Category: Petrie-Flom Center

Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”

The Petrie-Flom Center Staff Leave a comment

Please save the date for this upcoming conference at Harvard Law School on May 17, 2013:

Issues and Case Studies in Clinical Trial Data Sharing:

What Have We Learned?

Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

LOCATION:  Wasserstein Hall, Milstein West A, Harvard Law School

1585 Massachusetts Avenue, Cambridge, MA

Speakers and registration information to be announced shortly

May 17, 2013 (8AM – 6PM)

Objectives:

  • To discuss opportunities for and implications of emerging clinical trial data disclosure standards
  • To review evidence from recent case studies in clinical trial data disclosure, especially related to disclosure of participant-level data
  • To review the rationale behind disclosure requirements of patient-level data and discuss whether the case studies demonstrate the goals have been met
  • To identify potential areas of collaboration among stakeholder groups, such as the formation of working groups to provide recommendations or standards in this area
  • To review variance in regulatory approaches and areas for possible harmonization
  • To identify other key areas of learning that may inform policy in this important area moving forward
  • To use conference findings as basis of a publication in a peer-reviewed journal that captures the case studies, provides insights into these issues and offers recommendations for moving forward

Petrie-Flom Interns’ Weekly Round-Up: 1/19-1/25

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 1/12-1/18

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

  • After an estimated 500,000 patients in the United States have received all-metal hip replacements that are failing early in many cases, the Food and Drug Administration is proposing rules that will require manufacturers to produce clinical data to support their devices’ safety and effectiveness.
  • A study published in Science identified people from online searches of DNA sequences, age, and a state. The result raises concerns about the difficulty of protecting the privacy of volunteers involved in medical research.
  • The Obama administration says it will give states more time to comply with the new health care law after finding that many states lag in setting up insurance exchanges.
  • The Department of Health and Human Services (HHS) announced $1.5 billion in new grants Thursday for states to continue building their insurance exchanges under the Affordable Care Act. California, Delaware, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oregon and Vermont received funding.
  • Pharmacies around New York City struggled to meet the demand for flu vaccinations on Sunday, a day after Gov. Andrew M. Cuomo declared a public health state of emergency in response to a drastic increase in the number of flu cases this year.
  • A new type of flu vaccine that requires less manufacturing steps and shorter production time won regulatory approval on Wednesday, and its manufacturer said that limited supplies are expected to be available this winter.
  • Quebec is slowly moving towards legal euthanasia. A committee of legal experts has delivered a 400-page report to the provincial government which argues that it should allow “medical assistance to die” when a patient is close to death and is suffering from unbearable physical or psychological pain.

Tomorrow! Food & Drug Law: Past, Present & Future

kparas Leave a comment

Food & Drug Law: Past, Present & Future
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS
Thursday, January 17, 2013
Wasserstein 2019; Milstein West AB
Harvard Law School
4:00pm (reception to follow)

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 to 1975, he was Chief Counsel for the Food and Drug Administration. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to present.

Introductions and Welcome

Martha Minow, HLS Dean

Tributes to Professor Hutt

  • I. Glenn Cohen, Assistant Professor, Harvard Law School; Faculty Co-Director, Petrie-Flom Center
  • Theodore Ruger, Professor of Law, Penn Law School
  • Lewis Grossman, Professor of Law, American University Washington College of Law

Reflections
Peter Barton Hutt

Questions and Discussion

Dean Minow and Audience

For questions, contact petrie-flom@law.harvard.edu, 617-496-4664

Co-sponsored by the Petrie-Flom Center and the HLS Dean’s Office

 

Petrie-Flom Interns’ Weekly Round-Up: 1/5-1/11

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 12/29-1/4

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

Does Whole Genome Sequencing Circumvent Gene Patents?

The Petrie-Flom Center Staff Leave a comment

By Nicholson Price [originally posted at Bio-IT World on Dec. 10, 2012]

What happens when, during the course of whole-genome sequencing (WGS) a patient or research subject, an investigator sequences and analyzes a disease gene that has been patented? The U.S. Supreme Court will shed some light on this question next year when it issues its ruling in the long-running Myriad Genetics saga.

Last month, the Supreme Court voted to hear the case of Association for Molecular Pathology v. Myriad Genetics to consider the question whether human genes are patentable. The plaintiffs—doctors, patients, researchers, and the American Civil Liberties Union—have challenged Myriad’s patents on the breast cancer genesBRCA1 and BRCA2, which cover, among other things, isolated DNA molecules with the sequences of those genes. A federal district court in New York ruled that the patent claims on isolated DNA molecules were invalid, but that ruling was reversed on appeal by the Federal Circuit in D.C. The Supreme Court decided to review the Federal Circuit’s decision and will likely rule on whether isolated human gene sequences are patentable next summer.

This case has profound implications for biotechnology, and diagnostics, as well as the emerging field of personalized medicine. Among the fascinating issues that will likely be addressed is whether WGS—an essential foundation for truly personalized medicine—violates human gene patents.

As WGS involves determining the sequence of an individual’s entire genome, there is concern in many quarters that WGS could violate essentially every patent covering an isolated human DNA sequence—of which there are thousands. Indeed, this concern has been raised by scholars, policy analysts and lawyers, including before the Federal Circuit and in the arguments over whether the Supreme Court should hear the case.

However, a closer look at the technology suggests that rather than violating thousands of gene patents, WGS methods violate few, if any, existing gene patents. Whatever the Supreme Court decides next summer, the widespread adoption of clinical WGS is not particularly threatened by gene patents.

Read More

Upcoming Event 01/17 – Food & Drug Law: Past, Present & Future

kparas Leave a comment

SAVE THE DATE!

Food & Drug Law: Past, Present & Future
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS
Thursday, January 17, 2013
Wasserstein 2019; Milstein West AB
Harvard Law School
4:00pm (reception to follow at 5:30)

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 to 1975, he was Chief Counsel for the Food and Drug Administration. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to present.

Introductions and Welcome

Martha Minow, HLS Dean

Tributes to Professor Hutt

  • I. Glenn Cohen, Assistant Professor, Harvard Law School; Faculty Co-Director, Petrie-Flom Center
  • Theodore Ruger, Professor of Law, Penn Law School
  • Lewis Grossman, Professor of Law, American University Washington College of Law

Reflections
Peter Barton Hutt

Questions and Discussion

Dean Minow and Audience

For questions, contact petrie-flom@law.harvard.edu, 617-496-4664

Co-sponsored by the Petrie-Flom Center and the HLS Dean’s Office