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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‘Organs-on-chips’ wins design award

BBC News, June 23, 2015
by James Gallagher

Silicon chips that mimic the function of living human organs have won the Design of the Year award...

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CVS Will Buy Target’s 1,600 Pharmacies, Clinics For $1.9B

Forbes, June 15, 2015
by Bruce Japsen

CVS Health (CVS) said today it would buy the pharmacy and clinic business of retail giant Target (T...

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Companies Can Fire Workers for Marijuana Use, Colorado Court Rules

New York Times, June 15, 2015
by Jack Healy

DENVER — Businesses can fire employees for using marijuana, even if they are smoking it off t...

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A Chinese Ebola Drug Raises Hopes, and Rancor

New York Times, June 11, 2015
by Sheri Fink

After a nurse who contracted Ebola in Sierra Leone was discharged Wednesday fro...

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Panel Tells F.D.A. to Back Second Drug to Help Heart

New York Times, June 10, 2015
by Gina Kolata

An expert committee that advises the Food and Drug Administrationrecommended on Wednesday that...

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Bill To Speed FDA Approvals Includes Rewards For Drugs Designed For Kids

Kaiser Health News, June 8, 2015
by Lisa Gillespie

Advocates for children with rare diseases are watching closely a congressional effort to streamline...

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‘Viagra for Women’ Is Backed by an F.D.A. Panel

New York Times, June 4, 2015
by Andrew Pollack

After an intense lobbying campaign, a federal advisory panel recommended approval of what would bec...

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White House Meeting Elicits Pledges to Reduce Antibiotic Use

New York Times, June 2, 2015
by Sabrina Tavernise

WASHINGTON — The Obama administration convened representatives of hospitals, food producers,...

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Japanese Companies Attack Neglected Diseases

New York Times, June 1, 2015
by Donald G. McNeil Jr.

Several Japanese drug companies have joined a new project to find medicines to treat two neglected...

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H.I.V. Treatment Should Start at Diagnosis, U.S. Health Officials Say

New York Times, May 27, 2015
by Donald G. McNeil Jr.

People with H.I.V. should be put on antiretroviral drugs as soon as they learn they are i...

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As Antibiotic Resistance Spreads, WHO Plans Strategy To Fight It

NPR, May 27, 2015
by Jason Beaubien

[...] At the WHO's annual meeting in Geneva this week, representatives from 194 countries ...

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New Push Ties Cost of Drugs to How Well They Work:

Wall Street Journal, May 26, 2015
by Peter Loftus

Express Scripts Holding Co., a large manager of prescription-drug benefits for U.S. employers...

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Multiple Sclerosis Patients Stressed Out By Soaring Drug Costs

NPR, May 25, 2015
by Richard Harris

[...] A recent study from Oregon State University and the Oregon Health and Science...

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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

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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

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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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