08.12.20

AGTC Formalizes Patient Advisory Council to Provide Insights and Guidance for Pipeline Therapies

Source: AGTC

Applied Genetic Technologies Corporation (AGTC), announced the formation of a Patient Advisory Council to build on its focus of incorporating the patient and caregiver voice into the company’s culture and clinical and preclinical programs.

Engagement with patients and caregivers has provided AGTC with substantive information that has guided its clinical trial design, enhanced its understanding of retinal disorders, and inspired its patient centric culture. The council, spearheaded by Jill Dolgin, PharmD, Head of Patient Advocacy at AGTC, is comprised of individuals with inherited retinal diseases (IRDs) and members from the global community of organizations that represent them.

“Patient engagement will continue to be a critical success factor for our programs moving forward, and we are very pleased to formalize the establishment of this distinguished group of patient experts, especially as we move into the next phase of development for our X-linked retinitis pigmentosa gene therapy candidate,” Sue Washer, President and CEO of AGTC, said in a company news release.

In July, AGTC announced next steps in the clinical development of the company’s potential treatment of XLRP caused by mutations in the RPGR gene following receipt of written feedback from the FDA. AGTC is expanding the ongoing phase 1/2 trial to dose additional patients in two masked dosing arms to collect additional functional data. In parallel, a planned phase 2/3 trial, which is expected to begin in Q1 2021, will be designed to evaluate sustained efficacy across multiple measures of potential benefit in patients with XLRP. 

“We are delighted to be a part of this advisory council established by AGTC to lend our voice and collective experience that spans more than five decades in the search for treatments to address blindness and vision loss,” Brian Mansfield, PhD, Executive Vice President of Research and Interim Chief Scientific Officer at the Foundation Fighting Blindness, said in a company news release. “Having the patient’s perspective at the center of clinical drug development is a crucial component for addressing the unmet needs of patients within the inherited retinal diseases community.”

Organizations and advocate members of the Patient Advisory Council include:

Organization Name Title
Foundation Fighting Blindness Brian Mansfield, PhD Executive Vice President of Research, Interim Chief Scientific Officer, and oversees the My Retina Tracker Registry patient database
  Todd Durham, PhD Vice President, Clinical Outcomes Research
  Michelle Glaze Associate Director, Professional Outreach, and an individual affected by retinitis pigmentosa (RP)
  Richard Faubion Senior Director, Development; individual affected by XLRP, and a stem cell transplant clinical trial participant
Fighting Blindness Canada Shari Shaw, MHSc Health Information Officer, and an individual with RP
Retina International Avril Daly CEO; Vice President, Board of Directors of the European Organization for Rare Diseases (Eurordis), and an individual affected by RP
Sofia Sees Hope Laura Manfree President and Founder, and parent of a child with Leber Congenital Amaurosis (LCA)
  Alison Lynch, JD Disabilities attorney, individual affected by achromatopsia, and non-gene therapy clinical trial participant

 

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