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Event info
Date:13 Dec
Time:8:30-11:30
Venue:Medicon Village, Lund, Sweden

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Contact person
Mia Ritterband-Rosenbaum

Mia Ritterband-Rosenbaum

Event Manager & PA to CEO

mrr@mva.org

+45 21 63 38 88

Innovate to Accelerate – Decision-Making in Oncology Clinical Development

Join us to gain a greater understanding of the cancer patient journey as our speakers discuss early phase trial design along with optimal data collection and endpoint analysis. You’ll also hear about applying the right digital solutions to balance the needs of the patient, optimizing recruitment and retention and expediting key decision-making.

This symposium unites key topics as we focus on providing answers to support both drug developers and cancer patients throughout clinical development. You’ll also get a chance to network with thought leaders from Fortrea.

Date: Wednesday the 13th of December 2023
Time: 8:30 – 11:30
Venue: Medicon Village, Auditorium, Building Inspira, Scheelevägan 4, Lund, Sweden

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Program

08:30 Networking, registration and light breakfast
09:00 Welcome
David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
09:05 The Changing Face of Patient-Focused Drug Development: The Typical Patient Journey in Oncology
Melissa Harris, Head of Global Patient Recruitment and Engagement, Fortrea
09:35 Innovative Early Clinical Oncology Development
Begoña de las Heras, Senior Medical Director Oncology, Fortrea
10:05 CTIS—The New European Regulatory Submission Process: First Experiences and Advantages
Claudia Granato, Regulatory Submissions Senior Manager, Fortrea
10:30 How Digital Innovation Will Shape the Future of Clinical Research
Clare Campbell-Cooper, Global Head Digital Health and Innovation, Fortrea
11:00 Networking
11:30 End of Good Morning Meeting

 

Speakers

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Melissa Harris, Head of Global Patient Recruitment and Engagement, Fortrea
Offers 22 years of industry experience with four years of Fortrea tenure creating patient-centric recruitment programs for all phases of studies across all therapeutics areas.
Applies innovative solutions to enhance patient recruitment campaigns while driving health literacy, diversity and inclusion, and patient access equity to reduce study burden and facilitate enrollment into everyday life.
Supports Voice of the Patient inclusion in all clinical studies conducted by Fortrea.
Begoña de las Heras, MD. Senior Medical Director, Oncology Therapeutic Expertise, Early Phase Oncology Leadership Center Lead
Offers more than 24 years of national and international clinical research and oncology experience, including the pharmaceutical and CRO industry; she joined Fortrea (formerly Labcorp/Covance) in 2016.
Focused on planning and execution of global oncology clinical development from FIH to registration.
Has held regional and global positions of increasing responsibility in oncology clinical drug development, with her main areas of expertise in the development of early phase oncology programs.
Has provided significant contribution to INDs, orphan drug applications and one NDA submission.
Co-authored eight book chapters, author/co-author of more than 20 papers in oncology and named as inventor of two patent applications, based on her contribution to the clinical trials.
Earned her medical degree from the University Autonoma of Madrid and completed her oncology residence at La Paz Hospital in Madrid.
Claudia Granato, Senior Manager Global Regulatory Submissions
Offers more than eight years of experience in global regulatory submissions from supporting early phase studies and large multinational Phase III trials in different therapeutic areas.
Possesses in-depth knowledge and hands-on experience of EU CTR, Clinical Trial Directive, ICH and GMP requirements.
Has successfully led multiple projects through complex regulatory submissions by managing interactions with health authorities.
Prior to joining Fortrea, Claudia has gained experience in drug development, translational science and regulatory affairs in the pharma industry.
Clare Campbell-Cooper, Global Head Digital Health and Innovation, Fortrea
Offers more than 25 years of industry experience and 10+ years of senior management.
Served as a Global Project Manager at Chiltern in 2003 and after the company was acquired by Covance became Executive Director of Oncology.
Currently helping to change the face of how clinical research is developing.
Specialised in development and helping both internal and external partners achieve their goals whether business, strategic or personal development.

 

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