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Trk 08: Reg Affairs [clear filter]
Sunday, June 26
 

8:30am

#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in designing individual clinical trials and overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval.

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples and case studies that illustrate approaches to adopt or to avoid.

Who should attend?

This tutorial is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

• Identify ways to increase the efficiency and success of product development programs;
• Describe key principles for successful regulatory interactions during drug development and marketing application preparation;
• Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents.


Speakers
avatar for Elaine Taylor

Elaine Taylor

Executive Director, Regulatory Consulting and Submissions, INC Research
Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 years... Read More →
avatar for Kathryn Wekselman

Kathryn Wekselman

Senior Director, Regulatory and Scientific Affairs, CTI Clinical Trial and Consulting Services
Kathryn Wekselman is Senior Director of Scientific and Regulatory Affairs at CTI Clinical Trial and Consulting Services in Cincinnati, OH. Before joining CTI in 2012, she worked for 5 years at CROs as a Director and Senior Director of regulatory consulting and submissions for pharmaceutical... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials Register today for this tutorial.

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. In 2015, Chinese good clinical practice (GCP) guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some GCPs are overturning common ways that were implemented since 2003. The CFDA is enhancing inspective forces on the quality and integrity of clinical trial outcomes. GCP requirements on medical devices and diagnostics have also been strengthened by CFDA. The procedures of investigator new drug/new drug application (IND/NDA) review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug and medical devices/diagnostic strategies in China. This tutorial will provide insights into critical considerations impacting IND/NDA practices involving drugs and medical devices/diagnostics development in China and upcoming CFDA reformations of regulatory submission review and approval.

Who should attend?

This tutorial is designed for professionals in regulatory affairs, drug development, medical device/diagnostics, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug and medical device trials.

Learning Objectives

• Describe basic CFDA regulatory requirements for an IND/NDA process;
• Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs;
• Discuss the updated Chinese GCP guidelines for IND drug trials;
• Explain how to be compliant with Chinese GCP standards in the implementation of clinical trial;
• State how to complete the IND/NDA application process to the CFDA.


Speakers
EH

Earl Hulihan

Professor, SUTCM
Professor Hulihan is Principal with ew hulihan and associates, inc. For over 35+ years, Hulihan has been active in the DIA, in Medicine, as well as providing regulatory consulting, auditing, and training services to the global pharmaceutical community and regulatory authority personnel... Read More →
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japanese drug development with East Asian and global drug development, accelerated approval pathways (sakigake; regenerative medicine), orphan drug regulation and J-NDA review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

This tutorial is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

• Explain the major elements of the Japanese regulatory system;
• Describe the regulatory procedures during development, registration, and post-approval;
• Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.


Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#31: Preparing for a US FDA Advisory Committee Meeting
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This tutorial teaches best practices for preparing for an FDA Advisory Committee meeting, and it is set up like an actual Advisory Committee meeting.

What You Will Learn:
• What is an advisory committee?
• What does an advisory committee “look like”?
• Critical factors for advisory committee preparation
• How to design the most applicable preparation program for your team
• Top ten “best practices” and “must avoids.”

Who should attend?

This tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

• Identify the critical factors in preparing for a successful advisory committee meeting;
• Recognize and evaluate those factors that are most applicable to your team;
• Design the most effective preparation for your team(s).


Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Independent Regulatory Consultant, PharmApprove
Kaia Agarwal is an independent strategic regulatory affairs consultant working with PharmApprove. She helps teams prepare and implement global regulatory strategy for their products as they prepare for critical interactions with regulators, including EMA and FDA. For over 27 years... Read More →
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#34: Ethical Issues in Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Who should attend?

This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.

Learning Objectives

• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject when educating clinical study site staff about ethical considerations.


Speakers
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

8:30am

#110: Updates and Pending Issues in the US Biosimilar Environment
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-544-L01-P; CME 1.25; IACET 1.25; RN 1.25

The US biosimilars market is maturing rapidly. In the past year, we’ve seen the first biosimilar launch in the US market, multiple draft guidances on biosimilars and biologics emerge from the FDA, and several biosimilar applications that focus on diverse range of complex reference products. The debate and discussion in the US around biosimilars highlights the importance of the biosimilars market to the US drug industry, and the continued impact of the 2010 Biologics Price Competition and Innovation Act. This panel will discuss recent developments in US biosimilars regulation from a manufacturer’s perspective, lessons learned, and areas that would benefit from further global policy discussion.

Learning Objectives

Discuss recent developments in US biosimilar regulation: Identify areas that would benefit from further global policy discussion.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Panelist
Karen M Hauda

Panelist
Mark McCamish

Panelist
Kimberly Greco



Chair
AR

Andrew Robertson

Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry... Read More →

Speakers
avatar for Kimberly Greco

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
avatar for Karen Hauda

Karen Hauda

Senior Director, Regulatory Policy, Novo Nordisk A/S
Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the... Read More →
avatar for Mark McCamish

Mark McCamish

Global Head Biopharm and Oncology Injectables Development, Sandoz, Inc
Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.


Monday June 27, 2016 8:30am - 9:45am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recently we have seen increased efforts of Asian regulatory harmonization. Hear speakers from Asian agencies and industry and learn how they try to collaborate and harmonize regulations to enable more efficient drug development in this emerging region.

Learning Objectives

Discuss recent changes in drug development regulations in Asia; Describe the Asian regulation trend relating to harmonization with ICH and other global initiatives; Identify how the industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent examples of global drug development utilizing multiregional clinical trials including Asia.

Chair

Akio Uemura, PhD

Speaker

Update on Clinical and Regulatory Environment for Drug Development in Korea
Min Soo Park

Rapidly Changing Regulatory Landscape in China
Dan Zhang

Impacts of ICH E17 Guideline in Asian Drug Development
Yoshiaki Uyama, PhD



Chair
avatar for Akio Uemura

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

Speakers
avatar for Min Soo Park

Min Soo Park

Chair, KCGI
Min Soo Park is a physician, trained specialist and Professor in Pediatrics (Neonatology) and Clinical Pharmacology. He received MSc in Clinical Pharmacology at Univ of Aberdeen, UK, and Ph.D. in Medicine at Ajou University, Korea. He served as VP of KoNECT and is in charge of clinical... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →


Monday June 27, 2016 8:30am - 9:45am
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#112: The Upcoming European Clinical Trials Regulation
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will give an opportunity to understand the requirements of the new European Clinical Trial Regulation, the IT developments for its implementation, and to discuss the expectations and preparedness for implementation by global sponsors.

Learning Objectives

Recognize the requirements of the new clinical trial regulation; Discuss major information technology developments required for its implementation; Describe the impact of the regulation for the main stakeholders; Identify the expectations and challenges to be faced by global sponsors.

Chair

Anabela Marcal, PharmD

Speaker

The EU Portal and Database: A Pillar of the Clinical Trial Regulation
Anabela Marcal, PharmD

Getting Ready for the Changes: A Sponsor Perspective
Nick Sykes, MS

Transparency in Clinical Trials: A European Update
Marie-Agnes Heine, MA



Chair
avatar for Anabela Marcal

Anabela Marcal

Head of Committees and Inspections Department, European Medicines Agency (EMA),
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.

Speakers
avatar for Marie-Agnes Heine

Marie-Agnes Heine

Head of Communication Department, Stakeholders and Communication Division, European Medicines Agency, European Union
Marie-Agnes Heine is Head of Communication Department at the European Medicines Agency, London. She is a senior external relations and communications specialist with 25 years of experience in communications strategy development and implementation, journalism, advocacy and media campaigns... Read More →
avatar for Nick Sykes

Nick Sykes

Senior Director, Worldwide Regulatory Strategy, Pfizer Ltd.
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip... Read More →


Monday June 27, 2016 8:30am - 9:45am
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.

Chair

Khyati Roberts, RPh

Speaker

The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead



Chair
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation... Read More →


Monday June 27, 2016 10:45am - 12:00pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.

Chair

Martha Ann Brumfield, PhD

Speaker

FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD



Chair
avatar for Martha Brumfield

Martha Brumfield

President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory... Read More →

Speakers
avatar for ShaAvhree Buckman-Garner

ShaAvhree Buckman-Garner

Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the... Read More →
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#220: Regulatory Changes in China and the Impact to Global Drug Development Planning
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

In August 2015, the Chinese Food and Drug Administration (CFDA) issued extensive changes to drug reviews and approvals. It has effectively redefined the definition of a new drug and the approval process for any new drug development as well as generics. While China is becoming the second largest pharmaceutical market, it would benefit all firms to carefully review and digest the impact of such a change to their global drug development planning; in turn, this allows them to take advantage of this change and properly adapt. This session will highlight the changes that have a direct impact on the clinical development strategy and share case studies with the audience to illustrate the best approach in handling these regulatory changes.

Learning Objectives

Recognize changes made by the Chinese Food and Drug Administration to drug reviews and approvals; Identify how to best leverage these changes for your new drug developments and generics.

Chair

Dan Zhang

Speaker

Innovative Biopharmaceutical Drug Development in China: Trends and Transformations
Helena Zhang

Regulatory Changes in China
Feng Yi

Outline of Reforming IND/NDA Practice in China
Fudong An



Chair
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →

Speakers
avatar for Feng  Yi

Feng Yi

Former Assistant to the Director-General, CFDA; SVP, Medical and Reg Affairs, Fountain (Beijing) Medical Technology Development Co., Ltd.
avatar for Helena Zhang

Helena Zhang

Senior Director and Chief Medical Officer, Quintiles
Dr. Helena Zhang, MD. MBA is Senior Director and Chief Medical Officer for Quintiles in the Greater China region. In this role she provides medical and ethical leadership of projects conducted by Quintiles in China. She enhances the strategic partnerships with top hospitals, Key Opinion... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-552-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on specific aspects of the regulatory development of novel combination biologics, as well as bifunctionals. Specific considerations for each of these modalities for different clinical stages and therapy areas will also be addressed, and a comparison/contrast of development requirements for each will be provided.

Learning Objectives

Describe the regulatory requirements for development of combinations of novel biologicals and bifunctional biologics.

Chair

Owen Fields, PhD

Speaker

Unique Challenges in the Regulation of Bispecific Antibodies
Raj G Nair, MD

Unique Preclinical and Clinical Aspects of Bifunctional Development
Rakesh Dixit, PhD

Q and A Panel
Badrul Chowdhury, MD, PhD



Chair
avatar for Owen Fields

Owen Fields

Vice President, Inflammatory and Immunology, WW Safety and Regulatory, Pfizer Inc
I received my Ph.D. in molecular and cellular biology from Berkeley. Following this I worked in food biotechnology regulation at the US FDA. I then moved to regulatory strategy at Wyeth where I worked in autoimmune disease, tissue repair, and other areas. After the merger with Pfizer... Read More →

Speakers
avatar for Badrul Chowdhury

Badrul Chowdhury

Director, Division of Pulmonary, Allergy, and Rheumatology Products, OND, CDER, FDA
Dr. Badrul A. Chowdhury is the Director of the Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration. Dr. Chowdhury is trained and board certified in Internal Medicine, and in Allergy and Immunology, and... Read More →
avatar for Rakesh Dixit

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune
RN

Raj Nair

Medical Officer, DPARP, OND, CDER, FDA
I am a medical officer within the Division of Pulmonary Allergy, and Rheumatology since 2013. I was previously an assistant professor in Rheumatology at Georgetown University with an interest in use of musculoskeletal ultrasound in diagnosis and management of patients with rheumatic... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Sean Tunis

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#266: Perspectives on Expanded Access to Investigational New Drugs
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-545-L01-P; CME 1.25; IACET 1.25; RN 1.25

Expanded access is the use of an investigational drug outside of a clinical trial or study. This forum will provide an opportunity to hear perspectives from regulators, industry, and patients on the use of expanded access in drug development.

Learning Objectives

Describe the different types of expanded access investigational new drugs; Explain why a sponsor might consider expanded access in their drug development programs; Recognize the patient's role and perspective on expanded access programs.

Chair

Kevin Bugin, MS, RAC

Speaker

Introduction and FDA Regulator Perspective
Jonathan P. Jarow, PhD

Industry Perspective on Expanded Access
Kenneth I. Moch, MBA

Patient Advocacy and Expanded Access
Robert Erwin

Industry Perspective on Expanded Access
Anne B. Cropp, PharmD



Chair
avatar for Kevin Bugin

Kevin Bugin

Director of Special Programs, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Office of New Drugs as the Director of Special Programs, leading various internally driven initiatives for the enhancement of the new drugs regulatory program. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple... Read More →

Speakers
avatar for Anne Cropp

Anne Cropp

Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and... Read More →
avatar for Robert Erwin

Robert Erwin

President, Marti Nelson Cancer Foundation
Robert L. Erwin is co-founder and President of the Marti Nelson Cancer Foundation, a cancer patient advocacy organization with a focus on access to experimental medicine. He has served as a member of the Cancer Policy Forum of the Institute of Medicine, a member of the Research Committee... Read More →
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... Read More →
avatar for Kenneth Moch

Kenneth Moch

Managing Partner, Salutramed Group, LLC
Mr. Moch is Managing Partner of The Salutramed Group, a strategic/operational advisor to life science companies. He has been co-founder or CEO of 4 firms developing therapies for life-threatening diseases and most recently was CEO of Chimerix. In August 2014, Mr. Moch and Arthur Caplan... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-549-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum will examine how the international regulatory community is responding to the challenge of pediatric product development (limited access to patients) with alternative strategies to generate meaningful data and enhance program efficiency.

Learning Objectives

Discuss the unique challenges and opportunities associated with development of therapies for pediatric populations; Describe how stakeholders can work together to improve the development of, evaluation of, and application of innovative strategies that will advance pediatric product development; Identify opportunities to translate policy into advances for the field of pediatric drug development.

Chair

Christina Bucci-Rechtweg, MD

Speaker

FDA Perspective
Lynne P. Yao, MD

FDA Perspective
Mary Dianne Murphy, MD

Health Canada Perspective
Ariel E. Arias

Panelist
Jordi Llinares Garcia



Chair
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 16 yrs of experience in Clinical Development and Regulatory Policy... Read More →

Speakers
avatar for Ariel Arias

Ariel Arias

Senior Advisor, Centre for Biologics Evaluation, BGTD, Health Canada
Dr Arias has many years of experience in the assessment of drug products. He has provided expert advice for a number of drug safety regulatory initiatives and represented Health Canada in various international drug regulatory technical committees (e.g., ICH, PAHO). He is an adjunct... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... Read More →
MM

Mary Murphy

Director, Office of Pediatric Therapeutics, Office of Special Medical Programs, FDA
Dianne Murphy, MD, FAAP, is Director of the Office of Pediatric Therapeutics (OPT) Office of the Commissioner at FDA. Dr. Murphy was a medical officer at Bethesda Naval; Dir. of the virology laboratory at the U. of Tenn., Knoxville & tenured Professor at the U. of Florida, Jacksonville... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-553-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient engagement in the development of medicinal products is a high interest topic with rapidly evolving methodological work. This session will articulate the needs and interests of patients, industry, and regulators.

Learning Objectives

Discuss the importance, context, approaches to and appropriate use of patient preferences, particularly in benefit-risk evaluation, across the product life cycle; Evaluate and propose solutions to regulatory and methodological challenges for patient engagement and the assessment of patient preferences.

Chair

Rebecca A. Noel

Speaker

Regulatory Perspective
Isabelle Moulon, MD

Patient Perspective
Andrea Stern Ferris

Industry Perspective
Bennett Levitan



Chair
avatar for Rebecca Noel

Rebecca Noel

Global Benefit-Risk Lead, Global Patient Safety, Eli Lilly and Company
Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA... Read More →

Speakers
avatar for Andrea Ferris

Andrea Ferris

President and Chairman, LUNGevity Foundation
Andrea is the President and Chairman of LUNGevity. In her role as President of LUNGevity, Andrea is responsible for setting and executing the strategic direction of the organization and its science programs. Prior to LUNGevity, Andrea had a variety of management experiences. She worked... Read More →
avatar for Bennett Levitan

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology, Janssen Research & Development, LLC
Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and his team has led numerous clinical teams in benefit-risk assessments and patient preference studies. He co-led... Read More →
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

Companies’ global development strategies and the competency of many maturing regulatory authorities are evolving. Which practices and processes will lead to an optimal future regulatory environment that expedite availability of new medicines?

Learning Objectives

Identify current global development and submission strategies for new medicines; Describe potential changes to the global regulatory landscape over the next ten years and realistic scenarios for regulatory review as medicines regulation evolves based on regulatory science; Discuss current and future regulatory barriers to global development and licensing and possible potential solutions.

Chair

Prisha Patel, MSc

Speaker

Industry Perspective
Joseph C. Scheeren, PharmD

WHO Perspective on Medicines Development in the Emerging Markets
Mike Ward



Chair
PP

Prisha Patel

Manager, Global Development Programme, Centre For Innovation In Regulatory Science (CIRS)
Prisha Patel is the Manager for the Global Development programme at the Centre for Innovation in Regulatory Science (CIRS), London, focusing on emerging markets. Her responsibilities include managing the emerging markets industry benchmarking and agency benchmarking projects and working... Read More →

Speakers
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-550-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patients with unmet medical needs want early access to medicines. Regulators need to feel confident that the the benefit-risk balance of a medicine they are licensing is positive. Regulators from the EU, Japan, and the US will discuss how access to medicines can be speeded up and the use of postmarketing data to reduce the uncertainties.

Learning Objectives

Recognize the concepts and current progress with speeding up access to medicines in different regions.

Chair

Stella C.F. Blackburn

Speaker

Sooner or Later? Cost and Benefit of Utilizing Rolling Reviews in US and Japan
Toshiyoshi Tominaga

EU Adaptive Pathways Process
Hans-Georg Eichler

Expedited Reviews and Using Postmarketing Data to Supplement Clinical Trials
Gerald J. Dal Pan, MD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#364: Cell and Gene Therapies: Current Global Landscape
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session aims to cover the current global regulatory landscape for products belonging to gene therapy, cell therapy, and regenerative medicine, a rapidly emerging class of medicinal products with huge potential for managing many unmet medical needs and contribute substantially to patient care. The complexity of the products and the regulatory development and expectations across different regions, both established and emerging, will be covered.

Learning Objectives

Identify and understand the challenges unique to the regulatory review of global clinical trials with gene therapies; Discuss the development of regenerative medicine after new pharmaceuticals and medical devices law was implemented in Japan; Describe the regulatory development of cell therapy in Taiwan, including comparison of regulatory development of cell therapy among selected Asia countries and future prospects.

Chair

Linda F. Bowen

Speaker

Examining the Global Regulatory Environment and Scientific Landscape for Gene Therapy Clinical Trials
Victoria Rocchi

Regulation of Cell Therapy Products in Asia
Chao-Yi Joyce WANG, MSc

New Approach to Development of Regenerative Medicines in Japan
Noriaki Murao, MS



Chair
avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for... Read More →

Speakers
avatar for Linda Bowen

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi
Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
avatar for Noriaki Murao

Noriaki Murao

Representative, NM Consulting
Noriaki received BS and MS degrees in pharmacy from Fukuoka University and Kyushu University. He spent his professional career for new drug development in pharmaceutical industries for four decades. He is currently running an independent regulatory consultancy business. He contributed... Read More →
avatar for Victoria Rocchi

Victoria Rocchi

Senior Regulatory Affairs Specialist, AnGes, Inc.
Victoria Rocchi is a Senior Specialist in Global Regulatory Affairs at AnGes, Inc. Ms. Rocchi has extensive experience in communications, project management and is a certified teacher. She began her career in the pharmaceutical industry at Merck Sharp and Dohme in Regulatory Operations... Read More →
avatar for Chao-Yi Wang

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei
Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA