We love to hear from our listeners. Send us a message. 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-braine...
Oct 04, 2021•35 min
We love to hear from our listeners. Send us a message. 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'...
Sep 27, 2021•45 min
We love to hear from our listeners. Send us a message. 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 Presid...
Sep 20, 2021•45 min
We love to hear from our listeners. Send us a message. 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 develo...
Sep 13, 2021•49 min
We love to hear from our listeners. Send us a message. 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 ...
Sep 06, 2021•59 min
We love to hear from our listeners. Send us a message. 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 B...
Aug 30, 2021•49 min
We love to hear from our listeners. Send us a message. 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 ...
Aug 23, 2021•47 min
We love to hear from our listeners. Send us a message. 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 ...
Aug 16, 2021•33 min
We love to hear from our listeners. Send us a message. 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 com...
Aug 09, 2021•38 min
We love to hear from our listeners. Send us a message. 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 develop...
Aug 02, 2021•33 min
We love to hear from our listeners. Send us a message. 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 ac...
Jul 26, 2021•31 min
We love to hear from our listeners. Send us a message. 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 hi...
Jul 19, 2021•49 min
We love to hear from our listeners. Send us a message. 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 autolo...
Jul 12, 2021•52 min
We love to hear from our listeners. Send us a message. 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 the...
Jul 05, 2021•37 min
We love to hear from our listeners. Send us a message. When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to its 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 Vassa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that&a...
Jun 28, 2021•48 min
We love to hear from our listeners. Send us a message. BridgeBio has a whopping 18+ 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. The company is no stranger to developing business strategies for success. Central to that success are partnerships with scientists and researchers to fuel pipeline expansion. On this episode of The Business of Biotech, BridgeBio Chief Business ...
Jun 21, 2021•45 min
We love to hear from our listeners. Send us a message. 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 fe...
Jun 14, 2021•40 min
We love to hear from our listeners. Send us a message. 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 experienc...
Jun 07, 2021•41 min
We love to hear from our listeners. Send us a message. 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 ...
May 31, 2021•40 min
We love to hear from our listeners. Send us a message. 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...
May 24, 2021•57 min
We love to hear from our listeners. Send us a message. 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, an...
May 17, 2021•51 min
We love to hear from our listeners. Send us a message. 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 ...
May 10, 2021•33 min
We love to hear from our listeners. Send us a message. 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 O...
May 03, 2021•49 min
We love to hear from our listeners. Send us a message. 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 includin...
Apr 26, 2021•40 min
We love to hear from our listeners. Send us a message. CUE Biopharma CEO Dan Passeri, J.D. joins us for a discussion on the development of the company's Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind his belief in the company's immunotherapeutic approach, and how the CUE-100 series of candidates in its pipeline are being developed to address the scourge of HPV-related head, neck, and other cancers expected in pre-HPV vacc...
Apr 19, 2021•42 min
We love to hear from our listeners. Send us a message. 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 co...
Apr 12, 2021•39 min
We love to hear from our listeners. Send us a message. Nevan Charles Elam, JD 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 Rezolute's approach to process development and manufacturing. Access this and hundreds...
Apr 04, 2021•39 min
We love to hear from our listeners. Send us a message. 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 promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in urgent need of timely therapy. Access this and hundreds of episodes of the Business of Biotech vide...
Mar 28, 2021•43 min
We love to hear from our listeners. Send us a message. Friend of the show and life sciences CFO extraordinaire Allan Shaw joins us for a discussion on the steps to biopharma success from an insider's perspective. We discuss the incremental steps that are necessary and common to success in the biologic therapy space, and the mistakes Shaw has seen in his many engagements with new and emerging biotech firms. From capital resource allocation to personnel decision making to preparing for the bu...
Mar 21, 2021•43 min
We love to hear from our listeners. Send us a message. Dr. Anat Cohen-Dayag transformed her company from a computational biology service provider to a clinical-stage biopharma with multiple cancer immunotherapy candidates, and she did it in a remarkably short period of time. Listen in as she discusses the human resources, financial, and capital strategies she deployed to build a biotech on the back of computational science, and shares her vision for the future of drug discovery. Access this and ...
Mar 15, 2021•39 min
