CURE/Yale BioHaven presents Biodel, Inc.

The CURE/Yale BioHaven Entrepeneurship Series opened 2011 with presentations by Dr. Frank Slack, co-founder of Mira Dx and associate professor at Yale University, and Martin L. Verhoef, president and CEO of Mira Dx.

Mira Dx is a genomics company dedicated to the development and commercialization of novel microRNA-based tests for risk assessment and companion diagnostics. Founded on research discovered at Yale University, its stated goal is to provide information that can help clinicians better understand cancer and enhance their decision making in treating the disease.

MicroRNAs are a recently discovered class of small non-coding RNAs that are negative regulators of gene expression in eukaryotic organisms. MicroRNAs show distinct expression patterns in different organisms, cell development stages, and disease models, and therefore play an important role in regulating gene expression. MiraDx is applying microRNA discoveries to develop molecular diagnostics that will provide individualized information on the likelihood of disease occurrence and response to certain types of therapy.

Last August the company announced the launch of its PreOvar test for women who may have inherited an increased risk for developing ovarian cancer. The test is based on technology licensed from Yale University.

"MiraDX is currently providing just this one cost effective genetic test, but we have many more like it down the road that are being prepared for marketing soon," Dr. Slack said. "We think that this has great potential benefit to women. A quick calculation tells us that it’s more cost effective for every female in America to be tested than for just the people who will get ovarian cancer to be treated. So it could help bring down the cost of healthcare if we can risk stratify individuals in a screening earlier in life."

"We're looking at fairly large markets," Dr. Slack said. "The market for ovarian cancer alone is about 30,000 individuals a year and for breast cancer it’s about 250,000 individuals a year. We're tapping an unmet need — the lack of cancer markers — by using this innovative idea that microRNAs are actually key regulators of gene expression, and mutations within their binding sites are actually found in cancer patients and can predict cancer risk."

If you look at the top companies in our space, one thing is very clear," Martin Verhoef said. "Success is driven by revenue. So that is really the focus we have now at Mira Dx. The time to build a company to a sustainable value, that would lead to an IPO or to acquisition, is now something like six or seven years. And since 2008, because of the recession, it's gotten worse."

During his presentation, Martin Verhoef listed the following "key issues" that need to be addressed in the development of a biotech start-up company:

strategy
financing
organizational development
product pipeline
commercialization
intellectual property
regulatory affairs
reimbursement
board of directors
strategic alliances

The Mira Dx speakers were introduced by Kimberly Muller of the Yale Office of Cooperative Reasearch.

The BioHaven series is presented by CURE and the Yale Office of Cooperative Research, with Wiggin and Dana and PricewaterhouseCoopers as lead sponsors. The series is also sponsored by Elm Street Ventures and the Economic Development Corporation of New Haven, with additional support from the Yale Entrepreneurial Institute and the Yale Healthcare & Life Sciences Club.

The BioHaven series continues February 16 with a presentation by NovaTract Surgical at the Anlyan Center, 300 Cedar Street, New Haven.