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BioInformant's Founder, Cade Hildreth, has interviewed hundreds of key opinion leaders (KOL's) from across the stem cell industry.

How Exosomes Are Revolutionizing Neuroimmunology with Dr. Stefano Pluchino

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Dr Stefano Pluchino - Pluchino Lab
Dr. Stefano Pluchino of the Pluchino Lab in Cambrige

I am honored to release this interview with Dr. Stefano Pluchino of the highly regarded Pluchino Lab in Cambridge, UK. Dr. Pluchino received his MD and PhD degrees at the University of Siena, Italy, and additional training at Cambridge University, UK.

Dr. Pluchino is an international expert on neuroimmunology-related applications of exosomes, with his lab exploring modalities by which neural progenitor cells (NPCs) engage in cell-to-cell communication. The focus of the laboratory is to explore cellular and molecular mechanisms regulating to the therapeutic plasticity of stem cells in preclinical models of CNS conditions, including multiple sclerosis (MS), stroke, and spinal cord injury. [Read more…]

Nucleus Biologics, Enabling Reproducible Science with David Sheehan (CEO)

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David Sheehan, CEO of Nucleus Biologics
David Sheehan, CEO of Nucleus Biologics

I am honored to release this interview with David Sheehan, CEO of Nucleus Biologics, a company that is revolutionizing the cell culture market. Nucleus Biologics delivers superior cell culture products by leveraging a transparent, consistent and proven supply chain that eliminates variability for its customers. With an estimated $28 billion lost per year to irreproducible biology research, the market is overdue for disruption.

In this interview, we explore Mr. Sheehan’s background, the disruptive nature of Nucleus Biologics, and his inspiring vision for the future. [Read more…]

FDA Regulation of Cellular and Tissue-Based Products with Dr. Riam Shammaa

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In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products. This is a timely interview, because the U.S. FDA recently filed two federal complaints seeking “permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”

The first FDA injunction was against US Stem Cell Clinic LLC of Sunrise, Florida, its CSO Kristin Comella and Co-Owner Theodore Gradel. The second injunction was against Drs. Elliot  Lander and Mark Berman, who control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of stem cell products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.

[Read more…]

Celularity – Big Bucks, Billionaire Investors, Bold Dreams

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Celularity Celularity is a biotechnology company that specializes in leveraging biologically active cell populations within the postpartum human placenta. Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity is uniquely positioned to harness the potential of most biocreative event on earth: human birth.

I had the honor of interviewing Celularity’s CEO, Dr. Robert Hariri, a pioneer and visionary within the stem cell industry. As a surgeon, biomedical scientist and serial entrepreneur, Dr. Hariri was previously the Founder and CEO of one of the world’s largest human cellular therapeutics companies, Celgene Cellular Therapeutics, a division of Celgene Corporation. In August 2017, Hariri brought Celularity Inc. into the spotlight by announcing a successful Series A financing with contributions from influential investors, including Sorrento Therapeutics, United Therapeutics Corporation, and Human Longevity, Inc. (HLI).

On February 15th, 2018, the company broke even bigger news when it announced that it had raised $250 million in funding, with contributions from the Genting Group, Tony Robbins, and Dreyfus Family Office, among others.

Below is Part 2 of a two-part interview with Celularity’s CEO, Dr. Robert Hariri. Click here to read Part 1.

[Read more…]

Minerva Biotechnologies, Interview with CEO Dr. Cynthia Bamdad

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Minerva Biotechnologies is a regenerative medicine company specializing in stem cell therapeutics that is developing cancer immunotherapies to target 75% of solid tumors and to prevent cancer metastasis. I had the honor of interviewing Cynthia Bamdad, PhD, CEO of Minerva Biotechnologies. In this interview, we discuss Minerva’s technology platform, product portfolio, IP strategy, and strategic goals. We also explore the significance of the company’s recently launched AlphaSTEM™ Culture System that is a simple method for inducing the naïve state in human stem cells. Enjoy! [Read more…]

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