Special Exhibit Hall Keynote Presentation · September 24 · 6:30pm
The Treacherous Path to Success in the Biotech Industry
After three decades of phenomenal scientific discovery in biotechnology, substantial uncertainty remains in the path of translating science into commercial success. Lessons from summiting the 7,000m Nepalese peak of Ama Dablam help in defining the goals and managing the risk of innovation in commercializing biological products. Setting the right goals and correct metrics is essential to mapping an efficient route to navigate the technical and regulatory uncertainty in manufacturing tomorrow's products today.

Charles L. Cooney, the Robert T. Haslam (1911) Professor of Chemical Engineering, in the Department of Chemical Engineering is the Faculty Director of the Deshpande Center for Technological Innovation, and the International Innovation Initiative (I3) at MIT. He received his Bachelor's degree in Chemical Engineering from the University of Pennsylvania (1966), Master's (1967) and Ph.D. (1970) degrees in Biochemical Engineering from MIT. Prof. Cooney's research and teaching interests span a range of topics in biochemical engineering and pharmaceutical manufacturing.

As founding faculty director of the Deshpande Center and the International Innovation Initiative he is interested in the process of stimulating technological innovation and translating innovation into new company creation. Other interests include rock climbing, skiing, high altitude mountaineering (with assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran), scuba diving and antique map collecting.

September 24 · 5:00pm
Biosimilars - Follow-on Biologics - Subsequent Entry Biologics - Biogenerics?
This presentation will discuss the current regulatory issues surrounding Biosimilars, Follow-on Biologics and Biogenerics. Specific concerns will be addressed with respect to how significant molecular differences will be identified and adjudicated as part of this process. The utility of bioassays and human clinical trials as compared to current analytical capabilities will be discussed and opportunities for regulators, the academic community as well as the generic and ethical pharmaceutical industry to work together to resolve these issues will be explored.

Robert Garnick is senior vice president, Regulatory, Quality and Compliance. In this role, Garnick is responsible for all the regulated aspects of Genentech's business including drug development, commercial production, and promotional and labeling compliance. He is currently leading an important effort to develop an effective long acting ophthalmic device for the treatment of age related macular degeneration.

Garnick joined Genentech in 1984 as manager of Quality Control. After a series of promotions in the Quality group, he became vice president of Quality in 1994. In 1997, he was named vice president of Regulatory Affairs. Garnick was named to his current position as senior vice president of Regulatory, Quality and Compliance in March 2001. Prior to Genentech, Garnick was manager of Quality Control at Armour Pharmaceutical Company and section head of analytical development at Merrell National Laboratories.

Garnick holds a Bachelor of Science degree in chemistry from Rutgers University and a doctorate in organic chemistry/natural products from Northeastern University. He was recently appointed an adjunct professor of Biochemistry at The Barnett Institute.

September 23 · 8:15am
How to Motivate Staff to Implement Lean Manufacturing to Raise the Bottom Line
Experience from over 1,000 process improvements has demonstrated the elements necessary for success of a lean program: passionate executive sponsor, endorsed project charter, engaged team, and a phased approach with realistic goals. Gain strategic tips for incorporating value stream mapping, design of experiments (DOE), mistake-proofing, failure modes and effects analysis (FMEA), Root Cause/Risk Analysis, statistical process control (SPC), process mapping, process management performance metrics, trend analysis, process re-engineering, analysis of variation (ANOVA), benchmarking and more.

Rob Bryant has taught over 150 Green & Blackbelt level classes in over 25 countries & 6 continents. He also serves as the Senior Malcolm Baldrige Examiner for the US Department of Commerce. The Six Sigma Green Belt and Blackbelt classes that Rob and his team have taught have resulted in over $150 million of savings and/or increased revenue.

At CSC he is responsible for the overall Lean/Six Sigma program including: Whitebelt, Greenbelt, Blackbelt & Master Blackbelt training, Lean Events, selling Six Sigma services to clients, putting an award program in place, and Six Sigma Analysis. Rob also leads the QA process ensuring that accounts achieve required quality certifications and improve/measure performance.

In his previous roles of VP of Quality and Compliance, and of Senior Executive of Quality, Environment, Health, Safety and Workers Comp (QEHS&WC), at DynCorp, he supported doubling the size of the organization through use of quality/performance tools for over 100 sites and 20,000 employees.

Mr. Bryant also used the same principles to learn to walk again with braces and crutches after a 55-foot fall that left him a paraplegic. He has set two world records: the longest walk by a paraplegic - 24 miles, and the Guinness World Record for Rowing (3,280 miles in 119 days on a rowing machine). He is the author of 3 books.

September 24 · 4:15pm
Paths to Flexible Regulatory Notification of Large Molecule Life-Cycle Changes
The seeds allowing for more flexible reporting options are sown early in the large molecule development process with an eye on reaping the benefits throughout the product lifecycle. This talk will focus on the unique aspects of large molecules in the generation and demonstration of this enhanced knowledge in the initial registration to best facilitate innovation and process improvements post-registration.

John Towns, PhD is Director, Global CMC Regulatory Affairs at Eli Lilly. Dr. Towns has both pre-approval and post-approval global CMC regulatory affairs responsibilities for Lilly's portfolio of chemically synthesized and biotechnology-derived drug substances and drug products, including the regulatory activities at the 15 global manufacturing sites.

Dr. Towns received a BS degree in Chemistry from Cal Poly in 1986 and a Ph.D. degree in Analytical Chemistry from Purdue University in 1991.

September 23 · 4:00pm
The Challenges and Successes of Creating a Biologics Organization within Pfizer
The presentation will examine the trials and challenges of establishing a Biologics Pharmaceutical Sciences and Manufacturing organization in a company that has a historical small molecule mind set. Hear details of the current status of biologics at Pfizer. Understand the major challenges with biologics formulations, process technology and manufacturing and how Pfizer is trying to leverage its extensive small molecule manufacturing experience to creatively resolve these issues.

Rick Rutter is the Vice President of Pharmaceutical Sciences Global Biologics organization in Pfizer, Inc. The organization that he leads is responsible for all clinical and commercial formulations and for manufacturing process develop for all of the large molecules in the Pfizer R&D portfolio. Rick has held this position since March of 2007. Previous to his current role he was Vice President for Science and Technology for Pharmaceutical Sciences Global Biologics. Prior to becoming part of Pfizer during the Pharmacia merger in 2003, Rick held a very similar position in Pharmacia leading the Pharmaceutical Sciences technology area for protein therapeutics.

Rick Joined Monsanto in 1983 in the macromolecule process development area of Pharmaceutical Sciences. He held a variety of management positions leading small molecule and large molecule process development. From 1991 to 1996 he managed the late stage API process development activities and the pilot plant operations in Skokie. From 1996 to 2000 Rick took on a project to define a unified Pharmaceutical Sciences & Manufacturing work process and governance system.

Rick received his Ph.D. in Biochemistry from University of Illinois in 1982 and did a National Institute of Health sponsored post-doctoral fellowship at the University of Illinois.