Biovista's Pharma Services combine the best of opinion-based medicine with evidence-based intelligent automation.

The services offer state-of-the-art predictive modeling and link identification capabilities for adverse event profiling and drug repositioning in a translational medicine context. Supported by one of the world's largest databases with over 4 billion biological correlations, they exploit seemingly disparate biological correlations to deliver novel insights and recommendations that are immediately actionable by the client.

Biovista's Pharma Services have been successfully applied in the following areas:

1. Benefit/Risk Assessment: predicting potential unknown or unexpected Adverse Events (AEs) Biovista can help with go/no-go decisions on new compounds, clinical trial design or with re-labeling requirements for existing drugs.
2. Risk Evaluation and Mitigation Strategies: identifying risks that correlate with target populations and other factors, Biovista can help design appropriate strategies in accordance with the FDA’s REMS requirements.
3. Withdrawals and Clinical Hold situations: providing plausible explanations for observed and unexpected AE in a Phase II or III trial, Biovista can help inform a Risk Mitigation Plan or suggest alternative development avenues, and under certain circumstances provide analysis on confounding indications that may help free a compound from clinical hold status.
4. Drug Repositioning and Loss of Exclusivity (LoE):  identifying potential novel applications of existing drugs, this service helps to further exploit existing IP assets, inform the due diligence evaluation of an in-licensed compound, fill the company pipeline, complete gaps in IP estates and protect against competitor actions.

BENEFITS

Biovista Pharma Services provide drug developers with seven distinct advantages:

1. Save time and money by producing strategic level product line recommendations that would normally require multiple FTEs and several months of R&D, in as little as a month.
2. Support drug and candidate “go/no-go” decisions by identifying context sensitive information that is non-obvious (not reported in the available data sources) yet potentially highly relevant to the question at hand.
3. Identify unique IP opportunities that may add years of exclusivity to drugs in development, prevent Loss of Exclusivity for existing drugs and provide extension of exclusivity strategies for drugs coming off patent.
4. Constitute an orthogonal and complementary approach to existing tools (in vitro/vivo experiments, software simulators, data mining etc.) providing additional confidence to decisions.
5. Present proactive pharmacovigiance/pharmacoepidemiology strategies for testing wet-lab or animal results for highly problematic safety issues.
6. Provide biological explanations for unexpected AEs during a trial or once a product is on the market that may provide a fast track for rescue from regulatory sanctions
7. Offer additional peace of mind to decision makers who need to be assured that ‘no-stone has been left unturned’ through comprehensive analysis of public and proprietary data.

Click on the services from the menu on the left to find out which one best meets your present needs.