June 7, 2012

Webinar Series
Innovative Analytical Approaches to Expedite Product Development

Part 4: Accelerating to Phase I Clinical Trials for All Dosage Forms

Accelerating to Phase I Clinical Trials for All Dosage Forms

At the early stages of drug development, vast resources are necessary to produce large amounts of drug substance to develop a clinically-viable dosage form, generate sufficient long term stability, manufacture a cGMP clinical lot and supply the required stability study in order to dose fewer than 20 healthy subjects in a typical Phase I study. This webinar will discuss compounding at the clinic’s pharmacy as a means to accelerate development and minimize CMC development resources.

Discussions will include:

• Distinctions between cGMP manufacturing and compounding
• Pharmacy facility requirements
• Development of simple formulas and processes
• Review of minimum stability data requirements
• Reduced testing requirements for drug product batches
• Approaches for biologic drugs for systemic delivery
• Regulatory implications for Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) filings
• Case study comparing cost and timelines for compounding vs. GMP production

This webinar is Part 4 of a series on Innovative Analytical Approaches to Expedite Product Development.

• Chief Scientific Officers, Principal Scientists, VPs and Directors of Research and Development
• Chief Medical Officers, Medical Directors
• VPs, Directors of Technical Operations
• VPs, Directors of Purchasing

For large and medium pharma and biotech companies

William Schachtner directs activities involved in the development and testing of oral, injectable and inhalation drug products for PPD’s cGMP labs. He has more than 30 years’ experience in pharmaceutical product development and testing with an emphasis in inhalation technology. Schachtner’s extensive experience includes the development and testing of multiple inhalation products and the regulatory requirements for CMC packages for investigational new drug, new drug application (NDA) and supplemental NDA submissions.

Before joining PPD, Schachtner operated a pharmaceutical consulting company advising clients on pharmaceutical processing, quality assurance and regulatory issues. He previously served as a research scientist in the inhalation development group at 3M Drug Delivery Systems for nearly 25 years. There, he gained unique insights into the development, quality, and regulatory aspects of pharmaceutical product development while involved in the development of pressurized metered dose inhalers with oversight of all aspects of pharmaceutical development including formulation, product, and process development, manufacturing transfer, scale-up and commercial product support.

Schachtner earned a bachelor’s degree in biology with a minor in chemistry from the University of Wisconsin – Eau Claire. He is a member of the American Association of Pharmaceutical Scientists (AAPS), American Society of Quality and Respiratory Drug Delivery and is currently the secretary/treasurer of the Inhalation and Nasal Technology Focus Group of AAPS.

Eugene McNally, Ph.D., is executive director of PPD’s regulatory affairs group for global chemistry, manufacturing and controls (CMC). In this role, he provides pharmaceutical development consulting for small molecules and biologics, consults with PPD clients on drug substance and product issues and provides clients and PPD teams with regulatory affairs strategies to expedite CMC development work, filings and responses to agency questions. In addition, McNally works closely with PPD’s cGMP labs to add new capabilities and technologies to their service offerings.

Before joining PPD in 2009, McNally was founding partner and principal consultant for Pharma Development Concepts, where he provided consulting on drug development strategies to biotech start-up companies. His extensive experience also includes positions of increasing responsibility at Cardinal Health (now Catalent Pharma Solutions) culminating in the role of vice president and general manager. There, he directed a $12 million biologics active pharmaceutical ingredient (API) development business with a staff of 60 biotech development and clinical manufacturing scientists. Throughout his career, he has emphasized process improvement, utilizing Lean Six Sigma and Kaizen methods.

McNally earned a bachelor’s degree in pharmacy from Duquesne University, as well as master’s and doctorate degrees in pharmacy from the University of Wisconsin – Madison. His accomplishments also include a wealth of professional publications and presentations. He is a member of the American Association of Pharmaceutical Scientists, member of the scientific advisory board for the University of Wisconsin Lenor Zeeh Experiment Station, and adjunct professor for the university’s school of medicine.

PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 45 countries and more than 11,500 employees worldwide, PPD has conducted clinical trials in over 100 nations, and we have worked with all of the top 50 pharmaceutical companies.

PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs). Our cGMP laboratories provide fully integrated product and analytical development services ranging from early characterization through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. With more than 200,000-square- feet of cGMP laboratory space, we have locations in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., to meet our clients’ needs.

For more information, visit www.ppdi.com.