MONDAY, 15 SEPTEMBER
Recent Advances in Oncology Drug Development
Professional Levels: I, II, III
11:00 am - 12:00 pm | Room 304
In the US alone, approximately 1.4 million men and women are expected to be diagnosed in 2008 with some form of cancer. As science continues to advance and new drug and therapeutic biologic cancer treatments are developed, the role of regulatory agencies in ensuring the safety and efficacy of these emerging medicines has become increasingly important. In this session, you will examine the role of regulatory agencies in facilitating development, review and action on promising new cancer therapies. You will also gain insight into devising strategies for constructive agency interactions as well as an understanding of the rationale behind recent approvals.
Session Leader:
Aileen Ryan, vice president, regulatory affairs, Optherion Pharmaceuticals
Speakers:
Aileen Ryan, vice president, regulatory affairs, Optherion Pharmaceuticals
Rajeshwari Sridhara, PhD, deputy director, Office of Biostatistics, Division of Biometrics V, Center for Drug Evaluation and Research, US Food and Drug Administration
Pediatric Drug Development in the US and EU
Professional Levels: I, II, III
11:00 am - 12:00 pm | Room 302
US and EU regulatory agencies have promulgated regulations governing pediatric clinical trials to promote the registration of new drugs for pediatric populations.
In this session, you will explore the unique challenges for pharmaceutical companies raised by recent legislation, while comparing pediatric regulations in the US and EU. Expert speakers will outline the role that regulatory agencies play in enhancing global pediatric development and share strategies for navigating the complex regulatory environment.
Session Leader:
Jethro E. Ekuta, DVM, PhD, group director, aggregate safety reports group, Bristol-Myers Squibb Company
Speakers:
Jethro E. Ekuta, DVM, PhD, group director, aggregate safety reports group, Bristol-Myers Squibb Company
Jean W. Temeck, MD, lead medical officer, Office of Pediatric Therapeutics, Office of International Activities and Strategic Initiatives, Office of the Commissioner, US Food and Drug Administration
Emerging Markets and Regulatory Agencies: Latin America
Professional Levels: I, II, III
1:30 - 3:00 pm | Room 302
Latin America is one of the most rapidly expanding pharmaceutical markets and its regulatory processes are evolving at an equally swift pace.
Expert speakers will share first-hand knowledge, outline the regulatory structure and current regulatory processes of the emerging pharmaceutical market of Latin America. You will also hear about the increased focus on clinical trials and speakers will provide insight into the future direction of this region’s regulatory environment. You will gain an understanding of the regulatory differences and similarities for countries within this region.
Session Leader:
Marcela Saad, PharmD, president and senior consultant, MarcM Consulting Canada
Speakers:
Wendy Buckland, vice president, Latin America, Pharmaceutical Product Development Inc.
Graciela C. Racaro, RPh, senior director, Latin America operations, Parexel International LLC
Marcela Saad, PharmD, president and senior consultant, MarcM Consulting Canada
Issues With Bioavailability, Bioequivalence and Therapeutic Equivalence
Professional Levels: I, II, III
1:30 - 3:00 pm | Room 306
For the majority of drug products, demonstrating therapeutic equivalence and bioequivalence is straightforward, but certain classes of pharmaceuticals—specifically complex, local acting and topical products—have historically posed difficult scientific and marketing challenges. These challenges are not seen exclusively by generic companies; major CMC changes by the originator may require the innovator to show equivalence as well.
In this session, you will hear perspectives from industry and agency representatives, regarding the challenges of, and approaches to, showing bioavailability, bioequivalence and therapeutic equivalence for your product. You will discover valuable solutions to overcoming these difficulties to effectively get your product to market.
Session Leader:
Patricia R. Anderson, RAC, vice president, regulatory services, Canreg Inc.
Speakers:
Barbara M. Davit, JD, PhD, acting director, Division of Bioequivalence II, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration
Avraham Yacobi, PhD, PharmD, president, research and development, Taro Pharmaceuticals USA Inc.
CDER Executive Staff Briefing
Professional Levels: I, II, III, IV
3:30 - 5:00 pm | Level 3 Ballroom
This popular and informative session features a senior staff representative from US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) who will address regulatory reform initiatives, current trends, new guidelines and CDER plans for the coming year as well as reflections on activities of the past year.
Session Leader:
Paul D. Huckle, senior vice president, regulatory affairs, GlaxoSmithKline Inc.
Speaker:
Douglas Throckmorton, MD, deputy director, Office of the Director, Center for Drug Evaluation and Research, US Food and Drug Administration
TUESDAY, 16 SEPTEMBER
Seeking Balance: Regulation, Innovation and Cost-Containment of Orphan Biopharmaceuticals
Professional Levels: II, III
11:00 am - 12:00 pm | Room 306
Before 1983, there were only 34 orphan products in the US, 10 of which were developed by industry. Today there are more than 200.
This session will explore the current regulatory landscape of orphan drugs from both US and EU perspectives, celebrating the successes while looking forward to assess tomorrow’s challenges and opportunities. You will gain a stronger understanding of pertinent regulations, programs and potential future initiatives and discover why a symbiotic relationship between regulatory agencies, industry and patient organizations is critical to orphan product development.
Session Leader:
Diane Edquist Dorman, vice president, public policy, National Organization for Rare Disorders
Speakers:
Timothy R. Coté, MD, MPH, director, Office of Orphan Products Development, US Food and Drug Administration
Diane Edquist Dorman, vice president, public policy, National Organization for Rare Disorders
Postmarket Surveillance for Pharmaceuticals
Professional Levels: I, II, III
11:00 am - 12:00 pm | Room 311
While medicines have led to major improvements in the treatment and control of diseases, they also may occasionally have adverse effects on the human body.
In this session, you will compare and contrast the current pharmacovigilance environment for pharmaceutical products marketed in the US and EU. You will be exposed to real-time pharmacovigilance and regulatory scenarios that demonstrate the challenges facing US companies who would like to gain market authorization in the EU. These challenges include selection of a Qualified Person for Pharmacovigilance (QPPV) and navigating the European regulatory complexities of approval and compliance with Volume 9A of The Rules Governing Medicinal Products in the European Union.
Session Leader:
Joseph P. Knight-McKenna, RAC, senior director, quality and regulatory compliance, Drug Safety Alliance Inc.
Speakers:
Joseph P. Knight-McKenna, RAC, senior director, quality and regulatory compliance, Drug Safety Alliance
Toni Piazza-Hepp, PharmD, deputy director, Office of Surveillance and Epidemiology, Division of Surveillance and Communication Support, Center for Drug Evaluation and Research, US Food and Drug Administration
Update on Defining Cardiac Safety Using QTc
Professional Levels: II, III
1:30 - 3:00 pm | Room 310
For new drugs, cardiac safety is the number one cause for delay or termination during the approval process by regulatory authorities. It is also the leading cause of market recalls.
In this session, you will gain an understanding of how the safety concerns posed by QT prolongation have been addressed by regulatory initiatives through ICH E14 and implemented by the US Food and Drug Administration’s (FDA) QT Interdisciplinary Review Committee. Presentations will review current FDA and ICH E14 guidelines for the usual non-cardiac development program and will discuss cytotoxic oncology drugs that do not fit into the classic ICH E14 paradigm.
Session Leader:
Joel Morganroth, MD, chief scientist, eResearch Technology Inc.
Speakers:
Howard J. Fingert, MD, senior director, therapeutic area safety head oncology, Pfizer Global Research and Development
Joel Morganroth, MD, chief scientist, eResearch Technology Inc.
CHMP/EMEA Executive Staff Briefing
Professional Levels: I, II, III
1:30 - 3:00 pm | Room 302
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the agency’s opinions on all questions concerning medicinal products for human use, in accordance with Regulation (EC) 726/2004.
In this session, you will hear an EMEA representative discuss the committee’s activities of the past year and address plans for the upcoming year.
Session Leader:
Susan E. James, vice president, worldwide regulatory affairs, R&D compliance and quality, GlaxoSmithKline Consumer Healthcare
Speaker:
Peter Richardson, PhD, scientific administrator, Quality of Medicines Sector, Human Unit Pre-Authorisation, European Medicines Agency
Quality by Design: ICH Q8, Q9 and Q10
Professional Levels: I, II, III
3:30 - 5:00 pm | Room 311
The International Conference on Harmonisation (ICH) Guidelines Q8, Q9 and Q10 have introduced new manufacturing concepts for drug products––quality-by-design, design space and quality systems.
You will learn how these new concepts will significantly impact the pharmaceutical industry and the regulatory landscape with regard to drug development and lifecycle management and uncover opportunities, challenges and experiences to date presented by ICH Q8, Q9 and Q10.
Session Leader:
Robert E. Yocher, RAC, vice president, regulatory affairs and corporate quality compliance, Genzyme Corporation
Speakers:
Joseph C. Famulare, deputy director, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration
Richard Shansky, PhD, senior director, regulatory affairs, Genzyme Corporation
Russell F. Somma, PhD, president, SommaTech LLC
WEDNESDAY, 17 SEPTEMBER
Emerging Markets and Regulatory Agencies: Asia
Professional Levels: I, II, III,
8:30 - 10:00 am | Room 312
The emerging Asian pharmaceutical markets—particularly China and India—provide numerous opportunities for companies looking to expand their global operations.
You will gain knowledge of regulatory agencies’ structures and processes in these countries, review activities of the last year and hear potential plans for the upcoming year. This session will expose you to the benefits and barriers of operating within this ever-changing regulatory environment.
Session Leader:
Maha Lakkis, PhD, RAC, senior manager and liaison, global regulatory affairs, Schering-Plough Corporation
Speakers:
Maha Lakkis, PhD, RAC, senior manager and liaison, global regulatory affairs, Schering-Plough Corporation
Munish Mehra, PhD, managing director, Global Drug Development Experts LLC
Rx-to-OTC Switch
Professional Levels: II, III, IV
8:30 - 10:00 am | Room 306
Over-the-Counter (OTC) approval of an established medicinal product benefits public health by increasing access to safe, effective medicines and allows parent companies to re-establish the brand, thereby seeing additional long-term return on their investments. Depending upon the market, the switch candidates can be limited; hurdles for regulatory approval high; and success may be impacted by the access level and pharmacist involvement.
During this session, you will hear industry representatives explore the unique challenges of extending product lifecycle through an Rx-to-OTC switch. You will assess US, Canadian and EU switch strategies focusing on decision makers, influencers and processes for a successful switch.
Session Leader:
David J. Schifkovitz, director, regulatory affairs, GlaxoSmithKline Consumer Healthcare Inc.
Speakers:
David J. Schifkovitz, director, regulatory affairs, GlaxoSmithKline Consumer Healthcare Inc. Robert Zielinski, RAC, regulatory affairs manager, GlaxoSmithKline Consumer Healthcare Canada Inc
Risk Assessment of Pharmaceuticals in the Environment (PIE)
Professional Levels: I, II, III
10:30 am - 12:00 pm | Room 312
Active ingredients of human medicinal products may be introduced into the environment after use in patients, posing novel health and environmental concerns for both federal authorities and private businesses. Environmental risk assessments facilitate the determination of methods to effectively minimize the impact of contaminants on public health and the environment.
In this session, you will learn why it is essential that an environmental assessment be submitted for new substances used in medicinal products to accurately evaluate their environmental impact and risk. Environmental specialists and industry speakers will examine how healthcare product manufacturers can develop and implement specific risk management strategies.
Session Leader:
Nathalie Ross, PhD, senior regulatory affairs associate, Canreg Inc.
Speakers:
Edward T. Furlong, PhD, research chemist, methods research and development program, National Water Quality Laboratory, US Geological Survey
Roger D. Meyerhoff, PhD, senior research advisor, environmental risk assessment, Lilly Research Laboratories, Eli Lilly and Company
Nathalie Ross, PhD, senior regulatory affairs associate, Canreg Inc.