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Invited Speakers:
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Lani Cammack, director GPRA CMC, Abbott Laboratories, has more than 20 years of experience supporting CMC activities in a variety of roles at Abbott Laboratories. Her previous responsibilities at Abbott include tenures in pharmaceutics, dissolution method development/validation and technical operations support to Abbott’s analytical laboratories. Cammack’s six years of CMC regulatory experience have been primarily focused in registering products in ex-US markets, supporting postapproval manufacturing changes in all markets and most recently, supporting integration activities resulting from acquisitions and other business alliances.
Lynn Gold, PhD, vice president, CMC Services, Camargo Pharmaceutical Services, has more than 20 years experience in the pharmaceutical industry. Gold began her career in R&D for Fresenius Kabi (formerly Pharmacia and Pharmacia & Upjohn), managing over 60 programs in various stages of development for a variety of external clients in the US and EU. The dosage forms were typically emulsions and the therapeutic areas ranged from nutrition, oncology, CNS, cardiology, ophthalmology to hematology. Gold joined Warner Chilcott Laboratories managing pharmaceutical development in woman’s heathcare and dermatology involving the preparation of several 505(b)(2) submissions for tablets and capsules. She joined Sonus Pharmaceuticals as VP of Research and Process Development in 2004 where she managed the oncology development program for intravenous emulsion products, primarily consisting of 505(b)(2) submissions. Gold earned a BS in chemistry from SUNY at Buffalo and a PhD in physical organic chemistry from the University of Rochester, followed by postdoctoral studies in chemistry at Duke University.
Deanna Murden, president, ePharmaCMC LLC, has more than 18 years of drug development and regulatory experience in the pharmaceutical industry. Murden’s experience includes global drug development strategy, regulatory Chemistry, Manufacturing and Controls (CMC), and lead health authority liaising for major product approvals worldwide. Murden is actively engaged in regulatory policy and is an industry leader on strategic aspects of eCTD standards and practices for CMC dossier management and compliance, bringing a holistic view to organizational operations and management of complex CMC storage and retrieval data systems. Murden is a graduate of two executive education programs from the University of Michigan’s Ross School of Business.
Edward Narke, MS, founder, Design Space InPharmatics (DSI), has more than 12 years of progressive drug development experience in regulatory affairs, manufacturing, quality assurance, and engineering with active pharmaceutical Ingredients, oral, parenteral and inhalation drug dosage delivery forms, and Biologics (Enbrel®). Narke has authored 100+ regulatory submissions and the clinical trial applications for multiple compounds in various therapeutic areas such as oncology, cardiovascular, anti-inflammatory and pain (Phase 1 - Phase 3). He has held regulatory affairs positions of increasing responsibility at YM BioSciences Inc, Wyeth Pharmaceuticals, and Lonzagroup Inc. Narke holds a BS in chemistry from the University of Pittsburgh and an MS in organic chemistry from Villanova University.
Andrew Papas, RAC, PhD, MBA, senior director for CMC global regulatory affairs, Shire HGT, has over 30 years of diverse experience in global regulatory affairs, quality assurance, CMC biotechnology, analytical sciences, chemical technology, QbD and chemometrics. Papas began his career as a chemist for the US FDA for 11 years with experience in: pharmaceuticals (CDER), NDA/ IND/ANDA reviews, radiopharmaceutical NDAs' and environmental monitoring (CDRH), radiation emissive medical devices and radiation health physics, food nutrition and radiation exposure survey (CFSAN), imported foods, pesticide monitoring programs, computer automation, and graduate education in chemometrics. He currently leads a global CMC RA group responsible for CMC regulatory strategy and life cycle management of Shire’s portfolio of biotech enzyme replacement therapies and orphan diseases. The portfolio consists of 4 commercial products that have received global approval spanning 45 countries with many development products in phase 0 to pre-BLA. Papas also served as associate director at Wyeth, consultant for Sepracor, and senior manager overseeing Polaroid’s organic and inorganic analytical laboratories in R&D and Pilot facilites. Papas’ experience spans portfolios of large and small revenue commercial and promising clinical biotech products with complex supply chains involving many corporate partners and contractors.
Ken Phelps, president, CEO and co-founder of Camargo Pharmaceutical Services, has more than 30 years of experience in the health science and services industry. He began his career synthesizing, characterizing and performing drug metabolism studies of potential carcinogens with the Eppley Center for Research in Cancer. Turning his focus to medical devices, he established a laboratory and started up the manufacturing of sterile blood collection tubes. Phelps then joined Merrell National Labs (which evolved into Aventis) directing a group developing new test methods, then as head of the several multi-national quality control laboratories. With the merger into Merrell Dow he assumed global responsibility for quality assurance, quality control and processing technology with an assignment based in Milan, Italy. Later he directed IT for multi-national manufacturing operations leading technical improvements across R&D, Accounting and Manufacturing Operations and integration of technologies with Dow Chemical. Utilizing this broad background, he joined Duramed Pharmaceuticals (now Barr Pharmaceuticals) with executive-level assignments in quality control, regulatory, project management and clinical and medical affairs where he served as a liaison to sales & marketing. Phelps has a BS in chemistry from the University of Nebraska.
Ambarish K Singh, PhD, associate director, global regulatory sciences-CMC, Bristol-Myers Squibb Co., holds a PhD in organic chemistry from the State University of New York at Stony Brook. He served as a postdoctoral fellow at Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York. Singh started his industrial career by joining the process research and development department of Bristol-Myers Squibb and contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol, Baraclude and Onglyza. He has published more than 25 scientific articles and holds six patents. During his career in process research and development, he has given more than 16 invited talks at universities, overseas pharmaceutical companies and professional conferences organized by American Chemical Society, Scientific Update, Association for Lab Automation and Cambridge Healthtech Institute. In 2007, Singh transitioned into Global Regulatory Sciences-CMC department, where he is an associate director and responsible for providing regulatory-CMC guidance and strategies for projects that are in development. He has interacted with FDA, EMA, and Health Canada on CMC questions related to QbD/PAT/RTRT strategies (Quality-by-Design/Process Analytical Technology/Real Time Release Testing). Singh has given several talks on QbD/PAT/RTRT within the company and recently at a conference organized by TUFTAD (Turkish Pharmaceutical Technology Scientists Association).
Tracy Verciglio is associate director, Abbott Global Pharmaceutical Regulatory Affairs, CMC. In this role, she has supported both marketed products and development compounds in multiple therapeutic areas. She holds a Bachelor’s degree in chemistry from the University of Illinois at Urbana-Champaign. Verciglio joined Abbott in 1996 as an analytical chemist, and has held a variety of positions in quality, and manufacturing and technical support prior to joining regulatory affairs in 2007.
David Ziering, PhD, director, regulatory CMC, Bristol-Myers Squibb Co., has worked in the pharmaceutical industry for 23 years, including seven years in analytical laboratories and 16 years in Regulatory CMC (Chemistry, Manufacturing and Controls). Prior to joining Bristol Myers Squibb Co. in 2001, Ziering developed his pharmaceutical craft with stints at Hoffman LaRoche, Sanofi Aventis, Johnson & Johnson and Baxter Healthcare. Currently, he leads a team of CMC regulatory professionals as a department director with an emphasis on development, registration and life cycle management, and represents CMC on the firm’s Genotoxic Impurities Advisory Committee. Ziering has been an invited speaker on CMC topics at professional conferences including those organized by RAPS, American Association of Pharmaceutical Sciences (AAPS), Institute for International Research (IIR), Cambridge Healthtech Institute (CHI), and International Pharmaceutical Academy (IPA). Ziering holds a BS in chemistry from Seton Hall University and received a PhD and postdoctoral fellowship from Princeton University.
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