EPISODES

mRNA Vaccine Platforms With Combined Therapeutics' Dr. Romain Micol

Sunday, December 3, 2023

Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare.  Continue Reading..

• Biotech Dealmaking With Regeneron's Nouhad Husseini

  Partnerships, acquisitions, licensing agreements, and other deals with Intellia, Decibel Therapeutics, BARDA, Alnylam, and Sonoma Therapeutics are just a sampling of Regeneron's strategic partnerships making news this year. Nouhad Husseini, SVP and Head of Business Development and Corporate Strategy at Regeneron is behind much of the dealmaking.

• Backpacks And Biotech With Luke Timmerman

  From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. In this episode, we'll get to know Luke personally, learn about his philanthropic work, and give you a healthy dose of optimism as we look ahead to the next decade in biotech.

• RNA Delivery Business With Liberate's Shawn Davis, Ph.D. & Walter Strapps, Ph.D.

  Earlier this year, Shawn Davis, Ph.D. left a pretty comfortable position at AstraZeneca (and Amgen before that, and Milliken – and others – before that) to lead Liberate Bio. He brought along another industry notable in Merck/Intellia alumnus Walter Strapps, Ph.D., who serves as CSO at Liberate. Why'd they do it?

• The Legend Steve Gorlin's Golden Rules

  Shortly after Thalidomide became a household word—albeit a very, very bad one—a biotech investor bought it for a couple hundred grand. Who on earth would want a drug pulled from the market for causing birth defects? Steve Gorlin did.

• CDMO + Emerging Bio Partnership With Forge's John Maslowski And Ray's Jenny Holt

  What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its CDMO? Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinions. So does John Maslowski, Chief Commercial Officer at the CDMO Forge Biologics. Think they align?

• Clinical Leadership with Cue Biopharma's Anish Suri, Ph.D. & Dan Passeri, J.D.

  On a road trip to Boston, the Business of Biotech caught up with podcast alum Dan Passeri, J.D., CEO at Cue Biopharma, and enjoyed a two-for-one with CSO and President Anish Suri, Ph.D. at Cue's headquarters just feet below the Auerbach Center.

• Bio Career Moves With Codagenix's Johanna Kaufmann, Ph.D.

  On this week's episode of the Business of Biotech, Dr. Johanna Kaufmann gives us an intimate retrospective on her career to date, sharing stories about her rapid ascension from Scientist 1 to executive leadership. We dig into her wild ride through M&A, her time at GSK, and the professional and personal development regimens she subscribes to.

• Veteran Advice From The C-Suite With Citius' Leonard Mazur

  Leonard Mazur has been in the business of biotech for a long, long time, and he has no intention of stopping now. He’s faced challenges won, lost, and ongoing, and he’s willing to share his experiences—from winning FDA approvals to bootstrapping his current effort at Citius Pharmaceuticals—with the transparent confidence of an industry veteran.

• Don't Be A D**k With Ochre Bio's Dr. Quin Wills

  Don't be offended by the title of today's Business of Biotech podcast. Dr. Quin Wills' application of what's become known as "Wheaton's Law" (look it up) is central to the ambitious goals his company, Ochre Bio, is pursuing.

• Pragmatic Computational Biology With Andrew Satz

  This week's guest on the Business of Biotech, EVQLV's Andrew Satz, says AI and ML in biopharma are like sex in high school. "Many of the people who say they're doing it really aren't, and the ones who really are aren't talking about it," he says. So, when it comes to the computational biology buzz, what’s real? What’s yielding benefit?

• Commercial Readiness With Orca Bio's Dan Kirby

  Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.

• Bio & The Business Of Aging With Life Biosciences' Jerry McLaughlin

  Core to the clinical-stage biopharma Life Biosciences belief set is that "contrary to popular belief, aging is not caused by random wear and tear, but instead is caused by a discrete set of biological mechanisms that can be targeted therapeutically.”

• Fiscal Turnarounds With Protalix's Eyal Rubin

  Within about five minutes of conversation with Protalix CFO Eyal Rubin, I learned that he doesn’t bite his tongue about the rigors of biotech business and finance management, which is precisely why I’m eager to talk with him on today’s episode of the Business of Biotech podcast.

• Building LEO Pharma's U.S. Presence With Brian Hilberdink

  In many respects, bringing an established foreign biopharma company to the U.S. market is not unlike starting one up from scratch. In other respects, it's even harder. The job's not for the faint of heart, which might be why the Danish company LEO Pharma tapped veteran biopharma leader Brian Hilberdink to lead its U.S. operations.

• Managing Momentum With Rezolute Bio's Nevan Charles Elam, JD

  Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its monoclonal antibody for congenital hyperinsulinism for a pivotal phase 3 trial.

• Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar

  The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics have yet reached the finish line.

• Biotech Cash Management With Allan Shaw

  It’s been said that clinical trials are where emerging biotechs go to die. If the science doesn't kill quickly, poor cash management will slowly. On this week's episode of the Business of Biotech, our favored biotech finance management maven, Allan Shaw, offers pointed advice on stretching cash runways for the long run.

• Establishing Research With Horizon Therapeutics' Robert Stoffel, Ph.D.

  Horizon Therapeutics has made plenty of waves in the biotech news cycle of late. Its formal establishment of a research team – comparatively pragmatic as that may be – could have impactful, long-term consequences.

• Surviving The Microbiome Market with MaaT Pharma's Hervé Affagard

  In this episode of the Business of Biotech, MaaT Pharma Founder & CEO, Hervé Affagard, offers a transparent look at how MaaT is beating the odds with clinical strategy and cash management.

• COO Liftoff With Rocket Pharmaceuticals' Kinnari Patel, PharmD

  COO is arguably the toughest job in the emerging biopharma C-suite. This episode brings us to a president and COO who's also a mom, a volunteer, and an advocate for diversity and equality in biopharma.

• ML-Enabled Drug Discovery With LabGenius' James Field, Ph.D.

  We explore the intersection of tech and bio with Dr. James Field, founder and CEO of LabGenius. If you're concerned with what ML will do to — or for — your biopharma business, don't miss this episode.

• Biopharma Comebacks With Vincerx's Ahmed Hamdy, MD

  Ahmed Hamdy, MD didn’t ask to be the subject of Nathan Vardi's new book​ For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug. In fact, he’d rather not relive that chapter.

• Origins Of A Biopharma VC Deal With Bernat Olle, Ph.D. And Parag Shah

  Here's a behind-the-scenes breakdown of how Vedanta Biosciences secured the support of K2 Health Ventures in its recent $100 million+ financing to fund a pivotal Phase 3 study.

• Population-Level Health Impact With Vaxxinity's John Krayacich

  Vaxxinity CBO John Krayacich played key roles on the teams that launched Lipitor, Lyrica, and Neurontin. Hear his take on seeing therapeutics for global patient populations to the commercial finish line.

• The Face Of African Biotech With Adrienne Leussa, Ph.D.

  Dr. Adrienne Leussa is one of our favorite follows. If the booming biotech scene on an incredibly diverse continent of 1.2 billion people interests you, she should be one of your faves, too.

• The Innovation Reduction Act With Allan Shaw

  Allan Shaw posits that the Inflation Reduction Act (IRA) will stifle momentum in the biopharma industry and suggests its impact will ultimately cost patients and payers more. Tune in to learn why.

• Propagating Peptides With Peptilogics' Jonathan Steckbeck, Ph.D.

  Peptilogics CEO and founder Dr. Jonathan Steckbeck walks us through his transition from academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, the big demand for antibiotic peptides, and more.

• Resilient Biopharma Leadership With Ambrx's Dan O'Connor

  We welcome back Dan O'Connor, CEO of Ambrx, to discuss the resurgence of Ambrx and leadership resilience in an industry that demands it on this episode of the Business of Biotech.

• Funding A Neurodegeneration Startup With Coya Therapeutics' Howard Berman

  Howard Berman, Ph.D. knows well the tragedy of cognitive decline. Now CEO of Coya Therapeutics, Berman joined the Business of Biotech to share his strategy during a stingy stretch in capital markets.

• A More NIIMBL Biotech Workforce With John Balchunas

  What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? NIIMBL's John Balchunas says advanced degrees and pedigrees aren't the answer. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda designed to meet biopharma manufacturing's real-world skilled labor needs. 

• Building Flagship Pioneering With Avak Kahvejian, Ph.D.

  Flagship Pioneering is fertile ground for a bevy of blossoming biotechs, and one of its most prolific sowers is General Partner Avak Kahvejian, Ph.D. On this episode of the Business of Biotech, Kahvejian takes us under the hood of one of the most burgeoning businesses in biotech, sharing details on the people, processes, and technologies fueling its rapid growth.

• Therapeutic Molecules From Moss With Drs. Andreas Schaaf And Björn Cochlovius

  Learn about a company that's developing proteins to fuel its own pipeline — and its partners' — from a most ubiquitous plant that grows virtually everywhere. It grows particularly well in bioreactors outfitted with custom grow lights and presents some significant advantages over CHO cell line development. 

• Gene Tx For Hearing Loss With Sensorion's Nawal Ouzren

  We often talk about biotechs taking "big swings." Sensorion CEO Nawal Ouzren is swinging for the fences with a lineup of gene therapies designed to address multiple forms of hearing loss, which affect multiple millions (if not, billions) of people worldwide. Listen in as Ouzren shares her holistic and aggressive plans with the Business of Biotech. 

• Functional Ectopic Organs With LyGenesis' Michael Hufford, Ph.D.

  LyGenesis is developing a pipeline of allogeneic cell therapies using the lymph node as an in vivo bioreactor to grow functioning ectopic organs. What sounds like sci-fi is a potentially life-changing therapy for liver, kidney, pancreas, and thymus disease sufferers. The Business of Biotech takes us to Pittsburgh for a conversation with LyGenesis CEO Dr. Michael Hufford, Ph.D.

• Approvals & Mergers: Inside Enzyvant With Bill Symonds, Pharm.D.

  Enzyvant CEO Bill Symonds, Pharm.D. discusses the approval of Rethymic, the merger of Altavant and Enzyvant, and the company's intentions for a brand new regenerative medicine manufacturing facility in Research Triangle Park. From drug approvals to mergers, from internal manufacturing capacity to founders-turned-presidential candidates, this one's got it all. 

• Next-Gen Nanobodies With MoonLake's Jorge Santos Da Silva, Ph.D.

  Approved therapies for inflammation have fallen short for patients, says Moonlake Immunotherapeutics CEO Jorge Santos Da Silva, Ph.D. What's the problem, and why does he think his camelid-derived nanobody candidates are poised to outperform big-pharma standards from the likes of UCB and Novartis? Find out on the Business of Biotech.

• Lessons From The Bone Therapeutics/Medsenic Merger

  On the surface, the merger of Medsenic and Bone Therapeutics doesn't look obviously synergistic. But Francois Rieger, Ph.D., CEO of the resulting company BioSenic, says that on the scientific level, it's a perfect union. And the veteran biotech founder says the business should always follow the science.

• TCRs In Personalized Oncology With BlueSphere Bio's Keir Loiacono

  BlueSphere Bio CEO Keir Loiacono, Esq., works with a sense of urgency inspired by his own cancer journey. Business of Biotech toured Bluesphere's state-of-the-art facility, then sat down with Loiacono to learn his story and discuss the company's vision for the future of personalized, adoptive T-cell therapy.

• BoB@JPM: Self-Replicating RNA With Elixirgen's Akihiro Ko

  Elixirgen Therapeutics CEO Akihiro Ko discusses a unique, temperature-controlled in-vivo gene expression technology designed to address common cell therapy administration challenges and unwanted, off-target immungenicity effects, shares progress on the company's ex-vivo candidate for telomere biology disorders, and more.

• BoB@JPM: Gene Writing With Tessera's Michael Severino, M.D.

  Flagship Pioneering plucked Michael Severino, M.D. away from AbbVie to run point at Tessera, a startup it's backed to pioneer a new category of genetic medicine it calls gene writing. The Business of Biotech caught up with Severino at the JP Morgan Healthcare Conference in San Francisco last month. We learned what lured him away from leadership positions at Merck, Amgen, and AbbVie, how gene writing differs from gene therapy and gene editing, why the team at Tessera believes its technologies can write and rewrite DNA at the scales necessary to cure most genetic diseases, and where he plans to take the company from here. 

• BoB@JPM: Post-IPO With Bolt Bio Drs. Randall Schatzman and Edith Perez

  We caught up with Bolt Biotherapeutics CEO Randall Schatzman, Ph.D. and CMO Edith Perez, M.D. at the JP Morgan Healthcare Conference in San Francisco last month for a conversation on the IPO process, the impacts it's had on the go-forward plan at Bolt Bio, the company's clinical progress, and its collaboration strategy moving forward. 

• BoB@JPM: Academia To Industry With Oncolytics' Matt Coffey, Ph.D.

  Matt Coffey, Ph.D. earned his Ph.D. in 1998 and turned his doctoral thesis into a biopharma company called Oncolytics in 1999. Dr. Coffey shares on his abrupt transition from academia to industry, tells tales of the company's backstory, and updates us on its aggressive clinical activity spanning 7 wide-ranging oncology programs.

• BoB@JPM: Support Of A Blossoming Pipeline With Sangamo's Sandy Macrae, Ph.D.

  The Business of Biotech podcast took to the streets of San Francisco during the 41st Annual J.P. Morgan Healthcare Conference. This week's episode features a conversation with Sangamo Therapeutics CEO Sandy Macrae, Ph.D., who rationalizes the company's aggressive pipeline development and its decision to invest in multinational AAV and cell therapy manufacturing facilities in France and California. Dr. Macrae zeroes in on the relationship between people and processes that's enabled the company to grow to more than 500 associates working on nearly 20 cell therapy, gene therapy, and genome engineering programs. 

• Building A Better COVID Vaccine With Ocugen's Shankar Musunuri, Ph.D.

  Is it past time for a new approach to the COVID vaccine? Ocugen Chairman of the Board, Founder & CEO Shankar Musunuri, Ph.D. says yes, and his ideals would mark significant improvements: fewer shots, better durability, less post-vaccination transmission, and safety proven by time-tested technology. 

• Modality-Agnostic Drug Discovery With Cullinan Oncology's Nadim Ahmed

  Cullinan Oncology CEO Nadim Ahmed shares how his company's drug discovery efforts have yielded a wide range of multi-modal oncology candidates. We dig into the company's transition from R&D to the clinic, how it's built an uncommonly comfortable cash position through partnership, and its ambition to become a commercial-stage biotech. 

• Women In Biotech With Bill & Melinda Gates MRI's Piper Trelstad, Ph.D.

  On this episode of the Business of Biotech, Piper Trelstad, Ph.D. dives into how the Bill & Melinda Gates Foundation Medical Research Institute is tackling health problems among the world's most vulnerable populations and shares how the biopharma industry can proactively support and advance women in technical roles. 

• Computational Drug Discovery With Gain Therapeutics' Matthias Alder

  Gain Therapeutics CEO Matthias Alder offers up a deep, yet abundantly clear explanation of his company's application of compute power to speed up drug discovery. At Gain, computational models help researchers winnow down not just which molecules might have therapeutic effect, but also how adept those molecules will be at binding—and staying bound—to their target.

• Dissecting Spesolimab's Approval With Boehringer Ingelheim's Carine Boustany

  Join Matt Pillar for a conversation with Carine Boustany, PharmD, Ph.D. and SVP, US Research Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. On this episode of the Business of Biotech, we walk through the story leading up to the recent approval of spesolimab. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. Dr. Boustany shares the antibody's fortuitous discovery, the challenges her team faced on the path to approval, and how those challenges were overcome.

• AI & Computational Biology With Recursion's Chris Gibson, Ph.D.

  Recursion's unique, technology-aided approach to drug discovery has yielded one of the deepest, fastest-growing pipelines in emerging biotech. It starts with a 20-petabyte-and-growing database designed to create comprehensive "maps of biology" that enable insight into the relationships between molecules and cell types. On this episode of the Business of Biotech, we take a deep dive into the approach—and what Recursion intends to do with all that data—with the company's co-founder and CEO, Chris Gibson, Ph.D. Don't miss this window into the world of a true pioneer in computational biology.

• Financing Biopharma Innovation With Allan Shaw

  Friend and frequent guest Allan Shaw rejoins the Business of Biotech to reflect on his recent presentation on innovative biotech financing at the BioFuture event in NYC. We also dig into Bruce Booth's "Atlas Venture Year In Review," revisiting and unpacking some quoteworthy material and metrics from both sources. 

• Gene Therapy For Chronic Inflammation With Xalud's Howard Rutman, M.D.

  While many gene therapy development efforts focus on rare disease, Xalud Therapeutics is taking a swing that, measured in addressable patient market terms, is considerably bigger. Osteoarthritis, or OA, is a chronic, progressive joint disease that affects over 30 million people in the United States. On this episode of the Business of Biotech, we catch up with Xalud Chief Medical Officer Howard Rutman, M.D., MBA for a discussion on the company's late-stage plasmid DNA gene therapy that's showing promise in OA and other chronic inflammatory conditions. 

• The Antibody Engine With Abpro's Chan Brothers

  With a scientific advisory board led by Bob Langer, Ph.D. of Moderna fame and a new partnership with global powerhouse Celltrion worth a potential $1.75 billion, Abpro is on the move. On this episode of the Business of Biotech, brothers Ian and Eugene Chan, M.D. take us behind the scenes of the company's progress.

• In-Vivo CAR T Update With Umoja Biopharma's David Fontana, Ph.D.

  2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year. This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, Ph.D., whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.

• RNA-Based Therapeutics With Nutcracker Therapeutics' Dr. Geoff Nosrati

  Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.

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• Making Medicine From Tick Spit: Akari Therapeutics' Rachelle Jacques

  The emerging biotech Akari Therapeutics thinks there's a broad range of medicinal value in proteins found in—wait for it—the saliva of ticks. Akari has painstakingly developed a recombinant version of one such tick saliva-derived protein, called nomacopan, and put it to work in phase 3 trials to treat rare but deadly HSCT-TMA.

• Product Vs. Platform With Surface's Vito Palombella, Ph.D. And Robert Ross, M.D.

  Earlier this month, Surface Oncology shared that it will open a second stage of its monotherapy trial of SRF388, an antibody targeting IL-27, on the heels of a promising phase 2 data readout. Shortly before that release, the Business of Biotech caught up with Surface's CSO Vito Palombella, Ph.D. and CEO Rob Ross, M.D. in the company's Cambridge, MA HQ. We discussed the first-of-its-kind target, the company's "product versus platform" strategy and how it fits in the industry's current "platform" vibe, the finer points of building and maintaining a startup bio culture, the difference between that Bob Ross and the Rob Ross, M.D., and whole lot more. 

• Leveraging Lymph Nodes With Elicio's Dr. Peter DeMuth

  MIT-born startup Elicio Therapeutics' novel Amphiphile Technology Platform is designed to directly engage the lymphatic system in the deployment and delivery of therapeutic payloads. We caught up with Chief Scientific Officer Peter DeMuth, Ph.D. at Elicio HQ in Boston to learn how the platform works.

• Engineering Proteins For Food Allergies With Ukko's Dr. Anat Binur

  Anat Binur, Ph.D. is CEO and Co-Founder at Ukko, where she's leading an effort to create new allergy therapeutics by engineering the proteins that induce immune response in people who suffer from food allergies. The effort at Ukko is deeply rooted in computational biology. The company leverages artificial intelligence to analyze how the allergen proteins interact with patients' blood in an effort to determine the specific attributes of the proteins that trigger immune response. Then, it applies a unique combination of compute power and biology to identify and understand the changes it wants to engineer and predict the best possible designs. Learn how Ukko is fostering a culture of IT and biology collaboration and what lured this dynamic entrepreneur into biopharma on this episode of the Business of Biotech. 

• Anatomy Of A VC Deal With Dima Kuzmin & Paul Bresge

  4BIO Managing Partner Dmitry ‘Dima’ Kuzmin and Ray Therapeutics Co-Founder & CEO Paul Bresge share the recipe for a successful relationship between biotech VC firm and startup. Bresge offers insight into VC engagement strategy and pitch, Kuzmin dishes on what investors look for in terms of "fundability" and what throws red flags.

• Oncology Discovery Advances With AbbVie's Steve Davidsen, Ph.D.

  AbbVie VP of Oncology Discovery Research Steve Davidsen, Ph.D. is a living, breathing timeline of the company's cancer research and development efforts. He got his start with the company— Abbott at the time— way back in 1986. As such, he's charted the adoption of multiple advanced technologies that have contributed to the realization of dozens of molecular weapons in the fight against cancer. On this episode of the Business of Biotech, Dr. Davidsen shares the latest on AbbVie's adoption of computational biology and how it's contributing to discovery and development efficiencies, why he's an AbbVie "lifer," how he manages and motivates a large team of research scientists, and a whole lot more. 

• IND For TIL Therapy With Obsidian Therapeutics' Paul Wotton, Ph.D.

  Obsidian Therapeutics CEO Paul Wotton, Ph.D. takes us behind the scenes to reveal what precipitated the FDA's clearance of its IND application for a novel, engineered tumor-infiltrating lymphocyte therapy. Learn how the company navigated the path to a first-of-its-kind therapy developed in partnership with the University of Texas MD Anderson Cancer Center.

• Regenerative Wound Care With BioStem Technologies

  Jason Matuszewski and Andrew VanVurst built a company that's developed a local microenvironment activation platform drawing on a combination of small molecules, cytokines, and growth factors to promote tissue repair and regrowth using perinatal tissue. Its internal development and cGMP manufacturing facilities are changing the paradigm for wound care. 

• Epigenomic Programming With Omega Therapeutics' Mahesh Karande

  Using computational biology to hasten the effort, Omega Therapeutics' plan is to "coopt nature's universal biological operating system for gene control and cell differentiation."  Omega is leaning heavily into computational biology along the way, having mapped what CEO Mahesh Karande characterizes as 95% of the IGD landscape.

• IDO Target Perseverence With IO Biotech's Mai-Britt Zocca, Ph.D.

  Under the leadership of Mai-Britt Zocca, Ph.D., IO Biotech is advancing novel, immune-modulating cancer therapies targeting IDO. On this episode of the Business of Biotech, she shares the approach, how it differs from previous attempts, and how her company is working to advance its programs in the wake of IDO's fall from grace.

• Pursuit Of A Universal Flu Vaccine With Longhorn Vaccines & Diagnostics' Jeff Fischer

  With a unique multi-target approach, what it considers the world's best adjuvant, and a host of learnings from the COVID-19 vaccine efforts, Longhorn Vaccines & Diagnostics is gaining ground on a universal influenza vaccine. On Business of Biotech, Co-Founder and President Jeff Fischer gives a transparent look at the science and the partnerships that are giving him cause to believe his company will succeed where so many have failed. Listen now!

• Genetic Testing & Neurodegenerative Disorders With AviadoBio's Lisa Deschamps

  Lisa Deschamps' story is one of determination and fortitude. She got her start in the life sciences where it begins and ends for many — "carrying the bag" in big pharma sales — then proceeded to crush the odds on her way to the C-suite at Novartis. Today, she's CEO at AviadoBio, a disruptive gene therapy startup prepping an intra-thalamic Frontotemporal Dementia candidate for the clinic with a heavy Series A in its hip pocket. On this episode of the Business of Biotech we get to know Lisa, her company and its therapeutic approach, her advocacy for genetic testing, and how she's applying her determination and fortitude to enabling more women to become life science leaders.

• Biotech M&A Anomalies With Allan Shaw

  While many clinical-stage biopharmas are contracting or holding the line through the current market slump, Portage Biotech leaders Ian Walters, Allan Shaw, and company are making moves. The company recently acquired Tarus Therapeutics and iOx Therapeutics Ltd., extending its pipeline and positioning itself to meet some aggressive investor expectations. On this episode of the Business of Biotech, Shaw dissects the deals, digging into the M&A strategy at Portage and offering advice from the batter's box to leaders of early-stage biotechs.

• Observations On Outsourcing With Molecule To Market's Raman Sehgal

  Raman Sehgal has made a career out of putting his energy— and he's got a lot of it— into building biotech outsourcing companies and the people who make them run. After years spent supporting several from within, he launched a firm dedicated to helping CROs, CDMOs, CPOs, and other providers to the biotech ecosystem build their businesses.

• What's A Biologic Revolution? With Vaxxinity's Mei Mei Hu, J.D.

  On this week's Business of Biotech podcast, Vaxxinity CEO Mei Mei Hu joins me to share Vaxxinity's strategy, what "democratization" and "revolution" really mean, why traditional vaccines and biologic therapies are converging to form the "third biologic revolution," and a whole lot more. 

• Fed Funding: Creative Capital Generation With James Thomas Coates, Ph.D.

  As biotech capital markets continue to restrict access to funding for emerging biopharmas, you might be surprised by how many federal dollars get left on the negotiating table. To that end, James Thomas Coates, Ph.D. and his team at Decisive Point have carved out a niche in the venture capital space. 

• Oligonucleotide Opportunities In DMD With PepGen's James McArthur, Ph.D.

  Duchenne muscular dystrophy affects an estimated one in 3,500 male births worldwide.  Approved treatments haven't demonstrated strong clinical outcomes, but James McArthur, Ph.D. and his team at PepGen are seeking to change that with a pipeline of disease-modifying peptide-conjugated oligo candidates derived from the company's EDO platform. 

• Diabetes: Changing The Insulin Paradigm

  While renal disease treatment technologies have seen moderate incremental improvements, there hasn't been a step-change advance in diabetes care since the discovery of insulin more than 100 years ago. Arecor CEO Sarah Howell, Ph.D., shares an approach to improving the quality of life for some 200 million insulin-dependent patients worldwide.

• Innate Immunity & Mouse Models With LIfT Biosciences' Alex Blyth

  Serial inventor and entrepreneur Alex Blyth had long held interests in health and science, but losing his mom to pancreatic cancer was the inflection point that launched LIfT Biosciences in 2016. Now, the preclinical company is on a mission to develop the world's first 'off-the-shelf' cell therapy to destroy all solid tumors, irrespective of strain or mutation, beginning with pancreatic cancer. On this episode of the Business of Biotech, Blyth shares the company's scientific approach and progress, and we explore the shortcomings of legacy clinical protocols including the inherent problems and limitations of mouse models.  

• Antibody Cocktails With Immunome's Dr. Purnanand Sarma

  Immunome CEO Purnanand Sarma, Ph.D. discusses the discovery of novel therapeutic antibodies and their antigen targets by leveraging highly educated memory B cells from patients who have learned to fight off their disease — like picking an all-star team of players who have been in the game, and who are well-trained to win. 

• Antibody-Cytokine Combinations With Philogen's Dr. Dario Neri

  Philogen co-founder, CEO, and CSO Prof. Dario Neri shares the incredible story of the company's progress and explains Philogen's approach to delivering bioactive agents to the site of disease using antibodies or small organic ligands, thus increasing therapeutic activity and helping spare normal tissues. 

• Fibroblasts In Regenerative Medicine With Pete O'Heeron & Dr. Hamid Khoja

  FibroBiologics Chairman, CEO, & Founder Pete O'Heeron share the manufacturing technology that's driving the company's exploitation of fibroblasts to develop regenerative therapies for indications ranging from degenerative disk disease and multiple sclerosis to cancer immunotherapies and therapeutics. 

• Lara Sullivan, M.D. On Site-Specific ADCs, Change Management

  Lara Sullivan, M.D. shares the science and technology driving progress at Pyxis Oncology and serves up a master class on change management, honed during her tenure managing high-stakes product portfolios at Pfizer. 

• The Biotech Beatdown With Allan Shaw

  Frequent guest and business of biotech brainiac Allan Shaw joins us to dissect the beleaguered biotech capital markets. We pick apart what's driving sentiment and how we got here, whether the industry is over-inventoried, what's getting funded, what's not, and what biotech leaders should be doing in an investment landscape marked by hyper-discernment. 

• Inflammation & Antibodies With Ampio Pharmaceutical's Mike Martino, CEO

  Ampio Pharmaceuticals is currently weaving the gauntlet of a clinical hold triggered by COVID's disruption to clinical studies of its lead candidate Ampion, and recently launched an independent investigation into that trial and others. On this episode, Ampio Pharmaceuticals chairman and CEO Mike Martino joins the Business of Biotech for a candid discussion on the company, the candidate, the disruption, and the go-forward plan. 

• What's Next For COVID Vaccines: Tonix Pharmaceuticals' Seth Lederman, M.D.

  As COVID-19 cases climb yet again, Tonix Pharmaceuticals Chairman and CEO Seth Lederman, M.D. shares his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants and grab its share of the highly competitive, and highly lucrative, vaccine market.

• Running Interference: RNAi With Silence Therapeutics' Craig Tooman

  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. 

• 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. 

• Bioengineering 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. Glean insight from Cartesian's experiences and learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond.

• 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. Cleve, Matt Pillar, chief editor at BioProcess Online, and Erin Harris, chief editor at Cell & Gene, have a candid discussion on the regulatory trends shaping the advance of a pipeline of gene therapies for the treatment of serious, life-altering diseases.

• 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.