The Business Of Biotech Podcast

EPISODES

Running Interference: RNAi With Silence Therapeutics' Craig Tooman

Sunday, May 15, 2022

Fresh on the heels of his appointment as President & CEO at Silence Therapeutics, Craig Tooman joins the Business of Biotech to share how he applies his finance-minded leadership to steward the advance of a pipeline of RNAi gene silencing candidates spanning indications from hematology to cardiovascular disease to rare diseases.   Continue Reading..

• Live Biologics & The Microbiome With 4D pharma's Duncan Peyton

  4D pharma's flagship early-stage clinical candidates are live biotherapeutics, a relatively new class of biologics that seek to impact disease state by modulating the microbiome. CEO Duncan Peyton is leading the effort to understand how the health of the microbiome relates to a wide range of diseases, including immuno-oncology, central nervous system disorders, respiratory disease, auto immune indications, and gastro intestinal disease. 4D pharma is even working on a live biotherapeutic vaccine platform. Join Duncan on this episode of the Business of Biotech as we discuss this new frontier of therapeutic exploration.

• Gene Tx For Renal Disease With Purespring CEO Richard Francis

  Under the leadership of CEO Richard Francis, Purespring Therapeutics is operating with the audacious goal to take its therapeutics all the way to the commercial finish line. On this episode of the Business of Biotech, Francis offers a transparent look at the company’s growth strategy and the progress it’s achieved to date.

• Fighting Blindness & Funding The Fight With Opus Genetics' Ben Yerxa, CEO

  Opus Genetics is an early-stage gene therapy company launched just last year and in unique fashion on the back of the patient advocacy group the Retinal Degeneration Fund. Already, its pipeline has developed into three candidates, the lead among them addressing Leber congenital amaurosis. Opus CEO Ben Yerxa, Ph.D. serves in triplicate as CEO at the RD Fund, Foundation Fighting Blindness, and Opus Genetics. His plate is full, but he's a man on a mission. On this episode of the Business of Biotech, Dr. Yerxa shares his story, that of Opus Genetics' unique approach to addressing inherited retinal diseases, and how the company is addressing current funding, development, and capacity challenges in the cell & gene manufacturing space.

• Gynecological Cancer Therapies With Context Therapeutics' Martin Lehr

  Context Therapeutics Co-Founder & CEO Martin Lehr shares stories from his self-described "recovery from venture capital," the work his company is doing in gynecological cancers, and how his small company manages a modality-agnostic approach and investigator-sponsored trials across multiple clinical candidates, four of which are in phase 2 clinical trials. We also discuss his "extracurricular" work with BioBreak, Life Science Leader, and Life Science Cares, and why those organizations are important to him personally and professionally. 

• Commensal Viral Vectors With Ring Therapeutics' Tuyen Ong, M.D.

  Tuyen Ong, M.D. shares on his challenging formative years, the unspoken love between a father and son, facing down racism as a poor Chinese kid in Vietnam and London, and how those experiences shape his leadership as CEO at Ring Therapeutics. Oh, and we talk about some really cool commensal viral vector science, too.

• Antibodies For Severe Allergies With IgGenix's Jessica Grossman, M.D.

  IgGenix CEO Jessica Grossman, M.D. discusses the gender gap in the biopharma c-suite, why women work harder than men, what it means to be a female biopharma leader, and IgGenix's approach at isolating and re-engineering allergen-specific IgE antibodies into IgG antibodies designed to alleviate allergic cascade. 

• SparingVision's Stéphane Boissel On Insourcing Bio Talent & IP

  Since assuming the President and CEO role at SparingVision in August 2020, Stéphane Boissel has been making big moves in the arenas of talent acquisition and IP expansion. Those efforts are securing the company's development of a number of genomic medicines to address inherited retinal disease. On this episode of the Business of Biotech, Boissel shares the company's foundation story and the role venture philanthropy played in it, his strategy for attracting and retaining big-league talent, and the why behind his vigorous allegiance to internal development. 

• Biotech M&A Trends With Allan Shaw

  Allan Shaw waxes on his expectations for M&A and collaborative partnership opportunities for new and emerging biotechs in 2022 and beyond. Learn what biotech leaders should be asking about intentionality, what's attractive to potential suitors, and why startups unprepared to go the distance have conceded a major factor in partnership/buyout negotiations. 

• LNP Gene Coding With SalioGen Therapeutics' Ray Tabibiazar, M.D.

  This episode of the Business of Biotech is fire. It's an interview with SalioGen Therapeutics Chairman and CEO Ray Tabibiazar, M.D., whose last name literally translates to "Dr. Fire." Tune in to learn how he got that name, and how genomic coding—adding a new genomic code to turn on, off, or modify function of new or existing genes—works.

• CAR T-Cells Therapies Get Closer To Solid Tumor Application

  While success has been seen in animal models, solid tumors have proved a vexing challenge for CAR T-cell therapies. On this week's episode of the Business of Biotech, we're joined by Anixa Biosciences Chairman, President, & CEO Amit Kumar, Ph.D. Dr. Kumar shares on the company's progress with a CAR T-cell therapy that aims to attack both tumor cells and the tumor vasculature, in hopes that it might be the first to destroy solid ovarian cancers.

• AI-Driven Biologics With Fountain Therapeutics' William Greene, M.D

  With its hypothesis-free, target-free, AI-driven drug discovery platform, Fountain Therapeutics is turning the traditional drug discovery pathway on its ear to address a variety of age-related disease. On this week's episode of the Business of Biotech, Fountain CEO William Greene, M.D. joins us to discuss the approach, its rationale, and how the company is applying substantial support from the likes of Eli Lilly, Alexandria Venture Investments, R42 Group, Khosla Ventures, and Nan Fung Life Sciences.

• Regulatory Harmonization With Aurion Biotech's Dr. Daniela Drago

  Dr. Daniela Drago, Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey through the clinic and beyond.

• Plant-Based Biologics With iBio's Randy Maddux

  iBio is attempting to turn the CHO cell development paradigm on its ear with hydroponically-grown N. benthamiana. COO Randy Maddux says the approach could be modularized to speed cycle times and dramatically reduce upstream costs at scales large and small. iBio is proving out the approach on candidates for oncological, infectious, and fibrotic diseases.

• NK Cell Therapy Accessibility Ft. Dr. Kleanthis Xanthopoulos

  Shoreline Biosciences CEO Kleanthis Xanthopoulos, Ph.D.shares on why the cell and gene immunotherapeutic market has underperformed to date, why he believes autologous is not the long-term path forward, and the safety and accessibility advantages he sees in an allogeneic-based, pluripotent stem cell approach. 

• A Hybrid mAb Manufacturing Model With John Glasspool

  On this episode of the Business of Biotech, Anthos Therapeutics CEO John Glasspool discusses the advantages and challenges of the hybrid manufacturing approach at Anthos, and how its mAbs have demonstrated an 80% reduction of the rate of VTE in post-operative total knee arthroplasty patients compared to the standard of care (enoxaparin).

• Biotech Capital Markets Forecast With Allan Shaw

  As Allan Shaw likes to say, "there have never been so many people with their hands out, and there has never been so much money to go around." But how sustainable is this seemingly perennial boom in the biotech capital markets? Will the road go on forever and the party never end, or are there signs of a slowdown on the horizon?

• Venture Philanthropy For Type 1 Diabetes With T1D Fund's Katie Ellias

  The JDRF's T1D Fund is exemplary of an indication-specific advocacy group's aggressive pursuit of a cure through venture philanthropy. Managing Director Katie Ellias explains the fund's unique approach, why Type 1 Diabetes is an important and potentially lucrative indication, and how the venture philanthropy model applies to the life sciences startup community.  

• Bye Bye Broad Spectrum: A Precision Approach To Infectious Disease

  Locus Biosciences CEO Paul Garofolo shares on the company's effort to develop precision therapeutics for infectious diseases at Locus, the company's decision to build its own cGMP manufacturing facility in Research Triangle, and the business opportunity the field addresses in the effort to overcome antibiotic resistance. 

• Bioenginnering Human Tissue With Humacyte's Dr. Heather Prichard

  Humacyte COO Dr. Heather Prichard joins the Business of Biotech for a discussion on the company's pipeline of candidates for the repair, replacement, and reconstruction of human vascular vessels, including the company's scale-up story and the science and engineering behind a unique approach to regenerative medicine using human tissue. 

• Top Stories Of 2021 With Allan Shaw

  Allan Shaw offers a no-holds-barred retrospective on the top stories and trends of 2021. From the frontlines of the COVID-19 pandemic to the questionable approval of Aduhelm to leadership instability at the FDA and more, Shaw dissects the year past and predicts how those stories will influence the biotech industry in 2022 and beyond.

• Complete CAR T Manufacturing Control with Cellectis' Steve Doares

  Cellectis' decision to build and operate its own trans-Atlantic manufacturing facilities was a strategic one. On this week's episode of the Business of Biotech, SVP of U.S. Manufacturing Steve Doares talks internal manufacturing rationale, discusses interoperability between its Paris and Raleigh, N.C. plants, and shares how the company keeps meeting the challenges presented by COVID-fueled supply chain disruptions head-on. 

• Elevation Oncology's Dr. Shawn Leland On Genomically-Guided Medicine

  Elevation Oncology is improving both the accuracy of and accessibility to genomic testing for cancer patients. In tandem, the company is in the clinic with its lead candidate seribantumab for cancer patients with solid tumors that express a genomic change called an NRG1 fusion. Founder & CEO Shawn Leland, PharmD, RPh shares the company's unique approach. 

• Inhalable mAbs And Vaccines With TFF's Glenn Mattes

  Glenn Mattes' TFF Pharmaceuticals is looking to break the parenteral barrier by manufacturing biologics — mAbs and vaccines, more specifically — that can be inhaled, rather than injected. It's a timely endeavor, and TFF's business model is a collaborative one that seeks to explore dry powder biologics options through partnership, in addition to its own pipeline.

• Democratizing Biologics With Brian Finrow, J.D., And Craig Behnke, Ph.D.

  Lumen Bioscience's cofounder and CEO, Brian Finrow, J.D., and EVP of production/development, Craig Behnke, Ph.D., discuss the development of therapeutic proteins from readily available food algae spirulina. It's driving a diverse pipeline of candidates into the clinic, for indications reaching from the gut to the heart and lungs.

• Cornering The Antibody Market: Akesobio CEO Dr. Michelle Xia, Ph.D.

  10-year-old Akesobio's stats are mindboggling: 20 drug development programs, 12 antibodies in clinical-stage development, 6 bi-specific antibodies (2 at clinical stage), 4 antibodies with IND approvals, and 22 clinical trials initiated. CEO Michelle Xia, Ph.D. shares how the company has managed such supercharged growth.

• Turning The Liver Into A mAb Factory: Homology's Arthur Tzianabos, Ph.D.

  Homology Medicines' approaches to gene therapy and gene editing have the potential to disrupt both the gene therapy space and the mAb manufacturing and administration paradigms. Here, Homology president and CEO Arthur Tzianabos, Ph.D., shares the company's approach and rationale for investing in its own development and manufacturing capacity.

• Maximizing mRNA With Precision Nanosystems' James Taylor, Ph.D.

  Dr. James Taylor, president and CEO at Precision Nanosystems, believes genomic medicine will ultimately become the largest therapeutic class. Listen in as Dr. Taylor discusses why RNA and DNA delivery are game-changers, and what Precision Nanosystems is doing to push the ball downfield.  

• Sarepta's Brian Winstead: Foundations Of Flexible Manufacturing

  Sarepta Therapeutics Director of Pharmaceutical Engineering Brian Winstead and Project Farma VP Tony Khoury discuss what flexible manufacturing means, where it works, and where it doesn't. Listen in as Winstead shares the flexible manufacturing philosophy at Sarepta.

• Beating The CDMO Capacity Crunch

  On this episode of the Business of Biotech, we're tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.

• The Clinical Trials Conundrum With Allan Shaw

  The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. 

• AltruBio's Gene Lee, Ph.D. On CMC Developability Assessments

  AltruBio VP of Technical Development Gene Lee, Ph.D. discusses CMC developability assessments; what they address, when to begin, and why they're integral to rapid entry into Phase 1 clinical trials.

• CDMO With A Pipeline Featuring Forge Biologics President & CEO Dr. Timothy J. Miller

  Inspired to develop a treatment for Infantile Krabbe Disease, the founders of Forge Biologics picked a unique but strategic approach to funding the initiative. They built a CDMO that aims to become one of the largest on the planet in the cell and gene therapy space. On this week's episode of the Business of Biotech podcast, co-founder, President, & CEO Timothy J. Miller, Ph.D. joins us to discuss the strategy, why it was a no-brainer given the white-hot market for contract development and manufacturing space, the state of the biologics manufacturing capacity crunch, and what companies like Forge are doing about it. 

• Building A DNA Delivery System With Poseida Tx CEO Eric Ostertag, M.D., Ph.D.

  Eric Ostertag, M.D., Ph.D., wanted to launch a biotech. When University of Pennsylvania department heads said no to a licensing deal for lack of a CEO, Dr. Ostertag convinced them he could run the company. Many bold moves later, Dr. Ostertag is founder and CEO at Poseida Therapeutics, a company that's doing things never seen before in the field of CAR T-cell and gene therapies for multiple myeloma and prostate cancer. On this week's episode of The Business of Biotech, Dr. Ostertag gives us a tour of the architecture supporting Poseida's unique 3-tiered development and manufacturing platform. 

• From Bayer To Startup Bio With AltruBio's Dr. Judy Chou

  Judy Chou, Ph.D. was a big-pharma MVP. She earned her academic stripes in the hallowed halls of Yale, the Max Planck Institute, and Harvard Medical School before taking on principal scientist roles at AbbVie, Pfizer, and Genentech. That experience parlayed into SVP positions at Tanvex, Medvation, back to Pfizer, and on to Bayer, where she was most recently SVP and Global Head of Biotech before taking the leap into the startup scene as President & CEO at AltruBio in 2020. On today's episode of the Business of Biotech, Dr. Chou shares personal and professional insight into how she's applied what she learned in Big Bio to transform a clinical-stage developer of mAbs designed to treat a broad range of immunological diseases.

• Creating Competitive Differentiation With Allan Shaw

  The biologic therapy market is crowded, and judging by the recent parade of IPOs, competition for investment, mindshare, talent, and ultimately share of market is only getting stiffer. On this week's episode of the Business of Biotech, our friend and biotech business guru Allan Shaw joins us for a foundational conversation on creating competitive differentiation at every stage of biopharma growth. We cover the connections between developmental strategy and the competitive commercial landscape, the moral obligation to differentiate between promise and plausibility, the commoditization of brilliant science, and the necessity to align balanced plans with wild dreams.

• Gene Therapy Manufacturing Advances With Aruvant CTO Dr. Palani Palaniappan

  Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. joins the Business of Biotech with special guest Tony Khoury, EVP at Project Farma to discuss recent advances in gene therapy manufacturing. We cover the role of artificial intelligence in the discovery of AAV capsids that can avoid the immune system, the growth of non-viral vectors, the scale up advantages of suspension technologies versus adherence, the evolution of the regulatory environment, manufacturing capacity and talent constraints, and much, much more. 

• iNK T-Cell Immuno-oncology For Solid Tumors With Dr. Ian Walters

  Dr. Ian Walters' company, Portage Biotech, is focused on addressing the 75% of cancer patients who show no, or limited, response to existing therapies such as checkpoint inhibitors. Leading that charge are the company's invariant natural killer T cell agonists, designed to activate the innate and adaptive immune system, as well as a growing portfolio of proteins, antibodies, and small molecules. On this episode of the Business of Biotech, Dr. Walters shares what's fueling the company's progress, including its unique financing strategy and its approach to de-risking platform development for novel immuno-oncology therapies.

• How To Apply For BTD And Win It With Drs. Ira Gupta & Shanthi Ganeshan

  Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.

• Cold Chain Integrity & Sustainability With Celyad Oncology's Thomas Lequertier

  Maintaining therapeutic integrity through cryopreservation and super cold supply chains have challenged, and continue to vex, biologics producers. On this episode of the Business of Biotech, Celyad Oncology Head of Cell Therapy Manufacturing Thomas Lequertier shares best practices for the cryopreservation of cell therapies while minimizing cell degradation, maintaining their integrity on the journey from the lab to the patient, and what the future holds for cold chain biologic therapy logistics. 

• Peptides & Proteins: Resetting The Immune System With Revolo CEO Jonathan Rigby

  Revolo Biotherapeutics has entered phase 2 clinical studies of two molecules for autoimmune or allergic diseases that act to reset the immune system “upstream,” or ahead of the inflammatory cascade. On this episode of the Business of Biotech, Revolo CEO Jonathan Rigby shares the outsourced manufacturing strategy behind the endeavor, why it's so important to avoid immune suppression and how the therapies work to avoid it, and how the company managed to raise a $53 million Series B to fund development in the midst of a raging global pandemic.

• Intranasal Prophylactics For Flu & Coronavirus With Leyden Labs' Koenraad Wiedhaup

  As Leyden Labs Founder & CEO Koenraad Wiedhaup puts it, we breathe in galaxies of viruses on a daily basis. As those viruses multiply and mutate, our approach to mitigating their risks is largely reactive. That's why his new company is busy developing a prophylactic approach to protecting populations from a host of influenza and coronaviruses via a self-administered intranasal spray. Learn how the company came to be, how its development efforts were buoyed by a recent $40 million series A investment, and why Wiedhaup believes intranasal prophylactics are ready to play a role in prevention of the next pandemic on this episode of the Business of Biotech podcast.

• Talking SPAC With Allan Shaw

  Special-purpose acquisition companies, or SPACs, are all the rage as start-up financing vehicles go, and they're particularly well-suited for emerging biopharma companies. On this episode of the Business of Biotech, we dig deep into the advantages, limitations, and potential pitfalls of the SPAC with a man who was executing SPAC deals before SPAC deals were cool. Whether you're a biotech investor or a biopharma leader looking to acquire or be acquired, you'll want to tune in to this episode for insight into the special-purpose acquisition company strategy.

• A Vaccine For Type 1 Diabetes With Diamyd Medical's Dr. Ulf Hannelius

  As leaders at Diamyd Medical made plans to manufacture clinical supply of therapies aimed at preserving and restoring insulin production in Type 1 diabetes patients, outsourced production was on the table. Then, the company doubled down on its intentions and built out its own manufacturing facility. On this week's episode of The Business of Biotech, Diamyd Medical President & CEO Dr. Ulf Hannelius tells us all about the therapies his company is developing, plus the why and the how behind the company's choice to manufacture them in-house. 

• CAR T Process Automation With Kite Pharma's Charles Calderaro III

  Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps. 

• Biopharma PR 101 with Matt Middleman, M.D.

  When is the appropriate time for a new life sciences company to wind up the PR machine? What's the difference between public and investor relations, and how do they complement each other? What's newsworthy? What's not? What are the latest tools of the trade in an increasingly social-driven PR practice? What results should you expect, and how are those results measured? On this episode of the Business of Biotech, we address these questions with physician and professor-turned public relations practitioner extraordinaire Matt Middleman, M.D. , founding partner and CEO at LifeSci Communications, LLC.

• A Scale-Up Story With Solis BioDyne Drs. Kadri Artma and Angela Vaasa

  When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to the limit. In short order, it doubled, and then tripled, its manufacturing capacity. Then it doubled, and then tripled, its workforce. Meanwhile, it adopted a host of new platforms to serve the demand of its clients. Drs. Kadri Artma and Angela Vaasa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that's allowing the renowned producer of reagents to the life sciences industry to meet market demands. 

• Academia + Industry with BridgeBio's Dr. Michael Henderson

  BridgeBio has a whopping 30+ pre-clinical to clinical-stage candidates in its pipeline, representing an impressive array of modalities and targets. It boasts a couple of commercial wins under its belt. Central to its success are partnerships with scientists and researchers to fuel pipeline expansion. Here, BridgeBio CBO Michael Henderson, M.D. walks us through the formula behind the company's academia-led growth strategy.

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

  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 feedback is an underappreciated source of intelligence, and the resources available to cell and gene developers to further their "pipelines" of bench-level talent.

• 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.