PR Pharma Summit 2024 Agenda

State of the Pharmaceutical Industry in Puerto Rico

Francisco E. Colón-Ramirez, Of Counsel, Porzio, Bromberg & Newman, P.C.

Humberto Mercader, Deputy Secretary for Strategic Initiatives, Department of Economic Development and Commerce (DEDC)

Iván Román, Advisor to the Board of Directors, Pharmaceutical Industry Association (PIA)

Eric Santiago, President, PR Manufacturers Association (PRMA)

The pharmaceutical industry in Puerto Rico is one of the most important sectors of the island's economy, contributing to more than 30% of its GDP and employing over 75,000 people. However, it also faces significant challenges, such as the impact of natural disasters, the federal tax reform, competition from other regions, and regulatory changes. In this session, top leaders representing the island’s legal, economic, manufacturing and pharmaceutical industry sectors will explore the current state of the pharmaceutical industry in Puerto Rico, including its strengths and weaknesses, opportunities and threats, and its future prospects. The panelists will also discuss the best practices and strategies to overcome the challenges and to continue to foster innovation and growth.

Coming and Going: Exporting FDA Regulated Products from Puerto Rico

Dara Katcher Levy, Director, Hyman, Phelps & McNamara, P.C.

Karla L. Palmer, Director, Hyman, Phelps & McNamara, P.C.

Join Hyman Phelps & McNamara attorneys, Dara Katcher Levy and Karla L. Palmer, as they discuss timely and important FDA and DEA issues relating to the exportation and importation of pharmaceutical products to and from Puerto Rico. They will explore the nuances of drug and biologic product “exportation” from Puerto Rico, and, in turn, “importation” into the United States, and review recent regulatory actions by the FDA, including the agency’s first Section 804 Importation Program (“SIP”) which authorizes the importation of eligible prescription biologics between Florida and Canada.

A View from Washington: A Regulatory and Legislative Outlook

Nolan Ahern, Deputy Policy Director for House Republican Whip, Tom Emmer
Elizabeth Fowler, J.D., Ph.D., Director of the Center for Medicare and Medicaid Innovation, U.S. Department of Health and Human Services
Nick Uehlecke, Principal, Todd Strategy Group

Moderated by Todd Strategy Group's Nick Uehlecke, this session will include regulatory and legislative updates from Dr. Elizabeth Fowler, Director of the Center for Medicare and Medicaid Innovation, and Nolan Ahern, Deputy Policy Director for the GOP House Whip Tom Emmer. From their individual vantage points, they will discuss the outlook for the pharmaceutical industry in 2024 and beyond.

Navigating Global Turbulence: Drop Your Anchor in Puerto Rico

Carlos Fontan, Director, Office of Incentives for Business in Puerto Rico, Department of Economic Development and Commerce

Aurelio Fuentes, Co-Founder & Partner, DECA Analytics

Isabel Hernández, CPA, Partner, Kevane Grant Thornton, LLP

Robert M. Schechter, Principal, Porzio, Bromberg & Newman, P.C.

Colton Wandke, CAIA, Co-Founder & Partner, DECA Analytics

With interest rates up, inflationary pressures abound and a tight labor market in many sectors and geographic locations around the globe, choosing the right location for a business venture can be mission critical to margins, growth and stability. This session, including experts from leading compliance, accounting and corporate advisory firms, will explore challenges business leaders face in today’s economic climate and how they can leverage a strategic location, skilled workforce and tax incentives in the U.S. territory of Puerto Rico to navigate a competitive marketplace and drive innovation, stability and ROI.

Somewhere Beyond the Sea: Experiences and Challenges of State Licensing and Distribution

Frank Fazio, Senior Vice President, Distribution and Licensing Services, Porzio Compliance Services (Moderator)

Margarita Marti-Lopez, Compliance Manager, McNeil Healthcare LLC

Jose Hernandez-Perez, Project Manager, Novartis Pharmaceuticals Corp.

Designed for professionals who are interested in expanding their business to Puerto Rico or who want to learn more about this dynamic and growing market, this course will provide an overview of the Puerto Rico pharmaceutical industry, focusing on the state licensing and distribution requirements for manufacturers and wholesalers both on and off the island. Our panel of experts, featuring representatives from leading healthcare and pharmaceutical companies, along with Porzio Compliance Services’ Senior Vice President of Distribution and Licensing Services, will discuss the legal and regulatory framework and the best practices for compliance. They will explore the challenges and opportunities of operating in Puerto Rico via case studies and testimonials from industry experts and practitioners who have successfully navigated the Puerto Rico licensing and distribution system, and have achieved their goals of market potential.

Conducting Internal Investigations: Best Practices to Address Compliance Concerns, Reduce Risk, and Access Results

Michelle D. Axelrod, Principal, Porzio, Bromberg & Newman, P.C.

Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.

This session will provide participants with the knowledge and skills to conduct effective internal investigations in the pharmaceutical and medical device industry. Join Porzio, Bromberg & Newman, P.C. Life Sciences Regulatory and Compliance principals, Michelle Axelrod and Jennifer Romanski, as they discuss the legal framework for conducting investigations, the best practices for planning, conducting, and documenting interviews, and the strategies for reporting and resolving compliance issues. They will also address the common challenges and risks that investigators face, such as confidentiality, privilege, and retaliation concerns. By the end of the course, participants will be able to apply the principles and techniques of internal investigations to their own work environments to help achieve results that are fair, thorough, and compliant.

DOJ Investigations, Product Adulterations and Class Actions: Dealing with a Corporate Emergency

Vito A. Gagliardi, Jr., Managing Principal, Porzio, Bromberg & Newman, P.C.

Karen Garnik, APR, Global Vision Communications

William Hughes, Jr., Principal, Porzio, Bromberg & Newman, P.C.

Raquel Rivera, Counsel, Porzio, Bromberg & Newman, P.C.

Nick Uehlecke, Principal, Todd Strategy Group

How do you handle a real crisis that is an existential threat to the company? In 1982, six people died after someone tampered with five bottles of Tylenol. Johnson & Johnson proceeded to recall about 31 million bottles of Tylenol, and the Washington Post hailed the response as "Johnson & Johnson has effectively demonstrated how a major business ought to handle a disaster." Subsequently, Congress and the FDA enacted new laws and regulations. Product tampering isn’t the only crisis to be concerned about: federal civil and criminal investigations, class-action and mass tort lawsuits, and even an adverse press article or Tik-Tok video can threaten the business of the company. Each of these events will require legal, public relations, and even lobbying actions. Five experts who have had real experience with corporate emergencies will provide insights on how an immediate, coordinated and effective legal, public relations and lobbying strategy can save the company’s reputation, money, and even its very existence. Topics include: 1) a government criminal or civil investigation into the company; 2) product tampering or adulteration; 3) class-action and mass-tort lawsuits; 4) congressional hearings and/or administrative investigations; and 5) adverse media.

Event Agenda

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