Posts Tagged regulators validate
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on November 20, 2014
Recently, Karl Handelsman, Founder, Codon Capital, talked about the Lean LaunchPad Entrepreneurship program, at www.bio2devicegroup.org event. Handelsman, with Allan May (Managing Director at Life Science Angels), are instructors in the Lean LaunchPad for Life Sciences program at UCSF and also will be teaching at NIH, in the future. Handelsman is the Therapeutics cohort and May is the Medical Device cohort.
It is a mistake to assume that pre-clinical programs are risky and they need to focus on easier low hanging fruit or they must take 10+ years and a billion dollars to create value, said Handelsman. We have a duty to search for the path to unlock the value of the idea as industrially relevant innovation, and there are examples of biotech startups reaching that point in 18-30 months, said Handelsman. Lean LaunchPad program teaches scientists and clinicians in startups to do a real world assessment of their idea or technology, before plunking down millions of dollars, in an idea. Entrepreneurs receive training in determining their product’s market viability, regulatory risk, potential clinical utility, and also likely financing vehicles before making big dollar investments in research, design, and manufacturing.
Entrepreneurs need good operational models that build a context of value creation, said Handelsman. Investors like value, not milestones. “Investors want to invest money and they want to hear a business case, and operational milestones don’t get you there”, stressed Handelsman.
Big things often have small beginnings and start with contributions from many small pockets. Sharing the case of a company that started with collaboration and became the behemoth, Genentech, Handelsman said, entrepreneurs need to start thinking about collaboration, not competition, and begin to look at models of collaboration that would create true value. After all, strategic alliances built the Silicon Valley and there are many diverse and creative ways of creating partnerships. Entrepreneurs need to talk with others and be really good listeners.
Successful entrepreneurs are not thoughtless risk takers, but approach problems in a disciplined way. Value creation for therapeutics begins with thoughtful consideration of who would benefit from solving a certain problem; patients, payers, insurances companies or any other entity? Once entrepreneurs can figure that out, they can go to a VC and explain the business case. Value creation, after all, is not what entrepreneurs think or believe, but an idea or concept that gets external validation from the customer. “Do not constantly worry about keeping the concept in the stealth mode, and talk to a lot of people”, advised Handelsman. VCs do not count, they are not potential customers. In the end, one could have a sexy product, but if it does not solve a pressing problem then it is not creating value. Real answers to key commercialization questions, in the case of therapeutics, lie outside the lab, and entrepreneurs need to actively engage and talk with customers, partners, regulators and so on to figure out the value of their product. Lean LaunchPad methodology therefore, helps to validate the product, before commercial strategy is considered, saving time, money, resources and in some cases, helping guide the change in the trajectory, for more meaningful outcome.