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PRE-CONFERENCE WORKSHOPS | Monday, September 23, 2019
Continental Breakfast
WORKSHOP A: A Blueprint for Success — The Role of Medical Affairs in Ensuring a Successful Product Launch

Across the core launch phases, medical affairs teams play a critical role in preparing the market for a successful product launch. Developing a compliant, strategic launch plan through high-impact scientific activities that harmonize all levels of your medical and commercial groups is crucial for a successful product launch.

  • Learn how early commercial and new product planning teams determine the needs of the marketplace, lay the foundation, and develop the marketing ahead of a launch
  • Determine how to build a value proposition for different types of drugs in particular spaces
  • Understand where medical affairs picks up from the hand-off and how they manage the relationships from clinical development
  • Examine best practices for managing key pre-launch activities in anticipation of market introduction
  • Discuss the role of field medical in identifying key thought leaders, understanding their awareness, and developing a plan of action to educate and engage these key stakeholders

*This session contains a 30-minute networking break

Matthew Bryant, Pharm.D., Vice President, Global Medical Affairs, EIGER BIOPHARMACEUTICALS
Tony Russell, Senior Director, Product Strategy and Commercial Planning, THERAVANCE BIOPHARMA
WORKSHOP B: Ensure Compliant Communications During Scientific Exchange and Off-Label Data Dissemination

Regulatory bodies recognize the value of truthful and non-misleading scientific or medical publications on unapproved new uses of a product. However, the major challenges with off-label communications are being able to provide accurate scientific data and protecting the patient, all while extending the market for a particular product

  • Explore the distinction between solicited and unsolicited queries and discuss regulatory expectations for medical affairs teams
  • Clarify how to provide scientific research and medical findings that are clearly nonpromotional
  • Develop tools and techniques to provide ethical, accurate and balanced off-label data while adding patient value in a compliant manner

*This session contains a 30-minute networking break

Workshop A Concludes
Workshop B Concludes
WORKSHOP C: In Pursuit of Evolving Medical Training — Blending Scientific Content With Communication Skills

In our dynamic industry, excellence in medical training can provide a competitive advantage for MSLs as they engage with health care practitioners. Developing a rigorous and engaging medical training plan enhances MSL performance, making the MSLs a true partner with providers. In this workshop, learn about different ways to engage your field team in scientific content and communication/presentation skills (and perhaps have a little fun during your medical training).

  • Learn techniques to blend scientific content training with communication skills, including journal clubs, post-conference training, debates, and HCP engagement
  • Discuss ways to onboard field team members and ensure field readiness
  • Explore ways to prepare for a product launch and to ensure the MSLs are confident and capable of field excellence
  • Challenge your communication skills with an activity to emphasize the importance of being able to communicate effectively

*These sessions contains a 30-minute networking break

Shannon Colton, Ph.D., Director, US Medical Training, EMD SERONO
WORKSHOP D: Establish an Integrated Approach to Managing Medical Information and Medical Communications to Leverage Insights and Deliver Value to Patients

In the age of empowered consumers, medical affairs groups can play a central role in informing data needs and ensuring the delivery of relevant medical information and impactful communications that address the needs of patients.

  • Cultivate synergies in scientific communications and medical information services to provide useful resources to patients and healthcare professionals
  • Centralize scientific content creation for improved quality, speed, and reduced cost
  • Identify the need for resource development and align communication resources across field and internal medical affairs

*This sessions contains a 30-minute networking break

Workshop C Concludes
Workshop D Concludes
MAIN CONFERENCE, DAY ONE | Tuesday, September 24, 2019
Chairperson’s Opening Remarks
Interpret FDA Guidance: How the Agency May Use Data to Support Regulatory Decision-Making
  • Consider opportunities and challenges for generating industry-wide standards
  • Improve value communication and promotional activities by adopting a real-world evidence-based communication strategy that is supported by a regulatory framework
  • Learn how to face real-world evidence challenges through an operational and regulatory perspective
Nneka Onwudiwe, Pharm.D., Ph.D., MBA, Founder and Chief Executive Officer, PHARMACOECONOMICS CONSULTANTS OF AMERICA (PECA) LLC
Explore the Evolving Regulatory and Payer Landscape and the Use and Acceptance of Real-World Evidence for Product Approval
  • Gain an understanding of regulatory and payer expectations and requirements for RWE
  • Consider how to conduct clinical trials that show value and generate enough evidence to back them up
  • Highlight new ways of real-world data generation (digital technology, machine learning, etc.)
Jefferson Tea, Vice President, Medical and Scientific Affairs, TAKEDA PHARMACEUTICALS
Leverage Online Discussion Platforms for Optimal Stakeholder Engagement
  • Identify the logistical and resource barriers to domestic and global stakeholder engagement
  • Learn about innovative communication solutions that leading organizations utilize to overcome these challenges
  • Discuss how to use these solutions to deliver improved engagement outcomes while maintaining regulatory compliance
Michael Kirby, Vice President, Business Partnerships, WITHIN3
Networking Break
TRACKED SESSIONS BEGIN | Tuesday, September 24, 2019
Track Chair Opening Remarks
Track Chair Opening Remarks
A Framework to Help Take Your Organization From Data Collection to Insights
  • Understand the framework behind insights collection: From national security to understanding what your teenagers are really up to
  • Develop insight collection tactics to match your organization’s needs
  • Hear how to turn data into actionable Insights
Mirta Grifman, Ph.D., Senior Director, Medical Affairs, SAMUMED
Blake Mobley, Ph.D., Chief Information Office, SAMUMED
Medical Affairs and Patient Advocacy — Where Do They Meet?
  • Gain an overview of the overall global strategy to roll out patient-centric programs
  • Identify opportunities to partner with patient advocacy groups and determine who is the best partner for your company
  • Leverage these partnerships to understand what is best for the patient and don’t miss the opportunity to measure endpoints and outcomes important to key external stakeholders
  • Work with compliance partners to create innovative, patient-centric programs
  • Measure the performance and success of patient centricity
Heather S. Ambrose, Director, Acute Care Field Medical and Patient Advocacy, BTG INTERNATIONAL
The Benefits of Early Medical Affairs Involvement in Clinical Trials to Identify Protocol Challanges and Drive Patient Recruitment
  • Explore the formation of a new medical affairs function called Investigator Science Liaisons (ISLs) that focuses on deep scientific communication with investigators early on during clinical trials
  • Bring scientific expertise regarding current treatment practice, profile physician practices, needs and preferences
  • Identify protocol challenges by delivering real-time insights from the investigators and improve under-recruitment and site selection
  • Understand the advantages of early engagement with leading experts to develop honest and transparent relationships and keep physician’s interest in future collaborations
Natalia Denisova, Vice President, Head of Medical Affairs, MPHAR
Panel: Intersection of Medical Affairs and Patient Advocacy
  • Explore the overlap between medical affairs and patient advocacy at various companies
  • Understand how field medical can drive partnerships with patient advocacy
  • Discuss how field medical is uniquely positioned to create multi-stakeholder value
Carol Hoang, Pharm.D., MBA, Vice President, Medical Affairs, ADVERUM BIOTECHNOLOGIES
Sagar Shah, Pharm.D., Senior Director and Head, Field Medical Affairs, AKCEA THERAPEUTICS
The Key Elements of Building a Real-World Evidence (RWE) Generation Group
  • Review what RWE and observational studies are and examine the different categories under this umbrella
  • Understand what real clinical effectiveness is in the real world and what real impact is on patients and the healthcare system outside of a clinical setting
  • Hear how to determine evidence gaps from a clinical and market access perspective, and bridge these gaps with what payers are expecting
  • Build a best-in-class field medical team that can be well versed real-world data and evidence and understand the value proposition for payers
Jefferson Tea, Vice President, Medical and Scientific Affairs, TAKEDA PHARMACEUTICALS
Launch Excellence: Preparing a Field Medical Team for an Upcoming Launch — Label Training and Certification
  • Describe a training plan that addresses both scientific content and communication skills to prepare a field team for launch
  • Review a process for evaluating field team members to ensure launch readiness and to identify areas of development
  • Highlight the importance of establishing a culture of trust and learning to enable support from leadership and the medical affairs team
Shannon Colton, Ph.D., Director, US Medical Training, EMD SERONO
Networking Break
Establish the Value of Medical Affairs to Ensure Proactive Collaboration and Alignment With Functional Partners
  • Discuss how to bridge the gap when working a highly matrixed organization between preclinical, clinical operations, and medical affairs
  • Develop a culture of collaboration with open communications within cross-functional teams to allow for efficient channel management and rapid bidirectional information flow
  • Consider the types of personality traits that can be beneficial when building out a new team
  • Explore how to proactively manage your team’s career and continue their development
Johan Baeck, Vice President, Clinical Development and Medical Affairs, JOUNCE THERAPEUTICS
Effective Management of Field-Based and Remote Personnel: Fundamentals and Nuance
  • Build a culture of trust from afar with transparent communications and reminding teams of shared purpose and goals
  • Track and manage accountability, productivity, and priorities for your team across different geographies
  • Give teams a sense of “shared competence” and encourage them to utilize each other as resources
Kate Pietrovito, Senior Director, Medical Affairs Operations, Biocompatibles, BTG
Prioritize Investigator-Initiated Research to Inform Your Organization’s Development Strategy and Generate Evidence for Registration Trials
  • Discuss the importance of investigator-initiated trials in a product’s lifecycle strategy, while remaining compliant with regulatory requirements
  • Understand how investigator-initiated research can identify new areas of treatment and help inform your development organization on target areas they should be focusing on clinical trials
  • Hear case examples of IITs providing key data and the shortest path for registration
Jose Ricardo Perez, M.D., Executive Medical Director, US Clinical Development and Medical Affairs, EXELIXIS
Panel: Remote Leadership Challenges — Creating Field Team Harmonization
  • Identify barriers to creating a high-performing field team
  • Address common challenges faced by field medical leaders when managing remote teams
  • Discuss innovative approaches to measuring the value of your remote personnel
Kate Pietrovito, Senior Director, Medical Affairs Operations, Biocompatibles, BTG
Sagar Shah, Pharm.D., Senior Director and Head, Field Medical Affairs, AKCEA THERAPEUTICS
Cocktail Reception
Day One Concludes
TRACKED SESSIONS DAY TWO | Wednesday, September 25, 2019
Continental Breakfast
Fit-to-Purpose: Establishing Medical Affairs in a Start-up Environment
  • Discuss key considerations when designing and growing a medical affairs organization in a small-company environment
  • Compare and contrast medical affairs responsibilities in a small-company or start-up environment vs. larger or more established organizations
  • Delineate emerging roles of medical affairs in the rare disease space, with a focus on gene and cell therapy
Leslie Meltzer, Ph.D., Vice President, Head of Medical Affairs, ORCHARD THERAPEUTICS
Streamline Efficiencies and Improve Techniques to Build and Run Advisory Boards
  • Learn how to manage your brand by prioritizing markets and considering their similarities and differences
  • Discuss key areas of strategic planning necessary to make decisions on the scope and reach of your advisory boards
  • Explore the tactical implementation of advisory board management before, during and after each meeting
  • Review the involvement of key internal and external decision makers necessary to optimize the advisory board
Scott McConnell, Pharm.D., VP, Medical Affairs, CHIASMA
Key Questions to Ask and Common Pitfalls/Blindspots to Avoid When Developing a Medical Plan
  • Explore the needs of the organization and when to build certain functions based on where you are in your life cycle
  • Hear how to coordinate across functional areas to avoid misalignment and confusing strategies with tactics
  • Ensure accountability and built-in temperature checks to monitor progress and/or course-correct when necessary
Jodi Smith, Ph.D., Medical Director, EMD SERONO
The Role of Medical Affairs in the Digital Evolution of Medicine
  • Consider the current healthcare landscape and where we are headed
  • Discuss what role medical affairs groups should play
  • Review examples of what has and has not worked
  • Understand what’s necessary to be successful with digital projects
Roy Palmer, Ph.D., Global Medical Innovation and Effectiveness Lead, PFIZER
Networking Break
Optimize your Communication Model With Regional Affiliates to Leverage Existing Resources During Launches
  • Review a case example of leveraging an existing franchise to launch a new product in a
    rare disease space
  • Have the affiliates play a bigger role and co-develop materials to achieve a resourceminimal launch
  • Learn from past launches to create a streamlined model for preparing for market
Cristina Costantino, Ph.D., MBA, Senior Global Scientific Director, GENENTECH
Implement and Utilize KPIs and Metrics to Demonstrate the Value of Field Medical
  • Consider the actual value of KOL/thought leader interactions in different settings
    (congresses vs. offsite meetings, etc.)
  • Determine which interaction and activity provides more quality and leads to stronger
  • Explore how to incorporate measures indicative of the quality of an activity, especially
    those that result in actions from KOLs
Matthew J. Maneen, Ph.D., Senior Director and Head of U.S. Field Medical, AVANIR PHARMACEUTICALS
Best Practices for Managing Medical Affairs Activities When Collaborating With Alliance Partners
  • Examine the various motivations that drive strategic collaborations and partnerships between companies in today's healthcare environment
  • Consider the potential cultural differences that may exist between biotechs and big pharma or U.S. and ex-U.S. companies and how to ensure a successful partnership
  • Understand the importance of establishing a model to manage medical affairs when working with a strategic partner
  • Mitigate the risks of opening new regions and territories in partnerships or out-licensing scenarios
Diana Stefani-Hunyady, M.D., MBA, BCMAS
PANEL: The Establishment of Internal Firewalls to Avoid Compliance Violations Between Commercial and Medical Affairs Teams
  • Assess why compliance and overregulation are concerning issues for medical affairs leadership, as evidenced by recent surveys
  • Discuss the use of firewalls and the challenges they present for MSLs and sales teams in their communication with therapeutic area experts
  • Determine how intense a firewall should be to allow for efficient communication while simultaneously maintaining compliance
Ross Goldstein, Director, Medical Affairs, RETROPHIN
Scott McConnell, Pharm.D., VP, Medical Affairs, CHIASMA
Track Chair Closing Remarks
Track Chair Closing Remarks
Conference Concludes

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