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Day Two: Wednesday, 25 June 2024 - ET (Eastern Time, GMT-05:00)
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Day Two: Wednesday, 25 June 2024 - ET (Eastern Time, GMT-05:00)
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8:30am - 8:45am
Chairs Opening Remarks
Showing 1 of 1 Streams
Managing Risk for Commercial Activities
8:45am - 9:45am
Pre-Launch Compliance Considerations for Specialty Pharmaceuticals
- Advice from those who have already successfully launched: 3 key things I wish I had known
- Nuances and readiness do’s and don’ts for launching a new product and/or launching a new indication for an approved product
- Timelines, best practice and approach: from training employees and preparation for PDUFA date to pre-approval for payer communication
- Updates on preapproval payer formulary interactions
- Dealing with competitors: what are your competitors saying? How do you train your salespeople to respond when they hear incorrect information about your product?
- Best practice for medical and promotional information review: comparative claims and competition
- How to evolve your policy library so it gives the right direction before and after launch
- Status on off label communication: nuances for communications for unapproved use of approved product
- Update on the Pre-approval Information Exchange (PIE) Act, passed by Congress on December 23, 2022, and signed as part of the Consolidated Appropriations Act, 2023
- Dominick DiSabatino - Partner, Sheppard Mullin
- Peter Lee - Vice President, Chief Compliance Officer, Mirati
- Erica Powers - Head of US Commercial Compliance and Compliance Operations, Sage Therapeutics
- Elizabeth Daniels - Acting Deputy GC/Chief Compliance Officer, Pharvaris
9:45am - 10:30am
Approaches to Disease State Education
- What are the factors that help determine if and how disease state education is permissible?
- How do you handle the evolving disease state campaign before, during and after launch?
- How do you handle disease state education when you have a novel mechanism of action?
- Sherri Borgal - Associate Director, Ethics & Compliance, Alnylam
- John Knighton - General Counsel, Chief Compliance Officer, BioTissue
- Christian Dingler - Senior Director Risk Management, Global Compliance, Insmed
10:30am - 11:00am
Networking Break
Showing 1 of 1 Streams
Managing Risk for Commercial Activities
11:00am - 11:45am
Compliance Considerations and Future Status of Free Genetic Testing Programs
- Elizabeth Jobes - Global Chief Compliance Officer, Immunocore
- Laura Gamel - Senior Director, Ethics and Compliance, Lantheus
11:45am - 12:45pm
PRACTICAL SENARIOS and LIVE BENCHMARKING Evolving Roles for Medical Affairs
- How are commercial and medical relationships in speciality pharmaceutical firms developing? Examining guardrails and blurring boundaries between medical education and sales/promotion
- Creation of new roles: who is out in field interacting?
- Scenarios on how to manage risk and structure the team when talking to HPCs
- Approaches to monitor and audit trends to tackle medical and commercial interactions
- Live benchmarking with the audience on the relationship between medical and commercial
- Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics
- Eric Teasdale - Senior Director, US Business Ethics & Compliance, Ipsen
- Chad Morin - Senior Vice President, Chief Compliance Officer, Kiniksa Pharmaceuticals
12:45pm - 2:15pm
Networking Lunch
Showing 1 of 1 Streams
Managing Risk for Commercial Activities
2:15pm - 3:00pm
Managing Partnerships with Independent and Specialty Pharmacies in Specialty Pharmaceuticals
- What are the typical types of relationships between the specialty pharmaceutical firms and specialty pharmacies?
- What is typically acceptable from a kickback perspective in terms on contracts and services?
- How do you guard against potential kickbacks e.g., establish business need, FMV, proof of performance
- Should or how should compliance monitor these relationships?
- Hypothetical case studies using audience participation to identify key decisions points and indicators of risk and solutions
- Alexis Shaw - Executive Director, Compliance, Paratek Pharmaceuticals
- Sandeep Sharma - Deputy Chief Compliance Officer, Paratek Pharmaceuticals
Showing 1 of 1 Streams
Training and Monitoring Risks
3:00pm - 3:30pm
Compliance Considerations for Health Equity Initiatives
- Sarah Schendel - Compliance & Training Specialist, Wave Life Sciences
3:30pm - 4:00pm
Networking Break
Showing 1 of 1 Streams
Training and Monitoring Risks
4:00pm - 4:45pm
Developing High Impact Training Programs as Culture and Working Practices Evolve in Specialty Pharmaceutical Firms
- Different approaches on how to be more engaging with training in small and medium size companies
- Matching different styles of training to the culture of the organisation
- Strategies to promote and support ongoing education of the evolving legal and regulatory landscape to the organization
- Positioning compliance training as a tool to enable productivity and empower actions
- Delivering a robust training program: tracking your training initiatives to prove it has happened and strategies to hold people to account to ensure the training is meaningful
- Yvonne Clark - Vice President, Head of Corporate Compliance, Spark Therapeutics, Inc
- Sherri Borgal - Associate Director, Ethics & Compliance, Alnylam
- Bill Hrubes - Senior Compliance Manager, PharmaEssentia
4:45pm - 4:50pm
Networking Coffee Followed by Close of Conference