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

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

DAY TWO | THURSDAY, APRIL 9

8:30 REGISTRATION & WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 EVOLVING MSL ROLES: ENHANCING RECRUITMENT THROUGH CLINICAL TRIAL LIAISONS

  • Exploration of increasing MSL involvement in clinical research and trial efficiency
  • Advantages in deploying medical science liaisons as clinical trial liaisons
  • Utilizing technological applications to increase access to field medical teams

9:45 PANEL DISCUSSION: PAYER PERSPECTIVES ON THE NATURE OF DATA USEFUL TO EXHIBITING PRODUCT VALUE

  • Unveiling pre-launch data interpretation mechanisms
  • Defining the applicability of diverse data sets:
    • Phase I through III
    • Real world evidence
    • Patient reported outcomes
  • Opportunities in early communication with payers
  • Data useful to new VS. established product reviews

Robert Kettler, MD, WISCONSIN PHYSICIAN SERVICES

Kristine Bordenave, MD, FORMERLY HUMANA

Paul Gerrard, MD, PALMETTO GBA

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 CAPITALIZING ON THE EMERGENT ROLE OF SOCIAL MEDIA IN THE KOL LANDSCAPE
The traditional character of key opinion leaders is evolving as social media is increasingly understood to be a legitimate conduit for professional discourse and information exchange on scientific matters. Recognizing the potential in social media platforms’ immense user bases, medical affairs teams are searching for ways to extend product narrative impact by leveraging digital KOLs as channels to wider, more diverse audiences and information sources. Developing methods to identify and involve new authoritative thought leaders in the pre-launch process is essential to capitalizing on the opportunity the new media wave represents.

  • Profiling digital KOLs & engaging in partnerships
  • Identifying access to patient & scientific communities
  • Specifying modes of media engagement with digital KOLs
  • Applicability for building awareness in local markets
  • Sustaining proliferation of product advocacy online

Rob Consalvo, Director, H1 INSIGHTS

 

11:45 PANEL DISCUSSION BUILDING CRITERIA FOR EFFICIENT KOL IDENTIFICATION & EARLY ENGAGEMENT

  • Identifying established KOL profiles
  • Tailoring KOL mapping to disease state
  • Innovative channels for identification
  • Proactive KOL engagement for maximum impact

MODERATOR: Rob Consalvo, H1 INSIGHTS

Sylvia Hanna, MD, ALLERGAN

Anna Tallman, DERMAVANT SCIENCES

Ellie Corigliano, PhD, MERCK

Carol Hoang-Roller, ADVERUM BIOTECHNOLOGIES, INC.

 

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 BREAKOUT DISCUSSIONS BY COMPANY SIZE: OPTIMIZING MSL TEAM RECRUITMENT STRATEGIES
In the highly competitive pharmaceutical market, identifying, hiring and retaining MSL talent with distinct therapeutic knowledge proves to continuously challenge medical affairs teams, eager to build the most pertinent and efficient team for field operations in a timely manner. Additionally, encountered difficulties in the race towards MSL on-boarding varies from one manufacturing organization to the next, largely dependent on the size of the company and potential funds to support the effort. This small group discussion format enables participants to share on common pitfalls with peers, and brainstorm solutions to overcome obstacles in establishing a highly proficient MSL team in resource constrained environments.

GROUP 1: Large – Royce Waltrip, MD, MALLINCKRODT

GROUP 2: Medium – Monica Sukhatme, INNATE PHARMA

GROUP 3: Small – Michael Banks, BESTMSLS

 

2:15 PRACTICALLY DEFINING AND ASSESSING THE USE OF REAL WORLD EVIDENCE IN PRE-LAUNCH STRATEGIES
Despite widespread recognition that real world evidence is pivotal to articulating the singular value of a product, medical affairs face difficulties in ensuring appropriate data is generated, as the pertinence of data sources and study types modulate according to disease state, mechanism of action, and evolutions in standards of care. Squaring variable evidence targets against undefined stakeholder expectations continues to challenge executives in discerning actionable approaches toward value maximization. Close analysis of successful strategies will provide participants insight into effective data source selection and utilization to practicably service pre-launch endpoints.

  • Defining key stakeholders’ expectations
  • Identifying advantages and limitations of data sources
    • Patient Reported Outcomes
    • HCP data banks
    • Health economics data
  • Ranking use-value of potential study options

Tehseen Salimi, MD, VP Medical Affairs & Real World Evidence, G1 THERAPEUTICS

 

3:00 LEVERAGING PATIENT REPORTED OUTCOMES TO SUPPORT PRE-LAUNCH CLINICAL ENDPOINTS
Insofar as unmet need implies a patient-centric approach to product development, the patient’s voice can provide immense value in sharpening the focus of a product’s promise in the eyes of relevant stakeholders. And though industry executives are increasingly finding value in utilizing patient reported outcomes data to further amplify a product’s clinical value, a challenge consists in functionally integrating patients and patient advocates into the pre-launch process and validating outcomes data as an endpoint. As outcomes data trends towards becoming more impactful, medical affairs teams are searching for innovative ways to include and verify the import of the patient’s voice to reinforce pre-launch value claims.

  • Including patients in pre-launch processes
  • Validating PROs as pre-launch endpoints
  • Determining the efficacy of outcomes data
  • Utilization of patient advocates for value prop

Ronald Walls, MD, MBA, US Head of Operations, VP Clinical Development Medical Affairs
CSPC PHARMACUETICAL GROUP

 

3:45 COFFEE AND NETWORKING BREAK

 

4:00 MAXIMIZING THE UTILITY OF CLINICAL DATA THROUGH EFFECTIVE POST-HOC ANALYSIS

  • Common pitfalls in clinical data interpretation
  • Role of post-hoc analyses in clearing data results
  • Engaging KOLs to verify proper data parameters
  • Addressing potential biases to clinical data outcomes
  • Adjusting value narrative with focus on competitive pressures

Eric Pierre Guenin, Senior Director Medical Affairs, ORTHO DERMATOLOGICS

 

4:30 END OF CONFERENCE

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