Celavie Biosciences Adds Strategic Business Development Team to Bring Novel Stem Cell Technology to Market
OXNARD, Calif., Sept. 22, 2016—Celavie Biosciences LLC welcomed a team of leaders in market strategy, medical technology, pharmaceutical R&D, regulations, and product commercialization to help bring their novel stem cell technology to market. Celavie is working on stem cell-based regenerative therapies for the treatment of Parkinson’s disease and other disorders of the central nervous system (CNS), for which there are no long-term treatments or cures.
“We have a powerhouse team in bringing lifesaving medical tech to market,” says CEO and President Sandy Solmon. “Our R&D to date has shown great promise. We needed leaders with experience navigating the medical technology industry and regulatory bodies so we can get these treatments to the people who need them and realize our goal of relieving suffering worldwide.”
The new additions to the team include:
- Raymond J. Hage, Jr., Strategic Advisor—
Over 25 years in pharmaceuticals and biologics; 11 years with Eli Lilly in sales, sales management, marketing, pricing, market research, and strategic planning; Director of US Women’s Health; led global launch and pricing for Prozac™ and other high-profile drugs; Founder, President, CEO, and Board Member, Hapten Sciences, Inc., developing novel, early-stage products that contribute to the well-being of people worldwide;
- James Robinson, Manufacturing and Regulatory Advisor—
Over 30 years of experience in pharmaceutical manufacturing, process development, and quality operations; Vice President, Technical Operations, Vaccines, Biologics and Sterile Manufacturing, Merck & Co.; featured in Life Science Leader Magazine in 2012 for transforming Merck’s approach to vaccine manufacture;
- Howard Schwartz, Legal Advisor – DLA Piper® USA LLP—
Over 20 years meeting the specialized corporate, commercial and transactional needs of growing companies; structures and negotiates mergers and acquisitions, complex collaborations, joint ventures, and financings for multinational bio-pharmaceutical and device companies; recognized in the 2016 edition of The Best Lawyers in America for the practice area of biotechnology;
- Nancy Clementi, MD, Medical and Regulatory Advisor—
Over 25 years across disciplines in the pharmaceutical industry, including promotional review and compliance, MSL strategies and issues, medical information/call centers, clinical research in all phases, medical marketing and product; held executive positions at Wyeth, including Vice President of New Products Marketing and VP Global Medical Communications within Global Medical Affairs; and,
- Kathy Lenhard, RN, Clinical Monitor—
Over 25 years in healthcare, with 22 years of clinical operations expertise for the pharmaceutical, biotechnology and medical device industries; led a clinical trial during the 2009 H1N1 pandemic in Mexico City, enrolling 4550 subjects in five months at one clinical site; co-authored publication in the July 2011 issue of Vaccine Journal.
They join CEO Solmon, who is Celavie’s lead investor and who also serves as CEO and Founder of multinational Sweet Street Desserts®; Oleg Kopyov, MD, PhD, Celavie’s Executive Vice President and Chief Scientific Officer; and Alex Kopyov, Vice President of Clinical R&D.
Celavie’s therapies use undifferentiated allogeneic pluripotent stem cells to repair and restore damaged tissues. Celavie and veterinary subsidiary Celavet Inc. use the latest technological breakthroughs to produce large banks of undifferentiated stem cells with uniform qualities utilizing closed-system bioreactors. The cells are grown in a specialized patented medium that allows them to maintain their sterility and genetic stability over the course of the manufacturing process. Celavie recently conducted the first-in-human trial of stem cells in Parkinson’s patients, with promising indications, and is now planning its Phase II clinical trials. Celavet is working to restore function in orthopedic conditions of large and small animals, with noticeable tissue repair observed in trials conducted on over 400 horses.