by Ron Guido
Senior Vice President, Global Regulatory Affairs & Quality
That the New York City area is fertile ground for the next big biotech product is unarguable. With about a dozen medical research institutions, and countless scientists in hospitals and universities it only follows that ideas would abound. But turning great ideas into approved, lifesaving treatments — well, that’s quite a different story.
University scientists and small startups are the seedbeds of great ideas. New York has both. But turning those ideas into medical products takes lab work, specialized data analysis, formulation, pilot manufacturing, and submission of specialized applications containing supportive data to government regulators. Not to mention, the experience to navigate the complexities of development e.g. picking the correct therapeutic targets, measuring meaningful clinical outcome, and developing supportive data analyses. This takes a combination of bricks-and-mortar infrastructure as well as access to specialized expertise. Lacking any of these could result in a great idea never seeing the light of day.
After several successful running starts at providing that supportive environment (bio based incubators in Long Island, Manhattan, Brooklyn — to name a few), New York City has yet to emerge as the “next Boston” or “next San Francisco” hothouse for biotech startups. One possible answer was to provide more; a great NYC location, with broader support— founded by scientists, and bearing in mind the many complexities of development.
Realizing the unique development needs of the NYC biotech startups, Keystone for Incubating Innovation in Life Sciences (or, Kiiln) is developing a new bioincubator located in NYC’s East Harlem. It’s unique in its approach and in a location that is convenient to all who could benefit from it. The approach of this incubator, founded by scientists, is to provide a supportive environment to aid the scientist – entrepreneurs in moving from the “0 – 1 person company” to launching a successful product benefitting patients.
Beyond a place to rent lab space, KiiLN will offer a fully functional infrastructure, co-located with the people who have the ideas. This will permit these scientists to focus the development of their ideas without having to divide their attention on operational issues like lab layout, licenses, and permits, IT infrastructure, meeting space, mail and package handling, and facility security. In addition as it develops, the incubator can — and likely will – develop relationships with preferred groups that provide specialized services in the drug development sector.
For the scientist, the availability of specialized contractors allows small organizations to have required capabilities without needing to expand staff. This approach also pays additional dividends, in that the internal teams learn by working in close contact with experienced individuals from the specialized service providers, expanding internal staff capabilities as a welcomed side effect.
In an era where new drug products are routinely abandoned due to development missteps or unanticipated additional data requirements, following the correct development path is essential to success and may serve to shorten lead time to market — a high value accomplishment. Further, ALL biotech companies are watching both burn rate and head count, yet also need to develop demonstrable proof of a product’s value. Whether the role is to support initiation of human trials or to develop good data to support divestiture, a well-planned broad based incubator can be of inestimable value in answering these seemingly divergent needs for high quality data with a low overhead investment. Perhaps, just the formula needed to jump start fertile ground to yield needed therapeutic solutions.