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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. 

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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.

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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's allowing the renowned producer of reagents to the life sciences industry to meet market demands.  

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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 Officer Michael Henderson, M.D. walks us through the formula behind the company's academia-led growth strategy. 

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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.

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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. 

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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.  

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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. 

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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. 

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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. 

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