ARENSIA Spotlight
The New Normal in Exploratory Clinical Trials: Challenges and Future Trends
Our Unique Meeting Format
Claudia Hesselmann, CEO, ARENSIA Exploratory Medicine GmbH, Düsseldorf, Germany
- Strategies for country and site selection for trials with adaptive multi-cohort designs
- Efficient infrastructure for study execution: vendor selection & cross-functional coordination
- Challenges in balancing flexibility and predictability: number of sites, budget, IMP planning, study systems, etc.
- Approaches for cohort management: ‘real-time’ data collection, cleaning, and review etc.
Cara Pilowa, Sr. Director, Clinical Operations at VirBio Inc
- Unique model of dedicated research clinics
- Strategies for fast patient enrollment and retention
- Take away from pandemic experience
- Keeping operations open during war in Ukraine
Claudia Hesselmann, CEO, ARENSIA Exploratory Medicine GmbH, Düsseldorf, Germany
Evgeny Levenko, Country Manager, ARENSIA Research Clinic, Kyiv, Ukraine
- Unyielding rules vs practical feasibility under state of emergence
- Collaboration with Regulatory Authorities to adapt to new challenges
- How to make the processes more flexible to be able to adapt to new realities faster while assuring quality and integrity
Heather Paden, VP, Clinical Operations, PureTech Health, Boston, USA
- Developing patient-friendly study design
- Bringing the study to the patient: off-site study visits and their limits
- Use of digital platforms and social media for better patient engage
Moderator:
Olga Carvalho, Principal Clinical Trial Leader, Genentech
Pharmaceutical company representative:
Julia Ford, Associate Director, Clinical Operations, Gossamer Bio, San Diego, USA
Dr. Alina Jucov, Medical Director, ARENSIA Research Clinic, Chisinau, Moldova
Melanie Flores, Client Services, Early Phase Center of Excellence, Advarra
- Developing patient-friendly study design
- Bringing the study to the patient: off-site study visits and their limits
- Use of digital platforms and social media for better patient engage
Megha Patel, Associate Director, Global Trial Leader, Johnson & Johnson
Meet the Facilitators
The Spotlight will be lead by our expert facilitators:
Claudia Hesselmann, PhD
Co-founder & CEO ARENSIAHeather Paden
VP, Clinical Operations PureTech Health, Boston, USACara Pilowa
Senior Director, Clinical Operations VirBio Inc., San Francisco, USAAlina Jucov, Assoc. Prof, MD, PhD
Principal Investigator & Medical Director ARENSIA Research Clinic, Chisinau, MoldovaJulia Ford
Associate Director, Clinical Operations Gossamer Bio, San Diego, USAEvgeny Levenko, MD, PhD
Country Manager ARENSIA Research Clinic, Kyiv, UkraineMelanie Flores
Client Services, Early Phase Center of Excellence AdvarraMegha Patel
Associate Director, Global Trial Leader Johnson & JohnsonOlga Carvalho
Principal Clinical Trial Leader GenentechMore about ARENSIA
ARENSIA EXPLORATORY MEDICINE is a German operator of proprietary research clinics in Eastern Europe, dedicated to performing complex Phase Ib, IIa and PROOF-OF-CONCEPT clinical trials with novel molecules, involving patients across numerous disease areas. Given the outstanding patient recruitment rates achieved by ARENSIA clinics, we are able to substantially reduce the overall number of sites, countries and recruitment periods for any early phase patient trial.