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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 TWO | WEDNESDAY, NOVEMBER 13

8:30 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Linda Bowen, Head of Regulatory Policy and Intelligence
SEATTLE GENETICS

9:00 CASE STUDY: EFFECTIVE COMMENTING TO SHAPE US & GLOBAL REGULATORY GUIDANCES
To actively effect change for emerging regulations and policies, intelligence and strategy teams elicit feedback from internal stakeholders to align comments for US and international health authorities. Collecting informative comments can prove difficult as draft guidances impact a variety of functions, requiring intelligence teams to elect relevant thought leaders on the topics and proactively engage with an array of internal stakeholders for feedback. In addition, intelligence and strategy executives must understand the difference in the commenting processes for the US, which is known to be more open to industry feedback, and emerging markets, which tend to demand an in-person audience for reviewing comments.

  • Engaging executives through a streamlined comment collection process
  • Differences in the commenting processes in various markets
  • Biggest opportunities to effect change within the US or globally
  • Intelligence role as the connection between policy & other functions

Charles Celeste, Director, Regulatory Policy & Intelligence, LEO PHARMA

 

9:45 BREAKOUT GROUPS: DEEP DIVE ANALYSIS INTO SPECIFIC US & GLOBAL REGULATORY TRENDS
Each regulatory trends or new regulation requires specific methods to analyze and interpret the requirements as well as determine the overall impact to the organization and life science industry. Challenging regulations, such as the European Union Medical Device Regulation (EU MDR), require intelligence and strategy teams to consistently inspect newly released publications from notified bodies on a weekly basis, whereas other trends, such as updates on the FDA’s digital health pilot program, are reviewed less frequently and without immediate action required. This peer-to-peer learning session allows intelligence and strategy executives to dive deeper into concerns surrounding specific regulatory trends as well as the unique effects on the life science industry.

  • GROUP 1: DIGITAL HEALTH/SAMD
    Jessica Hale, MERCK
  • GROUP 2: REAL WORLD EVIDENCE
    William Garvin, BUCHANAN, INGERSOLL & ROONEY
  • GROUP 3: EU MEDICAL DEVICE REGULATION
    Kirsten Paulson, PFIZER

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 BREAKOUT GROUPS: METHODS TO COLLECT GLOBAL REGULATORY INTELLIGENCE
Global life science organizations face many challenges while reviewing international policies and developing strategy for specific markets, due to unique regional regulatory pathways and constantly evolving landscapes. This peer-to-peer learning session allows participants to exchange concerns and best practices for collecting regulatory intelligence in complex regions, ensuring knowledge share of time and cost effective methods. To enable discussion, the audience will break into smaller groups, focusing on specified regions that prove challenging for policy development and intelligence collection as listed below, with the possibility of adding further groups and markets deemed necessary by the audience:

  • GROUP 1: EUROPEAN UNION
    Kirsten Paulson, PFIZER
  • GROUP 2: INTERNATIONAL COUNCIL FOR HARMONIZATION
    Julia Jiang, Formerly OTSUKA PHARMACEUTICAL
  • GROUP 3: ASIA PACIFIC
    Lisa Wells, WL GORE & ASSOCIATES

 

11:45 CASE STUDY: DEMONSTRATING THE VALUE & IMPORTANCE OF REGULATORY INTELLIGENCE TO MANAGEMENT
In recent years, management teams have requested regulatory intelligence functions to illustrate the value added to the collective company and to individual product success. In many cases relevant findings cannot be measured until much later, such as once a product has been developed and received approval or a final guidance is released. Regulatory intelligence teams exhibit value through a variety of metrics including number of comments submitted or FDA meetings conducted and although these are important evaluations, meaningful significance is added when these figures are linked to affecting a final guidance released by the FDA or the organization saving resources due to faster time to market or overall reduced costs.

  • Analysis of qualitative vs. quantitative measurements
  • Tracking comments to view effect on final guidance
  • Demonstrating reduced costs due to collected data

Jessica Schlegel, Sr. Specialist Device and Digital Health, MERCK

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 – 3:15 INDUSTRY CASE STUDIES: IMPACT OF REGULATORY INTELLIGENCE ON PRODUCT & ORGANIZATIONAL STRATEGY
As regulatory intelligence teams disperse information throughout the organization, much of the collected data is utilized in developing product and overall corporate strategy. Product teams use intelligence to understand current and emerging competitors on the market, ways to speed time to approval through established regulatory pathways, and ensuring compliance with all requirements. Regulatory strategists also employ intelligence to affect the company direction and strategy to determine best regions to enter based on policy and clinical specifications as well as product lines that showcase a niche opportunity within the industry.

 

1:45 CASE STUDY ONE: UTILIZING REGULATORY INTELLIGENCE FOR PRODUCT STRATEGY

  • Engaging with development teams in early product design phases
  • Adding value to functions including marketing, technical operations, etc.
  • Regulatory intelligence effect on speed of approval & time to market

Julia Jiang, Independent Consultant, Former Global Regulatory Intelligence Lead, OTSUKA PHARMACEUTICAL

 

2:30 CASE STUDY TWO: INFLUENCE OF REGULATORY INTELLIGENCE ON CORPORATE STRATEGY DEVELOPMENT

  • Sculpting the regulatory landscape to align with company strategy
  • Use of competitive intelligence to determine optimal markets to enter
  • Finding opportunities for product lines & new organizational endeavors

Vada Perkins, BAYER

 

3:15 WORKSHOP: APPLICATIONS OF COMPETITIVE INTELLIGENCE TO AFFECT REGULATORY STRATEGY & PRODUCT APPROVAL
Although gathering competitive intelligence can prove difficult within the life science industry as manufacturers endeavor to protect proprietary information, many organizations aim to compile data through a variety of tools and databases to impact product strategy. Competitive intelligence contains valuable information regarding manufacturing practices, marketing efforts, and product reimbursement, which is ultimately utilized in developing regulatory strategy for similar emerging therapies. This workshop gives attendees the opportunity to collaborate in small groups while discussing hypothetical scenarios and methods to collect competitive intelligence, with time allotted to reconvene and report back on solution methods with the group as a whole.

  • 15 minutes: Presenter introduction, setup & small group introduction
  • 30 minutes: Small group collaboration, discussion of data collection methods
  • 15 minutes: Reporting corrective solutions to the group

Meg Drew, Senior Director, Global Regulatory Affairs, ABBVIE

 

4:15 END OF CONFERENCE

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