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Trk 01: Clinical Operations [clear filter]
Monday, June 27
 

8:30am

#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
Limited Capacity seats available

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

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA



Chair
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is currently the Executive Director of the Association of Clinical Research Professional (ACRP). Earlier in his career he developed the patient enrollment team at Eli Lilly where he worked for 24 years. Most recently he spent for 6 years at a global CROs. He is on the... Read More →

Speakers
avatar for Beth Harper

Beth Harper

President, Clinical Performance Partners, Inc.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor... Read More →
avatar for Lewis Millen

Lewis Millen

Operational Intelligence Leader, Roche Products Limited


Monday June 27, 2016 8:30am - 9:45am
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-520-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient recruitment is a challenging activity, which becomes even more so in rare diseases where populations are small, patients are geographically dispersed, and eligible subjects may not be physically (or economically) capable of traveling to a trial site. Unfortunately, current recruiting methods (e.g., listing on trial and patient organization websites, relying on key opinion leaders and trial investigators, billboards) may be limited in reach, overly reliant on busy physicians, and too costly or cost-ineffective. It behooves clinical trialists in rare diseases to consider mechanisms beyond these standard approaches. The aim of this session is to catalyze unconventional thinking and to provide a framework to organize innovative recruitment ideas.

Learning Objectives

Discuss the challenges of patient recruitment in rare diseases; Compare conventional and out-of-the-box ideas for patient recruitment; Illustrate a framework for organizing innovative recruitment ideas.

Chair

Badri Rengarajan, MD

Speaker

Leveraging Claims Data for Targeted Recruitment
Donny Chen, MBA

Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention Problems
Bethany Bray

Bringing Clinical Trials to Patients: Leveraging Convergent Data Sources to Accelerate Recruitment
Scott Douglas Schliebner, MPH



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
avatar for Bethany Bray

Bethany Bray

Chief Executive Officer, Co-Founder, AutoCruitment
Bethany Bray, Oncology and Neuroscience Researcher, Entrepreneur and Technologist, founded AutoCruitment (a technology-enabled digital patient recruitment platform) with a vision to utilize the power of the internet to address recruitment, enrollment and retention problems in clinical... Read More →
avatar for Donny Chen

Donny Chen

Senior Director, Medical Affairs Research Operations, PPD
Donny Chen, senior director of medical affairs research operations at PPD, has spent the last 18 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated... Read More →
avatar for Scott Schliebner

Scott Schliebner

Senior Vice President, Center for Rare Diseases, PRA Health Sciences
Scott Schliebner is a clinical strategist with a 20+ year background in clinical development specializing in rare diseases and orphan drug development. His experience encompasses all trial phases; a broad variety of study designs; interventional and observational studies; across a... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-513-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will present preliminary findings and future project plans for the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program, comprised of three project areas: legal and regulatory issues, scientific and technological issues, and stakeholder perceptions.

Learning Objectives

Describe objectives, methods and preliminary findings of the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program; Identify barriers, real and perceived, that inhibit widespread adoption of mobile technology in clinical trials; Consider opportunities to mitigate identified barriers to adoption.

Chair

Kristen Miller

Speaker

Clinical Trials in the 21st Century : If They Could Put a Man on the Moon…
Robert A. DiCicco, PharmD

Patient Perspective
Cynthia Geoghegan



Chair
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA
Kristen Miller helps to lead FDA’s activities with Clinical Trials Transformation Initiative (CTTI), a public private partnership between FDA and Duke University that identifies and promotes practices to increase the quality and efficiency of clinical trials. She joined the FDA... Read More →

Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over... Read More →
avatar for Cynthia Geoghegan

Cynthia Geoghegan

Patient Representative, Patients and Partners LLC
A patient advocate and cancer survivor with decades of health policy, communications and capacity-building experience, Cindy Geoghegan founded Patient & Partners to ensure that the patient perspective is strategically integrated into industry, academic, government and non-profit efforts... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#235: Global Clinical Supply Logistics Study
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.00; IACET 1.00; RN 1.00

The Tufts Center for the Study of Drug Development has recently conducted a study gathering metrics on the impact of clinical supply logistics on global studies among 14 biopharmaceutical, CRO, and provider companies. A comprehensive survey was conducted and study data on logistics were gathered.

Learning Objectives

Describe the top strategies that companies use to optimize distribution networks; List some insights gained into shipping practices and approaches to investigational drugs and supplies; Identify performance indicators for successful distribution strategies.

Chair

Mary Jo Lamberti

Speaker

Distribution Networks and Strategies
Eric A. Valentine, MBA

Cycle Time Metrics and Impact on Study Conduct
Cheryl D. Mahon, PharmD



Chair
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 →

Speakers
avatar for Cheryl Mahon

Cheryl Mahon

Director, Clinical Pharmacy, Astellas Pharma US, Inc.
Cheryl Mahon is a Director at Astellas Pharma US, Inc, responsible for the North American Clinical Supply Coordination team since 2007. This group is part of a global function responsible for forecasting, planning, packaging/labeling, distribution and return of clinical materials... Read More →
avatar for Eric Valentine

Eric Valentine

Global Director, Clinical Distribution Services, Catalent Pharma Solutions
Eric Valentine is the Global Director of Distribution Services for Catalent Pharma Solutions, responsible for developing the facilities network and logistics strategies in support of Catalent's Clinical Supply Services business. He has a background of 20 years' experience serving... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning
Limited Capacity seats available

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

TransCelerate members will share successful risk-based monitoring (RBM) implementation lessons learned during this interactive session. Regulators, sponsors, CROs and clinical research site personnel will gain practical insight for an RBM implementation strategy.

Learning Objectives

Discuss successful practices and lessons learned through an evaluation of TransCelerate company risk-based monitoring (RBM) studies and recent publications; Describe key change considerations needed to successfully implement an RBM strategy both from a site and sponsor perspective; Summarize what this unique collaboration of 20+ sponsors is doing to assist vendors in understanding the technology gaps with respect to existing tools and systems that support RBM methods.

Chair

Brett Wilson

Speaker

TransCelerate RBM Successful Practices and Lessons Learned
Joanne Benedict, MSc

TransCelerate's Approach to Understanding and Managing Site and Other Stakeholder Expectations, Wants, and Needs
Kate Owen

Site Representative
Allison Camacho

Searching for a Technology Solution to Support Risk-Based Monitoring
Mary Cusack



Chair
avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on... Read More →

Speakers
avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization... Read More →
AC

Allison Camacho

Research Manager, Dallas Diabetes and Endocrine Center
Allison Camacho joined Dr. Julio Rosenstock as his Research Manager of the Dallas Diabetes and Endocrine Center in 2002. Currently, Allison’s responsibilities include managing eight coordinators, five supporting staff, and manages the budgets and contracts for the site, ensuring... Read More →
avatar for Mary Cusack

Mary Cusack

Associate Director, Global Clinical Operations, Bristol-Myers Squibb Company
Mary has over 17 years of pharmaceutical experience of which over half have been spent at Bristol-Myers Squibb in Global Clinical Operations. Mary serves as the Business Integration Lead. In this capacity, she has responsibility to manage technical implementations within clinical... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-514-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of apps every day is a way of life, but in biopharmaceutical companies, teams struggle with how and when to use them. We will share DIY (build in house) and Amazon (off the shelf) case studies, their outcomes, and learnings.

Learning Objectives

Discuss the current landscape of clinical trial apps and health apps; Explain user adoption and outputs from use of mobile apps in trials; Describe cases from two companies who have built apps in-house or bought “off the shelf” apps for use in clinical trials, including successes and challenges in implementation, adoption and execution.

Chair

Jane E. Myles, MS

Speaker

Implementing Mobile Technology from the Site Perspective
James Kremidas

Build, Inspire, or Spin Off: Case Studies on Tech Develoment in Clinical Research
Joseph Kim

Own or Lease: Lessons Learned from a Platform Owner
Jeffrey Lee, MBA



Chair
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation, Covance
Jane is driving the global impmenentation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →

Speakers
avatar for Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing... Read More →
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is currently the Executive Director of the Association of Clinical Research Professional (ACRP). Earlier in his career he developed the patient enrollment team at Eli Lilly where he worked for 24 years. Most recently he spent for 6 years at a global CROs. He is on the... Read More →
avatar for Jeffrey Lee

Jeffrey Lee

Chief Executive Officer, mProve Health
Jeff is Founder of mProve Health, his 4th entrepreneurial venture. After a decade of experience in the mobile industry, with clients ranging from HBO/Disney/Fox to Barack Obama, Mr Lee formed mProve to leverage mobile technologies in the clinical research field. Omniscience has risen... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.00; IACET 1.00; RN 1.00

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough



Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance & Integrity, Hospital Corporation of America (HCA)
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical Research... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-515-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Internet of Things (IoT) refers to objects simultaneously producing data in an automated way. It is revolutionary to clinical research and pushes the limits of current policy, requiring us to examine regulation that could limit its potential.

Learning Objectives

Describe potential advantages and benefits of the Internet of Things (IoT) in clinical research, and the complexities and barriers to adoption; Summarize the impacts and issues involved in leveraging the IoT within health care and clinical research in particular.

Chair

Ellen Kelso

Speaker

Does “Big Data” for Enhanced Recruiting Invade Patient Confidentiality?
Lea Studer



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Lea Studer

Lea Studer

Senior Vice President of Marketing Communications, SCORR Marketing
Studer is an accomplished marketing and communications professional with more than 20 years of experience developing and implementing compelling, award-winning marketing and communication strategies and tactics in the global life sciences industry.


Wednesday June 29, 2016 4:00pm - 5:15pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#403: Running Personalized Medicine Trials: Facts and Figures
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-516-L01-P; CME 1.25; IACET 1.25; RN 1.25

Personalized medicine is a hot topic in drug development. But how exactly do you run trials with a personalized medicine target in mind? Is there a different way to plan for trial operations when you must include only those patients who express a biomarker? What are the implications to running a trial when you're testing a biomarker hypothesis in the trial itself, instead of using a validated biomarker? And how do you effectively partner with CROs to execute these plans? This session will offer industry-wide data on current trends and findings and insights on the pitfalls and opportunities of personalized medicine trials, as well as share experiences of running many trials with the goal of developing truly personalized medicines.

Learning Objectives

Define personalized medicine and share industry-wide data about the use of personalized medicine strategy in clinical trials; Describe regulatory insights and perspectives on operationalizing trials with personalized medicine objectives; Discuss lessons learned and tips to successfully run trials with personalized medicine endpoints.

Chair

Jane E. Myles, MS

Speaker

Challenge and Change in Personalized Medicines: A Survey of Industry Perspectives
Christopher Paul Milne

FDA Perspective
Michael Pacanowski, PharmD, MPH

Clinical Operations Perspective
Caoimhe Vallely Gilroy



Chair
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation, Covance
Jane is driving the global impmenentation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →

Speakers
avatar for Caoimhe Vallely Gilroy

Caoimhe Vallely Gilroy

Biomarker Operations Therapeutic Area Leader, I2ON, Roche
Caoimhe is a Biomarker Operations Therapeutic Area Leader in immunology, infectious diseases, ophthalmology and neuroscience at Roche UK, leading a team of biomarker operational experts in the execution of late stage clinical trials, with complex biomarker strategies. Caoimhe has... Read More →
avatar for Christopher Milne

Christopher Milne

Director of Research and Research Associate Professor, Tufts Center for the Study of Drug Development
Dr. Milne is currently Director of Research at Tufts CSDD, Research Associate Professor at Tufts Univ. School of Medicine, Innogen Center Associate (Univ. of Edinburgh), as well as a member of the editorial boards of DIA’s journal (TIRS) and Pharma Focus Asia. His research interests... Read More →
MP

Michael Pacanowski

Associate Director for Genomics and Targeted Therapy, OCP, CDER, FDA
Dr. Pacanowski is the Associate Director for Genomics and Targeted Therapy in the Office of Clinical Pharmacology at FDA. His team of translational scientists works to advance the use of pharmacogenomics and other biomarker innovations in drug development through review of investigational... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA