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Trk 01: Clinical Operations [clear filter]
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

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
 
Wednesday, June 29
 

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

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