Biomolecular and Tissue Engineering: New Frontiers
The biomolecular and tissue engineering panelists at the 40th anniversary celebration of Duke’s biomedical engineering department said that in such a new and vibrant field, staying informed and staying connected are essential to success.
“It’s a very dynamic industry. There is no alternative but to stay on top of things from your industry standpoint,” said Vinayak Bhat, who earned his PhD in biomedical engineering from Duke, and is currently the vice president and general manager at Elixir Medical Corporation.
Elixir develops treatments that are combinations of medical devices and drugs, focusing on cardiovascular applications. One of the devices close to going on the market is a fully bioresorbable cardiovascular stent: after the newly opened artery has stabilized, the body absorbs the stent.
Jamie Kemler agreed that entrepreneurial engineers in this field need to stay current. “It’s important within tissue engineering to stay abreast of a number of different disciplines,” he said. He recommended that students and entrepreneurial hopefuls read journals, go to conferences, and network. “It’s a highly networked industry,” he said. “It’s important to stay in touch with friends and colleagues.”
Kemler, who got his BSE in biomedical engineering from Duke and an MBA from the Harvard School of Business, has worked for a number of biomedical companies. He’s currently a group president at Stryker Corporation, where he’s been involved in developing biologics for orthopedic applications.
His team at Styker experienced a setback last year when an FDA panel voted against use of their candidate biologic molecule for a specific spinal application. “The greatest challenge is not the science, or the clinical process, but the regulatory process,” he said.
Kemler also compared his experiences of working with large and small companies. He said in small companies, he enjoyed staying close to the technology. In large companies, he enjoyed the opportunity of working and living internationally.
Michelle Williams, who earned her PhD in biomedical engineering at Duke and is now the chief scientific officer at Osiris Therapeutics, talked about the science and commercialization of two of the therapeutics she’s helped develop at Osiris. Both of the therapeutics use adult stem cells (not embryonic stems cells). Williams described Osteocel as “stem cells on a bony matrix” used for bone repair. Osiris sold the product for $85 million in 2008. Prochymal is used to treat patients with graft vs. host disease (GvHD), a condition in which a bone marrow transplant rejects the patient.
Williams said she’s learned a lot about regulatory issues by attending FDA meetings in Washington, DC. The meetings are open to the public, and she said it’s immensely helpful to learn firsthand about the concerns and opinions of the different groups at FDA. Bhat seconded Williams’ comment, adding that these meetings are available for viewing online.
Williams said, “The FDA has taken a lot of heat today, but you have to understand the pressure they get from society. They get reamed for approving things. When something doesn’t go right, they get blamed.”
Osteocel was considered by the FDA as a type of tissue transplant, which required a different—and shorter—regulatory process. Prochymal is currently going through the FDA process now, but children with life-threatening GvHD can be treated with it as part of the compassionate use program because there are few other treatment options besides steroids. Williams shared a couple of case studies of children who had made remarkable turn-arounds after being treated with Prochymal, and said that as a mother herself, she found deep satisfaction creating a product that can help sick children.
Williams said that therapeutics for diseases with few or no existing treatments can have a smoother ride through the regulatory process. “Look for refractory diseases, look for orphan or rare diseases,” she said.
Bhat, who has 15 patents and 20 pending applications, said that while choosing a market, developing a therapeutic, and going through the regulatory process, “You’re trying to minimize risk at every step.” One way he does that, he said, is through redundancy: “Build redundancy into your plans, processes, products; have a Plan A, Plan B, and Plan C.”
He also shared other lessons he’d learned in his schooling and career: “Every problem is an opportunity; look at how it can be solved. Seek a mentor. Never stop learning. Don’t give up easily.”
The biomolecular and tissue engineering panel was moderated by Lori Setton and Kam Leong, both professors in the biomedical engineering department at Duke.