OPERATIONAL PLAN "STEMCELL INCUBATOR COMPANY":D:eek:;)
Month 1-2: Assembly of Team. Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. -DONE
Month 1-4: In-licensing of Intellectual Property. The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development. -DONE
Month 3-6: Interaction with Regulatory Agencies. Regen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials.-DONE (CLINARTIS)
Month 6-18: Clinical Implementation. Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy. NEXT UP
Month 18-24: Exit. It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."
MANAGEMENT TEAM | REGEN BIOPHARMA, INC.
David R. Koos, PhD, DBA
Chairman and Chief Executive Officer
David Koos is the Founder, Chairman & CEO of Entest BioMedical Inc. Dr. Koos has over 26 years of investment banking and venture capital experience with a primary focus on fully reporting medical and biotechnology ventures. He holds a Ph.D. degree in Sociology and a Doctor of Business Administration in Finance. Additionally, he has authored or co-authored several peer reviewed journal articles primarily on biotechnology related subjects.
J. Christopher Mizer
President and Chief Operating Officer
Christopher Mizer is the founder of Vivaris, Ltd. and serves as President and Chief Executive Officer. Vivaris invests in and acquires middle-market businesses that are leaders in their market niches. Mr. Mizer serves as a director of each of the portfolio companies and guides key strategic decisions and their execution. He also serves as the operating president on an interim basis when companies are going through periods of ownership succession and new management team members are being assembled.
Mr. Mizer is a former Vice President and Officer of the investment banking division of Key Capital Markets, where he focused on merger, acquisition, and financing projects for Fortune 500 clients, private companies, and successful entrepreneurs. Prior to joining Key Corp., he was a consultant and certified public accountant with Ernst & Young. He earned the B.S. and M.S. degrees (biology) and B.A. (economics) and MBA (finance and accounting) degrees from Case Western Reserve University.
Thomas E. Ichim, PhD
Chief Scientific Officer and Director of Research
Dr. Ichim is one of the leading authorities in the world on stem cell biology. To date, he has published 82 peer-reviewed articles and is co-editor of the textbook RNA Interference: From Bench to Clinical Translation. He is also inventor on over 30 patents and patent applications. He currently serves as the CEO of Medistem, Inc., was formerly chief of scientific development, and is the scientific founder / co-founder of Medvax Pharma, ToleroTech, bioRASI, and OncoMune.