SUMMARY OF QUALIFICATIONS

• Expertise in formulation and process development/validation and preformulation. Developed several oral solid dosage forms including tablets and capsules, oil-filled hard gelatin capsules, Injectable/Nasal solution formulations and lyophilized products.

• Recognized as knowledgeable in analytical method development and validation, process and equipment validation. Developed and executed protocols for validation work of solid and topical dosage forms.

• Hands-on knowledge of large-scale manufacturing of solid, semisolid and liquid dosage forms.

• Hands-on knowledge of writing the CMC portions in IND, NDA and ANDA filings.

• Worked with CRO’s and CMO’s since June 2005

I worked on the following molecules so far, which are in the market:

Drug Name Product Name

Butorphenol Stadol

Chlorpropamide Diabenese

Cholestyramine Questran

Citalopram Celexa

Etoposide Vepesid

Gatifloxacin Tequin

Isotretinoin Accutane

Levofolinic acid Fusilev

Megesterol Megace

Memantin Axura

Metformin/Glyburide Glucovance

Nefazodone Serzone

Pravastatin Pravachol

Progesterone Progestin

Sotalol Betapace

Sulfamethoxazole/Trimethoprim Cotrimaxazole

Sumatriptan Imitrex

Tetracylcine Terramycin

Tolbutamide Orinase

Tretinoin Retinoic acid capsules

PROFESSIONAL EXPERIENCE

May 2008 to November 2009, PharmaBioServe, Puerto Rico, Consultant at Johnson & Johnson

Product Development

• Evaluated various 360° spray packaging options for a liquid product, supervised extractable testing and spray analysis, Worked with Analytical R&D to conduct photostability and chemical stability experiments. Completed successful manufacture of development and registration batches.

Packaging Issue

• Conducted experiments to evaluate the depth of packaging issue for a cream product. Proposed solution to the problem and conducted line-trials following by a validation batch. The packaging issue was resolved with the new packaging configuration.

Manufacture of validation batches and packaging

• Supervised manufacture of validation batches and packaging operations (tube and bottles).

August 2007 to March 2008, Director, Product Development, PTC Therapeutics, South Plainfield, NJ

Management of Clinical Supply manufacturing

• Responsible for the manufacture of large-scale clinical batches a solid-dosage form with a CMO (roller compaction process). Proposed the process refinement based on in-house experimentation.

• Responsible for packaging of granules of the same product in sachets.

• Responsible for the manufacture of clinical batches of solid dispersion formulation filled in hard gelatin capsules. Implemented a new in-process microscopy test according to PAT initiatives.

• Initiated ICH stability studies on both the products.

• Worked with QA on a daily basis on various aspects.

Product Development

• Resolved batch failure issue of a solid dispersion product by determining an appropriate highest strength for the product.

• Developed a tablet formulation of an absolutely water insoluble molecule by conversion of the crystalline API to an amorphous form and stabilizing it. Produced the low bulk density complex to granules by the roller compaction process and made tablets. Scaled up the manufacture of the same in a very short time.

Preformulation

• Identified a CRO to conduct salt selection and polymorphism studies for two products. Finalized protocols and wrote contracts.

Reason for the Job Change

To be discussed in person.

January 2006 to July 2007 Director, Product Development, Spectrum Pharmaceuticals, Irvine, CA

Project Leader

• Led the team for the first NDA product. Duties involved project planning, and scheduling of activities, conducting team and sub-team meetings.

• Conducted market analysis of the product in Europe and Japan (the product is being sold in those regions) and propose strategies to upper management. Provide recommendations

• Led a team to select the brand name of the product.

• Managed project negotiations, due diligence, accounting, budgeting and facilitate / oversee project development with CRO’s and CMO’s.

Manufacture of Clinical Supplies

• Technology Transfer to a CMO in Baltimore. Resolve Engineering batch failure and process problems by recruiting an expert lyophilization CRO.

• Successfully manufactured clinical supply batches.

• Completed the release of batches and initiation of stability studies.

• Worked closely with the QA group to write SOP and manufacture clinical supplies (non-conformances, investigations, specifications etc.)

NDA filing

• Reviewer of the CMC section for the NDA filing, NDA approved in March 08.

• Led discussions among team members to decide the brand name of the product.

Development of Products

• Initiated the product development activities for the RTU liquid and tablet (controlled release) formulations for the lead product.

• Successfully developed a RTU injectable formulation for another project. Performed method development and initial validation.

• Developed a Nasal-Spray formulation. Involved in formulation development and characterization of spray performance (plume geometry, plume angle etc.) to match with the brand product.

• Developed the granulation process for a tablet formulation. The drug loading was about 80% and the API had very poor flow properties. Developed a simple granulation process using water.

Reason for the Job Change

I was staying by myself in CA and my family was in NJ. We decided not to relocate to CA and I took up a job in NJ.

June 2005 to December 2005, Director, Formulation, Metaphore Pharmaceuticals, Fort Lee, NJ

• Successfully increased the bioavailability of a highly water-soluble/ low permeability drug from 1% for the IR tablets to 25% for the softgel formulation.

• Designed a pulmonary drug delivery device for powder inhalation to minimize patient-dependency during usage. Completed a draft patent.

• Participated in intellectual property discussions, contract negotiations, purchasing agreements and technical brainstorming.

Reason for the Job Change

The company was taken over by ActivBiotics and all employees were let go.

January 2003 to May 2005, Associate Director, Formulation Development, Barr Labs, Pomona, NY

Team Leader

• Team Leader for several projects. Planned and coordinated project activities.

• Worked with cross-functional groups including scientific affairs, analytical, quality assurance, compliance, regulatory affairs, marketing, and manufacturing.

Formulation Development

• Characterized brand formulations and developed bioequivalent formulations. Three difficult-to-pass bio-study projects approved - which included immediate release, controlled release and liquid-filled hard gelatin capsule formulations. Obtained ANDA’s for these products. Many projects were discontinued for business reasons.

• Conducted process hazard analysis for a product (API causes birth defects) and developed a suitable manufacturing process to minimize drug exposure to employees.

• Involved in the development of orally disintegrating tablets, and lollipops for pain.

Compliance Worked closely with QA to develop SOP’s, and change control protocols.

Reason for the Job Change

I started the formulation group at Metaphore and intended to set up the department after the scheduled IPO.

August 2000 to December 2002, Manager, Preformulation/Exploratory Biopharmaceutics

Forest Laboratories, Inc., Inwood, NY

Preformulation Lab set up

• Initiated and developed the Preformulation group at Forest Labs. Purchased necessary instruments and hired scientists.

• Main scientific functions of the group were – generation and characterization of polymorphs, drug stability of API in solid and solution states, photostability, drug stability of formulations, and advanced microemulsion system.

• Set up Caco-2 lab.

• Designed a new in vitro dissolution model for oral administration, which encompassed various aspects occurring in vivo - dissolution, degradation, metabolism, protein binding and elimination.

IVIVC and BCS

• Developed IVIVC for memantine. Contributed to NDA towards the BCS section.

Reason for the Job Change

I missed formulation work at Forest and Barr offered me an opportunity to work in the formulation group. More importantly, I wanted to learn about generic industry.

June 1991-July 2000, Research Investigator II, Bristol-Myers Squibb, New Brunswick, NJ

Drug Discovery Support

• Represented Pharm R&D on several drug discovery projects. Involved in discussion with team members in selection of final drug molecules in the projects.

Preformulation Work

• Conducted and documented physicochemical characterization of several compounds. The studies involved thermal analysis, x-ray diffraction, pH-solubility, pH-partition coefficient, solution-state and solid-state stability, drug-drug interaction, microscopy, polymorphism issues etc.

• “Form” Team Leader for a major project.

Formulation Development

• Developed intravenous (small-volume and large-volume), oral liquid, conventional capsule, controlled release and solid dispersion (in hard gelatin capsule) formulations involving: drug-excipient compatibility study, development and stability study of prototype formulations, stability of IND formulations,

• Wrote specifications for the IND formulations.

• Wrote reports on formulation development and supported IND-filing and

• Wrote cleaning validation reports.

• Developed a solid dispersion formulation for a water-insoluble drug, which showed 18 times higher bioavailability than conventional capsule dosage form in dogs.

Reason for the Job Change

I was offered a better and challenging job opportunity at Forest Lab to set up the preformulation group.

August 1983 to August 1985, Manufacturing/Packaging Chemist, Glaxo Laboratories (I) Ltd., Nasik, India

• Manufacturing and Packaging Chemist for liquid, semi-solid and solid dosage forms.

Reason for the Job Change

I left Glaxo to pursue higher education in the US.

EDUCATION

• MBA (International Business), Fairleigh Dickinson University, Teaneck, NJ, 2001

• Ph.D. (Pharmaceutical Chemistry), University of Kansas, Lawrence, KS, 1991

• M.Pharm. (Biopharmaceutics), University of Bombay, Bombay, India, 1983

• B.Pharm., University of Bombay, Bombay, India, 1980

OTHER PROFESSIONAL ACCOMPLISHMENTS

Leadership Roles

• American Association of Indian Pharmaceutical Scientists (AAiPS) - Secretary (1999-2000).

• AAiPS News-letter editor (2006-2007).

• American Pharmaceutical Reviews - Editorial Advisory Board, since 2006.

• Southern California Pharmaceutical Discussion Group (SCPDG affiliated to AAPS) – Chairman, 2007.

• Member of Strategic Membership Committee of AAPS.

Moderator

• Roundtable in AAPS - Cultural Diversity in American Pharmaceutical Industry, 2000 and Dissolution Testing and IVIVC, 2003.

• Two-day conference - Lipid Formulations sponsored by Barnett International, Philadelphia, September 2004.

• Two-day conference - Nanotechnology in Pharmaceutical industry sponsored by Barnett International, March 21-22, 2005.

• Speaker and moderator at the Fine Particle Society Conference, San Diego, December 2006.

Invited Presentations

• Biopharmaceutics Classification System and in vitro–in vivo correlations, American Association of Indian Pharmaceutical Scientists (AAiPS) Dinner Discussion Series, New Brunswick, NJ, April 13, 2001.

• Synergism of Cyclodextrins/microemulsions to improve solubility of progesterone, Barnett International, September 28-29, 2004.

• Applications of Nanotechnology in Pharmaceutical Industry, Hosokawa Micron Group, Summit, NJ, April 12, 2005.

• Solubility of Drugs, Speaker in the General Session at the IVT conference held in Brussels, Belgium, June 2005.

• Lipid drug delivery, a 3-hour workshop at the IVT conference held in Brussels, Belgium, June 2005.

• Nanotechnology in Pharma Industry: An overview, Particle 2006 conference, Orlando, FL, May 2006.

• Application of Nanotechnology in Pharma Industry, The Fine Particle Society conference, San Diego, CA, December 2006.

Publications

1. Drug Development and Imperfect Design, Hemant N. Joshi, Int. J. Pharm. 343 : 1-3 (2007).

2. Review of Lipids in Drug Delivery Systems– Part II, Hemant N. Joshi and Navnit Shah, Am. Pharm. Reviews 8 : 120-126 (2005).

3. Review of Lipids in Drug Delivery Systems – Part I, Hemant N. Joshi and Navnit Shah, Am. Pharm. Reviews 8 : 70-78 (2005).

4. Summary Workshop Report: Biopharmaceutics Classification System – Implementation challenges and Extension opportunities, James Polli, Hemant N. Joshi et al., J. Pharm. Sci. 93 : 1375 – 1381 (2004).

5. Bioavailability Enhancement of a Poorly Water-Soluble Drug by Solid Dispersion in Polyethylene Glycol-Polysorbate 80 Mixture, Hemant N. Joshi, Ravindra W. Tejwani, Martha Davidovich, Vaishali P. Sahasrabudhe, Mohammed Jemal, Mohinder S. Bathala, Sailesh A. Varia and Abu T.M. Serajuddin, Int. J. Pharm. 269 : 251 – 258 (2004).

6. Characterization of dexloxiglumide in vitro biopharmaceutical properties and active transport, Sanna Tolle-Sanders, Andreas Grill, Hemant Joshi, Ram Kapil, Stefano Persiani and James E. Polli, J. Pharm. Sci. 92 : 1968 - 1980 (2003).

7. Study of Isopropyl Myristate Microemulsion Systems containing cyclodextrins to improve the solubility of 2 model hydrophobic drugs, Indranil Nandi, Mohammad Bari and Hemant N. Joshi, AAPS PharmSciTech 4, Article 10 (http://www.pharmscitech.org), (2003).

8. Analysis of Indian Pharmaceutical Industry with emphasis on Opportunities in 2005. Hemant N. Joshi, Pharm. Tech. 27: 74- 94 (2003).

9. Synergistic effect of PEG-400 and cyclodextrin to enhance solubility of progesterone, Indranil Nandi, Mohammad Bari, Michelle Bateson and Hemant N. Joshi, AAPS PharmSciTech 4, Article 1 (http://www.pharmscitech.org), (2003).

10. Advantages of cultural diversity in the pharmacy workplace, Hemant N. Joshi and Prasanna Gore, J. Managed Pharm. Care 1: 83-84 (2001).

11. Study of phase behavior of polyethylene glycol-polysorbate 80, and polyethylene glycol-polysorbate 80-water mixtures, Ravindra Tejwani, Hemant N. Joshi, and Abu T.M. Serajuddin, J.Pharm. Sci. 89:946-950 (2000).

12. Photostability and transmittance of four commercially available plastic wraps, Hemant N. Joshi, Susan Farmicola, James L. Pazdan, and Patrick Carpenter, Pharm. Tech. 74, 76, 78, 80, 82, 129 (April 2000).

13. Differentiation of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors by their relative lipophilicity, Hemant N. Joshi, Michael G. Fakes, and Abu T.M. Serajuddin, Pharm. Pharmacol. Commun. 5: 269-271 (1999).

14. Drug evaluation -Lintitript, Joshi, HN, Investigational drug database (Current Drugs), June 1998.

15. Calorimetric evaluation of hydration of cholestyramine, H.N. Joshi and T.D. Wilson. J. Pharm. Pharmacol. 47: 188-192 (1995).

16. Calorimetric studies on dissolution of hydroxypropyl methylcellulose E5 (HPMC E5) in water. H.N. Joshi and T.D. Wilson. J. Pharm. Sci. 82 : 1033 - 1038 (1993).

17. Drug release from membranes of hyaluronic acid and its esters. H.N. Joshi, V.J. Stella and E.M. Topp, J. Controlled Rel. 20: 109 - 122 (1992).

18. Hydration in hyaluronic acid and its esters using differential scanning calorimetry. H.N. Joshi and E.M. Topp, Int. J. Pharm. 80 : 213 - 225 (1992).

19. Dosage forms from polymeric prodrugs : Hydrocortisone esters of hyaluronic acid. L.M. Beneditti, H.N. Joshi, L. Goei, J.A. Hunt, L. Callegaro, V.J. Stella, and E.M. Topp, New Polymeric Mater. 3: 41 - 48 (1991).

20. Polymeric prodrugs : Recent experience with devices formed from steroid esters of hyaluronic acid. H. Joshi, L. Hume, L. Beneditti, L. Callegaro, V. Stella and E. Topp, Book on the Proceedings of the Fourth International conference on polymers in medicine : Biomedical and pharmaceutical applications, Riva del Garda, Italy, September, 1990.

21. Diffusion and drug release in polymer films prepared from ester derivatives of hyaluronic acid. J.A. Hunt, H.N. Joshi, V.J. Stella and E.M. Topp, J. Controlled Rel. 12: 159 - 169 (1990).

22. Microwave drying in aqueous film coating : study on free films. H.N. Joshi, M. Kral, and E.M. Topp, Int. J. Pharm. 51 : 19 - 25 (1989).

23. Recent advances in drug delivery systems: Polymeric prodrugs. H.N. Joshi, Pharm. Tech. 12: 118 - 130 (1988).

24. Spectrophotometric determination of cation concentration in olfactory mucus (NSL 04959). H.N. Joshi, M.L. Getchell, B. Zielinski and T.V. Getchell, Neuroscience Letters 82: 321 - 327 (1987).

25. Bioavailability of ten tetracycline formulations marketed in India. A.K. Kane, H.N. Joshi and H.P. Tipnis, Indian Drugs 21 : 229 - 232 (1983).

26. In-vitro availability studies of tetracycline products marketed in India. S.A. Kanvinde, H.N. Joshi, G.N. Chaudhari and H.P. Tipnis, Indian Drugs 20: 151 - 159 (1983).

27. Project report for The Indian Council of Medical Research, New Delhi, 1982. Title : Bioavailability study of tolbutamide and chlorpropamide formulations in human subjects.

28. Spectrophotometric determination of sulfamethoxazole and trimethoprim in cotrimaxazole tablets. H.N. Joshi, G.N. Chaudhari and H.P. Tipnis, Indian Drugs 19 : 446 - 450 (1982).

VISA STATUS: US Citizen

REFERENCES: Available upon request

Contact this candidate