Contract Pharma

CONFERENCE KEYNOTE PRESENTER

Pete Stevenson - Pfizer Global Manufacturing

Mr. Stevenson, Vice President/Team Leader of the Established Products Business Unit of Pfizer Global Manufacturing, joined the company as leader of the Pharmacia CentreSource business. In 2003 he was appointed leader of the Pfizer CentreSource business following Pfizer’s acquisition of Pharmacia. In 2005 he was appointed to the position of Vice President/Team Leader, Contract Manufacturing / Procurement / Pfizer CentreSource. In 2008 he was appointed to his current position. Prior to joining the company, he was leader of the worldwide pharmaceutical ingredients enterprise at Rhône-Poulenc in France. Pete Stevenson is a member of the Worldwide Pharmaceutical Operations’ Established Products Leadership Team. He received a B.A. in Economics from Gettysburg College and a Master’s degree in Economics from Columbia University.

Mr. Stevenson will deliver the Conference Keynote, Global Pharmaceutical Outsourcing: Drivers and Trends, at 9:20 a.m. on Thursday, Sept. 25.

FDA KEYNOTE PRESENTER

Diana Amador-Toro - Food & Drug Administration

Ms. Amador-Toro is the Investigations Branch Director of the NJ District Office in FDA’s Office of Regulatory Affairs (ORA). She has operational and administrative responsibility for a professional and technical field staff of 70 located in three offices. Prior to that, she was the Science Branch Director in the San Juan District Office where she was responsible for formulating operating policies and procedures, dealing with the analysis of samples, and research and investigations at the San Juan District Laboratory. Ms. Amador-Toro received her B.S. degree from the University of Puerto Rico in 1982 and in 1983 joined the FDA as an Investigator in the Newark District Office. In 1990, she transferred to San Juan as a Drug Specialist and subsequently became the first Pre-Approval Manager for both Drugs and Devices in the field. She has over 24 years of field experience in investigations and compliance activities and has conducted GMP training in Argentina and England. Ms. Amador-Toro is a graduate of the Executive Potential Management Program and has been the recipient of several FDA Commendable Service and Group Awards for accomplishments in Compliance, Investigations and Laboratory activities.

Ms. Amador-Toro will deliver the FDA Keynote Address, Investigational Issues, at 8:30 a.m. on Friday, Sept. 26.

FDA KEYNOTE PRESENTER

Nancy Rolli - Food & Drug Administration

Nancy Rolli was recently appointed to the position of Director, Compliance Branch of the FDA’s New Jersey District. Previously, she served as the NJ District’s NDA/ANDA Pre-Approval Manager. Prior to that she was a Drug Specialist in the NJ District Office. Ms. Rolli specializes in Pharmaceutical Inspections of both sterile and non-sterile dosage forms, as well as Active Pharmaceutical Ingredient Manufacturers in the U.S. and at foreign facilities.

Ms. Rolli is an active member of the Foreign Inspection Cadre and the New Jersey District Drug Cadre. She also provides training to industry and FDA investigators in New Jersey District and at the Agency’s Drug School. Ms. Rolli is a Level II Performance Auditor; a member of FDA’s Pharmaceutical Inspectorate and has served as an Acting Compliance Officer, Acting Supervisor and Acting Director of Investigations Branch.

Ms. Rolli will deliver the FDA Keynote Address, FDA Inspections and Compliance Activities, at 2:15 p.m. on Thursday, Sept. 25.

BEST OUTSOURCING PRACTICES PANELIST

Keith E. Anderson, Ph.D. - Ocera Therapeutics, Inc.

Dr. Anderson, vice president, pharmaceutical sciences at Ocera, has more than 10 years of international experience working in the field of Pharmaceutical Sciences in Canada, the U.S. and Europe. He most recently held the position of senior director, Pharmaceutical Development at Ligand Pharmaceuticals where he was responsible for all aspects of CMC (chemistry, manufacturing and controls) for Ligand Development and Commercial products. He has had extensive experience in process and product development for small molecules and biologics covering a variety of dosage formats, including parenterals, oral solid dosage forms, topicals, sustained release dosage forms, and inhaled products.

Dr. Anderson’s background includes experience in managing all aspects of virtual drug product development through contract manufacturing operations from early-stage preclinical development through tech transfer and commercial process validation.

Dr. Anderson will participate in the Panel Discussion, Best Outsourcing Practices for Specialty, Virtual and Emerging Pharma and Biopharma, at 1:30 p.m. on Thursday, Sept. 25.

John Avellanet - Cerulean Associates LLC

Mr. 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 a leading expert 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™, covering regulatory trends and cost-effective quality and compliance tactics. Mr. Avellanet holds corporate workshops on QbD and Lean Compliance, and serves as an independent subject matter expert for his clients.

Mr. Avellanet will deliver his presentation, Designing a Risk Managed Supplier Selection and Qualification Program, at 9:05 a.m. on Friday, Sept. 26

Chris Driscoll - Tunnell Consulting

Mr. Driscoll, with executive experience in 19 countries, is an internationally recognized expert in the implementation of operational excellence. Prior to joining Tunnell as a principal consultant, Mr. Driscoll held a variety of positions at Amgen, including executive-level roles in Quality, Manufacturing and Operational Excellence. At Amgen he helped streamline operations at multiple sites, deployed improvement methodologies like Lean manufacturing, and through training programs helped create a culture of excellence. Previously, he redesigned and improved the performance of multiple fabrication plants at Phillips Semiconductors. He has also held consulting, training, and organizational development positions at P4 Management Solutions and ICAL, Inc.

Mr. Driscoll will deliver his presentation, Operational Excellence Cost Reduction, at 10:00 a.m. on Friday, Sept. 26

Joe Dugan - CapGemini

Mr. Dugan has more than 20 years of strategic consulting experience throughout the life sciences industry including pharmaceuticals, biotechnology, healthcare and medical devices. He continues to provide strategic services, transformation, organizational change and human capital management solutions across many of the global industry leaders. Additionally, his strategic assignments for the U.S. government -- within FDA, Department of Homeland Security (DHS) and U.S. Military -- include developing, piloting and implementing AIDC and RFID solutions for “Chain of Custody” and “ePedigree” along with working on the establishment and implementation of EPC and UID standards. Mr. Dugan is credited with establishing the DHS’ Global Benchmarking Center for Security and Trade; collaboratively pioneering the “Chain of Custody” secure supply chain international standards using Automated Identification and RFID Technologies. He has significant experience with ePedigree solutions andapplications across the industry. In addition, Mr. Dugan has successfully led global IT Strategy Transformation as well as implementations of SAP R/3, Oracle, Supply Chain and BI/BW solutions throughout the life sciences industry.

Mr. Dugan will deliver his presentation, E-Pedigree & Serialization Issues, at 11:10 a.m. on Friday, Sept. 26

BEST OUTSOURCING PRACTICES PANELIST

Mark J. Ginski, Ph.D. - Alba Therapeutics

Dr. Ginski is Senior Director of Product and Analytical Development at Alba Therapeutics Corp. He 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 pro- grams 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, establishing and leading Exploratory Pharmaceutics and CMC programs for various preclinical and clinical development programs.

Dr. Ginski will participate in the Panel Discussion, Best Outsourcing Practices for Specialty, Virtual and Emerging Pharma and Biopharma, at 1:30 p.m. on Thursday, Sept. 25.

Robert Handfield, Ph.D. - NC State University

Dr. Handfield is the Bank of America University Distinguished Professor of Supply Chain Management at North Carolina State University, and Director of the Supply Chain Resource Cooperative (SCRC). The SCRC is the first major industry-university partnership to integrate student projects into the MBA classroom in an integrative fashion, and has 15 major Fortune 500 companies participating as industry partners. Dr. Handfield is the editor- emeritus of the Journal of Operations Management and is the author of several books on supply chain management, the most recent being Supply Market Intelligence, Supply Chain Re-Design and Introduction to Supply Chain Management. He has co-authored textbooks for MBA and undergraduate classes including Purchasing and Supply Chain Management (with Robert Monczka) and Operations and Supply Chain Management (with Cecil Bozarth). He has consulted with more than 25 Fortune 500 companies, including GlaxoSmithKline, Freightliner, Boston Scientific, Delphi, Chevron, British Petroleum, Nortel Networks, Chevron Phillips, Lyondell Chemical, Conoco Phillips, FedEx, Milliken, and others.

Mr. Handfield will deliver his presentation, Supply Chain Management & Outsourcing to Asia, at 11:15 a.m. on Thursday, Sept. 25.

BEST OUTSOURCING PRACTICES PANELIST

James Haviland - Barrier Therapeutics

Mr. Haviland is vice president, Quality Assurance & Regulatory Compliance, at Barrier Therapeutics (a division of Stiefel Laboratories). He brings over 30 years of experience ranging from early stage development through commercial operations, as well as spanning large organizations and small virtual operations.
In his current position Mr. Haviland is responsible for oversight of international outsourcing programs for the manufacture and distribution of clinical supplies and commercial products; managing CMO qualification/surveillance, lab operations, and process validation activities.

Mr. Haviland will participate in the Panel Discussion, Best Outsourcing Practices for Specialty, Virtual and Emerging Pharma and Biopharma, at 1:30 p.m. on Thursday, Sept. 25.

Gary Messplay - Hunton & Williams LLP

Mr. Messplay is a Partner in the Washington, DC office of the international law firm of Hunton & Williams LLP, where he is head of the firm’s Food and Drug Practice. He represents clients before the FDA, Drug Enforcement Agency (DEA), and other federal and state agencies. Mr. Messplay’s practice includes litigation, liability counseling, regulatory and administrative law matters, criminal and civil enforcement matters, and transactional work related to pharmaceutical products.

Prior to joining Hunton & Williams, Mr. Messplay was in-house counsel at Eli Lilly and Co., where he had global legal and regulatory responsibility for the company’s top-selling pharmaceutical product with annual sales exceeding $3 billion. He has written extensively in the pharmaceutical area and is a frequent speaker on topics related to the development, marketing and sale of pharmaceutical products. He is a member of the Food and Drug Law Institute and the Drug Information Association. Mr. Messplay is the FDA Watch columnist for Contract Pharma.

Mr. Messplay will deliver his presentation, Regulatory Affairs in Drug Manufacturing, at 10:35 a.m. on Friday, Sept. 26.

BEST OUTSOURCING PRACTICES PANELIST

Ashleigh Palmer - Critical Biologics Corp.

Mr. Palmer is an experienced biopharma chief executive officer and strategy consultant who has raised money, done deals and built substantial value for investors. Following a successful industry career in strategic marketing and business development, Mr. Palmer founded the critical care, specialty pharma company INOtherapeutics, Inc. (subsequently acquired for $670 million). As president and CEO of that company, he led the development and commercialization of the orphan drug INOmax® for the treatment of hypoxic respiratory failure in full-term neonates.

In 2006, Mr. Palmer co-founded and seeded Boston-based Critical Biologics Corp. (CBC). CBC is currently developing a breakthrough biotechnology platform that promises to reduce the high mortality seen in end-stage renal disease patients on dialysis and high-risk critical care patients admitted to the ICU. CBC’s theranostic platform screens patients for life-threatening deficiencies in plasma gelsolin, a vital protective protein, and restores circulating levels by recombinant protein replacement. Mr. Palmer currently serves as CBC’s full-time president and chief executive officer.

Mr. Palmer will participate in the Panel Discussion, Best Outsourcing Practices for Specialty, Virtual and Emerging Pharma and Biopharma, at 1:30 p.m. on Thursday, Sept. 25.

MODERATOR

Frank Chrzanowski, Ph.D.

Dr. Chrzanowski has more than 30 years’ experience in the development of pharmaceuticals. He was employed by McNeil Pharmaceutical/The R.W. Johnston Pharmaceutical Research Institute for 20 years, where he managed the Preformulation/ Physical Pharmacy Laboratories. Frank was the founding manager of the Pilot Plant Laboratories at Therics, Inc., and has been a consultant to drug companies for seven years.

Dr. Chrzanowski specializes in CMC Development Issues, Pharmaceutics, Analytics, Writing and Reviewing Regulatory Documentation such as reports and sections of IND/NDA/ CTD filings and SOPs. He has served as an expert witness in U.S. and Canadian Pharmaceutical Patent Litigation, is the author of 18 published manuscripts and 12 abstracts, and has been an invited speaker to 15 symposia, seminars and courses dealing with pharmaceutical development issues.

He has a BS in Pharmacy, MS and Ph.D. in Pharmaceutics, all from the Philadelphia College of Pharmacy and Science. This is his second year as moderator of the Contract Pharma Contracting & Outsourcing Conference.

2008 Conference » Meet the Speakers