Director of Chemistry

VIRENDRA KUMAR, Ph.D.

** ******** ***** *****

Wappingers Falls, NY 12590

kumarv01@.yahoo.com

Home: 845-***-**** Cell: 610-***-****

SUMMARY OF EXPERIENCE

Extensive pharmaceutical industry experience in the development of drugs from R&D through the marketing approval. Scientific & strategic leadership’s skills in organic chemistry for early drug discovery and developmental programs, Expert in organic/medicinal chemistry, process development/optimization and manufacturing of complex molecules from lab to commercial scales. Strong understanding of polymorphism, bio-catalysis, process chemistry, peptides, and knowledge of green chemistry. Review and evaluate synthetic accessibility, preclinical pharmacokinetic, pharmaco-dynamic and toxicological data to determine developmental potential of compounds. Author of CMC sections of INDs and NDA submissions and intellectual property applications. Utilize excellent communication skills to coordinate initiatives between diverse departments and deliver excellent service to internal and external customers with concise reports and informative presentations. Experience in internal and external contract manufacturing and selection of CMO,s worldwide in GLP and cGMP environments. Manage a team of 10-15 internal and 20-25 external scientists of various departments. Ability in budgeting process, project strategies, managing timelines, resources, in- licensing of compounds, and evaluate the performances of CMO’s.

PROGENICS PHARMACEUTICALS INC., Tarrytown, NY Oct 2007 – Feb 2010

Senior Director, Process Chemistry and R & D

Responsible for API process development activities for MNTX (Relistor®) manufacturing

•Involved in the development of lead and developmental compounds for HCV entry and PI3K inhibitors for HCV and Oncology programs. Suggested syntheses and modification of compounds based upon the Structure-Activity Relationships.

•Participated in the R&D reviews and discussions and presented the updates to senior managements

•Responsible for the selection of external contract manufacturing facilities for the synthesis of MNTX and other development compounds.

•Chose the CMO’s based upon the site visits and with the help of consultants

•Involved in the R & D departmental budget planning. Put together and manage the operational budget and timelines of the Chemistry group

•Supervised Directors of Medicinal and Analytical Chemistry & CMC

•Responsible for all Progenics small molecule API process development and manufacturing

•Acted as a liaison to small molecule research programs transitioning to development

•Reviewed the Regulatory submission documents for MNTX and other program

ADOLOR CORPORATION, Exton, PA Nov 1995 – Sept 2007

Senior Director, Process Chemistry (Nov 2005 - Sept 2007)

Responsible for all Process Chemistry activities associated with the development of development compounds

•Managed and supervised technical transfer of chemical processes and analytical methods for scale-up manufacturing at contract research and manufacturing organizations

•Authored appropriate sections of CMC regulatory submissions (IND and NDA). Entereg® approved for the treatment of post operative ileus (POI)

•Selected contact manufacturing sites in North America and Europe for the manufacturing of Entereg®, for the registration batches, validation batches and analytical support

•Managed the budget and timelines effectively to deliver final product

•Represented Process Chemistry on development project team

•Worked closely with drug product development and packaging of drug product for clinical usage

•Supervised in-house process development and project manager

Director, Process Chemistry (2001- 2005)

Responsible for managing various manufacturers and partners of Adolor’s lead compounds providing technical expertise.

•Involved in improvements, simplifications and cost effectiveness of the current processes

•Achieved the highest standard in design and control of processes for API in a timely manner

•Extensive knowledge of synthetic organic chemistry and cGMP requirements

•Presented senior management critical evaluation of vendors and provided recommendations

•Responsible for drug substance section of CMC for the submission of INDs and NDAs

•Interacted with FDA regarding the CMC topics during IND, end of phase two and pre-NDA meetings

•Worked closely with Quality Assurance and Regulatory Affairs Departments to resolve any cGMP and CMC issues

•Assisted Commercial Manufacturing group during Validation Process of Adolor lead compounds

•Managed several million-dollar budget and time lines of deliverables from manufacturers

•Supervised Project Manager of Process Chemistry

Assistant Director, Process Chemistry (2000 – 2001)

Responsible for manufacturing of all the development candidates for pre-clinical and clinical studies

•Negotiated the contracts and managed the manufacturing process, especially devoted to the timelines and expenses

•Managed the CMC section of the IND and NDA

Assistant Director, Medicinal Chemistry (1999 - 2000)

Responsible for the chemistry group and served as a liaison between chemistry and biology groups

•Directed and synthesized compounds for central/peripheral kappa, mu antagonist, and nociceptin (ORL-1) programs. Two of the kappa agonists are currently in phase I human clinical trials and one is in pre-clinical development as backup

•Patent coordinator of the company

Senior Research Fellow, Medicinal Chemistry (1995 - 1998)

•Established the chemistry department and recruited Ph.D. and B.S./M.S. scientists.

•Designed and synthesized novel peripherally active kappa agonists and mu antagonists.

•Prepared the current lead compound and the backup compounds for the programs.

SANOFI WINTHROP INC., Malvern, PA Aug 1981 - Oct 1995

Principal Research Investigator, Chemical Development (1994 - 1995)

Responsible for technology transfer of anti-cancer project

•Improved the existing procedures that would be amenable for large-scale preparations

•Synthesized compounds following GLP and GMP guide lines

•Validated manufacturing processes

Principal Research Investigator/Supervisor, Neuroscience Program (1991-1994)

•Designed and synthesized a unique series of NMDA channel blockers for neurodegenerative diseases

•Accomplished the separation of psychotomimetic and cardiotoxicity liabilities of this series of compounds

•Separated the enantiomers of these compounds either by diastereoisomeric crystallization or chiral HPLC procedures

•Collaborated with pharmacology, biology, and toxicology representatives of the team

•Organized the biological data and presented in the meetings

•Served as a project chemist for the program

•Supervised B.S. and Ph.D. scientists

Senior Research Investigator/Supervisor, Cardiovascular Program (1989 -1991)

•Synthesized potent, selective, and orally active cAMP-PDE III (adenosine 3',5'-cyclicphosphate phosphodiesterase) inhibitors, having longer duration of action than Milrinone for congestive heart failure.

•Prepared most potent and selective inhibitors of cGMP-PDE V (guanosine 3',5'- cyclicphosphate phosphodiesterase).

•Served as co-project chemist.

•Supervised B.S. and Ph.D. scientists.

Research Investigator/Supervisor, Human Leukocyte Elastase Program (1984 -1989)

Human Leukocyte Elastase Program

•Proposed and synthesized 2,6-disubstituted aryl carboxylic acid leaving groups for benzisothiazolone inhibitors of HLE for emphysema and related diseases: compounds have good bioavailability and orally active in animal models

Endocrinology Program

•Synthesized A-Ring fused furanosteroids as orally active pituitary gonadotropin inhibitors as back up to Danazol for endometriosis

•Prepared pro-drugs of Danazol resulting in improved bioavailability

•Devised the syntheses of methyl sulfonylfuranosteroids as potent orally active antiandrogens for BPH and prostate cancer

Principal Research Scientist, Analgesics/Rheumatology Program (1981 -1984)

•Prepared aminoalkyl indole derivatives related to pravadoline as non-opiate analgesics

•Proposed and synthesized C-attached N-heteryl indoles as metabolically stable derivatives that resulted in potent antinociceptive compounds

•Invented and synthesized morpholinoalkylindenes as potent agonists of cannabinoid receptor having analgesics and antiglaucoma activities

•Served as co-project chemist for the rheumatology program

STATE UNIVERSITY OF NEW YORK, Syracuse, NY 1979 – 1981

Research Associate - College of Environmental Science and Forestry

•Prepared 2,3-unsaturated derivatives of N-acetylneuraminic acid as potent transition state inhibitors of neuraminidase.

•Used column chromatography, TLC, HPLC, GC, and other modern analytical methods to separate and identify the complex products.

UNIVERSITY OF ARIZONA, Tucson, AZ 1976 - 1979

Research Assistant Professor (1977-1979)

•Prepared 2"-deoxy Kanamycin and Amikacin antibiotics. Devised a novel route for Amikacin antibiotic and executed the synthesis.

•Accomplished syntheses, structural modifications, and structure-activity relationships studies in the areas of aminoglycosides and antitumor antibiotics.

Research Associate (1976 - 1977)

•Synthesized epimino-aminoglycosides and modified analogs of ribostamycin antibiotic.

PURDUE UNIVERSITY, W. Lafayette, IN 1975 - 1976

Postdoctoral Fellow

•Prepared semi-synthetic aminoglycoside antibiotics.

EDUCATION

Ph.D. State University of New York at Buffalo, Buffalo, NY.

AWARDS

-Vision Accomplishment Award (Sanofi Winthrop)

-Vision Accomplishment Award (Sterling Winthrop)

-Gold Award, Team Achievement Award (Eastman Kodak Co.)

-Vision Accomplishment Award (Sterling Winthrop)

-Research Fellowship (SUNY at Buffalo).

PROFESSIONAL AFFILIATIONS

American Chemical Society

Organic Chemistry Division

Medicinal Chemistry Division

Drug Information Association (DIA)

TOTAL PUBLICATIONS: 43

RECENT PUBLICATIONS

1. William G. Earley, John P. Mallamo, Virendra Kumar, Chakrapani Subramanyam, John A. Dority, Jr., Matthew S. Miller, Diane L. DeHaven Hudkins, Lisa D. Aimone, Brian Ault " Novel Benzo[b]quinolizinium Cations as Uncompetitive NMDA Antagonists: The Relationship Between Log D and Closed vs Open Channel Block" J. Med. Chem., 38, 3586 (1995).

2. Michael A. Eissenstat, Malcolm R. Bell, Thomas E. D'Ambra, E. J. Alexander, Sol J. Daum, James H. Ackerman, Monte D. Gruett, Virendra Kumar, Kimberley G. Estep, E. M. Olefirowicz, Joseph R. Wetzel, Michael D. Alexander, John D. Weaver, III, Dean A Haycock, Daniel A. Luttinger, Frances M. Casiano, Susan M. Chippari, Joan E. Kuster, Joan I. Stevenson, Susan J. Ward "Aminoalkylindoles: Structure-Activity Relationships of Novel Cannabinoid Mimetics", J. Med. Chem., 38, 3094 (1995).

3. Thomas E. D’Ambra , Michael A. Eissenstat, Jeffrey Abt, James H. Ackerman, Edward Bacon, Malcolm R. Bell, Philip M. Carabateas, Kurt A. Josef, Virendra Kumar, John D. Weaver, III, Renee Arnold, Frances M. Casiano, Susan M. Chippari, Dean A. Haycock, Joan E. Kuster, Daniel A. Luttinger, Joan I. Stevenson, Susan J. Ward, Alexandros Markriyannis, Atmaram Khalanknor, W. Adam Hill “C-Attached Aminoalkylindoles: Potent Cannabinoid Mimetics’, Bioorg. Med. Chem. Lett. 6, 17 (1996).

4. Virendra Kumar, Michael M. Marella, Diane L. DeHaven-Hudkins, Luz C. Cortes Burgos, Joel A.Cassel, Jeffery D. Daubert, Robert N. DeHaven, Susan L. Gottshall, Erick Mansson, and Alan Maycock “Arylacetamides As Peripherally Restricted Kappa Opioid Receptor Agonists”, Bioorg. Med. Chem. Lett., 10, 2567 (2000).

5. Diane L. DeHaven-Hudkins, Alan Cowan, Luz C. Cortes Burgos, Joel A.Cassel, Jeffery D. Daubert, Robert N. DeHaven, George B.Kehner, Virendra Kumar “Antipruritic and Antihyperalgesic Actions of Loperamide Analogs”, Life Science, 23, 2787 (2002).

6. Virendra Kumar, Deqi Guo, Joel A.Cassel, Jeffery D. Daubert, Robert N. DeHaven, Diane L. DeHaven-Hudkins, Erin K. Gauntner, Susan L. Gottshall, Susan L. Greiner, Michael Koblish, Patrick J. Little, Erick Mansson, and Alan Maycock “Synthesis and evaluation of novel peripherally restricted kappa opioid receptor agonists”, Bioorg. Med. Chem. Lett., 15, 1091 (2005).

7. Virendra Kumar, Deqi Guo, Jeffery D. Daubert, Joel A.Cassel, Robert N. DeHaven, Erick Mansson, Diane L. DeHaven-Hudkins and Alan Maycock “Amino acid conjugates as kappa opioid receptor agonists”, Bioorg. Med. Chem. Lett. 15, 1279 (2005).

8. Virendra Kumar, Deqi Guo, Michael Marella, Joel A. Cassel, Robert N. DeHaven, Jeffrey D. Daubert, and Erik Mansson “"Use of Receptor Chimeras to Identify Small Molecules with High Affinity for the Dynorphin A Binding Domain of the Kappa Opioid Receptor", Bioorg. Med. Chem. Lett. 18, 3667 (2008).

TOTAL PATENTS: 53

RECENT PATENTS

1. U. S. Patent 6, 057, 323 (2000); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

2. U. S. Patent 6, 156, 769 (2000); Kappa Agonists Anti-Pruritic Pharmaceutical Formulations and Method of Prevention and Treating of Pruritus Therewith.

3. U. S. Patent 6, 180, 623 (2001); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

4.U. S. Patent 6, 239, 154 (2001); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

5. U. S. Patent 6, 303, 611 (2001); Kappa Agonists compounds Pharmaceutical Formulations Thereof.

6. U. S. Patent 6, 391, 910 (2002); Kappa Agonists compounds Pharmaceutical Formulations Thereof.

7. U. S. Patent 6, 476, 063 (2002); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

8. U. S. Patent 6, 486, 165 (2002); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

9. U. S. Patent 6, 492, 351 (2002); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

10. U. S. Patent 6, 750, 216 (2004); Kappa Agonists compounds Pharmaceutical Formulations Thereof.

11. U. S. Patent 6, 960, 612 (2005); Kappa Agonists compounds Pharmaceutical Formulations and Method of Prevention and Treatment of Pruritus Therewith.

12. U. S. Patent 7, 294, 647 (2007); Kappa Agonists compounds Pharmaceutical Formulations Thereof.

13. U. S. Patent Application 2007/00882053 A1 (2007); Solid Dispersions of Opioid Antagonists.

14. WO 2009/132313 A2 (2009); Morphinan Derivatives of Organic and Inorganic Acids

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