If your product addresses a viable market, it will have competition. Your commercial success can depend to a large extent on the good or bad experience that users–clinicians and patients–have while using your device or system. How can you ensure that users have a good experience? Join us to learn from Rajan Patel, founder and CEO of the firm iO life science. (Speaker info has been updated from the original)
As described in the 21st Century Cures Act, products eligible for Regenerative Medicine Advanced Therapy (RMAT) designation include cellular therapies, therapeutic tissue engineered products, human cell and tissue products, or any combination products that use such therapies or products. Multipotent stromal cells (MSCs) and induced Pluripotent Stem Cells (iPSCs) have been popular sources for manufacturing RMAT products due to their ability to undergo lineage-specific differentiation. Despite great promise, successful clinical translation of such cell-based products is often hindered by manufacturing challenges and the lack of reliable markers that can predict the products’ in vivo performance. For instance, MSCs are very heterogeneous and responsive to their surrounding environment, resulting in distinct subpopulations of cells with potentially different amounts of qualities needed for product potency. Since there are numerous biochemical and biomechanical factors regulating the functions of MSCs, it is critical to develop reliable high-throughput assays that enable the efficient exploration of large and complex parameter spaces for evaluating cellular function. Microscale in vitro systems offer the practicality to fulfill this unmet need. Several simple microfluidic channel arrays have been successfully implemented in screening the influence of paracrine mediators and various tissue microenvironment components in the regulation of cellular functions. In addition, microphysiological three-dimensional organoids and tissue-like structures such as chondrogenic cell aggregates and blood vessels have been incorporated into high-throughput, cell-based screening platforms in efforts to provide functionally relevant in vivo-like conditions. This presentation will give an overview of practical microscale technologies that are simple to operate while enhancing throughput, relevance, and reliability. How such technologies could be employed in the assessment of cell-based products will be discussed.
Dr. Joseph M. DeSimone is the CEO/Co-founder of Carbon, Inc. located in Silicon Valley. Prior to this, DeSimone was the Chancellor’s Eminent Professor of Chemistry at the University of North Carolina at Chapel Hill, and William R. Kenan, Jr. Distinguished Professor of Chemical Engineering at North Carolina State University and of Chemistry at UNC. DeSimone has published over 350 scientific articles (> 21,000 citations and H-index = 70) and has nearly 200 issued patents in his name with over 200 patents pending. DeSimone has mentored and trained 73 postdoctoral research associates and has graduated 80 PhD students from his group, 50% of whom are women and people from underrepresented groups in the sciences. = In June, 2016 DeSimone was recognized by President Barack Obama with the National Medal of Technology and Innovation.
DeSimone is one of fewer than twenty individuals who have been elected to all three branches of the U.S. National Academies: the National Academy of Medicine (2014), the National Academy of Sciences (2012), and the National Academy of Engineering (2005). He is also a member of the American Academy of Arts and Sciences (2005). DeSimone has received over 50 major awards and recognitions including the 2017 $250,000 Heinz Award for Technology, the Economy and Employment; the inaugural $250,000 Kabiller Prize in Nanoscience and Nanomedicine; the 2015 Dickson Prize from Carnegie Mellon University; the 2014 Industrial Research Institute Medal; the 2014 Kathryn C. Hach Award for Entrepreneurial Success; the 2012 Walston Chubb Award for Innovation by Sigma Xi; the 2010 AAAS Mentor Award in recognition of his efforts to advance diversity in the chemistry PhD workforce; the 2009 NIH Director’s Pioneer Award; the 2009 North Carolina Award; the 2008 $500,000 Lemelson-MIT Prize for Invention and Innovation; the 2002 John Scott Award presented by the City Trusts, Philadelphia, given to “the most deserving” men and women whose inventions have contributed in some outstanding way to the “comfort, welfare and happiness” of mankind; and the 2002 Engineering Excellence Award by DuPont.
DeSimone is the co-founder of several companies including Micell Technologies, Bioabsorbable Vascular Solutions, Liquidia Technologies, and Carbon. DeSimone received his B.S. in Chemistry in 1986 from Ursinus College in Collegeville, PA and his Ph.D. in Chemistry in 1990 from Virginia Tech. He currently resides in Monte Sereno, California with his wife of 30 years, Suzanne.
How are areas of opportunity for medtech invention discovered? Is there a single optimal approach to healthcare innovation or are there multiple approaches that work equally well? Do global healthcare companies use the same framework for innovation as start-up companies? Join us on October 30th to hear Dr. Sanaz Saatchi’s perspective and recommended methodologies to drive innovation. Previously, Dr. Saatchi led the development of cardiovascular medical devices from inception to commercial launch at Medtronic and helped multiple start-up companies determine the strategic product-market fit for novel technologies.
Your pitch deck is a key element of your fundraising strategy. You’ll be pitching live, of course, but also emailing it to potential investors and partners, who will have limited time to look at it because they’re considering many other pitches. Pitch decks can evolve over time—but it’s more efficient to get the job done right early on! Shubhra Jain is an investor with Cota Capital. Join us to hear Shubhra’s tips on what matters in a pitch deck and what can make a deck stand out to investors.
As part of FDA approval, a new medical device must follow guidelines for “Human Factors,” which address design and encompass usability and ergonomics. Because medical devices are so diverse, manufacturers often struggle to understand how the guidelines apply to their own product. At this talk, Dr. Russell Branaghan, Founder/President at Research Collective will describe strategies to help companies (1) improve their time to market and overall design through early implementation of human factors, and (2) pass their human factors validation test for FDA clearance.
The Rosenman Symposium is the premier event for the San Francisco Bay Area’s health technology community. It is held annually in June at the UCSF Mission Bay campus. Join us to learn from leaders in the health technology industry, meet dynamic startups, and connect with hundreds of players in the Bay Area ecosystem.
The federal government can be a key source of non-dilutive funding to fuel your advance to commercialization in health technology. But where to begin looking, and how to be sure you have not missed any opportunities? A comprehensive strategy is necessary, one that includes all relevant programs and players as well as granular details on which program managers to work with. Join us on June 5 to learn firsthand from Dr. Anna Kushnir and Bill McCann of SMI, a consulting firm that has helped hundreds of early-stage companies develop strategic plans to win federal funding.
Digital health is a sector of the health ecosystem that has enormous growth potential. What’s really piquing investors’ interest these days? Are there any special factors that make certain digital health companies more attractive than others? What trends are emerging, and what major unmet needs are still crying out for a solution that would bring investors running? Join us on May 1 to get answers from David Kim of the investment firm DigiTx Partners.
There is a seemingly limitless number of frameworks for strategy development. Using them well lays a critical foundation for aligning teams and investors and ensuring long term success. Kirsten Carroll will review the role strategy plays in business planning and the importance of not just developing a great one, but also communicating it effectively. She will provide examples of the frameworks that have served her particularly well in her own career with advice on when and how to use them.