Community Webinar/Q&A about the SDS PFDD meeting planned for this summer

Register at https://zoom.us/meeting/register/g7CpXvQMSkS8PiOs4XicXw

Join the community webinar and Q&A session to learn all about the EL-PFDD meeting on Shwachman-Diamond Syndrome and have all your questions answered! This is your chance to make a real impact on future treatments and a brighter future for all SDS patients. Be heard by the FDA, researchers, doctors, and all stakeholders.

We will hear from PFDD experts, our consultants, who are helping us plan and implement a high-impact PFDD meeting for Shwachman-Diamond Syndrome

After a brief introduction by your host, Dr. Eszter Hars/SDS Alliance, we will hear from out PFDD consultants James Valentine and Larry Bauer, of Hyman, Phelps, and McNamara. James Valentine 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. Mr. Valentine also works with clients on clinical trials operations and compliance matters.

About our speaker and consultant, James Valentine, and his role in the SDS PFDD meeting

We chose James as our partner and guide in planning the SDS PFDD meeting due to his unparalleled experience and dedication to the community and this mechanism to accelerate therapy development for rare diseases like SDS. Working with James, we are also benefitting from the support of his colleague Larry Bauer. They are both former FDA officials who were involved with the launch of the PFDD initiative in 2012 and in private practice have helped with over 70 EL-PFDD meetings to date, which is the majority of EL-PFDD meetings ever to take place! More details about the SDS PFDD meeting (planned for June 4th, 2025) and opportunities to get involved at www.SDSAlliancce.org/pfdd.

Our speakers at this webinar (Ask an Expert series): Larry Bauer and James Valentine from Hyman, Phelps & McNamara

• James has worked the last 13 years as a champion for the patient voice as part of the regulatory process.  James previously worked at the FDA where he was a patient liaison, helping to incorporate the patient voice into medical product review across the FDA’s various medical product centers and review divisions.  There, he helped to develop and launch the Patient-Focused Drug Development initiative. 

• Larry worked at the NIH for 17 years in clinical research, followed by a position at the FDA as a Regulatory Scientist in the Center for Drug Evaluation and Research’s Rare Diseases Program, a group he co-founded and worked for 10 years, where he advanced rare disease drug development.

In private practice, James and Larry have worked with many patient organizations to ensure their community’s voices were heard by decision-makers.  Relevant to our EL-PFDD meeting, they has been involved in helping plan and moderating three-fourths of the over 75 externally-led PFDD meetings.

More details at https://www.sdsalliance.org/post/sds-pfdd-intro