facebook

5th Annual Pharmaceutical and Biotech Medical Affairs Pre-Launch Strategies Conference

September 16-18, 2020 | Virtual Event Download AgendaRegister Now

DAY ONE | WEDNESDAY, APRIL 8

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 INDUSTRY CASE STUDIES: BLUEPRINTS FOR SUCCESS — ACHIEVING PRE-LAUNCH GOALS STRATEGIC ALIGNMENT WITH CORPORATE TEAMS
As medical affairs teams trend towards enhanced engagement in incipient stages of pre-launch activities, the strategic bridge-building function grows in both import and complexity. In addition to outlaying viable internal program goals, industry leaders are challenged with incorporating the objectives and timelines of corporate partners, such as R&D and clinical teams, into a unified strategic blueprint to effectuate streamlined progress towards value maximization and pre-launch success. Multiple case studies elucidating the strategic imperatives at play in pre-launch activities, as well as how to proactively communicate and establish efficient collaborations in-house, will sketch valuable blueprints for success.

LARGE COMPANY PERSPECTIVE
Ann Leon, Global Director, Medical Education & Communications, Transplant Therapies, CSL BEHRING

 

9:30 MEDIUM COMPANY PERSPECTIVE
Annette Chavez, Sr. Director Medical Affairs, LA JOLLA PHARMACUETICAL COMPANY

 

10:00 COFFEE AND NETWORKING BREAK

 

10:30 SMALL COMPANY PERSPECTIVE
Harry Kovelman, MD, VP Medical Affairs, HELIUS MEDICAL TECHNOLOGIES

 

11:00 COMPLIANTLY BRIDGING THE FIREWALL BETWEEN MEDICAL & COMMERCIAL TEAMS
In the interest of preserving the scientific integrity of product value-claims made in pre-launch stakeholder interactions, communications between medical affairs and commercial teams are subject to strict internal division. As team leaders are expected to sustain tactical separation, precautions must be taken to resist functional siloing to maintain strategic alignment with broader organizational goals. Remaining cardinally oriented towards corporate benchmarks while operationally distinct is a nuanced balancing act to be mastered and continuously refined.

  • Firewall limitations to cross-functional collaborations
  • Exact outline of distinct communication strategies
  • Achieving compliant teamwork with marketing and sales

Gelcys Campo, Executive Director, Medical Affairs, THERAPEUTICSMD

 

11:45 BREAKOUT DISCUSSIONS: OPTIMALLY SITUATING MEDICAL AFFAIRS TEAMS WITHIN THE CORPORATE STRUCTURE
Given the unique focus of each corporate department involved in the pre-launch process, the direction of medical affairs teams is heavily conditioned by the goals of the entity under which the team lies. As such, VPs and Directors are keen to understand the benefits and setbacks potentially associated with reporting to either R&D or Commercial as opposed to being housed independently within the manufacturing organization. This breakout discussion will explore the advantages and disadvantages of each structural iteration to afford participants insight into building out a team within the broader corporate organization.

GROUP 1: Annette Chavez, LA JOLLA PHARMACEUTICAL COMPANY

GROUP 2: Gelcys Campo, THERAPEUTICSMD

GROUP 3: Daniel Powers, AVEO ONCOLOGY

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 FIRST-IN-CLASS PRODUCT PRE-LAUNCH TIMELINE MANAGEMENT

  • Early and proactive interaction with in-house teams: R&D, clinical
  • Tailoring engagement activities timeline to organizational need
    • KOL outreach
    • Publication timelines
  • Enhanced schedule for disease state education of stakeholders
  • Metrics for measuring first-in-class pre-launch progress
  • Exemplary responses to unexpected scheduling obstacles

Alexander Flint, Director, Medical & Regulatory Affairs, EISAI

 

2:00 OPTIMIZING IMPACT OF CLINICAL DATA THROUGH EFFECTIVE PUBLICATION TIMELINES & STRATEGIES

  • Categorizing and maximizing phase I and II clinical data
  • Optimal timeline and publication planning milestones
  • Collaboration with clinical to reach publication targets
  • Identifying avenues for optimized audience outreach
  • Ensuring the correlation with the scientific narrative

Angela Davis, MD, Global Medical Affairs Director, Pulmonary, GRIFOLS

 

2:45 COFFEE AND NETWORKING BREAK

 

3:15 SYNEOS HEALTH CASE STUDY PRESENTATION

 

4:00 MAXIMIZING PRODUCT VALUE THROUGH REFINED ARTICULATION OF UNMET NEED

  • Internal education on target patient population disease state
  • Framing the therapeutic gap in current treatment paradigms
  • Clarifying target product attributes for meeting clinical need
  • Cross-functionally aligning R&D according to unmet need
  • Identifying potential for commercial sustainability

Diana Morgenstern, VP Medical Lead, North America, UPJOHN, PFIZER DIVISION

 

4:30 MASTERCLASS: CRAFTING THE SCIENTIFIC NARRATIVE FOR OPTIMAL PRODUCT POSITIONING
An effective scientific narrative impresses exceptional molecular functionality upon stakeholder audiences while at the same time demonstrating the product’s capacity to be integrated into treatment paradigms. While the story clinical trial data relates may suffice to secure regulatory clearance, medical affairs units must press beyond, strategically developing and capitalizing upon auxiliary resources in order to anchor product value-claims in compelling, practicable terms. Critical to effectuating pre-launch successes, mastering the execution of a resource-integrated, long term narrative strategy is a priority among industry leaders.

  • Timeline for narrative deployment
  • Operating in data-scarce milieus
  • Integrating real world evidence
  • KOL identification and engagement

Ashish Dugar, PhD, Vice President, Global Medical Affairs, SAREPTA THERAPEUTICS

 

5:30 END OF DAY ONE CONFERENCE

Share This