Agenda - Day Two: Wednesday, 25 June 2024 | Compliance Congress for Specialty Products

8:00am - 8:30am

Registration and Networking Breakfast

8:30am - 8:45am

Chairs Opening Remarks: Compliance Congress for Specialty Products

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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
Preapproval payer and formulary interactions best practices
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

Dominick DiSabatino - Partner, Sheppard Mullin
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
Christian Dingler - Senior Director Risk Management, Global Compliance, Insmed
Shoshanna Clark - Chief Compliance Officer, Cerevel

10:30am - 11:00am

Networking Break

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Managing Risk for Commercial Activities

11:00am - 11:45am

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?

Sandeep Sharma - Assistant General Counsel, Calliditas Therapeutics
Judy Losey - Senior Counsel, Commercial, Sobi Inc
Maria Ostrovsky - VP, Chief Compliance Officer, Associate General Counsel, Deciphera Pharmaceuticals
Heather Golding - Principal and Former General Counsel and Chief Ethics & Compliance Officer, Sobi North America, HGC LLC

11:45am - 12:45pm

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

Casey Horton - Managing Director, Epsilon Life Sciences
Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics
Eric Teasdale - Senior Director, US Business Ethics & Compliance, Ipsen
Natasha Trifun - Executive Director, Head of Compliance, R&D, Global Medical, External Funding & Global Functions, Alexion, AstraZeneca Rare Disease

12:45pm - 2:15pm

Networking Lunch

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Managing Risk for Commercial Activities

2:15pm - 3:00pm

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
Meenakshi Datta - Partner, Sidley Austin LLP

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Training and Monitoring Risks

3:00pm - 3:30pm

Compliance Considerations for Health Equity Initiatives

Sarah Schendel - Compliance & Training Specialist, Wave Life Sciences
Jim Flaherty - Senior Vice President & General Counsel, Rhythm Pharmaceuticals
Danielle Pelot - Partner, Choate, Hall & Stewart LLP

3:30pm - 4:00pm

Networking Break

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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 organization
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
Sara Frank - Principal, Choate, Hall & Stewart LLP

4:45pm - 4:50pm

Networking Coffee Followed by Close of Conference

Day Two: Wednesday, 25 June 2024Wednesday, 25 September 2024