Day Two - EST (Eastern Standard Time, GMT-5)
Day Two - EST (Eastern Standard Time, GMT-5)
Hear directly from top compliance officers across the specialty pharmaceutical industry to gain insight on their hottest challenges and greatest triumphs. Discuss what is on their radar and why it should also be on yours.
- Stefanie Doebler - Partner, Covington and Burling LLP
- David Ryan - Vice President, Legal, and Chief Compliance Officer, Ardelyx, Inc
- Tracy Palmer Berns - SVP, Chief Compliance & Quality Assurance Officer, Ionis Pharmaceuticals
- Brian Barry - Vice President, Deputy Chief Compliance Officer, Vertex Pharmaceuticals
- Francisco Ribiero - Vice President, Chief Compliance Officer, Immunogen
Settlements and investigations involving specialty pharmaceutical companies continue to dominate the headlines in 2023. Explore recent settlements and hear from government regulators and outside counsel who are spearheading the charge against healthcare fraud and discuss the key issues impacting the industry.
- Emily Hodge - Partner, Choate, Hall & Stewart LLP
- Kelly Lawrence - Chief, Health Care Fraud, United States Attorney’s Office, District of Massachusetts
- Abraham George - Chief, Affirmative Civil Enforcement, US Attorneys Office, District of Massachusetts
- Explore different state level transparency and reporting laws
- Understand the establishment of drug Affordability Boards
- What is the practical impact on pricing decisions and where might this all be headed?
- Katherine Chaurette - Senior Vice President, Healthcare Law and Compliance, Blueprint Medicines
- David Savidge - Director of Accounts, G&M Health LCC
- Olivia Krezeminski - Associate Director of Compliance, G&M Health, LLC
When building your stature as a compliance leader, it takes a mix of both technical and soft skills. Dive deep into the nitty gritty of what it means to be a compliance officer and how you can evolve to build not only a compliance program, but a compliance culture that truly engages your business.
- Learn about the specific soft skills that you can hone to influence your organization without authority
- Engage in discussion on leadership, negotiation, and confidence to help you better navigate tough conversations with colleagues and with leadership
- Discover new strategies on how to use your judgement to tackle unfamiliar challenges, effectively manage your time and improve preexisting processes
- Andrea Kocharyan - Vice President, Senior Counsel, Flagship Pioneering
- Sarah Whipple - Global Chief Compliance Officer, Apellis Pharmaceuticals
- Averi Price - VP, Chief Compliance and Legal Officer, Syndax Pharmaceuticals, Inc.
- Scott Applebaum - Chief Legal Officer, Corporate Secretary, VectivBio
The transformative potential of cell and gene therapy is undeniable, however as the science behind it continues to develop, so do the unique regulatory challenges. Take a closer look into the emerging trends, challenges and requirements associated with this new era of cell and gene therapy and in turn the compliance and legal risks that may surface.
The relationship between a manufacturer and their pharmacies can often double as a partnership, as both parties are integral to one another. However, what does it mean for compliance when a pharmacy oversteps certain boundaries? Discover how compliance can appropriately engage with pharmacies in the marketplace in order to avoid issues such as co-promotion, and as a result, fraud, abuse or kickback.
- Dominick DiSabatino - Partner, Sheppard Mullin
This Summit is designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing heads of compliance across the life sciences industry. The host facilitates discussions surrounding key questions, challenges and issues. Participants benefit from exclusive networking with peers, sharing concerns and acquiring additional best practices for enriching their compliance programs.
** Participants must hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the conference).
Invitations will be sent by the conference producer three weeks prior to the meeting. Final eligibility approval is at the discretion of Informa Connect. Contact Callie Mertel at firstname.lastname@example.org for additional details
Ensuring a smooth, productive and constructive coordination between a company’s legal and compliance teams is one essential aspect to an effective compliance program. Benchmark with colleagues on best practices in how each of the departments and their functions can be clearly defined, to create a relationship that is both collaborative and independent. Alternatively, benchmark on how to balance legal and compliance as a dual function. Discuss how effective coordination enables the company to better support their clients.
- Alicia Whittlesey - Vice President, Compliance & Regulatory Services, Porzio Life Sciences, LLC
- Kelly Pitt - Vice President, U.S. General Counsel and U.S. Head of Compliance, MorphoSys US Inc.
- Meghan Naas - Senior Director, Global Operations and US Compliance Officer, Zai Lab
The medical and commercial teams are functions that have been traditionally separated, the evolving marketplace complexities are forcing companies to reassess the relationship
- As medical teams strive to be more innovative, how can they do so without appearing commercial?
- With the potential of blurred lines, how can separation be maintained whilst also having an appropriate level of collaboration?
- What are appropriate ways to measure the success of a Medical Affairs organization?
- Meenakshi Datta - Partner, Sidley Austin LLP
- Maria Ostrovsky - VP, Chief Compliance Officer, Associate General Counsel, Deciphera Pharmaceuticals
- Angela Duger - Associate Director, US Compliance, Servier Pharmaceuticals, LLC
- Patricia Cone - Director, Ethics and Compliance, Boehringer Ingelheim USA Corporation