Resume of Jim Zeller

9113 N 116th Way^th

Scottsdale, AZ 85259

cell 616 485 9102

jim@jimzellerconsulting.com

James R. Zeller, Ph.D.

Objective	March 2005 to present Jim Zeller Consulting, LLC Scottsdale, AZ Leverage my experience in API development and production to help clients introduce their drug to the market in a time efficient manner Identify API processing problems early and offer solutions Advise clients on API manufacturers Advise clients on potential hurdles during process development Guide process chemists in developing the most cost efficient and robust process possible Perform Due Diligence on licensing drug candidates, from the API perspective Help prepare the CMC API portion of regulatory filings
Experience	2004 to Feb 2005 Cedarburg Pharmaceuticals Grafton, WI Vice President, Process Development and Manufacturing Directed process research and manufacturing; Product list includes Paclitaxel and Oxandrolone
	2001 to 2003 Pfizer, Inc Holland, MI Senior Director, Chemical R & D Led a department of 100 organic chemists, chemical engineers, analytical chemists, and pilot plant personnel Member of the Pfizer Drug Substance Management Team, Pfizer Chemical R&D Line Council, and Pfizer World Wide Pharmaceutical Sciences Leadership Team Various Executive Management Courses at the University of Michigan and Harvard University
	1991 to 2000 Warner Lambert/Parke-Davis Holland, MI Section Director, Chemical R & D Developed the preferred manufacturing route to gabapentin (Neurontin). Responsible for the transfer of this technology to API manufacturing plants Directed the development and optimization of the atorvastatin (Lipitor) process. Responsible for the transfer of this technology to API manufacturing plants Interacted with the FDA on the atorvastatin NDA and pre-approval inspection Successfully managed a late stage atorvastatin polymorph change Started a program to look at new processes for marketed products that resulted in $150,000,000 in cost savings to date

	1982 to 1991 Warner Lambert/Parke-Davis Holland, MI Scientist to Senior Research Associate (four promotions) Discovered the preferred manufacturing route to gabapentin (Neurontin)
Education	1977 to 1981 Wayne State University Detroit, MI Ph.D. Organic Chemistry 1973 to 1977 Bowling Green St. University, Bowling Green, OH BS in Chemistry and Biology
Awards	Warner-Lambert Co.- Pharmaceutical Research Division - 1990 Meritorious Scientific Achievement Award American Chemical Society – 2003 Heroes in Chemistry Award
Interests	Family life, sailing, bicycle riding, racquetball, tennis, outdoors
Presentations

J. R. Zeller, "The Chemical Development of a Novel Neuroleptic Agent," Symposium on Organic Chemistry and Natural Products, Hope College, Holland, MI, February 28, 1984.

J. R. Zeller, "The Nitration of 5-Chloro-1,3-Dimethyl-1H-Pyrazole: Risk Assessment Before Pilot Plant Scale-up," American Chemical Society Meeting, St. Louis, MO, April 10, 1984.

J. R. Zeller, "The Chemical Development of Gabapentin," Midwest Pharmaceutical Process Chemistry Consortium, Indianapolis, IN, October 12, 1993.

J. R. Zeller, "Atorvastatin: A Case Study of the Development of a Commercial Process," Chirex Meeting, Amelia Island, Florida, March 28, 1997.

J. R. Zeller, "Atorvastatin: A Case Study of the Development of a Commercial Process," The Third International Chirex Conference on Process Development Chemistry, Amelia Island, FL, March 28, 1997

J. R. Zeller, "Atorvastatin: A Case Study of the Development of a Commercial Process,"

Gordon Conference on Reactions and Processes, New Haven, NH, July 15, 1998.

J. R. Zeller, "The Chemical Development of Four Dihydropyrone HIV Protease Inhibitors," IBC’s International Symposium on New Synthetic Methods, Sanibel Harbour, FL, September 16, 1998.

J. R. Zeller, "The Synthesis of Four Dihydropyrone HIV Protease Inhibitors," Sepracor Symposium, Fort Myers, Florida, September 16, 1998.

J. R. Zeller, "The Chemical Development of Four Dihydropyrone HIV Protease Inhibitors," West Michigan Section of the American Chemical Society, Big Rapids, MI, September 22, 1998.

J. R. Zeller, "An Asymmetric Hydrogenation Based Process to Atorvastatin", Chiral 2003, Chicago, IL, October 21, 2003.

J. R. Zeller, "Process Chemists Rule"; ACS Prospective Conference - Process Chemistry in the Pharmaceutical Industry ; Tampa, Florida, February 29, 2004

PAPERS

C. R. Johnson, J. R. Zeller, "Sulfoximine Mediated Resolution of Ketones," Journal of the American Chemical Society, 1982, 104, 4021-4023.

C. R. Johnson, K. G. Bis, J. H. Cantillo, N. A. Meanwell, M. F. Reinhard, J. R. Zeller, and G. P. Vonk, "Preparation and Reactions of Sulfonimidoyl Fluorides," Journal of Organic Chemistry, 1983, 48, 1-3.

C. R. Johnson and J. R. Zeller, "N,S-Dimethyl-S-phenylsulfoximine: A Reagent for the Optical Resolution of Ketones," Tetrahedron, 1984, 40, 1225-1233.

J. R. Zeller, "The Nitration of 5-Chloro-1,3-dimethyl-1H-pyrazole: Risk Assessment before Pilot Plant Scale-up," ACS Symposium Series, 274, 1985, 107-114.

"An Efficient Method for the Synthesis of (R)-3-(1-Amino-1-methylethyl)pyrrolidines for the Antiinfective Agent, PD 138312," V. Fedij, E. A. Lenoir III, M. J. Suto, J. R. Zeller, J. Wemple. Tetrahedron, Vol. 5, No. 7, pp. 1131-1134 (1994).

PATENTS

US Patent 4,772,706 "Process for Quinoline-3-carboxylic Acid Antibacterial Agents," September 20, 1988.

US Patent 5,132,451 "Process for Cyclic Amino Acid Anticonvulsant Compounds," July 21, 1992.

US Patent 5,319,135 "Process for Cyclic Amino Acid Anticonvulsant Compounds," June 7, 1994.

US Patent 5,347,017 "Process for Chiral 3-(1-Amino-1,1-Bisalkylmethyl)-1-Substituted-Pyrrolidines," V. Fedij, J. Wemple, J. Zeller (1994).

US Patent 5,362,883 "Process for Cyclic Amino Acid Anticonvulsant Compounds,"

November 8, 1994.

US Patent 5,386,031 "Process for the Synthesis of 2-Amino-3,5-Dihydro-7-Substituted-4H-Pyrrolo[3,2-D]Pyrimidin-4-Ones," R. De Jong, R. Seamans, J. Zeller (1995).

US Patent 5,466,828, "Chiral 3-cyano-1-substituted-pyrrolidines," October 10, 1995, Victor Fedij, James Wemple, and James Zeller.

US Patent 5,693,845, "Cyanocycloalkylacetic Acid and Ester Intermediates for preparing Cyclic Amino Acid Anticonvulsant Compounds," December 2, 1997, Rex Allen Jennings, Don Richard Johnson, Ronald Everett Seamans, and James Robert Zeller.