Monday, November 14, 2011
11:30 Registration
12:30 Co-Chairs’ Opening Remarks
Neil Hazaray
Attorney, Bio-Medicines Therapeutic Area
Eli Lilly and Company
Diane Tolzman
Executive Director
Sales, Marketing and Global Compliance
Astellas US LLC
12:45 Constructing A Compliance Infrastructure for Life Sciences Companies: Best Practices for Using Objective Criteria to Evaluate Subjective Needs
Diane Tolzman
Executive Director
Sales, Marketing and Global ComplianceAstellas US LLC
- Comprehending the link between product commercialization and compliance and how this dictates compliance needs
- Knowing how key commercialization considerations dictate compliance needs
- Assessing key compliance risk areas based on:
- product portfolio
- sales model
- payor mix
- co-promotion activity
- distribution model
- other considerations
- will we conduct this or will we outsource it?
- Identifying the seven key elements of a compliance program under the Federal Sentencing Guidelines
- using the elements to design a flexible and global program that can adapt to corporate growth
- Formulating a compliance program work plan which fits corporate needs and satisfies these elements
- understanding key considerations for:
- selecting a chief compliance officer
- creating a compliance committee
- establishing a reporting structure
- defining the responsibilities of the Board of Directors
- allocating resources
- developing training programs
- implementing an auditing and monitoring program
- designing an investigative protocol and corrective action plan
- Collaborating with existing departments and corporate functions to establish a compliance structure and get the necessary “buy-in”
- Determining whether compliance objectives can be shared among various departments
- implementing safeguards
- compliance liaisons
1:30 Big Brother is Watching: Adopting New Practices to Comply with Sunshine Act Requirements and the Bad Ad Program
Maureen Harms
Assistant General Counsel
3M Healthcare
Neil Hazaray
Attorney, Bio-Medicines Therapeutic Area
Eli Lilly and Company
Aggregate Spend
- Shifting compliance priorities to meet the standards required in new Federal Sunshine Act legislation
- Requiring companies to disclose the value, nature and purpose of gifts, fees, payments and subsidies valued at more than a specified dollar amount
- Creating a mechanism to track, manage and report all spending expenses from reps, senior executives, medical meetings, clinical trials, grants, and speaking fees
- Designing a contract that clearly delineates a physician’s role when acting as an agent of the life science company versus a physician’s time spent in their own private practice
- Identifying required disclosures under state laws
- Ensuring internal systems are ready for Sunshine Act requirements
- Placing an emphasis on training the sales force and the physicians acting as an agent of your company
Bad Ad Program
- Deputizing physicians to report any kind of malfeasance in sales pitches and marketing efforts
- Mitigating the risks associated with physician-sales rep interaction
- Developing alternative ways to provide information on its drugs to doctors, including through dedicated hotlines and online technology
- Educating doctors and medical professionals on how to recognize a misleading ad
- Identifying legitimate versus frivolous reports
- Safeguarding company practices from increasing violations and reports of bad advertising
- Being proactively involved in FDA’s web-based continuing-education program
2:45 Afternoon Refreshment Break
3:00 Mitigating the harm of Losing Personal health Data: Marketing Your Pharmaceutical or Medical Device Without Violating Privacy Laws
Erik Hennings
Compliance Counsel, Privacy Officer, Legal Affairs
Prometheus Laboratories Inc
Ellen Janos
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
- Using collected information to best promote your life sciences company without violating email opt-out rules
- opt-out requirements and methods
- triggers for opt-out
- notice and disclosure requirements
- building in new customer notification procedures for shared information
- Reconciling the conflicts that arise among state and federal regulations regarding telemarketing
- Minimizing potential privacy violations when engaging in behavioral and social marketing
- engaging your consumers without jeopardizing their privacy
- protecting private health information in a social online setting
- Making sure that mobile marketing and text messaging do not violate patient privacy
- Notifying affected individuals when a data breach occurs
- Benchmarking your company’s processes and systems against companies that have already implemented data breach protocols
- Applying HIPAA protocols to pharmaceutical, biotechnology and device companies
- Reviewing the provisions of the HITECH Act that directly impact life sciences companies
3:45 Practical Manifestations of Risk: Using Your Corporate Integrity Agreement to Revamp Your Compliance Program and Mitigate Liability
Richard Eschle
Ethics & Compliance
Director, Regulatory Compliance
Novartis Pharmaceuticals Corporation
Fabiana Lacerca-Allen
SVP & Chief Compliance Officer
Elan Pharmaceuticals
Katherine Lauer
Partner and Global Co-chair Health Care and Life Sciences Practice Group
Latham & Watkins LLP
Scope and Trends
- Reviewing the Federal False Claims Act, State Anti-Kickback laws, and the applicability to life sciences companies
- Utilizing CIAs as a way of understanding what OIG is really telling the industry
- Analyzing the increased scope and trends emerging from these documents
- Redefining the roles of the compliance and in-house legal departments
- creating a symbiotic relationship
- Exploring the evolution of enforcement actions from sales and marketing violations through medical affairs deviations
- Reviewing circumstances in which corporate executives and employees have been indicted in addition to the company
Event Oversight
- Understanding why certain events and speaker programs have gotten companies into trouble
- Analyzing state law issues that arise from these programs
- Implementing best practices through compliance protocols to avoid situations giving rise to violation
- Looking at how CIAs define an intangible work product
- Laying out a sound strategy for utilizing advisory boards and speaker programs that will collaborate the needs of all departments involved
- Exploring the benefits and risks of using MSLs in advisory boards
5:00 Conference Adjourns to Day 2
Day 2 - Tuesday, November 15, 2011
8:00 Registration and Continental Breakfast
8:30 Co-Chairs’ Opening Remarks
8:45 Integrating Your Medical Affairs Department into the Compliance Team to Maximize Effective Compliance Functions
Virginia MacSuibhne
Director
Ethics and Compliance
Roche Molecular Diagnostics
Matt Werner
Director
Senior Compliance Counsel
Ventana Medical Systems, Inc.
a member of the Roche group
- Defining medical affairs within the purview of the Codes and Guidance
- Understanding the importance of medical affairs compliance to your overall global compliance program
- Reviewing critical changes in the PhRMA Code relative to medical affairs compliance
- Clarifying the range of permissible field-based dissemination of information by MSLs
- How pharmacovigilance and adverse events reporting under FDAAA should be factored into your compliance program
- How medical affairs has become a hot bed of compliance enforcement actions
- Exploring the proper relationship between sales and marketing and medical affairs
- Developing guidelines for post-marketing studies
- Examining off-label use concernso guidelines for off-label communicationso role of MSLs in these communications
- Advisory board protocols
9:30 Minimizing Compliance Risks Associated with Research and Development and high-Risk Clinical Trials
Francisco T. Rivas, J.D., LLM
Vice President & Chief Compliance Officer
Spectranetics Corporation
Susan E. Burnett
Partner
Bowman and Brooke LLP
Kristian Werling
Partner
McGuireWoods LLP
- Conducting a clinical research compliance assessment
- Developing policies and procedures that address sponsorship or funding of research activities
- trials
- market research
- articles
- Disclosing sponsorship of independent clinical trial studies
- Outlining best practices for executing investigator-initiated trials
- Assisting with the internal approval process for investigators who propose study ideas
- Fostering a relationship between the investigator and the sponsoring company
- Training programs for employees to explain proper method of conducting research in accordance with FDA requirements
- Abiding by PhRMA Principles for Conduct of Clinical Trials
- interactions with health professionals
- clinical trial registries
- summaries of all clinical-trial results
- ghostwriting prohibitions
- disclosure of financial conflicts of interest
- Determining what areas to review in a risk assessment
- assessing against objective standards
- Shifting compliance focus to activities such as patient recruitment, site selection, managing CROs, case report form processing and serious adverse event reporting
- Taking responsibility for outsourcingo defining internal controls
10:30 Morning Coffee Break
10:45 Implementing a Comprehensive Training and Monitoring System to Minimize the Risks of Sending Your Sales Team Into the Field
Dolores Nelson, JD
Senior Director of Compliance and Risk Management
Amylin Pharmaceuticals, Inc.
Kristin Rand, JD, MA, CHC, CCMEP
Compliance Director Policy, Ethics, Training & Communication
Genentech, Inc.
Monitoring
- Outlining best practices in how to monitor appropriate sales and marketing conduct
- Identifying risks in the field
- documentation, tools
- pitfalls of iPads and other electronic devices
- How are companies using compliance committees to monitor?
- Defining acceptable sales force activity
- setting defined spending amounts
- tracking money flow
- Utilizing the sales force to monitor and report adverse events
- Monitoring field-based personnel to ensure that the company is not in engaging in off-label promotion
- Conducting frequent ride-alongs with the sales reps
- best practices for monitoring in lieu of ride-alongs
Training
- Making compliance training an integral part of every job and function
- Updating training videos to ensure message is effective and current
- Getting “buy-in” and employee interest after the latest enforcement activity or news story dies down
- Educating the sales force adequately on the compliance risks of the drugs they are promoting
- Teaching the sales force how to best interact with a physician who uses a drug for both an on and off-label purpose
- Identifying acceptable sales force activity when new information becomes available
- Establishing sanctions and disciplinary actions for non-compliance
- Appointing regional field attorneys to be responsible for overseeing sales rep activities
11:45 Utilizing Audits and Risk Evaluation to Assess and Enhance the State of Your Compliance Program
Cindy Rheinhardt, CPA
Vice President Global Internal and Compliance Audit
Zimmer Holdings, Inc.
Howard A. Simon
Senior Vice President Human Resources and Corporate Services
Chief Compliance Officer and Associate General Counsel
InterMune, Inc.
Michelle Axelrod
Principal
Porzio, Bromberg & Newman P.C.
(former Assistant General Counsel at Sepracor, Inc)
- Using risk management principles to develop a meaningful and effective compliance audit program
- Improving existing audit program through the incorporation of innovative risk management techniques
- Assessing the proper roles of inside and outside auditors
- Analyzing audit results: how to develop strategies for managing and minimizing identified risks
- Safeguarding against unforeseen, undefined risks
- Determining the proper metrics for performing an audit
- Who conducts the internal audit?
- audit team
- independent auditor
- Setting up procedures that allow you to find noncompliance
- performing your due diligence
1:00 Main Conference Concludes Lunch for Post-Conference Workshop Attendees
Conference Details