Process Development

RICHARD R. COPP, Ph.D.

*** **** **

Oregon, Wisconsin 53575

C: 608-***-**** E-mail: *******@*****.***

Postdoctoral Fellow - National Cancer Institute - National Institutes of Health (NIH);

Ph.D. Organic Chemistry - Montana State University; BS Chemistry- Illinois State University

PROFESSIONAL SUMMARY_________________________________________________________

Organic chemist seeking senior level position in process research and development. Extensive experience in organic small molecule and peptide chemistry in CNS drug development as well as other therapeutic areas. Recipient of Abbott Laboratories Scientist of the Year Award. Multiple patents, publications and awards from achievements in route selection, process development and scale up problem solving and API delivery for clinical trials. Extensive outsourcing experience: managing CMO's for successful API manufacture and CRO's for formulations, analytical chemistry, radiolabeling, toxicity testing and scale up of intermediates.

EXPERIENCE____________________________________________________________________________

Mithridion, Inc., 505 Science Dr., Suite C, Madison, WI 53711. Vice President Chemistry, Feb 2006-Aug 2011. Invented novel, scalable process for API manufacture of lead drug candidate, MCD-386. Invented follow-on muscarinic agonist drug candidate through highly successful drug design and lead optimization studies.

Managed all chemistry efforts; process R&D and medicinal chemistry for peptides and small molecules.

• Route Scouting, Process Research, Process Development, impurity characterization and synthesis

• Process scale up, GMP manufacture of API, Process filing strategies

• Patents; expertise in patent document writing and intellectual property portfolio management

• Highly successful CRO and CMO management; contract negotiations, formulations, API delivery

• Expertise in analytical chemistry, FDA (ICH) guidelines, CMC documents

• Expertise in medicinal chemistry, lead optimization (ADMET), radiolabeling, tox screening

Quintessence Biosciences, Inc., 505 South Rosa Rd, Madison, WI 53719. Director of Synthetic Chemistry, Apr. 2003 – Mar. 2005. Developed peptide synthesis/ligation technology and products including Q-Link product.

• Designed small molecule peptidomimetic aspartic protease inhibitors and developed technology for the synthesis of focused libraries of enzyme inhibitors.

• Interfaced with molecular modeler to design potent peptidomimetic beta-secretase inhibitors.

PanVera Corporation, 501 Charmany Dr, Madison, WI 53719 Senior Scientist, Jun. 2002 – Apr. 2003. Direct organic synthesis projects for process improvements and manufacture of PanVera drug discovery products.

• Coordinate technology transfer of Betalactamase (BLA) reporter assay product from San Diego site to Madison and lead team through process R&D and product manufacture.

• Recruit, train and direct associate scientists involved with organic synthesis projects.

ProCertus Biopharm, 505 South Rosa Rd., Madison, WI 53719. Member-Scientific Advisory Board, July 2002-present. Head of Chemistry, Dec. 2001 to May 2002.

• Established medicinal chemistry program in support of new leads for chemoprotection screening.

• Secured patent protection for new lead actives and published scientific results.

Tetrionics, Inc, 645 Science Dr., Madison, WI 53711. Senior Scientist, Aug. 2000 to Jul. 2001.

Project leader for new API projects at Tetrionics.

• Evaluate new API projects: lead project Team through R&D and manufacturing start up; coordinate timelines with process, analytical and regulatory activities; interface with marketing/senior management, provide progress updates and development reports.

• Direct and mentor associate scientists.

Abbott Laboratories, D-38W, R13-3, 1401 Sheridan Road, North Chicago, IL 60064 Senior Research Scientist, Process Research and Development, CAPD, Abbott Laboratories, Dec., 1990 to Aug., 2000.

• Received Scientist of the Year Award, 1998.

• Responsibilities included supervising associates, contract scientists and operations personnel.

• Research efforts focused on designing alternative synthesis routes for clinical candidates, API manufacture under GMP guidelines, process improvements and pilot plant scale up, synthesis of process impurities, writing pilot plant directions meeting FDA guidelines.

• Abbott process support in North Chicago, IL and Queenborough, England, as well as with international vendors in Spain and Mexico. Coordinate technology transfer to international vendors supporting Abbott projects.

• Trained in molecular modeling using Oxford Molecular’s CAChe System.

Ricerca, Incorporated, 7528 Auburn Road, P.O. Box 1000, Painesville, OH 44077-1000 Research Chemist, Contract synthesis with Ricerca, Inc., Sep. 1989 to Nov. 1990.

• Carried out multi-step syntheses of various heterocyclic and carbohydrate-based targets, process impurities and agricultural product metabolites.

• Coordinated analytical services with Ricerca analytical chemistry department.

National Institutes of Health, National Cancer Institute, Bethesda, MD 20892 NIH Postdoctoral Fellow, Nov. 1987 – Sep. 1989. Preceptor: Dr. Victor Marquez. Synthesis and structure elucidation of carbocyclic nucleoside isosteres as potential antitumor and antiviral agents.

• Focused on the preparation of analogues of cyclopentenyl cytosine (CPE-C), a compound which was chosen as a clinical candidate by the NCI for antitumor studies.

• Synthesized new analogs with modifications in both the heterocyclic base and the carbocyclic sugar.

• Synthesized the 5’-triphosphate derivative of CPE-C to support biological studies.

Montana State University, Bozeman, MT, Graduate Research Assistant, Jan. 1981 – Oct. 1987. Ph.D. Organic Chemistry. Graduate advisor: Professor Bradford Mundy. Thesis title: “Stereoselective Synthetic Methodologies: Mechanistic Studies Toward Natural Products.

• Explored stereoselective alkylation and reduction methods for various dihydropyran systems with the aim of producing natural products containing the 6,8-dioxabicyclo [3.2.1] octane ring system.

• Discovered new synthetic routes for insect pheromones and a constituent of Japanese hops.

AWARDS________________________________________________________________________________

Scientist of the Year Award, Abbott Laboratories, CAPD, process R&D, 1998

Scientist of the Year Team Award, Abbott Laboratories, CAPD, process R&D, 1997

Intramural Research Training Award (IRTA), NCI-NIH. November, 1987 - September 1989.

A.R.H. Johansen Award for Graduate Teaching, awarded twice, Chemistry Department, Montana State University.

Stein Award Nominations, Abbott Laboratories, 1993 for novel, short chiral synthesis of Zileuton, 1994 for new Zileuton process and 1998 for new BPH tricycle process.

PATENTS/APPLICATIONS______________________________________________________________

Synthesis and Isolation of N-(aryl or heteroaryl)-alkyl-N-Hydroxyurea. 1999 US 6,080,874

Process for N-desmethylating Erythromycins and Derivatives Thereof. 1999 US 5,883,236

Polyamine Compounds and Compositions for Use in Conjunction with Cancer Therapy. 2008 US 7,314,959

Amino Thiol Compounds and Compositions for Use in Conjunction with Cancer Therapy. 2008 US 7,414,154

Patent applications; Omnibus applications, expect USPTO to split into 5 individual patents:

PCT International Application: WO 2010/102218 A1

PCT International Application: WO 2011/085406 A1

MANUSCRIPTS

Available upon request - 13 published manuscripts, one manuscript in press and three manuscripts in preparation or under review.

Contact this candidate