Bioethics and the Law of Reproductive Technology and Genetics:

Harvard Ed Portal, Allston, MA, September 13, 2016

Genetic enhancements. Reproductive technologies. Animal-human hybrids. Through new technologies and...

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Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics:

Petrie-Flom Center, Course begins September 6, 2016. Register now!

Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics

An introduction...

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Petrie-Flom Center Student Fellowship 2016-2017

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Petrie-Flom Center Student Fellowship 2016-2017
Petrie-Flom Center, Harvard Law School

Deadline: August 5, 2016, 9:00 AM

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS

The Center an...

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CALL FOR ABSTRACTS: 2017 Annual Conference
Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

Friday, April 28, 2017
Conferences
2016-2017
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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

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2016 Petrie-Flom Center Annual Open House

Wednesday, September 07, 2016 5:30 PM
Lectures and Panels
2016-2017
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

At this event, faculty, colleagues, and students with shared interests in health law policy, biotec...

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After IVF, Some Struggle With What To Do With Leftover Embryos

NPR, August 20, 2016
by Juli Fraga

[...] A study published in the March issue of the journal Fertility and Sterili...

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The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine&...

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Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing

New York Times, July 28, 2016
by Gina Kolata

Health regulators in the United States are talked about as the best in the world, but a new study o...

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Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks

Kaiser Health News, July 24, 2016
by Chad Terhune

Faced with superbug outbreaks in three countries by early 2013, Japanese device giant Olympus Corp....

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5 ways to avoid fighting over frozen embryos

Futurity, July 18, 2016
by David Orenstein-Brown, citing I. Glenn Cohen (Faculty Director)

[...] In a new paper, two experts review this history and propose five specific guidelines. The res...

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Embryo Disposition Disputes: Controversies and Case Law

Hastings Center Report, July/August 2016, Vol. 46, Issue 5
by I. Glenn Cohen (Faculty Director) & Eli Y. Adashi

Abstract:

When prospective parents use in vitro fertilization, many of them hope to generate more...

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Drugmakers Deploy New Patents To Delay Generic Versions Of Humira And Enbrel

Kaiser Health News, July 18, 2016

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

In ot...

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A designer will grow Alexander McQueen’s skin in a lab to use for leather bags and jackets

Quartz, July 16, 2016
by Marc Bain, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, an expert on the intersection of bioethics and law at Harvard Law School, s...

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Lower-cost biotech drug gets thumbs up from FDA panel

Washington Post, July 12, 2016
by Matthew Perrone, AP

WASHINGTON — The second-biggest selling drug in the world could get some cheaper competition...

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Elizabeth Holmes of Theranos Is Barred From Running Lab for 2 Years

New York Times, July 8, 2016
by Andrew Pollack

Federal regulators have barred Elizabeth Holmes, chief executive of Theranos, from owning or operat...

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Religion and Reproductive Technology

In Law, Religion, and Health in the United States (Holly Fernandez Lynch, I. Glenn Cohen, Elizabeth Sepper, eds.), forthcoming 2017, Cambridge University Press, 2017 (forthcoming)
by I. Glenn Cohen (Faculty Director)

Abstract:

This chapter will examines places where law, religion, and reproductive technology confl...

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Policy Advocacy Manager

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Policy Advocacy Manager
DNDi (Drugs for Neglected Diseases initiative), Geneva, Switzerland

Deadline: July 17, 2016

Terms of reference:

Title: Policy Advocacy Manager
Based: Geneva
Duration: Long ter...

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Digital Doctors And Virtual Medicine

WBUR, July 5, 2016
by Jane Clayson

The doctor’s appointment goes digital. Virtual visits, high-tech self-monitoring are here. We...

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Promoting Healthcare Innovation on the Demand Side,

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:

Innovation policy often focuses on the incentives of firms that sell new products. But o...

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Petrie-Flom, 10 years on:

Harvard Law Today, April 14, 2016

On March 29, current and former affiliates of the Petrie-Flom Center for Health Law Policy, Biotech...

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Health Acceleration Challenge

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Health Acceleration Challenge
Harvard Business School & Harvard Medical School

Deadline: May 16, 2016

There are few communities of professionals that are as innovative as those in health care. From inv...

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Associate Editor - Ethics

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Associate Editor - Ethics
American Medical Association Journal of Ethics

Deadline: Open until filled.

Associate Editor – Ethics

The American Medical Association (AMA), the nation’s largest...

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The Future of Health Law and Policy:
The Petrie-Flom Center’s 10th Anniversary Conference Celebration

Tuesday, March 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center celebrated its first decade and kicked off the next by looking at...

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CRISPR, Are We Ready to Rewrite the Human Genome?

ECUSA Boston, March 24, 2016
by Speaker: Rachel Sachs (Academic Fellow)

Rachel Sachs (Academic Fellow) was a speaker at the ECUSA Boston event "CRISPR, Are We Ready to Rew...

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FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating t...

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Genetically Modified Crops

Foundation of American Scientists

An introduction to genetically modified crops, including key ecological concerns. 

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Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of f...

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Food, Genetically Modified

World Health Organization

Educational page providing general and technical information on genetically modified foods. 

... Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, i...

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Genetically Engineered Crops in the United States

United States Department of Agriculture, February 2014

Report by the USDA Economic Research Service on recent trends in adoption of genetically engineered...

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Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of gover...

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Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well...

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USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and...

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Genetically Engineered Crops: Past Experience and Future Prospects

National Academy of Science

Website announcing NAS study on the benefits and risks of GE crops. 

... Read More

What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a biob...

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Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safe...

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Bioengineered (Genetically Engineered) Crops and Foods

American Medical Association

AMA statement on genetically engineered crops and foods. 

... Read More

Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking...

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Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening t...

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GMOs, Herbicides, and Public Health

New England Journal of Medicine, Aug. 20, 2015
by Philip J. Landrigan and Charles Benbrook

Describes the impact of two recent changes in the GMO landscape, and considers their larger implica...

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

Results from a national survey of U.S. biobanks, including information on location, reason for...

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Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes internat...

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Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the indus...

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Biobank resources for future patient care: developments, principles and concepts

Journal of Clinical Bioinformation, Sept. 2011
by Ákos Végvári et al

An overview of global biobank development, outlining the critical research role of biobanks an...

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Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority. 

... Read More

Clinical Trial Data Portal Gateway

EFPIA

This site offers a published list of major pharmaceutical companies’ online portals aimed&nbs...

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WMA Declaration on Ethical Considerations Regarding Health Databases and   Biobanks

World Medical Association, March 2015

A supplemental declaration to the Declaration of Helskini, which provides additional principle...

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Fertility Tourism: Options and Ethics

Creating A Family Radio, February 24, 2016
by Dawn Davenport, interviewing I. Glenn Cohen (Faculty Director)

Description:

What should you consider when going abroad (or coming to the United States) for ferti...

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Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and pu...

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Sharing of Clinical Trials Data: Benefits, Risks, and Uniform Principles

Annals of Internal Medicine, 2015
by Michael Rosenblatt et al.

This commentary discusses the benefits and risks of data sharing from the perspective of perso...

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Research Repositories, Databases, and the HIPAA Privacy Rule

NIH, January 2004

Discusses the impact of the HIPAA privacy rule on the creation of research databases and repos...

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Ethicist

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Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicist

Status: Full Time

File#: 2016-4494

Dept/Health System: Ethics

Site: Trillium...

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Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food w...

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Sharing and Reporting the Results of Clinical Trials

JAMA, Jan. 2015
by Kathy L. Hudson and Francis S. Collins

This article advocates for sharing the results of clinical trials as an important means for ad...

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Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

An extensive listing of biobanks, tissue banks, and biorepositories, with links to all institu...

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Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

[...] The draft guidance comes as over the past few years, FMT, which basi...

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Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA.

... Read More

Going Germline: Mitochondrial Replacement as a Guide to Genome Editing

Cell, February 25, 2016, Vol. 164, Issue 5
by By Eli Y. Adashi & I. Glenn Cohen (Faculty Director)

Mitochondrial replacement (MR) serves as a crucial test case and learning guide for the scientific,...

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the P...

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How to Make the Most of Drugs We Already Have

The Upshot, New York Times, February 22, 2016
by By Austin Frakt, citing Ben Roin (Academic Fellow alumnus)

From the article

[...] Moreover, if a drug company cannot ascertain the problem for which a prescr...

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Canaries in the Coal Mine:
People with Disabilities and Non-Invasive Prenatal Diagnosis

Monday, February 22, 2016 12:00 PM
Lectures and Panels
2015-2016
Wasserstein Hall, Room B015
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

A lecture by Tom Shakespeare

About the Speaker

Tom Shakespeare is Senior Lecturer at Norwich...

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The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

Presentation Abstract: 

Scientists have recently begun to appreciate the important role playe...

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Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law. 

... Read More

NAM Releases Report on Mitochondrial Replacement Therapy

Bill of Health Blog, February 3, 2016
by I. Glenn Cohen (Faculty Director)

From the Part II post: 
 
My last post was a summary of the NAM’s Reco...
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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Couldn't attend in person? Learn more about the event:

  • Learn more about the presentations...

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Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

From the article:

[...] Talk about sending the wrong signals about what sorts of drugs we value mo...

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“FDA in the 21st Century: A Panel Discussion”:

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch...

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Symposium on “Ethical Risk Assessment in Biomedical Big Data”

Organised by the Oxford Internet Institute, University of Oxford, in association with the Brocher Foundation., March 14-15, 2016
by Featuring I. Glenn Cohen (Faculty Director)

Please register via the event website.

Description

In biomedical research, the analysis of large...

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Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article: 

Most people would agree that it would be better to prevent cancer, if...

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Big Pharma, the game, makes it “easy to be villainous”

STAT, November 11, 2015
by Ike Swetlitz, referencing Rachel Sachs (Academic Fellow)

Excerpt from Article:

[...] While Wicksteed made the game for the general public, the scientific a...

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Neuroethics Seminar: Brain Hacking to Boost Your A-Game:
The Ethics of Cognitive Enhancement in Gaming and Competition

Wednesday, October 21, 2015 4:30 - 6:00 PM
Lectures and Panels
2015-2016
Armenise Building, D Amphitheatre
Harvard Medical School, 210 Longwood Ave., Boston, MA

Event Description

This event was free and open to the public. 

Personal enhancement isn'...

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Moral Bioprediction, Bioenhancement, and the Law:
A Lecture by Julian Savulescu

Tuesday, October 20, 2015 12:00 PM
Lectures and Panels
2015-2016
Pound Hall, Room 102
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

Description 

Increasingly, knowledge from biology and neuroscience allows us to identify biol...

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Regulating Secrecy

Washington Law Review, 2015 (Forthcoming)
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:      


Regulation interacts with intellectual-property exc...

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Postdoctoral Fellowship

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Postdoctoral Fellowship
McCoy Family Center for Ethics in Society, Stanford University

Deadline: December 7, 2015

For 2016-2017, we seek up to three new postdoctoral fellows.

We welcome candidates with substantia...

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Synthetic Biology:
Science, Policy, and Ethics

Thursday, October 08, 2015 4:00 PM
Lectures and Panels
2015-2016
Harkness South Dining Room (205)
Harvard Law School, Casperson Student Center, Cambridge, MA

Description

Synthetic biology, "which aims to apply standardized engineering techniques to biology...

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Call for Applications: OneStart Accelerator Programme

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Call for Applications: OneStart Accelerator Programme
OneStart, London & Boston

Deadline: December 01, 2015

Translate your research into the real world.

Join us at our official Boston Launch Night to learn...

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Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change Conference

UNH School of Law, October 26, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change

When: Monday...

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