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 Pharma's pre-clinical preparation, including his financing, talent acquisition, and clinical stu...
Mar 08, 2021•36 min
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 approach, which Dr. Stein anticipates yielding a low-cost alternative to standards of care in multipl...
Mar 01, 2021•38 min
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 discovery at NeuBase and beyond, with plenty of practical insight on how to adopt and leverage the t...
Feb 22, 2021•49 min
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 and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducan...
Feb 15, 2021•38 min
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-based manufacturing facility. Access this and hundreds of episodes of the Business of Biotech videoca...
Feb 08, 2021•47 min
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 (acute spinal cord injury) running on time despite the disruptions. Access this and hundreds of episodes...
Feb 01, 2021•37 min
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 to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Access this and ...
Jan 24, 2021•42 min
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 episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Su...
Jan 18, 2021•43 min
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 challenge faced by gene therapy companies. Access this and hundreds of episodes of the Business of B...
Jan 11, 2021•32 min
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--as we head into the new year. Access this and hundreds of episodes of the Business of Biotech video...
Jan 04, 2021•47 min
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 at the creative measures her company took to serve a geographically dispersed clinical patient popu...
Dec 21, 2020•38 min
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 episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.c...
Dec 07, 2020•41 min
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. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch t...
Nov 23, 2020•42 min
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 biopharma organization. Access this and hundreds of episodes of the Business of Biotech videocast und...
Nov 09, 2020•34 min
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 Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter . Get in touch with guest and ...
Oct 26, 2020•39 min
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 Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter . Get in touch with ...
Oct 13, 2020•38 min
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 episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. S...
Sep 28, 2020•38 min
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 Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to...
Sep 21, 2020•45 min
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's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidate...
Sep 14, 2020•35 min
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 begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent disc...
Sep 08, 2020•39 min
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, his employees, financing, and stakeholder expectations by drawing from has passion for—and understan...
Aug 31, 2020•40 min
We love to hear from our listeners. Send us a message. Dr. Randy Schatzman, CEO at Bolt Biotherapeutics , discusses his company's adjustment to pandemic disruption on the fundraising trail. He walks us through the remote-fundraising strategy that landed Bolt's recent $93.5 million Series C financing round, and how the company is moving towards an IPO in spite of market, civil, and political tumult. Access this and hundreds of episodes of the Business of Biotech videocast under the List...
Aug 24, 2020•40 min
We love to hear from our listeners. Send us a message. OSE Immunotherapeutics CEO Alexis Peyroles joins The Business Of Biotech: Summer Executive Sessions to discuss myeloid cells' role in immunology, why a team of transplant specialists is key to his company's therapeutic development approach, and creating differentiation as a clinical-stage immunotherapy company in an ever-growing sea of competitors. Access this and hundreds of episodes of the Business of Biotech videocast under the ...
Aug 17, 2020•34 min
We love to hear from our listeners. Send us a message. Arrowhead Pharma CEO Christopher Anzalone, Ph.D. gives us the inside story on the stake his company claimed on the now re-burgeoning RNAi space, the indications his company is targeting beyond liver disease, and how it's addressing the development and process challenges that must be overcome to further progress RNAi beyond the liver. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch t...
Aug 10, 2020•36 min
We love to hear from our listeners. Send us a message. While Immunomedics CMO Loretta Itri, M.D. is no stranger to taking drugs across the commercial finish line in big pharma, her most recent win with TRODELVY was very, very different. Here, Dr. Itri shares insight on her small biopharma's first commercial launch, the manufacturing and regulatory challenges overcome to get there, and why ADCs are coming of age. Access this and hundreds of episodes of the Business of Biotech videocast under...
Aug 03, 2020•41 min
We love to hear from our listeners. Send us a message. Heat Biologics founder and CEO Jeff Wolf took a creative approach to building his organization. With the science behind his company's platform to activate immune responses against pathogenic or cancer antigens in place, he proceeded to structure the organization and its people in a strategic fashion to support that platform. Learn how he did it–and how Heat's management philosophy is driving innovation and efficiency there–on this ...
Jul 27, 2020•36 min
We love to hear from our listeners. Send us a message. Obsidian Therapeutics CEO Dr. Paul Wotton didn't let pandemic-induced workforce restrictions impede his biopharma's progress. Instead, his team developed a software system purpose-built for biotechs to manage personnel and equipment per ever-changing guidelines. On this episode of The Business Of Biotech: Summer Executive Sessions, Wotton tells us how the application, dubbed SWFT, was built, how it's working, and why Obsidian ...
Jul 20, 2020•36 min
We love to hear from our listeners. Send us a message. The Business Of Biotech "Summer Executive Sessions" kick off with a candid conversation with Athersys CFO Ivor Macleod, who brings years of finance leadership at Roche, Merck, and other big pharmas to Athersys as the company readies its lead candidate for life beyond clinical trials. Join us for a discussion on how Macleod is applying big-league finance principles to an emerging biopharma company, and what he's learned about m...
Jul 13, 2020•35 min
We love to hear from our listeners. Send us a message. A strategic departure from the biotech incubator requires the coordination of moving parts aplenty. Development timelines, seed funding, facilities development, and team dynamics are just a sampling of the critical aspects discussed here with multi-time founder and Zumutor Biologics CEO Kavitha Iyer Rodrigues. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. S...
Jun 29, 2020•34 min
We love to hear from our listeners. Send us a message. On this episode of The Business Of Biotech, we're talking with Vivek Ramaswamy, who launched Roivant Sciences—parent company to a full 20 biopharma companies with dozens of pre-clinical through phase 3 candidates in their collective pipelines—back in 2014. Spinning them all up so quickly has required a skillful approach to recruiting—and maintaining—the company’s talent pool.Listen in as Ramaswamy walks through the art, science, and nua...
Jun 15, 2020•36 min
