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Cracking the Code of Cell Therapy 2.0

As the cell therapy commercialization partner of a 5-year Department of Defense program to manufacture on-demand blood products, Safi Biosolutions and its collaborators are working to ‘crack the code’ of Cell Therapy 2.0 challenges of manufacturing at appropriate scale, high consistency of product, and economically viable cost of goods by integrating world-leading expertise in cord blood stem cell expansion, bioprocessing optimization, manufacturing scale-up and cryostorage.

Lead development programs for manufactured, on-demand cell products and therapies include red blood cells for trauma, tailored red blood cells for specific transfusions (e.g. sickle cell disease) and a neutrophil progenitor cell therapy for the treatment of chemotherapy-induced neutropenia.

Recent news featuring Safi Biosolutions

Team

The co-founders and leadership team at Safi Biosolutions bring experience in ex vivo human blood cell development, biologic and pharmaceutical manufacturing, pre-clinical and clinical development, and regulatory submissions.

Doug McConnell MBACEO & Co-Founder

Prior to helping launch Safi Biosolutions in Q4 2019, Doug held strategic and operational leadership roles at Vertex Pharmaceuticals and Radius Health, spanning R&D, Quality, Regulatory and new product planning, supporting submission and launch of initial Vertex products INCIVEK, KALYDECO and ORKAMBI, and Radius Health’s TYLMOS. While at Vertex he also formed and led a virtual drug development unit for advancing pre-clinical stage candidates with external partners in emerging markets. Earlier in his career, Doug led strategic consulting initiatives for major Pharmaceutical and Biotech companies.

Jon Mogford PhDChairman & Co-Founder

Dr. Mogford is the Vice Chancellor Research for Texas A&M System’s 11 Universities and 8 State of Texas agencies. Previously, as the DARPA/DSO Deputy Director, he spearheaded expansion of the formal working relationship between DARPA and the FDA, and was recipient of the Secretary of Defense Medal for Outstanding Public Service. As a DARPA Program manager Jon led the 2008-12 DARPA Blood Pharming program.

Michael Mansour MD, PhDCo-Founder

Dr. Mansour is an Assistant Professor Harvard Medical School and Infectious Diseases physician at Massachusetts General Hospital, with expertise in molecular mechanisms for host immune and neutrophil responses to life-threatening fungal and bacterial pathogens. Michael started his research career in the biotech sector, prior to completing his MGH residency and combined infectious disease training program at Harvard Medical School.

Kyle Meetze MBACOO

Kyle brings over 20 years of strategic and operational leadership across an array of biomedical companies, universities, and healthcare institutions. He has led and participated in dozens of licensing, fundraising, and partnering deals. Most recently, as CBO of EdenRoc Sciences, Kyle led strategic planning, budgeting and oversight of operations, finance, contracting, HR, facilities & IT for 8 start-ups.

Rob Thomas PhDScientific Lead

Dr. Thomas is the founder and Managing Director of Advanced Bioprocess Services (UK) and Professor of Cell and Gene Therapy Manufacture at Loughborough University. Rob has over 10 years of relevant expertise in cell development process optimization and cost reduction for pre-clinical and clinical stage manufacture processes.

Katie Glen PhDLead Biologist

Dr. Glen brings 10 years operational and scientific leadership in bioprocess research programs at Loughborough University Centre for Biological Engineering and Advanced Bioprocess Services. Katie has extensive experience in cell culture, analysis, and process development for haematopoietic progenitor expansion and differentiation, including mL to multi-litre scale up of neutrophil progenitors and cost reduction solutions for red cell lineages.

David Sykes MD, PhDScientific Advisor

Dr. Sykes is an Assistant Professor at Harvard Medical School, clinician at the MGH Cancer Center and head of a research lab within the Center for Regenerative Medicine. David has a focus on neutrophil development and neutrophil disorders using a deep mechanistic understanding to support the rational development of therapeutics. Co-founder of Clear Creek Bio whose goal is to bring new treatments to patients with acute myeloid leukemia.