ADALTIS - IVD Company, Italy

Who we are?

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.

What are Biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than USD 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.

Contact:
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany
phone +49 (0) 89 - 86 46 67 100
fax + 49 (0) 89 - 86 46 67 110
info@formycon.com // www.formycon.com

Adipogen Life Sciences is a leading research reagents company with its corporate headquarters is in San Diego, USA and the Operational headquarters and production in Switzerland. A motivated team of highly-skilled individuals develops and manufactures new products for the Life Science Research Market in its main areas of interest including obesity & diabetes, immuno-oncology, inflammatory diseases, innate immunity (inflammasome) and antimicrobial resistance. A major focus is on innovative and advanced ELISA Kits. In addition to the antibody and protein facilities, Adipogen Life Sciences owns chemical laboratories, enabling the company to isolate unique natural products and to develop new and innovative small molecules and rare antibiotics.

Mabion Poland S.A. is a leading biotechnology company that was created in order to market the latest generation of biotech drugs based on humanized monoclonal antibodies.

This technology, developed in Mabion by itself, is a high-tech at the highest level. The process of humanizing monoclonal antibodies, being the apex of today’s biotechnology enables the production of targeted drugs that act selectively on cancer cells, providing greater efficacy and lower toxicity of the therapy.

Mabion was created in March 2007 by four national pharmaceutical companies: Celon Pharma Łomianki, one of the leading cancer drugs in Poland, Polfarmex from Kutno, which is a national leader in the market of prescription medicines, IBSS Biomed from Krakow, Poland’s largest and counting the European manufacturer of vaccines and Genexo from Warsaw operating in the market of drugs and medical devices, mainly in the field of diabetes. Mabion also created two entities carrying out research in the field of biotechnology: BioCentrum and Biotech Consulting.

Within a few years Mabion competence possessed the manufacture of any biotechnological drugs from the design phase through the choice of platform and manufacturing technologies to produce the finished drug. Currently in its laboratories in Łódź, the company conducts research and development on a number of biotech drugs, used in the treatment of cancer and metabolic diseases.

NEUROFIT, founded in 1996, is a pre-clinical CRO (Contract Research Organization) based in France and offering a comprehensive list of disease models and screening assays in the fields of psychiatry, neurology, multiple sclerosis, diabetes and pain. Neurofit works for major pharmaceutical and Biotech companies in Europe and the USA.
Neurofit’s core expertise in CNS and PNS includes animal behavior techniques, nerve conduction velocity measure, nerve fiber morphometry, primary neuronal cell cultures. Neurofit has long-standing experiences in psychiatric, neurodegenerative and autoimmune / inflammatory disorders. Our disease models are clinically relevant and predictive.
Neurofit routinely performs, as part of a study, collection of blood, serum plasma, cerebrospinal fluid as well as dissection of brain microstructures from compound-treated animals to provide customers with useful samples for their pharmacokinetic, biochemistry and immunochemistry analyses.

AKRN Scientific Consulting is a clinical research and regulatory consulting firm for medical devices and IVD.

AKRN is based in Spain and Sweden.

We provide clinical development services on a stand-alone basis, or as part of an integrated full-service solution together with our European CRO-partners.

Our clients include MedTech start-up companies as well as multi-national companies.

We are committed to partner with Medical Device companies developing innovative technologies improving health care for more people.

We are highly qualified, experienced, and accountable clinical research professionals that guarantee cost-effective and successful solutions crafted to each client’s needs. We combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to support our customers with solutions that can stand up to rigorous scientific and regulatory evaluations.

We follow the national and international current standards (ICH/GCP guidelines, European regulations, and national and regional legislation), and the client or AKRN internal SOPs.

Services:
-Clinical Trial Services
-Clinical Strategy and Planning
-Study Design
-Clinical Monitoring
-Post Market Clinical Follow Up PMCF

Regulatory Services:
-CE Mark Strategic Planning
-Technical File | Design Dossier
-EU MDD to MDR Transition
-EU IVDD to IVDR Transition
-Clinical Evaluation Report CER

Key Medical Areas:

In-Vitro Diagnostic IVD

Cardiovascular
-Heart Valve Disease
-Aortic Disease
-Atrial Fibrillation
-Coronary Artery Disease
-Hypertension
-Endovascular Aortic Repair EVAR
-Percutaneous Coronary Interventions PCI
-Transcatheter Aortic Valve Implantation TAVI

Neurovascular
-Neuromodulation
-Spinal Cord Injuries
-Neurovascular Mechanical Thrombectomy

General
-Critical Care and Sepsis Management
-Minimal Invasive Surgery

Software
-AI | Machine Learning
-MDSW | SaMD

Odontology
-Implant and Digital Dentistry

Endocrinology
-Endocrinology and Diabetes