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

Behind the Scenes at FUJIFILM Irvine Scientific (FISI) with Yutaka Yamaguchi (President)

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FUJIFILM Irvine Scientific (FISI) is the world’s leading manufacturer of cell culture media, reagents, and medical devices that are used across the cell therapy, regenerative medicine, assisted reproductive technology, and industrial cell culture markets. The company adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan.

While Irvine Scientific was founded in 1970, Fujifilm did not acquire the company until 2018, when it invested US$800 million to become a dominant force within the cell culture media and services market.

In this interview with Yutaka Yamaguchi, President of FUJIFILM Irvine Scientific (FISI), we explore the reasons for FUJIFILM’s acquisition of Irvine Scientific, the importance of the company’s dual manufacturing facilities, traits that differentiate FISI from its competitors, and trends within the Regenerative Medicine industry at large. [Read more…]

Propagenix – Interview with the President and CEO, Brian Pollok, Ph.D.

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Propagenix is a preclinical-stage platform technology company that is applying its unique technology to both internal and partnered cell therapy programs. The company is engaged in the development and commercialization of technology which originated from the laboratory of Dr. Richard Schlegel of Georgetown University.

[Read more…]

Hemostemix. The Canadian Biotech that Could Change Healthcare as We Know It.

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Hemostemix Inc. (“Hemostemix”) (TSX Venture:HEM; OTCQB:HMTXF) is a publicly traded  clinical-stage biotech company that develops and commercializes blood-derived stem cell therapies for medical conditions lacking adequate treatment options. Importantly, it is one of the first clinical-stage biotech companies to test a stem cell therapy within an international, multi-center Phase II clinical trial for patients with critical limb ischemia (“CLI”). CLI is a severe form of peripheral artery disease (“PAD”) that is caused by reduced blood flow to the extremities. [Read more…]

Behind the Scenes at Cynata Therapeutics with Dr. Ross Macdonald

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Cynata TherapeuticsCynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs).

I had the honor of interviewing Dr Ross Macdonald, CEO of Cynata Therapeutics. In this interview, we discuss Cynata’s technology platform, the company’s world first achievements, and its clinical trial underway for GvHD. We also explore the company’s strategic goals and the importance of its partnership with Fujifilm in Japan. [Read more…]

An Expert’s Perspective on Accelerated Pathways for Cell Therapy Approvals

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Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics
Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics

Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea. While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”

In the interview with Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics, we get an expert’s perspective on how the regulatory environment has changed and new opportunities that exist for bringing cell therapy products through the clinical trial process and into the global marketplace. [Read more…]

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