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Tuesday, February 9
 

10:30am EST

Virtual Environment Opens!
Navigate around our virtual environment to:
  • Explore the virtual exhibit hall to understand how leading service providers are helping their clients through this challenging time
  • Catch up with colleagues in our networking lounge
  • Collect white papers and resources in our Resource Center
  • View the agenda in the Theater and make sure your favorite sessions are added to your calendar so you won't miss them!
  • Earn points and prizes for being top engagers and top networkers over the three days of the event

Tuesday February 9, 2021 10:30am - 11:00am EST

11:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance, United States
Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →


Tuesday February 9, 2021 11:00am - 11:10am EST

11:10am EST

Collaboration for Adoption of Decentralized Trials
  • Learn an overview of the landscape of collaborations and consortia seeking to advance decentralized trials today
  • Explore the opportunity for "meta-collaboration" and how to best support collaboration across initiatives
  • Prioritize key challenges in decentralized research that may be best addressed through collaboration

Speakers
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance, United States
Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →


Tuesday February 9, 2021 11:10am - 11:40am EST

11:45am EST

Decentralized Clinical Trials and Diversity: Sharing Guidance from Patients and Physicians
  • Enabling research participation from home using a decentralized model seems to be the perfect solution to improving patient accessibility and diversity. But is it really that simple? 
  • Feedback and guidance from patients and physicians on successfully deploying DCTs to improve ethnic, racial, cultural, and linguistic diversity in research will be shared.

Speakers
avatar for Sarah Pilkington

Sarah Pilkington

Associate Director, Patient Innovation Center, PAREXEL
Sarah Pilkington is an Associate Director within Parexel’s Patient Innovation Center, dedicated to improving access to clinical research and patient and caregiver experience. Ms Pilkington has worked within clinical research organizations for 9 years with much of this time dedicated... Read More →


Tuesday February 9, 2021 11:45am - 12:15pm EST

12:20pm EST

Panel: How to Increase Diverse Representation in Virtual Clinical Trial Protocol Design
  • Discuss the importance of eligibility criteria, site selection, advisors, planned community outreach efforts, and material development.
  • Consider the need for increased diverse representation

Moderators
avatar for Michelle Shogren

Michelle Shogren

Sr. Director of Innovation – Pharma R&D Clinical Operations, BAYER
Michelle is the Director of Innovation for Pharma R&D Clinical Operations at Bayer. She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate... Read More →

Speakers
avatar for Peter Schaeffer

Peter Schaeffer

Projects, Clinical Platforms and Sciences TPR Analytics Director, GLAXOSMITHKLINE
Peter Schaeffer has worked in the pharmaceutical industry for approximately 20 years, in both the pre-clinical and clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs, and collaborated with teams... Read More →
avatar for Richard Dima, MD, CCRC

Richard Dima, MD, CCRC

Director, Clinical Research, Northwell Health
Richard Dima is the Director of Clinical Research at Northwell Health. He has enjoyed the last 6 years of his career in clinical research. After earning his medical degree he found his calling in clinical research after working with patients on a Naloxone study at the peak of the... Read More →
avatar for Lorena Kuri

Lorena Kuri

Head, Diversity Strategy, BRISTOL MYERS SQUIBB
Lorena Kuri, MBA is the Head of Diversity Strategy at BMS. In her role, she is responsible for developing the integrated diversity in clinical trials (DiCT) strategy to recruit a patient population that is more reflective of the real world.As a strong inclusion advocate, she leverages... Read More →


Tuesday February 9, 2021 12:20pm - 1:05pm EST

1:05pm EST

Networking in the Virtual Exhibit Hall
This is designated staffed booth time, so if you have questions, want to earn points for prizes, or are just wanting to talk to someone (remote working can get lonely) head over to our virtual exhibit hall and talk to your friendly and knowledgeable colleagues.

STRATEGIC NOTE: Clinical Partners often have the complete cross-sectional industry view of how different companies are handling specific issues brought on by the pandemic. Pick their brains for suggestions and advice on how to make your job easier. 

Tuesday February 9, 2021 1:05pm - 1:35pm EST

1:35pm EST

Reaction or Adoption? Ways to ensure decentralized approaches continue to prosper beyond the pandemic
  • Describe how barriers can be addressed to support broader use of decentralized approaches
  • Identify opportunities where decentralized approaches can be applied to clinical trials beyond the pandemic

Speakers
avatar for Wendi Lau, DRSc

Wendi Lau, DRSc

Former Vice President, Operational Improvement & Reporting Excellence, ASTELLAS
Wendi Lau is the former vice president of Operational Improvement & Reporting Excellence at Astellas Pharma. Ms. Lau has more than 28 years of experience in clinical research.  She has served in a variety of leadership roles, including Clinical Operations and Medical Writing.  More... Read More →


Tuesday February 9, 2021 1:35pm - 2:15pm EST

2:20pm EST

Using Next-generation Training to Drive Performance in Virtual and Hybrid Global Studies
  • Face-to-face SIVs and face-to-face training with sites can no longer be relied on, what now?
  • What should you expect from your training investment? Predictive analytics + comprehension + competency = reduced risks
  • Performance Management is more important than ever: Communications, Process, and Oversight

Speakers
avatar for Dave Hadden

Dave Hadden

Co-Founder and Chief Gamer Changer, PRO-FICIENCY
Dave is an entrepreneur and technology innovator known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS).Since selling Therasim, the first successful online VPS system for physicians, to WebMD in 2014, he has... Read More →


Tuesday February 9, 2021 2:20pm - 2:50pm EST

2:55pm EST

Panel: Framework to Enable Decentralized Clinical Trials
    • Review critical elements for decentralized studies
    • Understand that it is not just about technology and that change management is the key

Moderators
avatar for Len Rosenberg, Ph.D.

Len Rosenberg, Ph.D.

Head, Clinical Operations, BEAT AML, A DIVISION OF THE LEUKEMIA & LYMPHOMA SOCIETY
Dr. Rosenberg is a 35 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical... Read More →

Speakers
avatar for Alok Tayi, Ph.D.

Alok Tayi, Ph.D.

VP of Life Sciences, EGNYTE
Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company's strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management... Read More →
avatar for Mike Collins

Mike Collins

Senior Vice President, Clinical Operations & Data Sciences, AKEBIA THERAPEUTICS
Mike graduated from the University of Sheffield in the UK with a degree in Genetics. After a MSc in Applied Genetics; he completed his doctorate at the University of Birmingham on the quantitative genetics of behaviour in fruit flies.Originally a medical statistician by training Mike... Read More →
avatar for Aman Thukral

Aman Thukral

Director, Clinical Systems and Digital Operations, ABBVIE
Aman Thukral is the head of Digital Operations and Clinical Systems at AbbVie. He has over thirteen years of experience in clinical development, technology planning & business-technology alignment. He is responsible for eCOA operations, wearables, and sensors, piloting new technology... Read More →
avatar for Hassan Kadhim

Hassan Kadhim

Global Head of Clinical Trial Business Capabilities, Clinical Innovation, Industry Collaboration, BRISTOL MYERS SQUIBB
Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards... Read More →


Tuesday February 9, 2021 2:55pm - 3:40pm EST

3:40pm EST

Chairperson’s Closing Remarks
Speakers
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance, United States
Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →


Tuesday February 9, 2021 3:40pm - 3:50pm EST

4:00pm EST

Extending Decentralized Clinical Research into the Community: The Promise of Direct Access to Patients Zoom Roundtable Discussion
  • Operationalizing a decentralized study involves a complex patient care model
  • Taking research to patients: remove the "waiting game" from Patient Recruitment.

Speakers
avatar for Vanessa Gertsen

Vanessa Gertsen

Vice President of Study Operations, Decentralized Clinical Trials, CARE ACCESS RESEARCH
As Vice President of Study Operations at Care Access, Vanessa Gertsen oversees decentralized trial operations. In addition to decentralized trials, Vanessa specializes in site and patient engagement, digital innovation, and diversity and inclusion in clinical trials. Prior to Care... Read More →


Tuesday February 9, 2021 4:00pm - 5:00pm EST
 
Wednesday, February 10
 

10:30am EST

Virtual Environment Opens!
Navigate around our virtual environment to:
  • Explore the virtual exhibit hall to understand how leading service providers are helping their clients through this challenging time
  • Catch up with colleagues in our networking lounge
  • Collect white papers and resources in our Resource Center
  • View the agenda in the Theater and make sure your favorite sessions are added to your calendar so you won't miss them!
  • Earn points and prizes for being top engagers and top networkers over the three days of the event

Wednesday February 10, 2021 10:30am - 11:00am EST

11:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Madeline Feldman

Madeline Feldman

Director of Operations & Administration, MINDMED
Madeline is the Director of Operations & Administration for MindMed, a biotech company working with psychedelic inspired medicines, experiential therapies, and digital medicine to address mental health and addiction. Madeline’s background includes building and scaling startups... Read More →


Wednesday February 10, 2021 11:00am - 11:10am EST

11:10am EST

Panel: Discuss Global Implementations of Decentralized Clinical Trials
  • Review different tools and approaches for the global implementation of DCTs
  • Discuss quality strategy in the safe and successful deployment of DCTs

Moderators
avatar for Jennifer Reichuber

Jennifer Reichuber

Vice President, Organizational Solutions, HALLORAN CONSULTING GROUP
Jennifer Reichuber, MBAVice President, Organizational SolutionsJen has over 25+ years experience in health care, life sciences and technology solutions across the areas of product development, organizational development, strategic program definition and execution.  Jen has led several... Read More →

Speakers
avatar for Bari Kowal

Bari Kowal

Senior Vice President, Development Operations & Portfolio Planning, REGENERON
Bari Kowal became Head of Global Clinical Operations at Regeneron in 2017. She currently serves as Senior Vice President, Development Operations & Portfolio Planning and oversees clinical trial strategy and execution. Bari was previously at Pfizer as Vice President, Business Operations... Read More →
avatar for Sam Hariry

Sam Hariry

Global Head, Clinical Innovation, NOVARTIS INSTITUES FOR BIOMEDICAL RESEARCH (NIBR)
Sam is the Global Head of Clinical Innovation at the Novartis Institutes for Biomedical Research, and leads a team focus on modernising and adapting clinical trials and pharmaceutical operations. This includes areas such as adding technology to trials to bring better and more meaningful... Read More →
avatar for Shelly Barnes

Shelly Barnes

Global Clinical Innovations Lead, UCB
Shelly Barnes, UCB Global Clinical Science and Operation Innovations. Accelerating innovative strategies leading UCB into the era of Decentralized Clinical Trials and solutions driving the improvement of the patient experience within the conduct of our clinical trials. Delivering... Read More →
avatar for Dr. Hanna Preus

Dr. Hanna Preus

Senior Quality Director, OPIANT PHARMACEUTICALS
Global Quality & Compliance Expert and Business Strategist with nearly 20 years of versatile operational excellence experience in clinical trial industry across global processes and functions working within Pharmaceutical Companies and Contract Research Organisations across multi-cultural... Read More →


Wednesday February 10, 2021 11:10am - 11:55am EST

12:00pm EST

What to Expect When You Are Decentralizing
  • A concept-to-data tour of a decentralized trial
  • Answers to “What do I do?” in each stage
  • When technology is (and isn’t) the answer

Speakers
avatar for Jamileh Jemison

Jamileh Jemison

Head of Clinical Development, HEALTHMODE
Jamileh Jemison (she/her) is Head of Clinical Development for HealthMode. A physician scientist with 8 yrs experience in clinical operations and clinical development, focusing on cutting edge approaches that yield high quality data. Dr. Jemison built her approach running trials for... Read More →


Wednesday February 10, 2021 12:00pm - 12:30pm EST

12:35pm EST

Panel: The Impact of Technology on the Clinical Trial Workforce: Will the Workforce Adapt?
  • Discuss how to implement new tools at the study level
  • Determine what new roles will evolve in the workforce
  • Discuss how the existing workforce will evolve

Moderators
avatar for Jim Kremidas

Jim Kremidas

Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. Prior to ACRP, Jim consulted for a variety of clients such as investigator sites, academic institutions, sponsors, and suppliers. He was Senior Vice President... Read More →

Speakers
avatar for Tiffany McGinnis

Tiffany McGinnis

Country Head, US Site Management, DCT Initiative Leadership, BAYER
Tiffany McGinnis is a clinical research professional with 20 years of operations experience.  She has been a team leader in both CRO and sponsor organizations in various capacities.  Tiffany is currently the strategic lead for Bayer’s Global DCT Initiative, overseeing the development... 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) Director of Innovation and 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 Candace T. Saldarini, M.D.

Candace T. Saldarini, M.D.

Senior Director, Applied Innovation and Process Improvement, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION
Candace T. Saldarini is the Senior Director for Applied Innovation and Process Improvement at Otsuka Pharmaceutical Development & Commercialization. In this role, she leads projects that bring disruptive innovation and incremental process improvement to Otsuka. Candace’s focus is... Read More →


Wednesday February 10, 2021 12:35pm - 1:25pm EST

1:25pm EST

Networking in the Virtual Exhibit Hall
This is designated staffed booth time, so if you have questions, want to earn points for prizes, or are just wanting to talk to someone (remote working can get lonely) head over to our virtual exhibit hall and talk to your friendly and knowledgeable colleagues.

STRATEGIC NOTE: Clinical Partners often have the complete cross-sectional industry view of how different companies are handling specific issues brought on by the pandemic. Pick their brains for suggestions and advice on how to make your job easier. 

Wednesday February 10, 2021 1:25pm - 1:55pm EST

1:55pm EST

Virtualizing Your Clinical Trial by Implementing Home Healthcare and Off-Site Labs
  • Lessons Learned on Implementing Home Healthcare and Off-Site Labs: Dos and Don’ts
  • What we still do not know:
    • Uptake? Does the benefit outweigh the investment?
    • Will it make a difference in how we recruit and retain patients?


Speakers
avatar for Antonieta Sosa

Antonieta Sosa

Director, Clinical Innovation, JANSSEN RESEARCH AND DEVELOPMENT
Antonieta Sosa has over 20 years of experience in the pharmaceutical and biotech industry holding positions in Safety, Regulatory Compliance, and Clinical Operations in both small biotech and large pharma. In her current role as Director in the Clinical Innovation group, she is responsible... Read More →


Wednesday February 10, 2021 1:55pm - 2:30pm EST

2:30pm EST

Chairperson's Closing Remarks
Speakers
avatar for Madeline Feldman

Madeline Feldman

Director of Operations & Administration, MINDMED
Madeline is the Director of Operations & Administration for MindMed, a biotech company working with psychedelic inspired medicines, experiential therapies, and digital medicine to address mental health and addiction. Madeline’s background includes building and scaling startups... Read More →


Wednesday February 10, 2021 2:30pm - 2:45pm EST

2:45pm EST

Barriers and Solutions to Virtual Clinical Trial Adoption Zoom Roundtable Discussion
In this Zoom roundtable, please join the team from Halloran Consulting Group as they wrap up the event and lead the interactive discussion around barriers and solutions to virtual clinical trial adoption. As we are all navigating these virtual challenges together, they look forward to learning your stories, sharing theirs, and providing insight on solutions to address your biggest challenges in virtual clinical trial implementation.


Speakers
avatar for John Ferraro

John Ferraro

Principal Consultant, HALLORAN CONSULTING GROUP
John FerraroPrinciple Consultant, Clinical OperationsJohn Ferraro has more than 28 years of experience in Clinical Operations/Development within the biotechnology and pharmaceutical industry.  During this time, he has been successful in all sizes and types of organizations as well... Read More →
avatar for Jennifer Reichuber

Jennifer Reichuber

Vice President, Organizational Solutions, HALLORAN CONSULTING GROUP
Jennifer Reichuber, MBAVice President, Organizational SolutionsJen has over 25+ years experience in health care, life sciences and technology solutions across the areas of product development, organizational development, strategic program definition and execution.  Jen has led several... Read More →
avatar for Erin Stanley

Erin Stanley

Lead Consultant, Clinical Operations, HALLORAN CONSULTING GROUP
Erin StanleyLead ConsultantErin Stanley has more than 14 years of experience in clinical operations, quality management, and project leadership. Erin’s therapeutic experience primarily covers  neurology, psychiatry, cardiology, rare disease, and oncology, and her product knowledge... Read More →


Wednesday February 10, 2021 2:45pm - 3:45pm EST