Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Approval Pathways [clear filter]
Monday, June 27
 

8:30am EDT

#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

This forum will provide an overview of traditional small molecule drug development, and highlight special considerations, opportunities, requirements, and risks for specialized programs, such as oncology, vaccines, biologics, or breakthrough therapies.

Learning Objectives

Explain how oncology, vaccine, and biologic drug development are similar to, or different from, a traditional small molecule program; Compare and contrast oncology, vaccine, and biologic drug development with respect to project leadership and project management strategies, approaches, and resource investment decisions; Discuss the impact of breakthrough therapy designation on each of these.

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD



Chair
avatar for Eva Finney

Eva Finney

Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals... Read More →

Speakers
DR

David Robinson

Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Baxalta
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Forum

8:30am EDT

#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), Japan
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 EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:45am EDT

#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, United States
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 EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors
Limited Capacity seats available

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

Over the past decade, several policy strategies have emerged that promise to promote drug development in areas of unmet need, such as exclusivity previsions and advanced market commitments. Recently, one of these policy strategies, the priority review voucher (PRV), has garnered new attention and has re-emerged as a possible driver in R&D for rare pediatric diseases, neglected tropical diseases, and public health emergencies. The PRV program is a regulatory incentive administered by the FDA to promote drug development for certain underserved patient populations. Under the original PRV program, signed into law in 2007, FDA awards a voucher to sponsors for the regulatory approval of a novel drug targeting a particular neglected tropical disease; sponsors that redeem a PRV are subsequently allowed to designate any one NDA/BLA, regardless of indication, as priority review, reducing the target regulatory review period by four months. Since 2007, nine vouchers have been issued by the FDA, and reported sales of the voucher have continued to increase to as much as $350 million. This panel takes a closer look at the value of the PRV as an incentive, focusing on past experiences related to the PRV program, current use, legislative trends, potential value, and its role in encouraging much needed R&D for rare pediatric and neglected tropical diseases.

Learning Objectives

Explain the history and mechanics of the FDA priority review voucher (PRV) program; Describe current policy initiatives regarding the PRV program and industry response to the PRV incentive; Assess the value of the PRV as an incentive for rare and neglected diseases.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Priority Review Vouchers: A New Paradigm for Funding Research?
Patricia R Anderson, RAC

The Priority Review Voucher: The Value, the Pipeline, and the Opportunities for R&D
Andrew S. Robertson, JD, PhD

Priority Review Vouchers: Legislation and History - What You Need to Know
Alexander Varond, JD



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 Patricia Anderson

Patricia Anderson

Vice President, Regulatory Services, Mapi
Ms. Anderson has covered many aspects of drug development during over 30 years in the pharmaceutical and biotechnology industry. Ms. Anderson has held several positions which have included the areas of regulatory affairs, drug development, and due diligence for licensing. She has... Read More →
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare-Orphan Diseases, Symposium
 
Tuesday, June 28
 

10:30am EDT

#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

Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

10:30am EDT

#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 EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:30am EDT

#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-590-L01-P; CME 1.00; IACET 1.00; RN 1.00

Early consideration of the issues unique to rare disease development allows sponsors to proactively and adequately identify/address them during development and to have productive interactions with Health Authorities (HA). Unique program elements will be compared and contrasted, focusing on regulatory aspects of rare/orphan development and early HA consult to create successful programs that address the particular challenges. We will also discuss how to strategically take advantage of the various US and EU incentives such as market exclusivity, tax reduction, and expedited review process, as well as grants to facilitate the development of orphan drugs, to enhance orphan drug development.

Learning Objectives

Discuss the regulatory requirements unique to the global development of rare disease and orphan drugs, including the regulatory implications; Explain the regulatory considerations to create efficient, feasible, and sufficient rare disease and orphan drug programs; Summarize regulations regarding orphan drug designations in the US and EU; Discuss and demonstrate how drug developers can take advantage of the regulators' incentives to optimize their investment in orphan drug development.

Chair

Maureen Smith

Speaker

Maximizing the Advantages of US and EU Orphan Drug Designation Incentives
Irene Pan

Global Regulatory Considerations in Rare Disease and Orphan Drug Development: When Patients Are Waiting and Everyday Counts
Lauren Peterson Tornetta



Chair
avatar for Maureen Smith

Maureen Smith

Patient Advocate / Secretary, Canadian Organization For Rare Disorders (CORD)
Maureen Smith’s M.Ed. (Educational Psychology) interest in patient advocacy stems from a rare disease diagnosis at the age of 8. She is the Secretary of the Canadian Organization for Rare Disorders (CORD), co-chair of the Rare/Orphan Disease program track for the Drug Information... Read More →

Speakers
IP

Irene Pan

Senior Research Scientist, UBC: An Express Scripts Company
Irene Pan, MSc, is a Senior Research Scientist with UBC: An Express Scripts Company. With over 12 years of clinical research experience, Ms. Pan has conducted numerous studies in a wide range of therapeutic indications including ophthalmology, neurology, cardiology, oncology and respiratory... Read More →
avatar for Lauren Tornetta

Lauren Tornetta

Director, Global Regulatory Affairs, Pfizer Inc
15 years of experience across public and government (FDA) sectors with an MBA in biotechnology and an MS in biochemistry. Global experience leading reg strategy with drugs (NCE, line extensions, drug: drug codev, biologic products, and combination products [drug: device]), in all... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare-Orphan Diseases, Session

4:00pm EDT

#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 EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum
 
Wednesday, June 29
 

8:00am EDT

#302: Europe and the US: Making Outcomes-Based Health Care Possible
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-610-L04-P; CME 1.50; IACET 1.50; RN 1.50

Europe and the US are experimenting with ways to develop therapies based on their actual ‘real world’ performance. This session will discuss the benefits and challenges of outcomes-based health care, as well as the remaining barriers to implementation.

Learning Objectives

Describe the concept of outcomes-based health care; Define real world evidence, Adaptive Pathways, and Precision Medicine; Identify how we can use health data to improve the efficiency of clinical trials and research (better targeting, smaller trials, flexible models); Recognize the links between failures rates, trial sizes, and investments into new therapies.

Chair

Duane Schulthess, MBA

Speaker

European Approaches to Outcomes-Based Health Care
Hans-Georg Eichler

Engineering Outcomes: Driven Biomedical Innovation
Gigi Hirsch, MD

Big Data for Better Outcomes: Innovative Medicines Initiative - IMI Taking the Lead
Richard Bergström, MS

Measuring Outcomes and Performance
Steve Rosenberg



Chair
avatar for Duane Schulthess

Duane Schulthess

Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods... Read More →

Speakers
avatar for Richard Bergström

Richard Bergström

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following... Read More →
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 Gigi Hirsch

Gigi Hirsch

Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Her current efforts are leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster. Within the broad strategic framework of... Read More →
avatar for Steve Rosenberg

Steve Rosenberg

Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences
Steve Rosenberg, Senior Vice President and General Manager of Oracle Health Sciences Global Business Unit, has over 30 years of experience leading development, services, support, and consulting, in addition to significant industry experience in life sciences and healthcare. Some of... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

4:00pm EDT

#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, United States
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 EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session