Regulatory

  1. Gap Analysis With Dr. Pablo Valenzuela & Cristián Hernández-Cuevas 9/30/2020

    On the season finale of the Business of Biotech, we're joined by biopharma pioneer Dr. Pablo Valenzuela and a rising star in Chile's biotech scene in Cristián Hernández-Cuevas for a candid discussion on biopharma's compute power revolution, the influence of technology on gap analyses and next steps for emerging biopharma, and what's driving biotech growth in South America.

  2. Preparing For The Clinic With Amolyt Pharma's Dr. Thierry Abribat 3/8/2021

    Amolyt Pharma is developing a therapeutic peptide program targeting rare endocrine and metabolic diseases including hypoparathyroidism and acromegaly. Fresh on the heels of its lead candidate's foray into phase 1 clinical trials, we're joined by the company's founder and CEO, Thierry Abribat, Ph.D., for a deep dive into Amolyt Pharma's pre-clinical preparation, including his financing, talent acquisition, and clinical study strategies.

  3. Obesity Tx End-Around With Skye Bioscience's Punit Dhillon 10/20/2024

    While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

  4. C&G Regulatory Guidance with Lineage Cell Therapeutics' Brian Culley 6/23/2024

    When we last caught up with Brian Culley, CEO of Lineage Cell Therapeutics, it was January 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together and did so despite lockdowns that kept a largely aged patient population from setting foot anywhere near a healthcare clinic. On his long-overdue return to the Business of Biotech, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way.

  5. Commitment To GMP With Dr. Shabbir Anik 9/13/2020

    Sutro Biopharma Chief Technical Operations Officer Shabbir Anik has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career, making him a great choice to sit down for a chat about the mechanics of GMP and CMC strategy in new and emerging biopharma enterprises. Here, Dr. Anik shares stories from the front lines of Sutro's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

  6. Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar 8/9/2023

    The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.

  7. Taking ADCs Across The Finish Line 8/13/2020

    While Immunomedics CMO Loretta Itri, M.D. is no stranger to taking drugs across the commercial finish line in big pharma environments, her most recent win with TRODELVY was very, very different. On this episode, Dr. Itri shares insight on her small biopharma's first commercial launch, the manufacturing and regulatory approval challenges that were overcome to get there, and why antibody drug conjugates are coming of age.

  8. What's Next For COVID Vaccines With Tonix Pharmaceuticals' Seth Lederman, M.D. 5/23/2022

    As COVID-19 cases climb yet again, the Business of Biotech catches up with Tonix Pharmaceuticals Chairman and CEO Seth Lederman, M.D. for a conversation on his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants. In addition to sharing on his journey from academia to industry, Dr. Lederman discusses his company's approach to grabbing its share of the highly competitive, and highly lucrative, vaccine market.

  9. Steering Through Setbacks with AVEO Oncology's Michael Bailey 8/18/2024

    For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree.

  10. An Unanticipated Biotech Startup With OS Therapies' Paul Romness 11/3/2024

    Becoming a biotech CEO wasn't on Paul Romness' bingo card. He'd forged his place in the biopharma industry as a foremost public and policy affairs expert. Thirteen years at J&J, more than 5 at Amgen, and half a dozen at Boehringer Ingelheim had earned him the right to coast into a consulting gig that would enable him to finish out his career on his terms. Then his daughter's best friend Olivia, a teenage girl and neighbor he'd watched grow up, was diagnosed with osteosarcoma.