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Organization of Clinical Operations at a CRO

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Outsourcing Pharmaceutical Industry's strategic. tool ... Medium size pharmaceutical houses. Biotech companies. Virtual to small companies. Sponsors ... – PowerPoint PPT presentation

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Title: Organization of Clinical Operations at a CRO


1
  • Organization of Clinical Operations at a CRO
  • Anil Kane, Ph.D
  • Patheon Inc.
  • akane_at_patheon.com

2
Outsourcing Clinical Manufacturing
  • Outsourcing Pharmaceutical Industrys strategic
  • tool
  • Outsourcing increased dramatically since 1990s
  • 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.

2
3
Outsourcing - Clinical Manufacturing
Pharmaceutical outsourcing in the US is now
over US 30 billion - Arthur D.Little
3
4
Outsourcing Clinical Manufacturing
Sponsor / contractor relationship
  • Past
  • Master / slave relationship
  • CROs at the whim of sponsors
  • Today a paradigm shift
  • Sponsor / CRO strategic partnership
  • stronger and long term relationship
  • risk / profit sharing opportunities

4
5
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

5
6
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

6
7
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 RMs / PMs
  • Contractors have regulatory experiences
  • sites are FDA approved

7
8
Drivers to Outsourcing Clinical Manufacturing
  • Logistics of procurement advantage with a
    contractor
  • Bulk procurement of RMs / PMs reduce overall
    costs for
  • small clinical supplies

8
9
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

9
10
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
11
Outsourcing Clinical Manufacturing
Sponsors
  • Big Pharma
  • Medium size pharmaceutical houses
  • Biotech companies
  • Virtual to small companies

11
12
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

12
13
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

13
14
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

14
15
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

15
16
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)

16
17
Clinical Manufacturing Operations
Formulation Dev.
Project Management
Analytical Dev.
Business Dev.
Sales, Marketing
Manufacturing Packaging
Materials Mgt.
Quality Control
Services-IT Eng.
Quality Assurance
Regulatory CMC Group
17
18
Clinical Manufacturing Operations
QC/ Release Testing
Project Planning
Clinical Manufacturing/ Packaging - GMP facility
Materials
Clinical Stability
Info from FD/AD
Shipment
Documentation
18
19
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

19
20
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

20
21
Critical Steps in Outsourcing Clinical
Manufacturing
  • Quality Audits
  • Self Audit by contractors
  • Sponsor audits
  • cGMPs
  • IQ/OQ/PQs of equipment, HVACs, Water etc.
  • Training
  • Corrective Action / Preventive action (CAPA)
    Plan
  • Regulatory Inspection track records
  • References

21
22
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)

22
23
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

23
24
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

24
25
Clinical Manufacturing Operations
- Cleaning Verification Program - Master
Validation Plan - Product specific -
Contractor responsibility for compliance
25
26
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
26
27
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

27
28
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

28
29
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

29
30
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

30
31
Clinical Manufacturing Operations
  • Packaging
  • flexibility in packaging different dosage forms
  • primary packaging
  • secondary packaging
  • clinical kit - packaging

31
32
Clinical Manufacturing Operations
  • Quality Assurance / Compliance
  • SOPs
  • Training Curriculum
  • cGMP compliance
  • Approval of documents Master Batch Records,
    Deviation
  • reports, change controls, Reports etc.

32
33
Clinical Manufacturing Operations
  • Quality Control / Analytical Release Testing
  • In-process Testing
  • Bulk product release
  • Packaged product release
  • Generation of CofAs

33
34
Clinical Manufacturing Operations
  • Shipment of Clinical supplies
  • experienced staff
  • export procedures where applicable
  • special requirements for shipment (refrigeration
    etc.)

34
35
Outsourcing Clinical Manufacturing
Its all about building TRUST and long term
strategic relationship
Contractor
Sponsor C
Sponsor A
Sponsor B
35
36
Outsourcing Clinical Manufacturing
  • Myths about CROs
  • Outsourcing to a CRO is more expensive
  • Large CROs do not care about small companies.
  • Big Pharma gets a priority
  • Large CROs do not communicate effectively
  • CROs are training grounds hence high turnover.
  • CRO does not have the same passion for my
    development /
  • clinical program

36
37
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.

37
38
Outsourcing Clinical Manufacturing
Key Partnership Elements
  • Dos
  • Understand each others wants and needs
  • Establish project milestones and/or service
    model
  • Develop a sense of common purpose
  • Donts
  • Underestimate the need for information exchange
  • Assume that information flows perfectly
  • Keep apart functions that need to be
    co-ordinated
  • Keep trouble a secret

38
39
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

39
40
Sponsor CRO Relationship
Key Elements for Success
  • Tolerance in diversity of opinion
  • Efficient Project Management Tools
  • Open / honest discussion for problem
  • resolution
  • Measure Progress

40
41
The Right Capacity
The Right Services

The Right People
Outsourcing Clinical Manufacturing
41
42
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

42
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