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Global Clinical Trials Connect 2022 (September 21-22, 2022)

  • Conference
  • 2 Days: September 21-22, 2022 09:30 BST
  • Corvus Global
  • ID: 5601856
The Global Clinical Trials Connect 2022 will provide a platform to discuss on the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management.

The Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency and at the same time, the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.

This conference intends to focus on the global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations.

This program will certainly educate health care scientists on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.

The summit will facilitate an invaluable networking opportunities with decision makers and focus on real case studies, insightful presentations and round tables.


Key Discussions We'll Be Exploring

  • Patient Recruitment and Site selection
  • Innovative trial designs
  • Partnership & Collaboration - Sponsors, CROs, Sites and External Vendors
  • Patient centric clinical trials
  • Making Patient Engagement a Reality
  • New innovations in Patient Recruitment planning and execution on a clinical trial
  • Outsourcing strategies and models
  • Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome
  • Streamlined IRT development process
  • Pharmacovigilance & Clinical Trials
  • Post-Clinical Trial closed communities
  • How to future proof your clinical operations
  • Implementing Risk Based Monitoring
  • Streamlining R&D and lower costs in clinical trials
  • Adaptive Trial Model
  • Clinical Trial Auditing
  • Real World Clinical Trial Strategies
  • Data Quality & Technology
  • Clinical Data Strategy & Analytics
  • Electronic Data Capture (EDC) Systems
  • Decentralised Clinical Trials
  • Clinical Technology and Driving Innovation
  • M-Health, Wearable and Consumer Technology
  • Big-Data, IoT and Artificial Intelligence in Clinical trials
  • Blockchain technology for improving clinical research quality

Conference Streams Include

  • Globalisation in Clinical Trials
  • Optimizing Trial Design
  • Patient Recruitment & Retention
  • Site Selection & Feasibility
  • Patient Engagement & Patient Experience
  • Partnerships & Outsourcing
  • Clinical Trial Budgets and Contracts
  • Quality & Compliance
  • Risk based Trial Management
  • Clinical Operations
  • Clinical Trial Regulation
  • Data Management
  • Tech-Driven Clinical Trials
  • Decentralized Clinical Trials
  • Future Clinical Trials

Agenda

Day 1 - Wednesday - 21st September 2022 (Time Zone - BST)

09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

09:40 - Chairperson’s opening remarks
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

09:50 - Transforming the Way We Do Clinical Trials: Pragmatic Trials Combined with EHR Enabled Services
Mats Sundgren Mats Sundgren Director Health Informatics
AstraZeneca

10:15 - Novel approaches in Clinical Trial Design to Improve Efficiency of Research
  • Strategies & Methods for flexible design trials
  • The Adoption and Impact of Adaptive Trial Designs
  • Preclinical environment and trial designs Opportunities and Limitations
10:40 - Learnings from a Fully Decentralized Trial in Oncology and a Hybrid Decentralized in Autism
  • Connecting the developed and the developing nations
  • Dealing with differences owing to culture and ethnicity
  • Role of CROs and third party stakeholders
Thomas Wiese Thomas Wiese Principal Medical Director, Clinical Expert Team Leader
Roche

11:05 - How the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) is improving research transparency globally.
Ghassan Karam Ghassan Karam Project Manager
World Health Organization


Patient Recruitment & Site Selection


11:30 - How Digital recruitment is changing the face of clinical trials
Livia Dixon Livia Dixon Director Digital Recruitment Strategist
Novartis

11:55 - Innovative technologies for data-driven predictive modelling, forecasting and optimizing patient recruitment in clinical trials
  • Advanced technologies to maximize patient recruitment predictability at different stages
  • Forecasting recruitment under different restrictions
  • Optimal time-cost efficient recruitment design, sites / countries selection
  • Centralized statistical monitoring and detecting unusual data patterns
  • Forecasting future recruitment performance
Vladimir Anisimov Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis
Amgen

12:20 - Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

13:00 - Monitoring and Quality Assurance in site selection and patient recruitment to optimize clinical trials
  • Site pre-assessment and selection
  • Ensure patient protection and to deliver high quality data
  • Quality assurance can at times be difficult as regulatory requirements, standards and access to care differ globally - How are we going to handle this?
13:25 - Feasibility in clinical trials
  • Importance of conducting feasibility
  • The stages of clinical trial feasibility
  • Feasibility challenges
Dex Bilkic Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies
Bayer

13:50 - How can clinical research be truly patient centric?

The Journey of Bringing the Voice of Patients and Sites into End-to-End Clinical Development
Bert Santy Bert Santy Patient and Site Engagement Lead
Boehringer Ingelheim

14:15 - Panel discussion: Effective patient recruitment and retention in clinical trials to boost trial success
  • What will persuade and impact the patient?
  • Is there anything pharma can provide for a trial member that will increase the value of participation?
  • The aim of patient-driven clinical trials is to diminish the burden of participation by making the participant journey as convenient and pleasant as possible
  • Utilize fitting procedures and techniques to limit dropouts without, in any capacity, constraining a patient to remain in the study
Dex Bilkic Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies
Bayer

Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

14:40 - Harnessing the power of Deep Site Data and AI to advance clinical trials - Gain insights that would not be possible with traditional approaches


Patient Centricity & Patient Engagement


15:05 - Bringing the patient voice in the design of clinical trials and how patient engagement/inclusiveness must be planned and implemented throughout the lifecycle of clinical development
Lea-Isabelle Proulx Lea-Isabelle Proulx Patient Voice Partner
Roche

15:30 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

15:50 - Patient partnering strategies in clinical research
  • Patient partnership models to assist researchers assess which method of engagement could work best
  • Active role in setting research priorities
  • Patient associations leading research projects
16:15 - Multistakeholder approach from the patient perspective

A session on the multistakeholder contributor network that is the basis behind 'Patient Focused Medicines Development' initiatives
Carole Scrafton Carole Scrafton Patient & Health Advocate
FibroFlutters

16:40 - Global Clinical Development - Complex Generics
Siddharth Chachad Siddharth Chachad Executive Vice President & Head - Global Clinical Management
Dr. Reddy's Laboratories

17:05 - The patient's perspective: why their voice is so important in clinical research
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

Mary Lynne Van Poelgeest-Pomfret Mary Lynne Van Poelgeest-Pomfret International patient advocate
World Federation for Incontinent Patients - WFIP

17:30 - Interactive Breakout Discussions:

All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting.
  • Round Table 1: Innovation in Clinical Trials - Digital Approaches
  • Round Table 2: Patient Centricity
  • Round Table 3: Globalization and Country Specifics
  • Round Table 4: Recruitment Challenges - Patients and Sites
  • Round Table 5: Changing Clinical Trials - What needs to be addressed
  • Round Table 6: Patient Retention
18:00 - Chairperson’s closing remarks
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

18:10 - Networking Drinks Session

Day 2 -
Thursday - 22nd September 2022 (Time Zone - BST)

09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

09:40 - Chairperson’s opening remarks
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

09:50 - Topic TBC
Rebecca Jackson Rebecca Jackson Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
Janssen Pharmaceutical

10:15 - Enrolment and retention in clinical studies before and during Covid-19 pandemic: clinical challenges and new opportunities. A case report from a phase 3 clinical program in fibromyalgia
Domenico Merante Domenico Merante Global Clinical Development TA Lead Nephrology and Orphan Disease Area
Vifor Pharma

Decentralized Clinical Trials

10:40 - Exploring Decentralised and Virtual trials, with pilot studies and challenges encountered
Michael Zaiac Michael Zaiac Head of Medical Affairs Oncology Region Europe
Novartis

11:05 - Optimizing your Decentralized Clinical Trials with Real-World Data

11:30 - Setting up Your Decentralised Trial for Success
  • New business model based on the Technological advances and research activities integrated seamlessly into clinical trials
  • Developing custom made contracts by third-party vendors, CROs and sponsors for modern clinical trials
Angel Soubhie Angel Soubhie Head clinical trial scientists - Medical Director
Bayer

Outsourcing & Clinical Trials

11:55 - A key factor in vendor Selection - The role of the CRO in advancing patientcentric clinical trial approaches
Jan Schmejkal Jan Schmejkal Associate Director, Clinical Project Lead
Alexion Pharmaceuticals, Inc

12:20 - Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

13:00 - Panel Discussion - A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites, CROs, Sponsors and Regulators.

Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

Sonia Houston Pichardo Sonia Houston Pichardo Business Lead of MyStudyWindow
Boehringer Ingelheim

Quality, Compliance & Risk Management

13:30 - The effectiveness of new generation analytics models in RBM
Centralized monitoring can characterize key risk classifications and pointers from all clinical and operational source data available.
To evaluate risks to site performance, subject safety and data quality using Data and Analytics
Differentiating the relative risks between sites and subjects using the new age analytics models.
Shawntel Swannack Shawntel Swannack Director, Central Monitoring and Data Analytics
GSK

13:55 - Implementing risk based approaches within clinical trial
Laura Galuchie Laura Galuchie Senior Director & TransCelerate Program Lead
Merck

14:20 - Are we obsessed with Quality Tolerance Limits?
  • Choosing QTL Parameters wisely
  • Are you asking the right questions when considering the application of Quality Tolerance Limits (QTL)?
  • Controlling risk within diagnostic clinical studies
Mireille (Zerola) Lovejoy Mireille (Zerola) Lovejoy Director of Clinical Risk Management
GE Healthcare

Clinical Data & Tech Driven Clinical Trials

14:55 - FDA draft guidance on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Benoit Marchal Benoit Marchal Senior IT Project Manager (PMP)
F. Hoffmann-La Roche AG

15:20 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

15:40 - Interpretation and Impact of Real-World Clinical Data
  • Strategies for better decision-making
  • High-level models and simulations compelled by data will allow elimination of risky trials
  • The potential of real world data in clinical research goes past patient identification and patient recruitment
Mohamed Sharaf Mohamed Sharaf EMEA Medical Program Lead (Immunology)
Janssen Europe, Middle East & Africa (EMEA)

16:05 - Clinical trials in the era of digitization - the impact of smart innovations in clinical research
  • Rethinking the R&D Clinical Process
  • Patient-Centred Innovation in Clinical Trials
  • New trial designs and analysis methods
  • Discovering and validating sequential, personalized decision-making strategies
  • An Integrated Business Model - Using technology to streamline processes
  • Maria Palombini Maria Palombini Leader, Healthcare Life Sciences Practice
  • IEEE Standards Association
16:30 - Leverage AI to create value in Clinical Trials

16:55 - Panel Discussion: The Future of Clinical Trials - The Role of Advanced Analytics and Artificial Intelligence

Mohamed Sharaf Mohamed Sharaf EMEA Medical Program Lead (Immunology)
Janssen Europe, Middle East & Africa (EMEA)

Bhupathy Alagiriswamy Bhupathy Alagiriswamy Director
Credence Clinical Solutions Ltd

Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

17:25 - Novel techniques- Tech-driven clinical trials
  • Effectively using Technology is enabling patient centricity
  • How to implement mobile technology and make it work in clinical trials
  • Does consumer technology devices used in clinical trials?
  • IoT in digital transformation of clinical trials
17:50 - Integrating Blockchain into clinical research
  • Uses & challenges for Blockchain in Clinical Trials
  • Storing all types of data safely and securely
  • Better Clinical Trials Quality
18:15 - Chairperson’s closing remarks
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT

Speakers

Thomas Wiese
Principal Medical Director, Clinical Expert Team Leader
Roche

Bert Santy
Patient and Site Engagement Lead
Boehringer Ingelheim

Livia Dixon
Director Digital Recruitment Strategist
Novartis

Rebecca Jackson
Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
Janssen Pharmaceutical

Mats Sundgren
Director Health Informatics
AstraZeneca

Vladimir Anisimov
Principal Data Scientist, Data Science, Center for Design & Analysis
Amgen

Domenico Merante
Global Clinical Development TA Lead Nephrology and Orphan Disease Area
Vifor Pharma

Lea-Isabelle Proulx
Patient Voice Partner
Roche

Michael Zaiac
Head of Medical Affairs Oncology Region Europe
Novartis

Mireille (Zerola) Lovejoy
Director of Clinical Risk Management
GE Healthcare

Mohamed Sharaf
EMEA Medical Program Lead (Immunology)
Janssen Europe, Middle East & Africa (EMEA)

Maria Palombini
Leader, Healthcare Life Sciences Practice
IEEE Standards Association

Dex Bilkic
Manager, Study Start-up, Patient Recruitment and Outsourced Studies
Bayer

Shawntel Swannack
Director, Central Monitoring and Data Analytics
GSK

Benoit Marchal
Senior IT Project Manager (PMP)
F. Hoffmann-La Roche AG

Bhupathy Alagiriswamy
Director
Credence Clinical Solutions Ltd

Nancy Meyerson-Hess
Chief Compliance and Regulatory Officer
eMQT

Sonia Houston Pichardo
Business Lead of MyStudyWindow
Boehringer Ingelheim

Siddharth Chachad
Executive Vice President & Head - Global Clinical Management
Dr. Reddy's Laboratories

Brenda Yanak
Vice President, Global Biospecimen & Imaging Management
Bristol-Myers Squibb

Mary Lynne Van Poelgeest-Pomfret
International patient advocate
World Federation for Incontinent Patients - WFIP

Ghassan Karam
Project Manager
World Health Organization

Angel Soubhie
Head clinical trial scientists - Medical Director
Bayer

Laura Galuchie
Senior Director & TransCelerate Program Lead
Merck

Jan Schmejkal
Associate Director, Clinical Project Lead
Alexion Pharmaceuticals, Inc

Carole Scrafton
Patient & Health Advocate
FibroFlutters

Who Should Attend

This event is designed for senior-level attendees from various companies including Pharmaceutical, Bio-Tech, Bio-Pharma, CRO’s, Investigative Sites, Solution providers and Government institutions.


Attendees includes VPs, GMs, Directors, Heads and Managers of

  • Clinical Trials
  • Clinical Study Management
  • Clinical Operations
  • Clinical Research
  • Patient Organizations
  • Patient Recruitment
  • Outsourcing
  • Vendor Management
  • Site Management
  • Site Monitoring
  • Clinical Pharmacology
  • Clinical Data Management
  • Risk Monitoring
  • EDC
  • Clinical/Digital Innovation
  • Clinical Design/Protocol design/ Strategy makers
  • Clinical Research Sites
  • CROs and CMOs
  • Hospitals/ Associations
  • Regulatory affairs