PHARMICA Consulting Presents:

R&D Operational Excellence Workshop 

Operational Excellence is about consistently producing value for customers in a cost effective manner. Achieving it is a continuous process which requires constant tweaking based on economic forces and competitive pressures. This workshop will help clinical and R&D professionals better understand how to achieve Operational Excellence in a life science R&D environment thereby streamlining operations, increasing productivity and compliance, and facilitating collaboration with internal and external partners.

Register today and join other pharmaceutical professionals as they provide a variety of real-life case studies describing what they are doing to achieve Operational Excellence and share their best practices and lessons learned.

Workshop Agenda

8:30   Morning Coffee & Registration

9:15     Conference Director’s Welcome & Opening Remarks

Greg Cohee, PHARMICA CONSULTING

9:30     Keynote:  Trends Changing the Pharmaceutical Industry and Strategies to Achieve Operational Excellence

Considered an expert on R&D management, global outsourcing, process optimization, clinical protocol improvement, and ECT solutions adoption, Ken Getz will discuss some of the key trends and strategies that pharmaceutical companies are implementing to achieve Operational Excellence in today’s rapidly changing environment.  Mr. Getz worked for over seven years in management consulting, where he assisted biopharmaceutical companies in planning and implementing drug development strategies.  Currently, he is a senior research fellow at the Tufts CSDD as well as the founder and chairman of CISCRP, the founder and former CEO of Center Watch and serves on the Clinical Trials Transformation Initiative board of directors.  Ken is also on the editorial boards of the DIA Journal, Controlled Clinical Trials and Research Practitioner and writes a regular column for Applied Clinical Trials.   

Ken Getz M.B.A., Senior Research Fellow, TUFTS CSDD

10:30   Vendor Performance Management - The Importance of Metrics

Prior to being acquired by Pfizer, Wyeth implemented a vendor management initiative that used metrics to measure vendor performance and partnerships.  During this session, the following topics will be discussed.

·   Establishing the right vendor partnership/relationship

·   Setting metrics for measuring and managing effective supplier performance 

·  How the vendor relationships should be measured over time

Dianne C. Kikta, PhD, MBA, Vice President, Global Clinical Strategic Resourcing 

Pfizer

11:15   Networking & Refreshment Break

11:45   Utilizing Kaizen to Improve Clinical Processes in a Matter of Days & Weeks Rather Than Months & Years  

           This session will explore how Merck applied Kaizen to its clinical research operations and transformed key processes more quickly and effectively then was ever possible with more traditional approaches.

David Rodin, Lean Six Sigma Master Black Belt, Director Global Clinical Research Operations

Dr. Hassan Ansari, Head of GTO Coordination and Administration 

 MERCK 

12:30   Lunch & Networking

1:45    Accelerating Clinical Development Through Integration of BPM, Six Sigma,

           and Critical Chain

           Business Process Management (BPM), Six Sigma, and Critical Chain Project Management are all improvement methodologies that are capable of delivering significant business value to their respective practitioners. Even greater breakthroughs are possible when these three methodologies are integrated and focused on driving cycle time improvements. This presentation speaks to Lilly's early efforts at applying these approaches within their clinical development organization. 

 Terry L Endress, Senior Director and GPD Six Sigma Champion,Clinical Development,

Eli Lilly & Company

2:30        Operational Excellence in Drug Discovery - Science & Systems

J&J Pharma is a matrix organization with Therapeutic Areas (TA) and Centers of Excellence collaborating to deliver transformational patient solutions. Within the Immunology TA, the Research division is responsible for identifying innovative therapeutic mechanisms and partnering to discover & develop drugs. To manage this complexity we, the Strategy & Business Planning team, have developed a series of core processes that manage the day-to-day scientific activities across a variety of portfolio’s, from target identification to clinical development, and we are now using the SharePoint infrastructure to provide centralized and standardized views. This presentation will exemplify the core processes that are now housed in SharePoint and discuss how to balance operations and science without inhibiting the innovation that is essential within a Research function.

            Mark Cunningham, Assoc. Director, Strategy & Business Planning, Research Immunology,

J&J R&D

3:15    Networking & Refreshment Break

3:45       R&D's Operationally Excellent Adventure

In today’s environment, most companies are looking for new ways of doing business.  In order to hit internal performance and external financial targets, many executives are looking to significantly change their operational strategy.  For this to happen, companies must first reach for that elusive goal of operational excellence.  This session will discuss the hardships that exist on the journey to excellence and why the trip is necessary in the first place.  The session will focus on the real meaning of operational excellence, the obstacles that most companies face, and sensible approaches to getting started and reaching the ultimate goal.  By helping attendees understand both the rewards and challenges associated with bringing about operational excellence, this session will give attendees actionable knowledge to go forth and improve their companies’ bottom lines.

Eric Lake, Partner, PHARMICA CONSULTING

4:30     Meeting Closeout and Parting Words

4:45     Cocktail Reception (Until 6pm)

For more information about this workshop or if you are interested in speaking, please contact:

Greg at (215) 579-1650  or  greg@pharmicaconsulting.com