Biotechnology company proves resiliency is required

Published in UT San Diego, November 27, 2012

In 2004, several leading dentists approached Organogenesis about applying its bio-wound-healing technology to making a product for oral soft issue regeneration. Eight years and many millions of dollars later, the company received approval from the Food and Drug Administration for Gintuit, which helps to generate new gum tissue without resorting to painful palatal graft surgery.

Successful innovation in biotechnology is a long process that requires development of a compelling new product, a lot of money, approval from the Food and Drug Administration, and in many cases, an agreement from insurance companies and/or Medicare to pay for the treatment.

With a new technology, such as stem cells, the process can be even more daunting, and how to succeed was the topic of a presentation by Geoff MacKay, CEO of Organogenesis, at the recent Stem Cell Meeting on the Mesa organized by the Alliance for Regenerative Medicine and held at the Sanford Consortium for Regenerative Medicine in La Jolla.

The company’s turbulent history illustrates the importance of resilience, listening to your customer and careful preparation to bring a new, living-cell-based product to market.

Started in 1985 by an MIT professor, Organogenesis went public a few years later and then went bankrupt when it ran out of money. “We had 200 employees as a public company and went down to 12 employees and have rebuilt to 600,” said MacKay who joined the Canton, Mass.-based biotech after it emerged from bankruptcy in 2003. The investors who purchased it from bankruptcy still own the company that is now profitable, he said.

After several leading dentists and oral surgeons expressed the need for an oral tissue regeneration product, the company smartly formed advisory boards that helped with “what would be required to develop a living-cell-based therapy, to get it approved, and to understand the unmet need and how it could benefit patients,” MacKay said. “We understood cell therapy, and the advisers understood the treatment and the patient.”

The company followed one of our most important rules: Listen to your customer.

At the time, the standard of care was to cut off part of the palate and put it on the wound. Sometimes this would require multiple surgeries and painful recoveries.

New drugs and medical treatments must gain approval from the Food and Drug Administration. “Everything comes down to one day like the Super Bowl. You have enough data to fill a war room, and you have to distill complex science so it’s credible and compelling. You present to the FDA, which hires a panel who are not FDA employees,” said MacKay. “There is no room for error.”

The process started with the company submission and culminated about 10 months later with a public hearing. Like many entrepreneurs, the company underestimated the amount of time that it would take to prepare and the number of people who would be involved, said MacKay. “Sixty people worked for one year, which was a major time and financial commitment,” he said.

Former FDA panelists and specialists grilled the Organogenesis team to prepare them. “We did three mock-ups, three days each. The first dry run gave us shell shock. It made it clear to us that it’s one thing to know the data and another to speak in a compelling way in FDA language,” said MacKay.

Finally, at the public hearing, the panel members voted separately on the two criteria — efficacy and safety — and the results were flashed up on the screen. Gintuit scored 15-0 on efficacy and 14-1 on safety. (One panel member wanted longer-term safety data.)

Innovative treatments like Gintuit may provide part of the answer to reducing the cost of health care while creating better patient outcomes. But these treatments don’t happen overnight, and there are a lot of moving parts that need to come together.

Rule No. 218: Grand passion and relentless pursuit will take you further than good grades.

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