Peter E. Smith, PhD, CEO & President
Dr. Peter E. Smith brings 35 years of drug development industry experience to his role as CEO and President of Keystone Biologics. His career is filled with diverse clinical and non-clinical research, regulatory affairs, and quality assurance experience for more than 50 multinational pharmaceutical manufacturers including AstraMerck/Astra Zeneca, Aventis Behring/CSL Behring, Omnicare Clinical Research, Centocor and SmithKline and French as well as start-up companies. Pete is experienced in advancing both drugs and biologics to market, including the clinical development of cimetidine, the clinical and quality development of infliximab (Remicade) and abcixmab (ReoPro), and clinical experience with a plasma-derived IgG protein administered subcutaneously to patients with primary immune deficiency. He earned his PhD in Pharmaceutics from Temple University and is now at Adjunct Professor at Temple’s School of Pharmacy.
I have a true passion for science, particularly the promise of biologics in providing therapies to those suffering with chronic disease, and for the regulatory approval process, that drive our company’s foundation to provide the best science possible to ensure the highest standards of care, effectiveness, and patient safety.”
Research Quality Assurance, Inc.
Research Quality Assurance, Inc., offers more than four decades of industry experience in pharmaceutical regulatory affairs. These experts have most recently provided client consulting services including drug development planning, strategic assessment, submission while supporting dossier planning, execution, and maintenance. The team also has extensive therapeutic area expertise in oncology, immunology and antiviral drugs, and has conducted regulatory agency meetings with both CDER and CBER providing agency liaison services for domestic and international pharmaceutical companies.
Mary Anne Myers, PhD, Chief Science Officer
Dr. Mary Anne Myers is a medical anthropologist with 30 years of program management, research, and evaluation experience. She is highly experienced in pharmaceutical research, supporting site monitoring and quality assurance activities for major pharmaceutical firms including Astra Merck and AstraZeneca. Mary Anne also has significant experience in directing and evaluating federal research grants. She earned her PhD from Temple University.
Carl Friedman, MD, ABIM – Gastroenterology, Chief Medical Officer
Dr. Carl Friedman, Board Certified in Gastroenterology, has expertise in inflammation, tissue repair, and oncology. He offers Keystone Biologics more than 25 years of research experience with multiple sponsors including CSL Behring, GlaxoSmithKline Pharmaceuticals, and SmithKline Beecham Pharmaceuticals, SmithKline & French Laboratories. He received his MD from the University of Kentucky.
Harry Citrino, Esq., CPA, Legal Affairs and Finance
Harry Citrino heads the legal affairs and finance functions for Keystone Biologics. He has more than 35 years of legal experience, including patent expertise, and has been a certified public accountant for more than 40 years. Harry earned his JD degree from Widener University and became a member of the Pennsylvania Bar Association in 1997.