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09: Regulatory [clear filter]
Monday, June 20
 

1:30pm CDT

#118: Real-World Evidence Frameworks Across the World: Three International Perspectives
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-519-L04-P ; CME 1.00; RN 1.00

In this session, three global regulatory agencies will present their frameworks for the use of Real World Evidence. The focus will be on the types of questions that can be answered now, as well as a view of the opportunities in the future.

Learning Objectives

Describe the similarities and differences between global regulatory frameworks for real-world evidence (RWE); Discuss how regulators are using RWE and how they will use it in the future, including the types of regulatory procedures it can support.

Chair

Andrew Thomson, PhD, MA, MS

Speaker

Moderator
Rachele Hendricks-Sturrup, DrSc, MA, MSc

FDA Perspective
John Concato, MD, MPH, MS

Health Canada Perspective
Melissa Kampman, PhD, MS


Speakers
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States
Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
avatar for Melissa Kampman

Melissa Kampman

Manager and Senior Epidemiologist, Marketed Health Products Directorate, Health Canada, Canada
Melissa Kampman is a manager and senior epidemiologist at Health Canada. She holds an MSc in Chemical and Environmental Toxicology and a PhD in Population Health. Her training is in pharmacoepidemiology and pharmacovigilance. Her main areas of interest are population health, study... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat... Read More →

Monday June 20, 2022 1:30pm - 2:30pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum

1:30pm CDT

#119: Is it Time to Change the Accelerated Approval Pathway?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-520-L04-P ; CME 1.00; RN 1.00

A discussion on potential changes to accelerated approval pathways to streamline processes while continuing to maintain the gold standard of approval.

Learning Objectives

Explain advantages of the accelerated approval pathway; Discuss future potential changes to accelerated approval pathways.

Chair

Khyati Roberts, RPh

Speaker

Industry Perspective
Kristin Van Goor, PhD

Patient Perspective
Jeff Allen, PhD


Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Kristin Van Goor

Kristin Van Goor

Regulatory Policy and Intelligence, Global Regulatory Affairs, Vertex Pharmaceuticals, United States
Kristin Van Goor received her Ph.D. in Genetics from Yale University and continued her research as a post-doctoral fellow in the Cancer Genetics Branch of the National Human Genome Research Institute at the NIH. She then spent a number of years at PhRMA as the Assistant Vice President... Read More →
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, United States
Khyati Roberts leads regulatory policy advocacy efforts for U.S. and Canada and co-leads the day-to-day operations of the global regulatory policy and intelligence team at AbbVie. She has over 30 years of regulatory experience including nearly 14 years at the U.S. FDA/Center for Drug... Read More →

Monday June 20, 2022 1:30pm - 2:30pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

4:00pm CDT

#140: ICMRA: COVID-19 Response and International Collaboration
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-534-L04-P ; CME 1.00; RN 1.00

The first part of this session will provide an overview of initiatives and channels of collaboration established/intensified during the pandemic, applying regulatory flexibilities and agile approaches in this public health emergency setting. The second part will discuss lessons learned and will look at which of the introduced flexibilities could be sustained, both for emergency and non-emergency contexts.

Learning Objectives

Discuss initiatives of international collaboration and cooperation during the Covid-19 pandemic; Describe key achievements; Identify lessons learned.

Chair

Emer Cooke, MBA, MSc

Speaker

EMA Update
Marco Cavaleri, PhD

Update on Clinical Trial Design Issues
Yasuhiro Fujiwara, MD, PhD

Update on Pharmacovigilance and Vaccine Confidence
John Skerritt, PhD


Speakers
avatar for Marco Cavaleri

Marco Cavaleri

Head of Health Threats and Vaccines Strategy, European Medicines Agency, Netherlands
Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present) Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009) Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008) Scientific Administrator, European... Read More →
avatar for Emer Cooke

Emer Cooke

Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Peter Marks

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 →
avatar for John Skerritt

John Skerritt

Deputy Secretary for Health Products Regulation, Australian Department of Health, Australia
Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

4:00pm CDT

#139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-532-L04-P ; CME 1.00; RN 1.00

An expert panel will review the EMA and FDA benefit-risk frameworks and how to optimize these processes, including the addition of sponsor input to highlight critical considerations in the submission; and offer suggestions for effective public communications.

Learning Objectives

Compare and contrast FDA and EMA benefit-risk (BR) assessments and how they drive or factor into regulatory decisions for marketing authorizations; Discuss how these decisions are communicated to the public; Explore how sponsors may provide input on benefit-risk to EMA and FDA to better inform regulatory review and decision making and contribute to review modernization.

Chair

Julie Anne Zawisza, MA, MT

Speaker

FDA Guidance on Benefit-Risk Assessment for New Drug and Biological Products
Graham Thompson

EMA Update
Francesco Pignatti, MD

Industry Update
Pujita Vaidya, MPH

Industry Update
Ellis Unger, MD


Speakers
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
GT

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Staff (DSAS) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and... Read More →
avatar for Ellis Unger

Ellis Unger

Principal Drug Regulatory Expert, Hyman, Phelps & McNamara, P.C., United States
Dr. Ellis Unger is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara. A cardiologist with 24 years of FDA experience in drug regulation, safety, clinical trial design, and analysis, he started as a Medical Officer in CBER, ultimately serving 8 years as the Director, Office... Read More →
avatar for Julie Anne Zawisza

Julie Anne Zawisza

Senior Director, Global Regulatory Policy, MRL GRACS, Merck & Co., Inc., United States
Ms. Zawisza leads regulatory policy for Merck’s oncology business. She is active on PhRMA and BIO committees for biosimilars, new drug clinical development, CDx, adaptive trial design, and other key FDA policy initiatives. She is a Board member of The Alliance for a Stronger FDA... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum |   01: ClinSafety-PV, Forum
 
Tuesday, June 21
 

2:00pm CDT

#249: Regulatory-Grade Real-World Evidence: Distilling to Practice
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-569-L04-P ; CME 1.00; RN 1.00

Real-world evidence (RWE) is increasingly used to complement randomized clinical trials (RCT), provide a better understanding of real-world effectiveness, and address information gaps. This session will explore various best practices, tools, and methods used.

Learning Objectives

Describe various levels of real-world evidence (RWE) validity and their relationship to current regulatory RWE guidance; Identify rigorous methodological approaches to maintain evidentiary standards and the impact of underlying data quality in RWE study results; Evaluate future study design using advanced RWE to support medical affairs, market access, and regulatory objectives.

Chair

Dan Riskin, MD, MBA

Speaker

Developing High-Validity Real-World Evidence to Meet Clinical, Regulatory, and Commercial Objectives
Dan Riskin, MD, MBA

FDA Update
John Concato, MD, MPH, MS

Practical Tools to Advance Fit-for-Purpose Use of Real-World Data in Regulatory Decision-Making
Cathy W Critchlow, PhD, MSc

Evaluating Machine Learning Derived Real-World Data to Support Regulatory Decision Making
Irene Nunes, PhD


Speakers
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
avatar for Irene Nunes

Irene Nunes

Vice President, Head of Regulatory Affairs, Flatiron Health, United States
Irene Nunes is VP, Head of Regulatory Affairs at Flatiron Health, leading strategy and policy professionals focused on advancing RWD/RWE for regulatory decision-making and market access globally by working with pharmaceutical companies, regulatory agencies, HTAs, policy organizations... Read More →
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the global leader in high-validity real-world evidence (RWE). Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy includes... Read More →

Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   04: MedAffairs-SciComm, Forum |   09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:15pm CDT

#266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-579-L04-P ; CME 1.00; RN 1.00

This forum will discuss how FDA, industry, and academia engage in generic drug safety evaluations; provides new options for REMS; and pilots use of emerging tools and technologies to monitor and ensure generic drug safety and substitutability.

Learning Objectives

Review how pharmacovigilance (through FDA, industry and academic perspectives) ensures the continued safety and therapeutic equivalence of generic drugs; Describe options for risk evaluation and mitigation strategies for generic drugs; Explore use of data analytic tools/technologies that ensure continued safety and therapeutic equivalence of generic drugs.

Chair

Howard Chazin, MD, MBA

Speaker

Moderator: Industry Perspective
Jamie Wilkins, PharmD

FDA's Perspective
Howard Chazin, MD, MBA

Academic Perspective
Joseph Ross, MD, MHS


Speakers
avatar for Howard Chazin

Howard Chazin

Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States
Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical... Read More →
avatar for Joseph Ross

Joseph Ross

Professor of Medicine and Public Health, Yale University School of Medicine, United States
Joseph S. Ross, MD, MHS, is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale School of Medicine, an Associate Physician of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System, and Co-Director of... Read More →
avatar for Jamie Wilkins

Jamie Wilkins

Senior Director, Head - Risk Management Center of Excellence-Worldwide Safety, Pfizer Inc, United States
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum

4:15pm CDT

#274: Regulatory Convergence Successes and Opportunities
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-587-L04-P ; CME 1.00; RN 1.00

ICH and similar organizations add value to the development and regulation of pharmaceuticals by encouraging the alignment of regulatory policies and processes. What opportunities are there to continue to align policies and processes?

Learning Objectives

Evaluate the success of certain ICH guidelines in improving drug development; Identify opportunities to improve ICH guidelines or regulator implementation of certain ICH guidelines; Translate challenges in global pharmaceutical development and regulation/oversight into ideas for future ICH or WHO guidelines.

Chair

Aaron Josephson, MS

Speaker

Global Access To Medicines And Regulatory Harmonization: Are Patents The Challenge, Or Is Confidentiality?
Nielsen Hobbs

How are International Standards and Regulatory Science Building Trust, Increasing Competency, and Enabling Reliance?
Magda Bujar, PhD, MSc

Panelist
Theresa Mullin, PhD


Speakers
avatar for Nielsen Hobbs

Nielsen Hobbs

Executive Editor, US Policy and Regulatory, The Pink Sheet, United States
Nielsen Hobbs has more than 25 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing... Read More →
avatar for Aaron Josephson

Aaron Josephson

Senior Director, Global Regulatory Policy, Teva Pharmaceuticals, United States
Aaron develops and advocates for policies that enable more efficient and predictable regulatory systems aligned with Teva’s development programs, business objectives, and patient needs. Prior to joining Teva, Aaron worked at FDA for more than a decade in positions at CDER, CBER... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

4:15pm CDT

#275.1: PMDA Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-535-L04-P ; CME 1.00; RN 1.00

PMDA’s activity is based on "4Fs" (Patient First, Access First, Safety First, Asia First) as priority policy, which Dr. Fujiwara, chief executive, has set up. In this session, PMDA introduce our efforts on "4Fs" including the challenge to COVID-19.

Learning Objectives

Discuss the latest information regarding PMDA and Japanese regulations; Describe the dialogue between participants and senior PMDA officials concerning issues on drug/device regulation.

Chair

Nobumasa Nakashima, PhD

Speaker

Panelist
Naoyuki Yasuda, MSc

Panelist
Yasuhiro Fujiwara, MD, PhD

Panelist
Hiroyuki Arai, PhD


Speakers
avatar for Hiroyuki Arai

Hiroyuki Arai

Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Hiroyuki Arai has served as an Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) since April 2020. Before joining PMDA, he was a professor of Department of Health Chemistry, Graduate School of Pharmaceutical Sciences at the University of Tokyo (2000-2019... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

4:15pm CDT

#275: How to Interact with Regulators to Qualify a Digital Mobility Outcome?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-588-L04-P ; CME 1.00; RN 1.00

Through stakeholder engagement, the MOBILISE-D consortium has established the roadmap for the implementation of new tools to monitor patient disability and enable cost-effective access to optimal mobility management through personalized healthcare.

Learning Objectives

Describe the challenges faced to develop and qualify digital endpoints; Demonstrate that real-world digital mobility outcomes can successfully predict relevant clinical outcomes and help deliver innovative medicines; Identify the strategy and methodology used to overcome the challenges and the different stakeholders’ expectations.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Panelist
Anja Schiel, PhD

How to Interact with Regulators to Qualify Digital Outcomes?
Cécile Mathilde Ollivier, MS

Panelist
David Nobbs, PhD


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →
DN

David Nobbs

Digital Biomarker Technology and Science Lead, F. Hoffmann-La Roche Ltd, Switzerland
I am currently Digital Biomarker Technology and Science Lead at Roche, leading the development and validation of digital endpoints for drug development. My cross-functional team has successfully developed and deployed digital health technology solutions in seven clinical trials to... Read More →
avatar for Cécile Ollivier

Cécile Ollivier

Director - Regulatory Science Europe, Critical Path Institute (C-Path), Netherlands
Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation... Read More →
avatar for Anja Schiel

Anja Schiel

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum |   12: Value-Access, Forum
 
Wednesday, June 22
 

9:15am CDT

#310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-603-L04-P ; CME 1.00; RN 1.00

This fall, Congress will reauthorize the third iteration of the generic drug and biosimilar user fee amendments. Since the passage of the first user fee act in 1992, user fee programs have helped finance FDA’s review of human medical products. By authorizing the collection of user fees, FDA can help generate regulatory predictability and ultimately increase patient access to these critical products. Each reauthorization brings big changes and enhancements to the review program, some more nuanced than others. This session will discuss the current climate for generic and biosimilar products, the challenges companies face in bringing these products to market within the current regulatory framework, and how the new enhancements under GDUFA III and BsUFA III will increase patient access to affordable medicines.

Learning Objectives

Identify enhancements in FDA’s review of generic and biosimilar applications under GDUFA III and BsUFA III; Discuss challenges generic and biosimilar sponsors face in bringing their products to market.

Chair

Lisa Parks, RPh

Speaker

Panelist
Hillel P Cohen, PhD

Panelist
Molly Ventrelli

Panelist
Katherine Wilson, JD


Speakers
avatar for Lisa Parks

Lisa Parks

Principal, Daedal Regulatory Strategies, LLC, United States
Lisa holds an R.Ph. in Pharmacy from the Massachusetts College of Pharmacy in Boston, MA. Lisa is Principal of Daedal Regulatory Strategies, LLC, a consultancy specializing in navigating complex regulatory and scientific issues involving interactions with the FDA. In her previous... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States
Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →
MV

Molly Ventrelli

Senior Vice President, Regulatory Affairs, Fresenius Kabi USA, LLC , United States
Molly Ventrelli has over 30 years of experience in the generic drug industry with a primary focus in regulatory affairs. She has held various roles in Quality, Development and Pharmacovigilance as well. She is currently the Sr. VP of Regulatory Affairs for Fresenius Kabi US IV Generics... Read More →
avatar for Katherine Wilson

Katherine Wilson

Head, Global Regulatory Policy and Intelligence, Viatris, United States
Katherine (Katie) Wilson, leads Global Regulatory Policy + Intelligence at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

9:15am CDT

#311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-604-L04-P ; CME 1.00; RN 1.00

This session features regulator, pharmaceutical industry, and real-world data provider speakers discussing key considerations for designing observational studies that may be considered for regulatory decision-making

Learning Objectives

Describe the steps involved in the design of an observational study intended to support a regulatory submission; Discuss key real-world data (RWD) source and study development considerations for both the sponsor and the real-world data/evidence (RWD/E) provider

Chair

Jillian Mae Rockland, MPH

Speaker

Case Study
Matthew Rioth, MD, MSc

Case Study
David James Nimke, DrPH, MPH

Case Study
Robert Kalesnik-Orszulak, PharmD


Speakers
avatar for Robert Kalesnik-Orszulak

Robert Kalesnik-Orszulak

Director, Regulatory Innovation Lead for RWE and Data Science, Bristol Myers Squibb, United States
Rob Kalesnik-Orszulak is the Regulatory Innovation Lead for Real World Evidence (RWE) and Data Science at Bristol Myers Squibb (BMS). In this role, he is responsible for establishing the regulatory department's expertise, capabilities, and strategy around RWE from a regulatory perspective... Read More →
avatar for David Nimke

David Nimke

Senior Director, Real World Evidence- US Advanced Informatics and Analytics, Astellas, United States
David is the Real World Evidence – US and Digital Information Products Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Prior to this role, he worked in pharmacoepidemiology and... Read More →
avatar for Matthew Rioth

Matthew Rioth

Senior Medical Director, Syapse, United States
Dr. Rioth is a medical oncologist and biomedical informaticist at Syapse. As a clinical researcher he has participated in over 100 clinical trials spanning the full spectrum of clinical development. In his role at Syapse he works to use real world data to accelerate cancer resear... Read More →
avatar for Jillian Rockland

Jillian Rockland

Director, Regulatory Strategy, Flatiron Health, United States
Jillian Rockland leads Flatiron Health’s Regulatory Strategy team, which supports Flatiron Health’s life science partners in using RWD/E for regulatory decision-making. Previously, she oversaw Flatiron RWE product and operations, managing the scoping, creation and delivery of... Read More →

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

9:15am CDT

#313: China Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-662-L04-P ; CME 1.00; RN 1.00

The China’s drug regulatory landscape continue to evolve and drug development activities continues to grow rapidly. In 2021, the National Medical Products Administration (NMPA) approved 70 new drugs, setting a new record of annual new drug approvals. Over 1500 INDs of innovative drugs were approved by the Center for Drug Evaluation (CDE), representing a 65% increase compared to the year before. In this session, speakers from NMPA, CDE and the Center for Food and Drug Inspection (CFDI) are invited to present the update on regulatory policy, drug review and approvals, and initiatives and activities on regulatory inspections to ensure clinical trial quality and integrity.

Learning Objectives

Describe the latest information on China’s drug regulations, particularly in the areas of drug review and approval as well as regulatory inspections;. Discuss the trend and future perspective of drug regulations in the era of regulatory reform.

Chair

Xiangyu Wang

Speaker

Moderator
Wenny Du, MBA, MS, RAC

The Recent Progress of GCP Inspection In China
Jianan Wang

Panelist
Lili Cao, MS


Speakers
avatar for Wenny Du

Wenny Du

Director, Global Regulatory Lead, Amgen Inc., United States
Wenny Du, MS, MBA, RAC, is a Director, Global Regulatory Lead (GRL) for Oncology at Amgen Inc (California). She leads global regulatory teams to drive global regulatory strategy development and obtain regulatory approvals worldwide. Wenny has over 25 years of experience in various... Read More →
avatar for Lili Cao

Lili Cao

Deputy Director, China Center for Food and Drug International Exchange (CCFDIE), NMPA , China
avatar for Jianan Wang

Jianan Wang

Deputy Director of Inspection Division 1, Center for Food and Drug Inspection of NPMA , China
Jianan Wang is the Deputy Director, Division of Inspection I, in the Center for Food and Drug Inspection, NMPA. She is responsible for overseeing clinical trial inspections in new drug and medical devices. Joined CFDI, NMPA since 2004 as GCP/GLP inspector.
avatar for Xiangyu Wang

Xiangyu Wang

Division Director, Department of Science, Technology & International Cooperation, NMPA, China

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum

11:15am CDT

#330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-619-L04-P ; CME 1.00; RN 1.00

If randomized clinical trials (RCTs) are enlarged to address treatment benefits and risks in subgroups of interest, they will take longer to complete. This forum considers regulatory, clinical and pharma use of real-world evidence to supplement RCT to address diversity. This forum will be a lively panel discussion with perspectives from the regulatory, clinical, and biopharmaceutical perspective, focusing on best ways to fill these evidence gaps including use of real-world evidence.

Learning Objectives

Summarize the trade-offs between running larger more diverse clinical trials and time to trial completion and product approval; Explain how the lack of diversity in clinical trials impacts the reliability of evidence-based care algorithms; Describe one or more ways that real-world evidence can contribute to understanding diversity and how that would extend what is learned from trials.

Chair

Nancy A. Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Cathy W Critchlow, PhD, MSc

Panelist
Wayne Batchelor, MD, MHS, FACC

Panelist
John Concato, MD, MPH, MS


Speakers
WB

Wayne Batchelor

Director of Interventional Heart Program, Research and Innovation, Inova, United States
Dr. Wayne Batchelor currently serves as the Director or Interventional Cardiology, Director of Interventional Cardiology Research, Innovation and Education and Associate Director of the Inova Heart and Vascular Institute in Fairfax, VA and Adjunct Professor of Medicine at Duke Un... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & SVP, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA Real World Solutions and Adjunct Professor of Epidemiology at Univ of N Carolina at Chapel Hill. She leads the IQVIA Center for Advanced Evidence Generation and is a fellow of both the International Society for Pharmacoepidemiology... Read More →

Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  14: DIAmond, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum

2:00pm CDT

#352: FDA Rare Disease Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-629-L04-P ; CME 1.00; RN 1.00

Rare disease drug development continues to explode. As a result, development stratgies coupled with regulatory science and policy continues to evolve to keep up. Regulators from FDA will describe key trends and opportunities in this arena.

Learning Objectives

Discuss recent trends in the development and review of medical products for rare diseases; Identify new regulatory tools and guidance to support regulatory interactions around orphan drugs; Discuss how to apply unique strategies to overcome the unique challenges faced in clinical trials for rare conditions.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Patrizia Cavazzoni, MD

Panelist
Peter W. Marks, MD, PhD

Rare Disease Patient Community Perspective
Jennifer Farmer, MS


Speakers
avatar for Patrizia Cavazzoni

Patrizia Cavazzoni

Director, Center for Drug Evaluation, FDA, United States
Dr. Cavazzoni received her medical degree at McGill University and completed a residency in Psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was... Read More →
avatar for Peter Marks

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 →

Wednesday June 22, 2022 2:00pm - 3:00pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum |   05: Patient Engagement, Forum |   06: PreClinical Dev-EarlyPhaseCR, Forum
 
Thursday, June 23
 

10:00am CDT

#404: Combination Product Safety: A Journey of Organizational Transformation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-647-L04-P ; CME 1.00; RN 1.00

Panel discussion representing industry, FDA representation from OCP, and MHRA for global impact perspective.

Learning Objectives

Describe the impact of the combination product postmarket safety reporting rule by the FDA on industry; Discuss how its implementation has played out over the last two years and how FDA wants industry to modify its approach to the data being sent.

Chair

Khaudeja Bano, DrMed, MD, MS

Speaker

Moderator
Meredith Smith, PhD, MPA, FISPE

FDA Update
John Barlow Weiner, JD

Industry's Post-Implementation Journey Focused on PMSR Reporting of Malfunctions
Khaudeja Bano, DrMed, MD, MS

MHRA Update
Jenifer Hannon


Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Amgen, United States
Dr. Bano is the Vice President of Combination product Quality at Amgen. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s... Read More →
JH

Jenifer Hannon

Head of Benefit Risk Evaluation Team II: Gastrointestinal, Nutrition, Endocrine, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Jenifer Hannon provides strategic leadership and management within the gastrointestinal system, nutrition, endocrine and fertility therapy areas within the Risk/Benefit function at MHRA. Her overarching objective is to ensure that safe and effective medicines and medical devices... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for John Weiner

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 23, 2022 10:00am - 11:00am CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum

10:00am CDT

#410: Addressing Gaps in the Use of Real-World Evidence for Regulatory Decision-Making
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-653-L04-P ; CME 1.00; RN 1.00

The use of real-world evidence (RWE) for regulatory decision-making is a rapidly evolving space. Providers of RWE and regulators will describe the current state, identify current gaps in practice and policy, and identify key advancements needed to further the use of RWE.

Learning Objectives

Describe the current state for the use of real-world evidence (RWE) in regulatory decision-making and gain a general knowledge with respect to current health authority guidance; Discuss the current gaps in the use of RWE for regulatory use and gain perspective on the path forward; Identify key policy issues that need to be addressed in order to further advance the use of RWE in regulatory decision-making.

Chair

Brad Jordan, PhD

Speaker

Panelist
Alissa M Winzeler-Cotton, PhD

Panelist
Bart Barefoot, JD

FDA Update
Paul Kluetz, MD

MHRA Update
David Brown, MSc

EMA Update
Andrew Thomson, PhD, MA, MS


Speakers
avatar for Bart Barefoot

Bart Barefoot

Senior Director, European Regulatory Policy, GlaxoSmithKline, United Kingdom
Bart Barefoot, JD, is Senior Director of European Regulatory Policy at GlaxoSmithKline. He formerly served as GSK's global head of RWE policy development and engagement, where he led the company's efforts to advance the appropriate use of RWE in health care decision-making. He served... Read More →
avatar for David Brown

David Brown

Head of Statistics Team, Healthcare, Quality and Access, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
David Brown is the head of the Statistics team at the MHRA. He has over 20 years’ experience as a statistical assessor at the MHRA, and prior to Brexit was a member of both the biostatistics working party and scientific advice working party at the EMA. He was part of the group that... Read More →
avatar for Brad Jordan

Brad Jordan

Senior Director, Head of Regulatory Affairs Policy, Flatiron Health, United States
Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology... Read More →
avatar for Paul Kluetz

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 →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat... Read More →
AW

Alissa Winzeler-Cotton

Senior Vice President for Strategy, Research, and Medicine, Synapse, United States
AW

Alissa Winzeler-Cotton

Senior Vice President for Strategy, Research, and Medicine, Syapse, United States
Alissa Winzeler-Cotton, Ph.D., is the Senior Vice President of Strategy, Research, and Medicine at Syapse, where she helps to shape the company’s strategic priorities across multiple dimensions. In this role, she has served as one of Syapse’s representatives in developing the... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum
 
Monday, June 26
 

1:30pm CDT

Combating Misinformation with Authoratative Medical Product Information
Component Type: Forum
Level: Basic

Combatting misinformation is a critical goal that many stakeholders can agree we need to address. This session will work through key advantages and challenges on how to achieve this. The panel will walk through efforts to date and what we can do next

Learning Objectives

Discuss how to start the conversation; Describe the key advantages and challenges from different stakeholder perspectives on how to address misinformation.

Chair

Lina AlJuburi, PharmD, MSc

Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

1:30pm CDT

Novel Biomarkers and Surrogate Endpoints in a Rare Disease
Component Type: Forum
Level: Intermediate

Panelists will share their experience in utilizing novel biomarkers/ surrogate endpoints and provide lessons learned. The panel will then discuss the future of novel biomarkers and surrogate endpoints

Learning Objectives

Compare different experiences in using novel biomarkers; Identify best methods in using a novel biomarker.

Chair

Adora Ndu, JD, PharmD

Speaker

Rare Disease Endpoint Advancement Pilot Program: Stakeholder Perspectives on Success and Sustainability
Imein Bousnina, PharmD, MSc


Speakers
avatar for Imein Bousnina

Imein Bousnina

Program Director, US Regulatory Policy, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her 8 years at Roche-Genentech, she has specialized in FDA's regulation of New... Read More →
avatar for Adora Ndu

Adora Ndu

Chief Regulatory Affairs Officer, Bridgebio , United States
Adora Ndu, PharmD, JD, is Chief Regulatory Affairs Officer at Bridgebio Pharma. Prior to joining Bridgebio, Adora spent several years at BioMarin Pharmaceutical in various roles including as Group Vice President, and Head of Worldwide Research and Development Strategy, Scientific... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

4:15pm CDT

The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There?
Component Type: Forum
Level: Intermediate

The use of vaccine platforms holds great promise to advance regulatory science. The session discusses learnings from COVID-19, identifies opportunities and challenges to developing and regulating new vaccines, and looks ahead to what is possible.

Learning Objectives

Describe learnings from the COVID-19 pandemic regarding development and review of new platform vaccines; Define the opportunities and challenges to development; Review new platform and next generation vaccines.

Chair

Brenda Huneycutt, JD, PhD, MPH

Speakers
avatar for Brenda Huneycutt

Brenda Huneycutt

Director, Global Regulatory Policy, Merck & Co., Inc., United States
Brenda Huneycutt is a Director of Global Regulatory Policy with Merck, focusing on vaccine and antimicrobial regulatory policy. Prior to joining Merck, as a Director at FasterCures, a Center of the Milken Institute, she developed and executed on a variety of initiatives, including... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum
 
Tuesday, June 27
 

10:30am CDT

Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment
Component Type: Forum
Level: Intermediate

Regulatory and industry panelists, representing a global perspective, will discuss efforts to modernize requirements for clinical trials, review lessons learned during the pandemic, and further opportunities for regulatory innovation.

Learning Objectives

Discuss post-pandemic regulatory innovation and opportunities for clinical development programs; Describe ICH E6(R3) draft guideline, good clinical practice, and enabling more innovative clinical trial design and conduct; Identify opportunities for global alignment to support global development programs taking into consideration lessons learned during the pandemic.

Chair

Amanda Marie Roache, MS

Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

1:15pm CDT

Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions
Component Type: Forum
Level: Intermediate

This session will discuss timely new resources for sponsors seeking to employ digital health technologies (DHTs) in clinical trials, with a focus on addressing practical questions that arise during implementation.

Learning Objectives

Describe new, available resources for sponsors looking to employ digital health technologies (DHTs) within a single drug development program; Discuss these resources and how to apply them to use of a DHT in clinical trials; Identify gaps and where future resources are needed to advance the use of DHTs in clinical trials and drug development.

Chair

Megan Doyle, JD, MPH

Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →

Tuesday June 27, 2023 1:15pm - 2:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum
 
Wednesday, June 28
 

10:30am CDT

Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations?
Component Type: Forum
Level: Intermediate

FDA’s Project Optimus emphasizes the importance of dose optimization oncology. Often, oncology drugs are studied in combination with other therapies. This session will focus on dose optimization for combinations and challenges still to be addressed.

Learning Objectives

Explain how FDA expectations for dose optimization may be challenging for combinations; Discuss practical approaches for dose optimization in combinations and current challenges; Discuss unanswered questions and next steps for advancing dose optimization in this context.

Chair

Jacqueline Kline, PhD

Speakers
avatar for Jackie Kline

Jackie Kline

Vice President, Global Regulatory Affairs Oncology, Amgen, United States
Jackie Kline has worked in pharmaceutical and biotech research and development for over 25 years and currently serves as Vice President of Global Regulatory Affairs Oncology at Amgen. With a comprehensive understanding of global regulatory requirements, approval pathways and an aptitude... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

10:30am CDT

Health Canada Town Hall
Component Type: Forum
Level: Intermediate

to be developed

Learning Objectives

to be developed

Chair

Alysha Croker, PhD

Speakers
avatar for Alysha Croker

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum

4:00pm CDT

Mobilizing Cooperation with the African Medicines Agency
Component Type: Forum
Level: Intermediate

Following the selection of Rwuanda as the host for the Headquarters of African Medicines Agency (AMA) and the appointment of Director General, AMA will be ready to take off. We will hear the work of different stakeholders as they work to make AMA a reality.

Learning Objectives

Discuss the journey of operationalising the African Medicines Agency, and insights of the partners support in strengthening regulatory systems in Africa.

Speakers
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum
 
Thursday, June 29
 

8:30am CDT

International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy
Component Type: Forum
Level: Intermediate

With the fast-moving pace of innovation, this forum focuses on how medical device regulatory harmonization activities on emerging technologies are impacting drug strategy.

Learning Objectives

Assess potential impact of the International Medical Device Regulators Forum (IMDRF) regulatory frameworks on drug strategy and align device regulatory requirements as part of a broader drug development program; Discuss drivers, priorities, and challenges for medical device regulatory harmonization and standardization of emerging technologies; Describe IMDRF process for regulatory harmonization and opportunities for stakeholder engagement.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speakers
avatar for Ryan Hoshi

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States
Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, and advanced therapies. Before joining AbbVie, Ryan served as an international policy analyst... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum
 
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • Featured Topics
  • AI and Machine Learning
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  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
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