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

First name	Last name	Job title	Company name	Photo URL	Bio Position
Claudia	Hesselmann, PhD	Co-founder & CEO	ARENSIA	https://proventainternational.com/wp-content/uploads/2020/01/Claudia-Hesselmann-Arensia-Headshot-e1584469734743.png	Claudia Hesselmann, PhD, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.
Heather	Paden	VP, Clinical Operations	PureTech Health, Boston, USA	https://proventainternational.com/wp-content/uploads/2022/09/Heater-Paden.jpg	Heather Paden, Vice President and Head of Clinical Operations and Data Management, has more than 20 years of diverse experience in clinical research operations management, clinical science, trial management and monitoring, respiratory therapy, and education. Ms. Paden has extensive experience in cross-disciplinary management of large and small trials and has provided substantial contributions to the writing of protocols, clinical study reports, abstracts, and manuscripts. Her work has covered the therapeutic areas of rare disease, oncology, cardiovascular disease, CNS and respiratory disease. Early in her career, Ms. Paden practiced and taught in the field of respiratory therapy. She has authored several journal articles and has been recognized with corporate research rewards for her work in cardiovascular health.
Cara	Pilowa	Senior Director, Clinical Operations	VirBio Inc., San Francisco, USA	https://proventainternational.com/wp-content/uploads/2022/04/Cara-Pilowa.jpg	Cara Pilowa is a skilled Clinical Operations professional with 14 years of experience. Cara has led Ph1-3 global clinical trials across an array of therapeutic areas such as oncology, infectious disease and inflammatory diseases. Cara is currently leading Clinical Operations- Chronic Disease at Vir Biotechnology. In addition to overseeing clinical programs, she has an interest in strategic planning and process development to launch dynamic programs while supporting organizational growth.
Alina	Jucov, Assoc.	Principal Investigator & Medical Director	ARENSIA Research Clinic, Chisinau, Moldova	https://proventainternational.com/wp-content/uploads/2022/09/Alina-Jucov-1.jpg	Alina Jucov, MD, PhD is an Assistant Professor at the Department of Gastroenterology, State University of Medicine and Pharmacy, Chisinau, Republic of Moldova. Dr. Jucov is board certified internist and gastroenterologist. Currently, she is also Medical Director for ARENSIA Moldova Exploratory Medicine. Dr. Jucov has been the Principal Investigator for clinical trials related to viral hepatitis, including novel agents. She also is the co-investigator for numerous clinical trials in ulcerative colitis. Dr. Jucov is the author and co-author of national and international abstracts and publications in the field of viral hepatitis, NASH, and IBD. She is also a regular member of several international organizations such as EASL, UEG, ECCO, EPC, and national gastroenterological and hepatological organizations from Moldova and Romania.
Julia	Ford	Associate Director, Clinical Operations	Gossamer Bio, San Diego, USA	https://proventainternational.com/wp-content/uploads/2022/10/Julia-Ford-1-scaled.jpg	Julia Ford, 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.
Evgeny	Levenko, MD,	Country Manager	ARENSIA Research Clinic, Kyiv, Ukraine	https://proventainternational.com/wp-content/uploads/2022/09/Evgeny-1.jpg	Evgeny Levenko, MD, PhD, specialist in cardiology is the Country Manager, Ukraine. Evgeny leads ARENSIA activities in Ukraine, which primarily take place in the two ARENSIA Research Clinics located in Kyiv, Ukraine. With over 20 years of experience in Clinical Research, Evgeny has extensive experience in leading, planning (project management), conducting, as well as supervising in more than 80 studies of phases I – III of all degrees of complexity and size. Prior to joining ARENSIA, Dr. Levenko worked in the Ukrainian branches of several international CRO’s.
Melanie	Flores	Client Services, Early Phase Center of Excellence	Advarra	https://proventainternational.com/wp-content/uploads/2022/10/Melanie-Flores.jpg	Melanie Flores is the Vice President of Client Services, Early Phase Center of Excellence at Advarra. Melanie has been in the IRB industry for over 22 years and has held many positions. From IRB Coordinator, Board Member, Training Manager, Director of Compliance to the President of IntegReview, she brings lots of IRB perspectives to the table. In her current role at Advarra she has successfully launched the Early Phase Center of Excellence which aids the company in their mission to help conduct research Safer, Smarter, Faster.
Megha	Patel	Associate Director, Global Trial Leader	Johnson & Johnson	https://proventainternational.com/wp-content/uploads/2022/10/Megha-Patel.jpg	Megha Patel, Associate Director, Global Trial Leader at Janssen (Johnson & Johnson), has more than 15 years of experience in clinical operations, study management. Megha has worked in Medical Device and Pharmaceutical Industry through Class II/III devices and Phase 1/2 studies respectively. Megha has managed Phase 1 studies to large Phase 2 global studies with complex vendors. She has experience in Cardiology, Otolaryngology, and Infections Disease.
Olga	Carvalho	Principal Clinical Trial Leader	Genentech	https://proventainternational.com/wp-content/uploads/2022/10/Olga-Carvalho.jpg	Olga Carvalho has more than 18 years of experience in Clinical Operations, and has led Ph1-Ph4 clinical trials, mostly in the Oncology field. Is currently the Principal Clinical Trial Leader and Operations Lead of the Clinical Pharmacology Protocol Execution Team program. She provides the leadership in the development, oversight, and execution of operational strategies for the global clinical pharmacology and device studies in support of multiple programs within the Genentech-Roche portfolio. Prior to industry, Olga was an Oncology Nurse, Head Nurse, Study Coordinator/Research Nurse and Site Manager in Brazil. Olga has a Bachelor of Science in Nursing and postgraduate in Oncology from Faculdade de Enfermagem do Hospital Israelita Albert Einstein.

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

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.

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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

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