DAY TWO | TUESDAY, APRIL 30
8:30 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
Anthony Arleth, Managing Director, Market Intelligence, PENNSIDE PARTNERS
9:00 STRENGTHENING MSL OPERATIONS AND COMMUNICATION CAPABILITIES
- Resource allocation for implementation of MSL strategies
- Timeline of MSL involvement in pre-launch activities
- Outlining key stakeholders for MSL interactions
- Healthcare professionals
- Payer organizations
- Patient advocacy firms
- Communication avenues utilized by MSL teams
Ruthann Thomas, U.S. Director, Medical Science Liaisons (GI/ID), SHIONOGI
9:45 PAYER PERSPECTIVE PANEL: IMPACTFUL DATA FOR NEW PRODUCT REVIEW
- Ideal timeframe for new product data submissions
- Impact of product performance data on formulary decisions
- Clinical data
- Real world evidence
- Patient reported outcomes
- Pre-launch communication with manufacturers
- Regulatory considerations for new product review
Michael Katzman, BLUE CROSS BLUE SHIELD OF MASSACHUSETTS
Kenneth Snow, AETNA
Sean Quinn, HIGHMARK
10:30 COFFEE AND NETWORKING BREAK
11:00 MAJOR CHANGES ARE SWEEPING THROUGH OUR INDUSTRY, BUT OUR INDUSTRY IS NOT CHANGING, ARE WE IN DANGER?
Various estimates of peer-reviewed paper readership have cast doubt on the effectiveness of the methods the pharmaceutical and life-science industries have relied on to communicate. The challenges are great—new platforms, technologies, and the overwhelming amount of data and information that bombards medical healthcare professionals are creating waves of change the likes of which has never been seen in the industry. What are we doing to ride that wave, or are we about to be crushed by it?
Together, we can start a journey—based on facts, data, and reliable science—to make sure that the practice of medicine continues to improve.
Stephen Douthwaite, Partner, Head of Client Services, ALPHABIOCOM
11:45 GATHERING RELEVANT OUTCOMES DATA FOR PRELAUNCH MATERIALS
The collection of outcomes data throughout pre-launch processes contributes to value propositions, the solidification of product support, and drives definable results for launch. In order for medical affairs teams to ensure data implementation is useful during prelaunch, executives must utilize relevant information that supports initiatives of a new product, and determine which products benefit from the utilization of supporting data collection. Medical affairs teams can in turn, position pre-launch strategies to generate future constructive evidence for continued use to strengthen product launch efforts to come.
Diana Stefani-Hunyady, Global Medical Launch Lead, ELI LILLY AND COMPANY
12:30 LUNCHEON FOR ALL ATTENDEES
1:30 IMPACT OF UTILIZING REAL WORLD EVIDENCE DATA IN PRODUCT PRE-LAUNCH MATERIALS
The integration of real world data regarding disease states and product impact provide healthcare stakeholders from patients, HCPs to payers with a plethora of data to support clinical outcomes. The inclusion of RWE into product informational and training materials during the pre-launch stages is a tactic explored by many medical affairs teams to bolster early data showcasing a therapy’s impact on the disease state. It is critical for medical affairs pre-launch executives to have a thorough comprehension of data generation strategies and impact of RWE inclusion to ensure a success product launch.
Ashish Dugar, Vice President, Global Medical Affairs, SAREPTA THERAPEUTICS
2:15 PATIENT REPORTED OUTCOMES’ INFLUENCE ON PRELAUNCH ACTIVITIES
- Effectiveness of PRO implementation during pre-launch
- Incorporating PRO data across pre-launch materials
- Determining the audience that benefits from PRO inclusion at pre-launch
- Impact of patient reported outcomes on stakeholder decisions
Ann Leon, Director, Medical Therapeutic Area Leader, Immunoglobulin, CSL BEHRING
3:00 COFFEE AND NETWORKING BREAK
3:15 PANEL DISCUSSION: ANALYZING DATA INSIGHTS FOR STRATEGIC PRE-LAUNCH DECISION MAKING
Medical affairs teams are challenged with collecting big data and interpreting outcomes to make decisions regarding current and future pre-launch strategies. Insights gained from data analytics allow executives to build a more targeted approach when strategizing and developing a product’s pre-launch operational timeline resulting in more impactful uses of launch resources. With a large variety of applicable data sources available to executives, teams must ensure that relevant and quality data and analyses are being employed to ensure the best outcomes.
- Interpreting data insights
- Understanding target market
- Creating value proposition
Diana Stefani-Hunyady, ELI LILLY AND COMPANY
Ann Leon, CSL BEHRING
Ashish Dugar, SAREPTA THERAPEUTICS
4:00 COMPLIANTLY BRIDGING THE GAP BETWEEN MEDICAL AFFAIRS AND COMMERCIAL TEAMS
Medical affairs teams have historically been challenged with maintaining a fair and balanced perspective when relaying product data to healthcare stakeholders, but the increase for requests by HCP and payers for more outcomes related information has shifted the traditional role for executives. The inclusion of health economic and outcomes along with pharmacovigilance data to the deliverables expected of medical affairs teams has concurrently increased the level scrutiny by health regulators to ensure the continued dissemination of credible and medical information. It is critical for medical affairs executives to implement updated compliance policies for teams and conduct thorough training for medical and commercial departments to ensure compliant HCP interactions.
Machelle Manuel, Vice President, Head Global Medical Scientific Affairs
4:45 CLOSING REMARKS AND CONFERENCE CONCLUSION