How to Apply For BTD And Win It With Drs. Ira Gupta & Shanthi Ganeshan

We love to hear from our listeners. Send us a message. Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on ...

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The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. SUBSCRIBE to our new newsletter at www.bioprocessonline.com/bob. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, and regulatory challenges you’ll face as you navigate your company from an idea to success in the clinic. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by Bioprocess Online and Life Science Connect and brought to you by Cytiva.