ARENSIA Spotlight -1st November 2022, San Francisco

WHAT TO EXPECT

Our Unique Meeting Format

In today’s fast-changing world, staying competitive requires innovative thinking and adaptability. With the rise of novel technologies, keeping the pulse on developments has become more critical than ever before. The Clinical Development industry is facing competition with unprecedented challenges caused by disruptive events. Implementing innovative strategies appropriately gives early trials the flexibility they need while maintaining adherence to cost and time requirements.

After two years of virtual meetings, we are excited to launch our face-to-face spotlight to facilitate the frank discussion of these problems. A specialist panel of early phase industry professionals has been assembled to share their experiences from actual case studies, from a range of different perspectives. These include medical, regulatory, clinical, sponsor, and patient viewpoints. Including feedback from the full gamut of stakeholders and participants will be critical in progressing from Early Phase strategies to Proofs-of-Concept. The focus will be on practical aspects of the new clinical reality in planning and execution of early phase clinical trials with real-life case studies.

Among other exciting topics, we will discuss:

Understanding that Early Phase Trials are not small scale Phase III trials
Enhancing Cohort Management through reducing the number of sites
Strategies for flexibility and resilience embedded into study designs
Future Concepts for Early Phase Clinical Trials

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 ARENSIA

Heather Paden

VP, Clinical Operations PureTech Health, Boston, USA

Cara Pilowa

Senior Director, Clinical Operations VirBio Inc., San Francisco, USA

Alina Jucov, Assoc. Prof, MD, PhD

Principal Investigator & Medical Director ARENSIA Research Clinic, Chisinau, Moldova

Julia Ford

Associate Director, Clinical Operations Gossamer Bio, San Diego, USA

<p><strong>Julia Ford</strong>, a graduate of the University of Arizona with a degree in Communications and German, began her career in 2004 working for the International Society for Magnetic Resonance in Medicine (ISMRM) as an event planner. In 2006, Julia moved to San Diego and continued her event management role planning Investigator Meetings and large-scale conferences. In 2008 she transitioned into a Clinical Operations Management role with PPD with increasing responsibilities, including overseeing a large group of Clinical Operations employees across multiple indications. In 2015 Julia was recruited into a Clinical Trial Project Manager role at Eli Lilly and Company where she was responsible for multiple Ph2 and Ph3 trials in Ulcerative Colitis. In 2019, she moved to Gossamer Bio, a small biotech company in San Diego, where she led Ph1/Ph2 trials for ulcerative colitis prior to her current role leading the GB5121 clinical oncology program. Julia always puts patients and sites at the forefront of her operational strategies for her studies and brings a unique perspective to her role after recently supporting a very close family member through a terminal rare disease.</p>

Evgeny Levenko, MD, PhD

Country Manager ARENSIA Research Clinic, Kyiv, Ukraine

Melanie Flores

Client Services, Early Phase Center of Excellence Advarra

Megha Patel

Associate Director, Global Trial Leader Johnson & Johnson

Olga Carvalho

Principal Clinical Trial Leader Genentech

More about ARENSIA

More information

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.

Further Information

480 Sutter Street,San Francisco, CA, 94108

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Dinners & Spotlights

R&D

Clinical Trials ARENSIA Spotlight

ARENSIA Spotlight -1st November 2022

ARENSIA Spotlight

The New Normal in Exploratory Clinical Trials: Challenges and Future Trends

Our Unique Meeting Format

Our Unique Meeting Format

Registration and Breakfast

WELCOME & INTRODUCTION

ROUNDTABLE DISCUSSION PLANNING AND EXECUTION OF INCREASINGLY COMPLEX PHASE I/II PATIENT TRIALS WITH ADAPTIVE DESIGNS

MORNING REFRESHMENTS

ROUNDTABLE DISCUSSION PERFORMANCE OF COMPLEX EXPLORATORY TRIALS UNDER UNPRECEDENTED GLOBAL CHALLENGES: INSIGHTS FROM ARENSIA RESEARCH CLINICS

ROUNDTABLE DISCUSSION ASSURING STUDY QUALITY IN DISRUPTIVE TIMES

LUNCH

ROUNDTABLE DISCUSSION CLINICAL TRIAL THAT PUT PATIENTS FIRST: BALANCING RESEARCH OBJECTIVES AND PATIENTS’ NEEDS

Afternoon Break

ROUNDTABLE DISCUSSION PHASE I/II CLINICAL TRIAL OF THE FUTURE

GENERAL Q&A, REVIEW OF THE DAY

Drinks Reception & Canape

Meet the Facilitators

Claudia Hesselmann, PhD

Heather Paden

Cara Pilowa

Alina Jucov, Assoc. Prof, MD, PhD

Julia Ford

Evgeny Levenko, MD, PhD

Melanie Flores

Megha Patel

Olga Carvalho

More about ARENSIA

Further Information

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