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Agenda

PRECONFERENCE WORKSHOPS | Monday, September 24, 2018


8:00AM
Continental Breakfast
9:15AM
WORKSHOP A: Medical Affairs Powering Up for an Effective Product Launch
Medical Affairs plays a critical role in preparing the market for the successful launch of a product and can do so significantly and compliantly in advance of formal approval of the product by the regulatory authorities. A strong, collaborative partnership with their commercial, research and development teams can drive a strategically aligned launch plan that is high in scientific impact, and that helps to establish the product’s place in the treatment paradigm. This workshop will cover the essential components of a successful product launch including:
  • Scientific Exchange Plan for engaging and managing thought leaders
  • Scientific Communication Platform that ensures effective and consistent dissemination of information
  • Insight collection and analysis plan to litmus check the strategy for continued relevance
  • Robust publication, congress, medical information and continuing medical education plan
*This sessions contains a 30-minute networking break
Cristina Costantino, Ph.D., MBA, Senior Scientific Communications Director, GENENTECH
Tricia L. Gooljarsingh, Senior Director, Medical and Scientific Affairs, IRONWOOD PHARMACEUTICALS
WORKSHOP B: The Role of Medical Affairs and MSLs in Managing the Life Cycle of an IIT
Investigator-initiated trials (IITs) play a vital role in the discovery of new drug indications and have opened the doors to achieving promising clinical outcomes and generating evidence that can be valuable for key external stakeholder communications. With life science organizations receiving an increasing number of IIT requests, medical affairs teams need to effectively evaluate whether an IIT proposal aligns with a company’s strategic priorities and overall medical strategy while gaining cross-functional buy-in. This workshop will explore the role of medical affairs and MSLs across the lifecycle of an IIT, and highlight how to optimize the review process, provide proper oversight after approval, and ensure the timely and successful execution of an IIT.
  • Delve into how to manage goals and expectations when working with investigatorinitiated trials and strategically gain cross-functional support for a growing IIT portfolio
  • Determine ways to ensure quality outcomes through the understanding of feasibility, goals and resources
  • Review financial, logistical and regulatory/legal aspects regarding supporting IITs
  • Explore key tactics for MSLs and home office professionals to collaborate and effectively manage IITs
Kay Baldwin, Associate Regional Director, KERYX BIOPHARMACEUTICALS
Ilene Pedroso, Ph.D., MSL Director, INOmax – US and Australia, MALLINCKRODT PHARMACEUTICALS
12:15PM
Luncheon
1:30PM
WORKSHOP C: Rules of Engagement for MSLs – Appropriate Interactions With Internal and External Stakeholders
The MSL role establishes relationships with influential medical thought leaders to foster education and research of therapeutic agents, and to ultimately improve patient care practices. This unique role involves frequent interactions between the pharmaceutical industry and the medical community where cutting-edge science and research are discussed. This session will review the legal guidance (e.g., Food & Drug Administration {FDA}, Office of Inspector General {OIG}, Federal Anti-Kickback Statute {AKA}, Food, Drug and Cosmetic Act {FDCA}, and recent enforcements around Commercial and Medical Affairs interactions) that help define the legal and compliance “Rules of Engagement” by which MSLs function today.
  • Consider how we got to the current “Rules of Engagement” and where the guidance comes from
  • Discuss when to utilize an MSL
  • Understand how to respond to unsolicited requests
  • Explore compliant approaches to working with commercial, sales, reimbursement and managed market teams
*This sessions contains a 30-minute networking break
Scott Siegert, Pharm.D., MBA, Executive Director, Head of Medical Affairs, NEUROCRINE BIOSCIENCES
Daniel Snyder, Ph.D., Head, Medical Affairs, Therapeutics, REVANCE THERAPEUTICS, INC.
WORKSHOP D: The Growing Need for MSLs to Understand Pharma/Payer Trends in Order to Develop Impactful Communications and Effectively Disseminate Health Economic and Outcomes Data
Unprecedented changes in the healthcare landscape is forcing a broader role for Medical Science Liaisons. We’ll learn about the trend toward increasing the relevance of MSLs in supporting complex products in a complex marketplace and highlight how to optimize pharma/payer communications by understanding key trends:
  • Understand development costs and physician, patient and clinical decision-making when approaching the marketplace (including precision medicine)
  • Examine the rising cost of specialty products due to innovation, aging and expanding marketplaces and societal decision-making
  • Discuss innovative strategies that can analyze and predict patient behavior and improve outcomes
  • Leverage technology to tailor engagement, assess patient adherence and drive better outcomes
*This sessions contains a 30-minute networking break
David Bruhn, Pharm.D., MBA, Director, Health Outcomes Liaisons – Government, Medical Policy and Payers, US Medical Affairs, GSK
Susan Malecha, Pharm.D., MBA, Lead, National Managed Care Liaisons, PACE (Patient Access Collaboration and Exchange), U.S. Medical Affairs, GENENTECH
4:30PM
Workshop C Concludes
Workshop D Concludes
MAIN CONFERENCE, DAY ONE | Tuesday, September 25, 2018
7:30AM
Main Conference Registration and Continental Breakfast
8:30AM
Chairperson's Opening Remarks
Paul Rowe, M.D., Vice President, Head of Global Medical Affairs, Immunology – Airway, SANOFI
8:45AM
Keynote Session Enforcement Viewpoints and Priorities for the U.S. Department of Justice
  • Understand the principles that govern the Department of Justice’s enforcement decisions
  • Examine current areas of enforcement priority for the Department of Justice under the Food, Drug, and Cosmetic Act and the False Claims Act
  • Learn about the implications for life sciences companies of the “Brand Memo,” which addresses the use of guidance documents in affirmative civil enforcement cases, and the “Granston Memo,” which addresses government-initiated dismissals of False Claims Act qui tam suits
James M. Burnham, Civil Division, Consumer Protection Branch, U.S. DEPARTMENT OF JUSTICE
9:30AM
Panel Discussion Explore Different Operating Models for Medical Affairs Groups and Discuss How Organizational Structure Can Impact the Effectiveness of Your Activities
  • Review some traditional and innovative operating models for medical affairs across big pharmaceutical and biotech companies
  • Highlight different groups and areas of focus that can be impacted based on the reporting and budgetary structure for a medical affairs group
  • Discuss the difference between expectations and challenges faced by medical and cross-functional leadership and how that can affect a team’s ability to do their job well
Panelists:

Christiane Langer, M.D., Vice President, Head of Medical Affairs, AGIOS PHARMACEUTICALS
Paul Rowe, M.D., Vice President, Head of Global Medical Affairs, Immunology – Airway, SANOFI
Jeymi Tambiah, M.D., Senior Vice President, Medical Affairs, SAMUMED LLC
Radhika Tripuraneni, M.D., Vice President, Medical Affairs, PROTHENA BIOSCIENCES

10:15AM
Leveraging 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
Lance Hill, CEO, WITHIN3
10:45AM
Networking Break
TRACKED SESSIONS BEGIN | Tuesday, September 25, 2018
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
11:30AM
Track Chair Opening Remarks
Scott Siegert, Pharm.D., MBA, Executive Director, Head of Medical Affairs, NEUROCRINE BIOSCIENCES
Track Chair Opening Remarks
David Bruhn, Pharm.D., MBA, Director, Health Outcomes Liaisons – Government, Medical Policy and Payers, US Medical Affairs, GSK
11:45AM
How to Survive an Acquisition — A Medical Affairs Perspective
  • Review the different kinds of scenarios that require you to partner with another organization
  • Analyze the impact of this arrangement on the development and execution of medical activities
  • Determine what sort of arrangement best serves your business needs
  • Hear case examples and shared learnings from real-world scenarios from experiences
Elizabeth Faust, Ph.D., Vice President, Medical Affairs, KITE PHARMA
Create and Implement On-Boarding and Training Processes in Biotech/ Pharmaceutical Medical Affairs Departments
  • Collaborate with leadership across medical affairs (U.S. and Global) to understand current processes and/or existing resources
  • Develop an on-boarding agenda to ensure critical start-up skills are completed and crosscollaborative relationships are initiated
  • Incorporate training objectives in medical affairs goals/performance expectations to create a pool of peers across medical affairs that participate and lead training units
  • Assign mentors with clear outlined responsibilities
  • Create processes to provide evidence that initial training is complete and knowledge has been assessed
Christine Chatas, Director, Medical Liaisons, ALEXION
12:30PM
Luncheon
1:30PM
Give the Patient Voice a Seat at the Table
  • Examine concerns patients have expressed regarding historical drug development processes
  • Explain Amicus Therapeutics’ mission and achievements in becoming recognized as a patient-focused company
  • Share real-world examples of ways patients and patient advocacy organizations have shaped Amicus’ novel drug development and commercialization programs
  • Learn how best to become a patient-centric company
Mark Lyles, M.D., MBA, Executive Director, Medical Affairs Strategy, AMICUS THERAPEUTICS
Compliant Interactions Between Medical Affairs and Commercial Colleagues
  • Understand how medical affairs and commercial can collaborate with respect to broad company and product strategies, while maintaining independence and scientific/medical integrity when exercising professional judgment and making decisions
  • Develop actions and behaviors to help ensure compliance with related company policies, external laws and regulations, and industry standards and guidelines
  • Learn how medical affairs work in alignment with commercial personnel to provide non-promotional, scientific and medical support to other cross-functional teams within an organization
Ayman R. Kafal, Ph.D., MBA, Associate Director, Specialty Field Team, Medical Affairs, CSL BEHRING
2:15PM
Take a Patient-Centric Approach to Medical Affairs Engagement
  • Improve outreach with detailed, multifaceted profiling that quickly identifies the right influencers and patient populations for your medical engagement.
  • Optimize scientific engagements with real-time, online predictive data as well as offline analytics support to radically improved results at significantly greater speed.
  • Deliver field-level intelligence on competitor engagements to help you prioritize and compliantly improve the impact of outreach efforts
Richard Kho, Ph.D., Head of Life Sciences, KOMODO HEALTH
Stakeholder Interests in Value Discussions Drive the Need for Better Field Medical Coordination
  • Understand how the value discussion has evolved over time as a requirement by external stakeholders and learn the impact that both clinical and economic information can have for KOLs, payers, and healthcare systems
  • Identify the most impactful outcomes data and resources used by value-based health decision makers to make informed decisions
  • Discuss the different models that Field Medical Organizations leverage to address the value discussion externally and the value of coordinating field efforts between MSLs and Field HEOR/Managed Care Liaisons
Christian Dimaano, Ph.D., MPH, National Director, Oncology MSLs, Medical Affairs, Americas, ASTELLAS PHARMA
Julie Greely, Pharm.D., Senior Director, Field Excellence and HEOR, Medical Affairs, Americas, ASTELLAS PHARMA INC
3:00PM
Panel: How to Set Up Compliance Firewalls That Balance SOPs With Practical Needs
  • Review the history of events that have lead companies to develop the compliance framework they have today
  • Understand the origins, what has guided this framework and gain an overview of the legal perspective
  • Learn how to work collaboratively, semi-autonomously or purely independently of other departments based on the culture at your organization
Daniel Snyder, Ph.D., Head, Medical Affairs, Therapeutics, REVANCE THERAPEUTICS, INC.
How to Establish Your Medical Organization Prior to a Commercial Launch
  • Identify key leverage points to ensure successful market access
  • Establish and prepare your field medical team strategically
  • Put in place the right measures to demonstrate value and deliver on the promise
Julie Baron, Ph.D., Director, Field Medical Effectiveness, SHIRE
3:45PM
Networking Break
4:15PM
Effective Use of Mobile Microlearning for Point-of-Need Training: How One Fortune 50 BioPharma is Applying Technology for Increased Clinical Competency
  • Determine how the cloud can precipitate more knowledgeable KOL interactions
  • Hear what happens when clinical data meets Google on YouTube
  • Learn how medical affairs/clinical operations teams can move towards continuous learning
Philip Bedrin, Director of Sales, North America, SCIENCEMEDIA, INC.
Michael W. Young, Vice President Strategic Accounts, SCIENCEMEDIA
Maximize the Value of a Product Nearing the End of Its Patent Through Lifecycle Management
  • Discuss how to keep generating science throughout a product's life cycle
  • Sustain thought leader relationships beyond the life cycle
  • Examine steps to retain market interest and engagement as patent expiration approaches
Sheila Komara, Ph.Dc., RN, Senior Medical Science Liaison, MALLINCKRODT
5:00PM
Cocktail Reception
6:00PM
Day One Concludes
TRACKED SESSIONS DAY TWO | Wednesday, September 26, 2018
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
8:00AM
Continental Breakfast
8:45AM
Track Chair Recap of Day One
Scott Siegert, Pharm.D., MBA, Executive Director, Head of Medical Affairs, NEUROCRINE BIOSCIENCES
Track Chair Recap of Day One
David Bruhn, Pharm.D., MBA, Director, Health Outcomes Liaisons – Government, Medical Policy and Payers, US Medical Affairs, GSK
9:00AM
Successfully Operationalizing a Franchise-Level Scientific Communication Platform
  • Develop a franchise-level scientific communication platform (SCP) to achieve broad alignment on external communications supporting products, leverage strengths and opportunities, and optimize differentiation in a competitive landscape
  • Create a tool for its dissemination for use by a cross-functional team and gain alignment on highest-priority goals for scientific communications, including scientific pillars and key stakeholders
  • Discuss the benefits of an interactive tool that provides easy access to key information including franchise objectives, key communication points, and recommended counterpoints
  • Identify outstanding data needs that may drive future research directions to support communication goals and broader commercial goals
Tricia L. Gooljarsingh, Senior Director, Medical and Scientific Affairs, IRONWOOD PHARMACEUTICALS
Use Data Mining Techniques to Enhance Customer Engagement
  • Explore different avenues and technologies that can allow MSL teams to profile and segment customer channels to support customer engagement
  • Leverage external databases to identify discrepancies across therapeutic areas and extrapolate data for medical affairs needs
  • Use these insights to develop enhanced resources for MSLs to engage their customer base
If you are interested in leading this session, please contact Michael Williams at mwilliams@exlevents.com.
9:45AM
Harness the Power of Technology and Data to Take Medical Affairs to the Next Level
  • Consider how medical affairs is the hub of today's quality- and patient-centric healthcare system, responsible for educating and communicating with all healthcare stakeholders
  • Personalize education and communications to recipient‘s needs, preferences, and biases, in order to be most effective at changing behavior
  • Take an interactive look at the impact of personalization on quality healthcare
Katie Anders, Head of Medical Affairs Strategic Solutions (MASS), MEDSCAPE EDUCATION
Panel: Develop a Streamlined Process for Gathering Clinical and Field Insights and Translate That Data Internally to Shape Medical Strategy
  • Discuss some of the challenges of leveraging CRMs to extract field insights in an intuitive manner
  • Review the different types of intelligence collected
  • Develop a process to collect field intelligence, tier it based on importance/urgency, and report it up the management chain accordingly
  • Use this process as a metric that tracks the frequency and quality of the feedback reported by team members
Lynn Bass, Director, Medical Science Liaisons (Americas), SANTEN
Cristina Costantino, Ph.D., MBA, Senior Scientific Communications Director, GENENTECH
10:30AM
Networking Break
11:00AM
Best Practice in Fair Market Value Assessments for IIT Grants
  • Explore the pressures to ensure grants are defendable, transparent, and represents Fair Market Value (FMV) – Review the different ways companies are organized to assessing IIT grants FMV
  • Examine best practices, common pitfalls, and aspirations
Ying Jiang, Director, Customer Success, IQVIA
Cost-Effective Tactics for Bringing Awareness and Medical Education to a Specific Disease State
  • Identify well published and influential healthcare professionals that would be interested in training the next generation of KOLs/thought leaders
  • Establish common goals and processes for these seasoned veterans to mentor these young physicians
  • Consider the benefits of publishing open access papers online
Duke Dickerson, Ph.D., M.Sc., MBA, Regional Medical Director, Orphan and Rare Diseases, HORIZON PHARMA
11:45AM
Luncheon
12:45PM
Panel: When Will This Be Published? — Develop an Effective Medical Communications Strategy to Ensure Timely Dissemination of Disease Background and Drug Product Information
  • Draft a compelling publication plan in a dynamic environment
  • Optimize journal selection to reduce time from publication development to publishing
  • Utilize social media to improve the depth and breadth of target audience reach
Panelists:

Colville Brown, M.D., Medical Director, EGALET CORPORATION
Elizabeth L. Pham, Senior Director, Global Publications, HALOZYME THERAPEUTICS

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
1:30PM
Understand the Purpose of an Investigator-Initiated Trial From the Company Perspective
  • Hear some of the strategic reasons why companies can benefit for investigator-initiated research
  • Understand common pitfalls and challenges when managing IITs
  • Discover best practices for optimizing the life cycle of an IIT
Bruce M. Schechter, Pharm.D., CMPP,, Director, Scientific Communications, Rheumatology Therapeutic Area Lead, Medical Scientific Affairs Operations, IRONWOOD PHARMACEUTICALS
Weigh the Benefits of Establishing an MSL Rotational Program
  • Highlight some of the obstacles field medical faces in gaining experience and exposure within the organization
  • Identify opportunities and establish a framework for a MSL rotational program with buy-in from executive leadership
  • Gain an overview of the rotational program and discuss key insights
Kunal Ramani, Pharm.D., Senior Medical Science Liaison, STRONGBRIDGE BIOPHARMA
2:45PM
Track Chair Closing Remarks
Scott Siegert, Pharm.D., MBA, Executive Director, Head of Medical Affairs, NEUROCRINE BIOSCIENCES
Track Chair Closing Remarks
David Bruhn, Pharm.D., MBA, Director, Health Outcomes Liaisons – Government, Medical Policy and Payers, US Medical Affairs, GSK
3:00PM
Conference Concludes

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