Observations from the trenches – due diligence
There have been many due diligence projects lately and the IQuant Engine has been working overtime to support them. As the funding environment gets more difficult, many programs, especially those that are in late discovery and early development, suddenly need financing and they are being shopped around with abandon. Here are a few reflections on what I’ve seen:
- It seems alarmingly easy to generate positive drug treatment effects in rodent models of CNS disease. Some of this may be due to selection bias (there wouldn’t be a program to partner without demonstrated efficacy), but I can’t shake the worry that in vivo efficacy is not the stringent hurdle that it ought to be. If you’re looking to finance your new drug program, just realize that your efficacy data package is unlikely to be significantly more impressive than your competitor’s, and it won’t close the deal for you.
- More rigor is needed in measuring drug potency at the postulated molecular target. I don’t care if your drug-target interaction is difficult to quantify, your program needs a reliable measure of absolute potency.
- Pharmacokinetics (PK) is as important as rodent efficacy. PK includes drug plasma and brain concentrations after dosing as well as plasma and brain free fraction. Your efficacy results become substantially more believable if they are backed up by strong target engagement data. It is unbelievable how many drug programs don’t follow this fundamental precept.
- The proportion of programs that avoid FDA interactions during early development is rising. It is easier and cheaper to conduct Phase 1 studies ex-US, especially in Australia. Too often this happens in programs that don’t have a sufficient data to pass FDA muster. Conducting Phase 1 studies in Australia because it’s cheaper may make some sense, but using Australia to avoid FDA feedback is a mistake.
- Have a well-founded plan for establishing target engagement in early clinical trials. Preclinical data that validate target engagement biomarkers can help close a partnering deal. Not paying attention to this is an obvious gap that will only bring tears.
- Neuroinflammation is the new apoptosis. Currently every disease involves neuroinflammation and every drug has anti-neuroinflammatory action. It’s not passe yet, but mechanistic fashions have a way of shifting out from under you.
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Let us know how we can help enhance your research.
We work with scientists, drug discovery professionals, pharmaceutical companies and researchers to create custom reports and precision analytics to fit your project's needs – with more transparency, on tighter timelines, and prices that make sense.
Observations from the trenches – due diligence
There have been many due diligence projects lately and the IQuant Engine has been working overtime to support them. As the funding environment gets more difficult, many programs, especially those that are in late discovery and early development, suddenly need financing and they are being shopped around with abandon. Here are a few reflections on what I’ve seen:
- It seems alarmingly easy to generate positive drug treatment effects in rodent models of CNS disease. Some of this may be due to selection bias (there wouldn’t be a program to partner without demonstrated efficacy), but I can’t shake the worry that in vivo efficacy is not the stringent hurdle that it ought to be. If you’re looking to finance your new drug program, just realize that your efficacy data package is unlikely to be significantly more impressive than your competitor’s, and it won’t close the deal for you.
- More rigor is needed in measuring drug potency at the postulated molecular target. I don’t care if your drug-target interaction is difficult to quantify, your program needs a reliable measure of absolute potency.
- Pharmacokinetics (PK) is as important as rodent efficacy. PK includes drug plasma and brain concentrations after dosing as well as plasma and brain free fraction. Your efficacy results become substantially more believable if they are backed up by strong target engagement data. It is unbelievable how many drug programs don’t follow this fundamental precept.
- The proportion of programs that avoid FDA interactions during early development is rising. It is easier and cheaper to conduct Phase 1 studies ex-US, especially in Australia. Too often this happens in programs that don’t have a sufficient data to pass FDA muster. Conducting Phase 1 studies in Australia because it’s cheaper may make some sense, but using Australia to avoid FDA feedback is a mistake.
- Have a well-founded plan for establishing target engagement in early clinical trials. Preclinical data that validate target engagement biomarkers can help close a partnering deal. Not paying attention to this is an obvious gap that will only bring tears.
- Neuroinflammation is the new apoptosis. Currently every disease involves neuroinflammation and every drug has anti-neuroinflammatory action. It’s not passe yet, but mechanistic fashions have a way of shifting out from under you.
Our Services
Let us know how we can help enhance your research.
We work with scientists, drug discovery professionals, pharmaceutical companies and researchers to create custom reports and precision analytics to fit your project's needs – with more transparency, on tighter timelines, and prices that make sense.