ABOUT THE CONFERENCE

As stakeholders across the healthcare continuum of care continue to evolve in a time of dynamic changes to policy, payment coverage and medical needs, the pharmaceutical and biotechnology community are changing pre-launch strategies to engage the appropriate stakeholders in meaningful scientific dialogue to build support for new therapies throughout the industry. Challenges persist in an environment where priorities have shifted, responsibilities have changed, and timelines are in a continual state of flux, requiring an unprecedented level of flexibility in process and strategy in order to meet launch timelines and commercial goals. Medical affairs professionals are called upon to unify the scientific, medical and commercial message, engage with stakeholders throughout the spectrum of care, and deliver a timeline of pre-launch activities which ultimately support and ensure a successful product launch.

The Q1 3rd Annual Pharmaceutical & Biotech Medical Affairs Pre-Launch Conference will continue upon several years of successful professional industry education, providing executives with an opportunity to view launch timelines, programs and strategies of organizations that have successfully navigated multiple product launches. High level panel discussions, in-depth case studies of successful launch processes and workshops allowing for attendee engagement and learning will form the foundation of the meeting, while external stakeholders including private payers, healthcare providers and advocacy groups will complement the educational objectives, ensuring all stakeholder voices are integrated.

TOPICS TO BE ADDRESSED INCLUDE:

• Establishing a unified medical and scientific message to communicate across all pre-launch channels
• Identification and engagement of all stakeholders from physicians and patients to the payer community
• Generation and utilization of real-world, outcomes-based evidence and data within the pre-launch setting
• Improvement of observational methods during pre-launch to meet the increased demand for real-world evidence
• Publication planning best practices: From pre-commercial to launch, timelines for effective data publication
• Defining pre-launch timelines for medical affairs activities and effective action against timelines for success
• Appropriate and effective utilization of social and digital media channels in medical affairs pre-launch scenarios
• Product launch demonstrations: Multiple case studies highlighting varied paths and successful outcomes
• Engagement of the payer community during pre-launch phases in order to increase certainty of patient access
• Clarification on areas in payer engagement including PBM relationships, pre-authorizations and pricing barriers
• Utilization of health analytics and big data platforms in generating meaningful evidence to support launch
• Interpretation and implementation of FDA guidance surrounding communication of scientific data pre-launch
• Compliance concerns surrounding off-label conversations and FDAMA 114 guidance on payer communication
• Evolving commercial structures and the impact of increasing reliance on medical affairs to engage physicians
• Preparing for the next generation of medical affairs professionals: Skill sets required for success in pre-launch
• Definition of clear lines of responsibility and functional excellence within pre-launch medical affairs activities
• Leveraging medical science liaisons to navigate relationships with advisors, investigators and advocate groups
• Pricing strategies and the impact on patient access and evidentiary data required to support product inclusion
• Use of technology in medical affairs and pre-launch which supports robust content development and delivery
• Key performance indicators for medical affairs pre-launch activities, bridging the gap for commercial success

ABOUT THE CONFERENCE

The Q1 3rd Annual Pharmaceutical & Biotech Medical Affairs Pre-Launch Conference will continue upon several years of successful professional industry education, providing executives with an opportunity to view launch timelines, programs and strategies of organizations that have successfully navigated multiple product launches. High level panel discussions, in-depth case studies of successful launch processes and workshops allowing for attendee engagement and learning will form the foundation of the meeting, while external stakeholders including private payers, healthcare providers and advocacy groups will complement the educational objectives, ensuring all stakeholder voices are integrated.