Planning for Human Clinical Trials

Synedgen Appoints Toxicology Specialists

May 30, 2014–Claremont CA–Synedgen President, Dr. Shenda Baker announced today the appointment of two new senior consultants to fill key roles in advancing the company’s push into human clinical trials over the upcoming years.

Dr. Baker noted that Synedgen has advanced from a primarily research-based focus to an advanced development stage. Synedgen is moving forward with preclinical studies in promising new treatments in oral health, gastrointestinal and pulmonary inflammation and wound treatments to control infection and scar formation in dermal wounds. The planned preclinical studies support FDA requirements for clinical trials that target improving pulmonary function in patients with cystic fibrosis and enhancing healing and controlling infection in burns. The latter is supported by the US Army and DARPA (Defense Advanced Research Projects Agency) in order to transition Synedgen’s successful research into more effective treatments for both military and civilian injuries.

To support these efforts, Synedgen is pleased to announce the appointment of renowned toxicologists Merrill R. Osheroff, PhD, DABT, and Michael J. Schlosser, PhD, DABT, who will serve as consultants to the Synedgen team. Both individuals have extensive experience in drug development planning and strategy with focused expertise in non-clinical FDA regulatory toxicology.

“Drs. Osheroff and Schlosser are thoughtful specialists with extensive experience in the drug development and regulatory processes, which will be crucial to Synedgen as we transition our discoveries into FDA approved products. We welcome their guidance to help lead these efforts,” remarked Dr. Baker.

Dr. Osheroff received his doctorate from the University of Wisconsin-Madison in Pathology and Experimental Medicine and has 35 years of experience in the field of toxicology and drug development. Since 2007, his company, Osheroff Consulting Services, has been providing clients expertise in numerous aspects of drug development planning and strategy including regulatory submissions, due diligence of compounds for in-licensing, nonclinical studies and CRO qualification/outsourcing, and is actively engaged in project management to guide his clients to meet successful regulatory goals.

Prior to forming Osheroff Consulting Services, Dr. Osheroff served in many high-level management positions including Senior Program Director at the Battelle Memorial Institute in Columbus, OH; Executive Director and Site Head, Worldwide Safety Sciences-Kalamazoo at the Pfizer Corporation in Kalamazoo, MI; Director of MSE-Newstead and Director of Global Preclinical Outsourcing for Pharmacia Corporation in St. Louis, MO and Kalamazoo, MI; Board of Directors; Michigan State University/Kalamazoo Center for Medical Sciences;Director of Monsanto Safety Evaluation-Newstead Laboratory; and Director of Monsanto Laboratory Resources in St. Louis, MO.

Dr. Schlosser is a senior level pharmaceutical / contract research executive and successful entrepreneur with more than 20 years of R&D strategy, business operations and P&L experience. He has an impressive track record in drug discovery and development, regulatory applications, in-licensing due diligence, acquisitions, integrations, and start-up companies. Dr. Schlosser has direct experience with small molecules, proteins, and oligonucleotides within pharmaceutical and contract research environments.

In addition to serving as President of MSR Pharma Services, which focuses on translational small and large molecule discovery and development for pharmaceutical, biotechnology, angel / venture capital, and academic partners, Dr. Schlosser is a Lead mentor for Chicago Innovation Mentors, an organization co-founded in November 2010 by Northwestern University, University of Chicago, University of Illinois at Chicago, and iBIO Institute to assist local university affiliated life science start-up companies.