- Understand the etiology of drug side effects
- Show differences between drugs
- Help exonerate a drug that has been put on Clinical Hold status
A FDA Clinical Hold order is a major event in the development cycle of a drug: it halts the progress of the program and has a potentially significant impact on the sponsor’s bottom line.
Once a Clinical Hold letter has been received, the ability to respond in a concrete manner and in a short amount of time becomes critical. It can make the difference between an asset being shelved and having a new life breathed into it.
How we can help
Biovista’s B2B Clinical Hold service offers a range of solutions depending on the timing and nature of the clinical hold situation, and whether the sponsor is acting proactively or reactively to a suspected or observed side effect.
| Pro-active | Reactive | |
|---|---|---|
| Pre-clinical | Create sufficient information to assess patient risk | N/A |
| Clinical | Clinical Trial design assistance subpopulation identification eligibility/exclusion criteria | Generate biological Mechanism of Action evidence to help exonerate the investigated drug Drug differences profiling |
Once a clinical Hold order is issued, Biovista can help you:
- Explain the potential etiology of the side effect elucidating mechanistic factors whether known or unknown
- Elucidate important differences between your drug and another same-class drug with which the side effect has been observed (often CH orders are issued because a side-effect is observed with another drug in the same class as your own drug)
- Elucidate the role of confounding factors and co-morbidities in the context of the observed side effect
How we work
Biovista’s systematic discovery COSS™ platform supports our teams of biologists, medical doctors, epidemiologists in generating robust Mechanism-of-Action rationale to explain the occurrence of the observed or suspected side effect.
We work with your team, using where appropriate your in-house data to help make the case for your drug. Depending on the specific reasoning of the CH order we
- Create a multi-dimensional representation of the entire context of the side effect
- Elucidate potentially important drug class differences, however minute they may at first appear
- Analyze drug-drug interactions and co-morbidities, if any, to identify potential coupling effects
- Combine the above to create a strong case that may help exonerate your drug
Why Biovista
- Rapid reaction capability (down to a month) helps get the drug development program back on track in very short time-frames
- Proven track record
- A “no stone left unturned” approach covering multiple non-obvious eventualities allows us to create biological plausibility reasoning for possible interpretations of side effect occurrences and provide strong evidence to help exonerate the drug being investigated
- Significant time and money savings
For more information
To find out more information on our B2B Clinical Hold service and how we can help you get more from your portfolio, contact us or send an email directly to ps{at}biovista.com.