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GLOBAL REGULATORY STRATEGY
CONSIDERATIONS
SCIENTIFIC
SARAH POWELL
EXECUTIVE DIRECTOR, REGULATORY STRATEGIES
SEPTEMBER 14-17, 2008
BOSTON, MA.
Discussion Points
• What is a regulatory strategy?
• Who’s involved in setting strategy?
• What tools are available to assist in setting
strategy?
• How should the strategy be maintained?
Strategic Management
• Strategic management is the art and science of
formulating, implementing and evaluating crossfunctional decisions that will enable an organization
to achieve its objectives
Source: David, F Strategic Management, Columbus:Merrill Publishing Company, 1989
Drug/Device Comparison
Drug
Device
Molecules
Complex components
Toxicology
Biocompatibility
Short half-life
Durable Equipment
Long market life
Rapid product cycles
Drug interactions
Device Malfunction
Wrong Drug / Dose
User Error
Clinically studied
Bench studied*
Good Manufacturing Practices (cGMP)
Quality Systems
(ISO 9000)
*Depending on device class may require clinical studies
Regulatory Strategy
• Defines the plan for developing the product with the
goal of obtaining regulatory approval in desired
markets and lifecycle management/maintenance
post approval
Influences on Regulatory Strategy
External Influences
Competitive Products
Technology
Patients
Patient Advocacy Groups
Etc.
Regulatory Influences
Regulatory Authorities
Guidelines
Standards Organizations
Etc.
Internal Influences
Regulatory Affairs
Product Development
Manufacturing
Etc.
Regulatory Strategy
Developing Regulatory Strategy
• Know your target label
– What claims do you want to support?
– How is this different from competitive products?
Developing Regulatory Strategy
• Know your target market(s)
– Where do we want to obtain approval to market
commercially?
– What filing options are available for my product type?
• Orphan product, accelerated approval, conditional approval,
etc?
Developing Regulatory Strategy
• Know your target market(s)
– What are the regulatory authority expectations for
obtaining approval?
• Clinical trial support
• Previous marketing experience
• Manufacturing supportive information
• Etc.
– How do the expectations vary by region?
– What if any meetings will need to occur with authorities?
Developing Regulatory Strategy
• Know your target market(s)
– What competitive products are already marketed?
• What was done to support registration?
• What claims can they make in their labeling?
• What is the safety profile?
– What competitive products are in development and where
are they in the development process?
Developing Regulatory Strategy
• Know your target markets
– Intellectual property considerations
• What patent protections are available?
• Can security/integrity/quality be ensured?
• Define criteria for success
– May include approval(s) or “early kill”
Developing Regulatory Strategy
• Internal resource needs
– Global regulatory expert/manager
• Leads internal team
• Leads planning of strategic meetings with health authorities
• Manages creation of global regulatory strategy documentation
• Provides advice on global regulatory requirements and
submission standards
Developing Regulatory Strategy
• Internal resource needs
– Global regulatory expert/manager cont.
• Identifies corporate resource needs for strategy execution
• Helps define budget and timelines
– Internal Project Team
• Includes representatives from all disciplines related to product
development
• Strong working knowledge of product development process
Developing Regulatory Strategy
• Internal resource needs
– Internal Project Team cont.
• Experience in preparing information needed for regulatory
submission
• Understanding of global requirements for registration and
maintenance
• Understanding of competitive landscape
• Strong communication and presentation skills
Developing Regulatory Strategy
• External resource needs
– Consultants
• Can provide advice on local requirements or scientific issues
• Compilation of regulatory submissions and lifecycle
management
• Staff supplementation
• Marketing advisors
Developing Regulatory Strategy
• External resource needs cont.
– Contract Research Organizations
• Manages trial preparation activities and execution
– Investigator agreements, distribution of relevant materials,
informed consent, translations, etc.
– Health authorities
• Scientific advice
• Regulatory guidance
Developing Regulatory Strategy
• External resource needs cont.
– Attorneys
– Advisory boards
Information Sources
• Free information sources
– Regulatory authority websites
– Discussion groups/blogs
– Harmonization or standards setting organization websites
(ICH, HL7, ISO, etc.)
– Regulatory alerts or newsletters
Information Sources
• Fee or subscription based
– Professional journals or newsletters
– Regulatory intelligence databases
– Regulatory alerts or newsletters
– Freedom of Information requests
Strategy Execution and Maintenance
• Successful execution depends on
– Detailed project plan
– Clear designation of organizational roles and
responsibilities
– Effective support systems and procedures
– Effective communication and decision making
Project Planning
• Develop detailed project plan based on global
regulatory strategy document goals and objectives
– Include resource assignments and timelines
– Should be created early in project
– Revise as necessary
• Communicate, communicate, communicate
Accountability
• Clearly defined roles and responsibilities
• Realistic expectations
• Defined metrics/criteria for success
• Allow for the “early kill”
Support Systems and Procedures
• Planning tools
– Project planning
– Regulatory intelligence
– Registration/submission planning
– Registration/submission tracking
– Reporting capabilities are key
• Remember the communicate, communicate, communicate
Support Systems and Procedures
• Other Systems
– Document and records management
– Adverse event reporting
• Procedures
– Clinical study initiation and approval
– Submission standards (global and regional)
– Program management
– Etc.
Communication and Decision Making
• Regulatory strategy is a living document – you
must EXPECT change
– Some examples:
• Regulations evolve and change
• Agencies can change their minds
• New intelligence on similar product
• Change in target label or markets
• Pressure from patients, advocacy groups or media
Communication and Decision Making
• Modification to strategy is a business decision
– In the modern world of business, it is useless to be a
creative original thinker unless you can also sell what you
create. Management cannot be expected to recognize a
good idea unless it is presented to them by a good
salesman*
*Source: David M. Ogilvy
Communication and Decision Making
• Expect conflict
• Balance resource cost with expected revenue
– Time, money, people vs. income
• Be sensitive to cultural and language issues
• Write it down!
Communication and Decision Making
• Evaluate and criticize yourself
– What are we doing well?
– What could we do better next time?
• Celebrate the successes
– Remember success can be an “early kill”
Conclusion
• Think globally
• Be prepared
• Good project management is critical
• Expect change
• Use tools, systems, and people for their intended
purpose
• Communicate
Contact Information
Sarah Powell
Executive Director, Regulatory Strategies
E-mail: [email protected]
Phone: (916) 580-3852
Website: http://www.liquent.com