The Sharing Alliance is delighted that expert speaker and PDMA authority, Alan Minsk, will be joining us again to lead the PDMA discussion. Alan is Sharing Alliance Legal Counsel and also partner at Arnall Golden Gregory LLP, the leader of their Food & Drug practice team, and co-chair of their Life Sciences industry team.

In his lively workshop presentation that is considerably more than a 101, Alan will offer a realistic look at the PDMA today. Conversation will include interesting issues that arise when applying the law and maximizing compliance.

This is a don’t miss learning session, even if you think you’re already living everything PDMA!

Drug sampling is the first step in medication adherence for many patients. The interpersonal dynamics and information exchange around drug sampling provides great benefits to patients, prescribers, and pharma. Yet, prescriber access to drug samples in Health Systems has eroded in large part because Health System leadership has enterprise compliance and operational needs that are unmet.

Hal Walsh, SymmetryRx and Angela Dyer, HCA Healthcare will discuss supply chain gaps contributing to prescriber loss of access to drug samples for their patients. In addition, these industry experts will look at data illustrating the gaps in sample effectiveness insights that may be contributing to the under and over-allocation of samples. They will also discuss emerging technology to assure the availability of drug samples to patients of prescribers who use them in their practice of medicine.

“This Is the World Now. Logged On, Plugged In, All the Time.”
— John Connor

Are artificial intelligence applications like ChatGPT and OpenAI beneficial tools that will improve our home and business lives – or have the machines of Skynet begun their assault on humankind?

Fiction is rapidly becoming fact as the rapid introduction of AI presents significant opportunities while also raising valid questions and concerns. In this session we will explore all the hype around ChatGPT. This timely workshop brings together two industry leads Debbie Tay, Ferring Pharmaceuticals and Mark Jara, RxS to provide a glimpse into the future.

• What Is ChatGPT and OpenAI?
• Why should you care?
• Examples of ChatGPT questions and responses
• ChatGPT current use cases
• How ChatGPT is paving the way into Pharma
• Apocalyptic concerns? Are they real?
• What’s next for ChatGPT?

Plan ahead and avoid time travel to join Debbie and Mark as they explore the exciting potential of this cutting-edge technology.

Regulatory authorities expect an effective corporate compliance program to bemuch more than a company’s policies, procedures, and internal controls. Creating aculture that promotes ethical values, conducting impactful risk analysis andanticipating and identifying potential violations of Corporate Policies andProcedures are some of the core responsibilities of any Corporate ComplianceProgram (CCP).

This workshop, presented by industry experts and Sharing Alliance board members Teresa Farmer and Mark Adams, will outline various U.S. regulatory expectations ofa corporate compliance program and discuss how compliance professionals canfulfill those expectations.

Regulatory authorities will look at the following components to determine if youhave built an effective compliance program:
1) It must be well-designed;
2) Adequately resourced and empowered to function effectively and;
3) Work in practice

Not a day goes by when threat actors aren’t attempting to infiltrate pharmaceutical companies with nefarious intentions. This timely workshop brings industry leaders Marc Lavin, Pfizer, and Rajeev Nair, Knipper Health, together to deliver an insightful workshop designed to inform and educate on the following topics:

• The latest trends in IT and Data attempted breaches.
• Why do perpetrators target pharma?
• What’s their purpose or intent?
• Why would my sampling operations or data be a target?
• Why should I be concerned about my vendors’ cyber security capabilities?
• How do I know my vendor/partners are well positioned to defend from such intrusions, and entry to my systems and data?
• And, a few general tips for staying safe in this crazy, scary world!

Make sure to join them and your other compliance colleagues at this thought-provoking learning session. Bring your questions since there will be time for Q&A!

Have you tried to interpret all the changes to the new regulations in Oregon and what we are required to do to stay compliant? It’s a lot to say the least.

Steve Burdon, AVP, Global Sales Enablement and Strategy at Lilly USA and Brian Van Hoy, G&M Health, will be leading the lively conversation as we go over the current requirements and talk about how to be confident that we are keeping our organizations’ sales professionals compliant. Attend this timely session to learn more about these Oregon regulations, and then join in the open discussion on best practices.

Join Lisa Butler, Sharing Alliance President and Director DEA/PDMA Compliance at Novartis Pharmaceuticals Corporation when she presents this in depth workshop on DEA Controlled Substance Compliance.

The mission of the US Drug Enforcement Administration (DEA) is to prevent, detect and investigate the diversion of pharmaceutical controlled substances from legitimate channels of distribution. To do so, the DEA regulates persons, companies, and other entities that manufacture, distribute, and dispense controlled substances. Attendees of this workshop will get an overview of the Controlled Substance Act, the DEA Regulations, and an understanding of what to do when the DEA shows up at their door. Also discussed will be the proposed modifications to suspicious order monitoring and any recent updates and/or changes to the DEA regulations.

During this interactive learning session attendees will have the opportunity to discuss their challenges and learn how other companies manage the expectations of the DEA. So come learn with your industry peers in a collaborative workshop that will surely be as engaging as it will be educational.

Transitioning from a sales representative hand-carry, or hybrid program, to a DTP (Direct to Practitioner) program may address some concerns but still carries risk. This educational workshop, presented by experts-in-the-know Judy Fox, QPharma, and Monique Thomas, Supernus Pharmaceuticals, will aid attendees in identifying the benefits and options of DTP programs; provide solutions for recognizing and managing risks; and, offer a methodology for establishing an appropriate SLT rationale for a DTP program.

Workshop presenters will also facilitate an interactive discussion on business and compliance concerns and the benefits and solutions offered through DTP programs. Time will be allotted for Q&A so bring your questions and be ready for lively conversation!

Surely it comes as no surprise to those of us in the industry that drug samples constitute one of the most expensive resources we have!

Julio Lorenzo, Novartis Pharmaceuticals and Jim Stepkoski, Howell Marketing Services, are experts in the samples arena and eager to share their knowledge and opinions on this workshop topic.

Discussion will be focused on why we allocate samples and how it’s done.

Is there a new strategy, technology or regulation that is impacting or influencing your allocation process? Come to this workshop with your questions and comments, and be part of this lively samples conversation that affects us all.

Do you know what Copay Accumulators and Maximizer plans are? You should!

These strategies are increasingly having a greater impact on the patient landscape.

Industry expert and Sharing Alliance board member Marc Lavin invites you to attend this workshop to learn how these plans are affecting patients and the pharmaceutical industry. Discussion will be on learning how to provide better patient outcomes under these approaches, and developing ways of improving existing copay assistance programs.

Time will be allotted for Q&A. Workshop attendees will be able to submit questions in advance of the conference – watch for details.

Pharmaceutical marketing has come a long way since its inception, and the industry continues to evolve as new regulations and technologies emerge.

We’ve got two industry professionals lined up to present this new workshop. Jay Lambert from Synergistix and Deb Segura, the Sharing Alliance’s Executive Director will explore the history of compliant pharmaceutical marketing, the current state of the industry, and the future trends that will challenge how pharmaceutical companies effectively promote their products.

Make sure to attend this insightful workshop and come with questions! There will be plenty of time for Q&A.

The cost of prescription drugs in the U.S. has been a hot topic in politics with both the previous and current administrations. This workshop, presented by Brad King from Kowa Pharmaceuticals, will mainly focus on Drug Price Transparency covering the many laws states have passed along with any pending legislation to combat high drug costs and create more transparency. Most importantly, we will cover the many variations of these requirements and challenges faced by our industry to comply with reporting. This workshop will also touch on the few states that require controlled substance reporting regarding opioids and excise taxes.

Come prepared for an interesting discussion and bring your questions with you!

Moderator:
Lisa A. Butler, Director, DEA, PDMA & State Licensing Compliance, Novartis Pharmaceuticals Corporation

Panel Presenters:
Elizabeth Updike, Director & Sr. Managing Attorney, IQVIA
Jennifer Valentine, Senior Director, Regulatory Compliance & Data Governance, MedPro Systems

The term “State Licensing” can be broad and confusing if you do not understand what is required. The 10th Amendment gives US States the right to govern and therefore license manufacturers and distributors of commercial and Healthcare Practitioner Samples. There is a vast difference in how each state licenses companies for each different type of activity and how much information they request during the license application and renewal process. For Healthcare Practitioner samples, the PDMA (Prescription Drug Marketing Act) requires verification of Healthcare Practitioner state licenses prior to the distribution of samples. In this workshop, attendees will get an overview of the licensing requirements for both Commercial trade products and Healthcare Practitioner Samples and learn the complexities of both.

During this collaborative learning session presented by industry experts, attendees will have the opportunity to discuss their own challenges and learn how other companies manage the expectations of the individual states and the federal government. So come join your industry peers in an interactive workshop that will surely be as educational as it will be engaging.

CDMOs provide services that touch every aspect of a drug’s lifecycle, from the clinical pipeline through commercialization. Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), will discuss the role CDMOs play for Marketing Authorization Holders, how their relationships have evolved, and what the biggest regulatory, legislative and business drivers are for this critical sector in the bio/pharma industry.

We hope to see you at this enlightening learning session.