Odylia Therapeutics and the Foundation Fighting Blindness have teamed up to hold a four (4) part preclinical and translational research webinar series. This series will focus on genetic technologies for blinding diseases and will provide tangible advice and educational materials to researchers in the inherited retinal disease (IRD) space as well as the broader rare disease field.
Both Odylia and the Foundation Fighting Blindness are focused on supporting the research community in developing treatments and cures for inherited retinal dystrophies. The world has seen a gene therapy for IRDs reach the pinnacle of success with the 2017 FDA approval of LUXTURNA. Although this success has opened the door for other IRD gene therapies, there is still a multitude of genetically-driven diseases in this space that require a robust pipeline for therapeutic development.
This webinar series will provide actionable preclinical development information to researchers looking to advance their ideas into the clinic to help patients.
If you are currently working in or thinking about preclinical development, please join us for this engaging webinar series.
- All webinars will be virtual and recorded for later viewing
- Invited speakers will give a detailed presentation covering preclinical development topics, providing information to researchers to help shape their own projects/programs
- Each webinar will have a Q&A session enabling researchers to bring their personal questions and issues to the table for discussion. Please send advance questions, if applicable, to either email@example.com or firstname.lastname@example.org (Please put “Preclinical Webinar Question” in the subject line)
- Webinar #1: Tools for Preclinical Development: Creating a Target Product Profile and Effectively Engaging Regulatory Entities
- Webinar #2: Disease relevant translation models in ocular drug development: Types, challenges, advantages, and alternatives
- Webinar #3: Working with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to accelerate development
- Webinar: #4: Attracting funding opportunities and a look towards the future of ocular drug development
Tools for Preclinical Development: Creating a Target Product Profile and Effectively Engaging Regulatory Entities (October 2020)
Translating a potential therapy from the bench to the clinic takes an enormous amount of time, effort, and funds to achieve. Therefore, it is paramount that those working to this end should work as efficiently as possible. Early regulatory engagement can help streamline drug development. One guiding tool that can help this process is the development of a Target Product Profile (TPP). The purpose of a TPP is to provide an easy to follow format for discussions between the research sponsor and the Food and Drug Administration (FDA). This document will help guide therapy development from pre-IND through post-marketing programs. Effective preparation of the TPP will allow for (1) the exclusion of the need to introduce the history of the drug development program(s), (2) enhance the sponsors interactions with FDA staff, (3) guiding pre-new drug application (pre-NDA) meetings ensuring the goals are aligned with sponsor’s official NDA submission, and (4) overall the TPP is used to update the FDA during engagements.
We want our research community to begin their preclinical efforts with their end goal in mind. This webinar will allow our community to learn about and actively discuss the best way to create a TPP and engage with regulatory agents to effectively move their research from the lab to the clinic.
Webinar #1 Panelists:
- Stephen Brenner
- Stephen is a consultant with more than 40 years of experience in the academic, government, and industrial sectors applying innovative chemical and protein technology to drug discovery. Dr. Brenner is a former VP of Chemical and Protein Technologies at Bristol-Myers Squibb and the former Senior Director of Physical Sciences, DuPont Pharmaceutical Company.
- Suzanne Thornton-Jones
- Suzanne has a Ph.D. in Pharmacology and Toxicology from the Medical College of Virginia/Virginia Commonwealth University. In her current role at the Gene Therapy Program at the University of Pennsylvania, she leads the Regulatory Affairs department in developing the regulatory strategy for engagement of Health Authorities throughout the preclinical research, clinical trial, and registration processes. In addition to her regulatory responsibilities, she also leads the Compliance group, Good Laboratory Practice (GLP) Quality Assurance Unit, which is responsible for auditing preclinical studies used to support Health Authority regulatory filings. Prior to joining GTP, Suzanne worked in Regulatory Affairs for 12 years in the Pharmaceutical industry at Sanofi and AbbVie, and 6 years as a pharmacology/toxicology reviewer at the Food and Drug Administration, Center for Drug Evaluation and Research (FDA/CDER).
Webinar #1 Key Information:
- Date/Time: October 8, 2020 at 1PM – 3PM (EST)
- Platform: ZOOM Register Today
- Cost: No Fee
This webinar series is sponsored by