By Bob Marshall, Chief Editor, Med Device Online
Quick! You’ve just licensed disruptive technology from a university research institution. It holds the promise of improved treatment for a prominent disease around the globe; what do you do first?
The easy answer is, “Go talk with someone who has done it before.” But each product development situation is unique, and there are many different ways to proceed and succeed… or fail. Perhaps, the ideal source of good advice would be someone who has successfully led the commercialization of differing life science technologies multiple times: a serial life science entrepreneur.
I was tempted to call these serial life science entrepreneurs “unicorns,” as they are rare and often quite prolific in their accomplishments. However, doing some research, I discovered the term unicorn already has a definition within the entrepreneurial space: In finance, a unicorn is a privately held startup company with a current valuation of $1 billion or more. I searched for some current unicorns in the life science space and found both Moderna Therapeutics and Intarcia Therapeutics on the list. The former is a biotechnology company discovering and developing drugs and vaccines based on messenger RNA, and the latter is working on a once-a-year, type 2 diabetes treatment by administering exenatide via its Medici Drug Delivery System. Both companies’ technologies hold the promise to revolutionize the standard of care in significant or numerous treatment spaces.
This brings me to the subject of this article, a recent discussion with serial life science entrepreneur Raymond Vennare, discussing his latest venture, Cvergenx (a unicorn in the making?). Vennare is chairman of the board and CEO at the genomic informatics company developing decision-support tools for radiation oncology. But, this certainly is not his first walk on the high-wire.
Vennare was previously president & CEO of a medical device startup, president & CEO of a diagnostics startup, SVP & CIO of a bioinformatics startup, and president of an IT startup. In addition to his appetite for leadership and technology development, there is another side to this serial life science entrepreneur – Vennare appreciates fine art, good food, and unpretentious wine. He has even written a fascinating memoir, My Father’s Shoes: Life Stories and Other Memories. As a serial life science entrepreneur, Vennare’s goal has been to “find life-changing technologies to put into the hands of clinicians to improve lives.”
Cancer Treatment Gets Personal – One Size Does NOT Fit All
Hearing Vennare had a new masterpiece cooking and knowing his appreciation for conversation, I tracked him down to learn about Cvergenx. According to Vennare, Cvergenx has developed an informatics-based approach to radiation treatment planning, enabling radiation oncologists to personalize and optimize radiation therapy.
“A radiation oncologist will do their normal treatment planning for a patient, but also have the ability to incorporate precision genomic radiation therapy (pGRT). The biopsied tissue sample will be run on a microarray with a 10 gene signature in a CLIA lab from which the patient’s personal radiosensitivity index (RSI) is derived. The RSI score is then entered into a computer and the genomic adjusted radiation dose (GARD) algorithm is applied. The result appears on the radiation oncologist’s screen allowing the physician to personalize, adjust, and optimize the dose,” Vennare explained. “The treatment team will be able to compare the original plan developed for the patient to the alternative plan based upon the biological measure. This will appear as a physical overlay in the treatment planning system and indicate a potential alternative dose specific to the patient’s radiosensitivity or radioresistance. In effect, the radiation oncologist has an option to adjust the plan based on additional input from the biological measure, or proceed with their original treatment plan.”
The Road Less Traveled
I asked Vennare about Cvergenx’s origins and how this venture has differed from his previous entrepreneurial endeavors. He offered that Cvergenx was established in 2009 with in-licensed technology from Moffitt Cancer Center in Tampa, Florida. Through the licensing agreement, “Cvergenx owns world-wide exclusive rights to technologies developed in Moffitt,” Vennare clarified. “The way Cvergenx has been able to develop as a company so far, with minimal investment, is to partner with the Moffitt Cancer Center and Research Institute.” Though this approach is not unique to Cvergenx, it is rare to achieve this level of ‘collaboration’ with a research organization.
Vennare continued, “We focused on finding and creating value. We sought an initial pathway to minimize regulatory and clinical requirements which we found in pGRT as a decision-support tool. I think it is prudent to take a little risk pre-commercially to avoid the need for major investment and pre-building a large team. We have had limited engagements with consultants, as necessary, to guide and validate our strategy, and also began early discussions and sought partnering relationships with large oncology treatment providers with existing infrastructure in the U.S. and foreign markets.”
This minimalist approach to infrastructure buildout has left Cvergenx with a lot of options, minimal debt, and significant freedom to operate. The key for Vennare will be timing the build-out of the team and systems required for commercialization.
Unicorn In The Making?
Might Vennare have a unicorn in his hands with Cvergenx? Time will tell, but he is clearly focused on what is close at hand. “Currently, pGRT is a decision support tool within the existing standard of care, because the physician always has the ability to decide whether or not they want to use it,” Vennare said.
But a decision support tool alone is unlikely to take Cvergenx to the promised land, and Vennare knows it. When asked where this all leads, the savvy serial entrepreneur revealed his end game. “When the prospective clinical trials are done, we will be able to say this is a new standard of care to be applied to all oncology patients moving forward. That’s the home run! Sure, we can get into the marketplace now with what we have, but the ultimate goal is to have pGRT with a separate CPT code, and literally a completely new discipline within radiation oncology,” he said.
No doubt the new standard of care could provide improved, personalized care for cancer patients, and create significant valuation for Cvergenx.