CBI’s Compliance Congress for Specialty Products kicks off next Thursday, September 13th in Boston, and Dan O’Connor, Senior Vice President for PharmaCertify, will be there to catch up with our clients and colleagues and hear industry leaders and government regulators share strategies for proactively addressing current risks for specialty pharmaceutical manufacturers.
We’ve reviewed the conference agenda and here are the sessions and presentations we are looking forward to in particular:
Day One, Thursday, September 13
Prosecutors’ Perspectives Panel
Following the opening keynote address, the conference begins with this prosecutor panel focused on biotech and specialty pharma companies. Charles Grabow, Assistant US Attorney from New Jersey, and Gregg Shapiro, Chief of the Affirmative Civil Enforcement Unit for the DOJ in Boston, will be joined by Jane Yoon from Paul Hastings, LLP, to discuss the high-risk areas for this unique industry group. Government panels typically offer some of the most compelling and important information during conferences and since this conference is focused on such a defined segment of the industry, the conversation should be revealing and educational.
Coping Strategies for the Lonely Compliance Officer
In addition to having the most creative name of any of the presentations, this session features three professionals facing the challenges that come with being a compliance professional for an emerging pharmaceutical company. We will be curious to hear how Heather Godling from Sobi, Francisco Ribeiro of Tesaro, and Sarah Whipple at Akebia Therapeutics, creatively utilize the limited personnel and resources available to them to build and maintain a strong culture of compliance.
Expert Panel: Evaluate the Risks Associated with Disease State Awareness and Other Pre-Launch Activities
The “Pre-Launch Activities” part of this title caught my eye. No matter their growth stage, all companies need to be aware of the compliance risks and concerns they face now and as they progress toward launch. That extends to compliance policies regarding interactions with healthcare practitioners. Ideally, compliance training for a new sales team should be built and planned before the product is commercialized.
Ensure Transparency in Contributions to Independent Patient Assistance Foundations
Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support
Patient support programs are an emerging enforcement trend in the pharmaceutical industry as more and more companies enter into settlements at least partly related to the programs (e.g., Aegerion, United Therapeutics, Jazz Pharmaceuticals). Add the high cost of specialty pharmaceutical products to the mix, and it’s no surprise that CBI has scheduled back-to-back sessions on this important topic.
Day Two, Friday, September 14
Daybreak Discussion: Specialty Café – Forecasting Priorities from Now to 2020
In a novel presentation structure spread across two consecutive time slots (8:15 – 8:40 and 8:45 – 9:10), attendees will have the opportunity to sit in small groups, share ideas and listen to their peers discuss three timely topics: Risk-based Approaches for Advanced Therapies; PBM Contracting Considerations; and Compliant Medical Affairs and Commercial Interactions. The format offers a welcome twist from the typical large group presentation and should lead to a compelling exchange of peer-to-peer ideas. It’s a great idea.
Explore the Trends in Drug Pricing Legislation and Other State Initiatives
John Oroho, from Porzio Life Sciences, LLC, is a respected and established thought leader in the life sciences compliance industry and his presentation is a can’t miss opportunity to hear the latest news and regulatory updates on these two ever-evolving topics.
Scale Up Your Compliance Program for Global Operations
Going global can be fraught with risk and compliance traps. In terms of anti-bribery alone, pharmaceutical companies need to now consider Loi Bertrand, the EFPIA Code, the Medicines Australia Code of Conduct, and a cadre of emerging codes and regulations around the world. These on-going changes in the global landscape make the presentation by Masha Chestukhin of Sanofi, and Darryl Williams of MediSpend, an important pre-lunch session.
GDPR is Here – Now What Do We Do?
Are you confused about the General Protection Privacy Regulation (aka, GDPR) and its impact on you as a pharmaceutical compliance professional? You’re not alone. The questions concerning details like data inventory and documentation abound, and what exactly does it mean when data subjects have the “right to be forgotten?” What about training? Who needs to be trained? How does it impact the field employees interacting with HCPs? We look forward to hearing answers, ideas and opinions from David Ryan, Vice President, Associate General Counsel, Chief Compliance Officer at Epizyme and Trish Shorey, Privacy Officer, Global Compliance and Risk Management at Shire.
If you’re attending the conference, we want to hear from you. Let us know what you think of the sessions and presenters, and conference content. And of course, if you see Dan, he’d be happy to share demos of our newest compliance training solutions and discuss how we help clients build a stronger culture of compliance and reduce risk.
Thanks for reading!