2nd Annual Life Science Regulatory Intelligence, Strategy and Execution Conference

November 12-13, 2019 | Alexandria, VA

Sheraton Suites Old Town Alexandria

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DAY ONE | TUESDAY, NOVEMBER 12

7:45 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Linda Bowen, Head of Regulatory Policy and Intelligence
SEATTLE GENETICS

8:40 OPENING ICE BREAKER: DESIGNING COMPELLING REGULATORY NEWSLETTERS FOR INTERNAL DISTRIBUTION
In addition to sifting through various sources to collect pertinent intelligence, regulatory teams also inform internal stakeholders of policy developments and the possible effects to each business function as well as the overall organization. Regulatory intelligence executives generate intriguing newsletters by including necessary information in a visually appealing manner to hold the attention of stakeholders, and in some cases are compelled to prepare deeper dive reports on more challenging requirements, such as EU MDR. In this interactive session, all participants will have the chance to meet new attendees and connect through engaging conversations and immediately build contacts with peers to kick off the event networking platform.

 

MULTI-PART MODULE: THE EVOLUTION OF REGULATORY INTELLIGENCE & CURRENT SCOPE OF THE FUNCTION
Regulatory intelligence as a function is a fairly recent addition to life science organizations as the regulatory landscape continues to evolve at an increased rate with updates released on weekly basis, requiring the industry to employ executives with more of a focus on collecting intelligence. Since the addition of regulatory intelligence teams, the scope and depth of the job function has evolved tremendously due to a variety of changes such as the addition of technology into the analysis of regulations, constantly evolving regulations, and global expansion of businesses. Regulatory intelligence also varies greatly throughout the industry, with some organizations employing a large team and others utilizing a single member of the larger regulatory affairs team for intelligence collection, affecting the overall responsibilities and scope of the function.

 

9:00-10:30 INDUSTRY CASE STUDIES: CAPACITY OF INTELLIGENCE TEAMS BASED ON FUNCTION SIZE

  • Examining current responsibilities of intelligence team
  • Best practices to effectively utilize available resources
  • Proper delegation of tasks accordingly to team size
  • Assigning attention to topics based on business priority and/or risk assessment

 

9:00 CASE STUDY ONE: SMALL INTELLIGENCE TEAM PERSPECTIVE
Linda Bowen, Head of Regulatory Policy and Intelligence, SEATTLE GENETICS

 

9:30 CASE STUDY TWO: MID-SIZED INTELLIGENCE TEAM PERSPECTIVE
Libette Luce, Senior Director, Global Regulatory Affairs, BAUSCH HEALTH

 

10:00 CASE STUDY THREE: LARGE INTELLIGENCE TEAM PERSPECTIVE
Janet Vessotskie, Senior Director, Regulatory Intelligence & Policy, TAKEDA

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 PANEL: EVOLUTION OF REGULATORY INTELLIGENCE FROM INITIAL BEGINNINGS TO CURRENT INDUSTRY BENCHMARKS

  • Trends affecting the evolution of life science regulatory intelligence
    • Changes in regulatory trends & maintaining compliance
    • Use of technology including intelligence databases & AI
    • Global expansion increasing amount of intelligence
  • Progression of regulatory intelligence within individual organizations
  • Forecasted industry changes & expected growth of intelligence teams

MODERATOR:
Jessica Hale, PharmaD, MERCK

PANELISTS:
Richard Jahn, PFIZER

Linda Bowen, SEATTLE GENETICS

Janet Vessotskie, TAKEDA

 

11:45 PANEL: TOOLS & METHODS FOR REGULATORY INTELLIGENCE COLLECTION & BEYOND

  • Traditional data sources for regulatory intelligence
    • Review of commonly used industry tools
    • Best practices to effectively utilize databases
    • Cost benefit analysis of specific industry tools
  • Internal templates used to track intelligence & strategy
  • Mechanisms to track intelligence beyond new policies
  • Comparing methods of tracking US vs global regulations

MODERATOR:
Jessica Hale, Pharma.D, MERCK

PANELISTS:
Charles Celeste, LEO PHARMA

Libette Luce, BAUSCH HEALTH

Luke Zack, KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT

Chris Whalley, SEATTLE GENETICS

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 CASE STUDY: USE OF ARTIFICIAL INTELLIGENCE TO FILTER THROUGH REGULATORY SOURCES FOR DATA

  • Current utilization of AI for regulatory intelligence
    • Developed databases to filter multiple sources
    • Piloted industry machine learning technology
  • Ensuring delivery of correct & relevant information
  • Possible applications of machine learning technology
  • Sharing methods to disseminate data to strategists

Vada Perkins, BAYER

 

2:15 EFFECTIVE METHODS TO OBTAIN SIGNIFICANT SEARCH ENGINE INQUIRY RESULTS

  • Tips & tricks to positively affect search engine results
  • Narrowing down large search engine inquiry outcomes
  • Comparing & contrasting unique aspects of search tools

Chris Whalley, Senior Manager, Regulatory Policy and Intelligence, SEATTLE GENETICS

 

3:00 COFFEE AND NETWORKING BREAK

 

3:30 SELECTION PARAMETERS FOR ENGAGING IN INDUSTRY RELATED ASSOCIATIONS OR TRADE GROUPS
A critical component for the success of regulatory intelligence teams is involvement in industry focused associations which allow for greater access to information regarding enforcement trends and potential upcoming regulatory changes. The life science industry has a multitude of relevant and influential groups that can range from large spectrum associations that focus on the industry as a whole to small more therapeutic area specific trade groups which offer manufacturers are variety of engagement prospects. While the sheer number of available associations can offer great involvement opportunity, regulatory intelligence executives must be selective and ensure that the time and resources spent on association participation garner applicable and impactful information for the organization.

  • Determining impact of large vs. targeted associations
  • Viable number of association partnerships for executives
  • Reviewing outcomes from association involvement

Rachel Turow, Executive Counsel – Regulatory Law, TEVA PHARMACEUTICAL INDUSTRIES LTD.

 

4:15 REGULATORY ROUNDUP: UPDATE ON FDA POLICY AND TRENDS AFFECTING LIFE SCIENCE ORGANIZATIONS
Regulatory trends, such as utilizing real world evidence, patient focused drug development, regulatory flexibility and the intertwined evolving policies and politics around drug pricing and importation, are top concerns for regulatory intelligence teams. Life science organizations must be aware of and responsive to current policies as well as remain up-to-date on FDA activities affecting marketed and emerging medical products and company due diligence activities.Understanding these changes and trends are critical to identifying potential risks and opportunities to any organization’s drug development activities, today and tomorrow.

Kimberly Belsky, MALLINCKRODT PHARMACEUTICALS

Kendra Martello, MALLINCKRODT PHARMACEUTICALS

 

5:15 END OF DAY ONE CONFERENCE