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Tips & Tricks: Regulatory Path

By B-BIC | April 17, 2018

Create an outline of the regulatory plan that will enable marketing approval of your technology/product. Determine which FDA division is likely to have oversight for development and approval by visiting www.fda.gov as direct consultation with the appropriate FDA Division is an essential step to ensure the smoothest possible design and conduct of a development plan…

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Specialist Series: The Regulatory Path

By B-BIC | April 17, 2018

Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO   Most new technologies and products will require regulatory scrutiny and approval prior to marketing.  These requirements vary widely depending on the nature of the technology/product and their intended medical use, as well as the regulatory precedent set by existing…

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Tips and Tricks: Defining Your Market

By B-BIC | March 1, 2018

A “top-down” analysis is based on current technologies or products that address the medical need your technology/product is intended to address, and the market defined by their sales figures. The bottom-up analysis starts with identification and enumeration of the specific target patient population your technology/product will address.  What is the patient population and what are…

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THE ROAD TO COMMERCIALIZATION: A B-BIC Panel & Networking Event

By B-BIC | March 1, 2018

Join us for a moderated discussion with venture capitalists and scientific entrepreneurs about the steps to take your research from inception through to commercialization. Register Here March 29, 2018      4 – 6 PM Boston Children’s Hospital Karp Research Building, 1 Blackfan Circle 4th Floor Atrium, Boston, MA 02115     The Panel Includes: Jeffrey M.…

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Specialist Series: Defining Your Market 

By B-BIC | March 1, 2018

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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New Award: Congratulations, Dr. Jonghan Kim!

By B-BIC | February 26, 2018

RECIPIENT:  Dr. Jonghan Kim TITLE: Hydrogel-based nanochelator therapy for iron overload disorders TYPE OF AWARD: Drive TECHNOLOGY TYPE: Small Molecule CLINICAL AREA: Blood INSTITUTION: Northeastern & MGH DESCRIPTION: Iron overload, best represented by hereditary hemochromatosis (primary/genetic iron overload) and transfusional hemoglobinopathy (secondary/acquired iron overload), is a well-defined risk factor for several critical diseases, including heart failure, liver cirrhosis, arthritis,…

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FAST PITCH FOR FUNDING: FAQ

By B-BIC | February 5, 2018

Q:  Do I need to have slides?  A:  Pitches only need to address the suggested elements.  Use of reference materials or other visual elements is welcome if they help convey the product concept and can be shared using your laptop screen.  AV equipment will not be available. Q:  How formal will the pitches be? A:…

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TIPS AND TRICKS: Defining Your Competitive Landscape

By B-BIC | January 31, 2018

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). An important step in the process is to forecast how is the SoC landscape may shift during your technology/product development. Identify other technologies/products in development that…

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Specialist Series: Defining Your Competitive Landscape

By B-BIC | January 31, 2018

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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NEW AWARD: CONGRATULATIONS DR J. BRIAN MCALVIN

By B-BIC | January 31, 2018

RECIPIENT:  Dr. J. Brian McAlvin TITLE: A Novel Method To Treat The Systemic Inflammatory Response Syndrome (SIRS) TYPE OF AWARD: Pilot TECHNOLOGY TYPE: Therapeutic Device CLINICAL AREA: Blood INSTITUTION: Boston Children’s Hospital DESCRIPTION: We have developed highly-selective blood-filtering devices that are capable of filtering of individual, harmful molecules from the blood of patients rendered critically ill by the…

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