The Center of Regenerative Medicine aims to facilitate the transition of pre-clinical regenerative medicine research into clinical trial. At the Center of Regenerative Medicine, we recognize current science policy plays a large role in the process of gaining FDA approval for biologic therapeutics. Thus, we provide resources listed below for understanding policy, as well as information on how to advocate. Additional resources include updates on FDA guidance, the clinical trial process, and opportunities for students to engage with training in policy development.
Image generated by AI shows interplay between federal science policy, research, and patient care.
FDA Guidance on Biologics
June 2026: Master Protocols for Drug and Biological Product Development | FDA
June 2026: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products | FDA
Updates on clinical trials
May 2026: US pushes real time clinical trials to eliminate “dead time” in approvals | The BMJ May 2026: FDA Announces Major Steps to Implement Real-Time Clinical Trials | FDA
Summary: Artificial intelligence will send agreed safety and endpoint signals to FDA reviewers during the study to reduce administrative dead time between phases of the trial.
Publications to highlight
Regulatable In Vivo Gene Expression via Adaptamers – PubMed
Summary: Adaptamers allow for small molecule dependent modulation of gene expression. This could increase safety profiles of genetic therapeutics through control of transgene expression. This would eliminate the use of irreversible, constitutive gene expression treatment and allow for protein expression to be within the therapeutic window. This paper utilizes adenosine deaminases acting on RNA (ADAR) modulatable aptamers delivered via an adeno-associated virus to generate therapeutically relevant transgene expression in vivo.
Tips and Resources
You can submit comments to the FDA by clicking on guidance documents and selecting submit comment
- What is new for biologic evaluation by the FDA: What’s New for Biologics | FDA
- Click any document labeled “Draft Guidance for Industry”
- Scroll to submit comments online
There are societies designed to help you advocate for science policy
- Ways to get involved with advocacy: Science Policy and Advocacy Toolkit
To find the most recent updates on policy, check out policy news from AIP
- Policy updates this week: Science Policy News from AIP
There is literature dedicated to understanding policy
- Resources for understanding science policy: Journal of Science Policy and Governance
If a post-doc or student is interested in a science policy fellowship, ASPET and AAAS offer one-year fellowship opportunities