Development of an intellectual property (IP) strategy for the commercial advancement of a Direct Phase II SBIR-funded human platelet bioreactor

Period of Performance: 09/28/2016 - 09/27/2017

$50K

Phase SBIR

Recipient Firm

Platelet Biogenesis, Inc.
CHESTNUT HILL, MA 02467
Principal Investigator

Abstract

PROJECT SUMMARY/ABSTRACT Platelet BioGenesis is developing a microfluidic bioreactor to produce human platelets at clinical scale. Platelets are the 'band-aids' of the bloodstream, responsible for clot formation and blood vessel repair. Low platelet count is a significant consequence of cancer treatment, transplant, and surgery, for which plate- lets are a critical first-line therapy to prevent mortality due to uncontrolled bleeding. Platelets are de- rived exclusively from volunteer donors. Risk of bacterial growth during room temperature storage limits plate- let shelf life to 5 days, 2 of which are expended by bacterial screening, and 1 during transport to hospitals. As a result blood centers typically do not have more than a 1.5-day platelet inventory available for transfu- sion, making platelet unit inventory especially vulnerable to routine depletion[1, 2]. To address this ma- jor unmet need we are developing a platelet bioreactor that reproduces key features of adult bone marrow (physiological microenvironment) to trigger platelet production from human induced pluripotent stem cells (hiP- SCs, a replenishable source of progenitor cells which can be stored frozen for years) at clinical/commercial scale. This SBIR CRP Program proposal for Technical Assistance (SB1) outlines a comprehensive intellectual property strategy for Platelet BioGenesis to develop a proprietary, patent protected technology to produce cGMP-compliant human bioreactor-derived platelets at commercial scale for clinical use in 3 specific aims: Aim 1. Understanding the Patent Landscape. We will work with IP counsel to: (1) identify and assess licens- ing various third party patents and patent applications related to megakaryocyte differentiation protocols and the platelet bioreactor, (2) perform further patent searches (landscape and/or freedom to operate) to ensure that we are able to commercialize our technology without infringement, and/or (3) identify any additional third party patents that may be licensed by us to further improve our competitive commercial position. Aim 2. Protecting Proprietary Technology to Enable Commercialization. We will work with IP counsel to identify intellectual property generated by us and will formulate a strategy for protecting such intellectual prop- erty, either by filing patent applications or ensuring that the technology is maintained as a trade secret. Aim 3. IP Agreements. We will work with the IP counsel to: (1) review our non-disclosure agreements, em- ployment or consultant agreements to ensure the ownership and protection of our intellectual property, and (2) negotiate and enter into license agreements with cGMP-compliant hiPSC suppliers for access to relevant cell lines. cGMP-hiPSC line master banks will be maintained and differentiated into megakaryocytes under estab- lished supply agreements using proprietary cell culture protocols.