Agenda - Day One: Tuesday, September 24th | Compliance Congress for Specialty Products

7:45am - 8:30am

Registration and Networking Breakfast

8:30am - 8:45am

Chair's Opening Remarks: Compliance Congress for Specialty Products

Daryl Kreml - Chief Enterprise Risk and Compliance Officer, Sage Therapeutics

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Key Market Developments

8:45am - 9:45am

Top Enforcement Trends and Priorities for Small and Medium Size Companies in 2024

Examination of key focus areas and risks for small and medium size companies in specialty pharmaceutical companies from DOJ perspective
Lessons learned from recent DOJ investigations: key case analysis and impact on compliance programs

Emily Hodge - Partner, Choate, Hall & Stewart LLP
William Brady - Assistant U.S. Attorney, Health Care Fraud Unit, United States Attorney’s Office for the District of Massachusetts
Gabriel Scannapieco - Assistant Director, Consumer Protection Branch, United States Department of Justice
Kevin O'Keefe - Assistant Attorney General, Office of the Attorney General, District of Massachusetts

9:45am - 10:45am

Scaling Office of Inspector General (OIG) Guidance for Small and Medium Size Company Programs

Key areas of OIG guidance that provide best value, are easily implemented and are most scalable in specialty pharmaceutical small and medium size companies
Examining the November OIG guidance updates for small and medium size companies
Update on industry specific guidance

Rahul Khara - General Counsel, Disc Medicine
Shannon Moesaa - Former Vice President, Commercial and Healthcare Compliance Counsel, Karuna, a BMS Company
Brian Bohnenkamp - Partner, King & Spalding

10:45am - 11:15am

Networking Break

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Business Realities for Compliance

11:15am - 12:00pm

Emerging Business Models for Organizations Operating in Specialty Pharmaceuticals

New business reality: the need to do more with less, utilize new technologies and engage the marketplace differently
How are organizations positioning themselves differently? Examining evolving go-to-market strategies for small and medium size companies
Exploration of how the compliance function and risk management needs to evolve to face new business realities

Shoshanna Clark - Chief Compliance Officer, Cerevel
David Ryan - Vice President, Legal, and Chief Compliance Officer, Ardelyx, Inc
Darren Jones - Partner, Baker Tilly

12:00pm - 12:45pm

Elevating Compliance Officers: Strategies to Become High-Impact Business Partners

What is the actual role of the CCO in 2024 and beyond?
Utilizing compliance expertise to enhance decision-making and support business growth initiatives
How to structure the role differently and still operate with authority and independence
Innovative ways to impact and integrate yourself into the business: developing a proactive solutions orientated approach
Leveraging technology and automation to streamline compliance processes and increase efficiency

Stefanie Doebler - Partner, Covington and Burling LLP
Sara Blessing - Director, Legal & Compliance, Ionis
Eric Rogers - Vice President, Ethics & Compliance, Alexion
Daryl Kreml - Chief Enterprise Risk and Compliance Officer, Sage Therapeutics

12:45pm - 2:15pm

Networking Lunch

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Best Practice in Patient Centric Activities

2:15pm - 3:00pm

Patient Data Sharing and Privacy Requirements for Specialty Pharmaceuticals

Overview of key privacy regulations affecting the pharmaceutical industry, including GDPR, and CCPA
Challenges faced by pharmaceutical organizations in achieving compliance with varying regulatory requirements
Strategies for ensuring data protection and privacy across international borders

Andrea Kocharyan - Vice President, Legal Development & Compliance, Legal & Intellectual Property, uniQure
Alfred Brunetti - Principal, Life Sciences Regulatory and Compliance, Porzio, Bromberg & Newman
Jennifer Couture - General Counsel, OncoVerity, Inc.

3:00pm - 3:45pm

Key Risks and Best Practice to Manage Patient Support Hubs

Business considerations and best practice for patient support programs
Approaches and challenges: from in-house management to outsourced vendor management and employee considerations
The role of compliance in the implementation and monitoring/auditing of patient support programs

Joy Rota - Head, USBU Ethics & Compliance Advisory: Medical Affairs, Public Affairs, Patient and Market Access, Takeda Pharmaceuticals
Aaron Leskow - Manager, Healthcare Compliance, Immunocore
Anna Littman-Quinn - Senior Manager Forensic & Integrity Services, EY

3:45pm - 4:15pm

Networking Break

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Best Practice in Patient Centric Activities

4:15pm - 5:00pm

Approaches to Field Facing Patient Centric Activities and Emerging Models to Engage with Patients

Where are the risks for specialty pharmaceuticals? Dealing with smaller cohorts of HCPs, patient populations, patient advocacy organizations
Examining the tensions between patient centric activities, partnering with patients and compliance requirements in specialty pharma
Discuss the potential risk factors associated with patient relationships, such as patient compensation, interference with patient care, and guardrails that need to be implemented to avoid risk
What are the newer models of engagement and what are the extra layers of risks for specialty pharma firms: engaging with patient advocacy organizations, influencers and social media personalities
Tools and tips for developing robust compliance policies for emerging engagement models

Stefanie Doebler - Partner, Covington and Burling LLP
Rore Middleton - Vice President Compliance & Ethics, Blueprint Medicines
Lisa Shrayer - Head Therapeutics Counsel, North America, Vertex Pharmaceuticals

5:00pm - 6:00pm

Close of Day One Followed by Networking Drinks Reception

Day One: Tuesday, September 24thTuesday, 24 September 2024