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Pravin Chaturvedi
CONFIDENTIAL
2015
Pravin R. Chaturvedi, Ph.D.
27 Jenkins Road, Andover, MA 01810
Telephone: (978) 623-0053 Fax: (978) 623-0071, Mobile: 978-973-5271
Email: [email protected], [email protected]
More than 25 years of Experience in the Pharmaceutical Industry Ranging from Start-Up Drug
Discovery through Late-Stage Development, and Financing, Partnering & Commercialization
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Experienced in founding, managing, financing, and directing start-up pharmaceutical
companies (Scion, IndUS, Napo, Oceanyx)
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Held multiple leadership and Board positions (CEO/CSO and Member of Board of
Directors and/or Advisory Boards) in multiple institutions, both for profit and non-profit
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Experienced in discovery and development of novel drugs and managing their development
for global commercialization – leading to successful commercialization of multiple drugs
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Successfully participated in the discovery and/or development of six currently marketed drugs
for the treatment of CNS disorders, HIV and hepatitis C
Co-founded and led multiple new biotech companies (Scion Pharmaceuticals, IndUS
Pharmaceuticals and Oceanyx Pharmaceuticals)
Successfully built a product pipelines in CNS, CV, cancer, GI and diabetes therapeutic areas,
leading to rapid advancement of pipelines for multiple start-up companies
Successfully created a bi-continental, cross-border new drug R&D pharmaceutical company
(IndUS Pharmaceuticals) and its Indian subsidiaries (Sindu Pharmaceuticals Pvt Ltd and
Sindu Research Laboratories Pvt Ltd)
Scion Pharmaceuticals sold to Wyeth (now Pfizer) and IndUS Pharmaceuticals was acquired
by London Stock Exchange (LSE)-based, San Francisco headquartered Napo Pharmaceuticals
Re-structured Napo Pharmaceuticals and focused the resources on the lead gastrointestinal
(GI) product and advanced it successfully through the completion of pivotal clinical trials
Successfully partnered the lead Napo’s GI product with a major pharmaceutical company
with a GI therapeutic focus
Successfully spun out the preclinical assets from Napo and re-initiated the preclinical
programs for IndUS Pharmaceuticals
Completed acquisition of a Bay area biotech company (Applied Protein Sciences) to
supplement the IndUS preclinical programs
Experienced in deal making including licensing, mergers and acquisitions, spin-outs and
financing biotech enterprises
Established partnerships and managed alliances with pharmaceutical companies in the United
States, Europe, Japan and India
Experienced in business development activities associated with early-stage pharmaceutical
companies – both in acquisition of assets as well as out-licensing
Very experienced in recruiting and retaining experienced senior management staff across
scientific, business, finance and operations in the pharmaceutical sector
Successfully raised multiple rounds of financing through venture, debt and other modes of
financing for biotech companies
Experienced in all aspects of pharmaceutical scientific, operational, business and corporate
development strategies for value creation and growth opportunities
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Broad experience across all aspects of the pharmaceutical industry – including drug
discovery, development, delivery, manufacturing and commercialization for new drugs
Curriculum vita
1
Pravin Chaturvedi
CONFIDENTIAL
2015
Experienced in all Aspects of Drug Discovery, Development, Partnering and Commercialization
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Highly experienced leader of multidisciplinary teams which include business, finance, legal,
operations and scientific personnel
Successfully designed a new two-stage adaptive clinical trial design for a pivotal phase 3
study for a first-in-class drug and successfully negotiated the special protocol assessment
requirements with the FDA to allow the conduct and successful completion of the trial
Trained as a pharmaceutical scientist (pharmacologist) and experienced in establishing drug
development ventures culminating in clinical candidates and drugs
Successful member of drug development teams for five commercialized new drug products –
amprenavir, fosamprenavir, fosphenytoin, gabapentin and tacrine
Successfully led the “turn around” efforts for a lead GI product (crofelemer) culminating in
the successful completion of a pivotal phase 3 trial and out-licensing the program to a
pharmaceutical partner
Very experienced in drug discovery and/or development of new drugs for enzyme targets
(kinases and proteases) and ion channel (voltage- and ligand-gated) drug targets
Experienced in drug development of antivirals, anti-inflammatory, cancer,
hemoglobinopathies, immunosuppression and CNS agents
Successfully led to the discovery and IND filing of many novel, first-in-class drugs across
various enzyme and ion channel targets
Broad experience in global regulatory drug development strategies (across US, Europe &
Japan)
Successfully entered into and managed several corporate partnerships with large
pharmaceutical companies
Consultant/Mentor on broad life science business strategies, R&D plans for drug
development, as well as development of commercialization plans for life science intellectual
property
Preclinical & clinical pharmacology and clinical development of novel drug candidates
Broad experience in drug development across several therapeutic areas , including CNS,
oncology, inflammation, immunosuppression, cardiovascular, and infectious diseases
Experienced entrepreneur in founding new biotech enterprises, developing the business
strategy and financing the business
Knowledgeable in product portfolio rationalization, optimal resource utilization and
prioritization of business and research activities
Board of Directors and/or Scientific Advisory Board Positions
9/2001 to 12/2004: Board of Director, Scion Pharmaceuticals, Inc., Medford, MA
1/2005 to Present: Board of Director, IndUS Pharmaceuticals, Inc., Woburn, MA
6/2005 to Present: Board of Director, Sindu Pharmaceuticals Private Limited, Hyderabad, India
4/2008 to 12/2011: Board of Director, The indus Entrepreneurs (TiE) Boston, MA
2/2011 to Present: Board of Director, Sindu Research Laboratories Pvt. Ltd., Hyderabad, India
9/2011 to Present: Board of Director, Oceanyx Pharmaceuticals, Inc., Alachua, FL
7/2012 to Present: Chairman of the Board of Directors, FuelEd Schools, Inc., Houston, TX
7/2012 to Present: Chairman of the Board, Cellanyx Diagnostics LLC, Beverly, MA
Curriculum vita
2
Pravin Chaturvedi
CONFIDENTIAL
2015
11/2014 to Present: President, Board of Trustees, PRADAN USA, Boston, MA
12/2014 to Present: Adjunct Assistant Professor, Department of Medicine (Endocrinology),
Georgetown University Medical Center, Washington DC
5/2010 to present: Chair, Research Advisory Council (RAC), School of Pharmacy and Health
Sciences Center, West Virginia University, Morgantown, WV
1/2014 to Present: Advisory Board Member, TFC Biosciences, Worcester, MA
Entrepreneurship Experience: Founded or Co-Founded Multiple Start-up Biotech Companies
9/2001:
Co-founder, CEO & Director, Scion Pharmaceuticals, Medford, MA
3/2005:
Founder, Chairman, CEO & Director, IndUS Pharmaceuticals, Woburn, MA
9/2011:
Co-Founder, CEO & Director, Oceanyx Pharmaceuticals, Alachua, FL
Pharmaceutical Industry Experience
IndUS Pharmaceuticals, Inc.
Woburn, Massachusetts
3/2005 to 10/2007 & 3/2010 to present: Chairman, Chief Executive Officer & Director
Summary of Responsibilities
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Established the bi-continental business strategy for IndUS leveraging the chemistry and
natural product research from India and biology and drug discovery expertise from the US
Developed a novel drug development strategy for IndUS by combining ‘translational
medicine’ from the US with ‘traditional medicine’ from India
Developed the intellectual property assets for novel anticancer, anti-infective, anti-diabetic
agents
Successfully led the efforts to merge IndUS Pharmaceuticals with Napo Pharmaceuticals and
remained the President and CSO of Napo Pharmaceuticals
Established the necessary structural and functional components of a multi-continental (US,
UK and India) enterprise engaged in novel drug discovery and development
Developed and established the network of experts in US & India to provide a key competitive
advantage from a ‘knowledge network’
Established scientific infrastructure for research operations in India
Assembled a premier Scientific Advisory Board (SAB) for the Indian R&D subsidiary
Successfully spun out the preclinical programs in cancer, diabetes and infectious diseases
from Napo to re-initiate the research programs at IndUS Pharmaceuticals and completed asset
acquisition of a Bay area biotech company (Applied Protein Sciences) for the TGF portfolio
Napo Pharmaceuticals Inc.
San Francisco, CA
10/2007 to present: Chief Scientific Officer
Summary of Responsibilities
Curriculum vita
3
Pravin Chaturvedi
CONFIDENTIAL
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2015
Responsible for all research, development and operating functions of the company after the
acquisition of IndUS Pharmaceuticals by Napo
Led the clinical, regulatory, manufacturing and scientific activities for the lead development
program focused on a gastrointestinal product (crofelemer)
Successfully completed a pivotal phase 3 clinical trial for crofelemer using a first-of-a-kind
two-stage adaptive clinical trial design under a special protocol assessment (SPA)
Provide the scientific direction for the company’s second clinical development program for
the treatment of diabetes and metabolic disorders
Build and enhance the pipeline value of the company through development of early-stage
preclinical assets of the company across GI, diabetes and cancer areas
Integrated all the scientific and operational activities of the company across multiple sites in
the United States and in India
Led the Joint Steering Committees for key corporate partnerships for Napo on crofelemer in
the western as well as ROW territories
Key participant in the company’s financing and corporate partnership efforts leading to
successful corporate alliance as well as other sources of funding
Established the goals, strategies and plans for the company’s scientific and operational
milestones
Managed the budgets, timelines and expectations of the various development and therapeutic
programs of the company to meet the key goals of the company
Successfully spun out the preclinical assets to re-initiate the therapeutic efforts in the cancer
program through IndUS Pharmaceuticals
Oceanyx Pharmaceuticals, Inc.
Alachua, FL
9/2011 to Present:
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Co-Founder, Chief Executive Officer & Director
Co-founded a marine biology natural product drug research company with a leading academic
researcher and natural product scientist
Company leverages the research and technology platform developed at University of Florida
Oceanyx is currently raising initial funding and building a local management team in FL to
execute on its lead program
Scion Pharmaceuticals, Inc.
Medford, Massachusetts
9/2001 to 12/2004: Co-Founder, President & Chief Executive Officer, & Director
Summary of Responsibilities & Major Accomplishments
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Founding CEO of Scion Pharmaceuticals and responsible for financing the company through
multiple sources (private equity, debt financing, partnering, etc)
Set the business strategy and scientific goals and direction of the Company
Raised nearly $30MM to support execution of Company’s strategic plans
Developed the necessary strategic plans for Scion and established the goal of efficient ion
channel drug development
Actively engaged in negotiations with potential pharmaceutical partners (for either in- or outlicensing collaborations)
Rapidly reduced the ‘technology concepts’ to practice and successfully initiated and executed
on drug discovery programs
Curriculum vita
4
Pravin Chaturvedi
CONFIDENTIAL
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2015
Successfully acquired the discovery assets of a public company (CeNeS) to supplement
Scion’s rapid growth and internal research efforts
Recruited and retained a pharmaceutical-industry-experienced management team
Successfully created and built the necessary infrastructure to support and sustain drug
development activities
Sustained and/or modified Scion’s business strategy to accommodate changing market
conditions and needs of the Company
Successfully advanced two “first-in-class” research programs to treat major unmet needs in
the CNS and cardiovascular areas
Successfully managed the resources towards efficiently discovering and/or developing novel
first-in-class drugs for validated ion channel targets leading to Scion’s first IND
Supplemented Scion’s research programs with an opportunistic in-licensing strategy
Successfully attracted opinion leaders from basic and clinical research and development to
support Scion’s advancement into a mature pharmaceutical company
Continue to lead and direct the execution of all plans (business & scientific) for Scion
Active in promoting Scion’s corporate image as a successful ion channel drug company
Vertex Pharmaceuticals Incorporated
Cambridge, Massachusetts (2/1994 – 8/2001)
12/2000 – 8/2001: Senior Director, Lead Evaluation
Responsible for Pharmacokinetics, Drug Metabolism and Toxicology of New Chemical Entities
(NCEs) in Discovery and Development
12/99 – 12/2000: Senior Director
Responsible for Pharmacokinetics & Drug Metabolism, Toxicology, Clinical Pharmacology,
Bioanalytical and preclinical pharmacological evaluation of NCEs
12/97 – 11/99: Director
Responsible for preclinical and clinical pharmacokinetics & pharmacology, drug metabolism, and
toxicological assessment of NCEs
12/95 - 11/97: Senior Scientist & Head
Responsible for preclinical & clinical pharmacokinetics & pharmacology, drug metabolism and
overall preclinical assessment of safety and activity of NCEs
2/94 - 11/95:
Staff Scientist & Head
Responsible for the preclinical pharmacokinetics, pharmacology & drug metabolism of NCEs
Summary of Responsibilities and Major Accomplishments during the Vertex tenure
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Design, conduct and/or evaluation of all preclinical and clinical pharmacokinetic,
pharmacodynamic, pharmacological and toxicological investigations for new chemical
entities (NCE) and development candidates across all therapeutic areas
Discovery and Development of NCEs with Corporate Partners (major pharmaceutical
companies) leading to the development of successful drugs for HIV and hepatitis C
Experienced in regulatory submissions across US, Europe & Japan
Technical and managerial leadership of a large group of scientists across Vertex and its
partners leading to successful execution of alliances and partnerships
Manage internal resources (FTEs, facilities and capital expenses) as well as an external
budget to support all discovery and development programs
Curriculum vita
5
Pravin Chaturvedi
CONFIDENTIAL
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2015
Designed and built the preclinical and clinical pharmacology, pharmacokinetics & drug
metabolism, and toxicology facilities and capabilities including hiring the entire staff,
resulting in immediate impact on capabilities of the organization
Wrote the pharmacology and toxicology sections of several INDs and associated annual
reports, investigator’s brochures and amendments
Developed and presented preclinical pharmacological and safety assessment strategies to
management, scientific advisory boards, corporate partners, & regulatory agencies
Point person for responses to the FDA on all preclinical and clinical pharmacology issues in
regulatory submissions and clinical trial proposals
Key spokesperson at meetings with corporate partners across a varied set of therapeutic areas,
including antiviral, inflammation, cancer, immunosuppression and neurological indications
Set up and managed several academic and “fee for service” collaborations for NCEs for
preclinical and clinical studies (nonGLP, GLP & GCP)
Published several scientific articles and have issued and published patents
Alkermes Inc. (2/1993 – 2/1994)
Cambridge, Massachusetts
2/93 - 2/94:
Pharmacokineticist
Summary of Responsibilities and Major Accomplishments
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Design, conduct and evaluation of preclinical studies for a new peptidomimetic agent which
improved blood-brain barrier (BBB) permeability
Conducted novel preclinical drug interaction studies to support clinical trials for the
evaluation of the combination of therapeutic agents with the NCE
Design of all preclinical and clinical pharmacokinetic investigations of oral and parenteral
sustained release dosage forms
Writing pharmacology, pharmacokinetics, and metabolism (ADME) sections for regulatory
submissions
Set up and implemented the analysis for all pharmacokinetic investigations to allow timely
evaluation and reporting of findings for regulatory submissions
Successfully completed and reported the pharmacokinetic, pharmacology and toxicology, and
previous human experience requirements for regulatory submissions
Set up and managed academic collaborations for the pharmacological evaluation of novel
peptides for enhancing the permeability across the blood-brain barrier
Company representative at team meetings for corporate collaborations of injectable sustained
release formulations for biologics
Parke-Davis Pharmaceutical Research (11/1988 – 1/1993)
Division of Warner-Lambert Company
Morris Plains, New Jersey
8/90 - 1/93:
Senior Scientist
Liquid and Parenteral Formulations
11/88 - 7/90:
Scientist
Liquid and Parenteral Formulations
Summary of Responsibilities and Major Accomplishments
Curriculum vita
6
Pravin Chaturvedi
CONFIDENTIAL
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2015
Responsible for the development of parenteral and liquid dosage forms for CNS and oncology
indications for NCEs
Participated in the NDA filings for three new drugs that were subsequently marketed
Internal resource on pharmacology issues for Product Development
Develop laboratory and pilot scale processes for dosage form production
Write the chemistry, manufacturing and controls (CMC) sections of INDs and NDAs for
NCEs
Interact with the regulatory agency and partners on dosage form issues
Managed a group of junior scientists and technicians
Successfully completed the necessary studies for CMC sections of several INDs and NDAs in
a timely manner
Served as a key member of a team of senior level scientists in interacting with the FDA on
Quality Assurance & Compliance and Pre-Approval inspections
Oversaw manufacturing of clinical supplies for early and late-stage clinical trials for “NDAtrack” drugs
Developed a novel submicron emulsion formulation for a new antidiabetic agent
Developed and filed a patent on a novel microsphere-in-oil emulsion for a new antiepileptic
agent
Oboi Laboratories (6/1983 – 4/1984)
Bombay, India
6/83 - 4/84:
Production Supervisor
Parenterals Manufacturing
Summary of Responsibilities and Major Accomplishments
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Manage all aspects of the production of parenteral products from formulation to labeling of
finished products and ensure delivery for commercialization in a timely manner
Interact with (Indian) FDA on GMP issues and managed a staff of ten associates and develop
improved processes and/or formulations for various generic parenteral products
EDUCATION
West Virginia University, Morgantown, West Virginia
Ph.D. in Pharmaceutical Sciences
Dissertation: Pharmacokinetics of Eterobarb in the Rat
1984 - 1988
University of Bombay
Bachelor of Pharmacy
1980 - 1983
PUBLICATIONS & ABSTRACTS
1. Chaturvedi, P.R., Waters, D.H., Gwilt, P.R. and O’Donnell, J.P. (1985): Absorption kinetics
of furosemide in congestive heart failure. Annual meeting of the Academy of
Pharmaceutical Sciences (Abstract).
2. Chaturvedi, P.R., Comer, S., Waters, D.H. and Gwilt, P.R. (1986): The design and
interpretation of metabolic balance studies. Pharm. Res. 3(5): 163S (Abstract).
3. Chaturvedi, P.R., Gwilt, P.R. and Waters, D.H. (1987): HPLC assay for 1,4-dihydropyridine class of calcium entry blockers. Pharm. Res. 4(2): S-5 (Abstract).
Curriculum vita
7
Pravin Chaturvedi
CONFIDENTIAL
2015
4. Chaturvedi, P.R., O’Donnell, J.P., Nicholas, J.M., Shoenthal, D.R., Waters, D.H. and Gwilt,
P.R. (1987): Steady state absorption kinetics and pharmacodynamics of furosemide in
congestive heart failure. Int. J. Clin. Pharmacol. Ther. Toxicol. 25(3): 123-128.
5. Gwilt, P.R., Comer, S., Chaturvedi, P.R. and Waters, D.H. (1988): The influence of
diffusional barriers on presystemic gut elimination. Drug Metab. Dispos. 16(4): 521-526.
6. Chaturvedi, P.R., Gwilt, P.R. and Waters, D.H. (1988): HPLC assay for simultaneous
determination of eterobarb and its metabolites. Pharm. Res. 5(10): S-28 (Abstract).
7. Chaturvedi, P.R., Gwilt, P.R. and Waters, D.H. (1988): Pharmacokinetics of eterobarb in
the rat. Pharm. Res. 5(10): S-186 (Abstract).
8. Chaturvedi, P.R., Gwilt, P.R. and Waters, D.H. (1988): Eterobarb metabolite kinetics in
the rat. Pharm. Res. 5(10): S-210 (Abstract).
9. Teulie, P., Hong, W., Lodhi, S., Moniot, S., Daly, R. and Chaturvedi, P.R. (1989):
Adsorption of a kappa agonist, PD 129290, to various types of filters. Pharm. Res. 6(9):
S-57 (Abstract).
10. Patel, N.M., Lodhi, S.A., Moniot, S. and Chaturvedi, P.R. (1989): Physical factors
influencing the stability of parenteral emulsions. Pharm. Res. 6(9): S-145 (Abstract).
11. Chaturvedi, P.R., Lodhi, S.A., Moniot, S. and Husain, S. (1990): Water sorption/
desorption properties of elastomeric closures II: Effect of temperature and relative
humidity on the kinetics of water sorption. Pharm. Res. 7(9): S-99 (Abstract).
12. Chaturvedi, P.R., Lodhi, S.A., Moniot, S. and Husain, S. (1990): Water sorption/
desorption properties of elastomeric closures III: Effect of temperature and relative
humidity on the kinetics of water desorption. Pharm. Res. 7(9): S-99 (Abstract).
13. Zour, E., Lodhi, S., Nesbitt, R., Silbering, S. and Chaturvedi, P.R. (1991): Studies of
gabapentin in aqueous systems I: Evaluation of stability in aqueous buffers. Pharm.
Res. 8(10): S-108 (Abstract).
14. Kulkarni, N., Iverson, E., Silbering, S., Harris, M. and Chaturvedi, P.R. (1991): Studies of
gabapentin in aqueous systems II: Evaluation of stability in liquid dosage forms.
Pharm. Res. 8(10): S-123 (Abstract).
15. Chaturvedi, P., Iverson, E., Nardo, J. and Killeen, M. (1991): Optimization of a sphere-inoil emulsion containing gabapentin. Pharm. Res. 8(10): S-123 (Abstract).
16. Zour, E., Okoye, G., Lodhi, S. and Chaturvedi, P.R. (1992): A new methodology to
evaluate the mechanical properties of elastomeric closures. Drug Dev. Ind. Pharm. 18(3):
285-301.
17. Chaturvedi, P.R., Patel, N.M. and Lodhi, S.A. (1992): Effect of terminal heat sterilization
on the stability of phospholipid-stabilized submicron emulsions. Acta Pharm. Nord. 4(1):
51-55.
18. Zour, E., Lodhi, S.A., Nesbitt, R.U., Silbering, S.B. and Chaturvedi, P.R. (1992): Stability
studies of gabapentin in aqueous solutions. Pharm. Res. 9(5): 595-600.
Curriculum vita
8
Pravin Chaturvedi
CONFIDENTIAL
2015
19. Chaturvedi, P.R. and Geary, R. (1995): Intravenous bolus pharmacokinetics of VX-710 in
beagle dogs. Pharm. Res. 12(9): S-340 (Abstract).
20. Chaturvedi, P., Geary, R., Harding, M. and Schmalbach, T. (1995): Evaluation of the
pharmacokinetic interaction between VX-710 and paclitaxel in beagle dogs. Pharm. Res.
12(9): S-348 (Abstract).
21. Chaturvedi, P.R. (1996): Pharmacokinetics of Microparticulate Systems. In
“Microparticulate Systems for the Delivery of Proteins and Vaccines.” Chapter 11, pp 321347, Eds. Cohen, S. and Bernstein, H.B., Marcel Dekker, New York.
22. Brettman, L.R. and Chaturvedi, P.R. (1996): Pharmacokinetics and safety of single oral
doses of VX-366 (isobutyramide) in volunteers. J. Clin. Pharmacol. 36: 617-622.
23. Peck, R.A., Marshall, J., Ziessman, H., Hewett, J., Schmalbach, T., Chaturvedi, P. and
Hawkins, M. (1996): A phase I trial of doxorubicin and VX-710. Proceedings of AACR,
Washington DC, 37: p165, Abstract#1134.
24. Chaturvedi, P., Decker, C., Harding, M. and Schmalbach, T. (1996): Evaluation of the
pharmacokinetic interactions of VX-710 with doxorubicin and paclitaxel in beagle dogs.
Proceedings of AACR, Washington DC, 37: p373: Abstract#2545.
25. Navia, M.A. and Chaturvedi, P.R. (1996): Design principles for orally bioavailable drugs.
Drug Discovery Today 1(5): 179-189.
26. McCaffrey, P. G., Wang, Y.-M., Newsome, D. A., Leon, F. J., Li, B., Kim, E., Tung, R.,
Chaturvedi, P, Su, M. S-S. (1996) Pharmacokinetics and efficacy of studies of a new
butyrate prodrug for induction of fetal hemoglobin in anemic rhesus monkeys. Blood 88
(Suppl. 1 part 1-2), 311A.
27. Heiser, A.D., Bridson, G.W., Leon, E.L., Jones, P.L., Badia, M., Saunders, J., Armistead, D.,
Decker, C.J. and Chaturvedi, P.R. (1996): Single dose mycophenolate mofetil (MMF) and
mycophenolic acid (MPA) metabolism and disposition in bile-duct cannulated and intact
rats. 7th North American ISSX Meeting, San Diego, p 278.
28. Heiser, A.D., Bridson, G., Leon, E., Badia, M., Saunders, J., Armistead, D., Decker, C.J. and
Chaturvedi, P.R. (1996): Multiple dose mycophenolic acid (MPA) pharmacokinetics and
role of its metabolism in its gastrointestinal pathology. 7th North American ISSX
Meeting, San Diego, p 281.
29. Mathiowitz, E., Jacob, J.S., Jong, Y.S., Carino, G.P., Chickering, D.E., Chaturvedi, P.,
Santos, C.A., Vijayaraghavan, K., Montgomery, S., Bassett, M. and Morrell, C. (1997):
Biologically erodable microspheres as potential oral drug delivery systems. Nature 386:
410-414.
30. Rowinsky, E., Smith, L., Chaturvedi, P., Wang, Y.M.C., Campbell, E., Hatch, S., Harding,
M., Aylesworth, C., Eckhardt, G., Villalona, M., Drengler, R., Kraynak, M. and Von Hoff, D.
(1997): Pharmacokinetic and toxicologic interactions between the multidrug resistance
reversal agent VX-710 and paclitaxel in cancer patients. ASCO Annual Meeting, Denver,
CO, 16: p218a, Abstract #764.
Curriculum vita
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Pravin Chaturvedi
CONFIDENTIAL
2015
31. Peck, R.A., Hewett, J., Wang, Y.M.C., Chaturvedi, P., Harding, M., Hatch, S. and Hawkins,
M.J. (1997): A phase I pharmacokinetic study of paclitaxel plus 96-hour continuous
infusion of VX-710. ASCO Annual Meeting, Denver, CO, 16: p 218a, Abstract # 765.
32. Gold, B.G., Zeleny-Pooley, M., Wang, M.-S., Chaturvedi, P. and Armistead, D.M. (1997):
A nonimmunosuppressant FKBP-12 ligand increases nerve regeneration. Experimental
Neurology 147: 269-278.
33. Gold, B.G., Zeleny-Pooley, M., Wang, M.-S., Chaturvedi, P., Armistead, D.M. and
McCaffrey, P.G. (1997): FKBP ligands speed functional recovery and nerve
regeneration in the rat sciatic nerve following oral administration. Soc. Neurosci. Abstr.
23(Part 2): 449.12, p1131 (abstract).
34. Costantini, L.C., Chaturvedi, P., McCaffrey, P., Deacon, T.W. and Isacson, O. (1997):
Neuroprotective and regenerative effects of immunophilin ligands in an animal model of
Parkinson’s disease. Soc. Neurosci. Abstr. 23(Part 2): 573.11, p1452 (abstract).
35. Laitinen, L.M., Jones, P.L., Decker, C.J. and Chaturvedi, P.R. (1997): In vitro interactions
between the MDR inhibitors, VX-710 or VX-853, with the anticancer agents, Taxol,
doxorubicin, vincristine or etoposide. 8th North American ISSX Meeting, Hilton Head,
S.C., #83 (abstract).
36. Heiser, A., Leon, E., Decker, C., Wang, Y.-M. and Chaturvedi, P. (1997): Cerebrovascular
permeability of [14C]-141W94 (VX-478), a novel HIV protease inhibitor, in the rat. 8th
North American ISSX Meeting, Hilton Head, S.C., #70 (abstract).
37. Wang, Y.-M. C. and Chaturvedi, P. (1997): Altered distribution and elimination of
paclitaxel by the multidrug resistance (MDR) reversal agent VX-710 (biricodar
dicitrate) in cancer patients. Pharm. Res. 14(11) (Suppl): S-510, #3129 (abstract).
38. Gold, B.G., Zeleny-Pooley, M., Chaturvedi, P. and Wang, M.-S. (1998): Oral
administration of a nonimmunosuppressant FKBP-12 ligand speeds nerve regeneration.
Regeneration and Transplantation Neuroreport 9(3): 553-558.
39. Rowinsky, E. K., Smith, L., Wang, Y.-M., Chaturvedi, P., Villalona, M., Campbell, E.,
Aylesworth, C., Eckhardt, S. G., Hammond, L., Kraynak, M., Drengler, R., Stephenson, J.
(1998) Phase I and pharmacokinetic study of paclitaxel in combination with biricodar,
a novel agent that reverses multidrug resistance conferred by overexpression of both
MDR1 and MRP. J. Clin. Oncol. 16 (9): 2964-2976.
40. Decker, C.J., Laitinen, L.M., Bridson, G.W., Raybuck, S.A., Tung, R.D. and Chaturvedi, P.R.
(1998): Metabolism of amprenavir in liver microsomes: Role of CYP3A4 inhibition for
drug interactions. J. Pharm. Sci. 87(7): 803-807.
41. Costantini, L.C., Chaturvedi, P., Armistead, D.M., McCaffrey, P.G., Deacon, T.W. and
Isacson, O. (1998): A novel immunophilin ligand: Distinct branching effects on
dopaminergic neurons in culture and neurotrophic actions after oral administration in
an animal model of Parkinson’s disease. Neurobiology of Disease 5: 97-106.
42. Chaturvedi, P.R. (1999): Pharmacokinetics. In Encyclopedia of Controlled Drug Delivery,
Volume 2, pp. 833-851. Edited by E. Mathiowitz, John Wiley & Sons, Inc., New York.
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43. Shefner, J. M., Brown, R. H., Cole, D., Chaturvedi, P., Ogenstad, S., Pastuszak, K.,
Matthews, R., Upton-Rice, M., Cudkowicz, M. (2000) Neurophilin ligands enhance motor
unit size in the FALS mouse. Neurology 54 (7 Supp. 3): A1555.
44. Decker, C.J., Heiser, A.H., Chaturvedi, P.R., Faust, R., Ku, G., Moseley, S., and
Nimmesgern, E. (2001): The novel IMPDH inhibitor VX-497 prolongs skin graft survival
and improves graft versus host disease in mice. Drugs Exptl. Clin. Res. XXVII: 263-269.
45. Peck, R.A., Hewett, J., Harding, M.W., Wang, Y-M.W., Chaturvedi, P.R., Bhatnagar, A.,
Ziessman, H., Atkins, F. and Hawkins, M.J. (2001): A Phase I and Pharmacokinetic study
of the Novel MDR1 and MRP1 inhibitor biricodar, administered alone and in
combination with doxorubicin. J. Clin. Oncol. 19(12): 3130-3141.
46. Chaturvedi, P.R., Decker, C.J. and Odinecs, A. (2001): Prediction of pharmacokinetic
properties using experimental approaches during early drug discovery. Curr Opinion
Chem Biol. 5: 452-463.
47. Perni RB, Almquist SJ, Byrn RA, Chandorkar G, Chaturvedi PR, Courtney LF, Decker CJ,
Dinehart K, Gates CA, Harbeson SL, Heiser A, Kalkeri G, Kolaczkowski E, Lamar J, Lin K,
Luong Y-P, Rao BG, Taylor WP, Thomson JA, Tung RD, Wei Y, Kwong AD & Lin C
(2006): Preclinical profile of VX-950, a potent, selective and orally bioavailable inhibitor
of hepatitis C virus NS3-4A serine protease. Antimicrobial Agents & Chemother. 50(3):
899-909.
48. Mangel, A.W. and Chaturvedi, P.R. (2008): Evaluation of crofelemer in the treatment of
diarrhea-predominant irritable bowel syndrome patients. Digestion 78: 180-186
49. Orloff, J., Douglas, F., Pinheiro, J., Levinson, S., Branson, M., Chaturvedi, P., Ette, E., Gallo,
P., Hirsch, G., Mehta, C., Patel, N., Sabir, S., Springs, S., Stanski, D., Evers, M., Fleming, E.,
Singh, N., Tramontin, T. and Golub, H. (2009): The future of drug development:
advancing clinical trial design. Nature Reviews Drug Discovery 8(11): 949-957
50. MacArthur, R.D., Hawkins, T., Brown, S.J., LaMarca, A., Chaturvedi, P. and Ernst, J. (2012):
ADVENT trial: Crofelemer for the treatment of secretory diarrhea in HIV+ individuals.
Conference on Retrovirus and Opportunistic Infections (CROI), Poster Number O-117,
March 2012 (abstract)
51. King, S.R. and Chaturvedi, P. (2012): The development of crofelemer: Connecting
ethnobotany, conservation, biocultural diversity, global public health and indigenous
knowledge. Planta Med 78: 1038-1039
52. Chaturvedi, P.R., Antonijevic, Z. and Mehta, C. (2014): Practical Considerations for a
Two-Stage Confirmatory Adaptive Clinical Trial Design and its Implementation:
ADVENT Trial. In “Practical Considerations for Adaptive Trial Design and
Implementation”. Editors He, W., Pinheiro, J. and Kuznetsova, O., published by Springer
Science & Business Media, New York, NY, pp 383-411.
ISSUED US PATENTS
1. Chaturvedi, P.R. Treatment of the CNS effects of HIV. U.S. Patent Number 5,646,180,
issued on July 8, 1997.
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2. Bemis, G.W. and Chaturvedi, P.R. Methods and compositions using butyrate esters of
threitol. U.S. Patent Number 5,763,488, issued on June 9, 1998
3. Bemis, G.W. and Chaturvedi, P.R. Methods and compositions using butyrate esters of
threitol. U.S. Patent Number 5,945,407, issued on August 31, 1999
4. Chaturvedi, P.R. and Ette, E. Optimal compositions and methods thereof for treating
HCV infections. US Patent Number 6,824,769, issued November 30, 2004
5. Chaturvedi, P.R. and Ette, E. Compositions comprising IMPDH inhibitors and uses
thereof for treating HCV infections. US Patent Number 7,371,372, issued May 13, 2008
6. Forbes, W., Bortey, E., King, S. and Chaturvedi, P. Methods and compositions for treating
HIV-associated diarrhea. US Patent Number 8,962,680, issued February 24, 2015
PATENT APPLICATIONS
1. Chaturvedi, P.R., Boger, J.S. and Tung, R.D. Methods of increasing the bioavailability of
stable crystal polymorphs of a compound. International Publication Number WO
98/57648, December 23, 1998.
2. Chaturvedi, P., Su, M. and Tung, R. Oral low dose butyrate compositions. International
Publication Number WO 00/56153, September 28, 2000.
3. Chaturvedi, P., Su, M. and Tung, R. Oral low dose butyrate compositions. US Patent
Application Number 20020115716/A1, August 2002
4. Chaturvedi, P.R. and Ette, E. Optimal compositions and methods thereof for treating
HCV infections. US Patent Application Number 20030068302/A1, April 2003
5. Zelle, R. and Chaturvedi, P.R. Human N-type calcium channel blockers. US Patent
Application Number 20040204404/A1, October 2004
6. Zelle, R. and Chaturvedi, P.R. Human N-type calcium channel blockers. US Patent
Application Number 20090012095/A1, January 2009
7. Chaturvedi P.R., Namkung W., Verkman, A. and Tradtrandip, L. Methods for treating
diseases with proanthocyanadin oligomers such as crofelemer. US Patent Application
number 61/249,236, October 2009
8. Chaturvedi, P.R., Manivasakam, P., Grossman, S.R. and Cantor, S. Novel compositions of
combinations of non-covalent DNA binding agents and anticancer and/or antiinflammatory agents and their use in disease treatment. US Patent Application Number
61/621149, April 2012
9. Chaturvedi, P.R. Pharmacologically optimized multimodal drug delivery system for
nordihydroguiaretic acid (NDGA). US Patent Application Number 2013/0274346A1,
published October 2013
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