Posts Tagged commercialization

Lean LaunchPad for Life Science Entrepreneurs


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.

English: Molecular graphics images were produc...

English: Molecular graphics images were produced using the UCSF Chimera package from the Resource for Biocomputing, Visualization, and Informatics at the University of California, San Francisco (supported by NIH P41 RR001081). PDB rendering based on 1a8e. (Photo credit: Wikipedia)

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.

 

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Lean Drug Development Model based on Operational Efficiency & Shared Risk


Lean Drug Development Model based on Operational Efficiency & Shared Risk

Madhav Reddy, founder of Maya Clinicals, a Northern California based CRO, talked about a novel risk sharing, open model of drug development at http://www.bio2devicegroup.org . This new, lean drug development model sidesteps the traditional development paths and avoids committing large blocks of capital before human efficacy is proven.

No one can deny that the drug development process needs an overhaul. It takes 9 therapeutics in phase 1 to get 1 to market and number of novel drugs coming out has been flat, though expenses keep climbing up. Perhaps the big pharma overspends or relied too heavily in the past, on block busters or FDA needs to change the risk tolerance profile; but something needs to be done, whilst keeping in mind that drug development ultimately depends on basic science, said Reddy. Different models for more efficient drug development, are explored that include, university collaborations, orphan indications, strategic relationships, biomarkers, soft ware modeling, genomics, high throughput screening and so on.

What we need is breakthrough in basic science or a new operating model and an ability to get toxicity and efficacy data to push R&D productivity, at lower cost. There is no shortage of IP and big Pharma also excels at commercializing. But the so called valley of death that sucks up resources, is right in between the IP and commercialization, said Reddy. Before spending large blocks of cash, people want to see proof of efficiency and safety. Smaller companies often do not have adequate resources to execute these studies fully. Also, their resources get divided among their core focus and other tangential concerns like fundraising, team assembly and so on. While the big pharma has the resources, a problem is that a project with gravity sucks in the resources and many early stage compounds are dropped before they are fully investigated, in the early stage.

Reddy said, his new model for quick turn drug development addresses both the lack of parallelism at big pharmaceutical companies and the resource limitations of start-up companies. Maya Clinicals is a CRO, deeply focused on clinical trials and related logistics and is based on an operational platform with all the crucial pieces required for success. They are asking biotech companies to focus on their core strength, their compound and Maya would push it through, with efficient use of infrastructure, shorter startup and execution, efficiency in distributed setup, and geographic savings. Besides doing this in a fee for service model, Maya is also willing to share the risk and participate in the upside. Utilizing Maya’s operational efficiency, and equity sharing model a development program can be brought down to 1/10 of the traditional cost. Compared to the traditional model however, the owners of the compound will have to give up a large portion of the equity in return for the increased speed and lower development cost.

With this new model, Maya Clinicals is counting on boosting its pipeline, run parallel programs in identical indications, and overcoming the limitations of startup model, and get the upside from equity sharing based on its operational efficiency. Maya is not counting on its ability to pick compounds at this stage. Instead, Maya is picking proven entrepreneurs and then relying on mathematical probabilities of success. Maya does not have a preference but indicated that that re-purposed compounds, and those targeting infectious diseases will be quickest. Maya is clear however, that its core ability is not in choosing a compound but in pushing it through and getting a faster idea of its probability of success, based on basic science. The talk was followed by Q&A.

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