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Pharma Business Development Consulting

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					                                              `Resume

                                   John C. Budzinski Ph.D.
                                           1850 Lenape Road
                                     West Chester, Penna. 19382
                                          Cell (610) 357-0274,
                                   e-mail johnb@phelixpharma.com



                                  EXECUTIVE SUMMARY

Over 30 years management, technical and business experience in R&D, Administration and
Manufacturing with recent focus on all aspects of pharmaceutical outsourcing including consulting
and serving as manufacturing representative. Strong knowledge of outsourcing processes, vendor
capabilities, worldwide (including China) sourcing opportunities and regulatory requirements with
many industry contacts. Audited more than 175 companies for manufacturing and regulatory
suitability, including 60 companies in China. Broadly networked with other pharmaceutical
professionals to outsource API, finished dosage, QA and packaging. Broad international
experience and knowledge of pharmaceutical outsourcing to help create and manage capital
conserving, highly cost effective, responsive and secure supply chains.

Career Experience:

       Pharmaceutical outsourcing                           Organizational development
       Vendor identification/selection                      Sales – APIs and Intermediates
       Contract and price negotiations                      Intellectual property management
       Technical transfer and support                       Auditing for mfg. suitability
       Strategic supply chain planning                      R&D Discovery and Process Dev.


   Phelix Pharma Outsourcing Consultants, Inc.

   Founder and Principal Consultant                     (2002 – Present)

   Outsourcing consulting for large and small fine chemical, pharmaceutical and
   biopharmaceutical clients to identify and manage outsourcing suppliers for R&D and
   commercial supply of Active Pharmaceutical Ingredients (APIs), cGMP intermediates,
   finished dosage and unique raw materials Services to client organizations include: R&D
   process development, R&D sourcing, commercial sourcing, site evaluations, company due
   diligence, market intelligence, contract negotiations and expert witnessing. Staff training
   and assistance to increase outsourcing expertise and productivity.

   Global Pharma Sourcing, LLC                       (Founded 2002)

   Co-Founder with Dr. Phil Ma and Managing Director

   Global Pharma Sourcing is a sales agent for suppliers of pharmaceutical intermediates, and
   API’s. Our suppliers are generally located in low manufacturing cost countries, especially
   China. We work with pharma companies and suppliers to pharma companies to identify
   sources of material that meet their R&D and commercial requirements. In addition, Global

John C. Budzinski, Ph.D.                  1
    Pharma Sourcing, provides consulting services to companies wishing to learn more about
    sourcing from China.



    DuPont Pharmaceutical Company (now Bristol Myers Squibb)

    Senior Director, Strategic Sourcing               (1993 to 2002)

    RESPONSIBLE FOR:
-     Commercial out-sourcing for intermediates and API’s
-     Supply chain strategies and capacity planning.
-     Contract and vendor relationship management
-     Cost control/reductions for new and existing products.
-     Vendor management to assure QA and RA compliance
-     Vendor selection and vendor strategy to identify key suppliers
-     Business Mgr. with P&L responsibilities. - warfarin API sales & finished dosage to 3rd parties

    Director, Wilmington Area Site                    (1990 to 1993)

    Facilities management for all 5 DuPont Merck Wilmington sites (1.3 MM sq. ft. of lab and office
    space, 100+ reports). Reduced costs by over 25% by streamlining facilities management of 6 lab
    and office locations into a single unit. Site capital and operating budget responsibilities covering all
    facilities, general services, HR administration, safety, health and animal resources.



    E. I. DuPont De Nemours


    R&D Operations Manager, Medical Products Dept.                  (1989 to 1990)
    Managed two R&D lab sites (350M sq. ft., 60+ reports). Responsible for facilities, R&D Patent
    Liaison function, R&D training, safety, health and animal resources.


    Senior Compensation Consultant, DuPont Corporate HR Dept. (1988 to 1989)
    Developed pay and progression systems for DuPont technical professionals. Led Corporate
    Committee to define new position evaluation system for DuPont.



    Senior Supervisor Process R&D, Agricultural Products (1983 to 1988)
    Directed 20-25 scientists in development and technology transfer of new, cost effective
    manufacturing process routes for bulk actives -- process development, scale up from lab to pilot
    plant and technology transfer to internal or external contract manufacturers .


    Laboratory Administrator, Agricultural Products Dept.                 (1982 to 1983)


    John C. Budzinski, Ph.D.                 2
Administrative resource to R&D Directors. Responsible for R&D budgets, Patent Liaison group,
R&D administration and design of new R&D facilities.




John C. Budzinski, Ph.D.             3
Research Supervisor, Agricultural Products Dept.                    (1978 to 1982)
Directed group of 8-10 Ph.D. scientists in discovery of new crop protection chemicals. Led major
part of sulfonylurea herbicide program, set new strategic direction for insect control program and
developed aggressive patent strategies to protect inventions.


Patent Liaison, Agricultural Products Dept.                              (1977 to 1978)
Special assignment working between R&D and Legal to optimize intellectual property value
through patent strategies, filing and prosecuting of U.S. and foreign patents .


Research Chemist, Biochemicals Dept.                                     (1973 to 1977)
Organic synthesis targeted at discovery of innovative biologically active compounds for use as
pharmaceuticals and crop protection agents -- synthesis of novel compounds, development of
structure activity relationships and new synthetic route identification.


Academic Background


Postdoctoral Fellow, Arizona State Cancer Research Institute, Arizona State University
(Prof. G.R. Pettit)
Isolation, identification and synthesis of natural products with antineoplastic and anti tumor activity
from marine organisms.


Ph. D. Organic Chemistry, Washington University,
(Prof. A. G. Hortmann)
Dissertation on novel synthetic methods, terpenoid biosynthesis with discovery of a novel
monoterpene rearrangement.


B. A. Chemistry, Washington University, St. Louis, Mo.



Editorial Board - Pharmaceutical and Bio-Pharmaceutical Outsourcing, PharmaSource


Recipient – 1999 Summit Award - DuPont Pharmaceutical’s highest award of excellence for
advancing technical and business goals for Sustiva™.


Six U. S. patents, with multiple fore ign equivalents




John C. Budzinski, Ph.D.                 4
                     Outsourcing Lectures and Publications


Working With Contract Manufacturers: Technology Transfer, Validation and
Managing for the Long Term, Technology Transfer Symposium June 22-23. 1998,
Philadelphia, PA.


Choosing and Working with API Contract Manufacturers, Outsourcing
Pharmaceutical Manufacturing for Pre Clinical and Commercial Materials,
September 14-15. 1998, Princeton, NJ


Avoiding "The Dark Side" of Outsourcing, Outsourcing of Drug Development,
October 21-22, 1999 Vienna, Va.


Identifying Chemical Outsourcing Partners and Managing the Relationship over the
Life of the Contract, Outsourcing Pharmaceutical Chemistry Services, May 15-16,
2000, Princeton, NJ


John Budzinski, Identifying Chemical Outsourcing Partners and Managing the
Relationship over the Life of the Contract, American Pharmaceutical Outsourcing,
Sept./Oct. 2000


Managing Strategic Outsourcing Relationships for the 21st Century, PERI Continuing
Education Course, December 8-9, 2000, Washington, DC


Managing Strategic Outsourcing Relationships for the 21st Century, PERI Continuing
Education Course, December 5-7, 2001, Washington, DC


API Tech Transfer and Support, Development to Commercialization and Beyond
March 18, 2002


Outsourcing Bio/Pharmaceutical Manufacturing, Recognize and Exploit the Value
Outsourcing Can Yield, Center for Business Intelligence, June 26, 27, 2003,
Boston Mass.



John C. Budzinski, Ph.D.           5
Sourcing of pharmaceutical intermediates and API’s from China and India , SOCMA
Purchasing Workshop, Informex Conference, January 19, 2004, Las Vegas,
Nevada.


Pharma – The Next Generation, SOCMA Corporate Excellence Conference,
Cambridge Maryland, September 14, 2004


Sourcing from China – Two Perspectives,
December, 2004


Weighing the Risk and Benefits of Outsourcing to China and India,
Partnerships with CMO’s, Managing and Improving Outsource Manufacturing
Relationships, April 4-6, 2005, Dallas, Texas



Strategies for Vendor Selection, Risk Management and Trouble Shooting,
IQPCs Contract Management for Pharmaceutical and Biopharmaceutical Company
Conference – Workshop Leader (with Gary Conte, V.P. Charkit International)
November 26-29, 2005, San Diego, Ca.


Sourcing Pharmaceutical Materials and Services from China, Web Seminar
Sponsored by Pharmaceutical & Science Group, Advanstar & PharmSource
Presented with Dr. Philip Ma, Global Pharma Sourcing, Feb 12, 2006


Outsourcing R&D Services Session and Panel Discussion Leader, Process R&D
Summit
Cambridge Healthtech Institute, Oct. 2-5, 2006, Philadelphia, PA.




John C. Budzinski, Ph.D.          6

				
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