Prabu Nambiar_ PhD_ MBA_ RAC

Document Sample
Prabu Nambiar_ PhD_ MBA_ RAC Powered By Docstoc
					                                              Prabu Nambiar, PhD, MBA, RAC
                                         15 Rocklawn Road, Westborough, MA 01581
                  Home: (508)-870-1790; Cell: 774-288-9842; E-mail:

Experienced and proven pharmaceutical development executive professional with over 20 Years of industry experience
in the areas of Chemistry, Manufacturing and Controls (CMC) and drug development; Regulatory (RAC) Certified;
Result-oriented leader/ team player with excellent communication and interpersonal skills; Proven problem solver; Led
CMC teams in successful filing of several INDs, NDAs and post approval CMC supplements; Direct liaison experience
with FDA (Anti-infectives, Cardiorenal, Neuropharm Gasterointestinal, Oncology and Pulmonary Divisions) and EMA;
Proficient in QbD and science based regulatory strategies, in accordance with FDA/ICH and GMP/GLP requirements.

    B.Sc., M.Sc., Chemistry, Madras University, India (1980 / 1982)
    Ph.D. Organic Chemistry, Oregon State University, Corvallis, Oregon (1988)
    Executive MBA, Boston University (2004)
    Regulatory Affairs Certified (RAC) by RAPS in 2002; Recertified in 2005 and 2008

  Provide CMC regulatory support for Phase 1, 2 and 3 and post-approval activities
   o Develop science & technology and QbD based CMC strategies for expedited development and registration ;
        Also develop adaptive CMC strategies for the implementation of risk-based and QbD development paradigms
   o Participate in cross functional meetings involving R&D, Manufacturing, Quality, Project Management,
        Business Development and Marketing groups to provide CMC regulatory input
   o Liaise with global affiliates / partners for international registrations
   o Provide CMC strategy for line extension and life-cycle management activities
   o Provide CMC assessment during due diligence for potential in-licensing compounds
   o Provide regulatory training to R&D
  Manage CMC regulatory submissions for developmental and marketed products
   o Prepare, review and finalize CMC sections of investigational (IND/CTX) and marketing applications
        (NDA/MAA), briefing packages (EOP-2, pre-NDA, other CMC-related) and Annual Reports (IND/NDA)
   o Generate and submit accurate and timely responses to CMC inquiries from regulatory agencies
   o Resolve CMC related development/regulatory issues by interaction and effective communications with
        regulatory agencies via face-to-face meetings and teleconferences
   o Prepare, review and file CMC supplements to implement manufacturing changes/line extensions
  Compliance / GMP / Quality
   o Submit Establishment Registration and Drug Listing; State licensing
   o Provide global change control assessments
   o Review batch records for regulatory compliance
   o Provide CMC regulatory support during regulatory inspections
   o Provide CMC guidance to contract manufacturers and laboratories

Technical / Pharmaceutical Development
   Application of Quality by Design (QbD) aspects in pharmaceutical development and commercialization
   Application of organic, biochemical and analytical chemistry to solve CMC issues in drug development
   Isolation, identification and synthesis of impurities in drug substances and products
   Elucidation of mechanism of degradation of drug substances and products
   Design of stability protocols including forced degradation studies and, data evaluation
   Establish drug substance/product specifications
   CMC documentation for IND/NDA/Post-approval submissions in CTD format & briefing packages

Managerial & Leadership
  Establish CMC regulatory group; Hire and train new members
  Provide leadership, mentorship and guidance to direct reports and junior members
  Establish goals and objectives and development plans for direct reports
  Participate in establishing systems, policies and procedures for the regulatory and development activities
  Participate in various departmental initiatives improving systems and strategic excellence
  Manage outsourcing of CMC regulatory activities
  Participate in professional association activities to facilitate the adaptation of science based regulations
 Syner-G Pharma CMC Consulting, LLC (February 2008 – Present)
    Founder and President
    Services Offered: Strategic CMC regulatory consultation for all aspects of development/commercial products; Design strategies
    to resolve complex CMC regulatory & quality issues and enable expedited filing and approval; Facilitate meetings with health
    authorities related to CMC issues (pre-IND, End of Phase I/II, Pre-NDA and others as needed); Design strategies to respond to
    health authority inquiries related to all filings (IND/NDA); CMC training. Author and review CMC submissions. Design
    submission strategies for QbD based development projects; Provide science based strategies and support to achieve full cGMP
    compliance and successful regulatory inspections.

 Vertex Pharmaceuticals, Inc. Cambridge, MA, April 2008 – August 2011
    Vice President, Regulatory Affairs-CMC
    Provided CMC Regulatory leadership and guidance for all investigational products. Provided regulatory support for QbD based
    development, manufacturing and registration strategies, Pediatric plans, EOP-2/pre-NDA meetings, API starting material strategy,
    control strategy for genotoxic impurities & commercial launch support. Established post-approval CMC regulatory conformance
    function; Managed and provided leadership and mentorship to a group of highly talented RA-CMC professionals.
    Major Accomplishments: Several successful key CMC meetings with FDA & EMA; First cycle approval of Incivek (telaprevir) in
    the US and Canada (priority review), Support pre-approval inspections for QbD based NDA; Filing of VX-770 (Kalydeco)
    NDA/MAA for Cystic Fibrosis.

 Cubist Pharmaceuticals, Inc. Lexington, MA, May 2005 – March 2008
    Senior Director, Regulatory Affairs–CMC
    Direct all CMC Regulatory activities for investigational and marketed products. Project manager for C. Difficile Toxin Binder
    project (in collaboration with Ilypsa)
    Major projects: Cubicin, Lipopeptide, C. Difficile toxin binder, HepexB (combination antibodies)
    Major Accomplishments
        Post-approval CMC changes for Cubicin (six CMC supplements)
        Global filing of Cubicin in EU/Switzerland/Australia/New Zealand/Canada/Taiwan/S. Korea/China/Japan
        Alliance partnership Chiron, Novartis, Astra-Zeneca and Merck Banyu)
        Recognitions: Gold Cube Award for science based post-approval strategy; 2007 Annual Cubist Compliance Award

 Wyeth Pharmaceuticals, Collegeville, PA, September 2004 – April 2005
    Director-II, Worldwide Regulatory Affairs–CMC
    Direct the global CMC Regulatory group (7 people) for Anti-infective, Gastrointestinal and Cardiovascular therapeutic areas and
    also companywide Annual Reporting
    Major projects: Zosyn, Minocin, Bicillin, Tygacil and Protonix
    Major Contributions:
        Tygacil NDA (US and EU) (approved in 2005);          Global CMC conformance review

 Sepracor, Inc., (now Sunovion), Marlborough, MA, December 1998 – August 2004
    Sr. Director, Technical (CMC) Regulatory Affairs (Jan. 2004 – Sept. 2004)
    Director (May 2001- December 2003); Associate Director (Dec. 1998 – April 2001)
    Direct the CMC Regulatory group that handled CMC regulatory activities for all investigational and marketed products (pulmonary
    and allergy, neuropharm, urology and cardiovascular therapeutic areas)
    Major Accomplishments
        Established the CMC Regulatory group (2 Assoc. Dir, 1 Sr. Manager and 2 consultants)
        Directed CMC regulatory activities for 3 NDAs, 10 sNDAs and 9 INDs
        Coordinated 3 End-of-Phase II and 3 pre-NDA meetings
        Xopenex® (R-Albuterol) Inhalation Solution: Approval of NDA and 5 major CMC supplements
        Xopenex (R-Albuterol ) Metered Dose Inhaler: Original IND through the NDA (1 cycle approval in 2005)
        Lunesta (S-Zopiclone): Original IND through the NDA (approved in 2004)
        Brovana (R,R-Formoterol): IND support and NDA strategy (1 cycle approval in 2006)

 Bristol-Myers Squibb Pharmaceutical Research Institute, NJ, September 1991 – November 1998
    Manager, CMC Regulatory Affairs (March 1998 – November 1998)
    Manage global CMC regulatory activities for oncology and immunology projects (1 NDA, 2 Phase III, 5 Phase I/II)
    Major Accomplishments
       Prepared CMC sections of one NDA and one MAA dossiers
       Filed 2 Type-II Drug Master Files on behalf of Japanese collaborators

Prabu Nambiar, Ph.D. MBA, RAC                                                                                            Page 2 of 3
    Bristol-Myers Squibb Pharmaceutical Research Institute…. Continued
    Manager, CMC Documentation (February 1996 – February 1998)
    Manage CMC documentation activities for phase-I, II & III projects in anti-infectives, cardiovascular, metabolic disease, and
    oncology projects
    Major Accomplishments
       Handled CMC-documentation for 15 INDs including two products which resulted in FDA approval
       Established systems to (i) streamline CMC documentation resource timelines; (ii) BSE risk assessment

    Sr. Research Investigator (May 1995 - January 1996);                Research Investigator (September 1991 - April 1995)
    Support Chemical and Pharmaceutical development activities by analytical profiling, isolation and identification of impurities in
    drug substances and drug products; Synthesis of impurities & degradants for reference standard and/or toxicology studies;
    Provided drug substance / impurity structural elucidation reports for regulatory filings
    Major Accomplishments
        Identified several “critical” impurities in developmental and commercial drug products (>20 projects).
        Led a Task Force and successfully solved an odor problem in a potential block-buster cardiovascular drug. The team
         earned BMS-PRI President Award for this outstanding and important contribution.
        Co-chaired the Chemical R&D Seminar Committee from 1994 to 1996.
        Earned 3 BMS-PRI President's Awards & 3 “On the Spot” Awards for exemplary contributions

   Post-Doctoral Research Associate, Brown University, Providence, RI. (Aug. 1988 - Aug. 1991)
    Advisor: Prof. David. E. Cane; Topic: Mechanistic enzymology of natural products biosynthesis
   Graduate Research Assistant, Oregon State University, Corvallis, Oregon. (July 1984 - July 1988)
    Advisor: Prof. Steven J. Gould; Thesis: Biosynthesis of nucleoside antibiotic (blasticidin S).
   Graduate Teaching Assistant, Oregon State University, Corvallis, Oregon. (Sept. 1983 - June 1984)

   Recipient of National Merit Scholarship for Academic Excellence in undergraduate work.
   Recipient of STEP grant from the American Chemical Society (Aug. 1986).

   Academia
       o 12 Publications / 5 Presentations / 5 Expert commentary articles
   Industry
    o    3 publications including a Book Chapter, a Cover article and a Workshop Summary report
    o    3 Invited lectures (McGill University, Concordia University and Villanova University).
    o    Organized / Moderated / Presented over 30 CMC topics (round table, symposia, workshop, webinar, short course or poster)
         at various meetings. A frequent invited speaker on the topic of Pharmaceutical Stability.

   Reg. Training-I (IND) & Reg. Training-II (NDA and Post-Approval) offered by Drug Information Association
   Principles and Practices of Reg. Affairs, course offered by School of Pharmacy, Northeastern Univ. Boston
   Introduction to Drug Law & Regulation offered by Food & Drug Law Institute
   FDA Workshops: Regulatory Issues Related to Inhalation Compounds; Post-approval Changes; API manufacturing changes;
    Biopharmaceutics Classification System and Waiver of Bioequivalence; Container-Closure system; Blend Uniformity; ICH Q6A
    & Q7A; Quality System Based Inspection; Quality by Design
   ICH/FDA Workshop on QbD (ICH Q8, Q9, Q10) Implementation
   AAPS Short course – Monoclonal Antibody Manufacturing
   Validation Fundamentals, QA Auditing, and Preparation and Passing a PAI; Annual Product Review
   Managing Multiple Projects, Objectives and Deadlines, Effective Negotiating (Karrass)
   The Dale Carnegie Training: Effective Communication; Leadership for Managers

   United States Pharmacopeia (USP) Expert Committee Member (Physical Analysis), 2010-2015
   Member, American Association of Pharmaceutical Scientists (AAPS)
    > Member of AAPS Finance Committee, 2011; Programming Coordination Committee (PCC) 2010
    > Past-Chair (2010), Chair (2009), Chair Elect (2008), Vice Chair (2007) Regulatory Science Section
    > Representative for the Members Group Coordination Committee (MGCC) 2007-2009
    > Chair, RS Section Strategic-Vision Committee, 2006
    > Member of RS Committees: Programming, Awards and Abstract Screening
   Member, American Chemical Society (ACS)
   Member, Regulatory Affairs Professional Society (RAPS)

REFERENCES:Available upon request.

Prabu Nambiar, Ph.D. MBA, RAC                                                                                              Page 3 of 3
Attachment                                                                         Publications and Presentations

                                           Prabu Nambiar, Ph.D., MBA, RAC
                                              (Formerly P.C. Prabhakaran)

1. Cane, D. E., Tandon, M.; Prabhakaran, P. C. J. Am. Chem. Soc., 1993,115, 8103.
2. Cane, D. E., Lambalot, R. H.; Prabhakaran, P. C.; Ott, W. R. J. Am. Chem. Soc., 1993,115, 522.
3. Cane, D. E., Prabhakaran, P. C., Tan, W.-T., Ott, W. R. Tet. Lett., 1991, 5457.
4. Cane, D. E., Prabhakaran, P. C., Oliver, J. S., McIlwaine, D. B. J. Am. Chem. Soc., 1990,112, 3209.
5. Cane, D. E., Salaski, E. J., Prabhakaran, P. C. Tet. Lett. 1990, 31, 1944.
6. Whitehead, I. M., Ewing, D. F., Threllfall, D. R., Cane, D. E., Prabhakaran, P. C. Phytochemistry, 1990, 29, 479.
7. Cane, D. E., Prabhakaran, P. C., Salaski, E. J., Harrison, P. H. M., Noguchi, H., Rawlings, B. J. J. Am. Chem. Soc.,
1989, 111, 8914.
8. Orr, G.R.; Danz, D.W.; Pontoni, G.; Prabhakaran, P.C.; Gould, S.J.; Coward, J.K. J. Am. Chem. Soc., 1988, 110, 5791.
9. Prabhakaran, P.C.; Woo, N.-T.; Yorgey, P.S.; Gould, S.J. J. Am. Chem. Soc., 1988, 110, 5785.
10. Prabhakaran, P.C.; Gould, S.J.; Orr, G.R.; Coward, J.K. J. Am. Chem. Soc., 1988, 110, 5779.
11. Gould, S.J.; Tann, C.-H.; Prabhakaran, P.C.; Hillis, L.R. Bio-Org. Chem., 1988, 16, 258.
12. Prabhakaran, P.C.; Woo, N.-T.; Yorgey, P.S.; Gould, S.J. Tet. Lett., 1986, 27, 3815.

• Organic Synthesis procedure (with Prof. J. D. White, Oregon State University)
   Org. Syn., 1989, 68, 227 (Preparation of 4, 13-diaza-18-crown-6)

• Co-authored the following expert commentary articles (with Prof. D. E. Cane, Brown University)
   Chemtracts (Organic) 1989, 2, 66 (Sequence specific RNA scission by 1,10-phenanthroline-Cu)
   Chemtracts (Organic) 1989, 2, 131 (Novel peptide -turn mimetic)
   Chemtracts (Organic) 1989, 2, 138 (Hybrid sequence selective RNAse)
   Chemtracts (Organic) 1990, 3, 126 (Biosynthetic mechanism of C-P bond formation)
   Chemtracts (Organic) 1991, 4, 48 (Mechanism of acetyl transfer in fatty acid biosynthesis)

1. Cane, D. E., Prabhakaran, P. C., Tan, W. T., Lambalot, R. H. 'Whole cell biosynthetic studies of macrolide antibiotics'.
Presented at the International Symposium on Biology of Actinomycetes, Madison, WI August 11-16, 1991
2. Prabhakaran,P.C.; Gould,S.J. 'Involvement of -arginine in the biosynthesis of Blasticidin S'. Poster presented at the
199th ACS National Meeting, Boston, MA. April 22, 1990
3. Prabhakaran, P. C., Cane, D. E. 'Aristolochene biosynthesis: Stereochemical and mechanistic investigations'. Presented at
the 199th ACS National Meeting, Boston, MA. April 26, 1990
4. Prabhakaran,P.C.; Woo,N.-T.; Yorgey,P.S.; Gould,S.J. 'Biosynthesis of Blasticidin S'. Presented at the 192nd ACS
National meeting, Anaheim, CA. September 10, 1986
5. Prabhakaran,P.C.; Gould,S.J. 'Biosynthesis of Blasticidin S'. Presented at the 41st ACS N.W. Regional Meeting, Portland,
OR. June 18, 1986

1. Cover article: U. Shah, P. Nambiar and G. Vudathala. “The Regulatory Path to Biosimilars: Past, Present and Future”,
AAPS News Magazine, February 2011

2. Workshop Summary: M-L. Chen, V. P. Shah, D. Ganes, K.K. Midha, J. Caro, P. Nambiar, M.L. Rocci Jr., A.G. Thombre, B.
Abrahamsson, D. Conner, B. Davit, P. Fackler, C. Farrell, S Gupta, R. Katz, M. Mehta, S.H. Preskorn, G. Sanderink, S.
Stavchansky, R. Temple, Y. Wang, H. Winkle, L. Yu. “Challenges and opportunities in establishing scientific and regulatory
standards for assuring therapeutic equivalence of modified-release products” European Journal of Pharmaceutical Sciences
40, 148–153, 2010 / Clinical Therapeutics, 32 (10), 1704-1712, 2010 / The AAPS Journal, 12(3):371-377, 2010

3. Book chapter: P. Nambiar and S. Koepke, on “CMC Sections of Regulatory Filings and CMC Compliance During
Investigational and Post-Approval Stages” in FDA Regulatory Affairs, 2 Edition, Editors: D. Pisano and D. Mantus, Informa
Healthcare, 2008

Publications / Presentations – P.Nambiar                                                                    Page 1 of 3
1. Organized and moderated a Short Course titled “Global Drug Registration” offered by AAPS (2005)
2. Presented at the 3rd Annual Pharmaceutical Stability Conference (by SMi) London (2005)
3. Presented/Moderated the 4th Annual Stability Conference (by SMi), London (2006)
4. Presenter at the Stability Testing conference (organized by SWE), Boston (Oct. 2006)
5. Organized and moderated Regulatory Science Symposium on “Technology Development and Transfer: Scientific, Quality and
    Regulatory CMC Challenges” at the 2007 AAPS Annual meeting, San Antonio, TX (Oct 2006)
6. Organized and moderated Regulatory Science Sunrise session on “Exploratory IND” at the 2007 AAPS Annual meeting, San
    Antonio, TX (Oct 2006)
7. Organized and moderated Regulatory Science Round Table on “Biopharmaceutical and CMC challenges for Targeted Drug
    delivery” at the 2006 AAPS Annual meeting, San Antonio, TX (Oct 2006)
8. Poster presentation on the topic of “CMC Change Control” at AAPS Annual Meeting (2006)
9. Poster presentation on the topic of “Batch Analysis Section of NDA” at AAPS Annual Meeting (2006)
10. Presenter at the 2nd Annual Forum on Stability Programs (organized by CBI), Princeton, NJ (June 2007)
11. Organizer/Moderator at the AAPS/FDA Workshop on Pharmaceutical Stability, Bethesda (Sept. 2007)
12. Presented Global DS and DP Stability Requirements at the AAPS Short Course on CMC Challenges and Opportunities in
    Product Development and Registration (Nov 2007)
13. Organized and moderated Regulatory Science Symposium on “Developmental and Regulatory CMC challenges for Drug
    Device combination products” at the 2007 AAPS Annual meeting, San Diego, CA (Nov 2007)
14. Organized and moderated Regulatory Science Round Table on “Impact of QbD on Analytical and Pharmaceutical
    Development” at the 2007 AAPS Annual meeting, San Diego, CA (Nov 2007)
15. Poster presentation on the topic of “Managing API/ Drug Product CMC Changes” at AAPS Annual Meeting (Nov 2007)
16. Poster presentation on the topic of “Comparability Protocols” at AAPS Annual Meeting (Nov 2007)
17. Organized open Forum on “leveraging Comparability protocol for post-approval CMC Changes” offered at the 2008 National
    Biotechnology Conference of the AAPS, Toronto (June 2008)
18. Presenter at the 2nd Annual Forum on Stability Programs (organized by CBI), Philadelphia, PA (June 2008)
19. Organized and moderated Regulatory Science Round Table on the topic “Impurities not covered by ICH Q3A/B” at the 2008
    AAPS Annual meeting, Atlanta (Nov 2008)
20. Organized and moderated AAPS Regulatory Science Webinar on the topic “How to get your newly discovered drug candidate
    into first in human clinical trials in the USA” (June 2009)
21. Participated as the Scientific planning committee member for the USP Workshop on Topical and Transdermal Drug Products
    (Sept 2009)
22. Participated as the Organizing committee member and moderator for FDA/AAPS/FIP/PQRI Workshop on Challenges and
    Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release
    Products (Oct 2009)
23. Organized and moderated Regulatory Science Symposium on the topic “Regulatory Significance of CQAs and CPPs in
    Successful Drug Development and Registration” at the 2009 AAPS Annual meeting, Los Angeles (Nov 2009)
24. Organized and moderated Biotechnology /Regulatory Science Open Forum on Biosimilars-Development Considerations and
    Future Directions at the 2009 AAPS Annual meeting, Los Angeles (Nov 2009)
25. Co-organizer and Speaker at the Pre-meeting workshop titled “Stability testing for global submission” offered at the Indian
    Pharmaceutical Association Convention 2010, Chennai, India (March 2010; Co-sponsored with AAPS)
26. Co-organizer and co-moderator for the mini-symposium titled “Ask the Regulators” held at 2010 National Biotechnology
    Conference, San Francisco (May 2010)
27. Participated in the pre-meeting workshop on Pediatric Drug Development and presented on the topic of “Pediatric Drug
    Development and Global Regulatory Considerations” during the 2010 AAPS Annual meeting, New Orleans
28. Organized and moderated a Mini-symposium titled “Nonclinical Safety Testing of Pharmaceuticals: Global Regulations and
    Evolving Challenges” at the 2010 AAPS Annual meeting, New Orleans
29. Organized and moderated a Round Table event titled “Technology Transfer and Process Validation in the QbD Context” at
    the 2010 AAPS Annual meeting, New Orleans
30. Co-organized, co-moderated and presented at Sunrise session titled “Pharmaceutical Stability: Science and Regulations” at
    the 2010 AAPS Annual meeting, New Orleans
31. Presented on the topic of “Scientific and Regulatory aspects of Pharmaceutical Stability” at the Advances and Efficiencies in
    Stability Testing Conference hosted by International Pharmaceutical Academy, October 2010, Montreal
32. Presented on the topic of “Submission of Stability Data in the CTD Structure” at the Advances and Efficiencies in Stability
    Testing Conference hosted by International Pharmaceutical Academy, October 2010, Montreal

Publications / Presentations – P.Nambiar                                                                     Page 2 of 3
33. Presented on the topic of “Stability Studies for Post-Marketing and Life-Cycle Management” at the Advances and Efficiencies
    in Stability Testing Conference hosted by International Pharmaceutical Academy, October 2010, Montreal
34. Organized and co-moderated a Round Table event titled “Real-Time Release Testing” at the 2011 AAPS Annual meeting,
    Washington DC
35. Organized and moderated a Sunrise Session titled “Application of BCS Classification in Regulatory Filings” at the 2011 AAPS
    Annual meeting, Washington DC
36. Organized and co-moderated an Open Forum on the topic of “BIOSIMILARS: Regulatory Update and Practical
    Considerations for Successful Development” at the 2011 AAPS Annual meeting, Washington DC

Other Volunteering Activities:
1. Participated as a Volunteer/Mentor at the Mentoring Breakfast during the AAPS Annual meeting, Los Angeles (Nov 2009)

Publications / Presentations – P.Nambiar                                                                    Page 3 of 3

Shared By: