Program

NCB 2013 Final Program

Program Details


Short Courses – (choice of one)

Short Course #1:

Strategies for Accelerating Formulation Development
Ronald D. Snee, PhD
Snee Associates,LLC
Newark, Delaware
Ron@SneeAssociates.com

The life sciences industries are going through tremendous changes that have been increased by the recent global financial challenges. In order to help pharmaceutical and biotech companies improve their operations, the FDA is promoting the use of Quality-by-Design (QbD).  Much work has been done on the QbD concept of a “design space” from a manufacturing process perspective but little has been done on using QbD in formulation development including the development of formulation design spaces. Formulation studies typically involve the optimization of multiple ingredients including the API, lubricants, binders, disintegrants, etc. Such optimization can be seen as a difficult challenge when a large number of components are involved which the case is typically.

A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.  The issues addressed include the following:

  • The unique characteristics of formulation development and optimization
  • Definition of the region of possible formulations
  • Formulation strategies and designs for data collection
  • Models for formulation prediction and optimization
  • Design space construction and associated risk analysis
  • Creating formulations with component constraints
  • Guiding principles and tips and traps

Workshop Leader: Ron Snee, MS, PhD

Ron Snee is Founder and President of Snee Associates, LLC , a firm dedicated to the successful implementation of process and organizational improvement initiatives. At Snee Associates he provides guidance to pharmaceutical and biotech senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results.  Ron has recently authored several articles on how to successfully implement QbD, coauthored 2 books on tools of QbD and speaks regularly at pharmaceutical and biotech conferences and meetings on the subject. He is also an Adjunct Professor in the Temple University School of Pharmacy and the Rutgers University Pharmaceutical Engineering Program. He worked at DuPont for 24 years prior to starting his consulting career.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.  He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science.  He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture Award as well as numerous other awards and honors.  He is a frequent speaker and has published 5 books and more than 235 papers in the fields of quality, performance improvement, management, and statistics. His presentations were recently recognized with the Institute of Validation Technology’s Speaker of the Year Award.

Short Course #2:

Bayesian Statistics
Bruno Boulanger

Objectives:

  1. To present the main Bayesian concepts and some theoretical results.
  2. To illustrate Bayesian methodology applied to nonclinical pharmaceutical projects.
  3. To show how to move from a ‘p-value’ based decision making process to a prediction based one.
  4. To discuss the standard Bayesian software.

Dr. Bruno Boulanger, CSO, Company co-founder, Managing Director of Arlenda Inc.

Bruno Boulanger holds a PhD in Experimental Psychology from the University of Liège. After a post-doctorate at the Université Catholique de Louvain (Belgium) and the University of Minneapolis (USA) in Statistics applied to simulation of clinical trials, he joined Eli Lilly in Belgium in 1990. Since then, he gathered 20 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. After being the Head of European Early Phases within Eli Lilly driving an European-wide team, Bruno joined UCB Pharma as Director of Exploratory Statistics, contributing the implementation of Model-Based Drug Development strategy and applied Bayesian statistics. Bruno is also since 2000 Senior Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and statistics. He organizes or contributes since 1998 to Non-Clinical Statistics in Europe and setup in 2010 the First Applied Bayesian Statistics conference. He is also a USP Expert, member of the Committee of Experts in Statistics. Bruno has authored or co-authored more than 70 publications in applied statistics.