Vp Director Marketing,Contract - PDF

Document Sample
Vp Director Marketing,Contract - PDF Powered By Docstoc
					Capabilities Overview
          Updated February 2011
                                                Contents


•   Business Summary
    History, Background & Mission Statement

•   Facilities
    Capabilities & Systems

•   Operational Excellence
    Project Management Driven

•   Quality
    Organization, Philosophy & Current Status

•   Organization
                                                                    Overview


•     OsoBio is a contract manufacturing organization (CMO) that focuses on
      biologic and pharmaceutical injectable finished drug products – (sterile
      liquid, liquid suspension and lyophilized formulations).

•     The site has demonstrated the ability to handle virtually any category* of
      biological or pharmaceutical product, from clinical to commercial scale,
      specializing in difficult and complex products, including potent
      compounds, proteins, and monoclonal antibodies.

•     OsoBio has an excellent compliance record with approvals from almost
      every major global regulatory agency.

•     OsoBio is well positioned financially with a solid and diverse customer
      base and the backing of a strong ownership group
*does not include beta-lactams
                                            OsoBio – New name, rich history
                                                                                        2008
                                                                            A group of private
1980                            1993                   2001                investors acquires
Built by                        Acquired by            SP Pharma         the site, returning it
Summa                           Pharmacia,             becomes part
                                                       of Cardinal
                                                                          to its entrepenurial
Medical at the                  becomes
                                                       Health’s PTS                      roots
current site                    Pharmacia
                                Upjohn in              division
                                1995




         Adriamycin structure




        1988                                  1997              2007
Purchased by                             An MBO is      Cardinal PTS
Erbamont and                           executed with      is spun off,
     renamed                                 current        becoming
  Adria SP as                           management           Catalent
      primary                          and renamed
  product was                            SP Pharma
   Adriamycin
New Mexico Top 10 Manufacturer
                                                           Location & Facilities


•   Located in North Central Albuquerque
•   Four dedicated facilities
     –   Manufacturing
          • 2 Compounding / Formulation areas (4 suites)
          • 3 Grade A aseptic filling suites
          • 1,230 square feet of lyophilization capacity
     –   Warehouse
          • 139,000 square feet warehouse space
          • 2 Vial labeling and packaging lines
          • Cold Storage
     –   Laboratories
     –   Administration Building
•   Current operations are on a 24/5 schedule with capability for 24/7
                                               Manufacturing

•   2 Compounding / Formulation
                                                    4272 Balloon
    areas                                           Park Road NE
     –   3 Grade A aseptic filling suites
     –   2 cc to 100 cc vial filling
          • 2 TL 8 head filling machines
            (continuous glass supply)
          • 1 TL 4 head filling machine
            (batched glass supply)
     –   1,230 square feet of lyophilization
         capacity across four Lyos: (410,
         410, 300, 108 square feet)
•   Sterile liquid, suspension and
    lyophilized formulations (Aseptically
    filled and/or terminally sterilized)
•   Currently 24/5 operation
    expandable to 24/7
                      Inspection, Packaging & Sterile University

Warehousing
              o
     –   2 – 8 C Cold Storage ~ 7,000 ft2
     –   Ambient Storage ~10,000 ft2
     –   Total Warehouse Space ~ 139,000 ft2
            o        o
     –   -20 C & - 70 C Storage
     –   DEA compliant storage
Inspection, Labeling & Packaging
     –   Inspection: 2 Pace semi automated and 3
         Manual Inspection stations
     –   Labeling machines: 2 Weilers
     –   Cartoners: 2 Bosch & 1 Jones
                                                        4401 Alexander
Sterile University                                         Blvd. NE
     –   Full mock up of all manufacturing activities
     –   Allows training without exposing sterile
         core or interruption of normal
         manufacturing
                                            Support Facilities




Administration Building       Laboratories
• Engineering & Maintenance   •Chemistry Laboratory
• Metrology                   • Particle Laboratory
• Validation                  • Stability
• Technical Operations        • QA Documentation
• EH&S                        • Regulatory Affairs
• Human Resources & Finance   • Quality Compliance
.
                              . 
                                                           Systems

                   T

Trackwise for          Documentum &
Quality Systems        Training
CAPA, Change           Manager
Control, Audits,       Records, plans &
Complaints, etc.       SOPS
                                             Fully Integrated,
                                             State of the Art
                                                 Systems
Ross-ERP for           Calman for
Production             Maintenaice
Lot Status,            Calibrations, PM’s,
Inventory, & Work      & Qulifications
Orders
                                                 Clean Rooms



          Grade A
         Aseptic Suites




  Grade B
Aseptic Support




           Grade C          Grade D
         Compounding      Component Prep   Classifications
                                                                Clean Rooms

                        Grade D        Grade C          Grade B           Grade A

                                                                     • Fill lines
                 • Process equip
                                   • API Handling • Background for • Unloading of
                   components
                                   • Formulation      filling          sterilized
 Primary Purpose • Vial washing
                                   • Background for • Aseptic storage components
                 • Equipment
                                     capping        • Capping        • Loading of
                   cleaning
                                                                       lyophilizers

   Minimum Air
                          30              60              155               240
   Changes/hr

  Maximum non-
viable particle limit   100,000         10,000            100               100
    (0.5µm/ft3)
                                                  Operational Excellence


                             Drives the business from multiple
                                  perspectives (Customer,
                              Employees, Market, Business,
                                 Systems & Formal Project




                                                                 Improvement
                                       Management)




                                                                  Continuous
                Utilizes Six Sigma as a tool in
                   process and leadership
                development with a formally
                          trained staff




     Embedded, common
methodology deployed across all
operational and functional areas
                                          Project Management

                                              Define
                                              Scope


                                                          Regulatory
                              Equipment
                                                           Strategy
     A dedicated Project
  Manager is assigned to
each project as the primary
    customer interface to                 OsoBio-Client
  coordinate all activities               Project Team
 related to the successful
   implementation of the
           Project            Customer                     Risk
                               Needs                       Mgmt



                                            Timeline &
                                             Budgets
                                                       Quality Functions
                        •Validation
                        •Regulatory
 Quality Systems        •Change Control
                        •Quality Agreements
                        •APR & Audits



                        •Media Fills
                        •Sterility
   Microbiology &       •Environmental Monitoring
   Chemistry Labs
                        •Stability
                        •Product Testing



                        •Aligned with Operations to provide integrated QA support
Manufacturing Quality   •Incoming raw material release and finished product AQL
    Assurance           •Batch Record Review & Release
       (MQA)            •Computerized Environmental Monitoring System
                        •Complaints
                                                   Strong Compliance Position


                               Date          Agency                Type of Inspection                    Results
Facility Compliance                        FDA – CBER                General Inspection                  Approved
                               2005           ANVISA                   PAI Inspection                    Approved
•   Australia                           EMEA, MHRA, IMB            PAI/General Inspection                Approved
•   Canadian Authorities                   FDA – CDER            Multiple (2 PAI & 1 General)            Approved
•   EMEA                       2006
                                      Gulf Cooperation Council         PAI Inspection                    Approved
•   Gulf Cooperation Council
•   NM Board of Pharmacy                      ANVISA                  2 PAI Inspections         Approval granted for line 274
                               2007
•   FDA                                    FDA – CDER                General Inspection                  Approved
     • CBER                             EMEA, MHRA, IMB              General Inspection                  Approved
     • CDER                    2008
                                            FDA-CDER                 General Inspection                  Approved
     • CVM
                                      NM Board of Pharmacy           General Inspection                  Approved
                               2009
                                          MHRA - EMEA            Product Specific Inspection             Approved
                                           FDA – CBER                General Inspection                  Approved
                                              ANVISA             Product Specific Inspection              Pending
                               2010
                                          Mexican Health         Product Specific Inspection             Approved
                                               EMA                   General Inspection                  Approved



                                                 (No outstanding Observations from any agency)
                                    Diverse Customer Base*


                              European
                                 31%

     Big Pharma
         30%                                     Mid Pharma
                                                     4%




                                          Emerging
                                            14%
                          Biotech
                            21%




*Based on 2010 revenues
                                                     Investing for Growth


•   Rolling 3-year plan supporting facility maintenance, planned upgrades,
    and strategic business opportunities
•   Key Projects include
       – Pre-purchased tanks & equipment stocked in-house to reduce new
         customer timelines
       – 152 Filler / Washer / Tunnel: Key equipment upgrade to improve aseptic /
         containment capabilities / Improve speed / efficiency
       – Pre-filled Syringe Line: Expansion of capabilities offered
       – Automated Inspection: Improve glass quality, speed, & efficiency


2009                                   15%

2010                            10%               Total Projected Spend
                                                  (as a % of revenues)
2011                             12%
Organizational Structure
             Updated February 2011
            Employment Makeup by Function

                        Technical
                          21%



                                              Quality
                                               20%
Mfg                              SG&A
54%                               5%

      Current total employment ~ 350 people
                                                                  Senior Leadership Team
                                                                                 Collective Experience exceeds 125 years


Stuart Rose – CEO (Ph.D. Chemistry)
   37 years of experience in the pharmaceutical industry most recently as head of Supply Chain Strategies International. Prior
         experience includes positions with Penick Corporation (as President/CEO), ICN Pharmaceuticals (now Valeant
       Pharmaceuticals) as VP of Worldwide Manufacturing and as VP/GM ICN Europe and SVP for Par Pharmaceuticals.

Jeff Curl – VP Operations (B.S. Biology)
   21 years of pharmaceutical experience in sterile manufacturing with Aventis Behring, Cardinal Health, and OsoBio. Joined
           Oso’s predecessor company as Director of Operations in 2004 and promoted to current position in 2008.

Susan Schniepp – VP Quality (B.S. Microbiology)
    30+ years of professional experience managing quality assurance at Abbott Labs, Antisoma PLC, Hospira and Javelin
   Pharmaceuticals Inc. Currently serving on the board of directors for PDA and has served as chairwoman of the Monograph
          Development–Psychiatrics and Psychoactives Expert Committee for United States Pharmacopeia (USP).

Julie Miner – VP Finance (B.A. Accounting, C.P.A.)
   19 years of accounting experience, 9 years in manufacturing, services & construction and 7 years in corporate accounting.
       Ten years of direct manufacturing experience in various roles with General Electric, Cardinal Health, and Catalent.

Milton Boyer – VP Business Development (B.S. Chemistry; M.S. Biochemistry)
   21 years of experience in Fine Chemical/Pharmaceutical Sales, Marketing & Business Development. Extensive experience
     in API’s and narcotic raw materials. Prior experience includes positions with Siegfried USA and Chattem Chemicals as
                  Director Sales & Marketing and as Technical Director for Flexible Products Company (Dow)
                                                Organizational Structure


       Jeff Curl           Julie Miner      Susan Schniepp         Milton Boyer
     VP-Operations         VP-Finance         VP-Quality           VP-Bus Dev


 •Manufacturing       •   Finance           •  Quality Systems     • Sales/Marketing
 •Engineering         •   Cost Accounting   •  MQA                 • Contract
 •Maintenance         •   Payroll           •  Laboratories          Management
 •Packaging           •   HR                •  Regulatory          • Project
 •Inspection          •   Benefits             Affairs               Management
.•Warehouse          .•   Purchasing        .• IQA               . • Customer
                                                                     Service
 •Technical
  Operations
• EH&S
                                                                   Summary


Our goal at OsoBio is to be known as:

   – An injectables manufacturer that has specialized expertise and experience
     to handle the most unique and complex projects, volume-independent.
   – A company that sets the standard for regulatory compliance within the
     injectables manufacturing industry.
   – A company intently focused on customer responsiveness with attention to
     detail, flexibility and clear communication.


We welcome the opportunity to discuss your sterile filling
requirements in detail and let us show you how OsoBio can help
meet your manufacturing needs.
                               Thank You
Please visit our website to learn more about OsoBio

                               www.osobio.com

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:38
posted:10/14/2011
language:English
pages:24
Description: Vp Director Marketing,Contract document sample