THE INDUSTRY S ONLY CONFERENCE SERIES DEDICATED TO IMPROVING PAPER AND ELECTRONIC TMF MANAGEMENT TRIAL MASTER FILE SUMMIT

Transcription

1 THE INDUSTRY S ONLY CONFERENCE SERIES DEDICATED TO IMPROVING PAPER AND ELECTRONIC TMF MANAGEMENT 5TH TRIAL MASTER FILE SUMMIT Develop a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF January 20-22, 2016 / The Westin Arlington Gateway / Arlington, VA 28+ SPEAKERS, INCLUDING: CONFERENCE CHAIRPERSONS: ERIC RUBINSON Stacey Jandciu Ronak Kadakia Joanne S. Malia JANSSEN RESEARCH JANSSEN RESEARCH PURDUE PHARMA, & DEVELOPMENT & DEVELOPMENT L.P. Alex Markiel BIOMARIN PHARMACEUTICAL INC. Elizabeth Provenzano BIOGEN Director, Drug Development Business Operations, IVAN WALRATH Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Fabio Rodrigues BOEHRINGER INGELHEIM Michael Russert ABBVIE Shannon Simpson PATH THE 2016 TMF SUMMIT FEATURES: Nancy Snowden NCGS INC. 20 educational sessions covering all aspects of paper and electronic TMF filings Wendy Trimboli EISAI SPONSORED BY: KAREN ROY Senior Vice President, Client Solutions, PHLEXGLOBAL 6 case study presentations from Amgen, Bayer, BioMarin, Boehringer Ingelheim, Eisai and Janssen A TMF workshop for newcomers, which introduces the Trial Master File and the many challenges that TMF professionals face True e-integration. A single portal. A 5-hour interactive TMF training seminar on the keys to successful TMF management 9+ hours of networking with 175+ TMF professionals An engaging panel session on trends, the preparation of and expectations for a TMF inspection 14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies Updates on the DIA Reference Model Version 3.0, TransCelerate s eisf and the MCC s working group CMYK W ingspan Technology, Inc. W ingspan Technology, Inc.

2 DEAR COLLEAGUE, We first launched ExL s Trial Master File Summit in 2012 as an intimate 60-person conference primarily covering paper TMF management. Over the past four years we have evolved into a global TMF family with educational programs in the United States and the United Kingdom. Since 2012, we have hosted more than 500 delegates at our TMF events, and we are very excited to invite you to the 5th Trial Master File Summit on January 20-22, 2016 in Arlington, VA. This summit features our largest and most expansive agenda to date and is certainly the place to be for any TMF professional. Join us to develop and enhance your TMF processes to ensure complete, compliant, high-quality and inspection-ready TMFs regardless of whether you are utilizing an electronic, paper or CRO system. We know TMF management can often be overwhelming the amount of components and records that need to be documented during a clinical trial is astounding. That s why it s so important to learn from the experts shaping the industry and ensure your process is ready for audits and inspections. This year s three-day event features: A pre-conference workshop designed for anyone new to TMF A 5-hour training seminar on keys to successful TMF management, led by a sponsor executive, a CRO director and a TMF consultant 20 educational sessions A team of TMF experts chairing this meeting, including: > Eric Rubinson, Director of Drug Development Business Operations at Allergan > Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution at Pfizer > Karen Roy, Senior Vice President of Client Solutions at Phlexglobal An open session on managing a critical TMF to ensure completeness and meet inspection requirements, where conference delegates can get involved in the conversation 6 case study presentations 29+ hours of educational sessions and networking with TMF professionals We look forward to learning, networking and having TOO MUCH FUN with you in Arlington in January! Sincerely, Scott Grossman Division Head, Conference Production sgrossman@exlevents.com Especially liked the actual case studies and I appreciate when vendors present new tools and technology. Senior CTA Clinical Systems, ALKERMES WHO SHOULD ATTEND? This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas: TMFs and etmfs Clinical Trials/Research Clinical Document/Data Management Clinical Trial Administration/Management Quality Assurance/Control/Operations Strategic Operations and Planning Clinical/Project Operations Document Management Regulatory Affairs Clinical Document Coordination Clinical Development Clinical Study/Records Management Regulatory Compliance/Operations Regulatory Affairs Records/Information Management Good Clinical Operations Strategic Operations and Planning Informatics Clinical IT This event is also of interest to: TMF Service Providers CROs TMF Consultants Electronic Signature Service Providers Paper and Electronic Data Archiving Service Providers Data/Records Management Service Providers Sponsorship and EXHIBITION Opportunities Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Eric Morrin, Senior Business Development Manager at or emorrin@exlevents.com.

3 2016 WORKSHOP/TRAINING DAY WEDNESDAY, JANUARY 20, 2016 WORKSHOP: TMF 101 SEMINAR: TMF TRAINING 8:00 Registration Opens 11:45 Registration Opens 8:15 TMF 101: AN INTRODUCTION TO THE TMF WHAT S IN IT AND HOW IT IS MANAGED This workshop is geared toward professionals who are new to the TMF field. It provides the foundation attendees need to get the most out of the rest of this conference. It introduces the Trial Master File and the many challenges TMF professionals face. Areas of discussion include: The TMF, its definition and the content that makes it up Version 3.0 of the TMF Reference Model Functions within a company that create, collect and manage the TMF Current laws and regulations governing TMF management Lisa Mulcahy, Co-leader, TMF Reference Model Team, Owner, Principal Consultant, MULCAHY CONSULTING, LLC. Katherine Santoro, Senior CTA, Clinical Systems Study Start-Up, ALKERMES *This workshop includes breakfast. 11:30 TMF 101 Workshop Concludes Very enthusiastic presentations, kept us really engaged! CPM, CERULEAN PHARMA Excellent overview of events [from the] past year and why we are here...valuable lessons learned. Senior Project Manager, GSK 12:00 TMF TRAINING SEMINAR: KEYS TO SUCCESSFUL TMF MANAGEMENT The complicated process of the TMF almost always includes delegates who are responsible for documentation transfer, collection, creation and management, and sometimes even archival. Specifically, the sponsor-cro transfer of responsibility of TMF management is one that is often ill-defined, resulting in numerous problems. Relationships become strained early as expectations for timely management are not met, and errors in processing result in ever-annoying and rising rejection rates. This affects the quality of the TMF and its ability to be inspection ready on an ongoing basis. This workshop will address three areas to improve the TMF management process right from the start of the study and to ensure the TMF is complete and ready for inspection. Areas of discussion and exercises include: Evolutions and trends in TMF management Determining the expectations for TMF management as a requirement for the establishment of working relationships; avoiding the possibility of study-by-study variability Monitoring and routinely reporting key performance indicators Clearly establishing the expectations of the QC process to ensure the accuracy of content when the TMF is uploaded Defining the interval for QC for TMF completeness, issue reporting and issue resolution Important considerations for determining which etmf system the sponsor s or CRO s is the best to use to comply with processes and prepare for inspections Evaluating the pros and cons of each option on a company-bycompany basis Assessing each system s impact on the TMF plan Expectations for management and quality assessment/thresholds when a CRO manages TMF content on behalf of the sponsor Lisa Mulcahy, Co-leader, TMF Reference Model Team, Owner, Principal Consultant, MULCAHY CONSULTING, LLC. Kristen Snipes, Project Director, RHO Fabio Rodrigues, Clinical Operations Manager, BOEHRINGER INGELHEIM *This workshop includes lunch. 5:30 TMF Training Seminar Concludes This was a great conference overall and incredibly informative. Associate Director SSU regulatory, INC RESEARCH

4 DAY ONE THURSDAY, JANUARY 21, :45 Registration and Continental Breakfast 12:15 Luncheon 8:30 CHAIRPERSONS WELCOME AND OPENING REMARKS Eric Rubinson, Director, Drug Development Business Operations, Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL 8:45 OPEN DISCUSSION: MANAGE A CRITICAL etmf TO MEET INSPECTION REQUIREMENTS Understand the global/regional variability in inspection requirements Review how to remain compliant when TMF records reside in multiple systems across a given study Effectively manage multiple TMFs due to mergers and acquisitions Examine the pros and cons of using one TMF versus multiple TMFs, as seen from a sponsor s perspective Allow for interoperability between a sponsor-cro and sponsor-sponsor Explore the benefits and best practices of CRO oversight and TMF governance to support inspection readiness Determine best practices for managing legacy trials Eric Rubinson, Director, Drug Development Business Operations, Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL 9:30 CASE STUDY: SETTING UP YOUR PERSONNEL AND INFRASTRUCTURE TO SUPPORT A TMF RESTRUCTURING PROCESS Recognize the staffing needed to support a new TMF process when adapting to an etmf Create a checklist of needs that goes along with the new TMF processes Support the etmf and develop a plan for legacy trials Enhance the infrastructure requirements and determine the timelines needed to support them Develop a TMF process that ensures quality and supports document needs Alex Markiel, Senior Manager, DevSci Quality, BIOMARIN PHARMACEUTICAL INC. 10:15 Morning Networking Break 10:45 MOVE ALONG THE TMF MATURITY CONTINUUM Learn key criteria you should be examining when evaluating the state of your TMF Understand how to create a strategy that propels your organization along the TMF continuum Leverage industry benchmarks to drive process improvement Kathryn King, Vice President, Vault Clinical, VEEVA SYSTEMS 11:30 CASE STUDY: DEVELOP A TMF SYSTEM AND PROCESS TO IMPROVE YOUR TRIAL CONDUCT OPERATIONS Enhance your internal procedures to increase the efficiency of collating, managing and analyzing trial content Develop a process around TMF access Ensure all essential documents are collected, permitting an evaluation of the conduct of a trial and the quality of the data produced Stacey Jandciu, Manager, TMF Compliance Specialist, JANSSEN RESEARCH & DEVELOPMENT Ronak Kadakia, TMF Analyst, Lead, JANSSEN RESEARCH & DEVELOPMENT 1:15 CASE STUDY: MAP YOUR ORGANIZATION S TMF WHILE KEEPING STANDARDIZATION, FLEXIBILITY AND INTEROPERABILITY IN MIND Listen to an update on Version 3.0 of the TMF Reference Model Evaluate additional V3 deliverables, including interoperability and presentation Analyze examples of biotech and large pharma moves to V3 Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL 2:00 ACHIEVE CONTINUOUS TMF INSPECTION READINESS Improve your TMF though an information architecture system Ensure a governance process that covers the full life cycle of the TMF Put a process and tools in place to have a high level of maturity in TMF compliance, efficiency and effectiveness Highlight TMF inspection trends and perspectives Identify key steps critical to achieving inspection readiness Gauge the impact of governance and metrics on compliance and efficiencies Liz Provenzano, TMF Study Owner, BIOGEN 2:45 Networking Break 3:15 DEVELOP A QC REVIEW STRATEGY TO ASSESS QUALITY, TIMELINESS AND COMPLETENESS WITHIN YOUR etmf Recognize how a risk-based approach can assist in creating a process for QC review Develop a study QC review plan to outline your strategy Utilize a risk assessment to assist in developing a risk-based approach to monitoring data Conduct a QC review within your etmf for all strategic partners Wendy Trimboli, Associate Director, TMF Process Management and Quality Control, EISAI 4:00 PANEL SESSION: TRENDS, PREPARATION AND EXPECTATIONS FOR A TMF INSPECTION Plan for FDA, EMA, MHRA and PMDA inspections Review required TMF content during a health authority inspection Use an etmf to designate GCP problems before an inspection Outline effective strategies to ensure inspection readiness and ultimately reduce time and cost associated with an inspection Examine inspection trends and highlight the common findings of incomplete TMFs Explore TMF requirements to establish a fully compliant TMF Discuss practical examples of current preparation and conduct methods for etmf inspections Prepare for a regulatory inspection when using an etmf Understand the logistics and identify the tools necessary for a proper inspection Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Andrew Waite, Director, Records and Information Management, AMGEN Vinita Leslie, TMF Process Owner, BIOGEN Michael Russert, Assistant Director, Document Management, ABBVIE 5:00 Cocktail Reception 6:00 Day One Concludes

5 DAY TWO FRIDAY, JANUARY 22, :00 Registration Opens and Continental Breakfast 8:45 CHAIRPERSONS DAY ONE RECAP Eric Rubinson, Director, Drug Development Business Operations, Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL 9:00 DEVELOP A CRO OVERSIGHT PLAN TO ENSURE THAT THE TMF IS COMPLETE Manage the flow of trial information between the sponsor and CRO Determine how CRO oversight and TMF governance are achieved and monitored Ensure quality and compliance when utilizing a strategic partner s etmf Achieve a centralized CRO/sponsor etmf Structure files to be ready for inspection through effective communication and a quick turnaround of critical documents Outline an internal set of SOPs to harmonize the TMF when outsourcing to multiple CROs Dawn Niccum, Quality Manager, ENDOCYTE 9:45 PANEL SESSION: BEST PRACTICES FOR ENSURING TMF QUALITY BY IMPLEMENTING PROCESS IMPROVEMENT STRATEGIES Identify key considerations that impact quality and trial outcomes Hold all functional groups accountable for their actions in order to establish data integrity Establish procedures to ascertain quality and implement continuous improvements to ensure a high-quality TMF Adopt a process to store correspondences Create an electronic signature process so all electronic documents remain compliant Utilize a TMF document s filing plan for documents not within a CRO function Amer Alghabban, Vice President GxP Quality Assurance, Compliance and Training, KARYOPHARM THERAPEUTICS Supriya Shoroff, Clinical Document Specialist, MEDIVECTOR Nancy Snowden, CEO, NCGS INC. Cindy J. Mazur, Global Study Manager, CHUGAI PHARMA USA, LLC Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION 10:45 Networking Break 11:15 DEVELOP AN etmf BUSINESS CASE FOR IMPLEMENTATION Develop the problem statement Analyze alternative solutions Ensure strategic alignment Describe the preferred solution Create a cost/benefit analysis Document the business case Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY INC. 12:00 Luncheon 1:00 CASE STUDY: IMPLEMENTATION AND SELECTION OF AN etmf Compile a criteria checklist for an etmf Review how to decide between an outsourced solution versus in-house development Plan an approach to implementation that covers vendor selection, stakeholder involvement and the rollout process Evaluate the impact of using an etmf on document management, quality and trial inspection Martina Duevel, Senior Global Clinical Project Manager, BAYER PHARMA 1:45 ENHANCE YOUR TMF PROCESS THROUGH IMPLEMENTING TMF/eTMF METRICS Define a methodology to develop a set of TMF metrics that meet the needs of your organization Use TMF metrics to improve the quality and efficiency of your TMF process Monitor valuable data to enhance inspection readiness Review the MCC s TMF performance metrics initiative deliverables Linda B. Sullivan, Co-founder and President, METRICS CHAMPION CONSORTIUM Joy Mehlenbacher-Mohamed, Manager, Administration Group, BOEHRINGER INGELHEIM 2:30 Networking Break 3:00 CASE STUDY: YOURS, OURS AND THEIRS CONSIDERATIONS FOR A SINGLE QUALITY TMF Establish the importance of a TMF plan Develop expectations and incorporate an individual CRO s processes and structures Identify the challenges of paper files, electronic documents and s Ensure quality and completeness through the assistance of metrics Prove and improve the process through mock inspections Joanne S. Malia, Director, Medical Research Process Management, PURDUE PHARMA, L.P. Fantastic speakers and sessions! TMF Records Management, ELI LILLY Awesome presentation, great delivery, nice to also see an interest in different-sized companies. Clinical Documents Management, ACORDA THERAPEUTICS

6 DAY TWO FRIDAY, JANUARY 22, :45 CASE STUDY: CREATE A TMF STRUCTURE AND PROCESS FOR ELECTRONIC DOCUMENT RETENTION Understand the goal for ensuring TMF compliance for global trials and multiple regulatory authorities Address challenges for varying roles across projects Utilize the DIA reference model to ensure all essential documents are accounted for Craft a process to receive and file electronic documents, and develop departmental procedures accordingly Review the electronic system for document filing and quality checks Shannon Simpson, Clinical Trials Documentation and Regulatory Specialist, PATH Jennifer O Reilly, Clinical Trial Project Manager, PATH 4:30 CHAIRPERSONS CLOSING REMARKS AND KEY TAKEAWAYS Eric Rubinson, Director, Drug Development Business Operations, Ivan Walrath, Senior Director Business Process Owner - TMF, Registry and Study Execution, PFIZER Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL 5:00 Conference Conclusion Best TMF conference I have been to! Clinical Site Manager, BRISTOL-MYERS SQUIBB Especially liked the actual case studies and I appreciate when vendors present new tools and technology. Senior CTA Clinical Systems, ALKERMES Can t wait to come back next year and hear how TMF has developed. Director, Clinical Study Management, ASTELLAS MEDIA PARTNERS: Westin Arlington Gateway 801 North Glebe Road Arlington, VA The Westin Arlington Gateway is located in the vibrant Ballston area of Arlington and two blocks from the Ballston Metro Station, providing direct access to Washington, DC. This hotel is minutes away from Smithsonian Museums, The White House, the Kettler Iceplex community ice rink that is also the training facility for The Washington Capitals, and all that Arlington and Washington, DC have to offer. Discover endless possibilities to help reach your potential at this transformed Westin. Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Events has reserved a block of rooms at a group rate for participants. To make reservations guests can call and request the group rate for ExL s 5th Trial Master File Summit. We encourage conference participants to make reservations by January 4, 2016 in order to receive the group rate. Please book your room early as rooms available at this rate are limited. *ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly us at info@ exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided.

7 WAYS TO REGISTER: Phone: Fax: Online: Mail: ExL Events, Inc th Avenue, Fourth Floor New York, NY REGISTRATION FEES EARLY BIRD Register by December 4, 2015 STANDARD Register after December 4, 2015 ONSITE Conference Only $1,895 $2,095 $2,195 Conference and Workshop $2,195 $2,395 $2,495 Conference and Seminar $2,495 $2,695 $2,795 Conference, Workshop and Seminar $2,695 $2,895 $2,5 GROUP DISCOUNT PROGRAMS *Offers may not be combined. Early Bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call * SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person. SAVE 15% Can only send three? You can still save 15% off of every registration. TERMS AND CONDITIONS: By registering for an ExL Events, Inc. ( ExL ) event, you agree to the following set of terms and conditions listed below: REGISTRATION FEE: The fee includes the conference all program materials and designated continental breakfasts lunches and refreshments. PAYMENT: Make checks payable to ExL Events, Inc. and write C650 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. **Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.** CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date. To receive a refund or voucher, please cancel@exlevents.com or fax your request to CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees behalf, the credit voucher will no longer be valid. ExL Events, Inc. does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event. SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other expenses incurred by registrants. ExL Events liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date content speakers and/or venue. *The opinions of ExL s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites. Questions? Comments? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please Scott Grossman, Division Head of Conference Production, at sgrossman@exlevents.com.

8 WAYS TO REGISTER: Method of Payment: Check Credit Card Phone: Fax: Online: Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Card Number: Exp. Date: Mail: ExL Events, Inc th Avenue, Fourth Floor New York, NY Yes! Register me for the conference, workshop and training seminar. Yes! Register me for the conference and workshop. Yes! Register me for the conference and training seminar. Yes! Register me for the conference only. Name on Card: CVV: Signature: Please contact me: I'm interested in marketing opportunities at this event. I wish to receive updates on ExL Pharma's upcoming events. Conference Code: C650 Name: Title: Company: Dept.: Address: City: State: Zip: Phone: Fax: 5TH TRIAL MASTER FILE SUMMIT Develop a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF January 20-22, 2016 / The Westin Arlington Gateway / Arlington, VA 28+ SPEAKERS, INCLUDING: CONFERENCE CHAIRPERSONS: ERIC RUBINSON Stacey Jandciu Ronak Kadakia Joanne S. Malia JANSSEN RESEARCH JANSSEN RESEARCH PURDUE PHARMA, & DEVELOPMENT & DEVELOPMENT L.P. Alex Markiel BIOMARIN PHARMACEUTICAL INC. Elizabeth Provenzano BIOGEN IVAN WALRATH PFIZER KAREN ROY PHLEXGLOBAL