| Mark Boulding |
Mark Boulding is the Executive Vice President & Chief Legal Officer of PTC Therapeutics, Inc., a privately-held biopharmaceutical company located in South Plainfield, NJ. His responsibilities include negotiation of licensing arrangements, business development transactions, and grant agreements, interactions with the government and universities on technology transfer and contracting matters, development and management of PTC’s intellectual property portfolio, and management oversight of the finance, legal, quality assurance, regulatory and human resources departments and related functions. |
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Prior to working for PTC, Mr. Boulding was the General Counsel and Executive Vice President, Government and Regulatory Affairs of MedicaLogic/Medscape, Inc., a publicly-traded company offering healthcare software and information products to physicians and consumers. He joined MDLI following its acquisition in 2000 of Medscape, Inc., where he was also General Counsel and Vice President, Regulatory Affairs. Before Medscape, Mr. Boulding was a law firm partner in private practice in Washington, DC specializing in healthcare and technology law, with a focus on pharmaceutical, biotech, and high-tech companies. He is a member and past chair of the BIO General Counsels’ Committee. Mr. Boulding received his J.D. from the University of Michigan and his B.A from Yale College. He is admitted to practice law in New York State and the District of Columbia, and has a limited in-house license to practice law in New Jersey. |
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| Maria Hardin |
Maria Hardin has more than 26 years of experience in the non-profit sector, building and managing more than 40 medication patient assistance programs and eight Expanded Access Programs, two of which were for ALS therapies. Since her retirement as vice president of patient services with the National Organization for Rare Disorders (NORD) in 2010, she now works with JF Campbell Consultants. Clients include the pharmaceutical and biotech industries, non-profit health organizations, and specialty pharmacies. Her expertise is in strategic planning and business development of drugs and biologics, with emphasis on collaborating with the industries in developing sound EAPs for experimental therapies. Ms. Hardin has participated in numerous round tables for the purpose of encouraging an open dialogue among patient advocates, researchers, pharma/biotech industry leaders, and officials from the FDA. |
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| Ronald Marchesani |
Ronald Marchesani is vice president and director of quality assurance at Onyx Pharmaceuticals. His organization is responsible for the Global Release and Quality oversight of clinical and commercial drug products for oncology. The Quality organization is responsible for GxPs (GMPs, GCPs, GLPs) and OE (Operational Excellence) for the Global R&D organization. |
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Mr. Marchesani has also held various Quality leadership positions with several biologics and biopharmaceutical companies. He has worked on key novel products, including pandemic flu, the 2nd generation smallpox vaccine, and the first therapeutic treatment for Type I Gaucher disease, Ceredase. Ronald has been invited as a speaker at numerous events and has spoken on topics dealing with diverse Regulatory GMP expectations during product development, regulatory inspections and GMP compliance audits. |
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| David Rosen, PhD |
Dr. Rosen has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries and has served on the management teams for both public and private companies for the last 15 years. His experience covers both research and development, including preclinical development, CMC, and project management. His projects have covered the spectrum from discovery of novel therapeutic candidates through completion of phase 3 clinical trials in both the US and Europe. Therapeutics developed have included small molecules, synthetic peptides, and recombinant proteins. |
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Dr. Rosen began his career at Collagen Corporation, a medical device company, where he held scientific and project management positions working on orthopedic and soft tissue augmentation programs. His career continued with Celtrix Pharmaceuticals after it spun off from Collagen Corp enabling him to expand his experience in the CMC and facilities areas. He then spent approximately 3 1/2 years at Hyseq Pharmaceuticals where, as Vice President of Operations, he had responsibilities for preclinical development, CMC, and facilities before moving to Acologix Inc. as Sr. Vice President of R&D. Dr. Rosen received his Ph.D. in biochemistry at the University of California, Riverside |