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Agenda

PRE-CONFERENCE WORKSHOPS | Monday, September 25, 2017
8:00AM
Continental Breakfast
9:15AM
WORKSHOP A: BUILDING A MEDICAL AFFAIRS LAUNCH POWERHOUSE
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.
  • Create a medical strategic and tactical launch plan that aligns with your organization’s business objectives
  • Develop a meaningful scientific communication platform to communicate and differentiate the medical and scientific value clearly
  • Develop a comprehensive and actionable stakeholder (KOLs, clinicians, payers, advocacy groups, policy makers, etc.) engagement plan in a compliant way
  • Set clear strategy for data generation activities through identifying unmet medical needs and insights from stakeholders
  • Leverage medical information to educate healthcare practitioners
*This sessions contains a 30-minute networking break
Ramin Farhood, Pharm.D., MBA, Vice President, Head of Global Medical Affairs, AVEXIS
9:15AM
WORKSHOP B: DEVELOP YOUR MEDICAL INFORMATION CONTACT CENTER MANAGEMENT GAME PLAN
This three-hour workshop will provide a window into developing your Medical Information Contact Center Management game plan, Service Delivery Implementation as well as Customer Engagement and Satisfaction. Learn operational best practices leveraged from the Contact Center Industry to turn your traditional internal Medical Information call center into a progressive, global, Medical Information Contact Center supporting phone, electronic, and digital channels. Topics include:
  • Contact Center Management
  • Metrics to Measure
  • Engagement Quality Oversight
  • Performance Management – Internal Teams or External Suppliers
  • Globalization and Market Alignment
Kathleen Ritz, Director, Lead Medical Contact for Europe and Asia-Pacific Regions, BRISTOL-MYERS SQUIBB
12:15PM
Luncheon
1:30PM
WORKSHOP C: 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 non-promotional
  • Develop tools and techniques to provide ethical, accurate and balanced off-label data while adding patient value in a compliant manner
Davida J. White, M.D., Global Medical Affairs Director of MSL Training and Development, ALCON
1:30PM
WORKSHOP D: EXAMINE HOW TO OPTIMIZE THE APPROACH TO THE ICH E6 (GCP) ADDENDUM IN INVESTIGATOR-INITIATED TRIALS
The addendum to ICH E6 was finalized at the end of 2016 and has already been implemented in the EU (14 June 2017). The ICH E6 changes were intended to bring more effective and efficient processes to sponsors running clinical trials, but most sponsor organizations are still struggling to get to grips with the changes and impact, and have not yet evaluated the impact on IIT where the investigator assumes the sponsor responsibilities. This presentation will go beyond the usual scope of assessing the potential and benefits of an IIT, and it will address the risk for the company and the investigator (sponsor) of IIT.
  • Walk through the changes in ICH E6 that will impact IIT, from both a sponsor and investigator perspective
  • Provide a basic template to address the changes with recommendations for the investigator
  • Examine the site to ensure the ability to meet the ICH E6 standard
*This sessions contains a 30-minute networking break
A.W. Lawton, SME, TRANSCELERATE, Lecturer, STANFORD UNIVERSITY, Former Global Head of Data Management, BOEHRINGER INGELHEIM
4:30PM
Workshops Concludes
MAIN CONFERENCE DAY ONE - PLENARY SESSIONS | Tuesday, September 26, 2017
7:30AM
Main Conference Registration and Continental Breakfast
8:30AM
Chairperson’s Keynote Address: REVOLUTIONIZE MEDICAL AFFAIRS TO MEET THE NEEDS OF THE EVOLVING / HEALTHCARE LANDSCAPE
  • Review the growing number of key external stakeholders and their impact on the life science industry
  • Develop processes that will put your organization in a position to meet the needs of the marketplace
  • Highlight the need for better collaboration within medical functions
  • Understand the opportunity for medical groups to firmly position themselves as the strategic partner for internal and customer-facing communications
Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS
8:45AM
GATHER INSIGHTS TO INFLUENCE AND ACHIEVE BUSINESS OBJECTIVES
  • Reimagine insight creation as a systemic process
  • Use data to drive targeted information collection and support planning and execution across the product lifecycle
  • Engage to build community consensus around specific objectives
Tony Page, CEO, VOXX ANALYTICS
9:15AM
Panel Discussion DRIVE ALIGNMENT AND IMPROVE DIALOGUE ACROSS MEDICAL AND COMMERCIAL FUNCTIONS TO CREATE A UNIFIED BRAND STRATEGY
  • Compare and contrast the motivations and objectives for medical and commercial functions
  • Examine some common pitfalls that lead to communication challenges between the two groups
  • Hear perspectives from both sides of the organization regarding how to successfully work together toward the creation of an effective brand strategy
Panelists:

Julio Casoy, M.D., Senior Vice President, Medical Affairs, TURING PHARMACEUTICALS
Vimal Patel, Senior Director, Customer Engagement, SUNPHARMA
Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS

10:00AM
TAKE A LOOK AT MODERN AND EMERGING VENUES FOR ENGAGING STAKEHOLDERS AND REMOVING COMMUNICATIONS BARRIERS
  • Discover trends and tips to maximize program results through digital avenues
  • Examine key examples of recent innovations within varying size programs
  • Leverage online discussion platforms to optimize program outcomes
Lance Hill, CEO, WITHIN3
10:30AM
Networking Break
MAIN CONFERENCE DAY ONE - TRACK SESSIONS | Tuesday, September 26, 2017
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
MEDICAL INFORMATION AND CALL CENTER MANAGEMENT
11:00AM
Track Chair's Opening Remarks
Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS
Track Chair's Opening Remarks
David M. Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK
Track Chair's Opening Remarks
Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE
Track Chair's Opening Remarks
James Fratantonio, Pharm.D., Manager, Medical Information, ALKERMES
11:15AM
Keynote Session Build an Agile Medical Affairs Group that is Able to Evolve and Transition as the Company Changes
  • Highlight methods, roles, and responsibilities of larger pharmaceutical and biotechnology medical affairs teams and how and when they can be replicated within a smaller model
  • Assign cross-functional work streams to MA team members that can be efficiently executed
  • Pinpoint communication channel issues that arise in large medical affairs teams and increase collaboration between eld MSL and in-house teams
Ryan Arnold, Vice President, Head of Medical Affairs, SAGE THERAPEUTICS
Keynote Session Enhance MSL Capabilities at Various Stages of the Product Lifecycle: Optimizing Tactics, Tools and Communications
  • Explore the use of social media and news outlets to help familiarize your team with a disease state
  • Apply the appropriate analytics to identify and map key opinion leaders by territory
  • Conduct publication SWOT analyses to prepare for a product launch
  • Understand how the role of an MSL changes so that they are best positioned to make an impact post-launch
Arthur Chan, Ph.D., MBA, Head, MSL Capabilities, Development and Training, NOVARTIS
Keynote Session Explore Industry Perspectives in Collaborative Research
  • Identify the critical considerations when comparing research opportunities
  • Examine basic, yet often overlooked components needed for collaborative research success
  • Define best practices in collaborative research
Noam Frey, M.D., MBA, Vice President, Medical Affairs, JAZZ PHARMACEUTICALS
Keynote Session Reflect on the Future of Medical Information as a Value-Added Function in the Industry
  • Stimulate discussion and debate about the future practice of medical information
  • Name three factors that are imperative to MI utilization
  • Identify at least one potential consequence of the accelerated pace of technological change
  • Become aware of the Medical Information Code of Practice
Dominick Albano, Vice President, Global Medical Information, PFIZER
12:00PM
Develop Value- and Outcomes-Based KPIs By Conducting External Assessments of Medical Affairs
  • Assess opinion leaders’ medical and clinical scientific views of disease states and treatment profiles by specialty, region, and classification of opinion leader
  • Leverage third-party research to assess the attitudes of key opinion leaders toward your company and the perceived value of your MSLs compared to key- competitor field teams
  • Determine OL need-segments and quantify MSL’s ability to meet those needs
  • Track opinion leader decision making over time and understand drivers of value
Gary Kaplan, M.A., Vice President, Medical Affairs Research, CLINICAL SCORE
Design and Build a New Medical Science Liaison Team: Solving Challenges and Maximizing Value
  • Consider the various options for developing a team given identified resources
  • Define core MSL functions and how they may change given the organizational evolution
  • Examine the MSL role and skill sets required to successfully address current and future organizational needs
Tammy Coberly, Pharm.D., Executive Director, Medical Science Liaisons, HELSINN THERAPEUTICS
Examine Criteria to Determine When to Start an Investigator-Sponsored Trial
  • Consider tactics and how to engage stakeholders from the start
  • Propose risk mitigation strategies when launching pipeline programs
Sara So, M.S., Senior Manager, Scientific Alliances, SEATTLE GENETICS
Maximize the Use of the Medical Information Team
  • Compose your medical information team of highly talented individuals who are capable of wearing multiple hats within the medical affairs department, including responding to unsolicited medical inquiries, content creation (e.g., standard response letters, slide decks), congress planning/ execution, library/literature services, and promotional review
  • Avoid redundancy, maximize efficiency and productivity within the medical affairs department through successful Medical Information team operations, regardless of company size or resources
  • Set the stage for a high-functioning team that is valued cross-functionally and within the medical affairs department
Colleen Tholen, Associate Manager, Medical Information, AVANIR PHARMACEUTICALS
12:45PM
Luncheon
1:45PM
Explore the Use of Technology and Innovative Communication Channels to Engage Physicians and KOLs
  • Look at new tools and channels that can be used to engage KOLs in a non-traditional way
  • Understand the use of web-based collaborative communities as a discussion forum that is independent, but supported by industry
  • Leverage this engagement to generate awareness during clinical development and to discuss emerging news regarding specific disease states
Dannis Chang, Pharm.D., Strategic Program Lead - Business Innovations, U.S. Medical Affairs, GENENTECH
Examine the Various Skill Sets Required to Be a Successful MSL in Different Therapeutic Areas
  • Gain an overview of the basic challenges facing specific therapeutic areas
  • Outline the skill sets required to overcome these challenges
  • Review strategies and best practices for delivering the most value to your organization
David M. Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK
Consider Drug Supply from an IST Perspective
  • Examine key factors to consider when supply is pre-commercialization
  • Manage vendors through effective shopping and realistic timelines
  • Review how proactive internal processes can avoid potential problems
  • Consider infrastructure that allows for flexibility in the face of inevitable change
Sarah Henry, Senior Clinical Project Manager, KARYOPHARM THERAPEUTICS, INC.
Implement Quality Assurance (QA) Process of Medical Information Database
  • Recognize the need for QA of medical information inquires and responses in the database
  • Discuss common medical information reports for analysis and metrics
  • Analyze the QA process, categories, severity, and resolutions
  • Determine the best practices for medical information personnel training and documentation based on QA results
Avni Patel, Pharm.D., Associate Director, Global Medical Affairs, Medical Information, INTERCEPT PHARMACEUTICALS
2:30PM
Panel Discussion How Technology-Leveraged Continuous Learning Yields Better Clinical and Scientific Outcomes
  • Characterize the need to provide effective learner-driven training to benefit “point of learning” performance support
  • Evaluate technology tactics which make micro-learning effective for overall knowledge retention
  • Understand how micro-learning works in the context of an innovative continuous learning approach
  • Share best practices for deploying accessible training for MSLs/CRAs and review case study summaries
Panelists:

Michael W. Young, Vice President Strategic Accounts, SCIENCEMEDIA

The MSL at the Epicenter of the Field Intelligence Radar
  • Highlight the value of MSLs as the first signal detector for changes in the marketplace
  • Define competitive intelligence in the framework of MSL team activities
  • Leverage relationships with HCPs to gain a better understanding of the competitive landscape
  • Discuss appropriate intelligence-gathering tools and tips for MSLs in the eld
Lynn Bass, Director, Medical Science Liaisons (Americas), SANTEN
Field Medical Affairs in IITs: Leveraging Risk- Tolerance Models to Ensure Compliant and Strategic KOL Engagements
  • Understand the complexity of regulatory oversight on Investigator-Initiated Trials through landmark cases that helped shape the regulatory arena
  • Leverage knowledge of risk-tolerance models to compliantly align eld medical teams in the setting of investigator-initiated studies
  • Foster discussions and share best practices on the role of institutional compliance training and pre-emptive risk- mitigation strategies to ensure a successful IIT program
Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE
Align Communication Resources Across Field and Internal Medical Affairs
  • Identify the need for resource development
  • Engage the team in preparation of new internal initiatives and data dissemination
  • Educate and review new materials for external stakeholder communication
James Fratantonio, Pharm.D., Manager, Medical Information, ALKERMES
3:15PM
Networking Break
3:45PM
Navigate Medical Affairs in the World of Alliance Partnerships and Co-Promotions
  • Review the different types of alliances and partnerships
  • Establish a model to manage medical affairs through the alliance
  • Discuss the various challenges with respect to compliance, thought leader initiatives and organizational structures
  • Build trust with your alliance partners and minimize the overlap of team members from the same function on every project workstream
Poushali Mukherjea, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB
Explore the Use of Intelligence Reporting as a Field Metric
  • Discuss some of the challenges of leveraging CRMs to extract eld 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
Kristin C. Ryan, Pharm.D., Field Director, Medical Science Liaisons, ASTELLAS
Examine What Factors Can Improve the Likelihood of a Successful IIT
  • Review key goals for the investigator and pharmaceutical company to define an IIT structure that meets both parties’ needs
  • Build a structured foundation for the collaboration to ensure successful product-knowledge expansion
DIANE HANNA, Senior Regional Medical Liaison, SANOFI, Director of Clinical Research, MODERN DERMATOLOGY
Examine a Pharmaceutical Company's Perspective in Finding Medical Information Online
  • Review reputable sources of online medical information
  • Manage inaccurate and outdated online medical information
  • Provide mechanisms to update online medical information to external websites
  • Respond to customers who have incorrect medical information
Matthew Bryant, Pharm.D., Associate Director, Medical Affairs, THERAVANCE BIOPHARMA
4:30PM
Panel Discussion Explore Different Models for Managing Medical Affairs Activities in Co-Promotion Agreements, Strategic Alliances and Acquisitions
  • 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
Panelists:

Sarah Guadagno, Ph.D., Vice President, Medical Affairs, Communications and Information, ZS PHARMA
Poushali Mukherjea, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB

Continuing Development Programs to Facilitate Connections Between Field-Based Medical Affairs Professionals to Home Office Colleagues
  • Allow for knowledge exchange and awareness between the field and home offices in order to strengthen medical affairs department and personal development
  • Hear a multitude of ways to create and engage cross-functional teams within medical affairs
  • Learn about a rotation program for MSLs that exposes them to various medical affairs roles
  • Establish the value of MSLs in the eyes of home-office colleagues
Brandi Howard, Vice President, Global Clinical Development and Medical Affairs, EVOFEM
Develop an Efficient Process for Fair-Market Value Analysis of Budgets for Investigator-sponsored Trials
  • Learn how to develop a process to analyze IST budgets for fair-market value working closely with compliance
  • Determine company position on invoice-ables, milestone payments and overhead allowance
  • Assess whether outsourcing (within company or externally) is appropriate for your IST program
Elizabeth Mena, Associate Director, Medical Sciences, PHARMACYCLICS LLC
Panel Discussion Develop Innovative Mediums to Provide Patients With Digestible Medical Information
  • Develop engaging material that complements standard response documents and further patient understanding
  • Expand medical communication with HCPs and patients to include social media and online chats
  • Review regulations to ensure compliant communication through new mediums and channels
Panelists:

Dominick Albano, Vice President, Global Medical Information, PFIZER
Hoyee Leong, Ph.D., Director, Global Medical Information, Oncology, Global Medical Affairs, ABBVIE
Colleen Tholen, Associate Manager, Medical Information, AVANIR PHARMACEUTICALS

5:15PM
Networking Reception
6:15PM
Day One Concludes
MAIN CONFERENCE DAY TWO - TRACK SESSIONS | Wednesday, September 27, 2017
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
MEDICAL INFORMATION AND CALL CENTER MANAGEMENT
8:00AM
Continental Breakfast
8:45AM
Track Chair's Recap of Day One
Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS
Track Chair's Recap of Day One
David M. Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK
Track Chair's Recap of Day One
Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE
Track Chair's Recap of Day One
James Fratantonio, Pharm.D., Manager, Medical Information, ALKERMES
9:00AM
Medical Affairs Strategies in Managed Care: Out of the Box and Into the Conversation
  • Conduct an analysis of competitive products
  • Focus efforts on differentiating your product
  • Leverage existing structures and key relationships
  • Learn how to effectively communicate your value story in a managed care setting
Harry Kovelman, M.D., Vice President, Medical Affairs, PACIRA PHARMACEUTICALS
Assess the Career Path of an MSL
  • Identify reasons why scientific professionals seek the MSL position
  • Highlight the importance of show individual value to the team and organization and demonstrate how to excel in the MSL role
  • Evaluate longer-term career opportunities for the MSL, within the role and a company
  • Analyze alternative opportunities for the MSL seeking other options
Vicki L. Fisher, RN, Director, Medical Affairs Operations and Training, JAZZ PHARMACEUTICALS
Prevent Non-Compliance and Steps to Take When It Occurs in Investigator-Initiated Trials
  • Create an established group that evaluates research requests from sponsor-Investigators
  • Ensure effective oversight of the trial to ensure the written agreement is followed
  • Identify strategies and leverage MSLs to mitigate and remedy non-compliance
Kathryn Shantz, Operations Leader, Medical Evidence & Observational Research, ASTRAZENECA
Case Study Centralize Scientific Content Creation for Improved Quality, Speed and Reduced Cost
  • Review benefits and challenges of global content centralization
  • Consider technology enablers to promote content reuse
  • Review strategies for global medical content success
Rebecca Weingard, Director, Medical Affairs, BRISTOL- MYERS SQUIBB COMPANY
9:45AM
Analysis of Field Medical Growth and Industry Trends
  • Explore the latest analyses on the continued growth of eld medical across the industry, especially in specialty therapy areas
  • Review the drivers and current perceptions across the industry that are fueling this growth
  • Outline the implications and future needs of medical affairs organizations to meet these industry trends
Sarah Jarvis, Associate Principal, Medical Affairs Consulting Lead, ZS ASSOCIATES
Explore the Career Growth Prospects and Challenges for MSLs
  • Examine the MSL career trajectory and their possible defined career path
  • Consider potential alternative careers MSLs can transition to
  • Navigate the relationship between compensation levels and therapeutic areas
David Freilich, Senior Medical Science Liaison and Senior Team Trainer, IMPAX PHARMACEUTICALS
William Soliman, Ph.D., MPhil, M.A., U.S. and Global Medical Director, Rare Diseases, Hepatology/Gastroenterology, RETROPHIN
Davida J. White, M.D., Global Medical Affairs Director of MSL Training and Development, ALCON
Successfully Integrate a Quality Component into Investigator-Initiated Trials
  • Develop a strategy for an IIT program supporting the therapeutic area and/or research objectives
  • Review compliance with global requirements
  • Create a checklist to promote efficiency and maintain compliance with regulations
John Schenkel, Grant Manager, Global Medical Grants and Research Collaborations, PFIZER
Cultivate Synergies in Scientific Communications and Medical Information Services to Provide Useful Resources to Cancer Patients and Healthcare Professionals
  • Review SOPs/processes for Information Specialists
  • Implement efficient legal, medical and regulatory (LMR) review processes for accurate and timely dissemination of up-to-date disease state education and patient support information
  • Review Effective CI surveillance of trends in the “Engineered T cell Marketplace,” including FAQs and other useful resources to educate cancer patients and healthcare professionals
Joe Petroziello, Senior Director/Head of Scientific Communications, JUNO THERAPEUTICS, INC.
10:30AM
Networking Break
11:00AM
Closing the Loop: Pulling Through Field Insights to Medical Strategy
  • Describe a field insights model
  • Discuss tactics used to facilitate real-time discussions of insights between MSLs and product leads
  • Identify ways to encourage MSLs to share relevant, focused and timely field insights
  • Examine how cross-functional teams utilize field insights to shape their initiatives
Deborah Hails, Director, Hematology MSLs, US Medical Affairs, SHIRE
Soft Skills Needed for Impactful KOL Engagement
  • Adapt your style in order to work more effectively with various KOLs
  • Build and maintain reapport with top KOLs
  • Develop engaging presentation skills for the target audience
  • Learn how to get on a personal level with your KOLs for long term relationships
Georgea Pasedis, Pharm.D., Senior Medical Science Liaison, SHIRE
Navigate the Investigator-Initiated Trials Process From a Site Perspective
  • Understand site stakeholders, in addition to the principal investigator, through case studies
  • Establish clear expectation of deliverables to avoid delays
  • Review universal opportunities for improvement
  • Foster partnerships to optimize IITs
Joseph Cosico, Director, Clinical Research Operations, CEDARS-SINAI MEDICAL CENTER
Succeed through Collaboration by Integrating Frontline Operations from Different Organizations
  • Create an integrated call center via collaborative knowledge transfer
  • Understand the steps and processes to ensure sustained and consistent consumer support across different portfolios
  • Examine examples of a successful integration plan
Stéphanie Vézina, Pharm.D., Director,  Medical Customer Interface (MCI), Pfizer
11:45AM
Foster Collaboration Between U.S. and Global Medical Affairs
  • Describe the value-add of integrated dialogue between U.S. and global medical affairs in the development and execution of medical affairs strategies and operating plans
  • Discuss strategies and approaches for facilitating increased collaboration between global medical affairs and the U.S. affiliate
  • Outline innovative approaches for communicating the U.S. medical affairs cross-functionality perspective to the global teams, with an emphasis on gathering field insights
  • Provide scenarios/case discussions for troubleshooting collaboration challenges between U.S. and global teams
Leslie Meltzer, Vice President, Head of Medical Affairs, KERYX BIOPHARMACEUTICALS
Partnering from Within to Build the Best Team
  • Discuss the value of continuous exchange of ideas, debate and sharing of feedback as critical in building a new MSL team at a small company
  • Explain the value of leveraging past experiences of new colleagues to more practically train and onboard
  • Review the “power of the small” in testing new systems, operations and approaches for smoother and more satisfying implementation
Chris Robertson, Pharm.D., Director, Medical Affairs Operations and Training, DERMIRA
Andrew Smith, Ph.D., Senior Director, National Head of MSLs, DERMIRA
Optimize the Advancement of an Investigational Drug from Pre-clinical to Clinical Trials Through Research Collaborations
  • Identify internal and external factors that hamper the transition of an investigational drug from the non-clinical to first in human clinical trial phase
  • Apply strategic initiatives and resources that promote immersive deep dive, protocol design optimization, and seamless project team and project management
  • Design and apply benchmarking parameters to evaluate success of initiative selected
Nanette Hock, Clinical Research Scientist, Translational Development, CELGENE
Improve the Health Literacy of Medical Information Response Letters
  • Understand the current medical information landscape
  • Engage the four steps to better communication
  • Provide the optimal HCP experience through response letter transformation
Hoyee Leong, Ph.D., Director, Global Medical Information, Oncology, Global Medical Affairs, ABBVIE
12:30PM
Luncheon
1:30PM
Strategic Considerations for Developing Phase 3b/4 Study Portfolios Including Clinical Cohort (Real-World) Data
  • Review Phase 3 study portfolio and identify data gaps with prioritization
  • Phase 4 studies: develop and manage Investigator-Sponsored and collaborative studies to address data gaps
  • Collaborate with investigators and research networks to ensure access to relevant data sources
Richard Haubrich, M.D., Senior Director, HIV Medical Affairs, GILEAD SCIENCES
Case Study A Value-Based Approach to Price- Limiting Solutions Such as Virtual Reality
  • Outline current methods of data dissemination and inherent challenges with traditional methods
  • Identify new digital options that have proven to be valuable solutions to age-old problems
  • Discuss the methodology to managing digital engagement projects
Aaron Shaw, RN-BSN, Medical Director, Medical Science Liaison Team, PACIRA PHARMACEUTICALS
Examine Opportunities for the Industry to Support the Investigator in Investigator-Initiated Trials
  • Study cases during which fraud was committed accidentally to understand prevention measures are in place
  • Understand examples of industry support that meet FDA compliance
Harvey Arbit, Pharm.D., Professor, UNIVERSITY OF MINNESOTA COLLEGE OF PHARMACY
Case Study Component Authoring in Medical Information
  • Implement systems and processes that enable authoring smaller components of content that can be systematically combined to create broader pieces of medical information
  • Describe the rationale used to decide to move to this new approach to creating and managing content globally
  • Discuss successes and challenges in our approach
  • Highlight some early results from our experience
Michael Rocco, Director, Business Planning and Communication-Americas, PFIZER
2:15PM
Case Study Innovative Approaches to Engaging and Collaborating With Patient Advocacy Groups While Working With a Limited Budget
  • Consider the end goals and motivations for patient groups
  • Identify opportunities to support these organizations as an alternative to direct funding
  • Create objectives that are mutually beneficial and measure the ROI of these activities as a means to grow these relationships
Pauline Bianchi, Senior Director, Medical Affairs— Pulmonology, VERACYTE
Bridging the Gap Between MSL Field and Of ce- Based Medical Affairs Teams
  • Implement a structure that will capture global MSL insights, ensure alignment in resource utilization, and identify unmet needs across various regions
  • Demonstrate the value of MSL insights and strong partnerships between field and office-based medical affairs teams to effectively develop and deliver strategic medical and educational materials and tools
  • Engage in the ability to connect MSLs across the globe with each other and within office-based medical affairs functions in a manner that promotes unity, collaboration, and integration
Anisha Bhagat, Pharm.D., Manager, Global Medical Affairs, INTERCEPT PHARMACEUTICALS
Discuss FDA and the Drug Approval Process in the U.S. to Outline the Various Steps, Timelines and Milestones in Research Collaborations
  • Discuss most common trial structures to understand what sponsors must go through to get an FDA-approved drug to market
  • Review compassionate use and the “Right to Try” in the United States
Kasmin Delgado, Medical Science Liaison, VALEANT PHARMACEUTICALS
Dive Deep Into Strategies That Elevate the Customer Experience
  • Uncover best practices to effectively interact with increasingly engaged customers to ensure added value and increased customer satisfaction
  • Leverage innovation to elevate the customer experience and increase the impact provided to a variety of customers
  • Build a foundation for a new approach to customer service excellence through culture shifts
Christopher Bess, Associate Director, UCB Cares, UCB
3:00PM
Case Study How to Develop and Sustain High- Performance Promotional Review Committee Teams
  • Employ universal onboarding/training guidelines for PRC members
  • Accommodate multiple communication channels
  • Maintain consistency and prevent mixed messages from multiple teams that would confuse ad agencies
  • Standardize PRC processes across drugs/devices and indications to improve effectiveness of PRC review
Jay H. Mashburn, Ph.D., R.Ph, PMP, SeniorManager, Medical Affairs—Aesthetic and Corrective, GALDERMA
Forge Strategic Partnerships With Your Medical Information Group to Develop Meaningful Relationships With Thought Leaders
  • Explore different data sources and channels to increase your knowledge base of a therapeutic area
  • Highlight the importance of a collaborative relationship between MSL and medical information groups
  • Leverage these materials to connect with KOLs
Manijeh Pouliot, Pharm.D., BCPS, Regional Medical Liaison, Diabetes Medical Unit, SANOFI
Panel Discussion Overcome Barriers Throughout the Investigator Initiated Trials Grant Cycle
  • Define high quality IIT study characteristics
  • Differentiate various parties’ interests in high quality IITs
  • Describe any signals of barriers to high quality IIT studies
  • Explain various strategies for overcoming these barriers
Panelists:

Jeff Braziunas, Ph.D., Sr. Medical Science Liaison, Oncology, ASTELLAS
Christy Gilchrist, Ph.D., Director of Research, HSHS ST. VINCENT HOSPITAL CANCER RESEARCH INSTITUTE
Axel Grothey, M.D., Chair, ACADEMIC AND COMMUNITY CANCER RESEARCH UNITED (ACCRU)
Fawn Hangge, Program Manager, ACADEMIC AND COMMUNITY CANCER RESEARCH UNITED (ACCRU)
Eric Mortenson, Ph.D., Medical Science Liaison, Oncology, BRISTOL MEYERS SQUIBB

Divulge Practices to Move Into the Medical Information Space as a Clinical Pharmacist
  • Describe opportunities and challenges faced by clinical pharmacists interested in transitioning into the pharmaceutical industry
  • Highlight advantages individuals with prior patient-care experience bring to medical affairs teams
  • Identify areas of support needed by clinically-trained pharmacists to excel within medical affairs
Joal Mayor, Pharm.D., Associate Manager, Medical Information, SEATTLE GENETICS
3:45PM
Track Chair Closing Remarks
Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS
Track Chair Closing Remarks
David M. Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK
Track Chair Closing Remarks
Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE
Track Chair Closing Remarks
James Fratantonio, Pharm.D., Manager, Medical Information, ALKERMES
4:00PM
Summit Concludes

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