Loading…
Attending this event?

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Monday, October 24
 

9:00am EDT

WORKSHOP A - Critical to Quality Factors and Quality Tolerance Limits Workshop - Define and Implement Critical to Quality Factors, Quality Tolerance Limits, and Key Risk Indicators to Quickly Identify and Assess Risk
  • Define and Implement Critical to Quality Factors, Quality Tolerance Limits, and Key Risk Indicators to Quickly Identify and Assess Risk

Speakers
avatar for Karen Ragnauth

Karen Ragnauth

Sr. Manager, Risk Management Coordination, Shionogi Inc.
avatar for Stefan van den Akker, MSc.

Stefan van den Akker, MSc.

Sr. Director R&D Quality and Risk Management, Acadia Pharmaceuticals Inc.
Stefan started his career in clinical research over 20 years ago as a CRA and almost accidentally rolled into a more QA and process oriented role over 10 years ago. Novartis was a great learning school to experience many different aspects of clinical research and Quality Management... Read More →


Monday October 24, 2022 9:00am - 12:00pm EDT

9:00am EDT

WORKSHOP B - Vendor Oversight Workshop - Identify the Critical Components of an Effective Vendor Oversight Plan
  • Identify the Critical Components of an Effective Vendor Oversight Plan

Speakers
avatar for Prajna Kumar, PhD, MPA

Prajna Kumar, PhD, MPA

Executive Director, Head Clinical Development and Operations Quality, Alexion Pharmaceuticals, Inc.
avatar for Mary MacDonald, CQA, RQAP-GCP

Mary MacDonald, CQA, RQAP-GCP

Associate Director, Research & Clinical Development Quality Operations, Alexion Pharmaceuticals, Inc.


Monday October 24, 2022 9:00am - 12:00pm EDT

12:00pm EDT

Networking Lunch
Monday October 24, 2022 12:00pm - 1:00pm EDT

1:00pm EDT

WORKSHOP C - End to End Protocol Risk Assessment: A learning and practice course on RBQM requirements, critical risk identification skills, and team facilitation
  • Training on RBQM (QbD, QTLs, KRIs, Risk assessments, etc)
  • Review a protocol in a team setting and;
    • Facilitate a study risk assessment with a RACT tool
    • Identify critical data and processes
    • Identify risks, evaluate and develop mitigation plans
    • Identify QTL parameters and KRIs
    • Draft a study monitoring approach



Speakers
avatar for Jonathan Rowe

Jonathan Rowe

Principal - Head of R&D Quality, Operations and Risk Management, ZS
Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Risk Management at ZS Associates. In this... Read More →


Monday October 24, 2022 1:00pm - 4:00pm EDT

1:00pm EDT

WORKSHOP D - The Blind Spots Mirrors of Decentralized Clinical Trials
  • Should primary endpoints of current trials typically collected in the clinic need to be digitally redesigned for DCTs?
  • How can we use advanced analytics and AI to extract clinical insights otherwise invisible using traditional trial design?
  • Do we really have what we need to accurately interpret clinical data collected remotely when the context and circumstances of the patients are largely invisible?
  • Offering patients too much flexibility may compromise data integrity--where do we draw the line?

Speakers
avatar for Amir Lahav

Amir Lahav

Digital Healthcare Innovation, Head of Strategic R&D, Mitsubishi Tanabe Pharma America
Amir is a Digital Health Advisor and a leading innovator at the forefront of tech innovation and clinical research. Amir has nearly two decades of experience in the biotech and healthcare industries. He currently sits on the Advisory Board of leading HealthTech startups (Curbase... Read More →


Monday October 24, 2022 1:00pm - 4:00pm EDT

4:00pm EDT

Welcome Cocktail Reception
Join us as we kick off the Clinical Collective with our Welcome Cocktail Reception!
*Open to all attendees, speakers, and event partners!

Monday October 24, 2022 4:00pm - 5:00pm EDT

5:00pm EDT

Workshop Day Concludes
Monday October 24, 2022 5:00pm - 5:00pm EDT
 
Tuesday, October 25
 

7:45am EDT

Registration and Networking Breakfast
Tuesday October 25, 2022 7:45am - 8:45am EDT

8:45am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →


Tuesday October 25, 2022 8:45am - 9:00am EDT

9:00am EDT

Keynote Presentation by the FDA: To Be Announced
  • The advantages and disadvantages of decentralizing trial activities
  • The types of trial related activities that can take place remote from investigators
  • The use of digital health technologies to gather data directly from patients

Speakers
avatar for Leonard Sacks, MD

Leonard Sacks, MD

Associate Director for Clinical Methodology in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration
Leonard Sacks was born in Johannesburg, South Africa where he received his medical education at the University of the Witwatersrand. In 1988 he moved to the USA completing a fellowship in immunopathology at Upstate Medical Center in Syracuse NY, and a fellowship in infectious diseases... Read More →


Tuesday October 25, 2022 9:00am - 9:30am EDT

9:30am EDT

10:00am EDT

Panel: Overcome Barriers and Explore Enablers for the Adoption (and Scalability) of DCTs
  • Discuss patient convenience and comfort with health technology (an unfamiliar experience)
  • Explore maturing tools and their impact on data quality
  • Dissect the partner ecosystem including sites and investigators – How can we maintain engagement and overcome technological challenges and workload issues?

Moderators
avatar for Christiane Dinneen

Christiane Dinneen

Vice President Clinical Operation, Science37

Speakers
avatar for Curren Katz, PhD

Curren Katz, PhD

Senior Director, Data Science, Janssen R&D
Curren Katz, PhD brings 15+ years of healthcare experience across payer, provider and pharmaceutical. As Sr. Director of Data Science at Janssen R&D, Curren leads Portfolio Strategy & Governance and Real-World Data for Neuroscience. Since joining Janssen in May of 2021, Curren has... Read More →
avatar for Jimmy Bechtel, MBA

Jimmy Bechtel, MBA

Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)
Jimmy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum... Read More →
avatar for Sheila Woodhouse MD, MBA, FACC

Sheila Woodhouse MD, MBA, FACC

Senior Director, Digital Health Lead, Global Drug Development, Bristol-Myers Squibb
Dr. Woodhouse is Senior Director, Digital Health Lead, Global Drug Development, Clinical Trial Innovation across all therapeutic areas and Oncology Digital Health commercialization at Bristol Myers Squibb.  Prior to joining Bristol Myers Squib in 2022 she was and continues to be... Read More →
avatar for Vanessa Gertsen

Vanessa Gertsen

Sr. Director, Partners in Care Network Alliance, AstraZeneca


Tuesday October 25, 2022 10:00am - 10:45am EDT

10:45am EDT

Networking Break
Tuesday October 25, 2022 10:45am - 11:15am EDT

11:15am EDT

Using Sensor Technology and Home-based Digital Engagements to Drive DCT and Derive Meaningful Data
  • What technology should be used to decentralize a traditional study protocol?
  • Shouldn't every clinical trial have decentralized elements?
  • Can over-decentralization lead to data bias or composite data quality?
  • How decentralized study designs help ease barriers to participation and retention?

Speakers
avatar for Amir Lahav

Amir Lahav

Digital Healthcare Innovation, Head of Strategic R&D, Mitsubishi Tanabe Pharma America
Amir is a Digital Health Advisor and a leading innovator at the forefront of tech innovation and clinical research. Amir has nearly two decades of experience in the biotech and healthcare industries. He currently sits on the Advisory Board of leading HealthTech startups (Curbase... Read More →


Tuesday October 25, 2022 11:15am - 11:45am EDT

11:45am EDT

Innovative Training Strategies for DCTs
Adopting new study approaches like decentralized trials to improve study accessibility for patients requires adjustments across the entire operations spectrum of your study. Ensuring that your sites, regardless of their location, understand the study and their role is essential to a seamless study. Simulation-based eLearning is the only solution that provides real training results and real metrics that help manage risk.

  • Explore the future-state of performance-based training
  • Discuss how to interpret and apply learning results to optimize and de-risk your DCT
  • Discover how simulation-based training improves DCT study performance

Speakers
avatar for David Hadden

David Hadden

President, Founder and Chief Game Changer, Pro-ficiency
Dave is an entrepreneur and technology innovator known for pioneering the fields of simulation-based medical decision-support, training analytics, and virtual patient simulation (VPS). Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians... Read More →


Tuesday October 25, 2022 11:45am - 12:15pm EDT

12:15pm EDT

Networking Lunch
Tuesday October 25, 2022 12:15pm - 1:15pm EDT

1:15pm EDT

TRAILBLAZER-ALZ 3: A Decentralized Trial in Preclinical Alzheimer’s Disease
  • Key trial design elements of this decentralized preclinical Alzheimer’s disease study
  • Structure of decentralized clinical assessments in preclinical Alzheimer’s disease
  • Benefits of a decentralized clinical trial and the role that digital innovation can play

Speakers
avatar for Roy Yaari, MD

Roy Yaari, MD

Executive Director, Medical, Neuroscience, Eli Lilly and Company
Dr. Roy Yaari completed his neurology residency and fellowship in Alzheimer’s and dementia at the University of California, San Diego in 2006. Subsequently, he served as a neurologist and then director of the outpatient Memory Clinic at the Banner Alzheimer’s Institute in Phoenix... Read More →


Tuesday October 25, 2022 1:15pm - 1:45pm EDT

1:45pm EDT

2:15pm EDT

Panel: How Are Organizations Collaborating with Partners to Limit Challenges in the DCT Environment?
Moderators
avatar for Vanessa Gertsen

Vanessa Gertsen

Sr. Director, Partners in Care Network Alliance, AstraZeneca

Speakers
avatar for Sandeep Bhat

Sandeep Bhat

Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSK
Sandeep Bhat champions transformations in global clinical research through initiatives in innovation, information exploitation (Data Science, AI/ML), emerging technology, and paradigm shifts (Decentralized Clinical Trials / DCT). As a scientist, consultant, ops professional, and technologist... Read More →
avatar for Deborah A. Guattery MJ,BSN

Deborah A. Guattery MJ,BSN

Process and Standards Lead (Decentralized Clinical Trials), Pfizer
Deb has over 20 years of experience working in clinical research. She has a Master of Jurisprudence in Health Law from Delaware School of Law and a Baccalaureate of nursing from Arizona State University. Providing clinical research opportunities to all types of people has been a lifelong... Read More →
avatar for Kendal Whitlock, MPH

Kendal Whitlock, MPH

Head of Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance
Kendal K. Whitlock is the Head of Digital Optimization, RWE Clinical Trials, with Walgreens Boots Alliance. This role leverages data assets and partnerships to advance culturally responsive approaches to clinical research. In her role, Ms. Whitlock focuses on digital solutions to... Read More →
avatar for Ellen Weiss

Ellen Weiss

Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials – Quality Mobile Research
Ellen has been bringing awareness of decentralized clinical trial visits for patients to sponsors and CROs for nearly a decade. As the Vice President of In-Home Solutions at PCM TRIALS, she brings accrued experience from the earlier days of DCT to the exciting developments of the... Read More →


Tuesday October 25, 2022 2:15pm - 3:00pm EDT

3:00pm EDT

Networking Break
Tuesday October 25, 2022 3:00pm - 3:30pm EDT

3:30pm EDT

Understanding the Lifecycle of Decentralized Clinical Trials
The growth of decentralization in clinical trials has resulted in challenges in organizational change management, regulatory guidance, and development of new skill sets to accommodate new ways to engage with patients and provide clinical oversight to ensure patient safety and data integrity. In this session, the maturity model of decentralized clinical trials will be presented, discussing the rise of decentralization, a risk-based consideration of applying decentralization on your clinical trials, and the role of oversight and monitoring when using decentralization methodologies and technologies.

Speakers
avatar for Michael Tucker

Michael Tucker

Managing Partner, Patient Cloud, Medidata
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last seven years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world... Read More →


Tuesday October 25, 2022 3:30pm - 4:00pm EDT

4:00pm EDT

Panel: Explore Business Agility and Adoption Frameworks – How Can We Strengthen Internal Support as We Shift Towards Decentralization?
  • What capabilities do we need to strengthen internally to support a shift toward decentralization?
  • How can we enable the organization to change?
  • Explore where decentralization adds the most value to your organization’s portfolio
  • Discover which technologies and capabilities must we access to capture it
  • Updates to infrastructure: Which decentralization solutions and capabilities, if any, do we want to develop in house?
  • Implement training: Reduce confusion with training and process automation

Speakers
avatar for Shafaat Ali Khan, M.B., B.S.,

Shafaat Ali Khan, M.B., B.S.,

Associate Director-Site Engagement-Clinical Development, Eli Lilly and Company
avatar for Hazel Doydum

Hazel Doydum

Manager, R&D Development, Digital Engagement and Implementation, GSK


Tuesday October 25, 2022 4:00pm - 4:45pm EDT

4:45pm EDT

Chairperson's Closing Remarks
Speakers
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →


Tuesday October 25, 2022 4:45pm - 5:00pm EDT

5:00pm EDT

Networking Cocktail Reception
Tuesday October 25, 2022 5:00pm - 6:00pm EDT

6:00pm EDT

Conference Day One Concludes
Tuesday October 25, 2022 6:00pm - 6:00pm EDT
 
Wednesday, October 26
 

8:00am EDT

Networking Breakfast
Wednesday October 26, 2022 8:00am - 8:45am EDT

8:45am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Mathew Rose, MD MS

Mathew Rose, MD MS

Co-Chair, IEEE
Dr. Mathew Rose is the Co-Chair for the IEEE-SA IC19-004-01 committee on Data Harmonization for Enabling Remote Clinical Trials and Founder/CEO of SAAVHA Inc, a social impact company focused on personalizing and reducing administrative friction around healthcare and research patient... Read More →


Wednesday October 26, 2022 8:45am - 9:00am EDT

9:00am EDT

Keynote: Assessing the Financial Value of Decentralized Clinical Trials
  • We developed a risk-adjusted discounted cash flow model (expected net present value) to measure the net financial benefit of decentralized clinical trials (DCTs)
  • Benchmark development data indicate that DCTs provide benefits from shorter clinical phase cycle times, reduced screen failure rates, and fewer substantial protocol amendments
  • This pilot study found a nearly five-fold return on investment (ROI) if DCT methods are applied to all phase II trials, a 13-fold ROI if applied to all phase III trials, and nearly a seven-fold ROI if applied to both phase II and phase III trials

Speakers
avatar for Joseph DiMasi, PhD

Joseph DiMasi, PhD

Director of Economic Analysis, Tufts University


Wednesday October 26, 2022 9:00am - 9:30am EDT

9:30am EDT

Partner Keynote: TBA
Wednesday October 26, 2022 9:30am - 10:00am EDT

10:00am EDT

Panel: Explore Modalities in DCT Trial Conduct to Preserve Patient Safety
  • Discuss the relationship between sponsors, CROs, and sites throughout the DCT process
  • Explain how this differs from the traditional model in designing protocols - all while preserving patient safety
  • Review trial decentralization at patient homes and alternative sites
  • Discuss site activation and digital site engagement

Speakers
avatar for Shafaat Ali Khan, M.B., B.S.,

Shafaat Ali Khan, M.B., B.S.,

Associate Director-Site Engagement-Clinical Development, Eli Lilly and Company


Wednesday October 26, 2022 10:00am - 10:45am EDT

10:45am EDT

Networking Break
Wednesday October 26, 2022 10:45am - 11:15am EDT

11:15am EDT

The TENOR Study: Proving Patient Centricity Can Exist in a DCT World
This session will cover:
  • Mechanisms to incorporate patient input during the study design process
  • Tactics to boost recruitment and retention
  • Creative ways to enhance scientific integrity while conducting a virtual trial



Speakers
avatar for Eileen Leary, PhD, RPSGT

Eileen Leary, PhD, RPSGT

Director, Clinical Scientist Lead, Jazz Pharmaceuticals
Dr. Eileen Leary is a tenacious sleep nerd with over 20 years of research and data analysis experience. She began her career as a sleep technologist before transitioning to data science and earning both a MS and PhD in Epidemiology and Clinical Research from Stanford University. Dr... Read More →


Wednesday October 26, 2022 11:15am - 11:45am EDT

11:45am EDT

Partner Presentation TBA
Wednesday October 26, 2022 11:45am - 12:15pm EDT

12:15pm EDT

Networking Lunch
Wednesday October 26, 2022 12:15pm - 1:15pm EDT

1:15pm EDT

What Will It Take for Sites and PIs to be Ready for Decentralized Trials?
Speakers
avatar for Christina Brennan, MD, MBA, CCRC

Christina Brennan, MD, MBA, CCRC

Vice President, Clinical Research, Feinstein Institutes for Medical Research
Christina Brennan, MD has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 22 years of extensive clinical research experience, including... Read More →


Wednesday October 26, 2022 1:15pm - 1:45pm EDT

1:45pm EDT

Partner Presentation TBA
Wednesday October 26, 2022 1:45pm - 2:15pm EDT

2:15pm EDT

Panel: A Look into the Future of Clinical Trials: DCT Today and Beyond
  • Discuss the pros/cons of hybrid versus completely virtual models
  • Navigate the effects of DCT on Clinical QA (e.g. Updating QMS to include additional SOPs, enhancing vendor management qualification and oversight process)
  • How to be Inspection Ready in a DCT-world

Moderators
avatar for Nikki Cammarata

Nikki Cammarata

Consultant, Halloran Consulting Group, Inc.
Nikki Cammarata has more than 7 years of experience in conducting early and late phase clinical trials.  Nikki’s role at Halloran is to use her experience within clinical operations and clinical systems to deliver accurate and efficient services to clients. She has experience as... Read More →

Speakers
avatar for Christiane Dinneen

Christiane Dinneen

Vice President Clinical Operation, Science37
avatar for Kimberly Hawkins

Kimberly Hawkins

Global Head of Clinical Project Operations & Dossier Delivery, Sanofi
Kim has 25 years of operational experience managing all phases of the drug development process. Kim started her career at Boston Medical Center as a Research Assistant working on pediatric AIDS and Oncology trials. After working in academia, she moved into industry and held various... Read More →
avatar for Shawna Ruffin

Shawna Ruffin

GCDO Trial Leader/Associate Director, The Janssen Pharmaceutical Companies of Johnson & Johnson


Wednesday October 26, 2022 2:15pm - 3:00pm EDT

3:00pm EDT

Chairperson's Closing Remarks
Speakers
avatar for Mathew Rose, MD MS

Mathew Rose, MD MS

Co-Chair, IEEE
Dr. Mathew Rose is the Co-Chair for the IEEE-SA IC19-004-01 committee on Data Harmonization for Enabling Remote Clinical Trials and Founder/CEO of SAAVHA Inc, a social impact company focused on personalizing and reducing administrative friction around healthcare and research patient... Read More →


Wednesday October 26, 2022 3:00pm - 3:15pm EDT

3:15pm EDT

Conference Concludes
Wednesday October 26, 2022 3:15pm - 3:15pm EDT
 
Filter sessions
Apply filters to sessions.