Life Science Regulatory Intelligence & Strategy Conference

Day One Agenda
Wednesday, February 26

8:00   REGISTRATION AND WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   OPENING ICE BREAKER: BUILDING NEW CONTACTS AND SHARING BACKGROUNDS WITHIN THE REGULATORY INTELLIGENCE LANDSCAPE
The opening ice breaker will kick off the event with an opportunity for all participants to move around the conference room and meet new delegates by engaging in short and targeted discussions. In this interactive session, participants are encouraged to meet with peers from different companies and briefly share insight into professional backgrounds, shedding light on the diversity of profiles in the participating audience and kicking off the program networking platform.

9:20   PANEL DISCUSSION: REGULATORY METHODS TO COLLECT, ANALYZE, AND INTERNALLY DISSEMINATE INFORMATION
• Advanced and usefulness tools for regulatory intelligence
• Gathering data through participation in external groups
           » Trade Associations
           » Professional Associations
• Advanced and usefulness tools for regulatory intelligence
Natalia Shunmugan, ULTRAGENYX 
Scott Thiel, HOLOGIC
Lee O’Brien, ROIVANT
 
10:15   ORGANIZATIONAL APPROACHES FOR USING REGULATORY TOOLS AND STRATEGY FOR GREATER EFFICIENCY
• Tactics companies use to streamline applications
• Comparing methods of tracking US vs global regulations
• Mechanisms used to track intel beyond new policies
• Practices used by companies to utilize databases
Ethel Holtzclaw, Director, Global Regulatory Sciences Informatics and Intelligence
BLUEPRINT MEDICINES

11:00   COFFEE AND NETWORKING BREAK

11:30-12:30   SESSION SERIES: PULL THROUGH STRATEGIES: TRANSITIONING INTELLIGENCE INTO ACTIONABLE STRATEGIES

11:30   Part 1 – Assessing Processes, Regulations, and Acting on Intelligence Gathered
• Understanding the latest assessment processes used
• Examining industry experts’ actions on regulations
• Ways for team members to act on intelligence gathered
Meenakshi N. Muthiah, Director, Regulatory Intelligence
ASTRAZENECA

12:00   Part 2 – Actionable Strategy to Managing Risks within Companies
• Evaluating assessment tools for managing risks
           » For inspections
           » For suppliers
           » For vendors
• Using data platforms and new technologies
• Inspection intelligence and vendor intelligence
• Tactics to manage inspections, QMS, and auditing
Niraj Mehta, Executive Director, Head of GQ Strategic Programs and Regulatory Intelligence and Advocacy
MERCK
Austin Caudle, Regulatory and Quality Advisory Board
PARENTERAL DRUG ASSOCIATION (PDA)

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:30     PANEL DISCUSSION: LAUNCHING A REGULATORY INTELLIGENCE TEAM INTERNALLY 
• Considerations for building a group from scratch
• Practices for growing a successful intelligence network
• Outlining methods for establishing a local market presence
• Progressive tactics for leadership buy-in and team alliance
Charles Jagun, MERZ AESTHETICS
Scott Thiel, HOLOGIC
Shahreen Sharma, BEIGENE USA
Janeen Skutnik-Wilkinson, MODERNA

2:15     COMMUNICATING REGULATORY IMPACT TO YOUR ORGANIZATION: ADVANCED PROCEDURES FOR COMPLIANCE SUCCESS
• Collaboration across departments for regulatory success
• Adopting communication for strategic regulatory planning
• Value of cross-functional teams on regulatory outcomes
• Incorporating intelligence in decision-making processes
• Building partnerships with agencies to better capture data
John W.M. Claud, Counsel
HYMAN, PHELPS & MCNAMARA

3:00   COFFEE AND NETWORKING BREAK

3:30   REGULATORY FRAMEWORK FOR CYBERSECURITY AND DATA PROTECTION
• Assessing the latest data privacy and cybersecurity changes
• Data breaches and considerations related to data protection
• Coordinated efforts on managing associated risks
• Building a framework to address regulatory obligations
Alex Smith, Director of Regulatory Sciences, Global Regulatory
HOGAN LOVELLS

4:15     PRACTICAL UTILIZATION OF AI AND ML IN THE REGULATORY INTELLIGENCE LANDSCAPE
• Examination of the evaluation of AI tools and systems
• Decoding the impact of AI on budget and resources
• Ways AI can help professionals work proficiently
Aleksandr Merenkov, Associate Director, Global Regulatory Intelligence
GENMAB

5:00   Closing Remarks and End of Day 1

Day Two Agenda
Thursday, February 27

8:00   REGISTRATION AND WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30-10:00   SESSION SERIES: REGULATORY GLOBAL TRENDS

8:30  Part 1 – Global Trends Challenges and Opportunities
• Changes and challenges with the global strategy perspective
• Understanding initiatives occurring in other countries
• Methods for integrating strategy and intelligence globally
• Practical strategies to anticipate and prepare for global trends
Jemin Dedania, Director of Regulatory Affairs, Global Regulatory
HOGAN LOVELL

9:15   Part 2 – Resolving Regulatory Challenges and Standards That Drive Harmonization
• Harmonization, QMS, UDI, and premarket submission approval
• Assessing the use of real-world data and real-world evidence
• LDT regulations for US and EU: High-level comparison
Winson Teng, Senior Manager, Global Regulatory Intelligence & Policy
BD

10:00   COFFEE AND NETWORKING BREAK

10:30-12:00   SESSION SERIES: IDENTIFYING, LOCATING, AND ANALYZING REGULATORY PRECEDENT 

10:30  Part 1 – Utilizing Regulatory Precedence for Decision-Making
• Tools for conducting regulatory precedent research
• The need for an evaluation of regulatory precedents
• The overall benefits of leveraging regulatory precedents
• Processing collected data to establish actionable strategies
Lee O’Brien, ROIVANT
Meenakshi Muthiah, ASTRAZENECA

11:15  Part 2 – Chemistry, Manufacturing, and Controls (CMC) and Regulatory Considerations
• Considerations and anticipated regulatory outcomes
• Understanding the CMC component of regulatory strategy
• Establishing the product development strategy
• Regulatory CMC objectives, hurdles, and risks to success
• Key CMC milestones and decision points
Sree Malepati, Senior Manager, CMC Global Regulatory Affairs
OTSUKA

12:00  LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:00   PANEL DISCUSSION: REGULATORY IMPLICATIONS ON FDA’S FINAL LAB DEVELOPED TEST (LDT) RULE: CHANGES, REQUIREMENTS, AND CHALLENGES
• Reviewing regulatory knowledge changes for LDTs
• Assessing the impact and challenges on manufacturers
• Considerations on assay development in clinical studies
• Requirements on inspections, accuracy, and reliability testing
Gail H. Javitt, HYMAN, PHELPS & MCNAMARA
Raya Zerger, BECKMAN COULTER DIAGNOSTICS
Jewell Martin, BIOMARIN PHARMACEUTICAL

2:00-3:30   SESSION SERIES: SOLUTIONS FOR REGULATORY PROFESSIONALS TO ENSURE COMPLIANCE WITH GLOBAL REGULATIONS

2:00  Part 1 – Compliance Management and Reporting Solutions for Ensuring Compliance with Global Regulations
• Methods for seamless compliance management
• Regulatory reporting solutions for data and reports
Carla Amstein, Global Head Regulatory Intelligence
ALCON
Kelli Madden, Senior Regulatory Intelligence Specialist
TOLMAR

2:45  Part 2 – Tools and Approaches for Ensuring Compliance with Global Regulations
• Tools for real-time and shared content for dashboards
• Approaches to optimize resources amid diverse regulations
Anne Madej, Program Director- Regulatory Intelligence
GENENTECH
Kelly Carmona, Senior Director, Head of Regulatory, Product Development Quality Solutions
GENENTECH

3:30   Closing Remarks and End of Day 2