LIFE SCIENCE REGULATORY INTELLIGENCE AND STRATEGY CONFERENCE

OCTOBER 18-19, 2018 | ALEXANDRIA, VA

SHERATON SUITES OLD TOWN ALEXANDRIA

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DAY ONE | THURSDAY, OCTOBER 18

8:15 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Natalia Shunmugan, Director of Global Regulatory Intelligence & Policy, ULTRAGENYX PHARMACEUTICAL INC.

 

9:00 OPENING KEYNOTE PANEL: TRANSLATING REGULATORY INTELLIGENCE INTO ACTIONABLE STRATEGY
Whether an organization has a defined regulatory intelligence function or has policy monitoring incorporated into regulatory affairs team responsibilities, life science corporations must continually review new and existing policies, interpret based on the risk tolerance of the organization, and recommend various steps for integrating new regulatory requirements into existing structures. Increasingly, regulatory intelligence is also being leveraged to increase new product clearance certainty through review of competitive product approvals, to expand access through new indication approvals, and to speed time to market through integration of innovative study design. Reviewing the progressive importance of regulatory intelligence and strategy and the impact this critical function is having on the bottom line will set the tone for this meeting, featuring leaders representing a mix of both large and small corporations utilizing regulatory intelligence.

MODERATOR:
Christopher Fanelli, HOGAN LOVELLS

PANELISTS:
Vada Perkins, BAYER PHARMACEUTICALS

Natalia Shunmugan, ULTRAGENYX PHARMACEUTICAL INC.

Karen Hauda, NOVO NORDISK

George Odero, HOLOGIC INC.

 

9:45 PANEL: DEFINING THE SCOPE AND DEPTH OF LIFE SCIENCE REGULATORY INTELLIGENCE
While some life science organizations operate with larger regulatory intelligence teams, others are dependent on a much smaller team to ensure the company stays up to date on policy changes, leaving room for internal interpretation to define the roles and responsibilities of regulatory intelligence executives. With many similarities throughout the life science industry, there are unique aspects to each individual regulatory intelligence team depending on the needs of the overall entity. A panel of regulatory intelligence executives will highlight how individual companies tailor the scope and depth of regulatory intelligence based on expertise and company needs.

MODERATOR:
Janet Vessotskie, TAKEDA

PANELISTS:
Tricia DeSantis, BIOGEN

Darin Oppenheimer, MERCK

Charles Celeste, LEO PHARMA

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 OPEN DISCUSSION: DEFINING THE SCOPE OF REGULATORY INTELLIGENCE BASED ON COMPANY SIZE
In an open discussion format, attendees will discuss organizations of different sizes based on overall number of employees and annual turn-over, enabling an even exchange of ideas focused on the challenges and opportunities which exist for regulatory intelligence executives working in similarly sized entities.

  • Man power resources
  • Technology resources
  • Financial resources

Susan Laufer, NOVO NORDISK

Janet Vessotskie, TAKEDA

George Odero, HOLOGIC INC.

 

11:30 PANEL: INTERPRETING NEW REGULATORY REQUIREMENTS AND UPDATING INTERNAL PROCEDURES
Life science entities rely on regulatory intelligence teams to interpret new guidelines and regulations from authorities, including the FDA and EMA, and modify internal procedures and policies that are affected by the changing regulatory landscape. It can be difficult for intelligence teams to interpret new regulations if there is a lack of material provided by governing bodies or if the guidance contains an abundance of information, some of which might be irrelevant depending on the scope of the organization. A panel of regulatory intelligence executives will share best practices in the interpretation of new regulatory requirements, as well as experiences in updating internal policies which ensure alignment with regulations.

  • Engaging internal stakeholders to interpret regulatory requirements
  • Proactive responses for clearer clarification from authorities
  • Updating internal procedures to align with regulatory requirements

MODERATOR:
George Cusatis, MERCK

PANELISTS:
Teresa Sowinski, IMPAX LABORATORIES

Susan Laufer, NOVO NORDISK

Jack Joseph, BAXTER

Kyle Sampson, King & Spalding

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

GLOBAL MODULE: MONITORING & REACTING TO INTERNATIONAL REGULATORY CHANGES
In addition to oversight surrounding US FDA regulations, executives responsible for regulatory intelligence must also consider the global operating environment, where regulations are continually evolving and must be monitored for changes, reviewed and interpreted, and finally integrated into operating procedures. Moving beyond the operational challenges of gathering new guidance and regulatory documentation, executives must consider translation of documents and methods for integrating policies effectively into existing international frameworks. Through a multi-part presentation, executives will gain knowledge on how industry executives are managing international regulatory awareness, with a specific focus on current challenges in Europe and Asia.

 

1:30 PART ONE PANEL: STRATEGIES FOR MAINTAINING AWARENESS OF GLOBAL REGULATIONS

  • Strategies for monitoring international regulatory changes
  • Influencing policymaking in a global regulatory environment
  • Utilizing local resources to interpret new & developing policies


MODERATOR:

Darin Oppenheimer, MERCK

PANELISTS:
Jayne Ware, MERCK

Brian Mayhew, NOVARTIS

Ana Ladino, WEST PHARMACEUTICAL SERVICES

 

2:15 PART TWO: IDMP REGULATIONS & REFLECTION ON PILOT PROGRAM

  • Explosion in the number of data points to be monitored
  • Development of detailed and auditable metrics
  • Projected timelines for regulatory implementation

Vada Perkins, Head, Regulatory Intelligence, Director, Regulatory Policy & Intelligence, BAYER PHARMACEUTICALS

 

3:00 COFFEE & NETWORKING BREAK

 

3:30 COLLABORATION WITH GOVERNMENT AFFAIRS TO SHAPE LEGISLATIVE ENVIRONMENT
As government affairs teams are at the forefront of communication with regula¬tory groups, such as the FDA or the EMA, intelligence functions must collaborate with the appropriate executives to ensure company interests are discussed and concerns are submitted effectively through response letters and other methods to influence policies. It is also critical that intelligence teams work with govern¬ment affairs to participate in working groups to further showcase industry input to regulatory bodies. A co-presentation between members of the regulatory intelligence and government affairs groups will showcase one organization’s collaborative efforts to reduce risk of noncompliance and establish that the company’s concerns are communicated to impact policies.

  • Collaboration with government affairs to align internal policies
  • Creating effective response letters to influence policies
  • Participation in working groups to deliver industry input

Brian Mayhew, Executive Director, Global Regulatory & Development Policy, NOVARTIS

Taylor Booth, Director of Federal Government Affairs, NOVARTIS

 

4:15 UPDATE ON FDA INITIATIVES AFFECTING LIFE SCIENCE REGULATORY INTELLIGENCE TEAMS
Life science regulatory intelligence executives focus on both remaining compliant on updated FDA policies as well as staying at the forefront of newly released initiatives including pilot programs, guidance, and final rulings. Therefore, intelligence teams must remain aware of the direction and current focus areas for the FDA along with best methods create impactful input from an industry perspective. Recent changes and upcoming FDA initiatives will be discussed to showcase critical information for ongoing compliance and opportunities for industry interaction.

Christopher Fanelli, Senior Associate, HOGAN LOVELLS

 

5:00 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
*Please note participants will need to arrange for transportation to and from the restaurant, as well as handle individual payment for the meals.

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