Monday, April 19, 2010
7:00 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks
Victor F C Raczkowski, MD, MS
Senior Vice President Head of US Regulatory Affairs & GRA Liaison Intelligence
SOLVAY PHARMACEUTICALS, INC (Marietta, GA)
Josephine M. Torrente
Director
HYMAN, PHELPS & MCNAMARA, P.C. (Washington, DC)
8:15 Analyzing Post-Marketing Drug Safety Regulations and Manufacturers’ Obligations under FDAAA
Naghmana Bajwa, MD
Head Global Drug Safety & Pharmacovigilance
AMAG PHARMACEUTICALS (Lexington, MA)
Josephine M. Torrente
Director
HYMAN, PHELPS & MCNAMARA, P.C. (Washington, DC)
- Examining Title IX of the FDA Amendments Act of 2007
- when can the FDA require a REMS?
- REMS for products no longer on the market
- what types of obligations can the FDA impose on manufacturers?
- Defining Post-Marketing Requirement (PMR) and Post-Market Commitment (PMC) and making the distinction between the two
- understanding the purpose of a PMR and when the FDA can require one
- recognizing the manufacturer’s obligations under a PMR and a PMC
- Assessing the role of RiskMAPS under the new REMS regime
- what is the precedential value of RiskMAPS if any?
- Identifying the different types of REMS and the elements/components of each
- timelines for assessing effectiveness
- communications to patients and physicians
- restrictions on distribution
9:15 Developing a REMS Strategy and Successfully Negotiating with the FDA
Tim Cunniff, PharmD
Vice President of Global Regulatory Affairs, Pharmacovigilance and Clinical Quality Assurance
LUNDBECK, INC. (Deerfield, IL)
Seth Mailhot
Counsel
NIXON PEABODY LLP (Washington, DC)
Scott Cunningham
Partner
COVINGTON & BURLING LLP (Washington, DC)
- Preparing for a REMS or PMR at any stage in a product’s life cycle
- Determining when to bring safety/risk information to the attention of the FDA
- weighing the pros and cons of early discussions of potential safety issues
- Initiating REMS conversations with the FDA and taking a proactive role in guiding the negotiation process
- Framing the issues so the company can provide the best risk minimization information and plan for a REMS assessment
- Drafting the language of a REMS and medication guides
10:30 Morning Coffee Break
10:45 Exploring the FDA’s Guidance on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
Robin Geller, Ph.D.
Director of Risk Management and Safety Writing
Global Pharmacovigilance
BAXTER HEALTHCARE CORPORATION (Deerfield, IL)
Victor F C Raczkowski, MD, MS
Senior Vice President
Head of US Regulatory Affairs & GRA Liaison Intelligence
SOLVAY PHARMACEUTICALS, INC (Marietta, GA)
- Understanding the provisions of FDA’s REMS guidance
- Modifying current company practices
- Weighing the pros and cons of the REMS provisions
- Seeking guidance for issues not addressed
11:45 Networking Luncheon
1:00 Assessing and Managing Product Risks in the New REMS Regulatory Environment
James Nickas, PharmD
Head Regional Center Americas
Drug Safety Operations
GENENTECH, INC. (South San Francisco, CA)
Ajay Singh, MD
Assistant Vice President
PFIZER (Collegeville, PA)
- Developing an organizational structure that will support an effective risk management program
- what departments should be involved in risk management and product safety issues?
- getting departments that typically work separately to work together
- Surveying recent REMS decisions to create a checklist of factors that may signal that FDA involvement is likely
- Putting procedures in place to standardize the risk management process
- How are companies adjusting existing risk management policies and procedures to account for the new REMS regulations?
- Quantitative and qualitative methods for formally assessing benefit/risk
- creating standardized methods for capturing potential and identified risks
- various approaches to analyze safety data
- interpreting adverse event data with regard to potential risks
2:30 Afternoon Coffee Break
2:45 Measuring the Success of a REMS in the Absence of Clear Guidance from the FDA
Marcie Bough
Director, Federal Regulatory Affairs
AMERICAN PHARMACISTS ASSOCIATION (Washington, DC)
Christina M. Markus
Partner
KING & SPALDING (Washington, DC)
- Considering future reporting requirements when negotiating a REMS
- Identifying what should be measured in preparation for FDA reviews
- focusing on processes versus focusing on outcomes
- ensuring that what is measured is directly related to the success of the REMS
- Conducting patient, physician and safety communications assessments
- How are manufacturers preparing for the first round of 18 month reviews?
3:30 Complying with an FDA-Approved REMS
Fabio Lievano, MD
Senior Director Clinical Risk Management
MERCK & CO., INC. (Whitehouse, NJ)
Kathleen M. Sanzo
Partner
MORGAN, LEWIS & BOCKIUS LLP (Washington, DC)
- Recognizing the FDA’s enforcement authority for violations of REMS provisions
- how does FDA plan to wield its enforcement authority?
- Monitoring third-parties’ compliance with REMS commitments
- Creating inspection/audit procedures to ensure that REMS commitments are carried out
- Dealing with a finding that there has been less than 100% compliance
- How will enforcers such as the OIG, state AGs and the DOJ look at and think about REMS and PMRs?
- Lessons to be learned from RiskMAPS compliance
4:15 Training the Sales Force and Other Departments
Kenneth R. Palmer
Director, Commercial Regulatory Affairs
DAIICHI SANKYO, INC. (Parsippany, NJ)
- Determining who will convey REMS related safety information
- defining the roles of sales representatives and Medical Science Liaisons
- Tailoring policies and procedures for sales personnel and translating legal concepts into practical guidelines
- Preparing sales reps to respond to prescribers questions or concerns related to REMS
5:15 Conference Adjourns to Day 2
Tuesday, April 20, 2010
8:00 Continental Breakfast
8:30 Co-Chairs’ Remarks
8:45 FDA Roundtable – Agency Insights Into Developing, Implementing and Complying with REMS
Carla Cartwright
Associate Chief Counsel
FDA OFFICE OF THE CHIEF COUNSEL (Washington, DC)
9:45 Morning Coffee Break
10:00 REMS as a Tool for Profitability – Using REMS to Bring Specialty Drugs to Market and Maximize Profit
James N. Czaban
Partner and Chairman, FDA Practice Group
WILEY REIN LLP (Washington, DC)
The burden of REMS can be a blessing in disguise for manufacturers of products that raise challenging safety issues. This panel will discuss strategies for taking advantage of opportunities under the REMS system, focusing on the specialist market from the outset, and constructing regulatory and commercial infrastructures accordingly. Points of discussion will include:
- Bringing to market important specialty products with challenging safety profiles
- focusing on the specialist market from the outset and constructing regulatory and commercial infrastructures accordingly
- Using REMS when bringing orphan drugs to market
- REMS as a basis to facilitate and legitimize stronger communications with patients and prescribers
- Recognizing the role of REMS in obtaining financing and/or venture capital investments
- Maximizing pricing advantages
- Understanding lifecycle management issues and strategies
11:00 Risk Management Tools and Processes That Can Provide a Competitive Advantage in Drug Development and Commercialization
Gary Bloomgren, MD MBA
Executive Director, Global Safety
AMYLIN PHARMACEUTICALS (San Diego, CA)
Rachel Sobel, DrPh
Senior Director, Epidemiology - Specialty Care BU Group Head
PFIZER INC (New York, NY)
- Up-stream opportunities to better characterize product risk issues early in drug development
- Simple tools and processes that better position risk management planning and discussions with regulators prior to and during NDA submission
- Key success factors to monitor
- REMS learnings to date and an integrated model for proactive product risk management
12:15 Networking Luncheon
1:30 Case Study of the Botox REMS and Off-Label Issues Arising From REMS Obligations
Richard A. Bornstein
Associate General Counsel
OSI PHARMACEUTICALS, INC. (Melville, NY)
Scott M. Lassman
Partner
KLEINFELD, KAPLAN AND BECKER, LLP (Washington, DC)
Mark C. Levy
Partner
SAUL EWING LLP (Philadelphia, PA)
The July 2009 approved REMS for Botox which required the company to distribute communications related to off-label uses of the product raises several questions as to what information a company can provide about a product that is subject to a REMS. While the REMS requires the company to distribute off-label information, the company is prohibited from providing physicians with enough specific and detailed information such as dosages, proper injection technique and patient selection for the off-label uses. The company has since filed a lawsuit seeking the right to dispense additional safety information that would otherwise not be permitted under off-label regulations. This session will examine the Botox case and how REMS impacts off-label communications.
2:45 Afternoon Coffee Break
3:00 The Impact of Risk Management on Pharmaceutical Product Liability: Using REMS to Bolster a Preemption Defense
Howard L. Dorfman
Counsel
ROPES & GRAY LLP (New York, NY)
The Supreme Court decision in Wyeth v. Levine appeared to negatively impact the ability of drug manufacturers to successfully assert preemption as a defense in failure-to-warn pharmaceutical product liability claims. While a careful analysis of the decision suggests that the Levine case did not completely invalidate the preemption defense, it can be inferred that in order to successfully assert preemption, a drug manufacturer needs to show significant involvement and active deliberation on the part of the FDA in evaluating the product, its benefits and risks, and the actions taken by the pharmaceutical company in communicating and mitigating those risks. This session will examine the REMS process and how manufacturers can use the provisions relating to risk management to illustrate the increased level of FDA involvement necessary for successfully asserting a preemption defense as well as establishing a pro-active approach to minimizing product liability exposure from development through approval and commercialization.
3:45 Harmonizing U.S. and Non-U.S. Regulatory Obligations - Developing a Comprehensive Risk Management Program That Can Satisfy Multiple and Varied Regulatory Obligations
Nayan Acharya
Senior Director, Office of Risk Management & Pharmacoepidemiology
ELI LILLY & CO. (Indianapolis, IN)
Judith M. Sills
Global Head, Medical Safety Operations
Drug Safety & Epidemiology
NOVARTIS PHARMACEUTICALS (East Hanover, NJ)
- Understanding the key differences between pharmacovigilance expectations between the US and Europe
- What does a harmonized drug safety plan look like?
- Anticipating global regulatory developments
4:45 Conference Concludes
Conference Details
