The FDA’s Diversity Action Plan (DAP) is setting new standards, while other regulatory bodies like EMA, UK MHRA, and CADTH, are following suit with their own diverse approaches.
Sponsors must proactively consider a wider range of demographic and non-demographic factors, such as socio-economic status, health literacy, and geographic differences, so that clinical trials can be offered to a wider group of people, while at the same time considering evolving patient needs.
Watch the recording to discover how to design and implement an all-inclusive diversity strategy that enhances trial participation, supports regulatory compliance, and strengthens study outcomes.
- The current state of diversity in clinical trials and defining diverse patient populations
- Regulatory considerations and compliance with Health Authorities (HA), such as the FDA
- The European/Eurasian perspective and applications of Inclusive Research Strategies
- The role of socio-economic factors and patient diversity in developing countries, with a special focus on Georgia and Kazakhstan
- Innovations and technology in trial design, including hybrid and decentralised participation models
The Panelists
Agata Bloswick, Ph.D.
Chief Clinical Research Operating Officer, Biomapas
Agata has been working in the clinical research industry for over 20 years.
Agata actively supports women leaders and diverse voices in the healthcare industry, advocating that healthcare needs to be as diverse as the patients it serves. She is also focused on addressing the growing impact of climate change, including health equity gaps. Ultimately, her goal is to help clients achieve business success while providing patients with better healthcare options.
Dr George Ramishvili
Chief Executive Officer, New Hospitals Ltd
As the CEO of New Hospitals Ltd since 2017, Dr Ramishvili is responsible for the strategy and development of the healthcare business within the PSP group.
Previously to his current position, Dr Ramishvili worked at Roche, holding various positions in Georgia, including sales, marketing and country management roles focusing on improving patient’s access to innovative medicines. In his last three years with Roche, he served as the General Manager for the Roche Kazakhstan affiliate.
Léa-Isabelle Proulx
R&D Patient Voice Partner, Roche
Léa is a scientist by training and has been working at Roche for over 10 years.
Léa is a firm believer in developing trustful, long-term partnerships and collaborations between patients, industry and other stakeholders, where everyone has the opportunity to have their voice heard in order to improve outcomes that matter to patients and shape the healthcare ecosystem of tomorrow.
Benjamin Benskin
Vice President Strategic Partnerships, Lightship
Ben is a senior commercial and operational executive with over 20 years of industry experience.
Prior to Lightship, he had roles in strategic and operational delivery of clinical trials and programmes across the world in all phases and many therapeutic areas. Ben is skilled in interacting and building consensus for action and delivering across internal and external partners.
Evelina Davidonienė
Head of Global Regulatory Affairs Operations, Biomapas
Evelina has over 15 years of experience in regulatory affairs.
She has extensive knowledge of the regulatory environment and deep expertise in regulatory strategies, external engagement, and advocacy activities.
Before joining Biomapas, she drove teams in senior leadership positions at GSK. However, her strong understanding of compliance, quality, and market access has led her to a head of regulatory affairs operations role at Biomapas, where she excels as a passionate, communicative leader with an orientation for results, positive change and team growth.
Our Commitment To Diversity
Our range of services, including Biomapas Academy professional training, and consultancy to all members of the clinical research ecosystem: hospitals, health– and regulatory authorities, and dedicated Quality Assurance specialists, further establish our commitment to enhancing clinical research. We boast a dedicated network of clinical trial coordinators supporting research sites.
We take our corporate commitment to Environmental, Social, and Governance (ESG) standards seriously, and we work closely with our vendors who meet the same standards. We also partner with our clients to support and help them achieve their diversity goals in clinical trials. As a responsible industry player, we align our efforts with clients to promote sustainability and ESG principles throughout our collaborations.
We offer a wealth of expertise in innovation and ethical practices for all Biopharma companies seeking expansion into these regions. Together, we can shape the future of medicine.
