The Business Of Biotech Podcast

EPISODES

Orchard Tx's Bobby Gaspar On Manufacturing Hematopoietic Stem Cells

Sunday, January 24, 2021

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.  Continue Reading..

• Acepodia's Approach To ACC & CAR Manufacturing Scalability

  Acepodia's Dr. Sony Hsiao, CEO, and Dr. Mark Gilbert, SVP of R&D, join the Business of Biotech for a discussion on the company's approach to dramatically reduce the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates. Listen now and subscribe so you never miss an episode.

• The AAV Vector Challenge With Selecta's Dr. Carsten Brunn

  The Business Of Biotech’s Cell & Gene Miniseries opens with Dr. Carsten Brunn, President & CEO of Selecta Biosciences. Guest host Erin Harris joins our discussion on Selecta's ImmTOR platform and how the company is addressing the immunogenicity of the AAV vectors challenge faced by gene therapy companies. Listen now and subscribe so you never miss an episode.

• A Look Behind, A Look Ahead With Allan Shaw

  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. 

• How Clinical Trial Creativity Overcame COVID-19 Disruption

  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 population and ensure her company met clinical milestones.

• Gene Therapy Manufacturing At-Scale With Geoff MacKay

  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.

• Bacterial Therapy: Modulation of the Microbiome

  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.

• Foundations Of Biopharma Finance With Smital Shah, MBA

  Smital Shah brings a trifecta of chemical engineering, consulting, and finance experience earned at heavyweight companies like JP 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.

• Off-The-Shelf CAR T-Cell Therapy?

  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.

• CAR T Therapy Cost Control With Laurence Cooper, M.D., Ph.D.

  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.

• Gap Analysis With Dr Pablo Valenzuela & Cristián Hernández-Cuevas

  We're joined by biopharma pioneer Dr. Pablo Valenzuela and rising star Cristián Hernández-Cuevas, both of Andes Biotechnologies, for a candid discussion on biopharma's compute power revolution, gap analyses and next steps for emerging biopharma, and what's driving growth in South America.

• Drs. Edith Perez And Nathan Ihle: CMC Considerations For In-Human Studies

  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.

• Commitment To GMP With Dr. Shabbir Anik

  Sutro Biopharma CTO Shabbir Anik has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career. We sat down for a chat about the mechanics of GMP and CMC strategy in Sutro's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

• Data Quality For FDA Submissions With Dr. Robert Hariri

  The development of Celularity's therapies is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. The approach begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

• Dr. Gaurav Shah: Rocket's Chief Gene Therapist & Virtuoso

  On this episode of The Business of Biotech, 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. Learn how Dr. Shah manages the scientific process, employees, finances, and stakeholder expectations by drawing from his mastery of music.

• Dr. Randy Schatzman On Dodging Disruption: The New Fundraising Norm

  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.

• Myeloid Cells, Transplants, & Immuno-Oncology Inspiration

  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. 

• Arrowhead Pharma's Dr. Christopher Anzalone: Taking RNAi Beyond The Liver

  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.

• Immunomedics' Dr. Loretta Itri On Taking ADCs Across The Finish Line

  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.

• Building A Biotech Around Your Therapeutic Platform

  With the science behind Heat Biologics' platform to activate immune responses against pathogenic or cancer antigens in place, founder and CEO Jeff Wolf proceeded to structure the organization in a strategic fashion to support that platform. On this episode of The Business Of Biotech: Summer Executive Sessions, Wolf tells us how he did it.

• Solving The COVID-19 Workforce Crisis

  Obsidian Therapeutics CEO Dr. Paul Wotton didn't let pandemic-induced workforce restrictions impede his biopharma's progress. On this episode, Wotton tells us how a homegrown software application, dubbed SWFT, was built, how it's working, and why Obsidian has made it available to more than 30 (and growing) other biotechs, free of charge. 

• Bringing Big-League Finance Experience To An Emerging Biotech

  The Business Of Biotech "Summer Executive Sessions" kick off with Athersys CFO Ivor Macleod, who brings finance leadership experience at Roche and Merck to Athersys as the company readies its lead candidate for life beyond clinical trials. Learn how Macleod applies big-league finance principles to an emerging biopharma company.

• Leaving The Incubator With Kavitha Iyer Rodrigues

  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.

• Episode 6: Building An All-Star Biotech Team With Vivek Ramaswamy

  Roivant Sciences is parent company to some 20 emerging biopharma entities with dozens of candidates in their collective pipelines. Founder Vivek Ramaswamy shares practical and applicable advice on the people, positions, and characteristics that constitute a winning biopharma team, and best practices for recruiting and retaining them.

• Episode 5: Finding Funding In Volatile Times With Ben Zeskind

  This week's Business Of Biotech pod features Immuneering CEO Dr. Ben Zeskind, who launched his biotech on the back of creative financing in the throes of the Great Recession. A pivot into biopharma at the outset of the COVID-19 pandemic landed Immuneering a $20 million series A round to develop its pipeline.

• Episode 4: Building Your Pitch With Leslie Williams

  Leslie Williams is a multi-time biotech founder and board member who's honed her pitch-building skills to a fine point. On this episode of The Business Of Biotech, Williams shares best practices for building your pitch deck, how to draw out the nuance that makes your story unique, what to expect in your initial pitch session and follow-on meetings, and why the human element trumps everything else in an otherwise formulaic pitch process.

• Episode 3: The Biopharma Exit Strategy With Dr. Francois Nader

  On this episode of The Business Of Biotech, we talk with Dr. Francois Nader—a man who's orchestrated several wildly successful biotech exits—about why it's imperative to begin with the end in mind as you create value for stakeholders, and how to navigate your options when the time to exit is right.

• Episode 2: The Business Of Biotech: Allan Shaw

  Few are better suited to advise emerging biopharma leaders on the building blocks of biotech than Allan Shaw. On this episode of The Business Of Biotech, we'll absorb Shaw's to-the-point, practical advice on winning finances, building a pitch, assembling a biotech all-star team, leaving the incubator, navigating early regulatory considerations, and more. 

• Episode 1: Introducing The Business Of Biotech Podcast

  With the support of Cytiva, formerly GE Healthcare Life Sciences, we're launching a podcast to serve as a resource for the leaders of new and emerging biopharmas. We have an incredible group of guests—all of them founders who have taken biotherapy ideas and successfully turned them into clinical realities—lined up to share their insight with you. Here’s how the series, which is focused on the financial, organizational, HR, process, and regulatory aspects of launching a biopharma company, will play out.