

Call for Submissions: Journal of Law and the Biosciences

Deadline: Rolling admission.

Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, response...

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California Counties Sue 5 Narcotics Makers

Here & Now, NPR, May 22, 2014
by Robin Young interviewing I. Glenn Cohen (Faculty Director)

Two counties in California — Orange and Santa Clara — are suing five major drug compani...

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Public Workshop: Strategies for Responsible Sharing of Clinical Trial Data

Institute of Medicine, National Academies, May 5, 2014
by Featuring a presentation by I. Glenn Cohen (Faculty Director)

Petrie-Flom Center Faculty Director I. Glenn Cohen will participate in a session on "Oper...

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Reforming Brazilian Pharmaceutical Patent Policy:
Lessons from the Past and the Road for the Future

Wednesday, April 23, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

In this lecture by Pedro Paranaguá, he discussed the report issued by the Brazilian Hou...

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Dallas Buyers Club:
Free Film Screening and Panel Discussion

Wednesday, April 16, 2014 6:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

Students from across Harvard were invited to view a free screening of the Academy-award winning fil...

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Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. ...

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Make it Work!:

Harvard Law Review 128, 2014
by I. Glenn Cohen (Faculty Co-Director)

This short essay is part of a Harvard Law Review Symposium honoring Justice Breyer on his 20th Year...

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The “Problem” with the European Problem/Solution Approach to Inventive Step

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
by Harold C. Wegner, reviewing Timo Minssen (Petrie-Flom Visiting Scholar)

From the review: Patent applicants seeking to gain global patent protection beyond their home...

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Patents Without Patents:
Regulatory Incentives for Innovation in the Drug Industry

Wednesday, February 19, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing n...

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Patent Trolling:

by Robin Feldman and W. Nicholson Price II (Petrie-Flom Academic Fellow)

Abstract:

Patent trolls — also known variously as non-practicing entities, patent assertion...

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Health Law Year in P/Review

Friday, January 31, 2014 8:30 AM - 5:00 PM
Conferences
2013-2014
Wasserstein Hall, Milstein East B & C
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

Video of this conference is now available at online! (See below for links to specific panels.)

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Do Fixed Patent Terms Distort Innovation?:

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
by Eric B. Budish, Benjamin N. Roin, and Heidi Williams

Abstract: Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the...

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Health Law Workshop: Aaron Kesselheim

Monday, November 18, 2013 5:00 PM
Health Law Workshops
2013-2014
Hauser 105
1575 Massachusetts Ave., Cambridge, MA

Professor Kesselheim's paper, "Do March-In Rights Protect Public Interests in Medical Products...

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Pharma manufacturing woes dog industry

Chemistry World, October 23, 2013
by Sarah Moulton, quoting W. Nicholson Price II

[...] While many of these problems arise from quality control failures, according to Nicholson...

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Plan B:

Association of Reproductive Health Professionals, Contraception Journal, October 2013
by I. Glenn Cohen, Lisa Sullivan, Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates...

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Chris Hansen on “Dis-Owning Nature: The BRCA Gene Patents and the Supreme Court”

Program on Science, Technology, & Society at HKS, November 12, 2013
by Featuring I. Glenn Cohen as a discussant

ABOUT THE SPEAKER

Chris Hansen joined the ACLU in 1973. He spent 10 years at the NYCLU specializin...

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Praise for “Making Do in Making Drugs” by W. Nicholson Price II

Written Description: Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation, September 28, 2013
by Camilla Alexandra Hrdy

"'M&M chocolate candies are made with a precision far beyond the capabilities of many drug...

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The Globalization of Health Care
Book Talk and Discussion by Editor I. Glenn Cohen

Tuesday, September 24, 2013 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 3019
1585 Massachusetts Ave., Cambridge, MA
Watch Event Recordings

I. Glenn Cohen, Faculty Co-Director of the Petrie-Flom Center and Professor at Harvard Law School,...

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Making Do in Making Drugs:

Boston College Law Review, forthcoming
by W. Nicholson Price II

Abstract:  

Drug recalls, contamination events, and shortages are on the rise, but drug compa...

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When Truth Cannot Be Presumed:

Boston University Law Review, 2014
by Christopher T. Robertson

Abstract:      
The Food, Drug, and Cosmetic Act (“FDCA”)...

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Issues and Case Studies in Clinical Trial Data Sharing:
What Have We Learned?

Friday, May 17, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East, Harvard Law School
1585 Massachusetts Ave., Cambridge, MA
Watch Event Recordings

Objectives:

  • To convene key global stakeholders on a neutral platform to review evidence from rec...
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The Food and Drug Administration in the 21st Century:
The 2013 Petrie-Flom Center Annual Conference

Friday, May 03, 2013 - May 4, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East ABC, Harvard Law School
Watch Event Recordings

Conference Description

The Food and Drug Administration, the US government’s oldest comprehe...

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Personalized Medicine Patenting

Wednesday, March 06, 2013
Lectures and Panels
2012-2013
Austin Hall 111, Harvard Law School
Watch Event Recordings

Pharmaceutical researchers pursue medical treatment and diagnostic methods to target diseases speci...

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Compliance with and Enforcement of US Healthcare Laws:
Evolution of Modern Life Sciences Compliance

Monday, February 18, 2013
Lectures and Panels
2012-2013
Wasserstein Hall, Milstein West A, Harvard Law School
Watch Event Recordings

There have been a number of prosecutions of life sciences companies under the Food, Drug, and Cosme...

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Ontario judge gives green light to Yasmin, Yaz class action lawsuit

Global News, April 18, 2013
by Carmen Chai

In the U.S., these cases were ultimately consolidated.

"In the U.S., most class actions never go t...

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Food & Drug Law, Past, Present, & Future:
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS

Thursday, January 17, 2013
Lectures and Panels
2012-2013
Wasserstein 2019, Milstein West AB, Harvard Law School
Watch Event Recordings

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specia...

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Patent Policy and Innovation

Friday, April 23, 2010
2009-2010

This panel focused on how patent law affects various industries differently. The pharmaceutica...

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Developments and Implications of New Legislation on Follow-on Biologics

Wednesday, January 06, 2010
Lectures and Panels
2009-2010

This panel examined current legislative debates concerning the development of regulatory appro...

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Health Metrics Workshop

Thursday, November 05, 2009
Conferences
2009-2010

Over two days in November, the Center convened leading thinkers in the area of health metrics...

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Medical Prize Funds:
An Alternative Reward Mechanism for Medical Innovation

Thursday, November 05, 2009
Lectures and Panels
2009-2010

Patenting and other rewards that rely on protected markets to encourage research investment in...

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