The Business Of Biotech Podcast

EPISODES

GSK's Michael Mehler On The Cell & Gene Talent Crunch

Monday, June 14, 2021

Michael Mehler honed his cell therapy chops at Adaptimmune before joining GSK as Senior Clinical Development Manager, Cell Therapy Oncology in 2017. He and Cell & Gene chief editor Erin Harris joined the Business of Biotech podcast for a candid and detailed discussion on finding, hiring, and retaining cell and gene therapy professionals, facilitating their on-going training, bridging the gap between academia and industry, why clinical...  Continue Reading..

• RNA-Engineered Cell Therapy With Cartesian's Dr. Murat Kalayoglu

  Cartesian President & CEO Murat Kalayoglu, M.D., Ph.D. has led three of his company's six autoimmune, oncology, and respiratory candidates through Phase I/II clinical trials and two more of them are on the cusp of entering Phase I this year. With so many programs in and entering the clinic, he's a great choice for a conversation on GMP expectations for phase I first-in-human trials. Glean insight from Cartesian's experiences and learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond on this episode of The Business of Biotech. 

• Real-Time Clinical Analysis with Glympse Bio's Dr. Caroline Loew

  On this episode of the Business of Biotech, we're going deep with Glympse Bio President & CEO Dr. Caroline Loew to explore the possibilities and implications of the in-vivo, bioengineered, tunable sensors the company is developing for diagnostic and prognostic purposes in protease-mediates diseases. Currently in the clinic with applications for Non-Alcoholic Steatohepatitis and other fibrotic diseases as well as Non-Small Cell Lung Cancer and other solid tumors, Glympse is unlocking an unprecedented view of near-real-time therapeutic response and therapeutic efficacy that could have big implications on the way biologics are developed, refined, and studied in the clinic. 

• AAV & Lentiviral Gene Therapies with Sio's Dr. Pavan Cheruvu

  Fresh on the heels of a significant data readout on its AXO-AAV-GM1 candidate at the recent ASGCT meeting, Sio Gene Therapies CEO Pavan Cheruvu, M.D. joins the Business of Biotech podcast. We discuss Dr. Cheruvu's formative years and inspiration, his company's origins, its progress developing AAV and lentiviral gene therapies to treat GM1 gangliosidosis, Tay-Sachs / Sandhoff disease, and Parkinson's disease, and the challenges the company has overcome in a hybrid manufacturing environment that will ultimately transfer entirely in-house. 

• Med Device Meets Biopharma with OncoSec's Dan O'Connor, J.D.

  OncoSec CEO & Director Dan O'Connor, J.D. joins the Business of Biotech to discuss his company's development of proprietary application and injection technologies for direct delivery of its pipeline of immunotherapeutic candidates and combination therapies into the tumor environment. O'Connor shares leadership lessons gleaned from his service as a Captain in the United States Marine Corps during Operation Desert Shield, and how he's applied those lessons as his company charts the manufacturing and regulatory challenges along its unique development timeline.

• Drug Development: From Bench To Bedside With Allan Shaw

  CFO to the biopharma stars and frequent Business of Biotech guest Allan Shaw joins us for a candid discussion on the keys to efficiency as you move your candidate from the bench to the bedside. Shaw shares the common perils of insular thinking in biopharma and offers practical advice for avoiding those pitfalls. We discuss the value of being early in the context of the current biopharma market — early to study, early to differentiate, early to kill if necessary, and early to fund your project on its journey to the clinic. 

• Digital Transformation In Cell Therapy with Organicell Drs. Mari Mitrani & Michael Bellio

  Drs. Mari Mitrani, CSO and Michael Bellio, Laboratory Director are young pioneers in the study of the therapeutic potential of exosomes. Their research leans heavily into the digital realm, leveraging computational biology, bioinformatics, large-scale sequencing, proteomics, and mass spectrometry to analyze perinatal tissue-secreted exosomes and their impact on a host of indications the company is exploring. On this episode of The Business Of Biotech, Drs. Mitrani and Bellio offer insight into the digital discovery and manufacturing automation technologies in use at Organicell.

• Biopharma Regulatory Requirements with bluebird bio's Scott Cleve

  Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as Vice President of Regulatory Operations and Compliance at bluebird bio. Join Cleve, host Matt Pillar, and Erin Harris, chief editor at Cell & Gene, for a candid discussion on the regulatory trends shaping the advance of bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

• Filling A Vaccine Void with Cue Biopharma's Dan Passeri, J.D.

  CUE Biopharma CEO Dan Passeri, J.D. discusses the development of the Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind the company's immunotherapeutic approach, and how the CUE-100 series candidates in its pipeline are addressing a scourge of HPV-related head, neck, and other cancers. 

• Supercharging An ADC Program With SOTIO CEO Dr. Radek Špíšek

  SOTIO isn't your typical single-molecule, single-platform biopharma. Since its inception, the company has supported 14 clinical trials of oncology therapeutics developed leveraging multiple platform technologies. On this episode of The Business of Biotech, SOTIO Global CEO Radek Špíšek takes a deep dive into the development, HR, and funding strategies the company has deployed to build its IL-15, immune cell therapy, and antibody-drug conjugate candidates.

• mAb Manufacturing with Rezolute Bio's Nevan Charles Elam, J.D.

  Nevan Charles Elam, J.D. 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 discusses the company's approach to process development and manufacturing.

• Cell Therapy Platform Dev With Precigen CEO Dr. Helen Sabzevari

  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 platform's potentianl to reduce CAR T complexity with an overnight manufacturing process to affect patients in urgent need of timely therapy. 

• A CFO's Prescription For Biopharma Success

  Life sciences CFO extraordinaire Allan Shaw shares incremental steps to biopharma success and dishes on the mistakes he's seen in his many engagements with new and emerging biotech firms. From capital resource allocation to personnel decision making to preparing for the bubble to burst, listen in as Shaw shares his unfiltered advice.

• A Biopharma Pivot Story With Compugen's Dr. Anat Cohen-Dayag

  In a remarkably short period of time, Dr. Anat Cohen-Dayag transformed Compugen from a computational biology service provider to a clinical-stage biopharma with multiple cancer immunotherapy candidates. Listen in as she discusses the strategies she deployed to build a biotech on the back of computational science, and her vision for the future of drug discovery. 

• Preparing For The Clinic With Amolyt Pharma's Dr. Thierry Abribat

  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.

• Pioneering Antiviral Conjugates With Cidara's Dr. Jeff Stein

  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 multiple antiviral indications.

• AI & The Human Genome With Dr. Dietrich Stephan

  NeuBase Therapeutics COE 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 technology.

• The FDA's Progressive Appeal ft. Allan Shaw

  Allan Shaw rejoins the Business of Biotech with candid 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, and his observations on the outsized approval rate for orphan disease and oncology therapies. 

• Celyad CEO Filippo Petti On In-House Allogeneic Cell Therapy Manufacturing

  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.

• Keeping Cell Therapy Clinicals On The Rails With Brian Culley

  As did most biotechs, Lineage Cell Therapeutics faced significant challenges navigating multiple clinical trials, one among an aging, at-risk population, during the pandemic. 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.

• Orchard Tx's Bobby Gaspar On Manufacturing Hematopoietic Stem Cells

  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.

• 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, 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.