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Student Programming [clear filter]
Sunday, June 23
 

9:00am

SC42: #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-519-L04-P; CME 6.50; IACET 6.50; RN 6.50

The need to understand patient preferences for health and healthcare has become well established and demand for stated preference studies has grown exponentially in recent years. This short course is designed as an introduction to a range of stated-preference methods and the application of these methods in drug development, regulatory decision-making, and patient advocacy. The short course will also provide an overview of good research practices and principles that are broadly applicable to all stated-preference methods and describe how good research practices can be applied to discrete choice experiments and several other stated-preference methods. Topics to be covered will include designing a survey, developing an experimental design, analyzing data, and presenting results. This short course will include hands-on exercises and detailed case studies of recent empirical examples to illustrate concepts. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of methods for the development of evidentiary patient preference information. Expected attendees may include: industry, regulators, payers, patients and patient advocacy representatives.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify when & how to successfully develop and present patient preference information for use in a range of applications, including regulatory interactions such as new drug applications;
  • Discuss specific methodologies frequently used in the development of patient preference information.



Speakers
avatar for Rachael DiSantostefano

Rachael DiSantostefano

Senior Director, Benefit Risk / Epidemiology, Janssen Research & Development, LLC
Rachael L. DiSantostefano, MS PhD, is a Senior Director of Benefit-Risk in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has more than 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and... Read More →
avatar for Brett Hauber

Brett Hauber

Senior Economist, Vice President of Health Preference Assessment, RTI Health Solutions
Brett Hauber is Senior Economist and Vice President of Health Preference Assessment at RTI Health Solutions and Affiliate Associate Professor in the School of Pharmacy at the University of Washington. His is an expert in stated-preference methods. He was principal investigator for... Read More →
avatar for Carol Mansfield

Carol Mansfield

Senior Economist and Head, Health Preference Assessment, RTI Health Solutions
Carol Mansfield, PhD, is a Senior Economist and Head in the Health Preference Assessment group at RTI-HS, where she conducts stated-preference studies for pharmaceutical applications. She has 25 years of experience conducting research related to health and the environment. She has... Read More →
CP

Christine Poulos

Senior Research Economist and Head, Health Preference Assessment, RTI Health Solutions
avatar for Kristin Bullok

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company
Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-518-L04-P; CME 6.50; IACET 6.50; RN 6.50

According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. This short course will demonstrate by using interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, challenges will be presented of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals and auditors involved in Good Clinical, Laboratory, or Manufacturing Practices.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe and train individuals on best industry practices in CAPA management;
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations;
  • Discuss case studies that will help solidify how to use the different tools and why to use each one.



Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Associate Director, Development Operations, Q&C/CTD, Kinapse
Accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences with R&D and commercial manufacturing (sterile and non-sterile) experience with 15 years industry practice. Overall background and specialties include GMP and GLP; which has... Read More →
avatar for Danielle Metzger

Danielle Metzger

Senior Consultant, CGI Technologies
Accomplished Quality Professional with a broad background in Pharmaceutical life sciences having R&D and commercial (sterile/non-sterile) experience with over 20 years practice. Specialize in Deviation/CAPA Management and TrackWise systems. Well versed in cGMP knowledge, FDA/EU regulations... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:45pm

Student Networking Luncheon
Component Type: Session

DIA is excited to welcome student and emerging professionals to the Global Annual Meeting. This luncheon is dedicated to helping our student to connect with one another and spend quality time with several members of the DIA 2019 Program Committee.


Sunday June 23, 2019 12:45pm - 2:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:30pm

#001: Self-Branding for Social Media
Component Type: Workshop
Level: Basic

How you are seen by others is important. You are your own brand. if one doesn’t manage one’s brand, it will be created for them by others.

Through this workshop we intend to demonstrate to attendees what this means, how it manifests itself and how it can positively or adversely affect your career success. Conference attendance is its own unique social media. From the time you arrive at the airport through the end of the conference, your brand is being seen. The various social media outlets will be discussed and appropriate use of them from the business perspective will be presented.

Learning Objectives

Recognize the importance of self-branding; Differentiate social media tools for career support versus sharing life with friends; Discuss the role your brand plays in your everyday life.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Michele Sacher



Speakers
avatar for Chris Matheus

Chris Matheus

President, Matheus BD Connections LLC
Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →
MS

Michele Sacher

Business Development Strategist, Unconventional Counseling
Michele Sacher, MS, MEC, most recently acted as a Business Development Consultant, working in Hollywood, CA, resulting in producing a professional Grammy Academy-member’s rock music video; “Gift of the Gab”. This was filmed on the Warner-Brothers Studios’ famous “backlot... Read More →


Sunday June 23, 2019 2:30pm - 3:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:45pm

#003: Effective Networking: Know Yourself
Component Type: Workshop
Level: Basic

Being effective in a clinical research career requires working well (networking) with others. Learning about personality types and how that makes for effective teamwork (networking) is beneficial. The myths of how each personality type networks will be explored and the differences will be explained. There will also be a portion of the workshop dedicated to practicing networking.

Learning Objectives

Differentiate how introverts and extroverts network effectively; Recognize the importance of networking; Explore myths of networking.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Michele Sacher

Facilitator
Christina Cantrell, MSc



Speakers
avatar for Chris Matheus

Chris Matheus

President, Matheus BD Connections LLC
Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →
MS

Michele Sacher

Business Development Strategist, Unconventional Counseling
Michele Sacher, MS, MEC, most recently acted as a Business Development Consultant, working in Hollywood, CA, resulting in producing a professional Grammy Academy-member’s rock music video; “Gift of the Gab”. This was filmed on the Warner-Brothers Studios’ famous “backlot... Read More →
CC

Christina Cantrell

Senior Patient Insights Leader, Genentech, A Member of the Roche Group
Christina has worked for over 15 years in clinical research, always with a focus on the patient’s experience and primarily in outcomes research and insights gathering. She has worked at both large and community hospitals, health technology vendors, and she currently works at Roche... Read More →


Sunday June 23, 2019 3:45pm - 5:00pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Monday, June 24
 

11:00am

#107: Emerging Technologies in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will present innovative uses of technology to collect data from and about patients in clinical research studies, including an update on Bring Your Own Device (BYOD) technology, the use of in-home monitoring for patients with neurological disorders, and the use of technology for expression detection. An EMA regulatory perspective will also be presented. Join the Study Endpoints Community for a follow up Round Table discussion on Monday, June 24, 1:15-2:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the current state of BYOD and how it may evolve in the future; Discuss new approaches to patient assessment in neurological disorders including passive data collection and use of the artificial intelligence; Describe the use of expression detection as a clinical outcome assessment tool. Discuss a regulatory perspective on emerging technologies.

Chair

Sonya L. Eremenco, MA

Speaker

BYOD: The Current State of Play and Future Potential for Electronic Clinical Outcome Assessments (eCOA)
Chris David Watson, PhD

Using Passive In-Home Monitoring and Artificial Intelligence to Quantify Patients with Neurological Disorders
Dina Katabi, PhD, MS

The Face is a Mirror of the Mind: The Potential of Expression Detection for New Clinical Outcome Measures
Bill Byrom, PhD

EMA Perspective
Anthony Humphreys, MPharm



Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Sonya Eremenco

Sonya Eremenco

Associate Director, PRO Consortium, and Acting Director, ePRO Consortium, Critical Path Institute
Sonya Eremenco is Associate Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute. Sonya has over 20 years of experience in PRO (and other clinical outcome assessment) instrument development, with a focus on multicultural development, linguistic... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
avatar for Dina Katabi

Dina Katabi

Andrew and Erna Viterbi Professor of Electrical Engineering and Computer Science, Massachusetts Institute of Technology (MIT)
Dina Katabi is the Andrew & Erna Viterbi Professor of Electrical Engineering and Computer Science, and the director of the MIT center for wireless networks and mobile computing. Katabi is a MacArthur Fellow, a member of the National Academy of Engineering. She received the ACM Grace... Read More →
avatar for Chris Watson

Chris Watson

Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#114: Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-528-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166ASOAHB; RN 1.00

This session will discuss potential cultural impacts on various patient engagement processes, especially in US, UK and Japan. Presenters will briefly overview the contextual differences, such as medical system, provide actual cases, and facilitate the participants to identify tips to listen to patients globally, in order to incorporate those into global drug development.

Learning Objectives

Describe general patient practice and value differences (including in patient-doctor relationships) between Eastern culture and Western culture, and also understand the background to those differences; Identify potential opportunities and limitations to leverage patient voices in different cultures; Discuss further incorporating global diverse patient voices into drug development.

Chair

Atsushi Tsukamoto, PhD

Speaker

Nurse Point of View
Noriko Fujiwara, MS, RN

Intercultural Point of View (UK)
Gareth Julian Monteath, PhD, MBA, MS

USA Point of View
Robert Hilke, MA



Speakers
avatar for Noriko Fujiwara

Noriko Fujiwara

Research Nurse, Project Researcher, Department of Palliative Medicine, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Ms. Noriko Fujiwara is a research nurse and a project researcher of the department of palliative medicine, the Institute of Medical Science, the University of Tokyo. She has over 10 years' experience in research field. She is a Certified Nurse Specialist in Cancer Nursing with the... Read More →
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →
avatar for Robert Hilke

Robert Hilke

Chief Executive Officer, Hilke Communications Corporation
Robert Hilke is the CEO of Hilke Communications Corporation, a firm specializing in providing intercultural communications and TOEIC training for global businesspeople, many of whom work in the pharmaceutical industry. Mr. Hilke's primary research interest is the management of diverse... Read More →
avatar for Gaz Monteath

Gaz Monteath

Executive Director, Link Global Solution Inc.
Dr. Gareth ("Gaz") Monteath is Executive Director at Link Global Solution Inc., an HR and OD consulting firm based in Tokyo. In his position, Gaz is responsible for the overall content and quality of programmes. LGS has long experience of working with pharmaceutical and medical instruments... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#144: Ready or Not: Business Continuity Planning
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-544-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166VN1HY6; RN 1.00

This panel discussion will discuss business continuity planning as a key operational tool across the healthcare ecosystem, with a focus on biopharmaceutical companies. Representatives with experience across a variety of companies will share their insights and experiences with business continuity planning.

Learning Objectives

Assess which business processes are most critical to maintain in the event of a business disruption, key steps in developing business continuity plans, and linkages to risk management and crisis management.

Chair

Leigh Shultz, PhD, PMP

Speaker

Panelist
Jinus Moghbeli Pashai

Panelist
Mobeen Faqih, PhD, MBA

Panelist
Colleen Merritt Severyn, PhD



Speakers
MF

Mobeen Faqih

Lead - Business Continuity (Supply Chain), Bristol-Myers Squibb
Highly accomplished leader with over 14 years of professional experience in the pharmaceutical industry across multiple functional groups. As a Strategic Product Leader, developed and led global teams for product launch and life cycle management, supplier performance and relationship... Read More →
avatar for Jinus Moghbeli Pashai

Jinus Moghbeli Pashai

Director of Risk Managament, Amgen
CS

Colleen Severyn

Director, Business Development, Supplier and Alliance Management, GRA, Merck & Co., Inc.
Colleen Merritt Severyn is director of Merck Global Regulatory Affairs and Clinical Safety (GRACS). Colleen currently leads the Business Continuity Program and GRACS Innovation Council. She has 17 years of project, portfolio and change management leadership experience. Previously... Read More →
avatar for Leigh Shultz

Leigh Shultz

Associate Vice President, Global Project and Alliance Management, Merck & Co., Inc.
Global R&D Project & Alliance Management at Merck, leading the R&D Project Management (non-oncology) and Alliance Management (all therapeutic areas). PhD in chemistry; started at Merck in 2001 as a chemist in Pharm R&D. Joined Project Management in 2004; PMP-certified in 2007.


Monday June 24, 2019 2:15pm - 3:15pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#166: Updates on China Regulatory Reform
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-563-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, experts from government, academia and industry will present and discuss updates in NMAP's regulatory reform and progress in drug review and approval, and development of Chinese pharmacopeia 2020.

Learning Objectives

Discuss and understand the latest progress in NMPA’s regulatory reform and the impacts on Chinese pharmaceutical regulation and drug development; Recognize China’s evolving regulatory environment and future development.

Chair

Ling Su, PhD

Speaker

Regulatory Reform Enhancing Drug Review and Approval
Xiao Yuan Chen, PhD

Regulatory Reform: Industry EWxoerience and Perspective
Wendy Yan, MD, MBA

Brief Introduction on Chinese Pharmacopoeia 2020
Xiaoxu Hong



Speakers
avatar for Ling Su

Ling Su

Professor, Shenyang Pharmaceutical University
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management... Read More →
avatar for Xiao Yuan Chen

Xiao Yuan Chen

Office Director, Tsinghua University
XH

Xiaoxu Hong

Deputy Division Director, Chinese Pharmacopoeia Commission
avatar for Wendy Yan

Wendy Yan

Senior Vice President, Head of Regulatory Affairs, BeiGene (Beijing) Co., Ltd.
Wendy Yan is Senior Vice President, Global Head of Regulatory Affairs, for BeiGene, a commercial-stage biotechnology company focused innovative molecularly-targeted and immuno-oncology drugs for treatment of cancer. She has more than two decades of regulatory affairs experience, having... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

7:30am

DIAlogue Session 1: Welcome to Day 2 of DIA 2019
Component Type: Session

Check in with our Student Advisor, Nancy Smerkanich, from the Global Annual Meeting Program Committee. Let us know how your experience is going so far and map out a game plan for Day 2 of DIA 2019!

Chair

Nancy Pire Smerkanich, DrSc


Tuesday June 25, 2019 7:30am - 8:00am
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel discussion will explore ways to improve connectedness of clinical data in today's CDM world and talk about if Single Source of Truth, Integrations or IoT (Internet of Things) are the best ways to move forward.

Learning Objectives

Describe why, what, where, when and how of data integrations between clinical systems; Describe recent technologies in CDM world and how these technologies are increasing the need for efficient integrations; Identify current challenges in data integrations between clinical systems; Discuss ways to improve efficiency of integrations and use cases where technology has improved integration.

Chair

Joby John, DDS

Speaker

Panelist
Nick Neri, MS

Panelist
Kelly Ritch, MBA, MS

Panelist
Jennifer Price



Speakers
avatar for Joby John

Joby John

Senior Director, Technology Operations, Bioclinica
Dr Joby John is a versatile Clinical Research executive with over 16 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →
avatar for Nick Neri

Nick Neri

Director of Data Services & Integration, ERT
Mr. Neri has over 20 years of industry experience, and has established himself as a thought leader in the industry for applying next generation concepts and technologies to the clinical research space. He currently serves as Director, Data Integration and Services, CoE at ERT. Previously... 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 →
KR

Kelly Ritch

VP, Clinical Trial Solutions, ArcheMedX
Dynamic and innovative executive with 20 years experience creating, managing, and driving high-performance, outcomes, and long-term value. Strategic thinker with strong analytical skills as well as a proven ability to affect positive change and significantly improve business processes... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#207: Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-575-L04-P; CME 1.25; IACET 1.25; RN 1.25

From Watson to self-driving cars to Netflix, the phrase “artificial intelligence” feels like a buzzword. What is reality versus hype and how can this emerging technology impact medical, regulatory, and commercial writing? This session will define the language of artificial intelligence(AI), discuss the potential impact for AI in creation and re-use of medical content, detail the emerging technologies of artificial intelligence in the writing space, and describe the challenges of developing a medical writing tool that uses AI. Participants will leave with an understanding of the practical applications of AI and how those uses could translate into disruption of medical writing, regulatory submissions, and more.

Learning Objectives

Define artificial intelligence (AI) and natural language processing (NLP) in the context of medical writing; Describe the potential for re-use of content across functional areas using AI; Discuss the challenges of developing and socializing an AI tool.

Chair

Robin Whitsell

Speaker

AI in Medical Writing Intelligent Creation and Reuse of Medical Content
Anand Kiran, MBA, MPharm

AI in the Medical Writing Landscape
Julia Forjanic-Klapproth, PhD



Speakers
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

President/Senior Partner, Trilogy Writing & Consulting
After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice and is an active... Read More →
avatar for Anand Kiran

Anand Kiran

Executive Vice President, Global Operations, Medical Solutions, Indegene
Anand Kiran is Executive Vice President of R&D Solutions and Global Delivery, Indegene. He is one of the co-founders of the company. Anand is responsible for business solutions and execution of R&D Solutions (Clinical, Safety, Regulatory and Medical) for Pharmaceuticals/Lifesciences... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc.
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 20 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#210: Increasing Personal Resilience To Manage Change
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-578-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166FSI3MB; RN 1.25

This interactive workshop will help you to identify how your behaviors influence how ready you are to deal with and manage change. You will learn to recognize key factors of resilience and implement approaches to increase your personal resilience.

Learning Objectives

Discuss why change is difficult and how your change type impacts how you adapt; Recognize what resilience is, why it is so important and what are the key factors to increasing your personal resilience; Develop an action plan on managing your personal resilience.

Chair

Kim Przenioslo, PMP

Speaker

Increasing Personal Resilience To Manage Change
Ryan Bailey, MA



Speakers
avatar for Ryan Bailey

Ryan Bailey

Senior Clinical Researcher, Rho, Inc.
Ryan Bailey, Senior Clinical Researcher, has over 13 years experience coordinating multi-disciplinary clinical research teams. He is a corporate leader for communication, innovation, and project management. His current interests within clinical research include: change management... Read More →
avatar for Kim Przenioslo

Kim Przenioslo

Director, Global Regulatory Affairs & Clinical Safety, Strategy Realization Off, Merck & Co., Inc.
Kim Przenioslo, is a Director, Global Regulatory Affairs & Clinical Safety (GRACS) Strategy Realization Office at Merck & Co. Inc, based out of Rahway, New Jersey. Kim leads the GRACS Change Management Center of Excellence, focused on building organizational capability, while driving... Read More →


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

8:00am

#220: DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of Risk-Based Approaches
Component Type: Workshop
Level: Basic
CE: IACET 1.25

An interactive workshop that instructs attendees on how to best implement and operationalize risk-based approaches to clinical operations and quality management by recognizing what their DISC ( D- Dominance, I – Influence, S – Steadiness and C – Compliant) profile makes them most apt to do and how each of these personality types plays a key role in the design, development, and implementation of a new idea and how each personality type has a varied risk tolerance.

Learning Objectives

Identify your DISC personality type; Identify strategies for analyzing the situation from an alternative viewpoint/DISC type to facilitate change management and adoption; Discuss how personality type variations in clinical trial execution impact risk-based approach implementation and may be leveraged for success.

Chair

Dawn Auerbach, MPA

Speaker

Facilitator
William E Bennett, III, MS

Facilitator
Jay A Turpen



Speakers
avatar for Dawn Auerbach

Dawn Auerbach

Executive Director, Client Development, The Avoca Group
Dawn Auerbach is the Executive Director of Avoca’s Client Development team. She is responsible for The Avoca Group’s sales processes and for driving new business within the organization. Dawn leads activities to develop proposals and deliver presentations. She is also actively... Read More →
avatar for William Bennett

William Bennett

Principal, CEO Empowerment LLC
After an extensive career in Marketing and Sales at a Fortune 50 corporation, Bill established himself as an Executive Coach in 1997. His coaching clients have included ADP, AT&T, Cisco Systems, The Federal Reserve Bank, Informatica, The New York Times Company, Salesforce, Thomson... Read More →
avatar for Jay Turpen

Jay Turpen

Senior Consultant, The Avoca Group
Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 30 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-605-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of past challenges and future opportunities for outcomes research in the Oncology and Alzheimer therapy areas. This will include an update on the state of eCOA and the use of connected devices inside oncology clinical trials as well as a review of existing and future endpoints that could be relevant for immunotherapies. The session will also discuss the eCOA led methodological improvements that are positively supporting Alzheimer clinical trials.

Learning Objectives

Describe the use of eCOA and connected health devices inside oncology clinical trials, areas of controversy and opportunity; Discuss current challenges in Alzheimer clinical trials - traditional approaches to eCOA implementation with central oversight; Identify Current challenges associated with measuring c the effects of immunotherapies with existing metrics and proposed metrics to measure outcomes into the future.

Chair

Brad Sanderson, MHS

Speaker

eCOA and Connected Devices for Supporting Oncology Patients in Clinical Trials
Brad Sanderson, MHS

Measuring and Understanding the Outcomes of Immunotherapies in Oncology
Imad Al-Dakkak, DMD, MPA, MPH



Speakers
IA

Imad Al-Dakkak

Director, Huron Consulting Group
Imad is a clinical epidemiologist with over 14 years of experience from government, industry, and academia across multiple disease areas. His areas of expertise include research methodology, epidemiology, study designs, database analytics, and evidence-based medicine. Imad is based... Read More →
BS

Brad Sanderson

Senior Scientific Advisor, Signant Health
Brad is a physiologist and researcher with over 15 years of industry experience. Brad is currently Senior Scientific Advisor - Head of Health Outcomes at CRF Bracket where he leads the Health Outcomes discipline and seeks to advance the company’s scientific and technical expertise... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#238: Build and Leverage Your Networks to Influence Stakeholders
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-19-597-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166OO2I8F; RN 1.00

Most project managers have to lead the project teams without positional authority. Learn how to cultivate a network of relationships whose influence can used to achieve personal and project success.

Learning Objectives

Describe your projects and explain how to expand your networks to include key influencers; Discuss how to leverage your networks to achieve personal and project priorities.

Chair

Jayanthi Reddy

Speaker

Industry Perspective
Maureen McNamara, MBA

Academic Perspective
Nancy Slater, MBA, PMP



Speakers
MM

Maureen McNamara

Executive Director, Global Project Management and Leadership, Daiicho Sankyo
Maureen has over 30 years industry experience primarily in drug development project management. She is currently Executive Director of Global Project Management & Leadership at Daiichi Sankyo Inc where she is responsible for leading project and portfolio management. Prior to this... Read More →
JR

Jayanthi Reddy

Director, Global Project Management, Merck & Co., Inc.
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.
avatar for Nancy Slater

Nancy Slater

Senior Director, Portfolio Program Management Therapeutic Area Head, AbbVie, Inc.
Nancy Slater, MBA, PMP is Senior Director, Portfolio Program Management Therapeutic Area Head for Virology and General Medicines at AbbVie. Nancy has over 24 years of Project Management experience in drug development, strategic process improvement initiatives and global lifecycle... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

DIAlogue Session 2: Publications Meet Up - Inside the DIA Journal
Component Type: Session

Want to get published? Curious about how decisions are made for DIA’s Therapeutic Innovation & Regulatory Science (TIRS) and Global Forum? This is your opportunity to ask DIA’s Global Associate Director of Content Collaboration! A science communicator, editor, and writer, Ranjini will help your understanding of the process as well as share tips for successful publication.

Chair

Ranjini Prithviraj


Speakers
avatar for Ranjini Prithviraj

Ranjini Prithviraj

Global Associate Director, Content Collaboration, DIA
Dr. Ranjini Prithviraj is Global Associate Director, Content Collaboration, at DIA. She provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publications. Prior to DIA, she was a Managing Editor... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-612-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical study data is increasingly becoming available in the public domain. This session presents how the data is being utilized by patients and how sponsors are modifying their internal procedures to prepare disclosure-ready documents. Join the Clinical Trial Disclosure Community for a follow up Round Table discussion on Wednesday, June 26, 1:00-2:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss how publicly available clinical data is being utilized by patient organizations; Describe approaches industry is taking to write clinical documents and provide clinical data for disclosure; Discuss Health Canada’s new regulation on publication of clinical trial information.

Chair

Robert Paarlberg, MS

Speaker

Overview of Health Canada’s Public Release of Clinical Information Initiative
Andre Molgat, PhD

Clinical Trial Disclosure and Transparency: An Industry Perspective
Liz Roberts, MSc

How Clinical Data is Being Used by Patients and Patient Organizations
Deborah E. Collyar



Speakers
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 →
AM

Andre Molgat

Senior Regulatory Affairs Advisor, Resource Management and Operations Directorat, Health Canada
André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training... Read More →
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →
avatar for Liz Roberts

Liz Roberts

Global Public Policy Lead, External Engagement Practice, UCB Inc.
Liz is Senior Director and Global Public Policy Lead at UCB where she is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform clinical trial transparency and responsible data sharing. She also leads other public policy priorities... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#283: Let's Talk Risk-Based Monitoring
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: Let's Talk Risk-Based Monitoring; CME 1.25; IACET 1.25; RN 1.25

Let’s face it, Risk Based Monitoring (RBM) has been in the forefront of our industry for more than 10 years. From the beginning, RBM challenged the belief that 100% source document verification (SDV) would yield quality data in clinical trials. Regulators responsible for making decisions based on reliable data were also challenging industry as to the utility of this monitoring methodology as a way to identify and manage issues in clinical trials. It took some time for the focus of RBM to shift risks in a clinical trial that would include identification and assessment, ongoing monitoring, mitigation as well as even prevention. We are now in an epoch of understanding that it’s about the management of risks in clinical trials that could impact the reliability of patient data, patient safety and patient rights and welfare. In March of 2019, FDA has provided a draft guidance to augment the 2013 guidance relating to risk based-monitoring whereby FDA is making recommendations for planning a monitoring approach, developing content for monitoring plans, and the monitoring of results. Since regulations establish the expectations, it remains up to the sponsor to determine the how in order to achieve the expectation.

RBM has come a long way however sponsors may still struggle with certain aspects in the multi-prong processes needed to be successful with RBM. This forum will present various approaches to RBM, and give the opportunity to learn from experts, so Let’s Talk Risk-Based Monitoring!

Learning Objectives

Describe what is comprehensive RBM , with an understanding of key components to achieve goals of Risk-Based Monitoring in Clinical Trials; Develop a risk-based approach to monitoring of clinical trials that will achieve the expectations for quality clinical data; Identify how to determine best approach based on risks within the clinical trial and consider how to best monitor ongoing risks.

Chair

Susan Callery-D'Amico, BSN

Speaker

A Comparison of SDV to MANA Method: A Risk-Based Monitoring Approach
Penelope K. Manasco, MD, MS

Holistic Approach to Risk-Based Management of Studies and Monitoring of Investigators
Gregg Larson, PhD



Speakers
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →
avatar for Penelope Manasco

Penelope Manasco

Chief Executive Officer, MANA RBM
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. She has spent 10 years in the area of clinical trial technology. Since starting MANA RBM, her focus has been on enhancing the processes of clinical research to rapidly identify and... Read More →
avatar for Gregg Larson

Gregg Larson

Vice President, Development Operations, AbbVie
Gregg’s career over 25+ years has spanned medical affairs, clinical research, and clinical operations. Gregg assumed his current role as VP, Development Operations in October 2017, which includes Site Management and Monitoring, Clinical Program Development, Strategic Clinical Operations... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#285: Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-641-L04-P; CME 1.25; IACET 1.25; RN 1.25

We will review the current work of the Study Endpoint Community wearables group. Specifically three areas: how to select a clinical endpoint derived from mobile sensor data; how to select a fit for purpose device and how to provide evidence to support its use; considerations regarding the positioning of endpoints derived from mobile sensor data alongside other clinical endpoints in the endpoint hierarchy.

Learning Objectives

Identify the format and content of an evidence dossier to support clinical endpoints derived from wearable devices in regulatory drug submissions; Outline key considerations in the practical implementation of wearables to measure intervention effects in clinical trials; Discuss endpoint hierarchy considerations when including new objective sensor-based clinical endpoints.

Chair

Bill Byrom, PhD

Speaker

Practical Considerations for the Implementation of Mobile Sensors for Measurement in Clinical Trials
Jennifer Goldsack, MA, MBA, MS

Developing an Evidence Dossier to Support the Use of Mobile Sensors to Collect Clinical Endpoints in Regulatory Submissions
Bill Byrom, PhD

Endpoint Hierarchy Considerations When Including New Objective Sensor-Based Clinical Endpoints
Emuella Flood



Speakers
avatar for Jennifer Goldsack

Jennifer Goldsack

Interim Executive Director, Digital Medicine Society (DiMe)
Jen Goldsack is the Interim Executive Director of the Digital Medicine (DiMe) Society and is Vice President of Digital Measurement at monARC Bionetworks.
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Emuella Flood

Emuella Flood

Director, Patient-Reported Outcomes, AstraZeneca
Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-632-L04-P; CME 1.25; IACET 1.25; RN 1.25

In today’s pharmaceutical and biotech industry we are at an inflection point with regard to the future of therapeutic development. In this forum the focus will be to explore how industry, agencies, and academic institutions collaborate to drive innovative technologies to speed therapeutic development. Specifically, the forum will explore how we are leveraging STEM (Science, Technology, Engineering, Mathematics) programs both independently and interactively to enable current and future entrepreneurial opportunities. The goal is to foster an environment where we best take advantage of the opportunities presented by advances in life sciences and technology.

Learning Objectives

Evaluate the quality of interaction among various stakeholders in cure-based drug development; Assess the quality of those interactions in their own environments; Recognize the importance of fostering an environment where creativity and an entrepreneurial spirit is nurtured. Determine how STEM (Science, Technology, Engineering, Mathematics) programs are put to use to address the aforementioned objectives.

Chair

Dan Tierno, MA, MBA

Speaker

Industry Perspective
Yaron Drucker, MBA

Student Perspective
Advaita Chandramohan

Panelist
Melanie Matheu, PhD



Speakers
AC

Advaita Chandramohan

Undergraduate Research Associate, University of Southern California
Advaita Chandramohan is a second year student at the University of Southern California studying Biomedical Engineering with an Electrical emphasis. Throughout her academic career, Advaita has participated in and led various STEM activities, leading to her continued interest in the... Read More →
avatar for Yaron Drucker

Yaron Drucker

Staffing Lead, Cloud Partners, Google
Yaron has a Bachelor's Degree in Electrical Engineering, and an MBA from Baruch College. In his early career, Yaron worked in aerospace and defense as an EMC/EMI Engineer, and at SAP for a year. He then worked at Microsoft for 7 years in various roles in digital media on the advertising... Read More →
avatar for Dan Tierno

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer
Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training... Read More →
MM

Melanie Matheu

Founder and Chief Executive Officer, Prellis Biologics, Inc.


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#308: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-649-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop brings together sponsors and patient groups for facilitated discussion of high-value engagement opportunities. Using evidence-based resources, attendees apply a simple prioritization process to identify new activities and evaluate ROI.

Learning Objectives

Discuss how to apply a straightforward process for identifying engagement opportunities with high value for both sponsors and patient groups; Describe the diverse factors that sponsors and patient groups consider in evaluating the benefits and investments associated with engagement opportunities; Identify new patient engagement and relationship opportunities & new ways to partner across the R&D continuum.

Chair

Jaye Bea Smalley, MPA

Speaker

Facilitator
Linda Brennan, MPH



Speakers
avatar for Linda Brennan

Linda Brennan

Director, Community Partnerships, Cystic Fibrosis Foundation
Linda Brennan is Senior Director, Community Partnerships at the Cystic Fibrosis Foundation (CFF), which brings the perspectives of people affected by cystic fibrosis (CF) into all the Foundation’s activities, including research and clinical development, and provides opportunities... Read More →
avatar for Jaye Bea Smalley

Jaye Bea Smalley

Director, Global I and I Patient Advocacy and Life Cycle Management, Celgene Corporation
Jaye Bea joined Celgene as Global Director, Patient Advocacy and Life Cycle Management, Inflammation & Immunology in March 2018. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#329: Global Clinical Trials: Make Them Really Global and Involve Africa
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-674-L04-P; CME 1.00; IACET 1.00; RN 1.00

Changing how we do global clinical trials, with the inclusion of emerging markets in this development process, is imperative. A panel of experts will discuss how to plan and involve pharma/biotech and technology providers.

Learning Objectives

Describe ways in which to integrate emerging markets in global clinical trials using innovative technologies;Discuss approaches to process optimization, mobile health digitalization, blockchain, and change management on how to undertake clinical trials within Africa as the process model: Identify challenges and solutions from actual cases and experience.

Chair

Adama Ibrahim, MBA

Speaker

Next Generation Real World Evidence with Blockchain
Alexis Normand, MPA, MSc

Panelist
Tina Barton, PhD, MBA



Speakers
TB

Tina Barton

Chief Operating Officer, Emerging Markets Quality Trials (EMQT)
Tina Barton is an experienced Board member and Chair, with a BSc, PhD in cancer research and MBA, and has held Senior Management roles in large global through mid-size to small emerging organisations, working in partnership to lead for success, as a customer-focused clinical research... Read More →
avatar for Adama Ibrahim

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →
avatar for Alexis Normand

Alexis Normand

Head of Blockchain for Health Consortium, Embleema
Alexis Normand is head of the Embleema Blockchain Consortium bringing together patients, their advocacy groups, life sciences companies (and regulators, ie FDA to set a new digital standard for sharing Real World Evidence (RWE), to have new treatments approved faster, while ensuring... Read More →


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

10:30am

#340: Digital Technology Advances Labeling Management and Patient Access
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-671-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will update the labeling management across regions in the EU and the Asia Pacific, in particular, the NMPA and PMDA will elaborate on current labeling management in China and Japan and envisage digital/electronic labeling management in the future. Also, the industry will share some industry initiated eLabeling pilot activities, finally, all will discuss the opportunities and hurdles of introducing digital/electronic labeling

Learning Objectives

Explain digital/electronic labeling policy and its pilot activities across different regions; Discuss the advantages of digital/electronic labeling and benefit to patients and prescribers; Describe the latest eLabeling policy and future trends in EU and the Asia Pacific, particularly in Japan and China

Chair

Vicky (Fengyun) Han

Speaker

Labeling Management Update from the PMDA
Mariko Tsukuda, MSc

NMPA Labeling Management and Envisage of Electronic Labeling Trends in China
Xiao Yuan Chen, PhD

Digital Labeling Innovation in Europe
Shimon Yoshida, PhD

Trends of eLabeling and its Innovation Pilot Activities in Asia Pacific
Vicky (Fengyun) Han



Speakers
avatar for Vicky (Fengyun) Han

Vicky (Fengyun) Han

Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific, Johnson & Johnson Pte. Ltd.
Vicky Han is Senior Director at Janssen Pharmaceuticals in charge of Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe, she dedicated 18 years in GSK, wherein 12 years in GSK China for leading regulatory affairs. In 2008, she moved to Belgium for dealing... Read More →
avatar for Mariko Tsukuda

Mariko Tsukuda

Reviewer, Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency (PMDA)
Mariko Tsukuda is Reviewer at Pharmaceuticals and Medical Devices Agency since 2014. Mrs.Mariko Tsukuda worked for implementation of ICH E2B(R3), which is electronic standard for ICSRs, in Japan as an ICH E2B member since 2014.
avatar for Shimon Yoshida

Shimon Yoshida

Executive Director, International Labeling, Pfizer Inc
Dr Shimon Yoshida is Executive Director at Pfizer, and heads the International Labeling Group in Global Regulatory Affairs. Dr Yoshida obtained a PhD in Chemistry from Reading University, UK, and held postdoctoral positions at Durham University before joining the Royal Society of... Read More →
avatar for Xiao Yuan Chen

Xiao Yuan Chen

Office Director, Tsinghua University


Wednesday June 26, 2019 10:30am - 11:30am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#343: Efficient Preparation of Global CMC Dossiers
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-676-L04-P; CME 1.00; IACET 1.00; RN 1.00

Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.

Learning Objectives

Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.

Chair

John Smart, PhD

Speaker

Global CMC Dossiers: Preparation is Key
Angela McGillivary, PhD

Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PhD



Speakers
avatar for Monika Jain

Monika Jain

Manager , Regulatory Affairs CMC, Regulatory Development Solutions, PPD
Monika Jain, Ph.D. joined the pharmaceutical industry in 1996. She is an internationally accomplished regulatory Chemistry, Manufacturing and Controls (CMC) scientist, with a long- standing background in pharmaceutical research and development of small molecule drug products.Since... Read More →
avatar for Angela McGillivary

Angela McGillivary

Principal Consultant, PAREXEL
Angela is a Principal Consultant at PAREXEL and is an Emerging Markets Regulatory Affairs Professional with over 20 years’ experience in the Pharmaceutical Industry. Angela McGillivary PAREXEL, Principal Consultant Angela has worked with global cross functional teams to develop... Read More →
avatar for John Smart

John Smart

Senior Director and Group Manager, Regulatory CMC, AstraZeneca
John has a PhD in Chemistry and over 20 years’ experience of CMC development within AstraZeneca including roles in Analytical & Product Development and Project Management. John is currently a Senior Director in Regulatory CMC with responsibility for regulatory submissions from Phase... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#345: Achieving High Performance Through Emotional Intelligence
Component Type: Workshop
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166EVD2LC; RN 1.00

In this workshop, participants will learn practical tips and tools for self-management. Elements will include effective listening, challenging assumptions, and breaking disruptive patterns. Participants will learn how to effectively address conflict in heated moments.

Learning Objectives

Demonstrate how to achieve high performance by helping leaders incorporate self-management; Describe the importance of self-management as a cornerstone in developing emotional intelligence, and how to apply practical tools to improve their self-management.

Chair

Nicky Rousseau, CPA, MBA

Speaker

Facilitator
Jennifer Cubino, MA



Speakers
avatar for Jennifer Cubino

Jennifer Cubino

Executive Vice President, Head of Data Sciences, BC Platforms
Jennifer Cubino is an clinical research industry veteran of 15 years. She has a diverse background in operations, strategy, technology development and oncology. Her focus remains developing high performing and engaged teams capable of tackling uncertainty and rapidly changing markets... Read More →
avatar for Nicky Rousseau

Nicky Rousseau

Senior Alliance Management Director, IQVIA
Nicky Rousseau helps leaders and their teams accelerate performance in dynamic and ambiguous environments. She provides leadership and team coaching programs to enhance problem-solving and emotional intelligence. Program participants build a foundation of self-awareness to improve... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

DIAlogue Session 3: From My Crazy Career Path to Inside the Industry and How I Ended Up Here!
Component Type: Session

Career journeys aren’t always from point A to B to C, sometimes they are point A to B back to A and over to C… Learn about DIA’s Senior Vice President and Managing Director for the Americas’ unconventional journey that involved both East and West coast positions, a government position with an unexpected twist, a direction shift to the industry side, leading him to now providing executive leadership to the oldest and largest life sciences organization – DIA. But it doesn’t stop there! Sudip wants to hear about your career ambitions – and the group can help figure out how to turn your dreams into reality! This is a conversation that you don’t want to miss.

Chair

Sudip Parikh, PhD


Speakers
avatar for Sudip Parikh

Sudip Parikh

Senior Vice President and Managing Director, DIA Americas, DIA
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it?
Component Type: Workshop
Level: Basic

Join this session to learn what differentiates successful people in the workplace and what you can do to emulate them. We'll learn the timeless principles that lead to success with an aim to help you create an immediate impact.

Learning Objectives

Discuss different aspects of a workplace environment; Recognize areas where we can make a positive impact; Define practices and tips for handling difficult situations.

Chair

Vidhi Vashisht, MS

Speaker

Timeless Principles of Personal Success
Vidhi Vashisht, MS



Speakers
avatar for Vidhi Vashisht

Vidhi Vashisht

Associate Director, Kinapse Ltd
Vidhi believes that success and wisdom doesn't always come with age and experience, but with an open mind and willingness to take action. While working as a medical writer, she developed passion for understanding and applying the timeless principles of success and saw the positive... Read More →


Wednesday June 26, 2019 2:00pm - 2:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#364: Effective Portfolio Management of Assets Across an Organization
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-688-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166TTL5PH; RN 1.25

This session will share information on portfolio management from different perspectives: integration of an asset into an established portfolio and ensuring alignment with an established strategy; brand development to articulate differentiation and how to approach this component from a portfolio lens; and leadership techniques and skills needed to manage portfolios.

Learning Objectives

Discuss portfolio management from different perspectives: Identify how to integrate an asset into an established portfolio and ensure alignment with an established strategy; Describe brand development to articulate differentiation and how to approach this component from a portfolio lens; Describe leadership techniques and skills needed to manage portfolios.

Chair

Mark Kryah, PMP

Speaker

Integration of an Acquired Asset into the Drug Development Portfolio
Nathan R. Kreischer, MS, PMP

Building for Commercial Success in Clinical Development: Defining your Asset’s Brand Story to Build Equity and Understanding
Kirstin Dawson

Leadership Capabilities That Enable Effective Project and Portfolio Management
Daniel Patrick, MBA



Speakers
avatar for Kirstin Dawson

Kirstin Dawson

Vice President, Account Director, Addison Whitney, A Syneos Health Company
As the Vice President, Account Director in San Francisco for Addison Whitney, Kirstin leads day-to-day communication & direction for both client projects and the account services team. Her background in healthcare marketing and experience across multiple disease states give Kirstin... Read More →
avatar for Nathan Kreischer

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc
Nathan is a Director within Global Project & Alliance Management at Merck. He has over 13 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →
avatar for Mark Kryah

Mark Kryah

Senior Advisor/COO, Bio-Medicines Business Unit, Eli Lilly and Company
Mark Kryah is COO/Senior Advisor in Eli Lilly’s Bio-Medicines Business Unit, leading Phase 3 development in Immunology. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for over... Read More →
DP

Daniel Patrick

Global Group Leader - R&D Program Management Office, Daiichi Sankyo
Dan Patrick has more than 25 years of experience in the Life Sciences and Financial Services industries. He is presently Global Group Leader, R&D Program Management Office, at Daiichi Sankyo Co. (a global pharmaceutical company) where he is responsible for developing and implementing... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-689-L04-P; CME 1.25; IACET 1.25; RN 1.25

The abundance of data collected in clinical research offers an increasing opportunity for insights into risks, quality, and compliance.To realize the full value, the data must be harnessed in a manner that is useful and meaningful, which can be a challenge. The key lies in developing analytics and models that provide insights. Leveraging data is particularly valuable in an environment where Risk Based Monitoring (RBM) is now the norm and the models and dashboards derived from analytics can proactively indicate risks and issues. Interpretation can drive compliance and quality decision making and a focus on what matters most. Advanced analytics and machine learning can also be leveraged to detect irregularities that may indicate falsification and misconduct.

This session will explore the potential of data analytics and modeling as applied to risk-based monitoring activities as well as quality assurance oversight of risk-base monitoring.

Learning Objectives

Design an innovative and efficient sampling SDV method reflecting trends of data error occurrence; Assess how measured risk changes over time, comparing change in risk relative to operational attributes, and judging the effects of risk-based monitoringon risk mitigation; Define key changes to risk-based monitoring programs that may require changes to quality assurance oversight, including audit programs; Discuss how site audits may shift focus from on-site audit activities to remote.

Chair

Matthew Krumrai

Speaker

Statistical Models of Risk Flux Reveal Dynamics of Risk-Based Monitoring Managed Clinical Trials
Kristin Stallcup, MS, PMP

Study on Designing a Method of Sampling SDV in a Clinical Trial Using Audit Trail Data
Yuhi Sakajiri

Subject Data Analysis and Potential Fraud and Misconduct Analysis for Data Quality in Clinical Trials
Wei Xue, DrPH

Maintaining Quality Assurance in a Risk-Based Monitoring Environment
Matthew Krumrai



Speakers
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
avatar for Yuhi Sakajiri

Yuhi Sakajiri

Student, Waseda University
Yuhi Sakajiri (born in Chiba, Japan, in May. 1995) received B.Eng. degrees in Industrial and Management Systems Engineering from the Waseda University, Japan, in 2018. Since 2018, he engaged in quality management research at the university's M.Eng. course. His research interest is... Read More →
avatar for Kristin Stallcup

Kristin Stallcup

Senior Director, Xcellerate Customer Success, Covance
Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring... Read More →
WX

Wei Xue

Centralized Monitoring Manager, IQVIA
Wei Xue is a Centralized Monitoring Manager in Data Trial Execution in IQVIA. Her expertise spans in statistical and machine learning analysis in risk-based monitoring, predictive analysis and potential fraud and misconduct analysis in clinical trials industry. Wei got her Doctor... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra



Speakers
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Stephen Corson

Stephen Corson

Senior Statistician II, Phastar
I am a Senior Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA