News

The Forum for Collaborative Research joins the HIV community in mourning the loss of Dr. Benigno Rodriguez, who passed away on July 9, 2020.

He was the principal investigator of the Case Western Reserve University AIDS Clinical Trials Unit (CWRU ACTU). Dr. Rodriguez was a physician scientist and clinical trialist who made significant contributions to the HIV/AIDS field. Dr. Rodriguez was honored for his contributions by being presented with the prestigious 2008 ACTG John Carey Young Investigator Award.

Dr. Rodriguez will be deeply missed.

HIV PREVENTION TRIAL DESIGN PROJECT

Towards a feasible regulatory path for new PrEP products

In 2019, under the umbrella of the PrEP Program, the HIV Prevention Trial Design Project was formed and builds on previous working groups and public meetings. The project is funded by the Bill & Melinda Gates Foundation in addition to industry sponsors. It uses the “totality-of-evidence” framework and adopts innovative trial designs, including a counterfactual estimate of HIV incidence in communities in which PrEP clinical trials are conducted.

The overall goal of the project is to develop a path to provide convincing evidence of a new PrEP product’s effectiveness and safety, maintain scientific rigor, and create a feasible/pragmatic path for development.

Washington DC, April 27, 2020 – The Forum for Collaborative Research announced the acceptance and online publication of the manuscript, “Standardization of Diet and Exercise in Clinical Trials of NAFLD-NASH: Recommendations from the Liver Forum” in Journal of Hepatology. 

“Lifestyle modification is the foundation of treatment recommendations for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis,” said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. “But clinical trial design is impeded by the absence of consistent approaches and documentation of lifestyle changes, and understanding the potential influence on trial outcomes.”

Washington DC, June 9, 2020 – The Forum for Collaborative Research announced the launch of a new course from the University of California, Berkeley School of Public Health: Managing the COVID-19 Pandemic: A Comprehensive Crash Course for Everyone.

The Forum for Collaborative Research joins the HIV community in mourning the loss of Dr. Ron Simmons, who passed away from prostate cancer on May 29th. Dr. Simmons was an activist and advocate for the black LGBTQ+ community and fought tirelessly for justice and equity for black communities who are disproportionately impacted by HIV. Dr. Simmons served as a distinguished faculty member at Howard University and in 1992, he joined Us Helping Us and served as President and CEO until 2016. Through the leadership of Dr. Simmons, Us Helping Us became the oldest and largest Black gay community-based AIDS service organization in the U.S. Dr. Simmons impacted many individual lives and organizations by working to reduce the burden of HIV.

Dr. Simmons' leadership was centered around collective action, equal rights, and unity. Many admired him as a powerful leader and for his lifelong dedication to addressing the HIV epidemic. His legacy will continue to live on. 

Please read these reflections from the Forum community.

“I was so saddened to hear of Ron’s passing earlier this week. His death comes at a time of serious national reckoning, making his advocacy for the well being of Black LBGTQ+ people all the more relevant. I am sorry he will not be here to witness progress directly, but the fruits of his passion for justice will reverberate throughout the coming months and years as we collectively work to ensure justice for all.”

-Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research

“The HIV community has lost a great leader with the passing of Dr. Ron Simmons. He was a visionary and a very effective community-engaged activist. He understood firsthand how the Black community was being ravaged by HIV, particularly Black men who have sex with men, and knew how to develop a local organization that has had national impact. His eloquence and tenacity enabled him to create highly effective coalitions that have been able to create services to improve the lives of many. He will be greatly missed.”

-Kenneth Taymor, MD, Infectious Disease Attending and Director of HIV Prevention Research at Beth Israel Deaconess Medical Center

Larry Kramer, HIV and AIDS Activist, passed away from pneumonia Wednesday morning. Larry Kramer was a pioneer in the fight against AIDS, he sought out the attention of government and medical officials to take action to address the epidemic. Kramer co-founded the Gay Men’s Health Crisis, which was the first organization to provide support and advocacy for AIDS patients. Kramer also founded the activism group Act Up, whose tireless efforts led to the acceleration of research and drug testing.

Kramer was also a playwright, author, film producer, public health advocate and LGBTQ rights activist. Larry Kramer will be remembered for his drive, passion, and determination to speak up and speak out against the injustice that the HIV & AIDS population faced. His contributions paved the way for the progress and many improvements that have occurred in the treatment and care of HIV & AIDS since the 1980s.

The Forum for Collaborative Research joins the HIV community in mourning the loss of Gita Ramjee, PhD, who passed away due to complications associated with SARS-CoV-2 infection. Please click here to read more on the HVTN website.

Washington DC, December 9, 2019 – The Forum for Collaborative Research announced the publication of a manuscript, "Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease" in the December 2019 issue of the peer-reviewed journal Gastroenterology.

Regulatory Science, Drug Development, and Public Health (PHW236A) will be offered online by the UC Berkeley School of Public Health from October 26, 2020 to December 20, 2020.

This interdisciplinary regulatory science course brings together participants working in regulatory agencies, public health, law, medicine, business, and policy to gain an understanding of the most prominent product regulation issues in the US and abroad. Innovation is needed to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases, and a sharpened lens on safety. This new exciting area of science requires a new generation of trained regulatory experts and professionals in academic, government, industry, and public health sectors. Building regulatory capacity is important for the US as well as for the rest of the world. Aiming to address this demand for increased training, the course provides the information needed to understand the most important health practice and product regulation issues in the US and abroad from the perspective of current regulatory standards, their standards for evidence, and the role of innovation in regulatory science. The course features networking opportunities with experts from regulatory agencies, biotech, and the pharmaceutical industry. These guest lecturers will discuss the ongoing need for interaction between government, academia, industry, and the public.  

The course is taught by Veronica Miller, PhD, and aims to provide an understanding of product regulation issues, standards for evidence, and the role of innovation in regulatory science.

Weeks at a Glance:

Week 1: Introduction to Regulatory Science and Regulation

Week 2: Regulation and Public Health

Week 3: Drug Development Pathway

Week 4: Innovation in Trial Design and Data Use

Week 5: Surrogate Markers, Expedited Approval Mechanisms and Biomarker Qualification

Week 6: Assessing Benefit-Risk and Long-Term Safety

Week 7: Regulation of Biologics, Vaccines, and Medical Devices

Week 8: Final Group Presentations and Proctored Assessment

Please visit https://berkeleyphw.catalog.instructure.com to register.

Student Testimonials

“Dr. Veronica Miller is a highly accomplished researcher and excellent teacher. She is one of the few out there who is able to see the 'big picture' and explain the nuances of the science-policy-practice interface. She also brings to the course unparalleled access to world-leading experts in public health, regulatory science and drug development. The course allowed me to think about things in a more precise and specific way. It also armed me with the knowledge I needed to get my first short correspondence in psychopharmacology published. I now have a second paper underway, and this wouldn't have been possible without the training I received in the course regarding the drug development process.”

- Laurence Wainwright Ph.D, Departmental Lecturer and Course Director, University of Oxford 

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"Thanks to Dr. Miller's course, I am no longer an outside observer to regulatory science and can see how our organization can have an effective and productive place within the drug development process."

- Rachel Gomel, Registry Director and Coordinator, PSC Partners Seeking a Cure  

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 “Taking this course helped me to develop a clear understanding of the policies underlying current drug and biomarker regulation, its impact on clinical trial design, benefit-risk analysis, drug safety, and medical ethics.”

- Bita Fathipour, Microbial Biology BS, UC Berkeley 

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​“The course has changed my perspective in such a way that I now view regulatory science as a broader scope of disciplines versus a single entity within the FDA.” 

- Clarissa Martinez, Public Health MPH, UC Berkeley 

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“After taking this class, I feel that I have a much better sense of the intricacies of regulatory science, and all the things one must consider when evaluating a product.”  

- Alexandra Tsitsiklis, Infec Diseases & Immunity PhD, UC Berkeley 

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“This course changed my perspective of thinking the regulatory process as a universal and straight-forward process for each drug. I think the course definitely changed my view about the complexity and importance of the regulatory process and I believe that my deeper understanding of regulatory science will be useful for my future bioengineering projects and biotech industry job.” 

- Charlene Pan, Bioengineering UCSF Joint PhD

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“This course highlighted the clinical and social needs behind these regulatory programs, and more importantly, discussed the benefit-risk consideration and risk mitigation measures involved in these programs in a depth greater than all classes that I have previously taken.”  

- Raymond Dong, Translational Medicine MTM, UC Berkeley 

Washington DC, June 12, 2019 – The Forum for Collaborative Research announced its recognition of International NASH Day (IND). Over 30 organizations are coming together today to raise awareness for NASH and promote early intervention of this disease, which affects more than 115 million people worldwide.