DIA 2017 Annual Meeting: Full Schedule

8:30am CDT

#101: Drug Repurposing: Where Will it Take Us?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-562-L04-P; CME 1.50; IACET 1.50; RN 1.50

Drug repurposing includes approved drug indication expansion, drug-like compound repositioning, and drug reformulation strategies to help get medicines to patients faster. Because repositioning leverages sunk costs for compounds that have failed to reach market, and approved drugs can be reformulated or repurposed to treat a different disorder, the cost often times to get the new therapy to market is reduced. Will “repurposing" disrupt the current market? How can academia, industry, and health authorities collaborate to advance drug repurposing efforts? What is needed to overcome economic, patent, and regulatory hurdles to get repurposed drugs to patients faster? These questions and others will be addressed during this DIAmond session by an esteemed panel of representatives from NIH NCATS, Cures Within Reach, industry, and academia.

Learning Objectives

Define the concept of drug repurposing; Discuss opportunities and challenges for academia, industry, and health authorities to collaborate to advance drug repurposing efforts; Review the economic, patent, and regulatory hurdles that exist to get repurposed drugs to patients faster.

Chair

Bruce E Bloom, DDS, JD

Speaker

Funder Perspective
Christine Colvis, PhD

Using Human Genetic Variation to Repurpose Existing Medications for New Diseases
Jill Pulley, MBA

Industry Perspective
Pamela Hill, MS, PMP

Industry Perspective
K. Gary Barnette, PhD

Speakers

K. Gary Barnette

Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC

With more than 20 years of industry experience, Dr. K. Gary Barnette brings to Camargo a wealth of knowledge of FDA regulations. At Camargo, Barnette is responsible for propelling the growth of the company and establishing excellent customer service practices by utilizing his substantial... Read More →

Bruce Bloom

President and Chief Science Officer, Cures Within Reach

Dr. Bruce Bloom is President and Chief Science Officer of Cures Within Reach, a non-profit saving lives using its CureAccelerator™ platform repurposing approved drugs/devices to quickly deliver safe and affordable treatments for unsolved diseases. He is an Ashoka Fellow, Patient... Read More →

Christine Colvis

Director, Drug Development Partnership Programs, National Center for Advancing Translational Sciences (NCATS)

Christine Colvis joined NCATS in June 2012 as the Center’s director of drug development partnership programs. Her team is best known for leading the Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program, which supports pre-clinical and clinical research... Read More →

Pamela Hill

Open Innovation Program Director, Principal Scientist, Emerging Innovations Unit, AstraZeneca

With more than 15 years of experience in the biopharmaceutical industry, Pam Hill has worked in the discovery phase supporting multiple therapy areas and brought mulitple drugs into clincial studies. Hill is currently leading the Open Innovation program at AstraZeneca which has revolutionized... Read More →

Jill Pulley

Executive Director, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center

Jill Pulley has focused her career on providing disease-neutral, large-scale infrastructure so that researchers can initiate and conduct high quality translational science in a compliant, efficient, and cost effective manner. She is Executive Director of the Vanderbilt Institute for... Read More →

Monday June 19, 2017 8:30am - 10:00am CDT
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

12: DIAmond, Forum

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Featured Topics Academic Clinical Researcher,Public Policy,Rare Disease,StudentProgramming
Credit Type ACPE, CME, IACET, RN
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8:00am CDT

#202: People Will Talk: Gathering Insights from Digital Listening

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-566-L04-P; CME 1.50; IACET 1.50; RN 1.50

There is growing interest from global stakeholders — biopharma, regulators, and patients — to analyze digital health information either posted online by patients or captured by pharma through patient/HCP requests. This information represents a large repository of safety and patient experience insights that could supplement data from existing sources. Panelists in this DIAmond session will address how digital health information can be analyzed to support medical affairs, pharmacovigilance and commercialization efforts. Topics addressed include an overview of techniques, use cases, compliance with regulatory guidelines, and patient privacy.

Learning Objectives

Describe the challenges of using social media data to supplement postmarketing safety data; Discuss the impact of social media data on compliance with regulatory guidelines.

Chair

Lorrie Schifano, PharmD

Speaker

Current Techniques for Analyzing Text That Can be Used in Medical Affairs, Benefit-Risk Assessment, and the Voice of the Customer
Jeffery Lanier Painter, JR, JD, MS

Digital Listening Throughout a Product's Life Cycle
Chi Bahk, MS

Current Parameters for Collecting/Utilizing This Data Compliantly
Phil Tregunno

Panelist
Gerald J. Dal Pan

Moderators

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline

Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →

Speakers

Chi Bahk

Business Operations Lead, Epidemico, Booz Allen Hamilton

Chi is a public health professional with expertise in utilizing non-traditional data sources such as online news and social media for health vigilance, especially in the areas of disease monitoring and patient understanding. She's worked as part of academia, tech start-up, and large... Read More →

Jeffery Painter

Chief Executive Officer/Founder, Jivecast

Jeffery Painter is the CEO and founder of JiveCast, a firm specializing in building analytics tools for a broad range of industries. While at GSK, Jeff was Director of Analytics in Medical Affairs where he led a data science team using text analytics to better understand the voice... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Tuesday June 20, 2017 8:00am - 9:30am CDT
S100c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

12: DIAmond, Forum

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Featured Topics Clinical Operations,Statistics,Quality-GXP,Patient Centric ,Global Regulatory,Data Management,Real World Evidence,StudentProgramming
Credit Type ACPE, CME, IACET, RN
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8:00am CDT

#303: International Regulatory Convergence

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

Join senior leadership from international regulatory agencies to hear the latest on multi and bilateral initiatives to avoid duplication and increase mutual reliance, strategic governance, and their impact on industry.

Learning Objectives

Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Agnès Saint-Raymond, MD

Speaker

Panelist
Guido Rasi, MD

Panelist
Dara Corrigan, JD

Panelist
Tatsuya Kondo

Panelist
Ian Hudson

Panelist
Lorraine Nolan, PhD

Panelist
Jarbas Barbosa

Panelist
Pierre Sabourin, MBA

Speakers

Jarbas Barbosa

Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)

Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →

Dara Corrigan

Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA

Leads a 5,000-member workforce devoted to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. She joined FDA in 2010, serving as... Read More →

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)

Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority , Ireland

Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →

Guido Rasi

Executive Director, European Medicines Agency

Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada

Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... Read More →

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands

Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →

Wednesday June 21, 2017 8:00am - 9:30am CDT
S100a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

12: DIAmond, Forum

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Featured Topics Global Regulatory,StudentProgramming
Credit Type CME, IACET, RN
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9:00am CDT

#401: FDA Forum

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

The FDA Forum will focus on inter-center collaboration between CDER, CDRH, CBER, and the Office of Combination Products. The recently established Oncology Center of Excellence will be highlighted as a new area of collaboration. FDA representatives will share how they collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.

Learning Objectives

Discuss how the various centers in FDA collaborate to provide advice regarding products in development, review marketing applications, and help accelerate medical product approvals.

Chair

John Barlow Weiner, JD

Speaker

Panelist
Peter W. Marks, MD, PhD

Panelist
Angela C. Krueger

Panelist
Douglas C. Throckmorton, MD

Panelist
Tamy Kim, PharmD

Panelist
Paul Kluetz, MD

Speakers

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →

Paul Kluetz

Deputy Director, Oncology Center of Excellence, OC, FDA, United States

Paul Kluetz is a medical oncologist and the Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. His interests include defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval, and opportunities... Read More →

Angela Krueger

Acting Deputy Director, Office of Device Evaluation, CDRH, FDA

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

Douglas Throckmorton

Deputy Director, Regulatory Programs, OCD, CDER, FDA

As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States.

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →

Thursday June 22, 2017 9:00am - 10:30am CDT
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

12: DIAmond, Forum

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Featured Topics Public Policy,Devices-Combination Products,StudentProgramming
Credit Type CME, IACET, RN
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10:45am CDT

#412: EMA/ FDA Question Time

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

In this forum, EMA and FDA leadership will engage in a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as use of real-world data, data transparency, mutual recognition agreement on GMP inspections and quality of medicines.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy and safety; Identify how to engage both agencies in the development of a medicine at the same time.

Chair

Sabine Haubenreisser
Sandra L. Kweder

Speaker

Real World Data: EMA Perspective
Alison Cave, PhD

Real World Data: FDA Perspective
Peter W. Marks, MD, PhD

Transparency: EMA Perspective
Juan Garcia-Burgos, MD

Transparency: FDA Perspective
Jarilyn Dupont, JD

Mutual Recognition Agreement on GMP Inspections: EMA Perspective
Anabela Marcal, PharmD

Mutual Recognition Agreement on GMP Inspections: FDA Perspective
Dara Corrigan, JD

Quality of Medicines: EMA Perspective
Agnès Saint-Raymond, MD

Quality of Medicines: FDA Perspective
Sarah Pope Miksinski, PhD

Speakers

Alison Cave

Principal Scientific Administrator, European Medicines Agency (EMA)

Alison Cave is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department. She has over 20 years of academic research experience in the cardiovascular field gained in the US and UK. Prior to joining the EMA she was... Read More →

Dara Corrigan

Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA

Jarilyn Dupont

Director of Regulatory Policy, Office of Policy, OC, FDA

Director of Regulatory Policy/FDA Office of Policy. Prior to June 2002 worked in Office of Legislation; detailed to Office of Chief Counsel and Acting Director of Office of Crisis Management. Counsel for US House Judiciary Subcommittee and legislative counsel for Member. Attorney... Read More →

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →

Sabine Haubenreisser

Liaison to the US FDA, European Medicines Agency, European Union

Sabine Haubenreisser, MSc, Ph.D., is a pharmacologist who joined the European Medicines Agency in 1997, where she held a variety of positions including scientific team leader and officer for external communications. In 2012 she was appointed EMA Liaison Official at the U.S. FDA in... Read More →

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States

Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

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, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States

Sarah Pope Miksinski

Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA

Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands

Thursday June 22, 2017 10:45am - 12:00pm CDT
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

12: DIAmond, Forum

format json
Featured Topics Global Regulatory,Public Policy,StudentProgramming
Credit Type CME, IACET, RN
Tags Forum