Advancing Science & Regulatory Innovation
 

Advancing regulatory science is essential to ensure that novel therapies reach patients with greater predictability and efficiency. As innovation grows more complex - spanning novel modalities, advanced analytics, and next-generation manufacturing – transparent, consistent, and predictable regulatory frameworks must evolve in tandem.

BIO Science and Regulatory (SciReg) advances science-based policy and the regulatory ecosystem by serving as the trusted voice and advocate for BIO members to enable  innovative, patient-centered biopharmaceutical development by...
 

• Collating/Amplifying Biotech Subject Matter Expertise  

• Developing Science-Based Policy  

• Advocating for Strategic Adoption/Implementation 

Why It Matters
 

Patient Access to Safe & Effective Therapies: An efficient and predictable regulatory framework enables innovation to patients.

Further Scientific Innovation: Adapting the regulatory framework to integrate advances in science is paramount to innovation.  

Transparently Enhance Together: To maintain America’s position as the world’s biotechnology leader, we must learn and adapt drug development and its regulatory framework as efficiently and transparently as possible.
 

Key Policy Positions for Advancing Regulatory Frameworks
 

The FDA is undergoing a strategic reevaluation of its policies under new leadership, prompted by rapid advancements in science and technology. BIO recommendations for FDA to pursue a proactive policy agenda that balances its dual mission: safeguarding public health and promoting timely access to safe and effective medical products.

• Strengthening America's Biotech Future: Strategies for Enhancing FDA as Global Gold Standard

• Sponsor-FDA Meeting Best Practices 

• Digital Health Technology (DHT) Evidentiary Templates
   

Key Data Collection for Informing Policy/Advocacy

Given the rapidly evolving scientific and regulatory ecosystem, it is critical to have a real-time understanding of any shifts in regulatory predictability, efficiency, or evolving expectation. BIO is introducing the BRIDGE (BIO Regulatory Issue Data Gathering & Exchange) program to move from anecdotal feedback to a more structured data-collection framework capturing member-reported regulatory issues/roadblocks impacting the timely review and approval of an innovative drug or biologic regulated by the FDA. Through the BRIDGE program, BIO will systematically aggregate member data with the names of companies and products removed, identify trend-level regulatory challenges, and engage FDA leadership on a regular cadence to improve visibility into areas of recurring friction.