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Biopharm Development & Manufacturing Average months to NDA approval uct pipeline and continuous discovery efforts are, therefore, hallas potential engines for advancing future pharmaceutical drug marks of success for both start-up and established large pharma development. companies. A SHIFT TOWARD RARE DISEASES An example of this is NanoSmart's IP expansion in the face of The pharmaceutical industry as a whole is seeing an increasing development challenges. NanoSmart initiated operations with a focus on rare diseases. In recent years, personalized medicine has platform technology when the initial discovery phase of its targetdominated much of the industry's focus for both large and small ing antibody was complete. The company is now working to use pharma. In fact, the proportion of all drug approvals that receive the targeted delivery system to reformulate various cancer drugs. orphan indications has been steadily increasing over the past 15 In order to accommodate a larger array of APIs with different bioyears. Large comchemical properpanies like ties, the compa25 25 Novartis, Roche, ny innovated a — Non-orphans and Genentech novel approach — Orphans have used the to the delivery orphan pathmechanism. The 20 20 way to efficiently lessons learned expand their from formulapipelines and tion challenges grow their marresulted in the 15 15 kets. expansion of the In conclusion, company's intelproduct developlectual property ment in a start-up portfolio with 10 10 setting is never a second plateasy, and only a form technology, fraction of compawhich opened 5 nies that attempt up additional 5 5 996 997 998 999 000 001 002 003 004 005 006 007 008 to commercialize paths to com2 1 1 2 2 2 2 2 1 199 1 2 2 2 their novel techmercialization Figure 1. Average NDA Approval Times (1995-2008). The FDA has historically approved orphan drugs faster than non-orphan drugs, with an average approval time for orphan drugs of 7.2 months. (Business Insights, 2010). nologies is able to and increased accomplish that prospects for goal. As daunting collaborative or as the obstacles may be, now more than ever, the tools, resources, licensing opportunities. and industry infrastructure exist to support and guide start-up LEVERAGE PARTNERSHIPS operations through the very challenging process of product develThe lesson learned from countless other companies that sucopment and commercialization. cessfully crossed the line of market approval is that development In order to succeed, start-ups must be able to advance effectively and commercialization goals are most attainable when there is a and efficiently on limited funding as well as mitigate the risks network of trustworthy, proven experts supporting the project. inherent to the development process as much as possible. In this Generally, it is much more difficult to cultivate all the necesway, companies can maximize the potential for successful product sary expertise in-house, and so the industry is witnessing a shift development and give their supporters the return on investment toward external partnerships and collaborations. In fact, much of they deserve. With the right commercialization strategy, it is posthe industry's focus over the past 10 years has been on developsible to cross the line of market approval with a fraction of the ing the infrastructure, capabilities, and regulatory frameworks funding that was once believed necessary. through external consortiums and innovation incubators. Such About the Author developments mean that new start-up companies have resources James Smith, Ph.D., is president of NanoSmart and support options that were not previously available. The colPharmaceuticals, Inc. He has over 15 years of experience in regulatory affairs and the development laborative environment between industry, government agencies, of novel technologies from concept through and academia is rapidly growing and establishing new paradigms commercialization. Dr. Smith obtained his Ph.D. in for interactive product development. This very exciting trend is pharmacology and toxicology from the University of precisely why innovator companies are being increasingly seen California, Irvine. 60 LifeScienceLeader.com November 2013