13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

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Pharmaceutical, Medical Device, and Biotechnology Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITs

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13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

  1. 1. Febr Reg iste uary r by 13 to R th 25, ecei Proudly ve o ur D 201 Presents: isco unte d Ra 1 te! – The –ORIGINAL INVESTIGATOR INITIATED TRIALSis still the best ! Join us and sharebest practices with organizations including: Pharmaceutical, Medical Device, and Biotechnology ACTELION Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITs AMYLIN April 14-15, 2011 ASTRAZENECA Dolce Basking Ridge | Basking Ridge | New Jersey COVIDIEN EISAI Tri-Located with ExL Pharma’s { 8th Annual MSL Best Practices Conference, and Medical Affairs Executive Forum Register Today and Gain Access to Presentations from all Three Events! IISRA CONTRACT NEGOTIATIONS Identifying Key Elements within a Contract and Strategies for Expediting Negotiations NOVARTIS Carrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK NOVO NORDISK IISRA UPDATE ON FAIR MARKET VALUE Investigator Initiated Sponsored Research Association Update on Best Practices to Efficiently Determine FMV For Investigator’s Time and Services PFIZER Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & Executive Director, IISRA SIGMA-TAU INTERNATIONAL IITSPHARMACEUTICALS Managing Compliance in Emerging Markets IITs to Optimize Research Quality , Patient Safety, and Inspection Readiness Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Manager, Emerging Markets, PFIZER SUNEVA MEDICAL BENCHMARKING IITS TALECRIS Adding Value to IIT Programs Using Benchmarking Data to Effectively Track PerformanceBIOTHERAPEUTICS Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN Sponsors: To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
  2. 2. Dear Colleague, Who Should Attend? ExL Pharma’s 13th Investigator Initiated Trials conference offers professionals from This conference is designed for representatives pharmaceutical, medical device, and biotechnology companies a complete understanding from pharmaceutical, biotechnology, and of the issues and strategies for managing and implementing, successful and compliant, local medical device companies with responsibilities and global IITs. ExL Pharma is the proud host of the longest running IIT event and original in the following departments: conference in this field, delivering new educational sessions, never heard before case studies, prominent speakers, loyal attendees (with over 80% from pharmaceutical, medical device, and  Investigator Initiated Trials, Research, biotechnology companies), and tremendous networking opportunities to help build relationships and Studies through memorable and relevant shared experiences. In addition, attendees also have the  Medical Affairs unique opportunity to hear best practices for determining fair market value from the Investigators  MSLs Initiated Sponsored Research Association (IISRA).  Medical Communications  Research Grants The 13th IIT event is being co-located with two other ExL Pharma events, the 8th MSL Best  Clinical Project Manager Practices conference and the new Medical Affairs Executive Forum. These three events share  Clinical Affairs Manager networking breaks, continental breakfast, and lunch, which allow for increased networking  Compliance, Legal and Regulatory Affairs opportunities filled with senior level medical affairs professionals and MSLs. This is a must attend  Program/Project Management event for everyone involved in investigator initiated trials looking to advance their knowledge  Contract Administrators and learn new strategies, while interacting with other IIT professionals.  Clinical Research Investigators  Clinical Data Analysts We look forward to greeting you in April! This event is also of interest to: Sincerely,  Consultants  Solution Providers for Data & Lifecycle Management  Law Firms Mary Ruggiero Kristen Hunter  Contract Research Organizations Conference Director Team Leader, Production mruggiero@exlpharma.com ExL PharmaDolce Basking Ridge300 North Maple AvenueBasking Ridge, NJ 07920 USATel: (800) 953-8033Fax: (908) 953-3105Dolce Basking Ridge combines a retreat-like setting with over 20,000 square feetof IACC approved function space. The award-winning Dolce Basking Ridge is theTri-state region’s setting of choice for business and pleasure. A recent multi-million dollar redesign has updated our accommodations, restaurant and lobbyto have the chic and contemporary feel of New York City while maintaining thequiet seclusion of Basking Ridge.Dolce basking ridge is less than an hour west of Manhattan from Interstate 287, 78 and 80.Newark Liberty Airport is a 30-minute drive, while LaGuardia and JFK Airports are just an hour away.Shuttle Information: Dolce Basking Ridge offers complimentary shuttle service within a 6 mile radius which would include to Basking Ridge Train Station.Airport Information: Newark International Airport is 30 minutes away.ROOM RESERVATIONS:If you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s IIT conference by Wednesday, March 23, 2011.We encourage conference participants to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate.
  3. 3. Day One – Thursday, April 14th PRE-CONFERENCE WORKSHOP 8:00 Registration and Continental Breakfast For Workshop Participants 9:00 IIT 101: BUILDING A SUCCESSFUL INVESTIGATOR INITIATED TRIAL PROGRAM • Key points to consider when developing a compliant IIT program • Understanding the role of publications in a successful investigator initiated trial program: • Determining the cost of the investment, and developing time management skills – Brief overview of how we got where we are today • Learning how to find new investigators – Understanding of the current environment • Understanding the review process of an IIT and how to network review committees for IIT proposals – Transparency, disclosures, conflict of interest (COI), • Choosing the right investigator to research the right topic for maximum results authorship, author payments, acknowledgments, use of • Balancing your company’s role in and oversight of the research medical writers and “ghostwriting” • Issuing grants and proposals, and how to review the material before submission – Ways to ensure compliance: • Understanding a variety of steps to consider to help mitigate risk against violation of applicable laws: - Policies/guidelines – Establishing proper intent and foster compliance with - SOPs FDA regulations - Training – Ensuring that the investigator is in control of the study - Documentation of publication activities – Determining fair market value - Regular audits – Avoiding influence of sales force in the IIT process - GPP2 – Limiting involvement in IIT studies after approval - Certificate program- CMPP – Promoting transparency and disclosure – Understanding the difference between company-sponsored publications and investigator initiated publications Moderator: Speakers: Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, Marc Massanari, PharmD, Global Medical Affairs, ASTRAZENECA & Executive Director, IISRA Health Economics & Outcomes Research, NOVARTIS Deborah St. James, Scientific Communications and Publication Planning, TALECRIS BIOTHERAPEUTICS 10:30 Networking and Refreshment Break 12:00 Luncheon for Workshop Attendees 12:00 Registration for Main ConferenceMain Conference Begins1:00 CHAIRPERSON’S WELCOME & OPENING REMARKS 2:45 IIT REGULATORY ENVIRONMENT Alexander Kostek, Global Investigator Initiated Research Group Leader, Understanding the Varying Interpretations on the Rules and PFIZER Requirements Governing IITs and How to Effectively Achieve Compliance • Updates on the changing regulation of IITs and the different interpretations and techniques to 1:15 SELECTING AN IIT ensure overall compliance Establishing a Governance Model for the Review and Selection of an IIT • What resources are required to fulfill a corporate integrity agreement (CIA) and what are the and Communicating these Decisions to the Investigator consequences and impact of a non-compliant CIA? • Building a committee board to review and select investigators and proposed IITs • What preventive programs can companies put in place when they are not under CIAs? • Selecting board members, defining individual roles, and managing the boards time • Explanation of the types of agreements when working in IITs, including MTA, CTA, and PSA • Learning key criteria for evaluating investigators and proposed IITs to make the best selection Renata J. Matsson, PhD, JD, Director, Compliance R&D, EISAI • Establishing a scorecard for reviewing IIT proposals • Communicating the committee’s decision to the investigator and clarifying expectations Marianne Parnell, Manager, Medical Affairs, SIGMA-TAU PHARMACEUTICALS 3:30 Networking & Refreshment Break2:00 CONTRACT NEGOTIATIONS 4:00 CORPORATE INTEGRITY AGREEMENTS Identifying Key Elements within a Contract and Strategies for Developing a Corporate Integrity Agreement (CIA) As it Relates and Expediting Negotiations Impacts IITs • Developing the contracting process with an IIT and selecting key issues and topics to be • This discussion highlights key areas of IIT support that should be considered as potential included in an IIT contractual agreement risks or targets of a CIA • Defining responsibility between the sponsor and investigator in the following areas: • Learn best practices after submitting a CIA - Payment Structure - Patient Injury • Overcoming obstacles when complying with CIA compliance requirements - Intellectual Property - Confidentiality - Study Data - Publication Rights Caroline Flotron, Senior Attorney, PFIZER - Indemnification • Effectively negotiating contracts to ensure the overall success of an IIT • Establishing tips for accelerating the contract negotiations Carrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
  4. 4. 4:45 IISRA UPDATE ON FAIR MARKET VALUE 10:30 Networking & Refreshment Break Investigator Initiated Sponsored Research Association Update on Best Practices to Efficiently Determine FMV For Investigator’s Time and Services 11:00 IITs FOR NON-APPROVED PRODUCTS • Understanding why IISRA guidelines are useful when supporting an IIT and what makes these Understanding the Differences and Challenges in Supporting an IIT for a FMV guidelines valid Non-Approved Product and How this Can Increase Access for Treatment • Efficiently determining the fair market value for supporting investigators involved in IITs Use and Dose-Finding • Methods to establishing a standard value for equipment and medical resources • Understanding the benefits of undergoing an IIT for a non-approved product and the reasons Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, why companies are getting more involved in these studies & Executive Director, IISRA • Evaluating the results of IITs on non-approved products and how this affects the sponsoring company5:15 ROUNDTABLE DISCUSSIONS • Complying with SAE reporting from IITs for non-approved products Choose from one of the following tables and be part of an intimate Scott Kelley, MD, Vice President, Medical Affairs, COVIDIEN discussion on different IIT topics 1) How M&A Affects IITs: Successfully adopting new IITs after an M&A and 11:45 BENCHMARKING IITs determining which IITs can be let go Adding Value to IIT Programs Using Benchmarking Data to Effectively 2) IIT Timeline Management: Lessons learned on keeping timely IITs and how to Track Performance handle unforeseen delays • Incorporating benchmarking into IIT preparations and executions 3) Financial Support of IIT Publications: Learning if and when the sponsor • Deriving meaningful conclusions from benchmarking data provides funding for the creation of publications, presentation of publications, • The big picture- looking beyond benchmarking when justifying an IIT program’s ROI and knowing what your company limits are Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN 4) IISRA Breakout: Membership and organizational milestones of IISRA and its development for investigator initiated research standards and best practices 5) Aggregate Spend Requirements: Discussing best practices to ensuring effective 12:30 Luncheon and compliant IIT processes within your organization and an update on the Physician Sunshine Act and its affect on your relationship with the IIT 1:30 IIT INSPECTION AND AUDIT 6) Safety Reporting Requirements: Understanding what your reporting Protecting Yourself from an FDA IIT Audit and Seamlessly Overcoming obligations are and how these requirements will change with new and pending an Internal Investigator Inspection legislation • The challenges and process of preparing for an FDA inspection and audit • Benefits of using a consulting firm to become ready for GCP audits and knowing what 6:00 Day One Concludes information must be provided • Knowing what is needed when conducting an audit on the investigator and study siteDay Two – Friday, April 15th Scott Tsurutani, Senior Clinical Program Manager, ACTELION 2:15 THE ROLE OF THE MSL Utilizing the MSL in an IIT and How they Help Enhance Communication8:00 Continental Breakfast with Investigators • Understanding the role of MSLs and the size of their network8:50 CHAIRPERSON’S RECAP OF DAY ONE • How involved do MSLs get in IITs Alexander Kostek, Global Investigator Initiated Research Group Leader, • Learning new communication skills with MSLs to maintain open correspondence and learn PFIZER updates on the status of the IIT and investigator • Understanding the relationship between the investigator and MSL and justifying the value of an 9:00 INTERNATIONAL IITs MSL in furthering medical strategy Managing Compliance in Emerging Markets IITs to Optimize Research Quality, • Compliance considerations when MSLs work with IITs Patient Safety, and Inspection Readiness Lisa Misell, PhD, Senior Director, Medical Affairs and Clinical Operations, • Learning what rules and requirements are relevant when approving and managing an IIT in an SUNEVA MEDICAL emerging market • Establishing responsibilities for managing IIT compliance 3:00 PANEL DISCUSSION • Identifying compliance issues and successfully resolving them SELECTING A CRO TO MANAGE IITs AND DEFINING • Balancing compliance and efficiency when conducting an emerging markets IIT THEIR FUNCTION AS AN INTEGRAL PART OF THE IIT Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Building and Improving Partnerships and Alliances with CROs Manager, Emerging Markets, PFIZER • What are the criteria used to select a CRO and who is involved in the decision making? • Determining whether to use one or multiple CROs9:45 IIT TRACKING AND PAYMENT SYSTEMS • Managing outsourced relationships: the challenges, benefits, and risk Implementing Software for Tracking IIT Compliance, Obtaining Updated Data, • Creating and maintaining positive and productive relationships with CROs and Streamlining Proposals, and Payments • Determining who should be negotiating with sites, investigators and other third-party vendors • Adapting a software system to streamline proposals to help expedite the contracting process of Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & an IIT Executive Director, IISRA • Learning how to track IIT registration, request submission, and review current IIT data to Alexander Kostek, Global Investigator Initiated Research Group Leader, PFIZER maintain timelines and manage expectations Scott Tsurutani, Senior Clinical Program Manager, ACTELION • Successfully maintaining a budget and tracking payments made to investigators to ensure compliance with existing rules governing IITs 4:00 Conference Concludes To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
  5. 5. EARLY BIRD PRICING MEDIA PARTNERS Register by Friday, February 25, 2011 to Take Advantage of Early-Bird Pricing: Conference + Workshop $1995 Conference Only $1695 STANDARD PRICING Register After Friday,February 25, 2011: Conference + Workshop $2195 Conference Only $1895 ONSITE PRICING Conference + Workshop $2295 Conference Only $1995 PM 36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT Five Ways to Register Fax: 888-221-6750 Mail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018 Phone: 866-207-6528 Online: www.exlpharma.com Sponsorship and Exhibiting Email: register@exlpharma.com Opportunities Do you want to spread the word about your organization’s solutions and services to potential clients who will beGroup Discount Program: attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a networkingSave 25% Per Person when Registering Four event, or distribute promotional items to attendees. ExLFor every three simultaneous registrations from your company, you will Pharma will work closely with you to customize a packagereceive a fourth complimentary registration to the program that will suit all of your needs. To learn more about these (must register 4 at one time). This is a savings of 25% per person. opportunities, please contact:Save 15% per person when Registering Three Steve DeckerCan only send three? You can still save 15% off of every registration.To find out more on how you can take advantage of these group discounts, Business Development Managerplease call 866-207-6528. 212-400-6234, sdecker@exlpharma.comIMPORTANT! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write codeP1706 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full, two weeks prior tothe commencement of the conference.Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, info@exlpharma.com, prior to the event with the name and contact information of the replacement attendee. There will be an administrative charge of$300 to substitute, exchange, and/or replace attendance badge with a colleague occurring within five business days of the conference.Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.*ExL Pharma’s liability is limited to the conference registration fee in the event of a cancellationTo receive a refund or voucher, please fax your request to 888-221-6750.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
  6. 6. te11 InvesTIgATOR SELECTING AN IIT th Proudly to R Febr Reg ua ister by 13 ve o ry 25 th Presents: ecei CORPORATE ur D , 2 isc 01 oun 1 INTEGRITY PUBLICATION ted Rate AGREEMENT InITIATeD TRIAls ! INVESTIGATOR RIGHTS CONTRACT NEGOTIATIONS PAYMENT STRUCTURE April 29-30, 2010 PHYSICIAN INITIATED TRIALS SUNSHINE sheraton national Hotel ACT NON-APPROVED PRODUCT IIT Arlington, vA FAIR MARKET VALUE { 6 Annual MSL Best Practices Conference. thAtEdSELECTING toA CROBoth Events! Register Today and Gain Access Presentations from COMPLIANT AE REPORTING Fair Market Value Transparency Pharmaceutical, Medical Device, and Biotechnology INTELLECTUAL IRB Exemptions State Laws 312.2(b) PROPERTY STREAMLININGReporting Professionals Gaining a Robust Understanding for Risk/Benefit Profile PROPOSALS and MSL Regulatory PAYMENTS Metrics AND Budgets Managing and Implementing, Local and Global IITs Guidance Safety Reporting ROLE Benchmark Progress US vs EU Publications CBER Perspective INSPECTION AND AUDIT IITS IN April 14-15, 2011 BENCHMARKING Informed Consent Grant Systems IT Challenges EMERGING MARKETS Technology Platforms Dolce Basking Ridge | Basking Ridge | New Jersey IND or IDE? MSL Value Sponsors: { 8th Annual MSL Best Practices Conference, and Tri-Located with Medical Affairs Executive Forum ExL Pharma’s Register Today and Gain Access to Presentations from all Three Events! ://www.exlpharma.com/events/investigator-initiated-trials Registration Form: Method of Payment:  Check Credit Card ExL Events, Inc. Make checks payable to ExL Events, Inc. 866-207-6528 555 8th Avenue, Suite 310 Card Type: MasterCard  Visa  Discover Amex 888-221-6750 New York, NY 10018 registration@exlpharma.com Card Number: Exp. Date: www.exlpharma.com Name on Card:  Yes! Register me for the conference and workshop: Signature:  Yes! Register me for the conference only Please contact me: 555 8th Avenue, Suite 310  I’m interested in marketing opportunities at this event New York, NY 10018  I wish to receive email updates on ExL Pharma’s upcoming events PLEASE MENTION PRIORITY CODE: P1706 Name: Title: Company: Dept.: Address: City: State: Zip: Email: Telephone: Fax:

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