Development Manufacturing

Paul Kennedy

Email: *********@********.***

Address: *** ******* ***

City: Ardmore

State: PA

Zip: 19003

Country: USA

Phone: 561-***-****

Skill Level: Director

Salary Range: $200,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Paul Kennedy, Ph.D.

113 Cricket Avenue Suite 224 * Ardmore, PA 19003 561-***-**** *********@********.*** * Page One

Biotechnology & Pharmaceutical Executive

Possesses 20+ years of seasoned pharmaceutical experience encompassing parenteral, liquid, solid, topical and radiopharmaceutical drug product development and commercial manufacturing, API development and commercial manufacturing, technology transfer, US and international CMC regulatory, quality and compliance experience and business development operations. Plans, creates, and staffs preformulation, formulation development and technical support groups and manufacturing for large pharma, biotechnology, contract and startup companies. Key player in the approval of numerous regulatory filings in the United States, Europe, Canada, and Japan.

Areas of Expertise

Preformulation/Formulation of small and macro molecules

Organizational Startups, Growth & Expansion, CMC Regulatory and Quality Compliance Technology Evaluation & Transfer, Parenteral, Solid & Topical Dosage Forms, Recruiting, Hiring, & Training, Contractor Selection & Monitoring, Manufacturing Operations

Budget Planning & Monitoring, Analytical Methods Development & Validation

Project Management, API Process Development and Commercialization

Facilities Design and Construction, Radiopharmaceutical Development and Commercialization

Career Highlights

REGULATORY APPROVALS

*Played a key role in the approval of over a dozen drug and imaging applications in the US, EU, Canada and Japan.

*Lead inventor of a room temperature stable dosage form of Ethyol(R) which is a novel chemo-protecting agent approved in the US, EU and Canada. This was accomplished through the use of a novel hydro-alcoholic freeze-drying process.

POSITION HIGHLIGHTS

*Avid Radiopharmaceuticals - responsible for bringing 11 radiopharmaceutical manufacturing sites online for the manufacture of Amyvid(R). Additional manufacturing sites being brought on line in Europe, Japan and Canada. Responsible for the manufacture of the manufacture of Amyvid(R) precursor AV-105.

*Aptuit - expanded the contract business by over 30% in a little over one year. Managed the pharmaceutical development division which consisted of over 60 projects supported by 140 individuals in the development and commercialization of solid and parenteral dosage forms.

*UPM Pharmaceutics - general manager of the solid and analytical contract group. Played a key role in spinning the company off as a separate business entity from the University of Maryland. UPM has since evolved in a key contract manufacturing organization providing solids and analytical methods development.

*QLT Inc. - supported the commercial manufacture of Visudyne(R) which was the first drug approved for the treatment of age-related macular degeneration. Approvals received in the US, EU and Japan. Addressed as needed manufacturing, quality and regulatory issues. Identified and qualified secondary API and drug product suppliers, performed technology transfers and assisted with the preparation of CMC documentation for submission to regulatory agencies.

*Glaxo-Wellcome - expanded the Steriles Research and Development group from 11 to 40 individuals and provided technical/manufacturing support to a 320,000 square-foot steriles facility. During this time NDAs and BLAs were approved for Pfizer, Lilly, Sanofi-Aventis, Genentech, Wyeth-Ayerst, Biogen-IDEC and Amgen. Assisted with a $63 MM expansion of the sterile facility to increase manufacturing capacity.

Paul Kennedy, Ph.D. 561-***-**** * *********@********.*** * Page Two

POSITIONS HELD

AVID RADIOPHARMACEUTICALS, INC a wholly owned subsidiary of Eli Lilly and Company (Philadelphia, Pennsylvania) 2008 to present

Avid is a leading developer of PET imaging biomarkers for the detection of Alzheimer`s and Parkinson`s dementia.

Vice President of Manufacturing: Responsible for manufacturing and CMC related activities. Amyvid(R), the first imaging agent for the detection of amyloid plaques in the brain in Alzheimer`s patients, was approved by the FDA in April 2012. European approval is expected in late 2012. A PET imaging agent for the detection of Parkinson`s disease and a second generation of Amyvid(R) are under development.

APTUIT INC (Kansas City, Missouri) 2006 - 2007

Aptuit, the third largest pharmaceutical contract organization in the world, was formed by the spinoff of the pharmaceutical division of Quintiles and occupies the facilities formerly owned by Aventis, HMR and Marion Labs.

Director of Pharmaceutics: Responsible for the development and manufacture of sterile (small and macro molecules), solid, liquid, ointment, topical, suspension and liquid capsule dosage forms. Managed 140 individuals, supported 60 development and 5 commercial projects. Client base represented small and large pharma and large and small biotechnology companies. Revenues were expanded from $20 MM to over $35 MM per annum.

CONSULTANT TO THE PHARMACEUTICAL INDUSTRY (Boca Raton, Florida)

Paul E. Kennedy, PH.D., LLC 2004-2005

Due to an illness in the immediate family it was necessary to leave the pharmaceutical industry and move to Florida. During this time I served as a consultant to the pharmaceutical industry until the health issue was resolved.

Pharmaceutical Consultant: Managed US and international projects ranging from contractor selection to formulation development and as a pharmaceutical expert for the litigation of a patented parenteral dosage form.

UPM PHARMACEUTICALS, INC. (Baltimore, Maryland) 2002-2003

UPM was founded with FDA grant monies awarded to the University of Maryland for the development of the FDA`s solid dosage form guidelines known as SUPAC. Once these guidelines were issued, UPM was spun off from the university as a contract manufacturing organization. UPM has since evolved into a major contract manufacturing organization providing services in the areas of preformulation, formulation, analytical methods development, stability and regulatory documentation.

General Manager and Vice President: Responsible for transforming an academic research organization into a fully integrated contract service provider which met all current GMP and regulatory requirements. Expanded development, manufacturing, regulatory and quality control departments and managed the built out of a state of the art solid dosage form production facility. Approved the purchase 10 MM dollars of analytical and manufacturing equipment. Served on the senior management team and attended board of director meetings.

QLT, INC. (Vancouver, British Columbia) 2001-2002

QLT is a Canadian based biotechnology company specializing in the development of drugs using photodynamic light therapy in the areas of ophthalmology and oncology. QLT received numerous awards for the development of Visudyne(R), the first drug approved for the treatment of age related macular degeneration. Sales reached over 400MM dollars per annum.

Head of Manufacturing and Pharmaceutical Development: Supported the commercial manufacture of Visudyne(R). Identified, qualified and received regulatory approval for secondary suppliers of the drug substance and drug product. Managed a group of 24 individuals supporting technical services, bioprocess and API development, preformulation, formulation, manufacture of clinical supplies. As required supported commercial operations. Participated on the portfolio team which led to the in-licensing of a drug for the treatment of non-small lung cancer and breast cancer. Served on the senior management team and participated in board of director meetings.

GLAXO - WELLCOME INC. (Greenville, North Carolina) 1998-2000

The site was responsible for the manufacture of some of the largest products sterile and solid dosage forms. To fill excess capacity, third party manufacturing contracts were established with large pharma companies such as Pfizer, Genentech, Amgen, Lilly and Aventis. The site was later sold to DMS for approximately one billion dollars which created the largest pharmaceutical contact manufacturing site in the world.

Director of Pharmaceutical Development - Steriles: Directed a staff of 40 individuals which supported the transfer of over a dozen liquid and lyophilized parenteral products to the Greenville site. Responsible for the selection, purchase and installation of development and commercial freeze dryers. Managed the manufacture of clinical and commercial products, generation of supporting CMC documentation and participated in FDA pre-approval inspections for Herceptin(R), Epogen(R), Xigris(R),Vfend(R), Embrel(R), Lovenox(R), Xigris(R), and Zevalin(R).

HYBRIDON, INC. (Cambridge, Massachusetts) 1995-1998

Hybridon was a biotechnology company specializing in oligonucleotide-based anti-sense therapies for the treatment of AIDS, cancer, CMV, HPV, psoriasis, and anti-inflammatory diseases.

Director of Pharmaceutical Development [U.S. & Europe]: Coordinated a team of five scientists conducting preformulation and formulation studies to develop parenteral, oral liquid, solid, and topical dosage forms. Supervised manufacturing, stability, labeling, packaging and distribution of clinical supplies to the clinical sites. Assisted with the chemistry, manufacturing, and control sections of regulatory filings. Researched, assessed, and implemented various drug delivery technologies applicable to the delivery of oligonucleotides.

US BIOSCIENCE (Conshohocken, Pennsylvania) 1991-1995

US Bioscience specialized in the development of oncology and AIDS drugs. In a period of four years two oncology and one AIDS drug were approved in the US, Europe and Canada. The company was purchase by Medimmune.

Director of Pharmaceutical Technology: Managed the preformulation and formulation of drug candidates for clinical trials. Identified, qualified and managed API and drug product contractors. Assisted regulatory with the submission of filings in the US, Europe and Canada. Developed a novel freeze drying process for Ethyol(R) which received patent approvals in the US and other major markets. Regulatory filings were approved for Hexalen(R), Nutrexin(R) and Ethol(R) in the US, Europe and Canada. Coordinated the technology transfer of Hexalen(R) drug substance and drug product to a European contractor.

NATIONAL INSTITUTE OF HEALTH (Bethesda, Maryland) 1986-1990

National Institutes of Health is the leading medical institute in the world and is responsible for directing health care in the U.S.

Laboratory Manager: Responsible for conducting preformulation and stability studies which supported several dozen INDs conducted at the Clinical Center of NIH. Prepared CMC sections for submission to the FDA. Supervised a group of ten individuals.

Education

UNIVERSITY OF KANSAS (Lawrence, Kansas) Directed by Professor Val Stella

*Postdoctoral Fellow, Department of Pharmaceutical Chemistry

Research: Preformulation and Formulation of Anti-Cancer Agents directed by Professor Val Stella. Research was funded by the National Cancer Institute

UNIVERSITY OF PITTSBURGH (Pittsburgh, Pennsylvania) Directed by Professor Don

Abraham

*Postdoctoral Fellow, Department of Medicinal Chemistry

Research: Design, Synthesis, and Testing of Anti-Sickling Agents for the Treatment of Sickle Cell Anemia.

UNIVERSITY OF PITTSBURGH (Pittsburgh, Pennsylvania) Directed by Professor Paul Dowd

*Doctorate of Philosophy, Physical Organic Chemistry

Thesis: Study and Mechanisms of Action of Vitamins B12 and K. Directed by Professor Paul Dowd

THIEL COLLEGE (Greenville, Pennsylvania)

*Bachelor of Arts, Biology; Minor, Chemistry (Magna Cum Laude)

Affiliations

UNITED STATES PHARMACOPEIA (USP)

*Elected to serve on the USP Board of Revision for the 1990-1995 term. Reviewed and approved changes to current monographs and approved new monographs for the 22nd Edition of USP. Evaluated and recommended specifications and test methods for inclusion in monographs.

NATIONAL CANCER INSTITUTE

*Elected to two NCI Pharmaceutical Resources Branch study sections to review and award contracts and grants to various academic and related institutions.

Addendum Page One

Publications

*John-Lister James, Michael Pontecorvo, Chris Clark, Abhinay Joshi, Mark Mintun, Wei Zhang, Nathaniel Lim, Zhiping Zhuang, Geoff Golding, Seok Rye Choi, Tyler Benedum, Tyler Benedum, Paul Kennedy, Franz Hefti, Alan Carpenter, Hank Kung, Daniel Skovronsky, -Florbetapir F-18: aHistopathologically Validated Beta-Amyloid Positron Emission Tomography Imaging Agent-. Seminars in Nuclear Medicine Vol. 41, Issue 4, 300 (2011).

*P.F Winter, W.H. Charlton, D. Hiebert and P. Kennedy, -Selecting Contract Freeze-Drying Services-. Pharm Tech, February 2000.

*G. Csako, D.M. Corso, J. Kestner, A.D. Bokser, P.E. Kennedy and F. Pucino, -Evaluation of Two Over-The-Counter Natural Thyroid Hormone Preparations in Human Volunteers-. Ann-Pharmacotherapy 26(4), 492 (1992).

*N.P. Lam, P.E. Kennedy, P.F. Jarosinski and J.F. Gallelli, -Stability of Zidovudine in 5% Dextrose Injection and 0.9% Sodium Chloride Injection-. Am J Hosp Pharm 48(2) 280 (1991).

*P.E. Kintzel and P.E. Kennedy, -Stability of Amphotericin B in 5% Dextrose at Concentrations Used for Administration Through a Central Venous Line-. Am J Hosp Pharm 48(2), 283 (1991).

*P.E. Kintzel and P.E. Kennedy, -Stability of Amphotericin B in 5% Dextrose Injection at 25C-. Am J Hosp Pharm 48(8), 1681 (1991).

*J. K. Baltz, P.E. Kennedy and J.F. Gallelli, -Visual Compatibility of Foscarnet With Other Injectable Drugs During Simulated Y-Site Administration-. AM J Hosp Pharm 47(9), 2075 (1990).

*P.F. Jarosinski, P.E. Kennedy and J.F. Gallelli, -Trimethoprim-Sulfamethoxazole Stability Studies in Solutions Containing 5% Dextrose Injection or 0.9% Sodium Chloride Injection, AM J Hosp Pharm 46, 732 (1989).

*P.E. Kennedy, C.M. Riley and V.J. Stella, -Degradation of the Antineoplastic Drug Clomesone (NSC 338947). A Kinetic and Mechanistic Study-. International J. of Pharm. 48, 179 (1988).

*K. Umprayn, P.E. Kennedy, J.C. Lee, W. Waugh, C.M. Riley and V.J. Stella, -Stability Indicating Assays for Cyclodisone (NSC 348948) and Clomosone (NSC 338947) Using High Performance Liquid Chromatography on Polystyrene-divinylbenzene Support with Ultraviolet Detection of their Conjugate Bases in Alkaline Mobile Phases. Application to Stability and Solubility Studies-. J of Pharm and Biomed Analysis, 5(6) 625 (1987).

*D.J. Abraham, D.G. Gazze, P.E. Kennedy and M. Mokotoff, -Design, Synthesis and Testing of Potential Antisickling Agents 5. Disubstituted Benzoic Acids Designed for the Donor Site and Proline Salicylates Designed for the Acceptor Site-. J. Med. Chem. 27, 1549 (1984).

*D.J. Abraham, P.E. Kennedy, A.S. Mehanna, D. Patwa and F.L. Williams, -Design Synthesis and Testing of Potential Antisickling Agents 4. Structure Activity Relationships of Benzyoxy and Phenoxy Acids-. J. Med. Chem., 27, 967 (1984).

*P.E. Kennedy, F. Williams and D.J. Abraham, -Design Synthesis and Testing of Potential Antisickling Agents 3. Ethacrynic Acid-. J. Med. Chem. 27,103 (1984).

*D. J. Abraham, S.E.V. Phillips and P.E. Kennedy, -Methylphenylmercury: A Novel Heavy Atom Reagent for Protein Crystallography-. J. Mol. Biol. 170, 249 (1983).

*P. Dowd and P.E. Kennedy, -Convenient Preparation of Sodium and Potassium Phenyl Selenides, Reduction of the Selenium-Selenium Bond by Sodium and Potassium Borohydride-. Synthetic Comm. 11, 935 (1981).

*P.E. Kennedy, -Methodology for the Resolution of -Methylene- -Carboxy--Butyrolactone and the Synthesis of Carbon-13 Labeled Substrates for the study of the B12 Nonenzymatic Rearrangement of -Methylitaconate-. Ph.D. Thesis, University of Pittsburgh, PA (1982).

Addendum Page Two

Abstracts

*K. Amsberry, R. Rajewski and P.E. Kennedy, -Preformulation and Formulation Development of GEM and GEM132-. Presented at the 1997 AAPS meeting in Boston, MA, November 1997.

*K. Amsberry and P.E. Kennedy, -Parenteral Formulation Development of the Antisense Oligonucleotide GEM 91-. Presented at -Antisense 1997- Meeting in Cambridge, MA, May 1997.

*A.D. Bokser, G.E. Lee, S. Betageri, P.E. Kennedy and J.F. Gallelli, -Determination of the Stability of Oral Solutions of Dideoxycytidine by High Pressure Liquid Chromatography-. Presented at the 6th AAPS Meeting in Washington, DC, November 1991.

*C. Mazurek, P.E. Kennedy, J.F. Gallelli and B. Goldspeil, -Compatibility of Suramin and Hydrocortisone Succinate in Solution-. Presented at the Mideastern Pharmacy Residents Symposium, Atlantic City, NJ May, 1990.

*C. Mazurek, P.E. Kennedy and J.F. Gallelli, -Compatibility of Suramin and Hydrocortisone Sodium Succinate in Solution-. Presented at the Eastern States Pharmacy Residents Meeting, Boston, Massachusetts, April 1990.

*P.E. Kinsel, P.E. Kennedy and J.F. Gallelli, -Stability of Amphotericin B in 5% Dextrose at Higher Concentrations-. Presented at the Eastern States Pharmacy Resident Meeting, Boston, Massachusetts, April 1990.

*P.E. Kennedy, S. Chang and J.F. Gallelli, -Physical Compatibility of Foscarnet with Other Injectable Drugs During Simulated Y-site Administration. Presented at the 46th ASHP Midyear Meeting in Atlanta, Georgia, December 1989.

*P.E. Kennedy, S. Chang and J.F. Gallelli, -Formulation and Stability of D-tryp Luteinizing Hormone Releasing Hormone-. Presented at the 4th National Meeting of AAPS, Atlanta, Georgia, October 1989.

*A.D. Bokser, P.E. Kennedy and J.F. Gallelli, -Formulation and HPLC Analysis of Peptide T-. Presented at the 4th National Meeting of AAPS, Atlanta, Georgia, October 1989.

*J. Baltz, P.E. Kennedy and J.F. Gallelli, -Physical Compatibility of Foscarnet with Other Injectable Drugs During Simulated Y-site Administration-. Presented at Mideastern Pharmacy Residents Symposium. Atlantic City, NJ, May 1989.

*P.E. Kennedy, S. Chang and J.F. Gallelli, -HPLC Analysis of Bemegride Bulk Powder and Injectable Formulation at High pH Using a Styrene-Divinylbenzene Copolymer Column-. Presented at the 3rd National Meeting of AAPS in Orlando, Florida, October 1988.

*P.E. Kennedy and J.F. Gallelli, -Stability of Injectable Drugs in Different Intravenous Solutions and Containers-. Presented at the 45th Annual ASHP Clinical Meeting in San Francisco, California, June 1988.

*J. F. Gallelli, H. Mahar, K. Tonat and P. Kennedy, -Chemical Destruction Methods for Antineoplastic Drugs. Part II-. Presented at the 44th ASHP Clinical Meeting in Washington, DC, June 1987.

*P. E. Kennedy, C. M. Howard, P. McNeilly and J.F. Gallelli, -Analysis of Glycopyrrolate Bulk Powder, Tablets and Capsules by Ion-Pair HPLC-. Presented at the 2nd National Meeting of AAPS in Boston, Massachusetts, June 1987.

*J. F. Gallelli, H. Mahar, K. Tonat, P. Kennedy and P.C. Vaccari, -Chemical Destruction Methods for Antineoplastic Drugs-. Presented at the 21st Annual ASHP Midyear Clinical Meeting in Las Vegas, Nevada, December 1986.

*P.E. Kennedy, V.J. Stella, K. Umprayn, J.C. Lee and W. Waugh, -Assays for Two Investigational Cytotoxic Agents Cyclodisone and Clomesone-. Presented at the APhA/APS Meeting in Minneapolis, Minnesota, October 1985.

Addendum Page Three

*D.J. Abraham and P.E. Kennedy, -Use of Ethacrynic Acid as an Antisickling Agent-. Presented at the NHLB Sickle Cell Drug Conference at NIH, May 1983.

Presentations

*P.E. Kennedy, -Preformulation and Formulation of Antisense Oligonucleotides-. Presented at Merck, West point, PA, February.

*P.E. Kennedy, -Preformulation and Formulation of Antisense Oligonucleotides-. Presented at Genentech, South San Francisco, CA, February 1998.

*P.E. Kennedy, -Preformulation and Formulation of Antisense Oligonucleotides-. Presented at Alkermes, Cambridge, MA, January 1998.

*P.E. Kennedy, -Topical Formulations of Oligonucleotides for the Treatment of Psoriasis-. Presented at the Clinical Advisory Board Meeting at Hybridon, Cambridge, MA, March 1997.

*P.E. Kennedy, -IM/SC Formulations of Oligonucleotides-. Presented at the Clinical Advisory Board Meeting at Hybridon, Worcester, MA, October 1996.

*G. Grimes and P.E. Kennedy, -Pharmaceutical Formulation and Quality Control at the NIH Pharmaceutical Development Section-. Presented at the FDA, Rockville, MD, November 1987.

*P.E. Kennedy and V..J. Stella, -Preformulation and Formulation of the Antineoplastic Agent Clomesone-. Presented at Eli Lilly Company, Indianapolis, IN, August 1985.

*P.E. Kennedy and V..J. Stella -Preformulation and Formulation of the Antineoplastic Agent Clomesone-. Presented at Berlex Laboratories, Cedar Knolls, NJ, July 1985.

*P.E. Kennedy and V.J. Stella, -Preformulation and Formulation of the Antineoplastic Agent Clomesone-. Presented at the Clinical Centre of NIH, Bethesda, MD, July 1985.

*P.E. Kennedy and V.J. Stella, -Synthesis, kinetics and Analysis of Prodrugs of Rapamycin-. Presented at the Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS, November 1985.

*P.E. Kennedy and D.J. Abraham, -Phenylacetic Acid Derivatives as Antisickling Agents-. Presented at the Regional Medicinal Chemistry Conference in Columbus, OH, June 1982.

*P.E. Kennedy, -The use of T1 Relaxation Rates to Monitor the Movement of Water Across the Red Cell Membrane in the Presence of Cetiedil-. Presented at the University of Pittsburgh Chemistry Department, Pittsburgh, PA, June 1981.

Patents

*-Crystalline Trimetrexate and the Process for Making the Same-. P. E. Kennedy, P. Morsdorf, I. Graffe and K. Ahrens. US Patent No. 5,716,960

*-Crystalline Amifostine Compositions-, P.E. Kennedy, R.A. Rajewski and J.M. Baldoni, US Patent No. 5,591,731

*-Crystalline Amifostine Compositions and Methods for the Preparation and Use of Same-, P.E. Kennedy, R. Rajewski and J. Baldoni. US Patent No. 5,424,471

*-Prodrugs of Rapamycin-, V.J. Stella and P.E. Kennedy. US Patent No. 4,650,803

*-Ethacrynic Acid: Its use As An Antisickling Agent-, D.J. Abraham and P.E. Kennedy. US Patent No. 4,887,995

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