Leading Stem Cell and Regenerative Medicine Experts Reveal Industry Trends at Bio-Trac Event

Bio-Trac, a leading BioHealth Capital Region (BHCR) biotechnology training organization, hosted a stem cell and regenerative medicine panel discussion on June 20th, 2019 at Montgomery College’s Bioscience Education Center. The panel brought together renowned thought leaders from across the stem cell and regenerative medicine space for a robust and energetic discussion about industry trends and the field’s future. 

Dr. Mahendra S. Rao, one of the most influential minds in stem cell research, moderated the discussion. Dr. Rao recently joined Bio-Trac as a Co-Director, was the Founding Director of the National Institutes of Health (NIH) Center of Regenerative Medicine and former Chief of the NIH Laboratory of Stem Cell Biology.

Panelists included Donald W. Fink, Ph.D., Expert Biologist with the U.S. Food and Drug Administration (FDA); Amritha Jaishankar, Associate Director of TEDCO’s Maryland Stem Cell Fund; Jean-Philippe Richard, Ph.D., Stem Cell Scientist with Reprocell, and Michael Ward, MD, Ph.D., Clinical Investigator with the National Institutes of Health’s (NIH) National Institute of Neurological Disorders and Stroke (NINDS).

Mark Nardone, Bio-Trac’s Director, welcomed the panelists and audience to open the panel discussion, stating, “We’ve been conducting hands-on biotechnology training workshops for the scientific community for over 30 years, initially at the NIH and in 2016 moving the program over here to the Montgomery College Bioscience Education Center… this is a phenomenal facility where we continue to do our training workshops…the Montgomery College community and the Bioscience Center is a well-oiled machine and a great resource for the BioHealth Capital Region. I want to thank Montgomery College for hosting this event.”

Dr. Rao kicked off an insightful and wide-ranging panel discussion about how to advance stem cell and regenerative medicine, which culminated in an active and engaging audience question and answer session.

“I will tell you why I thought this was an important event. I used to be a professor at the University of Utah a long time ago and one thing everyone would ask me was why I went there to do stem cell research. I would always say they had the right vision about training. It wasn’t just training at the higher levels; it was about training at the technician level and they had some of the best-trained research teams and that made a big difference in what could be done. That’s the difference that Bio-Trac has made. Thank you for that,” stated Rao.

The FDA’s Dr. Fink started the panel discussion by reminding the audience that stem cell and regenerative medicine has a long history and that scientists and organizations need to keep that history in mind as they attempt to move treatments through the FDA review process. He stated that remaining realistic and objective can empower better decision making and help the process operate more efficiently. Dr. Fink also provided insights throughout the panel about working with the FDA, advising researchers and companies to understand FDA expectations, know the best practices for doing business with the FDA, present the agency with clear data that helps move products forward and target broader spectrum disease areas.       

Dr. Ward shared that his lab at NIH/NINDS uses Induced Pluripotent Stem Cells (IPSC) to generate central nervous system (CNS) relevant cells to investigate neuro degenerative disease mechanisms. The NINDS lab uses stem cells and genome editing to study inherited disease mechanisms, adding that the use of stem cells has been game-changing for the field and is helping to advance the development new technologies for the treatment of devastating neurological diseases.

Dr. Ward also announced a brand new NIH initiative called the Center for Alzheimer’s and Related Disorders. This new Center is a joint partnership between the NIH’s National Institute on Aging (NIA) and NINDS. The Center will take an industry-style approach to projects that develop better resources for the CNS research community. One of the first projects, the IPSC’s Neurodegenerative Disease Initiative (INDI), is being launched with the goal of generating 300 validated cell lines related to neurodegenerative diseases that will ultimately be released to the public, forming a national cell line resource for the scientific community studying CNS- related diseases.

“We’ve noticed as a company that the neuroscience focus is increasing…we are increasing our capabilities to match this growing need…the next step for CAR T and stem cells is very likely in CNS. The need for neurodegenerative disease is just going to increase and increase,” stated Reprocell’s Dr. Richard. 

The audience Q&A session included dialog about the use of ISPC and Embryonic Stem Cells (ESC), FDA regulations surrounding stem cell safety, FDA approval timelines for stem cell and regenerative medicine treatments/products, the impact of CAR T cell therapies, how to achieve the surrogate measure of a disease for improved disease modeling/screening and the increasing need for combination, multi-cellular modeling tools.

The BHCR continues to grow as a hub for stem cell and regenerative medicine research and development with its proximity to federal agencies like the FDA and NIH, in addition to the growing number of startups and established stem cell and regenerative medicine companies operating in the region.

“I am in a very fortunate position where I see breakthroughs every day,” stated Dr. Jaishankar. “Where I would say that Maryland is already leading the way is with cell manufacturing…The state has had great innovation and funding and we’re beginning to make strides in the commercialization of these technologies as well.”

“We do think as a company that CAR T is paving the way but do think CNS…is going to be the next big thing. We do think that Maryland is uniquely positioned because of its geographic proximity to the NIH and the FDA. We chose Maryland over Massachusetts to keep our company in the U.S. because of this, the tax-friendly environment, the 270 Corridor, all the biotechs in Baltimore and the ability to increase our collaboration with these local companies,” added Dr. Richard. 

The insightful panel discussion hosted by BioTrac had more than 100 registrants and reflected the excitement about the BHCR’s growing importance to the future of stem cell and regenerative medicine. The panel event was followed by refreshments and networking in addition to a tour of the expansive Bioscience Education Center labs facilities, but not before a special honor was bestowed upon Bio-Trac co-founder, Mark Nardone.

In recognition for Bio-Trac’s 33 years of service to the scientific community by training more than 17,000 scientists from all over the world on cutting-edge research techniques and creating some of the most well-respected training programs in the industry; Bio-Trac was awarded a ‘Governor’s Citation’ from the State of Maryland. This fitting honor became a touching moment for Nardone, as well as several panelists and guests who have been associated with Bio-Trac for many years of that journey.

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