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Monday, June 24
 

3:30pm

#163: Strategic Integration: Is Anyone Getting it Right?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-560-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166060YI7; RN 1.00

Despite the regularity of asset or company acquisitions, integration into an existing portfolio is rarely straightforward. This forum will discuss successful (and less successful) strategies for integration across various healthcare organizations.

Learning Objectives

Describe the different components that lead to the successful integration of acquired assets or companies; Compare and contrast different strategies for strategic integration and discuss best practices from a business development, project and portfolio management perspective to promote streamlined integration of an asset or company.

Chair

Erin Mulrooney, MSc

Speaker

Industry Perspective
Vijayalakshmi Agnani, MBA, MS

Industry Perspective
Erin Mulrooney, MSc

Integration of Cultures and Teams in a Hospital Setting
Elizabeth Somers, MS



Speakers
avatar for Vijayalakshmi Agnani

Vijayalakshmi Agnani

Associate Director, Transactions, Global Business Development and Licensing, Sanofi
Vijayalaksmi (Viju) Agnani is currently Associate Director, Transactions in the Global Business Development and Licensing team at Sanofi. In this role, she engages throughout all phases of business development and licensing activities to lead and manage the execution of strategic... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Associate Director, Project Management, Merck & Co., Inc.
Erin Mulrooney joined the Global Project and Alliance Management group at Merck in 2016 as an Associate Director. She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management and Operations, Biocelerate
Erin Mulrooney joined the Global Project and Alliance Management group at Merck in 2016 as an Associate Director. She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she... Read More →
avatar for Elizabeth Somers

Elizabeth Somers

Executive Director of Infectious Disease, Global Project and Alliance Management, Merck & Co., Inc.
Liz is an Executive Director of Infectious Diseases in Global Project and Alliance Management at Merck. In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#169: How Statistics Can Help Improve Data Quality: ICH E6 R2
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-564-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E6 (R2) guidance stresses the importance of centralized monitoring, especially by leveraging statistical analyses in order to assess data quality. This session will discuss how statistical methodology fits in the overall quality risk management strategy for the trial portfolio.

Learning Objectives

Discuss centralized statistical monitoring approaches and their impacts to data quality and integrity.

Chair

Cheng Su, PhD

Speaker

Using Appropriate Count-Based Statistical Models for KPIs, Risk Metrics, QTLs, etc.
Michael Farnum, PhD, MS

ICH E6 R2: How Statistics Can Help Improve Data Quality
Stephen Young, MSc

Centralized Statistical Monitoring: A Large Pharma's Approach
Taras Carpiac, MBA



Speakers
avatar for Taras Carpiac

Taras Carpiac

Director, Head of Innovation and Process Improvement, Amgen, Inc.
MF

Michael Farnum

Senior Director, Covance
Michael Farnum is a Senior Director for Covance Informatics. In 5+ years working at Covance, he has helped to create the Xcellerate platform, consisting of data integration, analytics, and decision support tools that enable Risk-Based Monitoring, Medical Review, Statistical Review... Read More →
CS

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical
Cheng got his Ph.D. in statistics from NCSU and has 22 years of experiences in both nonclinical and clinical areas. Cheng has a broad interpest in applying statistical thinking and analytics to support drug research and development. His specific areas of expertise include high throughput... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#218: Real World Data to Real World Evidence
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

We discuss the advantages and disadvantages of real world data and real world evidence compared to other sources. Join the Clinical Research Community for a follow up Round Table discussion on Wednesday, June 26, 9:30-10:30AM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the importance of real world data for answering regulatory questions; Discuss the benefits and challenges of evidence derived from real world sources compared to clinical trials.

Chair

Richard Zink, PhD

Speaker

Real World Data to Real World Evidence: A Case Study of Direct-Acting Antivirals for the Treatment of Hepatitis C Infection
Richard Zink, PhD

Machine Learning 2.0: Causal Models and Big Data in the Era of Real World Evidence
Andrew Wilson, PhD, MS

Matching with Replacement: The COLLECTION of ‘Personal’ EFFECTs Should be Handled with Care
Sarah Anselm Short, MPH



Speakers
SS

Sarah Short

Sr. Statistical Mgr, RWE - Biostats & Medical Writing, ICON plc.
Sarah has over ten years’ experience in health related statistical analysis, primarily in disease or product registries and other prospective observational studies. Her experience encompasses a wide array of therapeutic areas and study designs. As a Senior Statistical Manager, she... Read More →
avatar for Andrew Wilson

Andrew Wilson

Scientific lead, Parexel
I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →
avatar for Richard Zink

Richard Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc
Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#237: The Rare Disease Experience in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-596-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a look at the rare disease patient’s experience, and provide professionals with insight on how to craft accessible trials that meet this patient population’s needs. The session will also focus on the importance of increasing the number of rare disease trials throughout the industry.

Learning Objectives

Discuss how the rare disease patient’s experience differs from those suffering from more common indications, and ways in which it is the same.

Chair

Steven L. Roberds, PhD

Speaker

No Two Patients Are the Same: The Rare Disease Experience in Clinical Trials
Christian Burns

Panelist
Isabelle Lousada, MA



Speakers
avatar for Steven Roberds

Steven Roberds

Chief Scientific Officer, Tuberous Sclerosis Alliance
Steve leads the development and execution of the TS Alliance's scientific strategy through partnerships and conversations with stakeholders including individuals and families affected by TSC, basic and clinical researchers, healthcare providers, government agencies, and other non-profit... Read More →
avatar for Christian Burns

Christian Burns

President, ClinEdge
Christian, an avid entrepreneur and research advocate, is the President & co-founder of ClinEdge & BTC. He is passionate about serving patients and sites by identifying innovative solutions that will transform the traditional clinical trial model. ClinEdge & BTC work directly with... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#245: Artificial Intelligence Enhanced Data Analytics for Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-602-L04-P; CME 1.00; IACET 1.00; RN 1.00

Artificial Intelligence (AI) enhanced drug development is becoming increasingly important in the era of precision medicine.This session illustrates with examples how AI can impact and facilitate modern drug development.

Learning Objectives

Recognize the benefit of using artificial intelligence (AI) approaches in modern drug development; Identify the regulatory paths using biomarker-based, AI-enhanced strategies in clinical trials; Outline how to incorporate advanced analytics into trial analyses and future trial designs.

Chair

Felix Frueh, PhD

Speaker

Panelist
Mohammad Afshar, MD, PhD

Panelist
Federico Manuel Goodsaid, PhD



Speakers
avatar for Mohammad Afshar

Mohammad Afshar

Chief Executive Officer, Ariana Pharma
Mohammad founded Ariana® to accelerate the development of novel drugs with the help of computational decision support technologies. It has developed KEM®, for rapid & exhaustive analysis of multi-parametric/multi-objective data for biomarkers, drug discovery, clinical and early... Read More →
FF

Felix Frueh

Executive Partner, Opus Three LLC
avatar for Federico Goodsaid

Federico Goodsaid

Associate Partner, Biomarkers and Regulatory Affairs, Opus Three LLC
B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D from Yale University, New Haven, in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University in Ithaca, New York and at Washington University in St... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#292: Conversations with the Participant: Layperson Summaries and Return of Results
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-634-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166MBS6XA; RN 1.25

In this forum, experts will explore the international patchwork of regulatory requirements and policy recommendations for improving trial participant engagement by publishing layperson summaries and returning research results.

Learning Objectives

Identify best practices in sharing study level trial results; Recognize how to plan for participant dialog in study design.

Chair

James Riddle, MS

Speaker

Panelist
Barbara E Bierer, MD

Panelist
Deborah E. Collyar



Speakers
avatar for Barbara Bierer

Barbara Bierer

Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School
Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for James Riddle

James Riddle

Vice President, Strategic Consulting, Advarra
James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular... Read More →
avatar for James Riddle

James Riddle

Vice President, Strategic Consulting, Advarra
James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Forum

4:15pm

#293: Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-635-L04-P; CME 1.25; IACET 1.25; RN 1.25

Evaluation of real world evidence (RWD) in the context of regulatory decision making depends not only on the evaluation of the methodologies used to generate the evidence, but on the reliability and relevance of the underlying RWD. FDA uses on-site inspections and data audits to evaluate all aspects of the conduct and reporting of FDA regulated research including data derived in real world settings. Speakers will provide views from regulatory perspective.

Learning Objectives

Discuss the importance of reliable data derived from sources other than traditional clinical trials to support regulatory decision making; Identify factors that FDA considers for assessing the reliability of real world data through on site inspections.

Chair

Kassa Ayalew, MD, MPH

Speaker

CPRD Update
Susan Beatty, MSc

FDA Update
Ni Aye Khin, MD, MS

Industry Update
Jonathan Raymond Andrus, MS



Speakers
avatar for Jonathan Andrus

Jonathan Andrus

Chief Business Officer, Clinical Ink
Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where... Read More →
avatar for Kassa Ayalew

Kassa Ayalew

Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDA
Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease... Read More →
avatar for Susan Beatty

Susan Beatty

Clinical Operations Manager, The Clinical Practice Research Datalink Group (CPRD); MHRA
Susan joined CPRD in 2017 as Clinical Operations Manager, responsible for the delivery of CPRD’s Interventional Research services. Previous to this role, Susan has over 18 years’ experience in clinical research, with senior positions at Oxford Biomedical Research Centre and Oxford... Read More →
NK

Ni Khin

Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Ni Khin is currently Division Director in Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA. In this position, she provides regulatory scientific oversight for CDER assigned bioresearch monitoring activities. She participates in onsite... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Wednesday, June 26
 

8:00am

#302: Triple-s (3S) Smart Safety Surveillance
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-682-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will inform attendees about the 3S project. Funded by the Bill and Melinda Gates the WHO are working with low and middle income countries with a high disease burden in specific areas that are subject to new treatments to increase their pharmacovigilance capabilities. MHRA are collaborating in the project to ensure regulatory pharmacovigilance capacity is increased to collect, analyse and act on safety data.

Learning Objectives

Describe the rationale for 3S; Discuss how industry is key to the success of PV in low and middle income countries; Identify the need for robust regulatory frameworks for PV.

Chair

Mick Foy

Speaker

Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)
Raj Long, MEd, MSc

Panelist
Andrea Best, DO, MPH



Speakers
avatar for Andrea Best

Andrea Best

Executive Medical Director, AbbVie, Inc.
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical... Read More →
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →
avatar for Raj Long

Raj Long

Senior Regulatory Officer, Integrated Development, Global Health, Bill and Melinda Gates Foundation
Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-648-L04-P; CME 1.25; IACET 1.25; RN 1.25

Use of multiple sub-teams, each focused on a topic (eg, safety, efficacy) and responsible for delivering content across multiple documents, can accelerate the delivery of marketing applications. Pros and cons of such approaches will be discussed. Join the Medical Writing Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the basic concepts of a topic-based approach to delivering marketing applications; Identify potential pros and cons of topic-based approaches in order to identify where such approaches may or may not be appropriate to marketing applications in the attendee’s own organization.

Chair

Frank Hubbard, PhD, MS

Speaker

What is Topic-Based Authoring and What is the Problem we are Solving For?
Frank Hubbard, PhD, MS

Accelerated Delivery of Efficacy and Safety CTD Components Using Topic-Based Authoring Strategies
Mary Jean Matus

Topic-Based Authoring: Clinical Pharmacology Components of BLA/NDA Submissions
Lisa Iacono Sheehan, PharmD



Speakers
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, Frank founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. From 2015... Read More →
MJ

Mary Jean Matus

Consultant, Medical Writer, Audubon PM Associates
Mary Jean Matus is a medical writer with Audubon PM Associates, Inc., a niche CRO specializing in regulatory documents and submissions in markets around the world. Mary Jean has 25 years of quality assurance and medical writing experience across a broad range of therapeutic areas... Read More →
avatar for Lisa Iacono Sheehan

Lisa Iacono Sheehan

Director Global Regulatory Strategy, Bristol-Myers Squibb
Lisa has been at Bristol-Myers Squibb for 15 years. Her first 10 + years was spent in Clinical Pharmacology where she ran clinical pharmacology studies and provided support for oncology and metabolic drug development. For 4 years, Lisa has been a Documentation Lead supporting Clinical... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#311: Improving Trial Quality by Better Preparing Site Teams
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-652-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will describe new CTTI recommendations that provide a pathway for: Implementing a more efficient and effective means of investigator qualification, determining whether a site team is a good fit for a particular protocol, and improving the understanding of how to apply GCP principles to the conduct of clinical trials.

Learning Objectives

Identify the limitations of current approaches to preparing investigators for conducting clinical trials; Describe strategies for eliminating the distinction between the “qualifying” and “preparing” investigators; Implement actionable recommendations to support a more fit-for-purpose, risk-based, and streamlined approach to investigator requirements.

Chair

Sabrina Comic-Savic, MD, MPH

Speaker

Panelist
Christine Marie Hildebrand

Panelist
Jimmy Bechtel

Industry Update
Janette Sylvia Panhuis, BSN, MBA, RN



Speakers
avatar for Jimmy Bechtel

Jimmy Bechtel

Senior Project Manager, Society For Clinical Research Sites (SCRS)
Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →
avatar for Christine Hildebrand

Christine Hildebrand

Physician Assistant, Sub-Investigator, Clinical Operations Lead, Amici
My name is Christine M. Hildebrand. I am a certified Physician Assistant and have been a clinical researcher and Sub Investigator for over 12 years. I received my undergraduate degree in Health and Nutrition Science from Brooklyn College and I trained at SUNY Downstate Medical Center... Read More →
avatar for Janette Panhuis

Janette Panhuis

Chief Operating Officer, Population Health Research Institute
Janette Panhuis is the Chief Operating Officer of Population Health Research Institute (McMaster) in Hamilton, Ontario, Canada. Ms. Panhuis joined PHRI in 2009 as the Director, Quality Assurance responsible for Quality Systems. Janette brings over 20 years of pharmaceutical research... Read More →
avatar for Veronica Todaro

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation
Veronica (Ronnie) Todaro, M.P.H., has led the national programs of the Parkinson’s Disease Foundation (PDF) since joining the organization in 2004. In this role, she has pioneered national programs focused on patient engagement both at PDF and in the broader community. She has advocated... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#318: Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-658-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session reviews the benefits and risks of collecting real world data through single-patient requests (SPRs)/expanded access programs (EAPs) in a pre-approval access (PAA) setting and discusses what may confer the highest value to an organization from a multi-stakeholder perspective.

Learning Objectives

Recognize relevance and value for an organization of collecting real world data: Discuss the value of real world data from a pre-approval access (PAA) setting as it relates to regulatory and access strategies; Describe benefits and risks of collecting real world data in an single-patient requests (SPR)/named-patient program (NPP) and its potential implications on regulatory and access strategies.

Chair

Beverly L Harrison

Speaker

Pre-Approval Access and Real World Evidence Landscape Set-up
Sasha Richardson, MBA, MSc

Panelist
Arnaud Foucher, MBA, MS

Panelist
Alison Bateman-House, PhD, MA, MPH

Panelist
Michael Fine, MD



Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, NYU Langone Health
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning... Read More →
avatar for Michael Fine

Michael Fine

Medical Director, Health Net
Dr. Michael Fine is a physician executive with over forty years of experience in all aspects of health care delivery. He is board certified in Internal Medicine and was among the first group of physicians who received additional certification in Geriatric Medicine. Doctor Fine began... Read More →
avatar for Arnaud Foucher

Arnaud Foucher

EMEA Medical Program Director, Medical Affairs, Europe, Middle-East and Africa, Janssen
Arnaud Foucher is EMEA Medical Program Director at Janssen, where he is responsible for the Company Regional Evidence Generation & Pre-Approval Access Programs, leading the EMEA Medical Program Management team. With a 20 years career in the pharmaceutical industry, Arnaud is focused... Read More →
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →
avatar for Sasha Richardson

Sasha Richardson

Managing Director, EY
Sasha is an Executive Director in EY's Commercial Life Science Advisory practice and brings over 20 years of global experience in the healthcare / life science sector. Prior to EY, she headed up the US (SF/NY based) and EU (London based) Commercial & Market Access Consulting Practice... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#332: eSource Adoption: Where We Are - Our Experiences from eSource Implementation
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-665-L04-P; CME 1.00; IACET 1.00; RN 1.00

The value of eSource is indisputable. TransCelerate member companies and other select organizations will share experiences of eSource implementation and discuss lesson learned to continue to progress towards the digitalization of clinical trials.

Learning Objectives

Discuss the application of eSource in clinical trials from an industry member consortium and others;Identify important lessons learned for future application and adoption of eSource within their organizations and continue to uncover unknowns in this emerging space related to technology and standards in need of further advancement.

Chair

Rakesh Maniar, MS

Speaker

Digital Health Data Strategy Playbook : An Approach to the Implementation of Novel Digital Technologies in Clinical Trials
Louisa Xu

Combining Multiple Device Data to Understand Disease States
Nora Husani

Workflows for eSource
Ken Bengston

Direct Data Collection: Eliminating Paper Source in a Paperless Pediatric Trial - A Case Study
Jennifer Price



Speakers
avatar for Rakesh Maniar

Rakesh Maniar

Global Head, Business Technology Services; Co-Lead, TransCelerate eSource Initia, Novartis Pharmaceuticals Corporation
Rakesh is a TransCelerate eSource Workstream Co-Lead and SCDM eSource Implementation Initiative Co-Chair/Co-founder. At Novartis, area of responsibilities includes technology optimization, enable adoption of new technologies & provide value added services for efficient clinical trial... Read More →
avatar for Jennifer Price

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research
Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →
KB

Ken Bengston

Director of eSource, Pfizer Inc
avatar for Nora Husani

Nora Husani

Senior IT Analyst, eSource, mHealth, Digital Biomarkers, Eli Lilly and Company
Nora Husani is a Senior IT Analyst at Eli Lilly and Company. She has a BS in Software Engineering from Miami University and has been working in the eSource, mHealth, and Digital Biomarkers space for 3 years.
avatar for Louisa Xu

Louisa Xu

Initiatives and Process Improvement Lead, Data Sciences and Statistics, AbbVie Inc.
Louisa is a Data Science Initiatives and Process Improvement Lead at AbbVie. She has been heavily involved with digital health initiatives and has a passion for innovation in life sciences and technology. Louisa has worked within several organizations at AbbVie including Clinical... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA