Written by Erin McKenna, B-BIC Deputy Director There are multiple frameworks out there that outline the process for developing promising biomedical research into a range of innovative solutions – pharmaceuticals, biologics, medical devices, and diagnostics.  Many of these processes leverage concepts that come from regulations developed by the FDA, the European Commission and others to…

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Over the course of 2019, our coaches and staff broke down the B-BIC application process to provide you with expert advice on all the of the questions we ask you to answer when applying for our program. For those who are not applying yet, the B-BIC proposal has many similarities to a business plan, which…

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Co-authored by Erin McKenna, B-BIC Deputy Director & Ron Blackman, B-BIC Sr. Project Manager. When considering a development path needed to move technology to the clinic and beyond, it’s essential to address two questions:  Who will support the development of your technology, and what will they want to see to believe it can be commercialized? Who Will Support…

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Contributed by Ed Berger Principal Larchmont Strategic Advisors Reimbursement strategy counsel to companies across the life sciences spectrum   A basic understanding of the healthcare reimbursement system is an important success factor for any entrepreneur developing a new medical product. Reimbursement is critical to opportunity assessment, business plan development, investor due diligence, and commercial success.  The…

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Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO As you prepare to move your technology or product out of the academic setting towards commercial development, a key step is to define the market potential for your technology/product.  Prospective investors will assess the opportunity in terms of the potential…

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Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO The first step in defining your competitive landscape is to identify and define the technology’s current competition and how they fit into or define current standard of care (SoC).  List the products or substitutes that you would aim to replace…

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Contributed by Ron Blackman In our previous newsletter, we described how to identify the unmet need that will be served by your device or therapeutic, and here we will help you build the case that you have a solution to meet that need.  A number of points should be addressed and we will go through…

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Contributed by Josh Tolkoff The most common reason for the commercial failure of a start-up entity is not having a compelling clinical need.  What exactly is an “unmet need”?  An unmet need is something more than an incremental improvement, and once it exists in the market it will make a substantial change for the better.…

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Contributed by Erin McKenna, B-BIC Deputy Director After the dip in investment in early-stage biotechnology in 2008, the number of funding opportunities for early-stage technologies has been increasing in recent years. Despite this promising trend, finding and securing the funding necessary to move your research out of the lab and towards commercialization is still a…

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If reimbursement is so important … why do so many companies address it so half-heartedly and so late? Edward E. Berger, Ph.D. Everyone knows how important reimbursement analysis and planning is to the success of innovative medical technology and life science products.  Ask any venture capitalist, private equity investor, strategic marketing analyst, or C-level executive;…

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