Day 1 - Tuesday, March 11, 2014

1:00
Pre-Conference Workshop

Day 2 - Wednesday, March 12, 2014

7:15
Registration and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks
8:45
The Basics: Understanding and Working with the FDA — Jurisdiction, Organization, and Operations
10:00
Morning Coffee Break
10:15
The Nature of the Approval Process
11:30
Understanding the Clinical Trial Process for Drugs and Biologics
12:30
Networking Luncheon
1:45
Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
2:45
Afternoon Refreshment Break
3:00
Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
4:00
Drugs and Biologics: Labeling
5:15
Conference Adjourns to Day Two

Day 3 - Thursday, March 13, 2014

7:15
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One
8:15
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
9:00
Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
10:00
Morning Refreshment Break
10:15
Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
11:15
Adverse Events Monitoring, Pharmacovigilance and Risk Management
12:15
Conference Concludes*
1:15
Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

Day 1 - Tuesday, March 11, 2014

1:00
Pre-Conference Workshop

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

Fundamentals of FDA Regulatory Law
Aimed at providing a primer to professionals who have limited or no experience working with FDA on regulatory matters, this workshop will provide you with a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and walk you through the preapproval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.

Topics to include:
• FDA Mission
• FDA Organization
• History of FDA Laws
• Acronyms and Terminology
• Clinical Trials Process
• Types of New Drug Applications
• The Review Process
• The Hatch Waxman Act
• Legal Barriers to Approval
• Biological Products
• The Basics of Device classification and approval
• Post-marketing issues and enforcement, including recalls

Resolving Ethical Challenges Encountered During the Drug Approval Process
This one hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority. For example:

(1) In the context of citizen petitions FDA requires certification that the petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules of Professional Responsibility.

(2) In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. The discussion will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.

(3) Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11. The discussion will cover the implications of Rule 1.11.

​1:00 p.m. – 5:00 p.m. (registration begins at 12:00 p.m.)

Day 2 - Wednesday, March 12, 2014

7:15
Registration and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks

Geoffrey M. Levitt
Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer Inc.

Scott Bass
Partner & Head, Global Life Sciences
Sidley Austin LLP (New York, NY)

8:45
The Basics: Understanding and Working with the FDA — Jurisdiction, Organization, and Operations

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

• FDA Overview

• How the FDA is organized
o Department of Health and Human Services and the Commissioner
o The 5 FDA Centers and the Office of Regulatory Affairs and their functions
• The 3 major centers and their roles
o CDER (Drug)
o CBER (Biologic)
o CDRH (Device)
• Understanding how CDER and CBER intersect
o intersection with CDRH
• Defining the scope of the FDA’s jurisdiction
• FDA funding
o PDUFA, GDUFA, MDUFA
• Examining how the FDA exercises its jurisdiction:
o rule making
o product decisions
o enforcement
o informal mechanisms
• Reviewing the laws that the FDA enforces
o Food Drug & Cosmetic Act
o Prescription Drug Marketing Act
o Public Health Services Act
o Hatch-Waxman Act
o Follow-On Biologics
o Recalls
o other applicable laws
• Defining drugs, biologics, and medical devices
• Labeling: when is a drug a drug and not a medical device or cosmetic, and the consequences
• Defining combination products
• Working with the FDA
o Administrative Procedures Act
o formal and informal dispute resolution mechanisms
• FDA’s policies and procedures
• Interrelationships with OIG and DOJ
• Recent developments at the FDA
o regulations and guidance
o enforcement initiatives
o personnel
o safety related actions at FDA

10:00
Morning Coffee Break
10:15
The Nature of the Approval Process

Daniel A. Kracov
Partner
Arnold & Porter LLP

Rx Drugs
• Understanding the difference between “new drugs” and other drugs
• Overview of the research, development, and approval process for new drugs
• The investigational new drug application (IND)
o when you need to file one
o what it needs to contain
o what it entitles you to do
o what you need to report when researching a drug in terms of adverse events
• The new drug application (NDA)
o when you need to file one
o what it needs to contain
o FDA review process and timing
o advisory committees
• Accelerated approval (fast track)
• Different uses of the REMS process in new drug approvals 

Biological Products
• What are biological products?
• What does it mean to say that they are also “drugs”?
o which “new drugs” require BLAs instead of NDAs?
• How do the research, development, and approval process for biological products differ from the process for new drugs?
• The biologics license application (BLA)
o when you need to file one
o what it needs to contain
o FDA review process and timing
o advisory committees
• Key similarities and differences between the drug and biological product schemes

OTC Products
• The concept of “OTC” (OTC-ness)
• The OTC Review
o which drugs are covered?
o what is a “monograph”?
o what does a monograph contain?
o what if you want to deviate from the monograph (innovate)?
• When is a new drug suitable for OTC?
o when must a drug be Rx only?
o how do you switch a new drug from Rx to OTC?
o can a new drug be Rx in some forms/dosages/etc., and OTC in others?
• Overview of how an OTC drug comes to market
o if it’s a new drug
o if it’s not a new drug

11:30
Understanding the Clinical Trial Process for Drugs and Biologics

James R. Ravitz
Partner
Arent Fox LLP

• Overview of the clinical trial process

o phases of testing (I-IV)
o which are mandatory?
o what happens in each phase?
o who conducts the testing?
o special considerations for Phase IV testing
• Regulatory requirements
o informed consent
o IRBs
o sponsor obligations
o investigator obligations
• FDA authority
o inspections
o refusal to accept data
o clinical hold
o disqualification of irb and/or investigator
• Other issues
o CROs
o SMOs
o who reviews the data?
o how do clinical trials for drugs differ from clinical trials for biologics?
• Disclosure of clinical trial information
o FDA Amendments Act of 2007
o FDAMA § 113
o clinicaltrials.gov
o PhRMA policies

12:30
Networking Luncheon
1:45
Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA

Part 1 –Patents, Trademarks and Other IP Protections and Mechanisms

Dickerson M. Downing
Principal
Law Offices of Dickerson M. Downing

​Patent Protection for Drugs and Biologics
• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection drugs and biologics
• Seeking extension of patent term for time spent in the drug approval process (Patent Term Extension, Supplemental Protection Certificates), and/or time spent obtaining a patent at the United States Patent Office (Patent Term Adjustment)
• 271(e)(1) “safe harbor”
• Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products 

Trademarks, Trade Names, and Trade Dress
• The art and science of selecting a brand name for a proposed drug product
o how does the branding process work for your product?
• Understanding the respective roles of the USPTO and FDA in the drug naming process
• Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
• Appreciating the use

2:45
Afternoon Refreshment Break
3:00
Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA

Part 2- Hatch-Waxman and BPCIA Overview

Carlos Angulo
Partner
Zuckerman Spaeder LLP

David Adams
Partner
Venable LLP

​Drugs
• Comparing the NDA, 505(b)(2) and ANDA (Abbreviated New Drug Application) drug approval routes
• ANDA filing: what does the FDA require?
• Showing bioequivalence in an ANDA
• ANDA Paragraph IV Certification, and response to Notice Letters
• The role of the Orange Book in the drug approval process: what is it and why is it Orange?
o listings and de-listings
o use codes
o importance of Orange Book listing
• Regulatory Exclusivity (FDA)
o regulatory (data) exclusivity
– NCE (new chemical entity)
– 5 years marketing exclusivity
– 5 years data exclusivity
– indication (new indication or use)
– 3 years marketing exclusivity
– NDF (new dosage formulation)
– ODE (orphan drug exclusivity)
– PED (pediatric exclusivity)
o overview of Hatch-Waxman and reforms under MMA
o the role of Orange Book under Hatch-Waxman vis-à-vis the MMA
– 30-month stay
– patent extensions
– ANDA-filer exclusivity (180 day)
Biologics
• Identifying products approved/regulated as biologics
• Overview of biosimilar (FOB) legislation and regulations
o Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• The rationale for safety and efficacy concerns surrounding second
generation biologics

4:00
Drugs and Biologics: Labeling

Eric D. Hargan
Shareholder
Greenberg Traurig LLP

The labeling of the drug/biological product is the final stage of the approval process. The labeling affects what you can do post approval. It is the point of transition between the approval process and post-approval world.

• Labeling overview: key regulatory requirements, information, and contents
• Review process for labeling
• How does the final labeling control the scope of post-market activities?
• When should the labeling be amended post-market?
o what is the process for doing so?
• How is the labeling a defense in products litigation?
• When can punitive damages may be rewarded with respect to labeling
• Assessing the impact of labeling on reimbursement

5:15
Conference Adjourns to Day Two

Day 3 - Thursday, March 13, 2014

7:15
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One
8:15
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)

Scott Bass
Partner & Head, Global Life Sciences
Sidley Austin LLP (New York, NY)

• Examining cGMPs (current Good Manufacturing Practices)and the scope of their importance in pharmaceutical/biological product commercialization

• Looking at how cGMPs factor into the scope of the FDA’s authority and history
• Exploring the scope of the FDA’s cGMP Initiative and how the concept of “risk-based” cGMPs is defined
• Defining the concept of validation
• How are laboratory investigations in relation to cGMPs conducted?
• Defining the term “quality systems”
• How are cGMPs factoring into products litigation?
• Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?

9:00
Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns

Karen Weaver
Vice-President & Associate General Counsel, Regulatory
CareFusion Corporation (San Diego, CA)

​FDA’s Risk-Based Classification Scheme
• Understanding the concept of risk-based classification
• Three main classes of medical devices
• Device reclassification

The Premarket Review Process
• Potential changes to 510(k) process and changes to diagnostics
o Should Class II medical devices be split in 2 with 510k-heavy and 510k-lite
• 510(k) exemptions for low risk devices and the role of the Investigational Device Exemption (IDE)
• Premarket notification (510(k)) process
o understanding the selection of “predicate” devices when 510(k) submissions are made and the consequences of choosing the
wrong predicate
• Premarket approval (PMA) process

Post-Market Requirements and Concerns
• What is the scope of the Quality System Regulation (QSR)?
• What are the reporting requirements under the Medical Device Reporting (MDR) and Reports of Corrections and Removals regulations?
• What other types of post-market requirements can FDA impose on medical devices, e.g., tracking?
• What claims can device manufacturers make regarding cleared/ approved devices, devices with pending 510(k) notices, and investigational devices?
• What are the consequences of illegal promotion of a device?

10:00
Morning Refreshment Break
10:15
Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know

Stephen Terman
Principal
Olson Frank Weeda Terman Matz, PC (Washington, DC)

• What is the FDA’s recall and oversight authority?

o from where does this authority derive?
o overview of 21 CFR Part 7
o guidance versus regulation
o voluntary recalls versus mandatory recalls
o market withdrawals and stock recoveries
• What medical device recalls need to be reported to FDA?
• When should a company institute a recall?
o can new labeling or a new product warning constitute a recall?
• When should the decision be made to work with the FDA?
o working with the FDA versus working alone?
– what are the risks and benefits in each course of action?
• Interaction between recalls and corrective and preventive action
• What are the consequences of not instituting a recall?
• FDA seizure and injunction power
• When can product be reintroduced to the market?

11:15
Adverse Events Monitoring, Pharmacovigilance and Risk Management

Jane Mathews
Assistant General Counsel
Sunovion Pharmaceuticals, Inc.

Linda Pissott Reig
Shareholder
Buchanan Ingersoll & Rooney PC

• What is pharmacovigilance?

• How pharmacovigilance uses adverse event reports
o how ADE reports come to a company
– solicited direct reports
– unsolicited direct reports
– indirect reports
o how companies investigate, analyze and use ADE reports
– causality assessments
– labeling changes
o requirements for reporting ADEs to regulatory agencies
– premarket stage; post-market stage
o how regulatory agencies use ADE reports
• Examining other tools for pharmacovigilance
• What is risk management?
o Risk Evaluation and Minimization Strategies (REMS)
o Risk evaluation in the approval process
o Risk minimization tools
o REMS assessments
• Enforcement of ADE reporting and REMS requirements
• Examining the relevance to product liability risks

12:15
Conference Concludes*

​* Luncheon will be served for delegates attending the afternoon

Mater Classes beginning promptly at 12:15

1:15
Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

Afternoon Refreshment Break (3:30-3:45)

Donald Ware
Partner
Foley Hoag LLP

Joseph A. Mahoney
Partner
Mayer Brown LLP

Chad A. Landmon
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT & Washington, DC)

​Biosimilars

• Overview of Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Biosimilar pathway vs. 505(b)(2) and BLAs
• Defining “biological” and “biosimilars” under BPCIA
o addition of the word “protein” to the PHSA definition of biologics
o identifying the “reference” product and proving biosimilarity
o analytical data requirements
o when will clinical data submission be necessary?
• Exploring interchangeability requirements
• Understanding the significance of the methods of making claims in this legislation
o query: if a protein is made by a completely different process than the reference product, is the patent infringed?
• Examining the effect of this abbreviated approval pathway on innovation
o how will this impact brand name and generic companies
• A look at FDA Rule making and guidance relative to biosimilars
• How will biosimilars fit in with life cycle strategies?
o targeting R&D efforts
o re-examining prosecution efforts
o anticipating vulnerable patents and litigation

Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability
• Defining bioequivalence in drugs and biologics
o drugs v. biologics
• What an ANDA-filer must demonstrate for bioequivalence?
o bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays
• Exploring bioequivalency under a biosimilar pathway pursuant to BPCIA
• How does bioequivalence relate to patents?
o patenting of bioequivalence characteristics
o extended-release drug products
o bioequivalence v. Doctrine of Equivalents – what is the difference?
o arguments about bioequivalence raised in Paragraph IV patent litigation
o infringement, copying (non-obviousness)
• How does bioequivalence relate to patents?
o patenting of bioequivalence characteristics
o extended-release drug products
o bioequivalence v. Doctrine of Equivalents – what is the difference?
o arguments about bioequivalence raised in Paragraph IV patent litigation
o infringement, copying (non-obviousness)

Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies
There are a number of different modes and methods of exclusivity (nonpatent). This session will outline what they are and what challenges, opportunities, and current controversies arise in relation to them, including the role that the FDA plays in regulating these modes of exclusivity. Modes and methods of exclusivity to be discussed include:
• Orphan Drug Exclusivity (7 years)
• New Chemical Entity Exclusivity (5 years)
• New Clinical Study Exclusivity (3 years)
• Pediatric Exclusivity (6 months)
• First Generic Applicant Exclusivity (180 days)

​1:15 p.m. – 4:45 p.m.