ViroStatics has been certified by AIFA as Phase I Clinical Trial Laboratory
In 2015, the Italian Medicines Agency (Agenzia Italiana del Farmaco; AIFA) issued the Determination 809/2015 with new requirements for phase I clinical trials. The new AIFA Determination imposes a certified organizational model on units and laboratories involved in phase I trials.
Meet In Italy for Life Sciences and Italian Healthcare Venture Forum 2017, Turin, Italy
ViroStatics has been selected to present at the Italian Healthcare Venture Forum 2017, taking place on October, 11-12th 2017 at the Torino Incontra Congress Centre in Turin, Italy. Our company is among the top 20 companies selected by the Selection Committee out of more than 70 innovative companies that have applied for the event.
The event stretches over three intensive (net)working days, during which business meetings, networking activities, pitching sessions, thematic workshops and, at the end, a convention on the life sciences key trends and innovation strategies will take place.
The event offers high visibility and opportunities for businesses and networking, creating dedicated dialogues between national and international, public and private stakeholders, by networking research-driven innovation.
July 30, 2017
ViroStatics has successfully concluded the Project “Thunder” under Horizon 2020 dedicated SME Instrument
“Thunder” project represents a feasibility study about the development of the innovative CDK inhibitor VS2-370 with a dual pronged applicability: treats certain HIV-associated cancers while simultaneously purging the HIV reservoirs which continue to threaten individuals suffering from AIDS. This dual pronged approach provides a clear pathway for regulatory approval which is not available to those drugs under development which are HIV specific. We achieved proof of concept demonstrating activity of the drug in vitro and in vivo in a relevant model of HIV-associated tumors (i.e Non-Hodgkin Primary Effusion Lymphoma, PEL).
During the project we have completed the documentation on VS2-370 intended for Pharmas and reached out to 34 likely potential future oncology-oriented partners with the primary goal to educate them ahead of a formal process after further pre-clinical studies. We have received positive feedbacks and agreed to proceed with the development of the product by completing the studies necessary for the Investigational Medicinal Product Dossier to allow the Pharma partner to run the first-in-man clinical trial.
Startup Olé includes a Startup Fair, a Pitching Competition and Curated Matchmaking with relevant corporates and investors and private networking. SMEs will have the opportunity to present their business, pitch to investors, attend workshops, network and much more.
March 20-22, 2017
BIO-EUROPE SPRING, Barcelona
December 12, 2016
Thunder Project selected for Phase I SME instrument by the European Community
June 29, 2016
Jadranka Rogan, MD, PhD joined the Team as Head of Clinical Development
She brings expertise in clinical oncology. In her 25 years service to Pharma Industry she covered positions of Medical director for Farmitalia Carlo Erba office for Eastern Europe, CSC Pharmaceuticals and Cyathus Exquirere, Vienna. Also she ran the Regulatory affairs office and Pharmacovigilance for CSC Pharmaceuticals and was Qualified person for Pharmacovigilance (EUQPPV) for Cyathus Exquirere. Currently, she is CEO of Inphares GmbH, a network of professionals with expertise in diverse fields of pharmaceutical research and development.
The project proposal THAMAR related to the development of our CDK inhibitor to target HIV-associated malignancies and to purge viral reservoir submitted under the Horizon 2020’s SME instrument phase 1 call H2020-SME Inst-2016-2017 in the area of Dedicated support to biotechnology SMEs closing the gap from lab to market by ViroStaticsfollowing evaluation by an international panel of independent experts was successful in a highly competitive evaluation process as an innovative project proposal.