Day 2- Thursday, September 11th - EST (Eastern Time, UTC-05:00
Discuss current regulatory hurdles and evolving guidelines impacting oligonucleotide drug development
Explore strategies for navigating regulatory pathways and fostering collaboration between industry, patient advocacy groups and regulatory agencies
Examine best practices for demonstrating safety, efficacy, and quality of oligonucleotide therapeutics throughout the development lifecycle
- Dmitry Samarsky - Chief Technology Officer, GALCONDA THERAPEUTICS
- Fred Fleitz - Group Vice President, CMC, Arrowhead Pharmaceuticals
- Christopher O'Donnell - Global Head of Cardiovascular & Metaboli, Novartis
- Steve Hughes - CMO, Avidity Biosciences
Uncover innovative partnership paradigms and strategic approaches that catalyze breakthroughs and expedite the evolution of RNA-based therapeutics, with a spotlight on emerging opportunities in the Asia-Pacific and European regions and established collaborations in North America.
Dissect the critical components of high-impact collaborations among biotech firms, pharmaceutical giants, and key industry players within the global RNA ecosystem.
Pinpoint promising avenues and navigate potential hurdles in forging transcontinental strategic alliances, particularly between North American companies to propel RNA research, optimize manufacturing processes, and enhance clinical translation efforts.
Examine case studies of successful local and international partnerships that have leveraged diverse expertise, to accelerate RNA therapeutic development and market access. Highlight strategies for fostering robust, long-term collaborations in the RNA pharma landscape.
- Karina Thorn - Corporate Vice President, Head of Research, Global Nucleic Acid Therapies Research, Novo Nordisk
- Michelle Hall - Associate VP - Genetic Medicine Research, Eli Lilly & Company
- Malgorzata Gonciarz - Global Head xRNA Therapeutics, Novartis