Summary

Explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A is provided.

Agenda Highlights

  • Regulatory processes for biologics
  • Review and approval process
  • Regulation of biological/drug development
  • Biologics License Application (BLA)
  • Biosimilar biologic products
  • Post-approval safety issues
  • Regulation of biological manufacturing
  • Advertising and promotion requirements
  • Enforcement tools and procedures
  • Changes to the statutory framework for regenerative medicine

Statutes Covered

  • The 1902 Biologics Act
  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Public Health Service Act of 1944 (PHSA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Prescription Drug User Fee Act and Biosimilars User Fee Act
  • 21st Century Cures Act

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of biologics law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

Agenda

subject to change

Wednesday, March 15

Due to the potential impact of inclement weather, the course will begin at 9:30 AM. Please see below for the amended schedule:

9:00–9:30 AM
Registration and Continental Breakfast

9:30–9:35 AM
FDLI Welcome and Announcements

Khara L. Minter, Assistant Director, Training Programs, FDLI

9:35–10:35 AM
Overview of Biological Products Law and Regulation

Deborah Shelton, Partner, McCarter & English LLP

10:35 AM–12:00 PM
FDA Review and Approval of Biological Products

Kate Cook, Executive Vice President, Drug and Biological Products, Greenleaf Health LLC

12:00–1:00 PM
Working Lunch and Presentation
Novel Products and Situations: Overview of Path to Market

Phoebe Mounts, Partner, Morgan, Lewis & Bockius LLP

12:00–1:00 PM
Networking Lunch

1:00–2:15 PM
Regulation of Biological/Drug Development

Natasha Leskovsek, Partner, Cooley LLP

2:15–3:15 PM
Biological License Applications (BLA)

Christina Markus, Partner, King & Spalding LLP

3:15–3:30 PM
Networking and Refreshment Break

3:30–5:00 PM
Biosimilar Biological Products

Krista Hessler Carver, Partner, Covingtron & Burling LLP

Thursday, March 16

8:00–8:30 AM
Continental Breakfast

8:30–9:45 AM
Post-Approval Safety Issues

Nathan Beaver, Partner, Foley & Lardner LLP
David Rosen, Partner, Foley & Lardner LLP

9:45–10:00 AM
Networking and Refreshment Break

10:00–11:15 AM
Regulation of Biological Manufacturing

Anne Kelly, Senior Quality Systems Expert, King & Spalding LLP

11:15 AM–12:30 PM
Regulation of Biological Marketing

Daniel Kracov, Partner, Arnold & Porter Kay Scholer LLP, and Member, FDLI Board of Directors

12:30–1:45 PM
Networking Lunch

1:45–3:30 PM
New, Emerging, and Continually Interesting Issues

Kate Cook, Executive Vice President, Drug and Biological Products, Greenleaf Health LLC

3:30–3:45 PM
Networking and Refreshment Break

3:45–5:00 PM
Violations, Enforcement, and International Issues

Michael Beatrice, Principal, Validant

5:00 PM
Adjournment

Speaker Biographies

KRISTA CARVER is a partner in Covington and Burling’s Washington, DC office, where she focuses on FDA regulatory and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries and related transactional matters. She has particular experience with biosimilars issues. She assisted biotechnology innovators in legislative matters leading up to enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and now represents clients in connection with FDA interpretation and implementation of the BPCIA.  Ms. Carver also counsels clients on an array of regulatory issues including orphan drug, Hatch-Waxman, and pediatric exclusivities and life cycle management strategies; priority review vouchers; breakthrough and fast track status; product jurisdiction; human cells, tissues, and cellular and tissue-based products (HCT/Ps); clinical trial data confidentiality and transparency; proprietary naming of pharmaceuticals; and medical device and diagnostic regulation. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions, and with legislative issues surrounding potential amendments to the Federal Food, Drug, and Cosmetic Act and related laws.  Ms. Carver writes and speaks regularly on subjects such as biosimilars and life sciences legislation. She co-authored a comprehensive article on the BPCIA, “An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009” (Food and Drug Law Journal, 2010). Ms. Carver is former chair of the Biotechnology Law Committee of the ABA Section of Science and Technology Law and a member of the Section Council. She also serves as Co-Editor-in-Chief of Covington’s InsideMedicalDevices blog.

KATE COOK is Executive Vice President at Greenleaf Health, LLC.  Kate Cook joins Greenleaf following a distinguished career of more than 20 years with the U.S. Food and Drug Administration (FDA). During her FDA tenure, Kate provided crucial direction on strategic initiatives related to the regulation of drugs, biological products and medical devices. Kate continues her commitment to public health at Greenleaf as Executive Vice President of Drug and Biological Products, where she provides strategic consulting services and works with clients to bring innovative medical products to patients.  Kate’s FDA career began in the Office of Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to biosimilars, vaccines, allergenics, human tissue and cellular products, blood products, medical devices and combination products. She also provided guidance on issues related to human subject protection and advertising and promotion. Kate’s FDA experience included serving as Associate Director for Regulations and Policy within FDA’s Center for Devices and Radiological Health (CDRH), where she led strategic development and implementation of policies and regulations applicable to medical devices and radiation emitting products. She also served as Senior Advisor in FDA’s Center for Biologics Evaluation and Research (CBER), where she played a pivotal role in the development and implementation of policies and regulations applicable to biological products, combination products and medical devices regulated by CBER.  Kate is the recipient of numerous FDA awards, including the FDA Award of Merit, the Secretary’s Award for Distinguished Service, the Commissioner’s Special Citation and the CDRH Director’s Special Citation.  Before joining FDA, Kate served as an Assistant District Attorney in the New York County District Attorney’s Office. Kate was responsible for the investigation and prosecution of more than 100 felony complaints from arraignment through trial and sentencing, as well as appeals of criminal convictions.  A graduate of Swarthmore College, Kate received her law degree from the New York University School of Law. She continues to provide pro bono and volunteer legal services via the Maryland Legal Aid Bureau and Baltimore City Senior Legal Services.

DANIEL KRACOV is a partner in Arnold & Porter’s Washington, DC office, where he co-chairs the firm’s Life Sciences & Healthcare practice. He helps life sciences manufacturers, trade associations and early-stage ventures negotiate challenges relating to the development, manufacturing, approval and promotion of drugs, biologics, medical devices and diagnostics. In addition to day-to-day regulatory counseling, he regularly handles high stakes investigations and enforcement proceedings, the development of global compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized expertise in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislation.

CHRISTINA MARKUS is a partner in the Washington, DC office of King & Spalding, and serves as Deputy Chair of the FDA & Life Sciences Group.  Her practice focuses on the regulation of drugs, biologics, and other products by the Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), and related state agencies (e.g., boards of pharmacy).  Ms. Markus represents companies in a range of regulatory compliance, enforcement, and business transactions (e.g., due diligence assessments) involving product development and approval, safety, labeling, marketing and advertising, and supply chain. Ms. Markus was selected as a “Life Sciences Star” in the 2012, 2013, and 2014 LMG Life Sciences publications, and as one of the Best Lawyers in America (2015 edition) for FDA Law.  She recently completed an appointment by the Institute of Medicine (IOM)/National Academy of Sciences as the legal member of the IOM Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  In response to a Congressional request, and with funding from FDA, IOM evaluated studies of drugs and biologics that have been performed under two statutory regimes that incentivize and, in some instances, mandate pediatric research through the drug approval process.  The Committee assessed historical execution under these laws and offered recommendations and briefings to FDA and the U.S. Congress, which were considered during the reauthorization of BPCA and PREA (signed into law in July 2012).

PHOEBE MOUNTS is a partner in the Washington, DC office of Morgan, Lewis & Bockius LLP.  She counsels companies developing drugs, biologics, medical devices, and human cell and tissue-based products on US Food and Drug Administration (FDA) regulations. Her scientific background enables her to assist clients with product approvals for emerging technologies, such as combination products and companion diagnostics, including counseling on regulatory pathway issues and developing preclinical and clinical studies. Phoebe prepares submissions to the FDA, including applications for orphan-drug designation, humanitarian device exemptions (HDEs), investigational new drugs (INDs), investigational device exemptions (IDEs), and 510(k)s, as well as meeting requests and background packages.

DEBORAH SHELTON is Leader of the Food & Drug Law Practice at McCarter & English LLP.  Deborah provides clients with deep industry-relevant expertise in biopharmaceuticals, informed by a strategic, rigorous, and pragmatic approach to client counseling gained from 20 years of serving in diverse settings, including in key external and corporate counsel roles.  She counsels clients navigating complex regulations that affect business planning, product development and approval, post-market compliance, life-cycle management, due diligence and contracting, litigation strategy, and legislative and regulatory advocacy.  Deborah has represented clients before the FDA, DEA, and CMS, as well as state and federal legislative bodies. She has nearly two decades of experience with Hatch-Waxman matters and regulatory exclusivities (including under the BPCIA, new chemical entity, orphan drug, and pediatric), a subject on which she has taught numerous courses for various organizations, including the Food & Drug Law Institute (FDLI). She works with clients from the investigational and approval stages through regulatory and post-marketing compliance.  Deborah has been an industry leader in the development of the legislative biosimilar pathway and FDA’s ongoing implementation.  She comes to McCarter & English from her role as Deputy General Counsel for Healthcare at BIO, the world’s largest biotech trade association. She joined BIO from a global biotechnology company, where she was lead U.S. counsel to the company’s Global Biosimilars Legislative and Regulatory Policy teams and the State Government Affairs team. Her leadership played a key role in shaping advocacy and response to the legal and regulatory challenges arising under the Affordable Care Act.  Prior to her work as corporate counsel, Deborah was a partner in the FDA practice of a Global 100 firm. During her years in private practice, Deborah provided regulatory counseling across FDA-regulated industries, including biopharmaceuticals, medical devices, food, dietary supplements, and cosmetics.  Deborah is a member of the advisory board for BNA’s Pharmaceutical Law & Industry Report. She was lead editor of FDLI’s Compilation of FDCA-Related Food and Drug Laws (2010) and the FDCA Statutory Supplement (2011), and has published and spoken extensively over the years on a wide array of issues of interest to the biopharmaceutical and other FDA-regulated industries.

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Pennsylvania: 13.5 CLE credit hours
Virginia: 13.5 CLE credit hours

Location and Overnight Accommodations

Course Location

Arnold & Porter Kaye Scholer
601 Massachusetts Ave NW
Washington, DC 20001

Overnight Accommodations

Renaissance Hotel, 999 9th Street NW
Hampton Inn, 901 6th Street NW
Fairfield Inn & Suites, 500 H Street NW
Embassy Suites by Hilton, 900 10th Street NW

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.