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Agenda

Workshop Day | Tuesday, April 14, 2020


9:00AM
Workshop A - 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

Lai H Jen, M.D., Executive Director, Oncology Global Medical Affairs, Head and Neck, Melanoma, and Hematology, Merck
Workshop B - The Ever-Elusive Balance of Quantity Vs. Quality in MSL Goals and Metrics
  • Outline what the key activities or goals of MSLs should be in this ever-changing role
  • Review how we measure the success of those goals and ultimately the MSL
  • Discuss whether metrics are the same as goals and how to balance quantity versus quality
  • Determine what a valuable or "quality" interaction should be and whether different types of events or activities should be weighted differently
Christine Chatas, Pharm.D., MHSA, Senior Director, Metabolic Medical Science Liaisons, ALEXION
12:00PM
Lunch
1:00PM
Workshop C - The Challenges and Opportunities in Disseminating Medical Information: Do We Need a Redesign of the Role of Medical Affairs in Ensuring Compliant and Effective HCP Interactions?

While the role of pharmaceutical companies to provide accurate scientific information to HCPs and the global medical community is well established, regulatory and compliance oversight continue. Pharmaceutical companies must take into account a range of regulatory and enforcement statutes as well as actions taken by various government agencies with overlapping authority and often differing enforcement perspectives. The Medical Affairs function is being called upon to take a more proactive approach in helping to develop and implement policies regarding medical communication with both the external medical community as well as internal stakeholders (including Commercial, R&D, HEOR). This presentation will review the basic provisions of the FDCA as regulatory guidances issued by the FDA and actions taken by the Office of the Inspector General (OIG) in enforcing the False Claims Act
(FCA) and the Anti-Kickback statute, among others, and discuss the need for a new paradigm relating to the role of Medical Affairs.

  • Understand the evolution of the current enforcement environment
  • Discuss the interpretation and importance of FDA guidance documents including the FDA Reprint Guidance, the Draft Guidance on Unsolicited Requests for Off-Label Information, Drug and Medical Device Manufacturers Communications with Payers and Formulary Committees, and Medical Product Communications Consistent with FDA-Required Labeling
  • Identify areas of concern for FDA and OIG as revealed through enforcement letters and Corporate Integrity Agreements (CIAs) as affecting company policies
  • Craft new policies to respond to current and future enforcement initiatives
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
Workshop D - Examine How to Best Develop Your IIT Team and Processes to Ensure Effective Management And Contracting

When developing an IIT program, how you align your resources, staff the team, and develop your processes can greatly affect how quickly you can finalize any contracting necessary to support IIT trials. This workshop will discuss two overarching areas that affect contracting: 1) Processes such as IIT portals and hands-off IIT submission processes versus relationship-based models; 2) Staffing such as fully insourced IIT teams, outsourced or IIT teams staffed by Flexible Staffing providers, and IIT teams with set contracts.

  • Weigh the pros and cons of the different types of submission processes that pharmaceutical companies use to support their IIT program and discuss how they are looked at by a site contract and budget team
  • Review different staffing models and why companies may choose to use a specific model for their IIT program
  • Discuss how the different models may affect your contracting timelines
Jay T. Alkam, Esq., Contracts Manager, Global Medical Operations, Allergan
4:00PM
Workshop Day Ends
Tracked Sessions | Workshop Day | Tuesday, April 14, 2020
9:00AM
KOL Engagement Seminar Opening Remarks
9:15AM
Future Proofing your Medical Affairs Organization and Your KTL Engagement Strategy
  • Building an internal Key Thought Leader (KTL) Community of Practice.
  • Aligning Business Strategy and Objectives to drive Medical Affairs and KTL Program
  • Developing a Standardized Policy that provides Guidelines for KTL Engagement Strategy
  • Delivering strategic guidance, leverage clinical, scientific, and economic knowledge to drive meaningful innovations
Kevin Appareti, Senior Director, Global Medical Science Liaison, Philips Healthcare
10:00AM
MSL As the Valued and Credible Asset to the Payer and Provider Community
  • Address key takeaways of building basic relationships
  • The importance of the following up and following through strategy
  • Understand “what you do” vs. “what you can do” and where your KOL can collaborate within your organization
Howard Berkowitz, Respiratory and Immunology, MSL, U.S. Field-Based Medical Affairs, Sanofi Genzyme
10:30AM
Break
11:00AM
Case Study: Following the Journey Fellowship to KOL
  • Follow the progression of up-and-coming fellows through an integration with your organization
  • Create a continuum in the career of a physician to build a KOL story
Ann Roen, Director, Professional Relations and Customer Insights, Medtronic
12:00PM
Lunch
1:00PM
Discover Tactics to Enhance Communication Between Medical and Commercial Teams
  • Discuss how to begin breaking down silos within the industry for higher efficiency and stronger bonds
  • Assess obstacles and hesitancies in communication and discuss methods for overcoming them
  • Define clear objectives for legal and other departments to ensure smooth process flows
  • Work compliantly in the same space with supporting teams to increase efficiency
Christopher Alfieri, Thought Leader Liaison, EMD Serono
2:00PM
Effectively Tier Thought Leaders to Determine the Fair Market Value of Payments
  • Select a range of metrics and criteria for developing a stratification model for KOL segmentation
  • Identify thought leaders based on level of experience and recognition
  • Craft compliant processes to collect and evaluate data in order to determine regional and international fair market value rates
2:45PM
Break
3:15PM
Leverage Regional Influencers to Drive Meaningful Engagement With Local Communities
  • Identify unmet medical education needs for 5 target stakeholder groups
  • Prioritize medical education needs and align with cross-functional business strategy
  • Define medical education strategy and validate through an Advisory Board
Rita Zambelas, Associate Director, Amicus Therapeutics
4:00PM
A Compliance Perspective on Effective Advisory Board/Consulting Arrangement Execution
  • Consider the legal and regulatory risks involved
  • Explore the need for compliance monitoring in advisory boards
  • Discuss the difference in perspectives between medical and commercial groups
5:00PM
Closing Remarks
5:30PM
Conclusion of Seminar
Main Conference Day One | Wednesday, April 15, 2020
Strategy
Operations & Tech
MSL
IIT
8:00AM
Breakfast and Registration
9:00AM
Chairperson's Opening Remarks
9:15AM
Keynote Presentation: The Role of Medical Affairs From Prelaunch to Launch
  • Provide an overview of crucial activities during the prelaunch period
  • Use clinical narratives and supporting evidence to develop a strong scientific platform
  • Gain valuable input from the different disciplines to develop a scientific lexicon for a brand that is consistent and aligned across various stakeholder groups
10:00AM
Develop a Medical Strategic Plan
  • Establishing framework and standards
  • Shape learning strategies based on your organizational needs
  • Impact and implementation of new technologies
Dan Hennessy, Vice President Field Medical Affairs, EMD Serono
10:45AM
Break
11:15AM
Determine the Hand off between Clinical and Medical Affairs
  • Discuss the hand off between clinical development, medical affairs, and commercial and issues that may arise
  • Understanding the global landscape and how to develop strategy for the Medical communication
  • Create a team of the right people from both groups to build impact
12:00PM
Lunch
1:00PM
The Benefits of Engagement From the Medical Affairs Team Early in the Product Life Cycle
  • Examine the increased responsibilities medical has taken over in the last decade and how they should be playing a leading role in the pre-launch phase
  • Understand how the success of engaging payers, generating costs and leveraging the patient journey is all predicated on how early medical is involved
  • Hear how to collaborate with clinical development and take an integrated approach to generate clinical evidence
Barry Lubarsky, Executive Director, Medical Affairs Strategy, Alkermes
Case Study: Use Real-World Evidence to Support Medical Affairs Operations
  • Discuss how to generate RWE with limited resources through product registries, outside investigators, partnerships, and demonstration projects
  • Discover how patient-generated data can assist in serving various stakeholder objectives
  • Understand the strategic role for medical affairs in generating and communicating RWE to all stakeholders
Jill Massey, Senior Vice President, Medical Affairs, Melinta Therapeutics
Case Study: Utilize Unbranded Scientific Exchange Programs to Ensure Effective Decision-Making
  • Discuss how your team can proactively engage customers through unbranded exchange programs
  • Ensure that you are clearly separating scientific exchange from promotional messaging
  • Use scientific and data-driven information to help HCPs make informed patient-care decisions
Jasmine Correy, Medical Science Liaison, Sanofi
Best Practices for Proposing an IIT Program and Preparing a Study Proposal
  • Strategies for identifying the best funding opportunities
  • Assess the stage in which you should start your IIT program
  • Write a compelling and successful budget justification
1:30PM
Panel – Launch Planning for Various Organizations Sizes and Scenarios
  • Examine the increased responsibilities medical has taken over in the last decade and how they should be playing a leading role in the pre-launch phase
  • Understand how the success of engaging payers, generating costs and leveraging the patient journey is all predicated on how early medical is involved
  • Hear how to collaborate with clinical development and take an integrated approach to generate clinical evidence
Yurek Paprocki, M.D., MBA, Medical Lead Director, Novo Nordisk
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
Use Data Mining Techniques to Enhance Customer Engagement
  • How analytics drive your outreach strategy
  • Segment customer base and target them using data analytics
Dan Hennessy, Vice President Field Medical Affairs, EMD Serono
Ariel Katz, CEO, H1 Insights
Key Strategies for Your Internal Investigator-Initiated Study Operations
  • Understand all specifications needed for your proposal
  • Learn how to streamline your proposal submission process throughout your company
  • Close the gap between what is submitted vs. what your internal review committee needs
Steven Zhang, Vice President, Medical Affairs, Kala Pharmaceuticals
2:00PM
Establishing a Medical Affairs Organization 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
  • Do Less with More
Establish a Centralized and Consolidated Training Hub to Ensure Global Alignment and Understanding of Value-Based Healthcare
  • 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
Panel: How Medical Affairs Can Help Prepare the Market for a New Drug Launch
  • Review how Medical Affairs (including Field Medical) can support market readiness in terms of external stakeholder engagement
Tommy Brock, Senior MSL, United Therapeutics
Luchy Hidalgo, M.D., Independent Consultant
Tonya L. Johnson, Pharm.D., Director, Global Medical Excellence, Allergan
Alan Polnariev, MSL, Ferring Pharmaceutical
Josh Yoder, Ph.D, Medical Science Liaison, uniQure
Best Practices for Negotiating Contracts to Improve Study Start-Up
  • Understand the motivations behind co-development deals and strategic alliances
  • Clearly communicate research areas of interest from the start to align expectations
  • Map out a plan to effectively manage the submission, review, and management of all IIT proposals and streamline operations
Michael Martineau, Senior Manager, Externally Sponsored Research, Ipsen
2:30PM
Break
3:00PM
Patient-Centric Framework As a foundation for Medical Affairs Strategy and Operational Effectiveness
  • Patient Wellbeing is the key to healthcare sustainability
  • Medical Affairs has a leadership role in defining target patient segments for industry innovation and defining value for the patient
  • Patient centricity should be an anchor for planning and executing Medical Affairs activities
Stanislav Glezer, Vice President, Global Medical Affairs – Diabetes Care, BD
Panel – Optimize Customer Engagement Through Use of Innovative Technology
  • Discuss changes in the role of Medical Affairs in interacting with the next generation of healthcare providers and their patients
  • Leverage the virtual reality (VR) tool and apps to enhance clinical education and training
  • Learn and discuss best practices for utilizing technology to elevate customer interactions
Panel: Communication Strategies: A Guide to Meaningful Conversations With HCPs, KOLs, Patients, Colleagues and Other Stakeholders
  • How do we generate good/valuable insights?
  • How do you bring the value and focus of the company to KOLs?
  • How to bring back insights/information that provide guidance on publications, educational modules, and developing strategies moving forward?
  • Technology, challenges (online/social versus in-person) technology you are leveraging
  • How to capture and report them?
Tonya L. Johnson, Pharm.D., Director, Global Medical Excellence, Allergan
Sheila Komara, Senior MSL, Mallinckrodt
Panel Discussion Best Execution Practices for IITs in Different Therapeutic Areas
Moderator:

Steven Zhang, Vice President, Medical Affairs, Kala Pharmaceuticals

Panelists:

Archie Stone, Ph.D., BCMAS, Vice President, Medical Affairs, Alcresta Therapeutics
Sudeesh Tantry, Vice President, Global Medical Affairs, Glenmark Therapeutics

3:45PM
How to Best Leverage Social Media and the Digital Ecosystem in Patient Recruitment
  • Examine the use of social media in patient recruitment
  • Review what is and is not working in partnerships between patient social networks and pharmaceutical companies and CROs
  • Discuss key elements of a social media community dedicated to aiding patient recruitment
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
Panel: Dissemination of Off-Label Information in a Compliant Manner
  • 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
Jacqueline S. Armani, O.D., FAAO, Medical Science Liaison, Alcon
Teresa Kelton, J.D., Pharm.D., MPH, Executive Director, R&D and Quality Counsel, Alexion Pharmaceuticals
Establish an Efficient and Compliant Process for Assessing the Fair Market Value (FMV) of IIT Budgets
  • Understand what fair market value is, how it is determined, and when it is utilized in IITs
  • Explore scenarios when deviations to the FMV would be considered and how the process works
  • Learn how to avoid lengthy negotiations around budget requests, specifically those outside of the FMV
4:15PM
Tailoring a Global Medical Strategy Based on the Needs of Regional Partners
  • Identify unmet medical education needs for five target stakeholder groups
  • Prioritize medical education needs and align with cross-functional business strategy
  • Define medical education strategy and validate through an Advisory Board
Establish an Integrated Approach to Managing Medical Information and Medical Communications to Leverage Insights and Deliver Value to 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
Discuss Global Vs. Region Centers of Excellence
  • Manage Centers of Excellence and How to Monitor Field Team
  • Nuts and Bolts of how to build this from the ground up
Tonya L. Johnson, Pharm.D., Director, Global Medical Excellence, Allergan
Identify the Key Challenges When Deciding Between an IIT or a Collaborative Study
  • Data Generation — a key pillar in Medical Affairs Strategy and Tactics
  • The Differences between an IIT and a Collaborative Study
  • When to employ an IIT vs a Collaborative Study using potential guideposts
5:00PM
Drinks Reception
6:00PM
Day One Concludes
Main Conference Day Two | Thursday, April 16, 2020
Strategy & Technology
Operations
MSL - Training and Retention
IIT
9:00AM
Redesign the Role of Medical Affairs to Ensure Compliant and Effective HCP Interactions
  • Understand the evolution of the current enforcement environment
  • Identify areas of concern for FDA and OIG as revealed through enforcement letters and Corporate Integrity Agreements (CIAs) as affecting company policies
  • Craft new policies to respond to current and future enforcement initiatives
Develop a Comprehensive Publication Plan Aligned With Corporate Strategy and Product Life Cycle
  • Prioritize certain data sets/types in the publication plan aligned with the product life cycle
  • Understand the importance of publication timing, authorship and journal selection
  • Ensure that the publication plan is integrated into the Medical Affairs field team strategy and tactics, as well as being flexible enough to address competitive intelligence feedback
Jennifer Almekinder, Director, Global Aesthetics Scientific Communications, Merz
Build the MSL Career Path and Facilitating Team Retention
  • Discuss how to facilitate career growth and create advancement opportunities
  • Improve team morale and engagement through team-building strategies and exercises
  • Work with internal and external stakeholders to demonstrate the value of the MSL team
Steve Valliere, Pharm.D., M.Sc., Director, Neurology Medical Science Liaison Team Lead — East, Clinical Research and Medical Affairs, Sunovion
Optimize the IISR Process From Protocol Submission Through Study Completion
  • Build a strong foundation when designing a new IIT program
  • Ensure thorough compliance to avoid interference in your timeline from the FDA
  • Manage communications with your MSL consistently
9:30AM
Evidence Development and Publication Planning and Strategic Processes
  • Develop an effective publication strategy to elevate the impact of your data
  • Ensure compliance with industry best practices and laws
Ensure Compliant Communications During Scientific Exchange
  • Mitigate the risk of noncompliance by implementing policies to reflect evolving government and industry guidance
  • Train, audit, and monitor the separation between scientific exchange and promotional messaging
Building Out MSL Teams: Difference Between U.S. and Ex-U.S. Scenarios
  • Differences in regulations, and the role/understanding of the MA role becomes challenging when dealing with a company based outside of the U.S.
  • Challenges in approval processes, position requirements and compensations are all difference once you move outside of the U.S. – with that, the process to develop a strong field medical team is slowed down
Lynn Bass, Director, Medical Science Liaisons (Americas), SANTEN
Effectively Demonstrate the Value of Investigator-Sponsored Research to Internal Leadership
  • Pinpoint key metrics used to evaluate IITs and how that can differ from leadership’s perspective
  • Balance the use of qualitative and quantitative analysis for investigator sponsored research operations
  • Demonstrate value for both clinical and commercial goals within an organization
10:00AM
Panel – Analyze the Involvement of Medical Affairs in Commercial Activities
  • Understand how to align strategically and keep tactics separate
  • Define the line between promotional activities and scientific exchange
  • Determine the appropriate firewall between medical affairs and commercial
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
Best Practices for Evolving Field Medical Teams and Managing Change
  • In managing an MSL team, what do you need to do as a new MSL in the field
  • Develop a Strategy for Team Growth with Effective Territory Management
Christine Chatas, Pharm.D., MHSA, Senior Director, Metabolic Medical Science Liaisons, ALEXION
Using Technology to Enhance and Advance Investigator Initiated Trials
  • Simplify submissions through website and portal software
  • Use technology to enable good project management (PMBOK)
  • Learn how technology can improve the site experience (reporting enrollment, SAEs, budgets, etc.)
Jeremy Keeton, ONC Investigator Initiated Trials Project Manager, ELI LILLY AND COMPANY
10:30AM
Panel Discussion Effective Strategies to Ensuring Your Collaborative Research Study Is Compliant and Advantageous: An Investigator Perspective
  • Strategies to ensure transparent communication between the investigator and sponsoring parties
  • Common compliance issues and how to avoid them
  • Checklist to ensure a forward-moving, goal-oriented study
Panelists:

Helene Bach, Ph.D., Director of Research and Sponsored Programs, Rutgers University
Sun-Ming Pan, MPH, Clinical Research Coordinator, Columbia University Irving Medical Center
Nitasha Phatak, M.D., Ph.D., Investigator Initiated Trial Expert, Methodist Health System

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
Effective Strategies and Models for Managing Contract MSL Teams
  • Explore different models for managing MSLs and field teams
  • Discuss the pros and cons of strategy development, oversight of field activities, and HR related matters
  • Learn innovative ways to improve communication between in-house management
  • and contract/vendor companies
The Shifting Role of MSL: Training to Enhance and Maximize Performance
  • Understand how field-based learning and training needs to be expanded throughout an organization
  • Impact of fully understanding compliance and legal communication structure
  • Navigate unmet needs for patient, provider, and provider communication
Rashonda Burkett, Director, MSL, Novartis
11:00AM
Break
11:30AM
Incorporate the Voice of the Patient Into Your Communication Plan
  • Prioritize certain data sets/types in the publication plan aligned with the product life cycle
  • Understand the importance of publication timing, authorship and journal selection
  • Ensure that the publication plan is integrated into the Medical Affairs field team strategy and tactics, as well as being flexible enough to address competitive intelligence feedback
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
Optimizing Field Intelligence: Getting the Right Information to the Right People at the Right Time
  • Find the balance between compliant push and pull of information with thought leaders
  • Leverage MSL insights to establish the team value proposition
  • Utilize strategic information collection and dissemination to inform pre- and postlaunch planning
Explore How to Collaborate with MSLs/Field Medical for IIT Success
  • Minimize the risks associated with your IIT investment
  • Guarantee a compliant investigation throughout the entire lifecycle process
  • Ensure cross-functional alignment on priorities and tactics
12:15PM
Lunch
1:15PM
The Path/Journey to Increasing Disease Awareness
  • Understanding the unmet need and creating a disease awareness narrative with the customer in mind
  • Building internal consensus around the scientific story – the importance of a scientific platform
  • Collaborating cross functionally to leverage the disease platform as an internal and external education tool
  • Understanding how disease state education can shape the conversation about the need to treat
Establish a Centralized and Consolidated Training Hub to Ensure Global Alignment and Understanding of Value-Based Healthcare
  • 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
The Evolving Role of the Medical Science Liaison in a Patient-Centric Healthcare Landscape
  • Appreciate the patient as the primary stakeholder and recognize the need to hear their voice
  • Determine the potential roles of the medical science liaison in this new landscape
  • Explore how the medical science liaison demonstrates value to both internal and external stakeholders
Global Regulatory Compliance for IITs Across all Levels of Your Organization
  • Explore the different risks associated with investing in an IIT program
  • Review the differences in global regulatory guidelines
  • Assess considerations for setting up IIT programs internationally
Stephanie Macholtz, JD, MBA, Senior Director, Ethics & Compliance, Apellis Pharmaceuticals
2:00PM
Best Practice Process for Scientific Communication Platform Development and Implementation
  • Gather Insights through conducting a landscape analyses of internal and external stakeholders
  • Conduct working session on objectives and strategies
  • Facilitate ongoing training and measurement practices
Monitor and Measure Call Centers and Medical Information Exchange
  • Support medical information and call center teams through structure and staffing
  • Maintain quality through monitoring key performance indicators
  • Best practices to reviewing and responding to medical information requests
The Evolving Role of the Medical Science Liaison in a Patient-Centric Healthcare Landscape
  • Appreciate the patient as the primary stakeholder and recognize the need to hear their voice
  • Determine the potential roles of the medical science liaison in this new landscape
  • Explore how the medical science liaison demonstrates value to both internal and external stakeholders
Discuss FDA and the Drug Approval Process in the U.S. to Outline the Various Steps, Timelines and Milestones in Research Collaborations
  • Examine criteria to determine when to start an investigator sponsored trial
  • Design a set of review standards for independent investigator proposals
2:45PM
How to Develop a Cutting-Edge Medical Plan That Is Tailored to the Needs of Your Organization
  • Consider how medical strategies can vary based on the size of a company and its governance structure
  • Examine traditional versus electronic impact factors and make sure your communications plan is aligned with your overall medical strategy
  • Integrate your medical strategy across regions in a complex organizational structure and measure success across different channels
Develop and Define Strategic Metrics to Demonstrate the Value of the Medical Affairs Group
  • Establish how to define, measure, and communicate the value of Medical Affairs to internal and to external stakeholders
  • Discuss how to measure and report both quantitative and qualitative measures of success for Medical Affairs
  • Define how to link meaningful metrics in Medical Affairs to desired outcomes
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
Using Technology to Enhance and Advance Investigator Initiated Trials
  • Simplify submissions through website and portal software
  • Use technology to enable good project management (PMBOK)
  • Learn how technology can improve the site experience (reporting enrollment, SAEs, budgets, etc.)
3:30PM
Conference Concludes

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