Navigating old-school regulatory complexities to bring new therapeutics to market

Novel therapeutics are bursting onto the scene at a rapid rate as innovators race to harness the power of mRNA, cell therapies, and other gene-based treatments. But according to data from our 2023 Global Biopharma Resilience Index, more than 90% of biopharma executives feel governments need to do more to support the rollout of these increasingly promising therapies.

In this discussion, Emmanuel Abate and Angela Johnson will examine some of the ways regulators and policymakers are working to bring new innovation and commercialization efforts to fruition. They’ll also consider what companies can do to help deliver on the potential of the latest breakthroughs in science and medicine.  

Speakers:

Emmanuel Abate, President, Genomic Medicine, and Head of Sustainability and Corporate Social Responsibility

Emmanuel Abate works to bring out the best in his team so they can better serve the scientific community working on tomorrow’s medical breakthroughs. He leads the genomic medicine business, which includes the recently acquired Precision NanoSystems as well as a diverse portfolio focused on nucleic acids, viral vectors, and cell therapies. Emmanuel also oversees the company-wide sustainability and corporate social responsibility strategy.

Angela Johnson, Global Regulatory and Compliance Leader, Cytiva

Angela’s 20+ year career includes experience with global strategic development and regulatory compliance spanning novel biologics, drugs, and devices. She has held leadership positions in clinical operations and regulatory strategy and compliance at GE Healthcare, contract research organizations including IQVIA Biotech (previously Quintiles), and venture-backed biotechnology organizations in cell and gene therapy leading to two successful IPOs. She is also part of the Northeastern University Regulatory Affairs faculty, a prior author for the RAPS Regulatory Fundamentals textbooks on regenerative medicines and clinical trials, and a multi-year member of the American Society of Cell and Gene Therapy (ASGCT) regulatory board.

Read our 2023 report to find out what the industry can do to address current challenges and build resilience for a brighter biopharma future. Visit: https://cytiva.link/8leta