Business Of Biotech

We love to hear from our listeners. Send us a message. Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and d...

We love to hear from our listeners. Send us a message. Learn how Precigen is advancing a deep pipeline of immuno-oncology, infectious disease, and autoimmune disorder candidates through the clinic on the back of its UltraCAR-T platform. CEO Dr. Helen Sabzevari describes the promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in...

We love to hear from our listeners. Send us a message. Friend of the show and life sciences CFO extraordinaire Allan Shaw joins us for a discussion on the steps to biopharma success from an insider's perspective.  We discuss the incremental steps that are necessary and common to success in the biologic therapy space, and the mistakes Shaw has seen in his many engagements with new and emerging...

We love to hear from our listeners. Send us a message. Dr. Anat Cohen-Dayag transformed her company from a computational biology service provider to a clinical-stage biopharma with multiple cancer immunotherapy candidates, and she did it in a remarkably short period of time. Listen in as she discusses the human resources, financial, and capital strategies she deployed to build a biotech on the bac...

We love to hear from our listeners. Send us a message. 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...

We love to hear from our listeners. Send us a message. Cidara Therapeutics President and CEO Dr. Jeff Stein joins the Business of Biotech to discuss his career mission to battle microbial organisms and his company's development of a novel approach to producing immunotherapeutic antivirals that couple potent antivirals to a human antibody fragment. We discuss the company's manufacturing a...

We love to hear from our listeners. Send us a message. From his Fellowship at the NIH Human Genome Research Institute to his leadership as CEO at NeuBase Therapeutics , Dr. Dietrich Stephan is recognized as a pioneer in the field of genomic precision medicine. On this episode of The Business of Biotech, Dr. Stephan shares how artificial intelligence is shaping the acceleration of genomic medicine...

We love to hear from our listeners. Send us a message. Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease...

We love to hear from our listeners. Send us a message. Join Matt Pillar and Erin Harris as we catch up with Celyad Oncology chief Filippo Petti on his company's  differentiated approach to the discovery and development of allogeneic CAR-T cell therapy candidates for the treatment of cancer. Petti shares the technology and how the company intends to scale in-house manufacturing in its Belgium-...

We love to hear from our listeners. Send us a message. Like most biotechs, Lineage Cell Therapeutics faced some significant challenges as it navigated multiple clinical trials, one of them in an aging, at-risk population, during a global pandemic. On this episode, CEO Brian Culley tells Erin Harris and Matt Pillar how he kept the company's programs for OpRegen® (dry AMD with GA) and OPC1 (acu...

We love to hear from our listeners. Send us a message. In this third installment of our cell & gene therapy manufacturing miniseries, Erin Harris and Matt Pillar sit down with Orchard Therapeutics CEO Dr. Bobby Gaspar. An update on the company's pipeline progress gives way to an in-depth discussion on the process challenges his company faces in the production of hematopoietic stem cells t...

We love to hear from our listeners. Send us a message. Acepodia CEO, President, & Co-founder Dr. Sonny Hsiao and Dr. Mark Gilbert, VP of R&D, join Erin Harris and Matt Pillar for a discussion on the company's approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates. Access this and hundreds of episod...

We love to hear from our listeners. Send us a message. The Business of Biotech kicks off our Cell & Gene Miniseries with Dr. Carsten Brunn, President & CEO at Selecta Biosciences . Guest host Erin Harris, chief editor at cellandgene.com , joins us for a discussion on Selecta's ImmTOR platform and how the company is addressing the immunogenicity of adeno-associated virus (AAV) vectors...

We love to hear from our listeners. Send us a message. The Business Of Biotech kicks off the new year with an up-close-and-personal talk with biotech investor and CFO extraordinaire Allan Shaw. We talk through last year's ups and downs and do a little prognosticating on what we're feeling bullish about--from unprecedented regulatory action to exciting progress on the cell and gene front-...

We love to hear from our listeners. Send us a message. The COVID-19 pandemic continues to disrupt biopharma clinical trials, especially those conducted with at-risk patient populations. From patient recruitment to data collection, clinical trials execution became considerably more challenging in 2020. On this episode of The Business Of Biotech, AGTC CEO Sue Washer gives us a behind-the-scenes look...

We love to hear from our listeners. Send us a message. Listen in as AVROBIO President & CEO Geoff MacKay tells the Business Of Biotech about the technology his company is using to drive at-scale gene therapy production for lysosomal disorders, replete with the story of how the company overcame a major manufacturing investment that didn't quite work as planned. Access this and hundreds of...

We love to hear from our listeners. Send us a message. Dr. Bernat Olle discusses the pioneering work his company, Vedanta Biosciences, is doing to modulate the immune system and provide colonization resistance against infectious pathogens—particularly those contracted during hospital stays. Learn about a company pioneering the exploration of immune-regulating and immune-potentiating bacteria. Acce...

We love to hear from our listeners. Send us a message. Smital Shah brings a trifecta of chemical engineering, consulting, and finance experience earned at heavyweight companies like J P Morgan , Leerink , and Gilead to her role at clinical-stage RNA therapy biotech ProQR Therapeutics . We sat down for a deep conversation on the recipe for successful business and finance operations in an emerging b...

We love to hear from our listeners. Send us a message. Find out what drove John McKearn, Ph. D. & CEO at Wugen, out of the lab at Pfizer and on to his quest to develop off-the-shelf cell therapies for T-Cell leukemias and lymphomas, Acute Myeloid Leukemia, and Multiple Myeloma. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifesc...

We love to hear from our listeners. Send us a message. Controlling the cost of personalized medicine: We go behind the scenes of the effort to build a system that simplifies production and reduces the cost of non-viral T cell therapies with Ziopharm Oncology CEO Laurence Cooper, M.D., Ph. D. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab...

We love to hear from our listeners. Send us a message. We're joined by biopharma pioneer Dr. Pablo Valenzuela and rising star 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. Access this and hundreds of episo...

We love to hear from our listeners. Send us a message. Bolt Biotherapeutics CMO Dr. Edith Perez and VP of CMC & Quality Dr. Nathan Ihle bring a unique combination of patient and production process expertise to the table for an enlightening conversation on preparing chemistry, manufacturing, and controls for an IND and ensuing first in-human studies. Access this and hundreds of episodes of the...

We love to hear from our listeners. Send us a message. 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&...

We love to hear from our listeners. Send us a message. If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity . The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply b...

We love to hear from our listeners. Send us a message. Rocket Pharmaceuticals CEO Dr. Gaurav Shah shares the parallels between his leadership in the gene therapy space and his successes as a Grammy®-nominated recording artist with the Business of Biotech podcast. This episode is full of actionable insight on the inspiration behind how Dr. Shah manages the science and process side of the business,...