Preclinical and clinical evaluation of radiopharmaceuticals can be sometimes seen as straightforward compared to non-radioactive molecules as the injected doses are often below toxic doses. However, the development of theranostics requires highly specific expertise and strong collaboration between preclinical and clinical development. The discovery and development process require multiple and highly specialized skills, the combination of which are often nonexistent in a single structure, even more so in the specialized field of radiopharmaceuticals.

The DRIVE™-Molecular RadioTherapy (MRT) offer is based on the complementary knowledge and know-how of each partner (Covalab, CheMatech, ABX-CRO and Oncodesign) representing an experienced and innovative network in nuclear medicine. The four companies have built a joint value proposition in which the generation of radiolabeled biological vectors, chelator production, design of the bioconjugated lead, preclinical proof of concept and the design of the regulatory and clinical package are managed effectively and efficiently under one roof.

This webinar will explore their key expertise with a focus on innovations from each partner, as follows:

Covalab — development and production of custom antibodies, antibody fragments and site-specific conjugation
CheMatech — custom design, synthesis and GMP production of chelators
Oncodesign — target identification and generation of preclinical radiopharmaceutical drug candidates:
- - Starts with early lead optimization with optimal chelating agents and radiolabeling with alpha or beta isotopes
  - Includes imaging biodistribution and efficacy studies in its large collection of preclinical in vitro and in vivo models
ABX-CRO — IMP radiochemistry development; dosimetry and regulatory preclinical package; clinical project management; data management and biostatistics; and integrated clinical and imaging study design

Join this webinar to learn about how the DRIVE-MRT solution enables the rationalization, design and optimization of targeted and effective radiopharmaceuticals against specific cancers, with a demonstration of preclinical proof of acceptable safety margins and a clinical support plan.

Keywords:

Speakers

Dr. Meddy El Alaoui, CSO, Covalab

Dr. Meddy El Alaoui is CSO at Covalab. He did his PhD in Biochemistry at the University of Lyon (France). Following this, he worked as a postdoc at Centre Léon Berard and the University of Cambridge (UK) on the development and validation of cross-linking technology on various antibody formats. In 2018, he joined Covalab to lead and develop the CovIsoLink® platform applied to antibody fragments. He is involved in several research programs for theragnostic applications of antibodies in oncology.

Message Presenter

Dr. Frederic Boschetti, CEO, CheMatech

Dr. Frédéric Boschetti is the CEO and founder of CheMatech. He obtained his PhD in Chemistry from the University of Burgundy, Dijon (France) in 2003. In 2005, he founded CheMatech, a company specialized in the production of chelating agents for nuclear medicine. He is involved in all research programs at the company and has high interest in chemistry, biochemistry and radiochemistry.

Message Presenter

Dr. Cyril Berthet, Head of Pharmaco-Imaging and Molecular Radiotherapy Department, Oncodesign

Dr. Cyril Berthet is the head of the pharmaco-imaging and theranostic platform at Oncodesign. He holds a PhD in Molecular and Cellular Biology from the University of Lyon (France). In 2002, he joined the Mouse Cancer Genetics Program at the National Cancer Institute in Frederick (USA), as a research associate. In 2007, he joined Oncodesign as a project leader and managed strategic partnerships in biomarker and drug discovery. He is particularly involved in molecular radiotherapy research programs and the Pharmimage consortium.

Message Presenter

Dr. Andreas Kluge, General Manager, ABX-CRO

Dr. Andreas Kluge has over 20 years of clinical research and development experience, including as founder, general manager and medical director for ABX-CRO, a full-service CRO for Phase I-III biological, radiopharmaceutical and anticancer trials based in Dresden, Germany. He is also founder and was founding CEO of ABX GmbH, one of the leading manufacturers of radiopharmaceutical precursors globally.

Dr. Andreas Kluge is also the founder, general manager and medical director for Therapeia, an early-stage development company in the field of neuro-oncology. He is also a co-founder of Telix Pharmaceuticals where he serves as chief medical advisor. Dr. Andreas Kluge has extensive experience in the practice of nuclear medicine and radiochemistry, molecular imaging and the clinical development of novel radionuclide-based products and devices. He is the author of numerous patents and publications in the field of nuclear medicine, neurology, infection and immunology. Dr. Andreas Kruge is a registered physician and holds a doctorate in Medicine from the Free University of Berlin.

Message Presenter

Who Should Attend?

This webinar will benefit those developing radiopharmaceuticals, with relevant job areas including:

Radiochemists and radiopharmaceutical scientists
Radiobiologists and preclinical experts in nuclear medicine
Partnership managers in radiopharmaceutical companies
Heads of preclinical and clinical development
Imaging and theranostic scientific experts

What You Will Learn

Join this webinar to learn about:

An introduction to the alliance of radiopharmaceutical experts
Innovations from target identification to clinical radiopharmaceutical development
The advantages of a premium nuclear medicine solution for drug discovery and theranostic programs
An integrated strategy for preclinical and clinical drug development plans

Xtalks Partners

Oncodesign

Oncodesign is a biopharmaceutical company dedicated to precision medicine, founded in 1995 by its current CEO and majority shareholder, and has been listed on Euronext Growth Market since April 2014. Its mission is the discovery of effective therapies to fight cancer and other diseases without therapeutic solutions. With its unique experience acquired by working with more than 1000 clients, including the world’s largest pharmaceutical companies, along with its unique technological platform combining Artificial Intelligence, state-of-the-art medicinal chemistry, pharmacology, regulated bioanalysis, medical imaging, Oncodesign is able to select new therapeutic targets, design and develop potential preclinical candidates through to clinical phases. Oncodesign has configured its organization to offer innovative services to its customers and to license its proprietary molecules. Applied to kinase inhibitors, which represent a market estimated at over $65 billion by 2027 and accounting for almost 25% of the pharmaceutical industry’s R&D expenditure, Oncodesign’s technology has already enabled the targeting of several promising molecules with substantial therapeutic potential, in oncology and elsewhere, along with partnerships with global pharmaceutical groups. Oncodesign is based in Dijon, France, in the heart of the town’s university and hospital hub, and within the Paris-Saclay cluster. Oncodesign has 230 employees within 3 Business Units (BU): Service, Biotech, Artificial Intelligence and subsidiaries in Canada and the USA.

Covalab

Covalab specializes in the development and production of high-quality monoclonal and polyclonal antibodies, and related services. Its scientific team includes world-renowned immunologists with over 30 years’ experience in innovative antibodies and their modifications to be used in research and diagnosis and as potential therapeutics. Founded in 1995 by Dr. Said El Alaoui, Covalab’s main goal is to achieve national and international credibility and to bring novel therapeutics to the clinic and then to patients.

CheMatech

Founded in 2005 as a spin-off of the Institut de Chimie Moléculaire de l’Univerisité de Bourgogne, CheMatech is a unique company in Europe specialized in the design and production of chelators (DOTA, NOTA derivtaives) for Nuclear Medicine and Molecular Imaging. These molecules are used for the radiolabeling of biovectors, such as peptides or antibodies. CheMatech provides its clients with a catalog of chelators suitable for most radiometals used for PET, SPECT or therapy and also offers custom syntheses, from the design of the chelator to the production in bulk. CheMatech is able to produce GMP chelators, and related molecules, for the production of APIs from gram to kilogram scale. CheMatech constantly innovates and offers new solutions thanks to an internal R&D activity and joint research programs with internationally recognized research teams. Based in Dijon, France, CheMatech’s facilities include 500 m2 of laboratories with a separate GMP area. With 1300 clients all over the world, the company is present in more than 30 countries.

ABX-CRO

ABX-CRO is an independent international CRO specialized in the field of preclinical and clinical (phase I – III services) contract research involving functional imaging methodologies with emphasis on molecular imaging with PET and SPECT, as well as Molecular Radiotherapy (MRT), oncology and neurosciences. Study design, placement, regulatory set-up, project management, clinical monitoring as well as technical quality assurance of imaging devices, collection, handling, analysis and reporting of image data is within the scope of its current activities. With a unique translational medicine approach, ABX-CRO takes products from the appropriate preclinical model, over Phase 0 microdosing, through to late-stage development, also providing comprehensive supportive functions (pharmacy/radiopharmacy solutions, medical physics, imaging, pharmacovigilance and regulatory services). ABX-CRO is based in Dresden, Germany, with global clinical coverage through local offices in Australia, South Africa, Spain and the US, and a global network of established partner organizations for clinical and regulatory functions.

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Establishing an Expert Network for Your Radiopharmaceutical Drug Development Program