Amedio CMC Consulting LLC

Curriculum Vitae

Publications

Patents

Presentations

 

John C. Amedio Jr., Ph.D., Principal

Amedio CMC Consulting, LLC, (857) 928-4521

 

Twenty-five years of experience in major and start-up pharmaceutical companies. Extensive project management experience covering Synthetic/Process Chemistry, Analytical Chemistry, Pharmaceutics (+20 employees), Quality Assurance, Regulatory Affairs (CMC) and Packaging/Labeling/Distribution. Delivered profitable and patented manufacturing processes (API and finished drug product, injectable and oral dosage forms; capsules, tablets and orally disintegrating tablets) for Arbaclofen, Zinapar™, Zibulin™, Zymafos™, Vasovist™ (currently Ablavar®), multiple NCE’s, including peptides and metal-based drugs (pre-clinical through commercial). Broad experience in organic chemistry, process research, process development and cGMP manufacturing (API and drug product from pre-IND to commercial). Managed the chemistry, manufacturing, and control (CMC) aspects for multiple programs simultaneously. Managed technology transfers to and from appropriate CMOs. Managed process optimization of bulk drug, fill / finish (parenteral, lyophilized), ophthalmic form, solid dosage form and analytical / QA, etc. at contract facilities. Managed analytical assay development, process development, and formulation development for the appropriate stage of each project. Managed and designed primary/secondary labeling and packaging (blisters, bottles). Authored/co-authored and reviewed CMC sections for numerous regulatory filings (IND, Amendments, Annual Updates,  IMPD and NDA), performed budget planning and forecasts, established hiring plans, and participated in overall strategic planning.

 

 

PROFESSIONAL EXPERIENCE

 

2009 - 2013, Vice President, Manufacturing & Process Development

 

Executive position with responsibility for managing all chemistry, manufacturing and controls (CMC); pharmaceutical sciences;  manufacturing operations and supply chain/packaging/distribution functions for two (2) clinical trial candidates and one (1) pre-IND product.

 

• Managed the technical development, manufacturing and supply chain for all the Company’s products from

  early stage development to Phase III/Commercial, while assuring compliance with all applicable regulatory

  authorities for the manufacture of pharmaceutical drug substances and drug products

- Supervised the various vendor relationships to produce the service level requirement to support supply

  chain needs

- Worked with product development and marketing departments to integrate supplier and brand launch

  for arbaclofen, as well as regulatory upgrades to existing packaging or formulations

- Monitored the on-time and complete performance of suppliers

- Proven track record with the U.S. Food & Drug Administration

• Managed all CMC regulatory filings

- wrote multiple amendments and annual reports

- wrote End-of-Phase II (EOP2) meeting briefing book

- lead participate for EOP2 FDA meeting

- responsible for USAN application for arbaclofen

• Experienced in both strategic planning and tactical management that led to the selection of contract

  manufacturers for clinical & commercial scale drug substance (API) & solid dosage forms (tablets, capsules

  and orally disintegrating tablets)

- Developed a proprietary synthetic route to R-baclofen (arbaclofen)

- Co-developed an orally disintegrating tablet (ODT) of arbaclofen (Phase III and Commercial)

• multiple dose forms, <15 seconds disintegration time

- Co-developed a capsule for arbaclofen (Phase III clinical trials)

- Co-invented a manufacturing process for two mGluR5 antagonists

• Cost reduction >50%

- Integrated cutting edge technology into the production of solid dose forms

• Co-developed an oral dosage form of a highly insoluble pharmaceutical, utilizing hot melt extrusion

  (HME) and Spray dried dispersion (SDD)

• Collaborated with Business Development to assess external opportunities and build our pipeline through

  in-license and/or M&A activities

• Authored technical and managerial overviews to Potential Investors/Corporate Partners and Board

  of Directors

• Managed an annual budget of 6M

 

 

2006 - 2009, Vice President, Manufacturing & Process Development

 

Responsible for managing all domestic and international chemistry, manufacturing and controls (CMC), manufacturing operations and supply chain/distribution functions for three (3) [all] of the company’s products (currently 5 dosage forms in clinical trials).

 

• Directed the worldwide CMC (Pre-clinical, Phase I and II) activities, including the development of product

  specifications, formulations, analytical method qualification/validation, ICH stability studies, container/closure

  designs, labeling, packaging and production processes for products in aseptic, solid dose and parenteral

  forms; including all active pharmaceutical ingredient production

- Managed production of API’s and drug product at four (4) domestic and four (4)  international sites

- Managed fifteen (15) contract manufacturers and research organizations.

• Managed all worldwide US, Canada and European CMC section filings

- Wrote four (4) IND CMC sections and three (3) annual updates

• All documents accepted as prepared. No CMC questions from the agency

• Identified evaluated & recommended contract manufacturers for clinical & commercial scale drug substance

  (API) & dosage forms for solid dosage and injectable (lyophilized and parenteral) projects

- Delivered first solid dosage form of an organic (peptide based) arsenic pharmaceutical

- Invented a process for the production of organic (peptide based) arsenic pharmaceutical API

- Invented a process for the production of isophosphoramide mustard (IPM) API

- Developed an injectable dosage form of a highly insoluble pharmaceutical

- Co-developed an oral dosage form of a highly insoluble pharmaceutical

- Developed a stable salt form for isophosphoramide mustard (IPM)

- Developed the first solid dosage form for IPM

• Transferred laboratory manufacturing processes/analytical methods to GMP manufacturing sites, and supervised process scale-up and analytical method validations

- Delivered multiple qualified analytical methods for the release and stability testing of API and

  drug product

- Responsible for all bio-analytical method development to support pre-clinical and clinical  PK/PD

• Developed validated analytical methods for Zinapar™, Zibulin™ and Zymafos™: Identification

  and quantification of the active ingredient and metabolites in plasma, urine and feces

• Responsible for QA compliance and guidance at contract manufacturing organizations.

- Managed all QA/QC vendor activities; audit vendors to assess cGMP compliance.

- Led the IQ/OQ/PQ validation at six (6) manufacturing sites

• Drafted & negotiated supply and quality agreements with contract manufacturers

• Designed primary/secondary labeling for API, capsules and injectables in US, Canada, EU and India

• Managed clinical supply vendors

• Reviewed and edited development reports, batch records, and technology transfer protocols for API and

  drug product

• Prepared and reviewed validation master plan and process validation protocols for API and drug

  product production

• Performed due diligence investigations for potential product and technology acquisitions

• Managed an annual budget of 8M

• Provided high-level technical and managerial project overviews to Investors/potential Investors, potential

  Corporate Partners (external) and Intellectual Property, Clinical, Pre-Clinical and Business Development

  functions (internal)

 

 

EPIX Pharmaceuticals, Cambridge, MA.

2005-2006      Executive Director, Chemical and Analytical R&D

2004-2005      Sr. Director, Chemical and Analytical R & D

                         Project Leader, Fibrin-Targeted Anti-thrombotics

2001-2004      Sr. Director, Chemical R & D

1997-2001      Director, Chemical Development

1995-1997      Group Leader, Chemical Development

 

Chemical R & D and Manufacturing

• Responsible for the invention, design, execution and implementation of multi-step chemical processes

  for potential new contrast imaging drug candidates and therapeutic drugs. These chemical processes are

  suitable for the cGMP commercial manufacture of drug substances

• Managed process discovery, process development and cGMP production of multiple drug substances at

  CROs within a laboratory, kilo lab, pilot plant and manufacturing facilities.  Led a team of process and

  analytical chemists in the delivery of numerous outsourced intermediates and key reagents for both

  contrast agents and therapeutics (peptides and small molecules)

• Managed quality audits during visits to custom manufacturers (drug substance and drug product

  manufacturers)

• Successfully transferred chemical and analytical development technology to custom manufacturers under

  GLP and cGMP guidelines, which included the translation of laboratory procedures to master batch records

  and scale-up procedures

• Manage all outsourcing relationships with respect to drug substance and drug product manufacture [US,

  Canada, India and Europe]

• Co-authored the CMC sections for two IND’s (one in electronic CTD format) and one NDA (both FDA and

  CTD format)

• Possess a detailed knowledge of US and International CMC regulatory requirements, policies and guidelines,

  including the Code of Federal Regulations (21CFR) and ICH

 

Analytical R & D

• Managed the Analytical R & D support for Medicinal Chemistry, Chemical R & D, Pharmaceutics,

  Manufacturing (API and drug product), Regulatory Affairs, Pre-clinical and Clinical trial products

• Responsible for method development, method validation, stability testing, drug product and drug

  substance testing

• Supported all issues concerning QA, QC, analytical methods, clinical trials and regulatory affairs

 

Pharmaceutical R & D

• Managed all aspects of Pharmaceutics and drug product manufacturing (cGMP), which includes supplies

  for pre-clinical study and clinical trials

• Supervised pre-formulation research, formulation development, process scale-up, product testing

  (stability, endotoxin, bioburden), technology transfer and outsourcing to third party manufacturers.

• Established specifications (i.e. impurity profiles) for all drug products (toxicology and clinical material)

 

Therapeutic Project Leader. Fibrin-Targeted Antithrombotics

• Organized project team for the first EPIX therapeutic research project, and established goals and work plans

• Provided high-level technical and managerial project overviews, including Board of Directors

• Supervised six functional managers within a matrix system (Synthesis, Pharmacology/Toxicology,

  Biochemistry, Medicinal Chemistry, Synthetic Chemistry and Intellectual Property)

 

 

Massachusetts College of Pharmacy and Health Sciences, Boston, MA

2005 - 2009      Adjunct Professor, Pharmaceutical Sciences

 

• Co-instructor for course titled: Good Manufacturing Practices Compliance

- Course Description: The course explores in depth the promulgated regulations through which the

  Federal government controls the drugs, cosmetics and diagnostics industries.  Major emphasis is placed

  on understanding the need for and the intent of regulations and developing mechanisms for

  implementation and compliance

- Three (3) credit course intended for both Graduate and Undergraduate students (B.S.P.S).

• Designed a course in Drug Discovery and Development

• Reviewed and graded multiple M.S level theses and oral presentations

 

 

Sandoz Pharmaceutical Corporation [currently Novartis Pharmaceuticals]

Sandoz Research Institute, E. Hanover, NJ.

1992-1993, 1994-1995      Associate Fellow, Unit Head, Chemical Research and Development

1989-1992      Assistant Fellow, Unit Head, Chemical Research and Development

 

• Responsible for the supervision of and hands-on invention, design, execution and implementation of

  multi-step chemical processes for potential new drug candidates: Phase I through Phase III clinical trials

  [PAF receptor antagonists, HMG-CoA reductase inhibitors, noninsulin dependent diabetes mellitus agents

  (NIDDM)]

• Supervised chemical development unit (one Ph.D., one BS scientist and one laboratory assistant).

• Teamed with chemical engineers and plant chemists for the pilot plant and production scale-up of

  multi-step chemical processes under cGMP (1-100 Kg, up to and including 5,000L reactors).

• Conducted the isolation, identification and synthesis of potential impurities for toxicological and

  analytical evaluation

• Investigated new environmentally compatible organic reactions and technologies: Sonochemistry, Microwaves

• Prepared cost analysis for multi-step chemical processes

• Wrote standard operating procedure documents (SOP’s) for both the process laboratory and pilot/

  development plant

 

 

Sandoz Pharma AG Basel, Switzerland.

1993-1994      Laboratory Head, Pre-Clinical Research, Kilolaboratory

 

• Supervised four BS/MS level scientists

• Worked simultaneously on four drug candidates under cGMP (Toxicological and Phase I clinical trial material,

   1-25 kg scale)

• Assisted pre-clinical chemists in the design and synthesis of potential drug candidates

• Supported pre-clinical chemistry by preparing reagents and intermediates

 

 

EDUCATION

 

1987-1989      Oregon State University, Corvallis, Oregon.  Post-Doctoral Research Associate, Advisor: Dr. James

                         D. White. Synthesis of complex natural products [(+)-Geodiamolide A (a cyclodepsipeptide);

                         (+)-Usaramine and (-)-Swazine (pyrrolizidine alkaloids)].

 

1982-1987      University of Delaware, Newark, Delaware. Ph.D. Organic Chemistry, Advisor: Dr. Douglass F. Taber.

                         Thesis: Transition Metal Mediated Enantioselective Cyclopropanations.

 

1978-1982       Manhattan College, Riverdale, New York. Bachelor of Science, Major: Chemistry,

                          Minor: Mathematics.

 

 

MISCELLANEOUS

 

  page 98, CHEM 5645), Northeastern University, 2010-present

• Member of the organizing committee for the annual symposium “Advances in Chemical Sciences

  Symposium”, Cambridge, MA, 2007-2010. Sponsored by NESACS, RCS-US and IUPAC

• Featured on the cover: “The Nucleus”.  The Northeastern Section of the American Chemical Society’s

• Member of the organizing committee for the First International US-Indian Conference on Organic Synthesis,

  Pune, India, January 6-9, 2006. Conference title: Building Bridges-Forging Bonds for 21st Century Organic

  Chemistry and Chemical Biology.  Sponsored by the American Chemical Society (ACS) and Council of

  Scientific & Industrial Research (CSIR)

• American Chemical Society (ACS) Career Presenter Consultant, Division of Career Services, 2005-2010

• Ph.D. Thesis Referee, National Chemical Laboratory, Division of Organic Chemistry, Pune, India

• M.S. Thesis Referee, Massachusetts College of Pharmacy and Health Sciences, Boston, MA

• Reviewer: Journal of Organic Process Research and Development, Tetrahedron and Tetrahedron:

  Asymmetry, Synthesis

• President’s Individual Performance Award, EPIX Pharmaceuticals, 1997

• Sandoz Research Institute Team Award Recipient, 1994

 

 

PROFESSIONAL AFFILIATIONS

 

• American Chemical Society (ACS)

• American Association for the Advancement of Science (AAAS)

• American Association of Pharmaceutical Scientists (AAPS)

• Parenteral Drug Association (PDA)

• International Union of Pure Applied Chemistry (IUPAC), Medicinal Chemistry Committee

 

 

Jones, B.; Komarnitsky, P.; Miller, G.; Amedio, J. and Wallner, B.P.  Anticancer activity of stabilized palifosfamide in-vivo: schedule effects, oral bioavailability and enhanced activity with docetaxel and doxorubicin, Anti-Cancer Drugs, 2012, 23(2), 173-84.

 

Levy, S.G.; Zhou, K.L.; Jacques, V.; Kalogeropoulos, S.; Schumacher, K.; Amedio, J.C. Jr.; Scherer, J.E.; Witowski, S.; Lombardy, R. and Koppetsch, K. Development of a Multigram Asymmetric Synthesis of 2-(R)-2-(4,7,10-Tris tert-Butylcarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)-pentanedioic Acid, 1-tert-Butyl Ester, (R)-tert-Bu4-DOTAGA, Organic Process Research and Development, 2009, 13(3), 535.

 

Caravan, P.; Amedio, J.C. Jr.; Ellison, J. J.; Cloutier, N.C.; McDermid, S. A.; Spiller, M.; Zech, S.; Looby, R. L.; Raitsimring, A. M.; McMurry, T. J. and Lauffer, R. B. When are two waters worse than one? A novel gadolinium(III) complex based on N-methyl-diethylenetriaminetetraacetate, Chem. Eur. J. 2005, 11, 5866.

 

Prashad, M.; Amedio, J.C., Jr.; Ciszewski, L.; Lee, G.; Villa, C.; Chen, K-M.; Prasad, K. and Repic, O. Practical Synthesis of 3-Carboxy-(2R)-[[hydroxy[(tetradecyl)oxy]-N,N,N-trimethyl-1-propanaminium Hydoxide Inner Salt (CPI975): A Carnitine Palmitoyltransferase I Inihibitor., Organic Process Research and Development, 2002, 6(6), 773.

 

Caravan, P.; Cloutier, N.; Greenfield, M.T.; McMurry, T.J.; McDermid, S.A.; Dunham, S.U.; Bulte, J.W.M.; Amedio, J.C.; Looby, R.J.; Lessman, J.J.; Supkowski, R.M.; Horrocks, W. DeW. and Lauffer, R.B. The interaction of MS-325 with human serum albumin and its effect on proton relaxation rates, J. Am. Chem. Soc., 2002, 124(12), 3152.

 

Amedio, J.C., Jr.; Van Wagenen, G.; Zavlin, G. Preparation of N,N-Bis[2-[N’,N’-bis[(tert-butoxycarbonyl)methyl]-amino]ethyl-L-aspartic acid: An Intermediate in the Synthesis of MRI Contrast Agents, Synth. Commun., 2000, 30(20), 3755.

 

Amedio, J.C., Jr.; Bernard, P.; Fountain, M.; Van Wagenen, G., A Practical Manufacturing Synthesis of

1-(R)-Hydroxymethyl-DTPA: An Important Intermediate in the Synthesis of MS-325, Synth. Commun., 1999, 29(14) , 2377.

 

Amedio, J.C., Jr.; Bernard, P.; Fountain, M.; Van Wagenen, G., A Practical Preparation of 4,4-

Diphenylcyclohexanol: A Key Intermediate in the Synthesis of MS-325, Synth. Commun., 1998, 28 (20), 3895.

 

White, J.D.; Amedio, J.C., Jr.; Hrnciar, P.; Ohira, S.; Lee, N.C.; Ohira, S.; Yokochi, A.F.T., Asymmetric Synthesis of Dimethyl Swazinecate and Structural Confirmation of its Parent Alkaloid (-)-Swazine, Chem. Comm. 1998, (5), 603.

 

Amedio, J.C., Jr.; Lee, G.T.; Prasad, K.; Repic, O., A Practical Preparation of Methyl 4-(trimethylsilyl)benzoate: An Intermediate In The Synthesis of SDZ63135, Synth. Commun., 1995, 25(17), 2599.

 

Amedio, J.C. Jr.; Sunay, U. B.; Repic, O., Metalated Carboxylic Acids: Improved Synthesis of SDZ 62-412, Synth. Commun., 1995, 25(5), 667.

 

Lee, G.T.; Amedio, J.C., Jr.; Underwood, R.; Prasad, K.; Repic, O., Vinylformylation Utilizing Propeniminium Salts, J. Org. Chem. 1992, 57, 3250.

 

White, J.D.; Amedio, J.C., Jr.; Gut, S., Ohira, S.; Jayasinghe, L.R., Stereoselective Synthesis of the Pyrrolizidine Alkaloids (-)-Integerrimine and (+)-Usaramine, J. Org. Chem. 1992, 57, 2270.

 

White, J.D.; Amedio, J.C., Jr.; Gut, S.; Jayasinghe, L.R., Synthesis of the Macrolactone Alkaloid (+)-Usaramine via Necic Acid Coupling to a Pyrrolizidine Borane, J. Org. Chem. 1989, 54, 4268.

 

White, J.D.; Amedio, J.C., Jr., Total Synthesis of Geodiamolide A, a Novel Cyclodepsipeptide of Marine Origin, J. Org. Chem. 1989, 54, 73.

 

Taber, D.F.; Amedio, J.C., Jr.; Gulino, F., Selective Decarbalkoxylation of β-Keto Esters, J. Org. Chem. 1989, 54, 3474.

 

Amedio, J.C., Jr., Transition Metal Mediated Enantioselective Cyclopropanations, Diss. Abstr. Int. B 1988, 48(8), 2316-17.

 

Taber, D.F.; Amedio, J.C., Jr.; Raman, K., Enantioselective Ring Construction with Control of Side-Chain

Stereochemistry: Synthesis of (+)-Isoneonepetalactone, J. Org. Chem. 1988, 53, 2984.

 

Taber, D.F.; Amedio, J.C., Jr.; Patel, Y.K., Preparation of β-Keto Esters by 4-DMAP-Catalyzed Ester Exchange, J. Org. Chem. 1985, 50, 3618.

 

Taber, D.F.; Amedio, J.C., Jr.; Jung, K-Y., P2O5/DMSO/Triethylamine (PDT): A Convenient Procedure for Oxidation of Alcohols to Ketones and Aldehydes, J. Org. Chem. 1987, 52, 5621.

 

Taber, D.F.; Amedio, J.C., Jr.; Sherrill, R.G., Palladium-Mediated Diazo Insertions: Preparation of 3-Alkyl-2-carbomethoxycyclopentenones, J. Org. Chem. 1986, 51, 3382.

 

 

US Patents

 

• 8,048,906: Optically pure and enriched isomers of chelating ligands and contrast agents

• 7,927,581: Peptide-based multimeric targeted contrast agents

• 7,238,341: Peptide-based multimeric targeted contrast agents

• 6,652,835: Targeting multimeric imaging agents through multilocus binding

• 5,919,967: Process for synthesizing phosphodiseters

• 5,608,061: Process for preparing 1,4,8,11-tetraazacyclotetradecane

 

 

US Patent Applications

 

• 20120219597: Pharmaceutical Formulations for Indibulin

• 20110212921: Synthesis and formulations of salts of isophosphoramide mustard and analogs  thereof

• 20100331403: Compounds and Methods for the treatment of Cancer

• 20080255056: Salts of isophosphoramide mustard and analogs thereof

 

Amedio, J.C., Jr.; Bernard, P.; Fountain, M. and Van Wagenen, G., A Practical Synthesis of Phosphodiester MRI Contrast Agents, American Chemical Society National Meeting, Boston, MA., August, 1998, ORGN 164.

 

Amedio, J.C., Jr.; Bernard, P.; Fountain, M. and Van Wagenen, G., Manufacturing Synthesis of MS-325: Process for the Synthesis of Phosphodiesters. Gordon Conference: Organic Reactions and Processes,

July 12-17, 1998.

 

Amedio, J.C., Jr.; Lee, George T.; Sunay, Ustun B.; Prasad, Kapa and Repic, Oljan, Convenient Syntheses of Some 5-Aryl Substituted Imidazo[2,1-a]isoquinolines, American Chemical Society National Meeting, Anaheim, CA, April, 1995, ORGN 409.

 

White, J.D. and Amedio, J.C., Jr., An Approach to the Macrolactone Pyrrolizidine Alkaloid (-)-Swazine, American Chemical Society National Meeting, Boston, Mass., April, 1990, Abstract: ORGN 0001.

 

Taber, D.F. and Amedio, J.C., Jr., Enantioselective Cyclopropanations of α-Diazo-β-ketoesters: Approach

Towards the Synthesis of (+)-Isoneonepetalactone, American Chemical Society Regional Meeting, New York Section, Pocono Mountains, Pa., 1985.

 

 

INVITED PRESENTATIONS

 

PDA Development and Regulation of Clinical Trial Supplies Conference, Boston, MA.

Seminar Title: Early Clinical Trial Material and Product Consistency in the Biotech Industry,

November 10-11, 2008.

 

American Chemical Society Career Development Day, Natick High School, Natick, MA.

Seminar Title:  Careers in Chemistry and Internships, October 26, 2007.

 

American Chemical Society National Meeting, Atlanta, Georgia, March 26-30, 2006. Division of Professional Relations.  Symposium Title: “To Ph.D. or not to Ph.D. – A Guide to the Perplexed Student?” Seminar Title: The Many Features of a Scientist, March 26, 2006.

 

American Chemical Society National Meeting, Atlanta, Georgia, March 26-30, 2006. Division of Professional Relations.  Symposium Title: “What does it take to succeed in the Pharmaceutical Industry?” Seminar Title: A Scientists Voyage through Multiple Disciplines, March 27, 2006.

 

Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts.

Seminar Title:  The Discovery and Development of Innovative Pharmaceuticals. February 22, 2006.

 

Conference title: Advances in Organic Chemistry and Chemical Biology, Indian Institute of Chemical Technology, Hyderabad, India.  Seminar title: Design and Synthesis of MR Imaging Chelates. January 11-12, 2006

 

Conference title: Building Bridges-Forging Bonds for 21st Century Organic Chemistry and Chemical Biology. National Chemical Laboratory, Pune, India.  Seminar title: The Discovery and Development of Peptide Based Thrombus MR Imaging Pharmaceuticals. January 6-9, 2006.

 

The 863rd Meeting of the Northeastern Section of the American Chemical Society, October 20, 2005.    Seminar title:  Exploring the Analytical and Organic Chemistry Interface:  The Development MRI Imaging Pharmaceuticals.

 

11th Brazilian Meeting on Organic Synthesis (BMOS), Canela-RS, Brazil, August 29-September 2, 2005.  Seminar title: Development of a Commercial Manufacturing Process for MS-325; Synthesis of Phosphodiesters, September 1, 2005.

 

 

Novartis Pharmaceuticals (East Hanover, N.J.) Industrial Chemist Seminar Series, August 24, 2005.  Seminar title:  The Commercial Manufacturing Process for Vasovist™

 

American Chemical Society National Meeting, San Diego, CA, March 13-17, 2005. Working in Biotechnology /BioPharmaceuticals: Promise, Problems, and Potential: Committee on Economic and Professional Affairs, ACS Division of Career Services. Seminar title: From Classroom to Laboratory to Manager: A Career Journey, March 16, 2005.

 

National Chemical Laboratory, Pune, India, September 13, 2004. Seminar title: MS-325: An MRI Pharmaceutical.

 

Indian Institute of Chemical Technology, Hyderabad, India, September 16, 2004. Seminar title: Commercial Manufacturing Processes for Gadolinium Chelate Imaging Pharmaceuticals.

 

Organic Process Research & Development, 3rd International Conference, Montreal, Canada, July 10-12, 2000. Seminar title: The Chemical Development of the Commercial Route to AngioMARK: An MRI Contrast Agent.

 

Dean’s Scholar Seminar Series, College of Arts and Sciences, University of Texas (Austin). Seminar title: Scaling Up to Success: The Role of Chemical Research and Development in the Manufacture of MRI Contrast Agents, March 23, 1998.

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