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Preconference Workshops

Sunday, 13 September 2009
8:00 AM - 5:00 PM

Regulatory Essentials: US

Regulatory Essentials: EU

Regulatory Essentials: Canada

Regulatory Essentials: Japan

Effective Medical Writing

Advertising, Promotion & Labeling

Advertising, Promotion & Labeling
Location: Philadelphia, PA
Room:
Speaker: Deborah Wolf, Robert Klepinski, Claudia Lewis-Eng, Philipp Novales-Li, Christina Markus, Sara Stults, Jean-Ah Kang, Brian Bohnenkamp, Thomas Felton, Dulce Foster, Debra S. Dunne

Description:

Plenary Sessions

Monday, 14 September 2009
8:30 AM - 10:00 AM

Keynote

11:00 AM - 12:00 PM

The Future of GHTF?

The Future of GHTF?
Location: Philadelphia, PA
Room:
Speaker: Carolyn Albertson, Rainer Voelksen, Michael Gropp, Roland Rotter

Description: The Global Harmonization Task Force (GHTF) was established in 1992 in an effort to achieve greater uniformity among national medical device regulatory systems. In this session led by international regulatory specialist Rainer Voelksen, you will hear from GHTF representatives on the impact and benefits of current initiatives for the medical device industry. The recently developed guidance on supplier quality and a new guidance on CAPA, as well as information on new countries using or considering GHTF-type systems when introducing a new regulatory framework, will be covered.

Quality by Design (QbD): A Framework for Success

Quality by Design (QbD): A Framework for Success
Location: Philadelphia, PA
Room:
Speaker: Robert Timko, Gerry DiDonato

Description: ICH Guidelines Q8, Q9 and Q10 have provided an avenue for flexible regulatory approaches to the filing of chemistry, manufacturing and controls (CMC) information, in both the initial marketing application and subsequent postapproval submissions. The first of the guidelines took effect in 2006 and several pharmaceutical manufacturers have utilized them in preparing regulatory submissions. In this session led by Gerry DiDonato, PhD, you will learn some of the regulatory challenges and opportunities faced by industry to date.

An Increased Binding of Premarket Phase and Postmarket Approval Studies

An Increased Binding of Premarket Phase and Postmarket Approval Studies
Location: Philadelphia, PA
Room:
Speaker: Melanie Raska, Michael Marcarelli, Kellie Windle

Description: In 2008, FDA proposed major revisions to prescription drug labeling, requiring that detailed information be provided about the use of drugs/biologics by women who are pregnant, nursing or of childbearing age. Led by regulatory expert Lisa Jenkins, PhD, this session will give you an overview of the proposed rule and provide current information on designs of lactation studies.

Gene Therapy: History and Current Status

Gene Therapy: History and Current Status
Location: Philadelphia, PA
Room:
Speaker: Joel Falk, Cindy Fisher, Daniel Takefman

Description: While curing diseases caused by genetic defects by introducing genetic material into individual cells may offer a significant medical benefit, gene therapy also has the potential to cause serious harm or even death. As a result, nearly 20 years after the first demonstration in humans, a genetherapy- based product still lacks approval. Senior regulatory manager Cindy Fisher, PhD, will lead the discussion on recent developments from the Center for Biologics Evaluation and Research's Office of Cellular, Tissue and Gene Therapy, to provide you with an understanding of what it takes to conduct clinical research and to develop a gene therapy product in today's highly controlled regulatory environment.

Tissue Engineered Combination Products--Coordination is Key

Tissue Engineered Combination Products--Coordination is Key
Location: Philadelphia, PA
Room:
Speaker: Joyce Frey-Vasconcells, Miriam Provost

Description: Tissue engineered products often consist of a biologic and a device, each of which can potentially be produced by a different company. Led by tissue expert, Joyce Frey-Vasconcells, this session will present a detailed analysis of the complexity and critical components of developing a tissue engineered product and the regulatory considerations involved. The interaction and coordination between different organizations within and outside your company that may come into play will be discussed.

How Marketing and Regulatory Can Work Together

How Marketing and Regulatory Can Work Together
Location: Philadelphia, PA
Room:
Speaker: Eric Langer, Howard Rosen

Description: Establishing a strong relationship and open communications between regulatory and marketing brings positive business results for healthcare product manufacturers. Led by marketing expert Eric Langer, this session will provide an overview of marketing’s responsibilities and goals. Discussions will center on reconciling organizational goals between regulatory and marketing and provide an understanding of what marketers do and how they think.

Pros and Cons of Alternative Models in Preclinical Studies

Pros and Cons of Alternative Models in Preclinical Studies
Location: Philadelphia, PA
Room:
Speaker: Alain Stricker-Krongrad, Maurizio Cattaneo, Thomas Hartung, Katya Tsaioun

Description: Alternatives to whole-animal testing include endpoint assays, cell and tissue cultures, the use of tissue slices, toxicokinetic modeling and structure-activity relationships and databases. Concordance between results from alternative tests and those from animals is an important issue in protecting public safety. Led by preclinical research specialist Alan Stricker-Krongard, PhD, this session will review alternatives and the steps being taken to ensure these methods can be just as predictive as animal models, as well as the regulatory implications of using alternative tests.

Good Clinical Practice Compliance in Clinical Trials

Good Clinical Practice Compliance in Clinical Trials
Location: Philadelphia, PA
Room:
Speaker: Judy Baushke, Gloria Miller, Felicia Angus

Description: Individuals from pharmaceutical companies, contract research organizations (CROs) and academic institutions involved with the supervision or oversight of clinical trials will learn the principles and requirements for Good Clinical Practices (GCPs) in this session led by compliance expert Gloria Miller, RAC. FDA and ICH Requirements for sponsors, monitors and investigators will be covered and techniques for evaluating compliance levels at clinical sites and how to implement corrective/preventative actions to ensure optimum GCP compliance will be introduced.

Common Pitfalls and Best Practices in IVD Analytical and Clinical Study Design

Common Pitfalls and Best Practices in IVD Analytical and Clinical Study Design
Location: Philadelphia, PA
Room:
Speaker: Juliet Carrara, Sally Hojvat

Description: Understanding the analytical and clinical study requirements to support a successful IVD submission is key to getting your new product approved. In this session led by regulatory expert Juliet Carrara, RAC, you will learn about the applicable regulations, guidance and standards and increase your ability to provide appropriate guidance to enhance your credibility within your organization and with reviewers. Discussions will address how to identify applicable standards; when to do analytical (bench) testing versus clinical studies; and examples of successful and failed proposals for alternatives to Clinical and Laboratory Standards Institute study design.

1:30 PM - 3:00 PM

CDRH Executive Staff Briefing

CDRH Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Mark Gordon, Cecilia Kimberlin, Les Weinstein, Nancy Ruth, Dorothy Clarke, Jonathan Sackner-Bernstein

Description: In this session led by policy expert Mark Gordon, MS, RAC, you will hear a detailed review of the past year at FDA’s Center for Devices and Radiological Health (CDRH) as well as an overview of initiatives, milestones and current trends for the next year. You will hear directly from senior-level CDRH and industry professionals and you’ll take home critical information impacting your organization.

Latin America Regulatory Update

Latin America Regulatory Update
Location: Philadelphia, PA
Room:
Speaker: Anthony Ventura, Maritza Moncayo, Adriana Serrão-Guilherme

Description: Latin America continues to be seen by the pharmaceutical industry as an appealing emerging market, due in part to its interest in outsourcing clinical trials, but also because of the potential for continued future market expansion. This session will give you insight into Latin America’s evolving regulatory landscape and its agencies. Major processes and requirements will be discussed so you can walk away with a better understanding of the regulatory opportunities and common challenges in the region.

Adaptive Clinical Trial Designs That Get Results

Adaptive Clinical Trial Designs That Get Results
Location: Philadelphia, PA
Room:
Speaker: Brigitte Zirger, Lisa Jenkins, Hsien Ming Hung, Judith Quinlan

Description: The proper use of adaptive clinical trial design can lead to more efficient data collection, a higher probability of success and quicker drug development. Led by regulatory expert Lisa Jenkins, PhD, this session will review changes to regulations and guidances impacting the use of adaptive clinical trials and present you with perspectives from regulatory agencies (Health Canada and FDA) on the various design methodologies. You also will learn about recent developments in the Canadian Progressive Licensing Project that bear on the use of adaptive trial designs during early and late stage development.

Cross Labeling--Fact or Fiction?

Cross Labeling--Fact or Fiction?
Location: Philadelphia, PA
Room:
Speaker: Bradley Thompson, Stuart Portnoy, Suzanne O'Shea

Description: In 2005, the Office of Combination Products (OCP) held a conference on the cross labeling “problem.” In 2008, OCP issued guidance on New Contrast Imaging Indications. Led by regulatory specialist Suzanne O’Shea, JD, this session will examine whether cross labeling really poses a significant problem and what OCP’s guidance suggests about the future of cross labeling. You will learn how separately marketed products might be considered combination products through labeling, when cross labeling is and isn’t required, some creative possibilities and whether it can ever work to your advantage.

Clinical Trial Requirements: Similarities and Differences (US, EU and Japan)

Clinical Trial Requirements: Similarities and Differences (US, EU and Japan)
Location: Philadelphia, PA
Room:
Speaker: Anita Fenty, Raj Kishore, M. Sue Norenberg, Gretchen Parker

Description: Globalization of marketing applications affects the preclinical, clinical and postmarketing phases of the healthcare product lifecycle. In this session led by compliance expert Anita Fenty MS, RAC, you will review the similarities and differences in clinical trial and adverse event reporting requirements among the US, EU Member States and Japan. How to best apply this information throughout the preclinical through marketing phases will also be covered.

Drug/Biologic Preapproval Inspection (PAI)--A Survivial Guide

Drug/Biologic Preapproval Inspection (PAI)--A Survivial Guide
Location: Philadelphia, PA
Room:
Speaker: Robert Yocher, Renita Johnson-Leva, Hari Nagaradona

Description: All pharmaceutical and medical device manufacturers are encouraged to be prepared for FDA inspections regardless of whether a pre-announcement has been received. In this session led by senior regulatory consultant Harindranath Nagaradona, PhD, you will examine the steps that a company would implement to prepare for and ensure a successful preapproval inspection (PAI), including developing corporate SOPs to consistently manage inspections at all applicable sites, properly training personnel at all levels, and interacting with FDA investigators in a positive manner.

The Expanding Role of Regulatory Advice: Guidance Meets Business Development

The Expanding Role of Regulatory Advice: Guidance Meets Business Development
Location: Philadelphia, PA
Room:
Speaker: Jeff Antos, William Sietsema, Joanna Schulman, Martina Molsbergen

Description: More than support functions, finance and accounting are key components of an organization’s success sometimes lightly regarded by regulatory professionals involved in the product lifecycle, corporate strategy and employee development. This session will address budgets, capital and cash flow information, elements of investments and return on investment (ROI) valuation information to help you increase your business acumen and leverage your voice in the strategic planning process within your organization.

Regulatory Models for Biosimilars

Regulatory Models for Biosimilars
Location: Philadelphia, PA
Room:
Speaker: Sandra Dennis, Joel Falk, David Rosen

Description: In this session, legal expert Michael A. Swit, Esq., will brief participants on the progress of pending bills in Congress that may provide a statutory path for biosimilars as the 1984 Hatch-Waxman Act did for drugs. The European regulatory system’s approach to generic biologics will also be reviewed; and comparability and techniques for proving bioequivalence with products that appear similar, but present significant variations in immunogenicity will be discussed. You will be able to give your company a better understanding of how the new model for generic biologics may differ from the small molecule model, and how that will create a different market for these products. /SPAN>market for these products.

3:30 PM - 5:00 PM

CDER Executive Staff Briefing

CDER Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Douglas Throckmorton, David Jefferys

Description: Wrought with accomplishment and challenge, 2009 was an eventful year for FDA’s Center for Drug Evaluation and Research (CDER). A senior representative will discuss the center’s initiatives and implementations over the past year during this session, moderated by international regulatory expert David Jefferys, MD. You will gain insight into CDER plans and priorities for 2010 and hear directly from CDER on issues that may significantly affect your company’s regulatory operations.

A Deeper Understanding of Companion Diagnostics

A Deeper Understanding of Companion Diagnostics
Location: Philadelphia, PA
Room:
Speaker: William Pignato, James Kelly, Lin Wu, Elizabeth Mansfield

Description: You will discuss personalized medicine, types of companion diagnostics, labeling considerations and case studies on development and regulatory strategy in this session led by senior regulatory expert James Kelly, PhD. Agency and industry perspectives will be included in the discussion.

Moving Stem Cell Products Into the Clinic

Moving Stem Cell Products Into the Clinic
Location: Philadelphia, PA
Room:
Speaker: Alice Varga, Deborah Lavoie, Donald Fink

Description: With much of the stem cell focus on research and development, not on the regulatory questions, many products are in the IND stage of development with no proven regulatory pathway for approval. Led by Debora Lavoie, JD, RAC, this session will explore how regulatory agencies and industry are developing regulations for cell and stem cell product development, preclinical and clinical trial design, to enable future product approvals for needed medical interventions.

A 2010 Approach to the Medical Devices Directive (MDD)

A 2010 Approach to the Medical Devices Directive (MDD)
Location: Philadelphia, PA
Room:
Speaker: Lorraine Hanley, Suzanne LaScalza, Gary Barrett, Jos Kraus, Molly Conforte

Description: Led by medical device expert Gary Barrett, this session will brief you on various MDD updates that will enter into force in March 2010 and provide you with an update on IVD regulations. MDD changes, including: EU expectations and direct effects on manufacturers; changes in labeling and instructions for use, single use, risk analysis, postmarket surveillance, clinical and technical files/dossiers and the essential requirements; and how these changes affect certification will be discussed.

PMDA Update: Future Initiatives and Challenges

PMDA Update: Future Initiatives and Challenges
Location: Philadelphia, PA
Room:
Speaker: Yuka Suzuki, Kyoichi Tadano, Madoka Murakami, Nobuo Uemura

Description: In this session, led by Japanese regulatory expert Kyoichi Tadano, PhD, hear directly from senior officials of Japan’s Pharmaceuticals and Medical Devices Agency about PMDA’s Fiscal 2009–2013 second midterm action and policy plan. Speakers will outline the second midterm plan and discuss future agency directions, as well as PMDA’s current initiatives and challenges for quicker medical device review and more effective lifecycle management.

Postapproval Changes for Combination Products

Postapproval Changes for Combination Products
Location: Philadelphia, PA
Room:
Speaker: Douglass Mead, Raymond Seda

Description: New technologies and advances in medical practice have served as catalysts for the introduction of combination products that offer safer, more effective and convenient treatments for patients. In this session led by regulatory specialist Raymond Seda, MBA, RAC, you will gain an understanding of FDA’s Office Combination Product (OCP) perspective and future initiatives and its role on guidance of and interaction with the lead centers (CDRH, CDER, CBER). Applicable postapproval requirements and practical examples of postapproval changes for combination products regulated as devices, drugs and biologics will be covered.

Registering Your Clinical Trial and Publishing Results: What You Must Know

Registering Your Clinical Trial and Publishing Results: What You Must Know
Location: Philadelphia, PA
Room:
Speaker: Karen Bannick, Robert Klepinski, Stefanie Doebler

Description: Clinical studies are a critical component of getting your product approved and onto the market. Requirements for clinical trial registration and study publication have changed significantly, and failure to register your trial could mean results will never get published. Your company could get fined up to $10,000 per day if you don’t disclose the study results within a year, regardless of the status of your FDA submission. Led by clinical studies specialist Karen Bannick McQuoid, this session will update you on new and evolving FDA requirements and show you how to get trial results published and available to the scientific community.

Technicals Fundamentals of R&D and Portfolio Management

Technicals Fundamentals of R&D and Portfolio Management
Location: Philadelphia, PA
Room:
Speaker: Scott Bruder, Paul Falkenstein, Jorge Ochoa, John McPherson

Description: Led by medical technology product expert Scott Bruder, MD, PhD, this session will expand your knowledge of Research and Development elements, such as establishing the unmet need and concept development; product specification and design/target evaluation and selection; in vivo and in vitro evaluation; and manufacturability and formulation considerations for drugs, devices and biologics. This session will also cover innovative clinical development strategies; strategic product mapping; and stage-gate sequencing for the product pipeline and portfolio management.

Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices

Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices
Location: Philadelphia, PA
Room:
Speaker: Suzanne O'Shea, Miriam Provost, William Voorhees

Description: Led by combination product consultant and expert Miriam Provost, PhD, this session will review the regulatory definitions for drugs and devices and provide insight into how these definitions may overlap. The legal, regulatory and scientific bases for jurisdictional determinations regarding chemical mode of action and how to resolve issues will be discussed through examples and case studies.

Tuesday, 15 September 2009
8:30 AM - 10:00 AM

Emerging Markets: Regulatory Challenges and Considerations

Emerging Markets: Regulatory Challenges and Considerations
Location: Philadelphia, PA
Room:
Speaker: Patrick Lee, Chang-Hong Whitney, Marcela Saad

Description: With the slow moving market in the West, more companies are looking to emerging markets to expand sales. Regulations in emerging markets are less mature and present many obstacles to Western businesses hoping to gain entry. This session, led by medical device consultant Chang-Hong Whitney, MBA, will focus on the regulations and regulatory challenges in the emerging markets of China, Taiwan and South America.

CBER Executive Staff Briefing

CBER Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Douglas Hunt, Robert Yetter

Description: Global regulatory affairs expert Douglas Hunt will lead FDA’s Center for Biologic Evaluation and Research (CBER) staff in a discussion about and an update on recent activities and trends, as well as upcoming initiatives and current developments. You will take home critical information impacting your organization.

Recent Advances in Oncology Drug Development

Recent Advances in Oncology Drug Development
Location: Philadelphia, PA
Room:
Speaker: Daniel Mannix, Axel Hoos, Bindu George

Description: New drug and therapeutic biologic cancer treatments and new uses for existing treatments are developed every year. Regulatory agencies must balance the need to ensure the safety and efficacy of these promising medicines against making them available to the public in a timely manner. In this session led by global regulatory expert Daniel Mannix, PhD, you will examine the role of regulatory agencies in facilitating the review and action on promising new cancer therapies, and gain insight into the use of different endpoints to support such approvals.

Combination Product Regulation in Asia

Combination Product Regulation in Asia
Location: Philadelphia, PA
Room:
Speaker: Ronald Szumigala, Jr., Mike Long, Nigel Hernandez, Donna Little

Description: Global regulatory expert Nigel Hernandez, PhD, RAC, will lead this session addressing current and future regulatory initiatives, legislation and requirements for combination products in China and Japan, including the framework and bodies (e.g., China’s SFDA re-registration requirements and type testing requirements and Japan’s PMDA and MHLW), the consultation process and relevant draft regulations. Case studies and important elements for combination products will be discussed, as will ASEAN and the common submission dossier template.

How to Respond to a Warning Letter

How to Respond to a Warning Letter
Location: Philadelphia, PA
Room:
Speaker: Susan Jacobs, Michael Heyl

Description: This session will review elements of regulatory inspection responses and outline key areas of evaluation you should consider before replying to an inspection or warning letter, including corrective and preventive action target completions. How to respond to FDA Form 483, what information and the level of detail to include, appropriate timeframes, and who should interact with the FDA district office will be discussed.

Developing Successful Public Communications Strategies

Developing Successful Public Communications Strategies
Location: Philadelphia, PA
Room:
Speaker: Janet Rose, Ilyssa Levins, Peter Carson, Barbara Box, Sheryl Williams

Description: Public relations expert Peter Carson will lead this session on how regulatory professionals can work effectively with their communications team to better meet their company’s marketing, corporate and scientific goals while remaining in compliance with regulations around data dissemination. An overview of the regulatory environment as well as opportunities and challenges associated with data dissemination throughout a drug’s lifecycle will be presented. Panelists will address regulatory challenges the emergence of social media presents.

Successfully Completing Failure Investigations and OOS

Successfully Completing Failure Investigations and OOS
Location: Philadelphia, PA
Room:
Speaker: Hal Hopkins, Laurel Hacche, Paresh Patel

Description: Led by compliance and quality Hal Dayton Hopkins, this session will give you an outline of the process for robust failure investigations and out-of-specification (OOS) investigations for regulated industry. The key elements in completing and documenting investigations to achieve regulatory expectations will be discussed, and best practices for determining root cause and ensuring closed loop systems for investigations will be reviewed.

10:30 AM - 12:00 PM

REMS: A Real-World Implementation

REMS: A Real-World Implementation
Location: Philadelphia, PA
Room:
Speaker: Frances Duffy-Warren, Michael Page, Rita Cassola, Kenneth Kostenbader, Robert Sharrar

Description: The Food and Drug Administration Amendments Act of 2007 imposed the requirement for postmarketing Risk Evaluation and Mitigation Strategy (REMS) plans for certain products. This legally enforceable obligation places greater burdens on pharmaceutical companies to design and implement a REMS program that meets FDA standards. Led by pharmacovigilance expert Rita Cassola, this session will review a REMS plan from inception through final implementation for a currently marketed product. You will learn some of the important considerations in executing an efficient company team effort and gaining final acceptance by FDA. Risk management requirements in the EU will be also be addressed, in comparison to key aspects with US requirements. There will be special focus on certain caveats that warrant special attention in the REMS.

Japan in Focus: Regulations for Medical Devices

Japan in Focus: Regulations for Medical Devices
Location: Philadelphia, PA
Room:
Speaker: Yuka Suzuki, Kyoichi Tadano, Shiho Tanaka, Yuzuru Okazaki, Kentaro Azuma

Description: This session, led by Japanese regulatory expert Yuka Suzuki, PhD, will provide you with information on current regulatory processes and basic requirements for medical device registration in Japan. In addition, regulatory and industry representatives will discuss the current status and challenges facing the cooperative Japanese-US effort, Harmonization by Doing (HBD), and its impact on international regulatory harmonization for medical devices.

Unique Device Identification--Requirements and Considerations

Unique Device Identification--Requirements and Considerations
Location: Philadelphia, PA
Room:
Speaker: John Crowley, Dennis Black, Richard Naples, Deborah Petretich Templeton, John Wallace

Description: The establishment and implementation of a Unique Device Identification System (UDI) is required by the Food and Drug Administration Amendments Act of 2007. Led by data standards expert Dennis Black, this session will give you an understanding of the UDI Law and FDA’s perspective on regulation, US market needs and mandates, ways UDI aligns with current manufacturing processes and business practices, global UDI needs and key implementation considerations. Efforts toward developing a global UDI for medical devices will be addressed.

EMEA Executive Staff Briefing

EMEA Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Agnes Saint-Raymond, Anthony Humphreys, David Jefferys

Description: Outlined in 2005, the EMEA roadmap details the European Medicines Agency’s five-year action plan and priority objectives. You will learn how regulatory initiatives in the EU may impact your company or product in this session moderated by international regulatory expert David Jefferys, MD. EMEA representatives will discuss progress on these objectives and other events of the past year, including recent activities of the Committee for Medicinal Products for Human Use. Plans and projects being undertaken for the coming year will also be covered.

Asia Regulatory Update

Asia Regulatory Update
Location: Philadelphia, PA
Room:
Speaker: Xin Min Yue, Gerry DiDonato, Munish Mehra

Description: Over the last decade, Asia has seen continued positive growth, making it a strategic region for development and marketing of medicinal products. Led by global regulatory expert Munish Mehra, PhD, this session will highlight national and regional requirements for obtaining permission to conduct clinical trials, Good Clinical Practices and filing for approval to place medicinal products on the market. You will discover current development strategies for China, India and Japan in order to understand the regulatory environment, challenges and opportunities in Asia.

Shedding Light on New Rules for Adverse Event Reporting

Shedding Light on New Rules for Adverse Event Reporting
Location: Philadelphia, PA
Room:
Speaker: Bradley Thompson, Colleen Hittle, Leighton Hansel

Description: In recent years, the combination products industry has grappled with how to address conflicting rules for reporting adverse events. FDA has published a concept paper on a proposed rule. Led by regulatory law expert Bradley Thompson, MBA, JD, RAC, this session will teach you how to apply current requirements to your company’s products and operations at both a strategic and tactical level. Industry reactions to the proposed rule, implications for drug and medical device companies that market combination products and case studies relevant to implementation will be discussed.

Submitting a BLA

Submitting a BLA
Location: Philadelphia, PA
Room:
Speaker: Jennifer Panagoulias, Joyce Frey-Vasconcells

Description: Many start-up companies have little or no experience in submitting Biologic License Applications (BLAs). FDA regulatory expert and consultant Joyce Frey-Vasconcells and other experienced professionals will discuss the FDA process and offer insights into regulatory strategies and timelines to help you meet all requirements for successful, approvable and timely BLA submissions.

Designing Clinical Trials with the Target Product Profile in Mind

Designing Clinical Trials with the Target Product Profile in Mind
Location: Philadelphia, PA
Room:
Speaker: John Wood, Jody Roth

Description: Placing an emphasis on the final product label early in development can produce significant benefits as you approach commercialization. In this session led by regulatory expert John Wood, you will learn how to establish a labeling strategy and leverage tools like FDA’s Target Product Profile to streamline development and ensure important commercial messages are built into the overall process.

1:30 PM - 3:00 PM

Improving Postmarket Device Surveillance with Healthcare Professionals

Improving Postmarket Device Surveillance with Healthcare Professionals
Location: Philadelphia, PA
Room:
Speaker: Susan Alpert, Rod Ruston, Daniel Jacob

Description: This session will include a discussion of the review of surveillance areas such as significant adverse events and medical device reporting and their links to management review, complaint boards and recalls, as well as the need to communicate this expertise to healthcare professionals.

Identifying Premarket Medical Device Issues

Identifying Premarket Medical Device Issues
Location: Philadelphia, PA
Room:
Speaker: Ronald Warren, Joel Kent

Description: In this session led by quality and regulatory affairs expert Joel Kent, RAC, you will be given a background on the subjects of FDA pre-IDE (investigational device exemption) processes for medical devices and Canadian medical device submissions. You will participate in small groups to review various case studies presented and propose workable solutions.

Improve Supply Chain Management

Improve Supply Chain Management
Location: Philadelphia, PA
Room:
Speaker: Natasha Zuyev, Londa Ritchey, Irwin Silverstein

Description: Securing the ingredient supply chain has become a hot topic for the pharmaceutical/biotech industry and legislators in recent months. In this session led by quality expert, Natasha Zuyev, you will learn key concepts for a robust supplier quality management system and how to ensure pharmaceutical ingredient quality and integrity throughout the highly complex global supply chain. This session will review challenges facing industry and suppliers, including a case study, and discuss proposed US legislation to control the ingredient supply chain as well as new industry initiatives to improve the ability to assure your pharmaceutical ingredient’s safety and prevent adulteration.

OCP Executive Staff Briefing

OCP Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Mark Kramer, Thinh Nguyen

Description: Most experts predict that combination products will continue to be a significant growth area for the healthcare industry. Industry expert and former OCP Director Mark Kramer, RAC, will moderate this session featuring leadership from FDA’s Office of Combination Products (OCP) discussing priorities and current policy initiatives, key regulations and guidance documents. You will benefit from the insight and perspectives of the Combination Products Coalition, a leading advocacy group for policy on regulatory issues affecting combination products.

Addressing Good Laboratory Practice (GLP) Testing Concerns

Addressing Good Laboratory Practice (GLP) Testing Concerns
Location: Philadelphia, PA
Room:
Speaker: Ann Wright, Cheryl Little, Alan Brown, William Barta

Description: Drug, device and/or chemical submissions all require GLP processes. If these initial data are not verified, robust and well documented, all subsequent information may be inadmissible. Led by GLP specialist Ann Wright, PhD, RAC, this session will introduce you to areas of concern with GLP testing in the early stages of new product development, including potential GLP preclinical testing issues involving an “in house” lab or contract research organization, and how the regulatory professional can be more aware of QA needs.

Top 10 Mistakes Sponsors Make in Clinical Trials

Top 10 Mistakes Sponsors Make in Clinical Trials
Location: Philadelphia, PA
Room:
Speaker: Jillian Reed, Amanda Weber

Description: Led by clinical study consultant Jillian Reed, this session will make you aware of the top 10 pitfalls medical device sponsors commonly encounter during clinical trials, such as investigational site selection, monitoring nightmares and missed enrollment deadlines. This information will help you assess both current and future clinical trials with an increased knowledge of how to complete your study successfully and get your product to market with minimal mistakes along the way.

Operations and Manufacturing Processes Demystified

Operations and Manufacturing Processes Demystified
Location: Philadelphia, PA
Room:
Speaker: Belinda Patrick, Sujal Bhalakia, Todd Jackson

Description: For top to bottom-line efficiency, it is important to understand how the intricacies of your company’s operations and manufacturing tenets impact the internal decision-making process. In this session led by Sujal Bhalakia, you will take away valuable insight on supply chain management, line flow, first pass yield, throughput, line balance and other operations and manufacturing fundamentals.

Counter-Bioterrorism Agents and the Animal Rule

Counter-Bioterrorism Agents and the Animal Rule
Location: Philadelphia, PA
Room:
Speaker: Virginia Johnson, William Egan, Karen Goldenthal

Description: In this session, William Egan, PhD, and speakers from both government and industry will address legal and regulatory issues regarding biologics/vaccines and the basics of FDA’s “Animal Rule”—what it can and cannot do and how it is being implemented in the development of counter-bioterrorism biological agents.

3:30 PM - 5:00 PM

Global Pediatric Development Programs: Fantasy or Reality?

Global Pediatric Development Programs: Fantasy or Reality?
Location: Philadelphia, PA
Room:
Speaker: Thomas Hassall, Mary Christian, Elora Gupta, Agnes Saint-Raymond, Melissa Tassinari

Description: Although US and EU requirements for pediatric programs are well established, industry is challenged to design programs that provide important information about the use of drugs and biologics in children while meeting the requirements of health authorities and not unduly exposing vulnerable populations to risk. Leading pediatric drug strategist Mary Christian, PharmD, will facilitate a panel discussion to review recent examples of challenges to global programs and explore a path forward. You will be able to provide sound strategic regulatory guidance within your organization’s development programs.

Case Studies: Advertising, Promotion and Labeling

Case Studies: Advertising, Promotion and Labeling
Location: Philadelphia, PA
Room:
Speaker: Tracey Fox, Virginia Garcia

Description: The regulatory environment for medical device advertising, promotion and labeling (APL) continues to evolve as new trends and technologies surface. Tips will be given on how to review APL materials, including internet-based materials; along with potential risks and background information on APL for medical devices. Attendees will be presented case studies that focus on lessons learned for different types of advertising, promotion and labeling and engage in problems-solving to propose tips for handling materials based on product approval documentation, compliance with the CFR and emerging internet-based promotional trends. Attendees are encouraged to read the accompanying session handouts prior to attending the session.

A Closer Look at Standards for Medical Devices

A Closer Look at Standards for Medical Devices
Location: Philadelphia, PA
Room:
Speaker: Mireille De Cre, Alex Grob, Roland Rotter, Scott Colburn

Description: This session will address the increasing role that standards (design, testing, labeling) are playing as de facto requirements for global premarket submissions, and why regulatory professionals need to understand more about this increasingly critical area. The discussion will include a look at how emerging developments and trends are shaping medical device regulation.

Ethical Standards in Clinical Research

Ethical Standards in Clinical Research
Location: Philadelphia, PA
Room:
Speaker: Diane Minear, Arthur Caplan, William Sietsema

Description: Many experts believe individual institutions and associations should adopt stricter standards of conduct in clinical research than those reflected in current federal regulations, which do not hold investigators or institutions responsible for supervising and training clinical trial staff. Led by development program expert William Sietsema, PhD, this session will show you how to recognize and address fraud and misconduct—from improper patient protection and falsification of data to sponsor payments to investigators for nonclinical study-related expenses and disclosure obligations under 21 CFR Part 54.

Key Points for GMP-Production Compliance

Key Points for GMP-Production Compliance
Location: Philadelphia, PA
Room:
Speaker: Robert Schiff, John Atwater, Efrem Zaret

Description: Understanding the key requirements of Good Manufacturing Practice (GMP)-production compliance is essential for regulated industry. Led by compliance expert Robert Schiff, PhD, RAC, this session will cover the GMP regulations, documentation requirements, corrective and preventive action (CAPA) plans, self-examination and internal auditing. Compliance from the receiving area to the warehouse, staging, manufacturing, packaging, shipping and quality control, and areas of FDA inspection focus will be discussed.

Health Canada Executive Staff Briefing

Health Canada Executive Staff Briefing
Location: Philadelphia, PA
Room:
Speaker: Patricia Anderson, Supriya Sharma

Description: Health Canada’s Blueprint for Renewal aims to modernize Canada’s regulatory processes by transforming its legislative, regulatory and policy frameworks. In this session led by Canadian regulatory expert Patricia Anderson, RAC, you will hear from a senior representative regarding the agency’s progress on this and other key initiatives as well as future plans. You will gain an understanding of how these changes could impact the requirements when operating within this well-established regulatory regime.

Government Affairs and the Regulatory Professional

Government Affairs and the Regulatory Professional
Location: Philadelphia, PA
Room:
Speaker: Paul Barry, Andrea Durkin, Steve Lapierre

Description: Led by legislative expert Paul Barry, this session will greatly enhance your ability to contribute to your company’s implementation of new policies and regulations. The role of government affairs in evolving regulations and business practices, individual company/trade group lobbying at the state and federal levels and forecasting/tracking of potential legislative actions will be addressed.

Biopharmaceutical Preclinical Safety Evaluation: The Case-by-Case Approach

Biopharmaceutical Preclinical Safety Evaluation: The Case-by-Case Approach
Location: Philadelphia, PA
Room:
Speaker: Joy Cavagnaro, Wei Liang, Melanie Hartsough, Ronald Wange

Description: To safely introduce novel therapies into clinical trials, preclinical safety evaluation programs for biopharmaceuticals are customized based upon specific product attributes (i.e., the case-by-case approach) and enhanced utilizing experience with similar products. In this session, toxicology expert Joy Cavagnaro, PhD, RAC, will lead current and former FDA regulatory scientists in a discussion of key considerations for the successful implementation of the “case-by-case” approach and how to better predict whether programs will be acceptable to regulators. Presentations will address recombinant proteins, monoclonal antibodies, and cell and gene therapies.

Wednesday, 16 September 2009
8:30 AM - 10:00 AM

Presenting Benefit/Risk Data for Regulatory Reviews

Presenting Benefit/Risk Data for Regulatory Reviews
Location: Philadelphia, PA
Room:
Speaker: Paul Coplan, Carrie Corboy, Bennett Levitan, Patrick Frey

Description: Regulatory agencies have increasingly expressed a need to improve methodology, transparency, consistency and communication of benefit/risk information for new drug (or indication) approvals. You will learn how safety and efficacy information is provided in NDA submissions, and the difficulties faced by reviewers of that data in assessing benefit vs. risk in a drug, in this session led by drug safety expert Carrie Corboy, PharmD. Methodologies being developed to address these difficulties and to standardize presentations in a qualitative and semi-quantitative manner will be introduced.

Traversing the Canadian Regulatory Landscape

Traversing the Canadian Regulatory Landscape
Location: Philadelphia, PA
Room:
Speaker: Mary Speagle, Greg LeBlanc, Brigitte Zirger, Roland Rotter

Description: You will learn the route your combination product must take in the Canadian approval process and hear information on Canada’s current regulatory environment for combination products in contrast with other jurisdictions in this session led by Canadian regulatory expert Mary Speagle, RAC. Discussions will include the role of the Therapeutic Products Classification Committee and application techniques for various policy and illustrative case studies will be presented along with upcoming initiatives under the Blueprint for Renewal.

CLIA: Ensuring Quality Laboratory Testing

CLIA: Ensuring Quality Laboratory Testing
Location: Philadelphia, PA
Room:
Speaker: Erika Ammirati, Brooke Bumpers

Description: This session, led by Brooke Bumpers will review the Clinical Laboratory Improvement Amendments (CLIA) of 1988, CLIA regulations for laboratories, FDA CLIA Complexity Categorization Process and CLIA Waiver Applications for in vitro diagnostics. Reimbursement considerations and processes will be discussed. You will take away strategies that can be implemented within your organization to improve business.

FDA's New Approach to Good Manufacturing Practice Requirements

FDA's New Approach to Good Manufacturing Practice Requirements
Location: Philadelphia, PA
Room:
Speaker: Kimberly Trautman, James Cohen, Zena Kaufman

Description: Currently, there are no regulations describing or prescribing Good Manufacturing Practices for combination products, and there is recognition within FDA, industry and the legal community that further regulatory and inspectional clarity and guidance are needed. Led by regulatory law expert James Cohen, Esq., this session will provide you with an overview of FDA’s proposed rule on CGMPs for combination products, the legal basis and rationale, the implications for device and drug companies, case studies on how to meet the requirements, alternatives to the proposed rule and views on whether FDA’s approach is the appropriate one for the agency and industry.

Rx-to-OTC Switch

Rx-to-OTC Switch
Location: Philadelphia, PA
Room:
Speaker: Susan James, Stephen Champion, Helen Darracott, Dennis Nelson

Description: Regulatory hurdles for moving a product from prescription to over-the-counter (OTC) status are stringent, but the switch can offer both public health benefits and enhanced return on R&D investment for the manufacturer. In this session led by global regulatory and compliance expert Susan James, industry representatives will explore the unique challenges of extending product lifecycle through an Rx-to-OTC switch, with switch strategies focusing on decision makers, influences and processes.

Safety Review in Medical Device Trials

Safety Review in Medical Device Trials
Location: Philadelphia, PA
Room:
Speaker: Carlos Lugo-Ponce, Jeff Hersh, Marguerite Brackley, Dana Washburn

Description: This session will address the basic elements of a medical device clinical trial safety system, including safety issues unique to devices, core elements of a premarket device trial safety review process, and highlights of the critical linkage of postmarket trials to overall postmarket surveillance requirements, risk management, and quality systems.

Validation Compliance: What's Required?

Validation Compliance: What's Required?
Location: Philadelphia, PA
Room:
Speaker: Penny White, Denis Kluba, Simon Rusmin

Description: Having a firm understanding of what areas require qualification and validation to meet FDA expectations is critical to the regulatory process. Regulatory law expert Denis Kluba, will lead this session, providing an overview of areas to be qualified/validated, with examples in equipment, purified water system, analytical methods, as well technical transfers from R&D to manufacturing or intra-plants.

Defining Homologous Use

Defining Homologous Use
Location: Philadelphia, PA
Room:
Speaker: Suzanne O'Shea, Areta Kupchyk, Joyce Frey-Vasconcells

Description: Many companies think they have a tissue product that is for homologous use and are surprised when they receive notification from FDA indicating otherwise. You will learn how to interpret and apply the criteria for HCT/P tissue regulation, as well as other information needed for FDA submission, in this session led by regulatory and tissue expert Joyce Frey-Vasconcells.

10:30 AM - 12:00 PM

Cardiac Safety From Clinical to Postmarketing

Cardiac Safety From Clinical to Postmarketing
Location: Philadelphia, PA
Room:
Speaker: Bernhard Heiles, Daniel Macneil, Patrick Martin, James Ermer

Description: Cardiac safety is still the number one cause for approval process delay or termination by regulatory authorities. It is also one of the leading causes of market recalls. Led by pharmacovigilance expert Bernhard Heiles, MD, PhD, this session will teach you about potential cardiac effects, such as heart muscle, electrical conduction or oxygen use, and ways to document and interpret them in light of regulatory requirements for drug development and lifecycle management. The importance of regulatory involvement in broad cardiac safety and risk management efforts will be highlighted enabling you to see the “big-picture” of cardiac safety throughout the lifecycle of your product.