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1. Drug Development: From Bench To Bedside With Allan Shaw 5/9/2021

   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. 

2. Digital Transformation In Cell Therapy with Organicell Drs. Mari Mitrani & Michael Bellio 5/2/2021

   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.

3. Biopharma Regulatory Requirements with bluebird bio's Scott Cleve 4/25/2021

   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.

4. Filling A Vaccine Void with Cue Biopharma's Dan Passeri, J.D. 4/18/2021

   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. 

5. Supercharging An ADC Program With SOTIO CEO Dr. Radek Špíšek 4/11/2021

   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.

6. Tools And Best Practices For Trending Environmental Monitoring Data 4/11/2021

   Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.

7. An Introduction To Trending In Environmental Monitoring Programs 4/5/2021

   Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

8. mAb Manufacturing with Rezolute Bio's Nevan Charles Elam, J.D. 4/4/2021

   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.

9. Cell Therapy Platform Dev With Precigen CEO Dr. Helen Sabzevari 3/28/2021

   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. 

10. A CFO's Prescription For Biopharma Success 3/21/2021

    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.