Harvard Medical School 2017 Bioethics Conference: The Ethics of "Making Babies"

Friday, April 07, 2017
Conferences
2016-2017
Harvard Medical School
Boston, MA

The use of assisted reproductive technologies raises far-reaching ethical and legal implications, ye...

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Health Law Workshop: Kathryn Zeiler

Monday, March 27, 2017 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Kathryn Zeiler is Professor of Law and Nancy Barton Scholar at the BU School of Law. Prior to j... Read More

Trump’s HHS Pick Favored Drugmakers, Device Makers And Doctors

Kaiser Health News, January 23, 2017
by Christina Jewett and Marisa Taylor

As Cabinet nominee Tom Price faces a Senate confirmation hearing Tuesday, a newly released trove of...

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6 Senators Assessing Trump’s HHS Nominee Own Health Care Stocks, Too

NPR, January 18, 2017
by Sydney Lupkin

President-elect Donald Trump's pick to run the Department of Health and Human Services is taking...

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Donors and Drug Makers Offer $500 Million to Control Global Epidemics

New York Times, January 18, 2017
by Donald G. McNeil, Jr.

Stung by the lack of vaccines to fight the West African Ebola epidemic, a group of prominent donors...

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Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

>Abstract: Inventors face a stark choice between two intellectual property systems of protecting... Read More

From Twitter To Treatment Guidelines, Industry Influence Permeates Medicine

NPR, January 17, 2017
by Charles Ornstein

The long arm of the pharmaceutical industry continues to pervade practically every area of medicine,...

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A New Fertility Technique Could Make ‘Designer Babies’ a Reality

Gizmodo, January 13, 2017
by Kristen V. Brown, quoting I. Glenn Cohen (Faculty Director)

From the article

:

In vitro gametogenesis, or IVG, is a technique that could allow any kind of...

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Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-148
0
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUI
T  
; AMGEN INC., AMGEN MANUFAC...

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FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Several praised the move to delay the final guidance, particularly as a new...

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Unexpected Risks Found In Replacing DNA To Prevent Inherited Disorders

NPR, January 1, 2017
by Jill Neimark

In September, reproductive endocrinologist John Zhang and his team at the New Hope Fertility Center...

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Mitochondrial Replacement Therapy: Unmade in the USA

The JAMA Forum, December 21, 2016
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article

:

Mitochondrial replacement therapy, an experimental approach that takes aim at mat...

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The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
by Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article

:

In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethi...

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Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits

New York Times, December 19, 2016
by Matt Richtel and Andrew Pollack, quoting Rachel E. Sachs (Academic Fellow alumna)

From the article

:

Rachel Sachs, an associate law professor at Washington University in St. Louis an...

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Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite

Forbes, December 15, 2016
by David Shaywitz

In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with...

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Cures Act Gains Bipartisan Support That Eluded Obama Health Law

New York Times, December 8, 2016
by Robert Pear

WASHINGTON — With self-congratulatory zeal and smiles all around, huge bipartisan majorities i...

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Should We Ban Anonymous Sperm Donation?

Vocativ, November 30, 2016
by Tracy Clark-Flory, quoting I. Glenn Cohen (Faculty Director)

From the article

:

There’s a push underway to change the way that most sperm is donated&n...

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Call for Abstracts: The Ethics of “Making Babies”
Harvard Medical School

Deadline: January 31, 2017, 5:00 PM

The use of assisted reproductive technologies raises far-reaching ethical and legal implications, ye...

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Morning View 11-28-16: Pharmaceuticals News

Institute for Clinical and Economic Review's Morning View, November 28, 2016
by Mitchell Stein, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

On Friday, building on the long-standing DC tradition of releasing gargantuan reg...

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Lame duck Congress looks for swift approval of massive medical innovation bill

AJC.com (The Atlanta Journal-Constitution), November 27, 2016
by Jamie Dupree, citing Tweet & Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

(Tweet by Rachel E. Sachs) My 1st thoughts on today's draft of 21st Cent...

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Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

Regulatory Affairs, November 16, 2017
by Zachary Brennan, citing Twitter accounts of Rachel E. Sachs (Academic Fellow Alumna), Ameet Sarpatwari, Aaron Kesselheim and Amitabh Chandra (Affilia

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matte...

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Online J-Term Health Law Courses
875 Summit Ave. | St. Paul, MN 55105

Deadline: January 02, 2017

The Mitchell Hamline School of Law Health Law Institute is pleased to offer two online health law co...

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Drug Pricing: Where Do We Go After the Election?

Institute for Public Health, Washington University in St. Louis, October 26, 2016
by Rachel Sachs

From the blog post

:

Martin Shkreli. Valeant Pharmaceuticals. Mylan. Just a year ago, most Americans...

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Health Law Workshop: W. Nicholson Price II

Monday, October 17, 2016 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Presentation: "Regulating Black-Box Medicine

"

This paper is not available for download. To request...

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Professor offers basics of bioethics and the law in 90 minutes:

Harvard Gazette, September 20, 2016
by Deborah Blackwell, reviewing lecture by I. Glenn Cohen (Faculty Director)

On September 13, 2016, Petrie-Flom Faculty Director I. Glenn Cohen delivered a lecture at the Harvar...

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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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PFC Spotlight: Student Fellow Alumnus Neel Shah

Petrie-Flom Center, September 8, 2016

>Dr. Neel Shah was a Student Fellow for the 2007-2008 academic year, while in his third year at Harva...

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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, biotech...

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Federal Government’s Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered

Biopreservation and Biobanking, September 2016
by Christopher T. Robertson and Jonathan D. Loe

>Note: The full article is behind a paywall

.

Abstract

:

In September, the U.S. Department of Health...

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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 Genetic

s

An introduction...

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Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post

:

Obviously Mylan didn't want to underprice its own branded drug, but it's pos...

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The GMO Labeling Fight Is Not Industry Versus Consumers

Forbes, August 26, 2016
by Steve Ansolabahere and Jacob E. Gersen (Director, Food Law Lab)

From the article

:

In late July, President Obama signed a bill requiring some form of labeling of fo...

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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&n...

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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 resu...

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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 e...

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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, sa...

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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 confli...

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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 Manage
r Based: Genev
a Duration: Long term...

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

Deadline: August 05, 2016

THE PETRIE-FLOM CENTE

R

STUDENT FELLOWSHIP PROGRAM, 2016-201

7

CALL FOR APPLICATION

S

The Center and...

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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 op...

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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, Biotechn...

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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 inve...

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Associate Editor - Ethics
American Medical Association Journal of Ethics

Deadline: May 27, 2016

Associate Editor – Ethic

s

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

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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 Rewr...

Read More

FDA - Food

U.S. Food and Drug Administration

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

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Genetically Modified Crops

Foundation of American Scientists

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

... Read More

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 fo..

. Read More

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, in...

Read More

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 govern...

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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 a...

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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...

Read More

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 bioba..

. Read More

Foodborne Outbreaks

Centers for Disease Control

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

Read More

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 f...

Read More

Food Safety

FoodSafety.gov

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

Read More

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 implicat...

Read More

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...

Read More

Codex Alimentarius

World Health Organization

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

Read More

Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

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

Read More

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 and...

Read More

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 ...

Read More

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 principles...

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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 fertil...

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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 pub...

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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 person...

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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 reposi...

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Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicis

t

Status: Full Tim

e

File#: 2016-449

4

Dept/Health System: Ethic

s

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 wa...

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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 adv...

Read More

Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

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

Read More

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 basic...

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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,...

Read More