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Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.

Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV's challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.

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Lee Nathan Rich

What if the future of medicine could be personalized, predictive, and empowered by data? In this episode of BioTalk, Rich Bendis discusses this topic with Dr. Leroy Hood and Dr. Nathan Price, the co-authors of the book “The Age of Scientific Wellness: Why the Future of Medicine Is Personalized, Predictive, Data-Rich, and in Your Hands.” Together, they discuss the scientific revolution reshaping the healthcare and medicine landscape.

Dr. Hood and Dr. Price shed light on how cutting-edge technologies, such as genomics and artificial intelligence, are enabling the shift from reactive medicine to proactive, individualized care. They explore the concept of “scientific wellness,” where data-rich insights revolutionize disease prevention and unlock the potential for extended health span. Join us on BioTalk for this thought-provoking exploration of the new frontier of medicine, where health optimization is at the forefront.

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How will protein engineering unleash a new era of therapeutic possibilities for BioHealth and the BioHealth Capital Region? Join us on this episode of BioTalk with Rich Bendis as Rich chats with Dr. Luis Alvarez, Founder & CEO of Theradaptive, who is at the forefront of protein engineering technology. Learn about Theradaptive’s ingenious approach to overcoming the challenges of naturally occurring proteins, elevating the efficacy and safety of therapeutics through precision-targeted delivery, and mitigating off-target side effects. From spinal fusion and orthopedics to soft tissue repair and targeted chemotherapeutics, Theradaptive’s breakthrough technology is set to transform the lives of millions grappling with debilitating conditions linked to loss of tissue function. Be part of the conversation that’s unlocking a world of untapped potential in the convergence of protein engineering and therapeutic discovery. Listen now here or via your favorite podcasting platforms:

A graduate of West Point, Dr. Luis Alvarez served in the U.S. Army for 20 years. Following a combat tour and seeing fellow servicemembers forced to undergo delayed amputations due to tissue damage, he was motivated to pursue a Ph.D. in biological engineering at MIT, where he was a Hertz Foundation Fellow. Dr. Alvarez founded Theradaptive following his time in the Army, using what he learned from his research to create a platform that can now deliver biologics in a highly targeted way. Previously, he was the founding deputy director of the U.S. Department of Defense’s Regenerative Medicine Program Office as well as lead for the DoD’s $720 million nerve agent pharmaceutical countermeasures program. As CEO and co-founder, Dr. Alvarez has seen the Theradaptive team grow from two to 32 people. The FDA granted the company three breakthrough designations for various spine indications, accelerating the process of reaching approval.

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Vishal and Rich

Ready to explore the frontiers of cancer therapeutics? Discover how AUM Biosciences, with a key presence in Montgomery County, Maryland, in the BioHealth Capital Region, is revolutionizing the development of innovative oncology medicines and transforming the fight against cancer resistance. Join us on this episode of BioTalk with Rich Bendis as we chat with Vishal Doshi, Chairman & CEO of AUM Biosciences, a visionary leader in the biotech industry. Tune in to the conversation that's sparking new hope in the battle against cancer.

Listen now via your favorite podcast platforms: Apple - https://apple.co/42LvH4A Google - https://bit.ly/40yTOBC Spotify - https://spoti.fi/40F2NkV Amazon Music - https://amzn.to/40hFz4L TuneIn - https://bit.ly/42Gpfff YouTube - https://bit.ly/3TMIuji

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Want to be on the cutting edge of disease treatment? Learn how companies like Immunyx Pharma are changing the landscape of immune modulation in the battle against diseases with the JLABS/BARDA Blue Knight program on this episode of BioTalk with Rich Bendis.

Also Available on popular podcast platforms like Apple https://apple.co/3LlbxIy, Google https://bit.ly/3l6O6ba, Spotify https://spoti.fi/405ln5B, Amazon Music https://amzn.to/3J58kde, TuneIn https://bit.ly/3JA8MBO, and even YouTube https://bit.ly/3LhYZS6.

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Lucy Alexander, Capabilities Lead, Global Supply Chain & Strategy with AstraZeneca, joins Rich Bendis on BioTalk to discuss leading world-class supply chain operations, developing new strategies, and the continued growth of AZ in the BioHealth Capital Region.

Listen via Apple https://apple.co/3Zov7b7, Google https://bit.ly/3JfYiav, Spotify https://spoti.fi/3ZGPekn, Amazon Music https://amzn.to/3ZqknsP, and TuneIn http://bit.ly/2M60Wmx.

Jake and Rich

Jacob Greenwood, Director of Business Development at CRB, joins BioTalk with Rich Bendis to discuss engineering in the industry, the Chesapeake Bay Area Chapter of ISPE, and his career in the BioHealth Capital Region.

Listen now via Apple https://apple.co/3lO9SQZ, Google https://bit.ly/41g3diC, Spotify https://spoti.fi/3xG8OkN, Amazon https://amzn.to/3SfEKpQ, and TuneIn https://bit.ly/3xG9M0I

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Linshom Medical CEO, Ric Hughen, joins Rich Bendis on BioTalk to discuss his career, their respiratory monitor, and growing a company in the BioHealth Capital Region.

Listen now via Apple https://apple.co/3GkByoi,  Google https://bit.ly/3C4TUY9, Spotify https://spoti.fi/3Gk6Ewh, Amazon Podcasts https://amzn.to/3WphyXb, and TuneIn https://bit.ly/3WOnWHB

Richard Hughen’s thirty years of medical device experience spans three Fortune 500 and three start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up that is first to deliver continuous predictive respiratory monitoring (CPRM) to the patient bedside and home.

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New BHI Executives-In-Residence, Jennifer Butler and Luis Gutierrez, join VP Economic Development Sarah Miller on BioTalk with Rich Bendis to discuss the recent launch of this program and cultivating the local life sciences ecosystem by working with start-up and growth-stage companies in diagnostics, medical devices, digital health, bioinformatics, AI/machine learning and therapeutics within Montgomery County, Maryland.

Listen now via Apple https://apple.co/3uJ1NhD, Google https://bit.ly/3W8RZcv, Spotify https://spoti.fi/3Hv93FA, Amazon Podcasts https://amzn.to/3hgMeL4, or TuneIn https://bit.ly/3WbCRem.

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The Polaris Genomics Leadership team of CEO Charles Cathlin, MPH, CSO Tshaka Cunningham, PhD, and CMO Anne Naclerio, MD, MPH visit BioTalk to discuss competing in the 7th Annual Crab Trap Competition, being a Veteran-Owned Business and growing in BioHealth Capital Region.

Listen now via Apple https://apple.co/3DOUiLK, Google https://bit.ly/3fowyob, or Spotify https://spoti.fi/3DNfd1F3

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Brett Shealy, Executive Director of the Life Sciences Banking Team with J.P.Morgan, joins Rich Bendis on BioTalk to discuss his Career, BioHealth Investment, and the upcoming 2022 BioHealth Capital Region Forum/Investment Conference/Crab Trap.

Listen now via Apple https://apple.co/3cK8ScJ, Google https://bit.ly/3etce4h, Spotify https://spoti.fi/3cNdIpo, Amazon Podcasts https://amzn.to/3eucMXi, or TuneIn https://bit.ly/3Rj8wIJ

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Crab Trap Judges and Sponsors, Sally Allain, MSc., MBA Head, JLABS @ Washington, DC Johnson & Johnson Innovation – JLABS, Srujana Cherukuri, Ph.D., Chief Executive Officer, Noble Life Sciences, Inc. & Lora Green, Partner, Wilson Sonsini Goodrich & Rosati, join Rich Bendis on BioTalk to preview the event taking place live on September 21st, 2022 at USP in Rockville. For the first time in its history, this year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000.

Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Wilson Sonsini
  • A $5,000 cash from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C.
  • Preclinical CRO services from Noble Life Sciences.

Listen now via Apple https://apple.co/3Kr1FKU, Google https://bit.ly/3e46gGS, Spotify https://spoti.fi/3ctQ4Os, or Amazon Podcasts https://amzn.to/3qbvtSB

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Gary L. Disbrow, Ph.D., Director of the Biomedical Advanced Research and Development Authority (BARDA), visits BioTalk to discuss his career, advancing research, development, and collaboration in BioHealth.

Listen to the podcast now via Apple https://apple.co/3zCsbMl, Google https://bit.ly/3p2aAIP, Spotify https://spoti.fi/3p2V0Ne, and Amazon https://amzn.to/3BSQWqf.