Bob Guldberg, executive director of the Petit Institute for Bioengineering and Bioscience, was asked about the upcoming Business of Regenerative Medicine, a workshop being hosted by the Georgia Institute of Technology for the first time, July 20-22, at the new Engineered Biosystems Building.

Guldberg considered everything the three-day course will cover. He thought of the science that will be discussed, the potential of the research, the eventual commercialization and utilization of cutting edge healthcare therapies and products, and all of that brought to mind one of the greatest scientist-engineers the world has ever known.

“Leonardo da Vinci said, ‘I have been impressed with the urgency of doing. Knowing is not enough; we must apply. Being willing is not enough; we must do,’” Guldberg says, quoting the ultimate Renaissance man.

It is with that spirit in mind that the Petit Institute has partnered with Case Western Reserve University, the Harvard Stem Cell Institute, and the Toronto Center for the Commercialization of Regenerative Medicine to offer this course at Georgia Tech.

The course will cover elements critical to business success in five rapidly growing and evolving technology market areas: mesenchymal stem cells (MSCs), cord blood and neural stem cell therapies, immunotherapies, tissue engineering and cell-based devices, and organ-on-a-chip and induced pluripotent stem cell (iPSC) technologies. 

“For each of these areas, the sessions will include a brief update on the state of the science, but then really focus on critical challenges to bringing regenerative medicine technologies to market, such as investor perspectives, FDA regulation, manufacturing challenges and reimbursement policy,” Guldberg says. “After going through a period of inflated expectations 15 to 20 years ago, the regenerative medicine industry is showing many positive signs of growth.”

For example, the cell therapy segment of the industry represents a multi-billion dollar global market all by itself.

“Investors and even big medical device and pharmaceutical companies have taken notice,” Guldberg says. “And there have been numerous new companies and licensing or merger deals announced over the last couple of years. Why all the interest? Simply put, regenerative medicine technologies offer unprecedented promise to provide curative therapeutics for a vast array of unmet clinical needs.”

Some of the hot areas, according to Guldberg: In immunotherapies, chimeric antigen receptor (CAR) T-cell therapies use a patient’s own T-cells, which are modified to recognize a cancerous tumor antigen. Gene therapy is gaining momentum for treating a wide variety of conditions (now that viral vectors have been improved with lower risks).

Also, recent advancements in genome editing may soon enable correction of single gene defect disorders, such as sickle cell anemia. Tissue engineered products involving combinations of biomaterial scaffolds, cells, and growth factors are starting to overcome significant regulatory challenges for treating traumatic injuries or replacing diseased tissues. And the discovery of iPSCs in 2006 has led to clinical trials for treating vexing health problems, such as age-related macular degeneration.

“One can think of healthcare innovation potential as being the overlap of what is possible with technology, what is desired or needed by patients and clinicians, and what is viable in the market place,” says Guldberg, who is optimistic about regenerative medicine’s potential, but adds, “there remain significant challenges to overcome in terms of showing these technologies are not only safe, but lead to improved outcomes for patients at costs that our health care system can afford.”

This will be the eighth annual Business of Regenerative Engineering course and the first held at Georgia Tech (last year’s event was in Toronto). Intended for business executives, financial market managers and analysts, technology transfer and development personnel, senior and junior scholars, as well as managers in government and academia, the three-day course will bring industry and academic leaders together for lectures, case studies, panel discussions and the opportunity to network, with the goal of success in this growing industry, turning potential into reality.

CONTACT:

Jerry Grillo
Communications Officer II
Parker H. Petit Institute for
Bioengineering and Bioscience