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Sunday, June 23
 

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management. Through hands-on experience with hypothetical case studies developed for this course, you will design a proactive approach for the identification and management of quality risks and issues; develop thresholds for triage thereby setting tolerance limits; and experience design trending leading to analytics to identify future signals and risks. You will leave with knowledge and access to materials that will enable you to design a framework for identification and mitigation of quality risks as well as management of issues with tolerance limits which could reside in your own organization’s risk management program.
The instructors will take you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the risk process;
  • Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
  • Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.



Speakers
avatar for Victoria Burk

Victoria Burk

Senior Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie. She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →
avatar for Tim Grey

Tim Grey

Senior Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

1:30pm

SC37: #37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-516-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course is designed to teach participants a step-by-step approach to designing patient materials and educational initiatives that effectively communicate concepts at a level appropriate for their audiences. Patient literacy (or health literacy) is certainly not a new topic, yet isn’t getting its much-deserved attention these days. Materials developed for patient communications or education often miss the mark. The application of literacy and numeracy principles is now more critical than ever, due to the increased tendency of patients to seek out disease state and treatment-related information on their own. In this interactive short course, participants will learn principles of patient literacy, receive a number of tools to assist them in developing their own patient-literate materials, and learn about excellent resources that can be used to help them continue to develop their skills in this area. Interactive exercises will provide opportunities to practice these skills. This will include evaluating existing materials, editing to improve literacy, and development of new materials. We will address both written and oral communication. Finally, an active discussion will provide strategies on how participants can work to encourage a culture of patient literacy within their own organizations, becoming champions of this approach and bringing about true cultural change. 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 individuals responsible for the design and development of patient-facing materials; clinical educators; developers of patient educational materials.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Define patient literacy, numeracy and health literacy, describe how each affects the quality of patient communications and educational efforts;
  • Identify common mistakes in patient-facing materials;
  • Develop a strategy for improving your organization’s patient-facing communications;
  • Develop a culture that embraces patient literacy principles.



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc
Kelly Franchetti has a diverse background comprised of nursing, patient advocacy and clinical research. This broad range of experiences gives her a unique view of patients’ and caregiver’s perspectives in the realm of disease management and treatment. As a critical care nurse... Read More →
avatar for Valerie Martin

Valerie Martin

Associate, Global Patient Insights and Engagement, ICON plc.
Valerie’s career has been centered around leading and managing large-scale, global patient recruitment and retention programs. She also has extensive experience crafting individualized site support initiatives to accelerate enrollment. She prioritizes the needs of each program’s... Read More →
avatar for Ariel Rosen

Ariel Rosen

Director, Global Patient Insights, ICON plc.
Ariel has over 15 years of wide-ranging experience in clinical research including tenures as a study coordinator at large academic medical centers. She has an MS in Clinical Neuropsychology and spent a large portion of her career focusing on CNS indications. Ariel has extensive experience... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

High-stakes meetings such as CHMP/PRAC oral explanations are often the ultimate chance for a pharmaceutical sponsor to convince EU regulators that the benefit:risk balance of their product is positive. Being well-prepared and performing professional is key to success. This include demonstrating intimate knowledge of your data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in your support. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of success. This short course focuses on how best to plan, manage, prepare and execute successfully at EU high-stakes meetings. Former CHMP members, pharma executives and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators. Focus will be on CHMP oral explanations, but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back-up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimize the stress on your team will also be touch upon. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these. 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 in Regulatory and Clinical teams.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify the key messages and supporting slides needed to conduct a successful EU regulators meeting;
  • Develop a comprehensive Q&A grid;
  • Develop a strategy and encourage the development of back – up slides when preparing questions.



Speakers
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6E 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

#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

#140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

Standardizing real world data, consisting of EHR and claims encounters, into a clinical trial endpoint relies on a complex process of selecting the appropriate data-set and filtering, mapping and merging healthcare encounters from EHR to trial endpoints.This session will describe and appraise approaches and challenges in formulating the endpoints, in both prospective and retrospective research projects, with a focus on cardiovascular endpoints as well as demographic data.

Learning Objectives

Describe process to extract clinical trial endpoints from EHR and claims datasets; Identify how to apply a process to supplement objective EHR and claims dataset endpoints with correlated patient-reported outcomes.

Chair

Debra Fasteson Harris

Speaker

Phenotypic Diagnosis of Rare or Difficult to Diagnose Diseases
Richard Gliklich, MD

PRO Perspective not Typically Available in EHR or Other Large Existing Real World Datasets
Amanda Harrington



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Debra Harris

Debra Harris

Associate Director (Operations), Pragmatic Health Systems Research (PHSR), Duke Clinical Research Institute
Debra Harris is the Associate Director of the Center for Pragmatic Health Systems Research at the Duke Clinical Research Institute where she focuses on the use of real-world data for clinical research. She is clinical trial-ist with more than 20 years of data management, cardiovascular... Read More →
AH

Amanda Harrington

Lead Clinical Trial Coordinator, Duke Clinical Reserach Institute


Monday June 24, 2019 2:15pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics What's Next
  • Featured Topics Real World Evidence,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

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

2:15pm

#149: Hype Versus Reality: Artificial Intelligence and Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss maturation of the development of artificial intelligence (AI) over time and how AI has matured more for R&D and signal detection and less so for regulatory support.

Learning Objectives

Discuss how artificial intelligence has matured over time.

Chair

Ranjini Prithviraj

Speaker

Results of DIA (Tufts) Survey of 1000+ Members About Their Ideas About Digital Health
Mary Jo Lamberti, PhD, MA

Artificial Intelligence in Regulatory Affairs
Patrick Brady, PharmD

What is Believed Can Be Done Versus What is Now Being Done
David Meyers



Speakers
avatar for Patrick Brady

Patrick Brady

Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence, Bayer AG
Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory... Read More →
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development
Mary Jo Lamberti leads multi-company sponsored research studies at the Tufts Center for the Study of Drug Development (CSDD). She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative... Read More →
avatar for David Meyers

David Meyers

National Director, US Life Sciences, Microsoft
Dave Meyers is National Director - US Life Sciences at Microsoft; focused on strategy, business development, and the solutions portfolio in pharma, genomics and precision medicine. He joined Microsoft in 1997 - held various technical, program management, and product development positions... Read More →
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 →


Monday June 24, 2019 2:15pm - 3:15pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#161: Making Trials Work for Special Populations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses a variety of ways to address patient needs that help recruit and retain special populations in clinical trials.

Learning Objectives

Identify useful guidelines and regulations regarding special populations in various countries; Discuss useful models of patient engagement that focus on special populations; Discuss case studies that show how some clinical trials have attracted special groups of patients.

Chair

Deborah E. Collyar

Speaker

Therapeutic Needs of Older Patients in the Era of Mobile Health
Dinah Duarte, MSc

Implementation of a Peer Advocate Model to Optimize Trial Enrollment, Diversity, and Retention
Caroline Donovan, MPH

Site Awareness and Best Practices for Inclusion of Diverse Populations in Research
Diana Foster, BSN, PhD, MSN



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 →
avatar for Caroline Donovan

Caroline Donovan

Manager of Patient Engagement, LuCIN, Lupus Therapeutics, LLC
Caroline Donovan, MPH is the Manager, Patient Engagement for Lupus Therapeutics, an affiliate of Lupus Research Alliance. She is responsible for the development and implementation of a peer education program in which prospective lupus clinical trial patients are matched with a trained... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Diana Foster

Diana Foster

CEO, Society For Clinical Research Sites
Dr. Foster serves as a consultant to the Society for Clinical Research Sites as the Vice President of Strategy and Development. In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site. She has been integrally... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

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

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OOD, OND, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Oncologic Diseases in OND/CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-608-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore and discuss agency-wide patient engagement programs and initiatives that provide patient stakeholders (patients, caregivers and advocates) opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review.

Learning Objectives

Describe how FDA has established organizational components to ensure patients are a priority; Describe avenues for patient stakeholders to engage with the agency; Explain key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss the value of patient stakeholder participation.

Chair

Samir Shaikh, MBA

Speaker

FDA Perspective
Patroula Smpokou, MD

Patient Perspective
Debbie Drell

Patient Perspective
Sabina A. Kineen



Speakers
avatar for Debbie Drell

Debbie Drell

Director of Membership, National Organization for Rare Disorders (NORD)
Debbie joined the National Organization for Rare Disorders (NORD) in 2017 with more than 18 years of nonprofit experience in public health education, awareness and advocacy. Most recently, she worked for the Pulmonary Hypertension Association, a NORD member organization. Debbie says... Read More →
avatar for Sabina Kineen

Sabina Kineen

Fabry Disease, Patient Advocate
Diagnosed with Fabry Disease in her early teens, Sabina provides a unique perspective as both a patient and caregiver. Over the years, she has shared her experiences living with a rare genetic condition, as well as helping manage the complicated and multi-faceted healthcare needs... Read More →
avatar for Patroula Smpokou

Patroula Smpokou

Deputy Director, Office of New Drugs, CDER, FDA
Patroula Smpokou, MD, currently serves as an acting deputy director in the Division of Rare Diseases and Medical Genetics at FDA’s Center for Drug Evaluation and Research where she is involved in the scientific review and regulation of products intended for rare genetic diseases... Read More →
avatar for Samir Shaikh

Samir Shaikh

Deputy Director, Patient Affairs Staff, Office of the Commissioner, FDA
Samir Shaikh works at the U.S. Food and Drug Administration (FDA) and serves as the Deputy Director for the Patient Affairs Staff (PAS) in the Office of the Commissioner. PAS leads and enhances patient engagement activities across the medical product Centers—facilitating dialogue... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session examines the use of home trial support services from the perspectives of the study sponsor, CRO partner and the potential patient participant. During this session we will discuss the logistics of home trial support, its benefits and pitfalls, when it is most appropriate to use and the patient perception of the service and how it may affect their willingness to participate.

Learning Objectives

Describe the benefits of use of home nursing (specifically, home trial support) in clinical trials from the sponsor, CRO and patient perspectives; Identify barriers to implementation of home trial support; Discuss scenarios where the greatest return on investment for home trial support is realized.

Chair

Ellyn Getz

Speaker

Academic Perspective
Ellyn Getz

Industry Perspective
Todd McGrath

Study Sponsor Perspective
Nour Ziyadeh, MS

Patient Perspective
Mary Koestler

CRO Perspective
Kelly Franchetti, RN



Speakers
MK

Mary Koestler

Assistant Professor, Clinical Trials Adminstrator, Memory and Aging Center, University of California San Francisco
avatar for Nour Ziyadeh

Nour Ziyadeh

Clinical Trial Oversight Lead, Alnylam Pharmaceuticals
Nour Ziyadeh is a Clinical Trial Oversight Lead ensuring compliance for Alnylam’s outsourced clinical trials. She has 15 + years of industry experience including third party auditing for the FDA, CRO , SMO and Pharma. She has held roles including Clinical Research Coordinator, Clinical... Read More →
avatar for Kelly Franchetti

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc
Kelly Franchetti has a diverse background comprised of nursing, patient advocacy and clinical research. This broad range of experiences gives her a unique view of patients’ and caregiver’s perspectives in the realm of disease management and treatment. As a critical care nurse... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
TM

Todd McGrath

Vice President Operations A/O, Medical Research Network
Todd has over 15 years' experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotech consulting and then holding operational positions at a clinical research organization. As Vice President Operations Americas Oceania at MRN, Todd... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 11B 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

2:00pm

#265: Decision Leadership: How Using a Structured Approach to Decision Making Can Help You Lead Teams Better
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-616-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166QAHX56; RN 1.25

This workshop will draw on best practice and case study examples to teach participants the basics of decisions science, with a focus on providing hands-on experience with a framework that can be immediately applied by participants at their organization.

Learning Objectives

Differentiate between decisions and outcomes; Identify the structural components of choice (decisions, uncertainties, values); Recognize decision problems and declare decision opportunities; Employ a proven decision framework for facilitating better decision making within project teams.

Chair

Tyler Ludlow, MBA


Speakers
avatar for Tyler Ludlow

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute
As a decision scientist, Tyler helps people turn decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, Tyler studied decision science at Stanford. He then spent a decade helping leaders at global 500 firms (including top pharma companies... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Student Programming
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Workshop

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

#286: The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-629-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial Intelligence (AI) and Machine Learning ML) have become buzzwords in every industry. While most of AI's potential is yet to be reached, pharma is starting to see tangible benefits that can be applied across the industry. This session will discuss new technologies and methods leveraging AI and ML to transform aspects of MedDRA coding, WHO drug coding, and data quality.

Learning Objectives

Explain and contrast the definitions of Artificial Intelligence and Machine Learning; Describe how AI has impacted MedDRA coding; Discuss how to review ways in which AI has been implemented to improve the efficiency and accuracy of WHO drug coding and the challenges experienced along the way; Identify how pharmaceutical companies and CROs have leveraged machine learning technology to improve data quality and overall drug submission success.

Chair

Stacey Yount, MA

Speaker

Introduction to Artificial Intelligence and Machine Learning: Application for MedDRA Coding
Cartic Ramakrishnan, PhD

How Can We Optimize the Use of Machine Learning for Increased Efficiency in Drug Coding?
Malin Jakobsson, MPharm, RPh

The Use of Machine Learning to Transform Clinical Trial Data Quality and Efficiency
Stacey Yount, MA



Speakers
avatar for Malin Jakobsson

Malin Jakobsson

Product Strategy Manager, Uppsala Monitoring Centre
Malin is Product Strategy Manager for WHODrug at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the... Read More →
avatar for Cartic Ramakrishnan

Cartic Ramakrishnan

Senior Technical Staff Member, Lead Cognitive Scientist, Life Sciences, IBM Watson Health
Cartic Ramakrishnan is a research scientist with a background in NLP and Machine Learning. He serves as lead scientist at IBM Watson health developing solutions to problems in the biomedical and healthcare domain. Cartic's recent work has focused on the development of NLP systems... Read More →
avatar for Stacey Yount

Stacey Yount

Vice President, Product, Medidata Solutions
As Vice President of Product at Medidata, Stacey Yount is the leader for the CTMS and Risk Based Monitoring platform. With 20 years of experience in clinical research, Stacey is an expert in data management, pharmaceutical efficiency, clinical development, CRO operations, and innovation... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-636-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include an update from members of the US FDA on progress and topics of current interest in US biosimilar policy, regulation, and outreach/education.

Learning Objectives

Discuss topics of current interest in US biosimilar policy.

Chair

Sarah Yim, MD

Speaker

FDA Update
Joseph B. Franklin, JD, PhD

FDA Update
Sarah Crowley-Ikenberry, MA

FDA Update
Christopher Downey, PhD



Speakers
avatar for Sarah Yim

Sarah Yim

Director (Acting), Office of Therapeutic Biologics and Biosimilars, FDA
Sarah Yim, M.D. is acting Director of the Office of Therapeutic Biologics and Biosimilars in CDER's Office of New Drugs (OND). Prior to joining the Biosimilars group in March 2019, she was director of the Division of Clinical Review in the Office of Generic Drugs (OGD) for 2 years... Read More →
avatar for Sarah Crowley-Ikenberry

Sarah Crowley-Ikenberry

Senior Communication Advisor, OTBB, OND, CDER, FDA
Sarah Ikenberry is Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars (OTBB), in the Food and Drug Administration’s (FDA), Center for Evaluation and Research (CDER) where she provides communication advice and support to senior leaders and the agency... Read More →
avatar for Christopher Downey

Christopher Downey

Review Chief, OBP, OPQ, CDER, FDA
Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from... Read More →
JF

Joseph Franklin

Policy Director for the Principal Deputy Commissioner, FDA
Joe Franklin is the Policy Director for the FDA Principal Deputy Commissioner. Until April 2019, Dr. Franklin was the Director of the Policy Staff in the Office of Therapeutic Biologics and Biosimilars at FDA. Previously, Dr. Franklin was an Associate Chief Counsel in FDA’s Office... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#297: Integration of Manufacturing Quality Assessment and Pre-Approval Inspections
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-642-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss various case studies that illustrate the mechanism for risk-based holistic assessment of pharmaceutical manufacturing, and how such assessment leads to a thorough and timely assessment.

Learning Objectives

Describe the benefits of holistic pharmaceutical manufacturing assessment that involves closer alliance between drug product quality assessment and facility inspection; Recognize manufacturing risks that act as triggers for pre approval inspections.

Chair

Joanne Wang, PhD

Speaker

Integrated CMC Review and Inspection for a Combination Product: A Case Study
Nikolas Burlew

Proposal to Improve Risk-Based Regulatory Application Assessment
Roger Nosal, PhD

Regulatory Considerations for Manufacturing Assessment and Pre-Approval Inspections
Derek Smith, PhD



Speakers
avatar for Nikolas Burlew

Nikolas Burlew

Executive VP, RSD Global Consulting, Clinipace
Nik is a pharmaceutical professional with over twenty-seven years of experience in Drug Development, Manufacturing and Quality Assurance. He leads the Regulatory and Strategic Development Global Consulting group within Clinipace, Inc. which is focused on advancing drug and biologic... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Global CMC, Pfizer Inc
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Derek Smith

Derek Smith

Director, Div of Inspectional Assessment, OPF, OPQ, CDER, FDA
Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug... Read More →
avatar for Joanne Wang

Joanne Wang

Acting Quality Assessment Lead, OPF, OPQ, CDER, FDA
Dr. Joanne Wang joined FDA in 2015 as a chemical engineer with expertise in drug delivery from complex devices, systems modeling, and in vivo superresolution imaging. She is currently the Acting Quality Assessment Lead in Branch IV, Division II of Office of Process and Facilities... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc



Speakers
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
avatar for Douwe Postmus

Douwe Postmus

Researcher, University Medical Center Groningen
Dr Douwe Postmus is employed as a researcher at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory, reimbursement... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
GT

Graham Thompson

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


Wednesday June 26, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

8:00am

#315: Measuring and Assessing Product Manufacturing Quality
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-662-L04-P; CME 1.25; IACET 1.25; RN 1.25

Quality in pharmaceutical manufacturing is essential for patients but difficult to define and measure. This session will explore qualitative and quantitative approaches to assess the ability of manufacturers to make high quality medicines. Methodologies from FDA and Industry to measuring product and manufacturing quality will be discussed such as quality metrics and the New Inspection Protocol Project (NIPP).

Learning Objectives

Describe different methodologies to assessing product and manufacturing quality; Discuss the role of FDA’s Office of Pharmaceutical Quality (i.e., Office of Surveillance) in determining risks associated with manufacturing facilities and products; Identify the vision of how FDA programs can enhance risk-based regulatory oversight of manufacturing quality.

Chair

Giuseppe Randazzo, MS

Speaker

How FDA’s Office of Pharmaceutical Quality Applies Quality Surveillance to Assure Drug Quality
Karthik Iyer, MS

Panelist
Erin Fox, PharmD

Industry Perspective
Cylia Chen, MS



Speakers
CC

Cylia Chen

Director of Quality, Amgen
Cylia leads development of external engagement strategies for Amgen and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. She is currently the co-leader of PDA Quality Metrics/Culture Task Force Team and have led a panel of experts... Read More →
avatar for Erin Fox

Erin Fox

Senior Director, Drug Information and Support Service, University of Utah Health
Erin directs the University of Utah Health Care Drug Information Service (UUDIS) and is adjunct associate professor at the UU College of Pharmacy. The UUDIS provides drug shortage content for the American Society of Health-System Pharmacists. Erin is recognized as an expert in drug... Read More →
avatar for Karthik Iyer

Karthik Iyer

Associate Director, CDER, FDA
Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →
avatar for Giuseppe Randazzo

Giuseppe Randazzo

Director, Office of New Drug Products, OPQ, CDER, FDA
Giuseppe serves as Director of the Office of New Drug Products (ONDP) in CDER at FDA. ONDP is responsible for conducting risk and team-based, quality assessments of INDs, NDAs, and active pharmaceutical ingredient (API) information supporting NDAs and ANDAs. Giuseppe has been at the... Read More →


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

8:00am

#319: How to Solve the Problem of Access for Rare Diseases
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-663-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel will share learnings and build on outcomes from the recent Rare Access to Critical Therapies (ACT) Stakeholder Summit convened by Global Genes and the Child Neurology Foundation, two patient advocacy organizations which brought together more than 200 individuals representing key stakeholders in the rare disease drug development space to build awareness and understanding about access to and pricing of rare disease therapies.

Learning Objectives

Discuss critical access issues related to rare disease drug development; Describe lessons learned from recent experiences to improve communication and collaboration among stakeholders and ensure the patient and caregiver needs are truly understood, considered and incorporated into access and pricing decision-making.

Chair

Sissi Pham, PharmD

Speaker

Panelist
Kari Luther Rosbeck

Panelist
Nicole Boice

Panelist
Scott Demarest, MD

Panelist
Sarah Pitluck, MSc

Panelist
Sean Tunis, MD, MSc



Speakers
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
avatar for Kari Rosbeck

Kari Rosbeck

President and Chief Executive Officer, Tuberous Sclerosis Alliance
Kari joined the TS Alliance in June 2001 and became President and CEO in November 2007. Kari has been involved in nonprofit fundraising and volunteer management for nearly 30 years. During Kari’s tenure as President and CEO, the TS Alliance established a comprehensive research program... Read More →
avatar for Sarah Pitluck

Sarah Pitluck

Head, Global Pricing and Reimbursement, Spark Therapeutics
Ms. Pitluck is the Head of Global Pricing & Reimbursement (P&R) at Spark Therapeutics. In her current role, Ms. Pitluck priced the first FDA-approved gene therapy for a genetic disease, LUXTURNA®. She is now working to ensure market access for all US patients in need of LUXTURNA... Read More →
NB

Nicole Boice

Founder, Global Genes Project
SD

Scott Demarest

Assistant Professor, Departments of Pediatrics and Neurology, University of Colorado School of Medicine; Children's Hospital Colorado
Scott Demarest received a Bachelor of Science in biology from the University of Texas at Austin before going on to medical school at the University of Texas Health Science Center in San Antonio. He completed his residency in Pediatrics and child neurology at Children's National Health... Read More →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Wednesday June 26, 2019 8:00am - 9:15am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Rare Disease
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

10:30am

#337: Application of Project Management Methodologies and Tools in NonProfit Institutions
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-668-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166QWTSEW; RN 1.00

Effective project management is crucial to every organization to execute effectively on strategic goals. Yet it may be a relatively new concept to healthcare and research organizations. Assessment of the need and development of the "right size" solution to encourage collaborative decision making, good stakeholder communication and robust planning will be discussed.

Learning Objectives

Discuss the need for project and portfolio management and assessment in academic and nonprofit institutions and learn how to implement project management in a non-traditional setting; Illustrate the use of and construction tools in resourced constrained environments.

Chair

Elizabeth Somers, MS

Speaker

Benefits of Adapting Project Management Methodologies to Meet the Specific Needs of an Organization
Elizabeth Somers, MS

How to Adapt Traditional Project Management Methodology for Research Institutions
Neha Pannuri, PMP

Developing and Deploying a Resource Management System in a Non-Profit Vaccine Development and Implementation Organization
Rami Scharf, DrSc, MBA, MSc



Speakers
avatar for Neha Pannuri

Neha Pannuri

Project Manager, Icahn Institute At Mount Sinai
Neha is a Project Manager at the Icahn Institute of Data Science and Genomic Technology at the Mount Sinai Hospital in New York City. She is primarily involved in the management of a multitude of projects including NIH-funded grants, industry collaborations, and internal strategic... Read More →
RS

Rami Scharf

Director Project and Portfolio Management, CVIA, PATH
Rami Scharf began his professional career training as a biologist at the Technion – Israel Institute of Technology, earning a doctorate in applied microbiology. He started working in industry, honing his project management skills while applying science to complex environmental issues... 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 →


Wednesday June 26, 2019 10:30am - 11:30am
Room 15AB 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

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

2:00pm

#367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-691-L04-P; CME 1.25; IACET 1.25; RN 1.25

The PDUFA VI ‘goals letter’ identified MIDD and CID as enhancing regulatory decision tools. Starting in FY2018, the FDA committed to conduct pilot program for these. This session presents the experiences and learnings from the two pilot programs.

Learning Objectives

Discuss the status and share experience of the MIDD and CID programs; Summarize high level insights on the scope and process of the programs.

Chair

Rajanikanth Madabushi, PhD

Speaker

Update on PDUFA VI MIDD Pilot Program
Rajanikanth Madabushi, PhD

Update on the PDUFA VI CID Pilot Program
Dionne Price, PhD

Moderator
Issam Zineh, PharmD, MPH

Panelist
Yaning Wang, PhD

Panelist
Cristiana Mayer, DrSc, PhD

Panelist
Brian Corrigan, PhD



Speakers
BC

Brian Corrigan

Global Head, Clinical Pharmacology, Pfizer Inc
Brian Corrigan is Vice President and Global Head of Clinical Pharmacology and Head of Clinical Pharmacology for Global Product Development at Pfizer in Groton, Connecticut. In these roles, Brian directly oversees the Global Clinical Assay Group, the Global Pharmacometrics Group, and... Read More →
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →
avatar for Cristiana Mayer

Cristiana Mayer

Director, Statistics and Decision Sciences, Janssen Research & Development, LLC
Cristiana Mayer is Director at Statistics and Decision Sciences, at Janssen R&D, Johnson & Johnson, with 20+ years of experience in the pharmaceutical industry. Cristiana is also the Head of the Adaptive Clinical Trials Center of Excellence at Janssen, and Vice-Chair of the DIA Adaptive... Read More →
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial... Read More →
avatar for Yaning Wang

Yaning Wang

Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA
Dr. Yaning Wang is the Director of the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained... Read More →
avatar for Issam Zineh

Issam Zineh

Director, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

Pediatric drug development for adult indications is mandated. Yet children should be protected from unnecessary risks. This session discusses innovative techniques using extrapolation from adult data as an efficient way to study drugs in children.

Learning Objectives

Explain the regulatory and ethical context of pediatric drug development; Discuss the role, assumptions, and data needed for using extrapolation from adult data; Identify innovative approaches using Bayesian methodologies to demonstrate the efficacy of drugs in pediatrics; Discuss ways to integrate pediatric into adult drug development.

Chair

Robert Meland Nelson, MD, PhD

Speaker

The Use of Extrapolation in Pediatric Drug Development
Robert Meland Nelson, MD, PhD

Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD

Design and Analytic Strategies for Incorporating External Data in a Global Pediatric Trial
Margaret Gamalo-Stiebers, PhD



Speakers
MG

Margaret Gamalo-Stiebers

Principal Research Scientist, Eli Lilly and Company
JL

Jeen Liu

Associate VP, Biostatistics, Allergan Inc.
I have worked in the Pharma industry for 20+ years as a statistician, currently responsible for biostatistics support of all the ophthalmology products for the company. Prior to joining Allergan, I have worked for Novartis, Astellas and Eisai. My experience in clinical trials covers... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development, Johnson & Johnson
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development and Pediatric Development Team Lead in Immunology at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-677-L04-P; CME 1.25; IACET 1.25; RN 1.25

Experts from the ICH E8(R1) working group provide an overview of the revisions to the ICH E8(R1) guideline on General Considerations for Clinical Studies and discuss how the revised guideline will support improved study design and conduct.

Learning Objectives

Discuss how the revised ICH E8 Guideline on General Considerations for Clinical Studies will modernize guidance for clinical study design; Describe how to identify critical-to-quality factors to support the meaningfulness and reliability of clinical study results; Discuss how the revised guideline will address a broader range of study designs and data sources.

Chair

Amanda Marie Roache, MS

Speaker

Panelist
Kerstin Koenig, PhD, MSc

Panelist
Mark S. Levenson, PhD

Panelist
Joanne Palmisano, MD, FACP

EMA Update
Agnès Saint-Raymond, DrMed, MD



Speakers
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Research and Development Quality, Bristol Myers Squibb
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Development GMP, GLP, GCP and... Read More →
avatar for Mark Levenson

Mark Levenson

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA
Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... Read More →
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

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


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-707-L04-P; CME 1.25; IACET 1.25; RN 1.25

Advanced Therapy Medicinal Products (ATMPs) include gene therapy, somatic-cell therapy, and tissue-engineered products. Collectively, these products are being developed in an evolving landscape and are associated with unique developmental challenges because of distinct manufacturing, clinical trial, and regulatory requirements. A 75-minute session is proposed facilitating the presentation and discussion of perspectives from several experienced regulatory agencies. An objective would be to provide a global overview of the various frameworks in place for the development of ATMPs, making note of ongoing and planned harmonization and cooperation projects.

This session will include collective short talks by CBER (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, and possibly a representative from Alliance for Regenerative Medicine (ARM) on the nature and importance of regulatory convergence with ATMPs. This would be followed by a interactive session with the speaker panel and the audience.

Learning Objectives

Describe the regulatory pathway for advanced therapy medicinal products in various global regions.

Chair

Peter W. Marks, MD, PhD

Speaker

EMA Update
Anthony Humphreys, MPharm

PMDA Update
Nobumasa Nakashima, PhD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for 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 Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6F 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