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U-Turn or Norm? #NoGoingBack and Decentralized Trials in a post-COVID-19 World

Craig Morgan
Head of Marketing, Study Startup

The effect of the pandemic on clinical trials has been profound. We have seen leaders in the pharmaceutical industry adapting quickly and boldly, to reliably manage this crisis.

COVID-19 has resulted in the compression of often decades-long digital transformation roadmaps and the adoption of new innovation strategies, such as decentralized clinical trials, to respond to the realities of the pandemic.

Stakeholders have been very vocal – there is no turning back – cumulating in the #NoGoingBack movement, arguing that the pace of innovation adoption must continue in a post-COVID-19 world.

But what is the anticipated impact of decentralized clinical trials on sponsors, CROs, investigative sites, and patients? Is the industry as a whole ready to make a switch to a more patient centric approach to running clinical trials? Or more importantly, will the industry embrace this change or revert back to its old ways post-COVID-19?

Please join us for this webcast:

Live: Tuesday, December 15, 2020

1pm EST | 12pm CST | 10am PST

On Demand: available after airing until December 15, 2021

In this webcast we will explore:

  • Impact of COVID-19 on the adoption of decentralized clinical trials
  • Perceived benefits of decentralized clinical trials from a sponsor, CRO and site perspective
  • Expectation of when decentralized clinical trials will be available at scale coupled with the estimated costs relative to traditional studies
  • Challenges to the implementation of decentralized clinical trials and misalignment amongst stakeholders

This webcast is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for virtual/decentralized trials
  • Sponsor and CRO roles responsible for clinical data management, collecting and evaluating trial metrics
  • Sponsor and CRO roles responsible for project management of studies and operational excellence

Panelists:

CRAIG LIPSET, Former Head of Innovation, Pfizer and Advisor and Founder, Clinical Innovation Partners

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.

He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Craig has received the red jacket 'hall of fame' recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who's Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.

CASEY ORVIN, Senior VP of Pharmaceutical Relationships, Study KIK and Honorary President, SCRS

Casey Orvin currently serves as VP of Pharmaceutical Relationships for StudyKIK, the leading full-service patient recruitment and retention technology company. Prior to his role at StudyKIK, he served as President of the Society for Clinical Research Sites (SCRS), a global organization representing over 9,500 clinical research sites in 47 countries within the pharmaceutical industry.

Orvin started his career at Research Solutions, a Site Management Organization over 20 years ago. He went on to serve as Executive Vice President of Business Development for Clinical Research Advantage/Radiant, successfully leading a network of over 75 research sites conducting clinical trials for pharmaceuticals, vaccines, and medical devices. In 2015, Orvin and the executive team merged with the largest site network in the world, Synexus, and continued to successfully manage 200+ research sites on 4 continents and in over 15 countries. Under Orvin’s leadership, several crucial partnerships were formed with major pharmaceutical companies which fueled the company’s rapid growth both geographically and within the medical community. Orvin facilitated the acquisition of two competitors securing the company’s spot as the largest clinical research site network in the world.

As a thought-leader in the industry, Orvin is regularly sought after as a keynote speaker and panelist and is often quoted by the leading publications covering the clinical research landscape. This year he was honored to be chosen as one of the 100 Most Inspiring People by PharmaVoice. Orvin feels passionately about the site voice being heard and believes strongly that site success impacts everyone in research.

JOAN CHAMBERS, Senior Director, Marketing & Outreach, Center for Information and Study on Clinical Research Participation (CISCRP)

Joan is the Senior Director of Marketing & Outreach at the Center for Information & Study on Clinical Research Participation (CISCRP) where she develops, plans and executes strategic integrated marketing campaigns to support CISCRP’s mission of raising awareness and understanding about clinical research and the important role it plays in public health.

Joan’s experience spans 20+ years in the health life sciences and currently serves on the Board of Directors for Greater Gift, the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/Informa Clinical & Research Excellence Awards (CARE), Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA). She was previously on the Advisory Board for CISCRP for over 10 years. In the course of her career, she has published in clinical trade journals and is a well-known speaker at industry conferences.

Joan was formerly COO at CenterWatch. Her career included roles at ClinX, SCORR Marketing, CHI, Tufts CSDD and PAREXEL.

KATHERINE VANDEBELT, Vice President of Global Innovation, Oracle Health Sciences

Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Kathy is using the power of technology to introduce new experiences and expectations to make the clinical research ecosystem better for patients, healthcare providers, sponsors and regulators. With over thirty years of experience in clinical research working in different geographies and across various therapeutic areas, Kathy has worked with various organizations to advance their clinical operations and business processes to a better operating model.

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