GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.

GLOBAL REGULATORY STRATEGY CONSIDERATIONSSCIENTIFIC

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 cross-functional 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

Competitive Products

Technology

Patients

Patient Advocacy Groups

Etc.

Regulatory Affairs

Product Development

Manufacturing

Etc.

Regulatory Authorities

Guidelines

Standards Organizations

Etc.

External Influences

Regulatory Influences

Internal Influences

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