News

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.

Washington DC, May 23, 2019 – The Forum for Collaborative Research announced publication of a new article, "Defining Improvement in Nonalcoholic Steatohepatitis for Treatment Trial Endpoints: Recommendations from the Liver Forum," in the peer-reviewed journal, HEPATOLOGY.

March 27, 2019 - AAP News, the official news magazine or The American Academy of Pediatrics has published an update from the FDA regarding the first meeting of the Rare Diseases Forum. The meeting drew over 100 stakeholders to discuss how to facilitate drug development for rare diseases. Click here to read their complete article.

Washington DC, March 22, 2019 – The Forum for Collaborative Research announced the publication of a manuscript, "Challenges, Considerations, and Principles to Guide Trials of Combination Therapies for Chronic Hepatitis B Virus" in the February 2019 volume of the peer-reviewed journal Gastroenterology.

The Forum for Collaborative Research joins the HIV community in mourning the loss of Professor Andrea De Luca who passed away earlier this month. Professor De Luca worked with members of The Forum on multiple occasions and made many contributions to the global fight against HIV/AIDS. Please click here to read more on the WHO web site.

The 4th Paris NASH Meeting was held July 5-6, 2018 at the Institut Pasteur in Paris, France. The meeting was co-organizated by Dr. Lawrence Serfaty, Hôpitaux Universitaires de Strasbourg, Dr. Arun Sanyal, Virginia Commonwealth University, and Dr. Veronica Miller, Forum for Collaborative Research. 

The materials from the 2-day meeting that have been made available can be found on our website, and also on the meeting website. 

On behalf of the International AIDS Society 

This is your last chance to apply for the Research-for-Cure Academy, taking place 31 October – 2 November 2018 at the Wits Rural Facility in Bushbuckridge, South Africa. The deadline for applications is 12 August 2018.

APPLY NOW

The International AIDS Society (IAS) invites early to mid-career HIV investigators and clinical scientists to apply for a fellowship to attend an interactive three-day workshop in South Africa on state-of-the-art HIV cure research, led by internationally renowned scientists. 

On behalf of the World Health Organization

On-the-go access to the following modules from the WHO PrEP Implementation Tool