November 13-14, 2007 Park Hyatt Bellevue Philadelphia, PA. Vivek Kadambi, Director, Drug Safety Evaluation, Millennium

Transcription

1 Preliminary Agenda REGISTER BY AUGUST 17 TH AND SAVE UP TO $400 November 13-14, 2007 Park Hyatt Bellevue Philadelphia, PA DISTINGUISHED PRESENTERSAND PANELISTS: Carmen Castaneda, M.D., Senior Medical Reviewer, Worldwide Drug Safety, Celgene Corporation Patrick M. Caubel, M.D., MBA, AVP, Head Pharmacovigilance North America, sanofi-pasteur Donald B. Chalfin, M.D., Associate Professor Epidemiology, Albert Einstein College of Medicine and CSO, Analytica International Vikram Dev, M.D., Head of Drug Safety, AstraZeneca Gerald Faich, M.D., MPH, FISPE, Senior Vice President, Epidemiology and Risk Management, United BioSource Corporation John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval, Covance, Inc. J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy, Purdue Pharma L.P. William L. Holden, M.D., Vice President, Pharmacovigilance & Global Head, Pharmacoepidemiology, sanofi-pasteur Nilima Justice, M.D., Senior Director, Product Safety Surveillance, Novo Nordisk, Inc. Vivek Kadambi, Director, Drug Safety Evaluation, Millennium Pharmaceuticals, Inc. Uwe Maennl, Vice President and Global Head of Pharmacovigilance, PAREXEL Joanna L. C. May, Business Alliance Consultant, Global Product Safety, Eli Lilly and Company John Parkinson, Ph.D., Head of General Practice Research Database (GPRD), MHRA Jill E. Robinson, Vice President, Global Safety Surveillance & Epidemiology, Wyeth Research Peggy Schrammel, Executive Director, Late Phase Development, PharmaNet Judith M. Sills, PharmD, Vice President and Head, Medical Safety Operations, Integrated Medical Safety, Novartis Pharmaceuticals Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management, United BioSource Corporation Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet Sean Zhao, M.D., Ph.D., Executive Director, Global Safety, Amgen Inc. PRESENTATIONS, IN-DEPTH CASE STUDIES, AND INTERACTIVE PANELS Integrating drug safety knowledge across a compound s life cycle Structured benefit-risk balance: Update on industry initiatives Risk management in early development: The pre-clinical/clinical safety feedback loop Decreasing liability and improving brand by employing a proactive communication and risk management strategy The other side of the benefit-risk ratio: Outcomes research as a means of demonstrating product benefit Leveraging drug registry tools to assess safety and performance Embracing the shifting paradigm from post- to pre-approval safety INCLUSIVE PRE-CONFERENCE CASE STUDY-BASED WORKSHOP: Identifying and Managing Pharmacovigilance Risk with a Business Partner Cambridge Healthtech Institute 250 First Avenue, Suite 300, Needham, MA Phone: Fax: chi@healthtech.com Corporate Sponsors:

2 Day One Tuesday, November 13, :30 am Conference Registration and Morning Coffee 8:30 Opening Workshop and Discussion Case Study-Based Workshop: Identifying and Managing Pharmacovigilance Risk with a Business Partner Facilitated by: Joanna L. C. May, Business Alliance Consultant, Global Product Safety, Eli Lilly and Company Objectives: Provide participants with framework, knowledge and skills to proactively assess and manage safety with a business partner Facilitate knowledge sharing, exchange of ideas and approaches to issues resolution with a business partner Outline: 1. Introduction o Why companies partner o What are the expectations of your company when collaborating on a product? (Regulators, shareholders, patients, etc.) o Review of regulations relating to licensing arrangements 2. Case Study o Introduce mock partnership to be discussed and evaluated throughout workshop 3. Risk Evaluation & Due Diligence o Additional pharmacovigilance risks are associated with partnering o Due diligence - Identification/validation of these potential risks o Due diligence themes o Due diligence report assessment 4. Case Study o Mock due diligence o Select appropriate due diligence themes o Develop mini-report 5. Implementation o Action plan for implementation o Capitalize on opportunities/partner strengths o Mitigate risks o Implementation Tools: License Agreement Safety or Regulatory Agreement Medical or Safety Committees Operational Committees Organized Project Teams for Special Needs Joint SOPs Alliance Metrics Periodic Assessments/Audits 6. Case Study o Identify needs of mock alliance o Propose appropriate tools for management 7. Ongoing Risk Management o Operational metrics o Informal, periodic assessment of processes and infrastructure, both joint and internal o Periodic assessments and audits, both joint and internal o Corrective action plans that address specific and systemic mitigation 8. Questions and Problem Solving o Participants ask questions of presenter(s) and each other o Current, specific scenarios may be raised by participants for group problem solving 10:45 Close of Workshop and Morning Coffee Break 2

3 KEYNOTES 11:30 Structured Benefit-Risk Balance: Update on Industry Initiatives John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. 12:15 pm Integrating Drug Safety Knowledge Longitudinally Across a Compound s Lifecycle as well as Across the Organization s Entire Product Portfolio Judith M. Sills, PharmD, Vice President, Medical Safety Operations, Integrated Medical Safety, Novartis Pharmaceuticals Corporation The evolving safety landscape, prompted by product withdrawals, negative perception of the pharmaceutical industry, and increased regulatory requirements for risk management drives a need to be more proactive in the management of drug safety. Consequently, companies need to develop an integrated risk management approach from preclinical development through post-approval to enable identification, assessment, management, and communication of safety risks and optimization of benefits to patients. Developing an internal process and infrastructure to support benefit-risk assessment and global risk management planning Alignment of global pharmacovigilance SOPs Defining roles and responsibilities for benefit-risk assessment and risk management Improving business process in benefit-risk management Transitioning from clinical trial risk management to peri- and post-approval risk management 1:00 Hosted Luncheon and Strategic Solutions Presentations (Sponsorship Available) 2:15 Best Practice in Developing a Drug Safety Surveillance Program to Minimize Risk Strategic alignment of drug safety services to meet pharmaceutical/biotech outsourcing needs Identifying the most efficient and cost-effective options available Experience as CRO in providing adverse event data capture, tracking, review, processing to provide on-time regulatory submission reporting Meeting client needs consistently to develop continued working relationships CASE STUDY Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval, Covance, Inc. In today's environment of heightened awareness to drug risks, it is no longer an option for drug development companies to take a "wait and see" approach to drug safety. This presentation will focus on implementing best practice considerations in developing a drug safety surveillance program to minimize risks. 2:45 Risk Management in Early Development: The Pre-Clinical/Clinical Safety Feedback Loop Vivek Kadambi, Director, Drug Safety Evaluation, Millennium Pharmaceuticals, Inc. John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. Optimizing the allocation of an organization s scarce and increasingly costly drug safety assessment resources Aligning resources early to design and execute a proactive risk management plan 3:15 Refreshment Break 3:45 Understanding Regulatory Authorities Evolving Drug Safety Risk Management Expectations and How They Should Be Applied in Practice Aligning risk management plans with an evolving regulatory environment Clarify the effect of the FDA risk management guidances and the European Clinical Trial Directive Understand multinational risk management approaches and initiatives from FDA, EMEA, MHLW and ICH Review practical approaches and new thinking from CIOMS VI and VII projects on clinical trial safety management 4:15 Implementing Pharmacovigilance Programs that Yield the Greatest Possible ROI in Terms of Both Increasing the Probability of Timely Approval and Mitigating Known and Unknown Safety Risks Costs and opportunities of Phase IV risk management programs Identifying how your risk management plans can be utilized as a new promotion tool How marketing can make best use of post-approval study findings 3

4 Meeting marketing objectives through effective dissemination of trial data Examining successful implementations of effective drug safety initiatives INTERACTIVE PANEL 4:45pm Costs and Opportunities of Phase IV Risk Management Programs Jill E. Robinson, Vice President, Global Safety Surveillance & Epidemiology, Wyeth Research Patrick M. Caubel, M.D., MBA, AVP, Head, Pharmacovigilance North America, sanofi-pasteur Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet Gerald Faich, M.D., MPH, FISPE, Senior Vice President, Epidemiology and Risk Management, United BioSource Corporation 5:30 Networking Reception (Sponsorship Available) 6:30 Close of Day One Day Two Wednesday, November 14, :30 am Breakfast Workshop or Morning Coffee (Sponsorship Available. Contact Arnold Wolfson at ) 8:30 Chairperson s Opening Remarks KEYNOTES 8:45 Proactive Risk Management Philosophy, Strategy & Tactics J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy, Purdue Pharma L.P. Proactive Risk Management requires regular assessment and minimization of risks associated with the products that comprise their portfolio. The long-term view of risk requires these be done throughout a product s life-cycle and, in the case of drug products that are subject to volitional misuse, an approach that goes beyond passive surveillance and seeks information on populations that were never intended to have the product. An integrated approach within the company is key, requiring coordination from manufacturing, through the supply chain, to the patient. 9:30 Decreasing Liability and Improving Brand by Employing a Proactive Communication and Risk-Management Strategy Vikram Dev, M.D., Head, Drug Safety, AstraZeneca Meeting patients demands for complete openness of drug safety information Educating an engaged patient and provider community on products benefits and risks Strategies to decrease liability, improve brand and better serve patients Approaches for communicating risk information to patients and providers Employing a broad risk communication campaign using multiple media, registries, patient advocacy groups, and online, twoway communication with patients and providers Supporting enrollment, education, reporting, and effective outcome measurement through online registries 10:00 New Approaches in Risk Communication, Labeling and Packaging to Optimize Medical Product Benefit while Minimizing Preventable Harm Devising and proposing Risk Management Plans (RiskMAPs) as a condition of product approval Best-practice guidelines for implementing risk management plans that guarantee efficient safety standards Understanding strategic, legal and regulatory aspects of safety within a drug s overall profile Approaches for communicating risk information to patients and providers Taking a proactive and preventative approach to damage control 10:30 Networking Coffee Break 4

5 11:00 am The Other Side of the Benefit-Risk Ratio: Outcomes Research as a Means of Demonstrating Product Benefit Peggy Schrammel, Executive Director, Late Phase Development, PharmaNet Donald B. Chalfin, M.D., MS, FCCP, FCCM, Associate Professor, Epidemiology and Population Medicine, Albert Einstein College of Medicine and CSO, Analytica International Much discussion has centered on quantifying and conveying to patients the risks associated with the use of new therapies. Single measures of risk are difficult to develop and their meaning can remain ambiguous to patients. The field of outcomes research has refined a number of methods for quantifying and conveying product benefits to patients, providers and payers. This session will provide an overview of some of these methodologies and illustrate how using these measures of product benefit can assist both health care practitioners and patients alike in making better treatment choices. At the conclusion of this session, attendees will be able to: Understand the difficulties of conveying product risk in a meaningful way to patients Identify measures of product benefit that have been refined by the outcomes research community Learn, through case studies, how a wider recognition of these methodologies could assist in clinical decision making 11:30 Practical Thinking Process in Selecting Safety Studies to Support Post-Marketing Safety Surveillance and Risk Assessment: Balance Feasibility, Cost, and Scientific Rigor Sean Zhao, M.D., Ph.D., Executive Director, Global Safety, Amgen Inc. Fulfilling post-approval safety commitments (PASC) and supporting risk management plans Confirming identified safety signals Determining public health impact of safety issues Studying pattern of utilization and determining background rate of safety observations Describing natural history of disease after a new product is introduced into the market Major considerations of selecting safety studies and advantages and disadvantages of commonly used study methodologies, including: Open label extensions Post-clinical trial follow-up Safety clinical trials Large simple safety studies Observational studies Registries Prospective/retrospective database analysis INTERACTIVE PANEL 12:00 Embracing the Shifting Paradigm from Post- to Pre-Approval Safety John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy, Purdue Pharma L.P. Judith M. Sills, PharmD, Vice President, Medical Safety Operations, Integrated Medical Safety, Novartis Pharmaceuticals Corporation Sean Zhao, M.D., Ph.D., Executive Director, Global Safety, Amgen Inc. Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval, Covance, Inc. Uwe Maennl, Vice President and Global Head of Pharmacovigilance, PAREXEL 12:30 Luncheon and Strategic Solutions Presentations (Sponsorships available) 5

6 1:45 pm Cutting-Edge Techniques for Risk Assessment: Analyzing and Reporting Data William L. Holden, M.D., Vice President, Pharmacovigilance & Global Head, Pharmacoepidemiology, sanofi pasteur Utilizing legacy data to enable better decision making Maximizing the effectiveness of signaling programs MedDRA and its application to data mining/risk-benefit analysis Data mining techniques for analyzing and classifying signals Applications, limitations, and analysis of safety databases and mining 2:15 A Globally Usable Risk/Benefit Management Tool John Parkinson, Ph.D., Head, General Practice Research Database (GPRD), MHRA Risk Management Plans are now required by a number of regulatory authorities and a natural desire by the industry is that one plan, perhaps with some minor modification, will suffice. A data analysis hypothesis strengthening methodology has been developed that can take streams of electronic health data, exposure and events, from one or a number of countries and provide absolute, risk and benefit outputs, stratified as required. This tool and topic are timely and important because: The risk management tool box has until now almost been empty The pharma industry have stated they want a global approach The pharma industry want to deal with risk and benefit as a whole 2:45 Networking Coffee Break 3:15 Leveraging Drug Registry Tools to Assess Safety and Performance Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management, United BioSource Corporation Designing and utilizing registries to maximize their potential as a risk management tool Utilizing registry initiatives to track ROI and continuing improvements Ensuring the use of best practices in adverse drug reaction (ADR) reporting Supporting enrollment, education, reporting, and effective outcome measurement through online registries CASE STUDY 3:45 Drug Safety in Biologicals Nilima Justice, M.D., Sr. Director, Product Safety Surveillance, Novo Nordisk, Inc. The agency is trying to expand systems to detect safety issues for blood, vaccines, and biotech therapies. This presentation will discuss this while looking at new approaches to drug safety and risk mitigation in biologics. How do biological products (biologics) differ from conventional drugs Events commonly seen with these products Safety monitoring for biologics and risk management plans CASE STUDY 4:15 Risk Management Approaches: RevAssist and S.T.E.P.S. Carmen Castaneda, M.D., Senior Medical Reviewer, Worldwide Drug Safety, Celgene Corporation The safety of drugs and risks associated with drug use is of public health concern. This presentation will provide an overview of Celgene s risk management programs. It will describe the pros and cons of such risk management programs. Learn the components of RevAssist and S.T.E.P.S. programs Gain insight on the upsides and downsides of RevAssist and S.T.E.P.S. Learn measures of effectiveness of RevAssist and S.T.E.P.S. programs 4:45 Chairperson s Closing Remarks 5:00 Executive Forum Closes 6

7 Hotel Information Park Hyatt Philadelphia at the Bellevue Broad and Walnut Streets Philadelphia, Pennsylvania, 19102, USA Tel: Fax: Travel Information Flight Discounts: Discounted fares are available on United, United Express, United code share flights (UA*) operated by US Airways, and US Airways Express. You can receive up to a 15% discount if you or your travel agent calls United's toll-free number , reference the Meeting ID Number 579YS. For reservations via phone, please call the hotel directly to make your arrangements. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early. Car Rental Information Special discount rentals have been established with AVIS for this conference. You can call AVIS directly at You must reference your Avis Worldwide Discount (AWD) Number J SPONSOR AND EXHIBIT INFORMATION Your company has a unique opportunity to influence a major gathering of life science executives, primarily from large pharma, who will come together at Post-Approval Drug Safety Strategies, produced as part of CHI s Pharmaceutical Strategy Series. Brand your company as a thought leader by participating as an active Sponsor. Presenting your solutions or services directly to our top-tier delegates can significantly impact their buying decisions and help you achieve your sales and business development objectives. Presentation opportunities include Embedded Agenda Presentations, Breakfast and Luncheon Workshops or, you may pre-select and gain access to your highest level prospects through an Invitation-only VIP Dinner or function (limited availability). CHI will support your Sponsorship and brand your company with strong marketing programs before, during and after the event. The earlier you secure your Sponsorship, the more opportunity for exposure. To explore ways for your company to participate, please contact: Arnie Wolfson, Manager of Business Development, Pharmaceutical Strategy Series Tel: ; awolfson@healthtech.com SPONSOR BIOS United BioSource Corporation delivers evidence-based solutions to enhance the medical and commercial potential of pharmaceuticals and biotechnology. Our capabilities include design and implementation of clinical trials and registries; epidemiology and risk management; outcomes research and health economics; electronic data capture; interactive voice response and web systems for clinical trials; reimbursement strategy; and investigator education and training. The PharmaNet Phase IV Development Group comprises dedicated professionals committed to adding commercial value to a product throughout its life cycle. With extensive product development experience in Phase IIIb-IV trials, expanded access programs, and registries, these professionals are experts at handling the complexities of late phase studies. We design and execute programs that meet the highest standards of scientific integrity and regulatory compliance while meeting commercial objectives. Since 1980, Covance Periapproval Services has focused exclusively on handling large-scale, actual use programs for products just prior to, during, or after approval. We are the only contract research organization (CRO) that has continuously focused on trials that occur during this phase of drug development. We can provide you the insight and expertise you need to fulfill regulatory commitments, expand the safety profile of your product and deliver information to support marketing claims. PAREXEL International is a leading global bio/pharmaceutical services organization offering significant expertise from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. This expertise is enhanced by advanced technology solutions from its Perceptive Informatics division through medical imaging, CTMS, IVRS/IWRS and integration services. Lead Sponsoring Publication: Web Partners: 7

8 TO REGISTER: Web: Phone: or toll-free in the U.S Fax: Mail: 250 First Avenue, Suite 300, Needham, MA YES! Register me for POST APPROVAL DRUG SAFETY 7040 P REGISTRATION INFORMATION Mr. Ms. Mrs. Dr. Prof. Name Job Title Company Address REGISTER 3 4th IS FREE Individuals must register for the same conference or conference combination and submit completed registration forms together for discount to apply. Please reproduce this registration form as needed. Div./Dept. Please send information about related CHI conferences and reports: Drug Development in China (PCC) Drug Development in India (PCI) Strategic Resource Management (SRA) Portfolio Management (PFO) City/State/Postal Code Country Telephone Would you like to receive event updates via fax? Yes No Fax * * is not a mandatory field. However, by excluding your you will not receive notification about online access to pre-conference presenter materials, coference updates and networking opportunities. PRICING INFORMATION Commercial Academic, Government, Hospital-Affiliated Two-Day Conference (Includes Morning Workshop) Early Registration until August 17, 2007 $1,895 $995 Advanced Registration Discount until October 5, 2007 $2,095 $1,095 Registration after October 5, 2007 or On-Site $2,295 $1,195 INSIGHT PHARMA REPORTS A series of reports that evaluate the salient trends in pharmaceutical technology, business, and therapy markets. Keep abreast of the latest advances in pharmaceutical R&D, their potential applications and business impacts, and their current and future position in the marketplace. For a list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia, rlaraia@healthtech.com, ADDITIONAL REGISTRATION DETAILS Each registration includes all conference sessions, posters and exhibits, food functions, and a copy of the conference CD. GROUP DISCOUNTS Special rates are available for multiple attendees from the same organization. Contact David Cunningham at to discuss your options and take advantage of the savings. I cannot attend but would like to purchase the conference CD for $500 (plus shipping). Massachusetts delivery will include 5% sales tax. Please send information on exhibiting and opportunities to present workshops. PAYMENT INFORMATION Enclosed is a check or money order payable to Cambridge Healthtech Institute, drawn on a U.S. bank, in U.S. currency. Invoice me, but reserve my space with credit card information listed below. Invoices unpaid two weeks prior to conference will be billed to credit card at full registration rate. Invoices must be paid in full and checks received by the deadline date to retain registration discount. If you plan to register on site, please check with CHI beforehand for space availability. Please charge: AMEX (15 digits) Visa (13-16 digits) MasterCard (16 digits) Diners Club (14 digits) Card # Exp. Date Cardholder Signature Cardholder s Address (if different from above) City/State/Postal Code Country HANDICAPPED EQUAL ACCESS In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting. SUBSTITUTION/CANCELLATION POLICY If you need to cancel a registration, you may: Transfer your registration to a colleague within your organization Credit your registration to another Cambridge Healthtech Institute program Request a refund minus a $100 processing fee per conference Request a refund minus the cost ($500) of ordering a copy of the CD NOTE: Cancellations will only be accepted up to two weeks prior to the conference. Program and speakers are subject to change. Video and/or audio recording of any kind is prohibited onsite at all CHI events. FAX or MAIL your registration to: Cambridge Healthtech Institute 250 First Avenue, Suite 300 Needham, Massachusetts T: or toll-free in the U.S F: