Pharmaceutical Clinical Supplies and Packaging Jobs - PowerPoint by yzy10050

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									   Organization of Clinical
     Operations at a CRO



Anil Kane, Ph.D
Patheon Inc.
akane@patheon.com

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    Outsourcing – Clinical Manufacturing

    Outsourcing – Pharmaceutical Industry’s strategic
                  tool

    • Outsourcing increased dramatically since 1990’s

    • Today pharma companies outsource 20-40%
      of the development budget

    • Approx. 60% of R & D spent on clinical trials
      hence clinical supply management critical to
      development budget / time.

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    Outsourcing - Clinical Manufacturing


     Pharmaceutical outsourcing in the US is now

     over US $ 30 billion


                            - Arthur D.Little




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    Outsourcing – Clinical Manufacturing

                  Sponsor / contractor relationship

     Past

     - Master / slave relationship

     - CRO’s at the whim of sponsors

     Today – a paradigm shift

     - Sponsor / CRO : strategic partnership

     - stronger and long term relationship

     - risk / profit sharing opportunities
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    Drivers to Outsourcing – Clinical Manufacturing


     • to accelerate drug development

     • enhance competitiveness

     • access world class technology / global manufacturing
       infrastructure

     • utilize expertise / experience of a CRO

     • focus internally on core competencies




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    Drivers to Outsourcing – Clinical Manufacturing


     • Lower capital investment, higher ROI (capital risk)

     • cover gaps in capacity

     • access to focused flexible manufacturing infrastructure

     • ensure a more tidy regulatory process




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    Drivers to Outsourcing – Clinical Manufacturing


     • Contractors have a vast experience working with many more
      molecules and complexities than many individual
      pharmaceutical houses.

     • Contractors offer creative solutions to their sponsors

     • Contractors have approved vendors resulting in better quality
       assurance of RM’s / PM’s

     • Contractors have regulatory experiences –
       sites are FDA approved




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    Drivers to Outsourcing – Clinical Manufacturing



     • Logistics of procurement – advantage with a contractor

     • Bulk procurement of RM’s / PM’s reduce overall costs for
       small clinical supplies




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    Drivers to Outsourcing – Clinical Manufacturing


    55% Companies outsource to improve company focus

    54% Companies rely on outsourcing to reduce or control
        operating costs

    38% to free internal resources for other purposes

    36% to gain access to world class capabilities

    18% to reduce time to market

    12% for risk sharing

                            Survey: The Outsourcing Institute –
                            a report – Interphex 2004
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Outsourcing – Clinical Manufacturing


 Disadvantages:

 • reduce organizational innovation

 • shift knowledge to suppliers organization

 • reduce control over activities

 • need a close monitor

 • regulatory risk

 • “Leaking” Intellectual property pr being “boxed in” by third party
   providers                                                     10
     Outsourcing – Clinical Manufacturing

      Sponsors


      • Big Pharma

      • Medium size pharmaceutical houses

      • Biotech companies

      • Virtual to small companies




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     Outsourcing – Clinical Manufacturing

     Evaluating a potential outsourcing partner – a checklist

     Capability

     • Experience
     • Expertise
     • Speed
     • Track Record

     Capacity

     • Right resources (equipment, personnel)
     • Responsiveness to changing requirement


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     Outsourcing – Clinical Manufacturing

     Evaluating a potential outsourcing partner – a checklist
     Quality
     • Quality control procedures and processes in place.
     • Continuous monitoring


     Compliance
     • understanding of applicable regulations
     • established QA plan
     • archiving system


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     Outsourcing – Clinical Manufacturing

     Evaluating a potential outsourcing partner – a checklist


     Financial considerations
     • financial stability
     • long term viability
     • cost of services


     Culture
     • ability to build a lasting, mutually profitable relationship
      with sponsor
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     Outsourcing – Services at CRO

     • API characterization
     • API Stability
     • Preformulation
     • Analytical Methods development
     • Dosage Form Development
     • Dosage form Stability
     • Packaging Development

     • Clinical Manufacturing
     • Packaging
     • Shipping
     • Storage & Distribution



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     Clinical Supply


      Active or placebo preparation used in clinical programs
      for the determination of safety and / or efficacy of a
      pharmaceutical formulation.

      - Material for Toxicology studies / animal PK study

      - Phase I & II supply

      - Phase III trials

      - Phase IV supplies (generally from commercial supplies)



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     Clinical Manufacturing Operations

                        Project     Formulation
                      Management       Dev.        Analytical
      Business Dev.
                                                     Dev.



       Sales,
                             Manufacturing
      Marketing                                      Materials Mgt.
                              Packaging


         Quality
                                                     Services-IT
         Control
                                                        Eng.
                         Quality      Regulatory
                        Assurance     CMC Group

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     Clinical Manufacturing Operations


       Project                                    QC/
       Planning                              Release Testing

                               Clinical
             Materials
                            Manufacturing/
                              Packaging            Clinical
          Info from FD/AD   - GMP facility         Stability




                                                 Shipment
           Documentation

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     Critical Steps in Outsourcing Clinical Manufacturing


        Confidentiality Disclosure Agreement (CDA)

        • prerequisite for any project discussion

        • reviewed and signed by both parties’ legal counsel

        • evaluate project feasibility




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     Critical Steps in Outsourcing Clinical Manufacturing


     Intellectual Property Rights

     • ownership of IP

     • Importance of contracts, assignments and licenses

     • addressed through diligence and Good Contractual Practices




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     Critical Steps in Outsourcing Clinical Manufacturing


       Quality Audits

       • Self Audit by contractors

       • Sponsor audits

           • cGMP’s
           • IQ/OQ/PQ’s of equipment, HVAC’s, Water etc.
           • Training
           • Corrective Action / Preventive action (CAPA) Plan

       • Regulatory Inspection – track records

       • References

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     Critical Steps in Outsourcing Clinical Manufacturing



       Project Questionnaire

       • completed by sponsor

       • clear definition of project scope (activities, responsibilities
         timelines)

       • useful tool to communicate project requirement / expectations
         to contractor


       Alternatively this is captured in “ Request for Proposal” (RFP)


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     Critical Steps in Outsourcing Clinical Manufacturing


       Project Questionnaire should answer the following questions:

       • drug classification (toxicity, therapeutic class etc)
       • availability of MSDS
       • handling procedures / precautions
       • special storage conditions / requirements
       • phase of the clinical program
       • cleaning verification requirement
       • requirement of analytical method/s development, formulation
         development




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     Clinical Manufacturing Plan / Proposal / Quote


      • well laid out steps in the project execution

      • detailed timeline for deliverables

      • assumptions

      • back up plan

      • cost estimate for the project




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     Clinical Manufacturing Operations


      - Cleaning Verification Program

      - Master Validation Plan

      - Product specific

      - Contractor responsibility for compliance




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     Clinical Manufacturing Operations


      Effective Project Management

      key to a successful partnership

      key to a successful execution / timely completion

      key to building long term relationship / future collaboration




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     Clinical Manufacturing Operations



      Analytical Development Laboratories

      • strong team of experienced analytical chemists

      • skills in Preformulation to Analytical support for routine testing

      • complete, flexible infrastructure to meet a variety of client / project
        requirement




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     Clinical Manufacturing Operations



      Formulation Development / Process Development

       most projects need some development / tech transfer work
       prior to clinical manufacturing hence the requirement for:

      • formulation development infrastructure / pilot plant

      • trained, experienced formulators / process development staff




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     Clinical Manufacturing Operations



       Materials Management / Sourcing

       • procurement of raw materials

       • procurement of packaging materials

       • experienced staff – a key to sourcing materials in a timely
         manner




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     Clinical Manufacturing Operations


      Manufacturing set up

      • systems – planning / scheduling manufacturing jobs

      • feasibility of manufacturing a variety of dosage forms

      • equipment / process trains for different scale of operations

      • skilled, trained experienced operators for manufacturing /
        packaging




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     Clinical Manufacturing Operations


       Packaging

       • flexibility in packaging different dosage forms

       • primary packaging

       • secondary packaging

       • clinical kit - packaging




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     Clinical Manufacturing Operations



      Quality Assurance / Compliance

      • SOP’s

      • Training Curriculum

      • cGMP compliance

      • Approval of documents – Master Batch Records, Deviation
       reports, change controls, Reports etc.




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     Clinical Manufacturing Operations



     Quality Control / Analytical Release Testing

     • In-process Testing

     • Bulk product release

     • Packaged product release

     • Generation of CofA’s




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     Clinical Manufacturing Operations



      Shipment of Clinical supplies

      • experienced staff

      • export procedures where applicable

      • special requirements for shipment (refrigeration etc.)




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     Outsourcing – Clinical Manufacturing

     Its all about building TRUST and long term strategic relationship




                       Contractor



                                     Sponsor
                                        C


             Sponsor
                A          Sponsor
                              B




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     Outsourcing – Clinical Manufacturing


      Myths about CRO’s

      • Outsourcing to a CRO is more expensive

      • Large CRO’s do not care about small companies.
        Big Pharma gets a priority

      • Large CRO’s do not communicate effectively

      • CRO’s are training grounds hence high turnover.

      • CRO does not have the same passion for my development /
        clinical program

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     Outsourcing – Clinical Manufacturing


      Myths about Sponsors

      • Large companies do not communicate effectively

      • Small companies use the bidding process as a way of
        getting free consulting.

      • Small companies always ask for more than they are willing
        to pay for.




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     Outsourcing – Clinical Manufacturing


      Key Partnership Elements

           Do’s
           • Understand each other’s wants and needs
           • Establish project milestones and/or service model
           • Develop a sense of common purpose

           Dont’s
           • Underestimate the need for information exchange
           • Assume that information flows perfectly
           • Keep apart functions that need to be co-ordinated
           • Keep trouble a secret


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     Sponsor – CRO Relationship


     Key Elements for Success

     • Mutual Trust and Respect

     • Clarity in Responsibilities

     • Clarity in contractual and payment terms

     • Channel of Communication

     • Minimal changes to team




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     Sponsor – CRO Relationship


     Key Elements for Success


     • Tolerance in diversity of opinion

     • Efficient Project Management Tools

     • Open / honest discussion for problem
      resolution

     • Measure Progress




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 Outsourcing – Clinical Manufacturing

                  The Right Capacity


                            The Right Services


                                   … The Right People



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      Outsourcing – Clinical Manufacturing


     • Good Clinical Trial Manufacturing Contractor has facilities and systems
       equivalent to those in Big Pharma

     • Reasons for outsourcing – time, capacity, infrastructure etc.

     • Key to Success - Information Flow
                     - Effective Project Management

     Repeat Business = TRUST / RELATIONSHIP
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