IndoUSrare Quarterly Webinar Series
RSVP today! October Guest Speaker James Valentine, JD, MHS, Attorney at Hyman Phelps McNamara and Rare Champion of Hope 2019 will speak on Rare Disease Patient Engagement with FDA: Setting the context for regulatory decision-making
Date And Time: Thu, October 15, 2020; 10:00 AM – 11:00 AM EST
The IndoUSrare quarterly webinar series is an educational event designed to provide a platform for sharing scientific, policy, and advocacy topics related to rare diseases across the world. We plan to bring diverse speakers from various specialties and geographies tailored to the interests of rare disease communities.
In this introductory webinar, guest speaker James Valentine, JD, MHS, Attorney at Hyman Phelps McNamara, 2019 Rare Champion of Hope, will provide guidance to patient advocates from around the world and other stakeholders on Rare disease patient engagement with FDA. The webinar will be hosted by Dr. Reena Kartha, Board Director of Research Programs at IndoUSrare.
Speaker Bio:
James Valentine, JD, MHS, is an attorney at Hyman, Phelps & McNamara, P.C. where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. He has helped several sponsors secure FDA approval of new molecular entities, often for serious and rare diseases. James has also been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated nearly 75% of the 30+ such meetings to date, and is also working on novel methodologies for capturing patient experience data. James has also authored an analysis cataloging FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.
Before joining the firm in 2014, James worked in FDA’s Office of Health and Constituent Affairs (previously Office of Special Health Issues) where he facilitated patient input in benefit-risk decision-making and served as a liaison to stakeholders on a wide range of regulatory policy issues. James administered the FDA Patient Representative Program, facilitated stakeholder consultations during the reauthorization of PDUFA and MDUFA, helped launch the PFDD program, and developed the FDA Patient Network.
In recognition of his work in advocating for rare disease patients, in 2019, Global Genes named him a RARE Champion of Hope. James is also an adjunct professor of food and drug law at the University of Maryland Carey School of Law.
Mr. Valentine earned his law degree from the University of Maryland Carey School of Law and his Master of Health Science in health policy from the Johns Hopkins Bloomberg School of Public Health.
About IndoUSrare:
IndoUSrare builds collaborative bridges between the West & the East to accelerate clinical research. A non-profit 501(c)(3) tax-exempt organization for connecting Asian-Indian diaspora affected by RARE diseases with global clinical trials. https://indousrare.org/
RSVP to this free Webinar: https://bit.ly/indousrare2
Thu, October 15, 2020; 10:00 AM – 11:00 AM EDT
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