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Day One, Tuesday, April 16th - ET (Eastern Time, GMT-05:00)
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Day One, Tuesday, April 16th - ET (Eastern Time, GMT-05:00)
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7:30am - 8:25am
Conference Registration and Continental Breakfast
8:25am - 8:35amLIVE STREAM
Informa Connect Welcome and Chairperson's Opening Remarks
- John Oroho - President and General Manager, RLDatix Life Sciences
8:35am - 8:45amLIVE STREAM
2023 Year in Review Video Reveal Presented by Potomac
8:45am - 9:15amLIVE STREAM
Top Areas of Concern for the Compliance Professional
- Keren Bisnauth, JD - Associate Vice President of Legal & Regulatory, RLDatix Life Sciences
- Audrey DeGuarde - Vice President of Customer Success and Compliance Operations, RLDatix Life Sciences
- Masha Goodman-Khan - Senior Director of Compliance & Legal Operations, Vericel Corporation
- Elizabeth Weiss - Head of Compliance, Americas & EMEA, Lupin Inc.
- Daryl Kreml - Senior Vice President, Chief Enterprise Risk and Compliance Officer, Sage Therapeutics
9:15am - 10:00am
2024 Presidential Election Insights—A Look at Potential Impacts on the Life Sciences Industry
- Seth Lundy - Partner, King & Spaulding
- Rod Rosenstein - Partner, King & Spalding LLP
- Kendrick Meek - Senior Advisor, King & Spalding LLP
- Ander Crenshaw - Crenshaw, King & Spalding LLP
10:00am - 10:30am
Networking and Refreshment Break
10:30am - 11:00amLIVE STREAM
PhRMA Address – Legislative and Pipeline Report for 2024
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
11:00am - 12:00pmLIVE STREAM
Enforcement Panel – Critical, Industry-Specific Updates from the Most Active Office’s for the Bio/Pharma and MedTech Industry
- Craig Bleifer - Partner, Akin Gump Strauss Hauer & Feld LLP
- Jacqueline Romero - United States Attorney, United States Attorney’s Office for the Eastern District of Pennsylvania
- Jason Gould - Chief, Health Care Fraud Unit, United States Attorney's Office, District of New Jersey
- Kelly Lawrence - Chief of Health Care Fraud Unit, United States Attorney’s Office, District of Massachusetts
12:00pm - 1:30pm
Networking Luncheon and CCOE Luncheon
Select One of Three Courses Based on Experience Level . This tailored programming is designed to accommodate you and where you are on your compliance and legal journey.
Showing 3 of 3 Streams
Beginner
Intermediate
Advanced Session for Senior Leadership
1:30pm - 2:45pm
Beginner
- Bio/Pharma Compliance Basics and Frameworks
- Key Learnings from Industry’s Most Recent CIAs and Enforcement Activity
*Participants in this session will be partnered with a senior leader post event as part of Informa Connect’s Compliance and Legal Mentorship Program.
- Scott Liebman - Partner and Chair, FDA Regulatory & Compliance; Co-Chair, Life Sciences, Sheppard Mullin Richter & Hampton LLP
- Dominick DiSabatino - Partner, Sheppard Mullin Richter & Hampton LLP
1:30pm - 2:45pm
Intermediate
- Enhancing Compliance Programs Based on 2023 OIG and DOJ Guidance
- New and Emerging Risk Areas for 2024 and Beyond
- Natasha Trifun - Executive Director, Head of Compliance, R&D, Global Medical, External Funding & Global Functions, Alexion, AstraZeneca Rare Disease
- Robert Melillo - Managing Director, G&M Health, LLC
- Rore Middleton - Vice President, Compliance & Ethics, Blueprint Medicines
- Stefanie Doebler - Partner, Covington and Burling LLP
1:30pm - 2:45pm
Advanced Session for Senior Leadership
- Collaborating with the Board to Advance the Needs of the Compliance Teams
- Staffing, Resource Planning, Career Progression
* Informa Connect reserves the right to qualify participants for this Summit. Attendees must be a CCO, VP or GC, or Senior Director and currently employed by a life sciences manufacturer.
- Ann Beasley - Senior Vice President and Chief Compliance Officer, Zai Lab
- Melissa Lozner - Senior Vice President, Chief Compliance Officer, Regeneron
- David Berger - Senior Managing Director, Ankura
2:45pm - 3:15pm
Networking and Refreshment Break
PCC Power Hour - Curated content delivered in case study format then expanded upon through interactive audience engagement for optimal learning and actionable takeaways.
Showing 4 of 4 Streams
Compliance Blueprint for Product Launch Success
PSPs and PAPs– A Look at the Evolution, Risks and Enforcement Activity
Transform your Audit Program and Planning with Advanced Analytics
Compliance Training in the Digital Frontier
3:15pm - 4:15pm
Compliance Blueprint for Product Launch Success
- Samantha Sutherland - Director, Baker Tilly
- Casey Armstrong - Experienced Manager, Baker Tilly
- Jennifer Sanfilippo - General Counsel and Chief Compliance Officer, Melinta Therapeutics
- Genevieve Spires - Deputy General Counsel, Melinta Therapeutics
3:15pm - 4:15pm
PSPs and PAPs– A Look at the Evolution, Risks and Enforcement Activity
- Donna White - Head of Compliance, North America, Chiesi USA Inc.
- Michael Hercz - Senior Vice President & General Counsel, Sentynl Therapeutics Inc.
- Samantha Barrett Badlam - Partner, Ropes & Gray LLP
3:15pm - 4:15pm
Transform your Audit Program and Planning with Advanced Analytics
- Fabien Saint-Gerard - Vice President, Head Internal Audit R&D and Strategy & Growth, Novartis
- Michael Shaw - Principal, Global Head of Risk & Compliance, ZS Associates
3:15pm - 4:15pm
Compliance Training on the Digital Frontier
- Daniel O’Connor - Senior Vice President, NXLevel Compliance
- Daryl Kreml - Senior Vice President, Chief Enterprise Risk and Compliance Officer, Sage Therapeutics
- Tracey Cunningham - Director, Compliance, Regeneron Pharmaceuticals, Inc.
PCC Power Hour - Curated content delivered in case study format then expanded upon through interactive audience engagement for optimal learning and actionable takeaways.
Showing 4 of 4 Streams
How to Perform a Transparency Audit and Assessment
Clinical and R&D Compliance –Emerging Trends and New Risk Areas
Mapping out an ESG Roadmap
Exploring the Impact of the Evolving US Privacy Landscape
4:15pm - 5:15pm
Performing a Transparency Audit and Gap Assessment to Establish an Effective Program
- Cristina List - Director, Compliance Advisory Services, MedPro Systems
- Makaylah Johnson - Manager, Compliance Advisory Services, MedPro Systems
- Tracy Palmer Berns - SVP, Chief Compliance & Quality Assurance Officer, Ionis Pharmaceuticals
4:15pm - 5:15pm
Clinical and R&D Compliance –Emerging Trends and New Risk Areas
- Noah Goldstein - Counsel, Life Sciences Regulatory and Compliance, Porzio Bromberg & Newman, P.C.
- Michelle Axelrod - Principal, Life Sciences Regulatory and Compliance, Porzio, Bromberg & Newman, P.C.
4:15pm - 5:15pm
Mapping out an ESG Roadmap
- Kari Loeser - Vice President & Chief Compliance Officer, Cytokinetics
4:15pm - 5:15pm
Exploring the Impact of the Evolving US Privacy Landscape
- Kris Hall, JD, CIPP/CIPM - Managing Director, Dovetail Consulting Group
5:15pm - 6:15pm
Networking Reception