AUSTIN, Texas (PRWEB) June 26, 2018
HCell Inc. (HCell) announced today that Robert P. Ryan Ph.D. and Marlene Haffner, MD, MPH have been appointed to its Board of Directors. HCell is a biotechnology company based in Austin, Texas focusing on treatment solutions for Alopecia Areata in the Pediatric Population.
“We are pleased to announce that Dr. Ryan and Dr. Haffner have joined Board of Directors of HCell Inc.,” stated HCell’s CEO, William Jang. “Their combined expertise in orphan drug development within the dermatology field and experience navigating the Food and Drug Administration (FDA) regulatory processes will be instrumental to HCell as we continue to test, refine, and bring our products to the market,” continues Jang. “Not only do we look forward to their guidance over our future strategic decisions but also to their inspiration as we continue to challenge and push ourselves in the advancement of science.”
Robert Ryan Ph.D. has more than 27 years of research, pharmaceutical and biotech experience, spanning the global development process from preclinical through Phase 4 trials. He currently serves as President and CEO of Innova Therapeutics. Prior to Innova Therapeutics, Dr. Ryan was the President and CEO of Scioderm, a company he co-founded in 2013. Dr. Ryan led the development of SD-101, a topical therapy for Epidermolysis Bullosa, progressing from pre-IND stage to an ongoing single Phase 3 US/Europe registration study in less than 2 years. Scioderm was the first biotech company to receive “Breakthrough Therapy” designation from the FDA. In September 2015, Dr. Ryan led a deal to sell Scioderm to Amicus Therapeutics, with upfront payments and milestones totaling approximately $957 million. Prior to Scioderm, LLC, Dr. Ryan held senior regulatory positions at three leading CRO’s, PPD, INC Research, and Quintiles where he also served as the Chief Regulatory Officer for Quintile’s very successful PharmaBio division.
Marlene Haffner MD, MPH is the Founder of Haffner Associates, LLC, established in 2009. Prior to this venture, she was the Director of the Office of Orphan Products Development at the FDA for 20+ years. During her tenure in that program, it grew to become the top orphan products program in the world. In addition to assisting in the development of more than 300 products in the US, Dr. Haffner is credited with assisting in the development of programs throughout Japan, the European Union, Australia, and beyond. Her extensive speaking engagements and academic publications coined the term “orphan products” within the pharmaceutical community. “Having worked with Marlene previously, and knowing her extensive experience in orphan product development, Marlene will bring significant value and contributions to the HCell’s Directory Board as we move forward and make HCell a significant success,” said Dr. Ryan.
Trained as an internist, hematologist and dermatologist, Marlene Haffner MD, MPH graduated from the George Washington University School of Medicine and pursued further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine in New York City. She received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore. Following her tenure at FDA and prior to forming Haffner Associates, Dr. Haffner served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world.
“Marlene and I are joining the Board of Directors of HCell and will provide HCell with development and regulatory insights that will advance the orphan product HC017AA for the treatment of Alopecia Areata in the pediatric population and also other therapeutic opportunities within HCell’s portfolio,” said Dr. Ryan. “I look forward to working the Board and Management of HCell and to support the company in the realization of its mission and objectives for its lead product HC017AA,” noted Dr. Haffner. “I am confident my experience and perspectives in the orphan drug development space can contribute to ensuring the rapid and successful development of this exciting program.”
About HCell Inc.
HCell Inc. (HCell), a biotechnology company based in Austin, Texas, focusing on treatment solutions for Alopecia Areata in the Pediatric Population. It recently obtained from U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) of HC017AA for the treatment of pediatric patients with Alopecia Areata, a devastating hair loss disease.
HCell is also working on initiating regulatory steps for HC0100, which comprises proprietary composition and procedure for the treatment of Androgenic Alopecia conditions in both men and women. Furthermore, HCell is planning pre-clinical development with the intent to launch a human clinical study in the United States. For more information, please visit http://www.hcell.net.
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