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Trk 01: Clinical Operations [clear filter]
Sunday, June 26
 

1:00pm

#37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on RBM, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This tutorial, hosted by TransCelerate BioPharma, Inc., will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

Who should attend?

This tutorial is designed for professionals involved with clinical and data operations.

Learning Objectives

• Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
• Discuss the use of key tools in the RBM process;
• Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


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 →
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

8:30am

#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.

Chair

Jennifer Lentz

Speaker

Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts



Chair
JL

Jennifer Lentz

Consultant, Global Informed Business Lead, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Business Lead at Eli Lilly and Company for the last 4 years. She has been involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer... Read More →

Speakers
avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI)
Dr. Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →


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

8:30am

#102: Digital Health Debate
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

The Digital Debate will bring together expert representatives from sponsor, site, CRO and marketing perspectives to debate the merits of digital media for patient recruitment and retention. We will discuss the challenges and optimal scenarios for utilizing digital channels to recruit patients.

Learning Objectives

Discuss insights from sponsors, CROs, and sites on their past and planned use of digital media for patient recruitment; Describe the challenges faced in implementing digital media for patient recruitment; Address issues in coordinating digital media campaigns among the entities and in integrating digital with traditional campaigns; Identify possible methods to overcome organizational barriers to effectively implement digital campaigns for patient recruitment.

Chair

Nariman Nasser

Speaker

Move from Pilot to Platform: Four Strategies to Enable Digital Health Approaches to Scale in Research Programs
John Reites

mHealth in Clinical Research and Development: Is It All Hype?
Brett Villagrand

Site Perspective
Joshua R. Korzenik, MD



Chair
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation, Roche
Nariman Nasser is Digital Strategist of Operational Intelligence and Innovation at Roche/Genentech. She previously was the Senior Director of Participant Recruitment & Study Management Services at UCSF's Clinical & Translational Science Institute. Ms. Nasser’s prior experience also... Read More →

Speakers
JK

Joshua Korzenik

Director, Crohn's and Colitis Center, Brigham and Women's Hospital
avatar for John Reites

John Reites

Senior Director, Head of Digital Health Acceleration, Quintiles Inc.
As the Head of Digital Health Acceleration, John Reites is focused on partnering and executing digital health innovation programs with biopharmaceutical companies, established innovators, start-ups and VC firms. Mr. Reites is a speaker and author of various publications, providing... Read More →
avatar for Brett Villagrand

Brett Villagrand

Principal, Carethings
Brett’s passion is for how innovation in technology can impact outcomes for patients. Most of his career was with Pharmaceutical companies Novartis and Genentech in product development and marketing roles. Until recently, was hired as an industry subject matter expert at Oracle... Read More →


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

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

#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
Limited Capacity seats available

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

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD



Chair
avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan... Read More →

Speakers
avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Global Clinical Development at SOUSEIKAI Global Clinical Research Center, serving as both liaison for international business development and investment, as well as an active member of the clinical trial team. It is his hope to help bridge the... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Global CEO, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active... Read More →


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

10:45am

#124: Risk-Based Monitoring in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



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 Jill Collins

Jill Collins

Executive Director, Global Operations management, Innovation, INC Research
Jill Collins, Executive Director, Global Operations Management, Innovation at INC Research, with 20 years of experience in clinical operations, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 19 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113C 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

10:30am

#208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study
Limited Capacity seats available

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

The patient centricity movement has generated substantial activity within both the public and private sectors, but to date no quantitative data have been gathered on the adoption and impact of specific patient-centric initiatives implemented by pharmaceutical and biotechnology companies to support processes within the medical product life cycle. Similarly, no effort has been made to harmonize the patient centricity principles and draft guidance recommendations developed by public and public-private consortia with industry drug development practice and policy. DIA, in collaboration with Tufts Center for the Study of Drug Development (CSDD), have undertaken a comprehensive study to address these critical needs. In this forum, the Tufts CSDD-DIA team, along with industry representatives participating in the study, will describe the study objectives and approach as well as work to date. In addition, they will share interim observations and insights from preliminary data that have been gathered and analyzed.

Learning Objectives

Discuss current outcomes and effectiveness of patient engagement in the medical product life cycle; Identify the benefits of standard metrics to advance the practice of meaningful patient engagement in medical product development and approval processes; Describe the objectives and approach of the DIA-Tufts CSDD study; Discuss observations of the study based on data collected to date, including patient engagement practice, metrics in use, and barriers to robust patient engagement programs.

Chair

Mary Jo Lamberti
Elizabeth Lincoln, MA

Speaker

Panelist
Kathleen A. Foley, PhD

Panelist
John Manganaro

Panelist
Jeffrey W. Sherman, MD, FACP

Panelist
Ellen Coleman



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 →
avatar for Elizabeth Lincoln

Elizabeth Lincoln

Global Director of Engagement, DIA
Prior to DIA, Elizabeth spent 12 years in Human Capital consulting at Accenture and five years at Career Concepts, Inc. She has worked across industries and for Fortune 100 as well as small, family-owned businesses in human resources and organization development. Since joining DIA... Read More →

Speakers
avatar for Ellen Coleman

Ellen Coleman

President and CEO, VOZ Advisors
As president and CEO, Ellen Coleman leads VOZ Advisors and is responsible for all aspects of the overall firm path and direction. Ellen brings considerable experience in working with patients with life-threatening and chronic illnesses giving her a view of the entire patient experience... Read More →
avatar for Kathleen Foley

Kathleen Foley

Senior Director, Pfizer Inc.
Kathleen A. Foley is a senior director and the Patient Centered Metrics Lead in the Global Health and Value Innovation Center at Pfizer, where she is responsible for the development of metrics contributing to the science of patient input. Dr. Foley has a master’s degree from the... Read More →
JM

John Manganaro

Deputy Director, Regulatory Policy and Intelligence, Bayer HealthCare Pharmaceuticals
John has over 20 years in the pharmaceutical industry in Medical and Regulatory Affairs. He has extensive experience with various topics ranging from medical information, safety, compliance, product quality, intelligence research and regulatory issues. John is currently Deputy Director... Read More →
avatar for Jeffrey Sherman

Jeffrey Sherman

Chief Medical Officer and Executive Vice President, Research and Development, Horizon Pharma, Inc.
Jeff has more than 20 years of experience in the pharmaceutical industry. He is President of the Drug Information Association (DIA) and a member of the Board of Directors. He also served as chairperson of the DIA 2008 Annual Meeting and received an Outstanding Service Award in 20... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
108B 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

10:30am

#307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options
Limited Capacity seats available

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

Site selection continues to be a challenge for study teams. How do you find the best sites, and how to you ensure they have access to the patients and can produce the data quality you need for your trials? In this symposium, we will share results of an extensive survey of physicians to learn about their actual referral patterns for clinical trials and the barriers/perceptions they have about referring patients to trials. We will also explore how to expand the sites we select beyond the typical academic center. How might community networks be better leveraged? How might we partner with patient advocacy groups to identify new and well suited sites to include in our trials? Pulling it all together - how can we then engage physicians other than the research sites to refer patients to our trials? And what information will be useful to both traditional and not so traditional sites to help them successfully enroll trials?

Learning Objectives

Compare data from physicians about clinical trial referral practices and perceptions; Describe experiences and lessons learned from partnering with a community network of physicians as a clinical trial site.

Chair

Jane E. Myles, MS

Speaker

Integrating Overlooked Health Care Networks into Clinical Trial Site Selection
Sowmya Banda

Study of Health Care Provider Perceptions and Patient Referral Practices
Mary Jo Lamberti

How Advocacy Is Impacting Site Productivity
David LeDuc



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
SB

Sowmya Banda

Graduate Intern, Clinical Trial Planning and Operations, Bristol-Myers Squibb Company
Sowmya is the Clinical Trial Planning & Operations Graduate intern at Bristol-Myers Squibb. She supports Feasibility Analytics as well as Diversity & Patient Engagement within clinical operations. She is also a PharmD Candidate at the Ernest Mario School of Pharmacy at Rutgers Un... 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 LeDuc

David LeDuc

Senior Director of Strategic Alliances, Addario Lung Cancer Medical Institute
As Sr. Director of Strategic Alliances, David leads efforts to identify and cultivate potential member institutions while leading the development of innovative partnerships to advance ALCMI's mission and accelerate the pass of research.  David has a breadth and depth of experience... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#308: Patient Recruitment Workshop: Survey Results and Practical Application
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-16-519-L01-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will incorporate the patient engagement survey results from the Tufts Center for the Study of Drug Development, a large group discussion, and small group breakouts to develop practical solutions for pediatric, rare disease, oncology, and other clinical studies.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the findings of the latest Tufts CSDD patient engagement surveys; Identify obstacles and opportunities to improve patient engagement in clinical trials; Propose at least three solutions which address patient engagement needs.

Chair

Robin F Marcus

Speaker

Facilitator
Stella Stergiopoulos



Chair
avatar for Robin Marcus

Robin Marcus

SVP Business Development & Strategic Initiatives, GlobalCare Clinical Trials
Robin is Sr. Vice President with GlobalCare Clinical Trials. In the past 25 years she has become known as an innovative healthcare executive focused on launching new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware & Home... Read More →

Speakers
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Research Fellow, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos leads multi-sponsored research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-517-L04-P; CME 1.25; IACET 1.25; RN 1.25

Are you considering creating a position for a director of patient engagement but have no idea where to start? Or do you just want to know more about what patients think about your drugs and what they want you to know? Learn how to do it from industry executives who have spent their time learning about patients and putting programs in place to advance advocacy efforts. They will also share real-world examples of pharma programs and experiences involving the patient voice.

Learning Objectives

Explain why it is important to have a director of patient engagement; Describe how to create the position, what the primary responsibilities should be, what the biggest challenges are in creating it, including how to overcome them; Discuss how to determine what patients think of your drug and efforts, what they are saying about it, and what they want you to know.

Chair

Ed Miseta, MBA

Speaker

Panelist
Roslyn F Schneider

Panelist
Beverly L Harrison

Panelist
Eric J. Peacock, MBA



Chair
avatar for Ed Miseta

Ed Miseta

Editor, Life Science Connect
Ed is the chief editor for the website Clinical Leader and a contributing editor to Life Science Leader magazine. He covers the latest trends, challenges, innovations, and best practices in the conduct of clinical trials. He has a BS in Business Economics and an MBA, both from The... Read More →

Speakers
avatar for Beverly Harrison

Beverly Harrison

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

Eric Peacock

Co-founder and Chief Executive Officer, MyHealthTeams
Eric Peacock is the CEO of MyHealthTeams. Eric cofounded MyHealthTeams with the belief that if you are diagnosed with a chronic condition, it should be easy to find the best people around to help you. To date MyHealthTeams has launched social networks in 24 different chronic conditions... Read More →
avatar for Roslyn Schneider

Roslyn Schneider

Global Patient Affairs Lead, Pfizer Inc
Roz leads Global Patient Affairs at Pfizer, a hub of patient centricity, driving integration of patient experiences and perspectives across the company and the product lifecycle. She held roles in Medical Affairs, Medical Strategy and Medicine Development for twelve years at Pfizer... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations
Limited Capacity seats available

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

There is no crystal ball for forecasting definitively whether an investigator or site will fulfill the promised number of participants for a clinical trial, finish on time and within budget, or provide high quality data. There are, however, some new ways of developing key performance metrics that can help organizations hone in on the right investigators for a particular study early on in the trial planning process. This interactive session features a panel of leaders in pharmaceutical industry analytics who will describe the current data environment for clinical trial operations, lay out innovative metrics and related data sources, and help the audience map out a plan for implementing performance assessments that use all the data available to them. This frank exchange of ideas and practical experiences to weigh the trade-offs among various metrics and processes will have a particular emphasis on risk-based monitoring trends.

Learning Objectives

Explain how organizations are using e-data sources to support risk-based monitoring (RBM) approaches; Compare RBM industry trends to your organization’s experience; Identify potential data sources and/or innovative metrics to predict and measure site performance; Formulate a plan for implementing performance assessments.

Chair

Angelique Hopkins, MPH

Speaker

RBM Industry Trends: How the Landscape Has Changed Between 2013-15
Linda B. Sullivan, MBA

Metrics, Not Magic: Predicting Risk of Site Failure
Lucas Glass, MS



Chair
avatar for Angelique Hopkins

Angelique Hopkins

Associate Director Clinical Trial Analytics, Bristol-Myers Squibb Company
Angelique Hopkins is an Associate Director of Clinical Trial Analytics in Business Insights & Analytics at Bristol-Myers Squibb supporting clinical trial planning. She has a B.S. in Biology from The College of New Jersey, a M.P.H from Drexel University and is completing her doctoral... Read More →

Speakers
avatar for Lucas Glass

Lucas Glass

Head of Machine Learning Research, QuintilesIMS
Lucas Glass manages global data science and machine learning research for clinical operations within QuintilesIMS . Prior to QuintilesIMS, Lucas worked as a statistician within the United States Attorney’s Office Healthcare Fraud Department where he worked on data mining and causation... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, WCG Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-521-L04-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will cover multi-ethnic, special populations, and patient diversity in clinical trials. It will illustrate an assessment of over 10,000 trials, recently conducted by sponsor companies, to quantify the differences of pediatric trials from adult studies. It will illuminate the learning’s in site identification, site qualification, and enrollment from the DOVE study, a 14-country study representing a mix of traditional and developing regions. It will then evaluate and analyze the available data regarding the characteristics of medicines approved for older patients in European Union and the US, contributing to the information in the geriatric population in order to discuss their access to innovative drugs.

Learning Objectives

Discuss country-specific differentiation in site activation, subject recruitment, and data quality, especially around developing regions, as demonstrated by the DOVE study; Classify the difference in performance between pediatric and adult studies; Describe the challenge of addressing geriatrics adequately in the assessment of medicines including the necessity to increase global regulatory dialogue and communication.

Chair

Lisa Palladino Kim, MS

Speaker

Pediatric Studies: Experiences, Best Practices, and Trends
Conrad Hawkins

Conduct of Clinical Trials in Special Populations and Developing Regions: Challenges and Opportunities
Stephen G. Reams, MA

Medicines Development for Geriatric Patients: Unmet Needs?
Dinah Duarte, PharmD, MSc



Chair
avatar for Lisa Kim

Lisa Kim

Director of Capstone / Lecturer, Rutgers School of Health Professions
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Trial Sciences Program. Lisa has 15 yrs of pharma expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt), which allowed... Read More →

Speakers
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 Conrad Hawkins

Conrad Hawkins

Associate Consultant, KMR Group Inc.
Conrad Hawkins is an associate consultant of KMR Group, a firm specializing in measuring and improving biopharmaceutical R&D performance, evaluating clinical productivity, clinical trial cycle times and enrollment processes as well as study start-up. His areas of expertise include... Read More →
avatar for Stephen Reams

Stephen Reams

Advisor, Clinical Project Management, Eli Lilly and Company
Steve has more than 27 years experience in the pharmaceutical industry, including assignments in both discovery research and clinical product development at Eli Lilly and Company. His roles have spanned multiple disciplines including clinical operations, data management, and clinical... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
113C 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