From The Editor
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Your Drug Development Team Holds The Key To The Clinic
4/9/2021
Amolyt Pharma founder and CEO Dr. Thierry Abribat credits his company’s fast clinical pace to the assemblance of an experienced drug development team. Here’s some of his advice for the leaders of new & emerging biopharmas.
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Can GDF11 Address Aging, One Disease At A Time?
3/24/2021
Led by Dr. Mark Allen and backed by heavyweights like Peter Diamandis, M.D. and Tony Robbins, biopharma startup Elevian is charting the CMC and regulatory path for Growth Differentiation Factor 11 to make a therapeutic play in a host of age-related diseases.
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Reshaping The Vaccine Manufacturing Paradigm
3/22/2021
Uvax Bio’s unconventional approach brings a heretofore ignored physical component to vaccine design. Co-founders Dr. Ji Li and Jiang Zhu share why they think their platform is poised to revolutionize vaccine development, manufacturing, and distribution.
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Regulatory Approval Trends In The Age Of COVID-19
3/17/2021
The FDA is approving more therapies at a faster pace, but it’s not all COVID, all the time. Allan Shaw helps us expose regulatory approval trends, and the implications of those trends on the biotech business.
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How Computational Drug Discovery Is Disrupting Biopharma
3/12/2021
NeuBase Therapeutics CEO Dr. Dietrich Stephan discusses the important role computational drug discovery plays as we emerge from what he characterizes as “a decades-long, multi-billion-dollar chemical engineering escapade with a very low success rate to find one drug.”
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A Differentiated Approach To Allogeneic Cell Therapy Manufacturing
3/3/2021
Celyad Oncology CEO Filippo Petti digs in on differentiating his company’s approach to developing and manufacturing allogeneic cell therapies for several oncology indications, including the company's technology platform and scale-up strategies in Celyad’s Belgium-based clinical manufacturing facility.
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Taking On The Talent Crunch In Biopharma, Cell & Gene Manufacturing
3/1/2021
Project Farma and Precision ADVANCE leaders Anshul Mangal and John Khoury address the biotherapeutic process and manufacturing talent gap, and propose resources to bolster global skill and capacity. Read about it, or watch the video of our conversation here.
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Keeping Clinicals On-Pace In The COVID-19 Age
2/26/2021
Lineage Cell Therapeutics CEO Brian Culley is inspired by the speed and agility at which the biopharma industry—including the FDA—are working to get new cell therapies to market, despite the clinical disruptions of the day. With three clinical-stage candidates, here's how Culley and company are addressing those challenges.
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Dr. Bobby Gaspar On Manufacturing, Commercialization Challenges
2/22/2021
Orchard Therapeutics CEO Dr. Bobby Gaspar, M.D., Ph.D. is one of only a handful of gene therapy leaders to see the light of market-approved therapy. Here, he offers advice for those seeing manufacturing, regulatory, and reimbursement challenges for the first time.
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$2,000-Per-Dose Cell Therapy In The Clinic
2/12/2021
With its ongoing Phase 1 clinical trial of ACE1702 for the treatment of HER2-expressing solid tumors, Acepodia founder, CEO, and president, Sonny Hsiao, Ph.D. and SVP of R&D, Mark Gilbert, M.D., make a case for fast, affordable, and effective off-the-shelf cell therapies.