VHIO's Transversal Clinical Trials Core Services & Units

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Elena Garralda

Executive Director, Research Unit for Molecular Therapy of Cancer (UITM) – “la Caixa”
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SUMMARY

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Inaugurated in June 2010, thanks to the support received from the Fundació Bancària ”la Caixa”, the Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa”, is dedicated to complex clinical trials with drugs in early development (Phase I and early Phase II trials), focusing on novel targets. Occupying a total surface area of 1000 m2 our Unit is located within the General Area of the Vall d'Hebron University Hospital, the Vall d'Hebron Barcelona Hospital Campus. This privileged environment with direct access to patients, coupled with VHIO's translational approach to research and superb scientific framework, has enabled our Unit to rapidly establish itself as one of the few comprehensive facilities in Europe to rapidly transform latest discovery into benefits for patients.

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By promoting tight connectivity between oncology care and research we establish novel treatment models for patients with highly selective drugs and advance insights into tumor diseases and how to treat them in an individualized way - getting the right therapy to the right patient at the right time. As the figures show, we are gradually doing so for an increasing number of patients. In 2017, 120 phase I clinical trials and 17 basket studies were performed at the Unit with a total of 445 patients enrolled. The Unit's facilities coupled with our multidisciplinary clinical teams, enable us continue to expand our portfolio of phase I studies.

Research carried out at our Unit by VHIO's Early Clinical Drug Development Group, centers on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist. In accordance with VHIO's purely translational model, our studies are also linked with several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists also collaborate closely in our trials to facilitate biomarker development, a profound understanding of the mechanism of action, as well as research into mechanisms of resistance.

In partnership with VHIO's Molecular Oncology and Cancer Genomics Groups, we perform molecular analyses of patients' tumors to select the best possible treatment with the experimental therapeutics available. Thanks to our Cancer Genomics Group's development of existing applications for faster results including n-counter Nanostring, BEAMing (Sysmex), Droplet Digital PCR (ddpCR) Bio-Rad Technology, MiSeq and HiSeq (Illumina), we continue to drive faster and more precise mutational analyses of tumor suppressor genes as well as translocations and gene amplifications. UITM incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.

Excellent patient treatment and care as well as pioneering research is also made possible thanks to the collaboration of many other oncology professionals including our team of Clinical Research Oncology Nurses (click here), pathologists from the Vall d'Hebron University Hospital's Molecular Pathology Department, radiologists and interventional radiologists, as well as our Clinical Trials Office (click here), Database Management, Clinical Research Oncology Pharmacy Unit (click here), and other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.

Research Unit For Molecular Therapy Of Cancer (UITM) - ”la Caixa”

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Director
Josep Tabernero

Executive Director
Elena Garralda

Executive Team
Gemma Sala
Angeles Peñuelas

Associate Investigators - Senior Consultants
Judith Balmaña
Joan Carles
Enriqueta Felip
Teresa Macarulla
Ana Oaknin
Jordi Rodón
Cristina Saura
Josep Tabernero

Associate Investigators - Phase I
Maria Alsina
Guillermo Argilés
Analía B. Azaro
Irene Braña
Marta Capelan
Cristina Cruz
María Elena Élez
Santiago Ignacio Escrivà
Lorena Fariñas
Patricia Gómez
Jorge Hernando
Cinta Hierro
Juan Jesús Martín
Alex Martínez
Ignacio Matos
Rafael Morales
Eva Muñoz
Alejandro Navarro
María Ochoa de Olza
Mafalda Oliveira
Nuria Pardo
Maria Coral Perez
Jordi Remon
Víctor Rodríguez
César Serrano
Cristina Suárez
Claudia Valverde
Helena Verdaguer
Maria Vieito
Esther Zamora

Director, Clinical Trials Office
Gemma Sala

Heads, Phase I Clinical Trials Office
Silvia Perez Pujol

Study Coordinators
Sonia Abad
Eulalia Aliende
Ainhoa Balague
Raquel Blanco
Lluïsa Carbonell
Raquel de La Torre
Maria Garcia
Maria Herranz
Iris Martinez
Sonia Martinez
Lidia Martinez De Arenzana
Laura Maynés
Montserrat Moreno
Gemma Mur
Laura Oliva
Adelaida Piera
Mireia Sole

Data Managers
Ariadna Arasanz
Ignacio Carcela
Marina Coll
Giovanni De Marino
Gloria Garcia
Jordina Llavall
Anna Martinez
Marta Monserrat
Sergi Pérez
Montserrat Pujadas
Isabel Rico
Rosa Maria Romero

Pharmacy
FOUITM

Maria Josep Carreras Soler

Pharmacy USIFO
Laura Maños

Nurse Supervisor
Ángeles Peñuelas

Nurse Coordinators
Sonia Valverde
Lydia Vélez

Nurses
Meritxell Cucurell
Elisabet Hernández
Margarida Marcos
Isabel Muñoz
Tania Sánchez

Nursing Assistants
Alicia López
María Martín
Ana Belen Ortiz

Nurse Supervisor's Assistant
Juan Manuel García

Secretary
Teresa Mendoza

STRATEGIC GOALS

  • Early drug development and translational research led by UITM physician-researchers and VHIO scientists: expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies, with special focus on first-in-human studies, novel-novel combinations, best-in class compounds, and a new class of drugs.
  • Perform complex trials such as organ dysfunction trials, Octopus as well as Basket studies, and link clinical research at UITM with VHIO's preclinical and translational research groups. Our Unit also collaborates with the different partners involved in drug development and translational research.
  • Genomic medicine trials in early drug development: perform molecular analysis of patients' tumors in order to select the best possible treatment with the experimental treatments available, co-develop medical informatics applied to genomic medicine, and integrate preclinical and clinical research by incorporating novel drugs, new insights, and study designs together with customized molecular diagnostics.
  • Immunotherapy: our Unit's taskforce in early drug development of immunotherapeutics and cell signaling focuses on second generation immunotherapies, including new cytokines, immunomodulatory agents and immune checkpoint inhibitors and combinations, as well as translational research in immuno-oncology.

HIGHLIGHTS

  • We have performed some of the most complex phase I trials, including those focused on molecularly-selected patient populations (trials in complex molecularly-selected patient populations Basket/Octopus trials) as well as trials in immuno-oncology.
  • We have expanded our expertise in drugs targeting developmental pathways, cell signaling (PI3K, BRAF, MET, FGFR), and immunotherapy (PD1/PDL1, OX40, CD40, engineered antibodies).
  • In collaboration with VHIO's Cancer Genomics and Translational Genomics Groups, we benefit from cutting-edge technology platforms including the MiSeq, Hiseq 2500 NextGen sequencers, and nCounter Nanostring to analyze circulating-free tumor DNA. We also co-develop customized molecular tests for VHIO's Prescreening Program (disease-oriented mutation panels for our NGS platforms).
  • We have developed alliances with many pharma companies as the preferred site for testing their novel and most relevant therapies, including GlaxoSmithKline OCTC, Roche ImCORE, and AstraZeneca/MedImmune. We also participate in a project supported by Horizon 2020's European Union funding for Research and Innovation to co-develop integrative bioinformatics tools for genomic analysis: MedBioinformatics (www.medbioinformatics.eu). Lastly, we have also partnered with Thomson Reuters/ Clarivate Analytics to develop tools for determining the relevance of mutations detected in tumors.

HORIZONS 2018

  • Initiation of Basket of Baskets (BoB) trial with our Cancer Core Europe Consortium partners.
  • Design and implementation of the next generation of biotechnological tools for molecular prescreening.
  • Development of translational projects in immuno-oncology and epigenetics, bridging the phase I program (and our strategic partnerships with the pharmaceutical industry) with the expertise of VHIO´s recently established Tumor Immunology and Immunotherapy Group headed by Alena Gros, and our new Chromatin Dynamics in Cancer Group led by Sandra Peiró, set to move into VHIO´s CELLEX Building at the beginning of 2017.