2009 Conference » Meet the Speakers


Pfizer Keynote Speaker



MacDara (Mac) Lynch, Vice President, Contract Manufacturing of Pfizer Global Manufacturing, joined Pfizer in 1972 as Shift Supervisor in the Citric Acid plant in Ringaskiddy, Ireland. While there, he spent 11 years in various technical, supervisory and managerial roles before transferring to the Pfizer European Headquarters in Brussels, Belgium in 1983. Mac returned to Ringaskiddy in 1984 and was Production Manager in the Organic Synthesis plant for two years. He moved to New York in 1986 and spent seven years working in the International Pharmaceutical division.

In 1993, he moved to Jakarta, Indonesia, where he was Country Manager for three years, during which time he was also Honorary Irish Consul for two years. In 1996, he moved to Lincoln, Nebraska as Site Leader. He was named Brooklyn Site Leader in 2000. In 2003, he became Vice President/Team Leader of the East Region and, in 2005, was appointed Vice President/Team Leader, U.S. East/Canada Region. In 2007, Mac became Vice President/Team Leader, Global Contract Manufacturing. Mac graduated from University College Cork in Ireland with a B.S. in Chemistry.


Day 1 FDA Keynote Speaker



Dr. Ali Afnán is senior staff fellow at FDA, Center for Drug Evaluation and Research (CDER), and the Office of Pharmaceutical Science (OPS). He was a regulatory policy author and advisor to the OPS director involved in the drafting of guidance documents on Process Validation and PAT. Previously, he worked at AstraZeneca as a senior technologist in the Pharmaceutical Engineering Department, where he was designer and project manager of the PAT implementation in what is believed to be the first PAT manufacturing facility in the pharma industry.

He has received a number of awards and citations during his career, including the FDA Commissioner’s Special Citation, CDER Center Director’s award for Team Excellence, and CDER's Scientific Achievement Award for Outstanding Intercenter Scientific Collaboration. Dr. Afnán received his Ph.D. in Instrumentation for Analytical Science at University of Manchester and his B.Sc. in Applied Chemistry at Cardiff University / Prifysgol Caerdydd.


Day 2 FDA Keynote Speaker



Douglas Kovacs is an investigator with the US Food and Drug Administration, New Jersey District and started with the agency in 1996.  He conducts drug GMP, pre-approval and postmarketing adverse drug experience inspections domestically and internationally.  Mr. Kovacs is also involved with FDA’s Drug Investigator Certification Program.


John Avellanet is a former Fortune 50 subsidiary C-level medical device and biotechnology executive where he created, developed and ran his company’s Records Management and Information Technology departments.  Throughout his corporate career, he has been personally accountable for regulatory compliance, product development and trade secret protection.

In 2006, Mr. Avellanet founded his independent consultancy, Cerulean Associates LLC, and has since become one of the leading experts on Quality by Design and lean, risk-based compliance. His articles have been syndicated and translated into multiple languages in Europe and Asia.  He is the regular compliance columnist for the Journal of Commercial Biotechnology and publishes a monthly newsletter, SmarterCompliance™, read by executives around the world as a way to keep up to date on regulatory trends and cost-effective quality and compliance tactics.

Mr. Avellanet holds corporate workshops on Quality by Design and Lean Compliance, and serves as an independent subject matter expert for his clients, helping them achieve compliance and profitability through his blend of practical guidance and cutting edge insight.


Chris Driscoll is a former Amgen Director with experience leading Quality, Manufacturing and Operational Excellence at Amgen locations in RI, CO and the headquarters in Thousand Oaks, CA. Prior to entering biotech, Chris led organizational effectiveness within a major semiconductors manufacturer, where he was charged with turning around the performance of underperforming facilities. In addition to his industry experience Chris has worked as a management consultant across industries in 19 countries. He is currently Principal Consultant at the Driscoll Consulting Group and this summer he published his first book, Managing the Core: Business Management in the New Economy.


Mark J. Ginski Ph.D. is Senior Director of Product and Analytical Development at Alba Therapeutics Corporation.  Dr. Ginski is an accomplished scientist with extensive experience in small molecule and peptide development spanning from early drug discovery through preclinical and clinical product development.  His experiences include lead candidate selection, preformulation and formulation development, development, transfer and validation of analytical and bioanalytical methods, and packaging, labeling and distribution of clinical trial supplies. Prior to joining Alba Therapeutics, he worked for Shire Pharmaceuticals Group where he played an integral role in developing and implementing Shire’s Proscreen and Optiscreen programs designed to facilitate lead candidate selection and product development for both Shire’s products as well as product from partnering companies.  Prior to his experience at Shire, he also spent several years at Guilford Pharmaceuticals, responsible for establishing and leading Exploratory Pharmaceutics and Chemistry, Manufacturing and Controls (CMC) programs for various preclinical and clinical development programs.

Dr. Ginski holds a Ph.D. in Pharmaceutical Sciences from the University of Maryland School of Pharmacy and a Bachelors Degree in Biological Sciences from the University of Maryland.  He has published numerous peer reviewed research and development papers and is an inventor for numerous global patents.


Bonni Kirkwood is the Northeast Lead for the Secure Value Chain service line of Deloitte's Life Sciences and Manufacturing Operations practice. Ms. Kirkwood has more than 17 years of consulting experience, including strategic planning and implementation of emerging technologies in the pharmaceutical and retail industries. She has assisted clients in developing international and domestic strategies to reduce their manufacturing risks and improve their supply planning, manufacturing, distribution and associated business processes. Ms. Kirkwood has been actively involved in serialization strategy development and prevention of counterfeit/gray market and illicit global activities and is an active member of the GS1 Healthcare and EPCglobal User Groups. Ms. Kirkwood is a registered Professional Engineer in California and holds and MBA from the University of San Francisco with a BS in Civil Engineering from Penn State University.


Michael A. Martorelli is a Director at the investment banking firm Fairmount Partners. In addition to participating in Fairmount's healthcare industry investment banking activities, Mr. Martorelli contributes to the firm's marketing and business development efforts with periodic industry reports and conference presentations. For most of the past decade, he has focused those writing and speaking efforts on pharmaceutical services companies, including those providing tools and technologies used in pre-clinical and clinical research functions. He has participated in conferences and similar programs covering varied outsourcing topics and sponsored by the Drug Information Association (DIA), the Association for Clinical Research Professionals (ACRP), the Tufts Center for the Study of Drug Development (CSDD), and other organizations. In addition to speaking, he has written for publications such as Contract Pharma, Dorland's Medical and Healthcare Marketplace Guide, Pharmaceutical Executive, and Clinical Research and Regulatory Affairs.

Mr. Martorelli came to Fairmount Partners after serving as Managing Director of Research and senior health care analyst at Investec Inc and its predecessor, PMG Capital. Prior to PMG Capital, he spent more than 10 years at Janney Montgomery Scott as a research analyst covering companies in various segments of the health care industry. Mr. Martorelli received both a BS in Business Administration and a Masters in Business Administration (MBA) from Drexel University. For the past several years he has taught graduate investment courses as a member of Drexel's adjunct faculty. He is a Chartered Financial Analyst (CFA) and a member of both the CFA Institute and the CFA Society of Philadelphia.


As a Contract Manufacturing Manger for Amylin, Cindy McNab is responsible managing the relationship between Amylin and one of its Contract Service Providers (CSP). Although the Contract Manufacturing Manager role is primarily intended to manage the relationship of commercial activities, Ms. McNab has led a cross-functional team through the late-stage development process including scale-up and process validations.

Ms. McNab has a degree in Chemical Engineering and started her career in pharmaceuticals as a production supervisor at Hospira’s manufacturing site in Austin, Texas. Prior to Amylin she worked in the Contract Manufacturing department at Hospira’s manufacturing site in McPherson, KS, supporting multiple customer projects for both clinical and commercial products. She has experience with both large and small volume parenteral manufacturing, clinical and commercial products, as well as both sides of the contract manufacturing relationship.


Deirdre Ogorzalek has nearly 20 years of international experience in the pharmaceutical industry, with a focus on the clinical supply chain. As Senior Director at Celgene, she provides strategic leadership for the global operation of the entire investigational material supply chain, ensuring that a full continuum of services exists to respond to clinical development program needs. Working as a key member of the Celgene senior management team, Ms. Ogorzalek proactively develops global cross-functional strategies, programs and policies to ensure the continued success of the corporation. She joined Celgene in 2004, utilizing her clinical supply management experience and her 10 years spent in drug product development to create and establish a global organization that handles the forecasting and planning of manufacturing, packaging, labeling, distribution and IVR services.

Prior to Celgene, Ms. Ogorzalek held several positions of increasing responsibility at Schering Plough, American Cyanamid and Eli Lilly.  She holds a B.S. in Biology and a B.S. in Chemical Engineering from Rensselaer Polytechnic Institute and a Master’s in Chemical Engineering from New Jersey Institute of Technology.  


Rachael Zuckerman is a research analyst at the Tufts Center for the Study of Drug Development, focusing primarily on R&D outsourcing and management. Her most recent research has covered the affects of mergers and acquisitions on pharmaceutical development and internal resourcing for drug development. She is currently an MPH candidate at the Tufts School of Medicine with a concentration in biostatistics and epidemiology.



More speaker bios coming soon!


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