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TITLE

Next Generation PrEP: Science, policy, and community impact

CODE

SA039

SESSION TYPE

Satellite

ROOM/CHANNEL

Room 517b/Channel 4

DATE TIME

29 July 18:15 - 19:45

ORGANIZER

The Forum for Collaborative Research

Engaging multiple stakeholders across industry, regulatory agencies, patient groups, and academic research to discuss important considerations for trials in next-generation PrEP products. How do clinical trials best assess efficacy for PrEP when standards of care are highly efficacious? How do regulators approach groundbreaking new trial designs in HIV prevention? How do these trial designs affect patients in the trials and those that may benefit from candidate drugs?

Registration

https://www.aids2022.org/

Washington DC, June 21, 2021 – The Forum for Collaborative Research announced the publication of “The Use of External Controls in FDA Regulatory Decision Making” in Therapeutic Innovation & Regulatory Science. This review describes the circumstances for approval of 45 products based on pivotal studies leveraging external controls, with retrospective natural history studies as the most common source of control data.

June 29, 2021
1-2 PM EDT

The John G. Bartlett Award
"Catalyzing Clinical Research to Improve Global Health"
Presented to

Jeffrey Murray

Deputy Director, Division of Antiviral Products, FDA

The Forum for Collaborative Research (The Forum) invites you to join a celebration to honor the memory of Dr. John G. Bartlett, a pioneer in HIV/AIDS study and treatment, and acknowledge Dr. Jeffrey Murray's twenty-nine years of service at the Division of Antiviral Products at the FDA. During this special celebration, the Forum will inaugurate the John G. Bartlett Award for Catalyzing Clinical Research to Improve Global Health to be presented to Dr. Jeffrey Murray by the FDA Acting Commissioner Dr. Janet Woodcock.

Dr. Murray, a visionary and forward-thinking leader, has promoted and contributed to innovations for approvals of new therapeutics to treat and prevent infectious diseases. For many years, he has inspired and championed the Forum for Collaborative Research’s work-- most recently, inspiring efforts towards advancing the regulatory path for new PrEP agents and developing expert consensus on the use of counterfactual HIV incidence estimates to serve as external controls. Dr. Murray has co-authored seminal peer-reviewed publications and FDA guidance documents for HIV drug development, HIV fixed-dose combinations for the President’s Emergency Plan for AIDS Relief (PEPFAR), and the development of drugs for the treatment of Influenza and Hepatitis C.

Dr. John J. Bartlett served as academic co-chair of the HIV Forum's Executive Committee. He was an internationally recognized visionary leader, a pioneer in HIV/AIDS study and treatment, and a receiver of many awards, including the Alexander Fleming Award for Lifetime Achievement, the Maxwell Finland Award for Scientific Achievement, and the Forum’s C. Everett Koop Public Health Leadership Award. Dr. Bartlett was at the forefront of fighting the AIDS epidemic since the early 1980s; he started an AIDS clinic at Johns Hopkins in 1983, directed clinical trials in Baltimore of new treatments that prevent HIV from replicating, and was co-chair and one of the founding members of the national committee that drafted the first and all subsequent treatment guidelines for HIV-infected patients. Dr. Bartlett was the Stanhope Bayne-Jones Professor of Medicine and Director of the Division of Infectious Diseases at the Johns Hopkins University School of Medicine, where he successfully built the infectious diseases division at the Johns Hopkins Hospital, one of the largest divisions at Johns Hopkins and one of the world's premier centers.

While serving as the HIV Forum’s co-chair, he frequently commented that Jeff Murray should receive an award for his commitment to improving treatment of HIV, viral hepatitis and other viral diseases through innovation in development.

It is an honor for the Forum to take Dr. John Bartlett’s words to heart and present this award, in his name, to Dr. Jeffrey Murray.

We hope you are able to join us in celebrating Dr. John Bartlett's legacy and pay tribute to Dr. Jeffrey Murray for their significant contributions to the fight against infectious diseases and their dedication to the Forum's mission.

To view the program click here.

For questions, please contact Tamar Tchelidze at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it

If you require an accommodation for effective communication (ASL interpreting/CART captioning, alternative media formats, etc.) please contact Astrud Reed at This e-mail address is being protected from spambots. You need JavaScript enabled to view it 7-10 days in advance of the event.

Washington DC, May 25, 2021 - We are delighted to announce that Brenda E. Rodriguez has joined the Forum for Collaborative Research, a program at UC Berkeley School of Public Health, as Deputy Director. Brenda comes with significant experience in global health, health sciences, higher education, and business administration. She will play a pivotal role in new Forum initiatives such as the Forum’s Collaborative Data Center at Berkeley Public Health and increasing the reach of our educational and training programs across Berkeley Campus, the US and internationally.

UC Berkeley interviewed Dr. Veronica Miller on a recent Forum publication, Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease, which was published in the journal, Gastroenterology.

The paper combs through the research to look for the best treatment - a "silver bullet" —to treat pediatric nonalcoholic disease. Read more of the article here.

 

The UC Berkeley Online MPH Program is offering a total of 14 Global Public Health fellowships for international MPH students in 2021.

• A generous gift from Gilead Sciences will provide 10 fellowships to students from World Bank designated LMICs. 
• Four fellowships will be awarded to MPH students based in India thanks to a generous gift from the Morris Family Fund. 

Fellows will be selected via a competitive evaluation process. Information about the fellowships and how to apply can be found on the Global Public Health Fellowships – 2021 page.

Washington DC, December 1, 2020 –  The Hep B Foundation, Hep B United and the HBV Forum are pleased to name Corrina Dan, RN, MPH, as the 2020 recipient of the Hepatitis B Federal Champion Award for her commitment to eliminating hepatitis B. Ms. Dan will receive the award at the Hep B United Virtual Summit on December 4th.

 Recording available here

We are delighted to announce this year's recipients of the PHW236A Regulatory Science, Drug Development, and Public Health course scholarship, Cynthia Buness, Gus Cairns, Rob Camp, François Houÿez, Guanqiao Li, and Gabriella Wan! Awardees represent organizations from across the disease areas represented by Forum projects. They will gain insights on the process of regulation for innovation in public health to be applied to their respective non-profit organizations including: @NPAF_tweets, @aidsmap, @eurordis, Tsinghua Clinical Research Institute, Tsinghua Univ. School of Medicine, and @LiverSaver.

https://berkeleyphw.catalog.instructure.com/courses/phw236a-regulatory-science-drug-development-and-public-health