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.
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.
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).
Chand Sishta, PhD, RAC, senior principal scientist, Global CMC, Pfizer Incorporated, received his PhD in inorganic chemistry from the University of British Columbia, and a post-doctoral fellowship at Northwestern University. His first eight years in industry were spent in a chemical company (Union Carbide) as a discovery scientist and a catalyst scale-up scientist, leading to a role as regulatory manager for food and drug focused business areas. Next, Sishta spent five years in quality assurance at Bristol-Myers Squibb, specifically in the new product development arena, providing quality assurance support for analytical, biologics, formulation and clinical supplies. In his current role at Pfizer, Inc., with Global CMC the product mix supported includes products from proof-of-concept through post-approval, varied therapeutic areas and dosage forms. His work includes internally-developed products as well as those that are in-licensed, and he also performs due diligence activities for new in-licensing opportunities. Sishta is currently in a secondment to Pfizer Supply Chain, supporting generics filings worldwide.
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.
