keyboard_arrow_right
Search keyboard_arrow_right
keyboard_arrow_left Hide
Day One: Tuesday, September 24th - ET (Eastern Time, GMT-05:00)
search
Day One: Tuesday, September 24th - ET (Eastern Time, GMT-05:00)
search
8:45am - 9:00am
Chair's Opening Remarks
Showing 1 of 1 Streams
Key Market Developments
9:00am - 10:00am
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
- Toby Unger - Chief, Medicaid Fraud Control Unit, Office of the Attorney General, District of Massachusetts
10:00am - 11:00am
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 - Vice President, Commercial and Healthcare Compliance Counsel, Karuna Therapeutics
- Lisa Meletta - Vice President, Associate General Counsel & Chief Compliance Officer, Geron
11:00am - 11:30am
Networking Break
Showing 1 of 1 Streams
Business Realities for Compliance
11:30am - 12:15pm
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
- Scott Applebaum - Chief Legal Officer, Corporate Secretary, VectivBio
- Shoshanna Clark - Chief Compliance Officer, Cerevel
12:15pm - 1:00pm
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
- Tim Moore - Vice President, Head of Commercial Legal & Compliance, Corium
1:00pm - 2:30pm
Networking Lunch
Showing 1 of 1 Streams
Best Practice in Patient Centric Activities
2:30pm - 3:15pm
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
- Sandy Estremera-Zink - Executive Director, Head of Compliance and Privacy, Abeona Therapeutics
3:15pm - 4:00pm
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
4:00pm - 4:30pm
Networking Break
Showing 1 of 1 Streams
Best Practice in Patient Centric Activities
4:30pm - 5:15pm
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
- Rore Middleton - Vice President Compliance & Ethics, Blueprint Medicines
- Lisa Shrayer - Head Therapeutics Counsel, North America, Vertex Pharmaceuticals
- Kelley Medeiros - Compliance Officer, Global & US Oncology, EMD Serono
5:15pm - 5:20pm
Close of Day One Followed by Networking Drinks Reception