In this Q&A with European Pharmaceutical Manufacturer, John McDermott, Vice President of Scientific Consulting, explores how Translational Pharmaceutics® is reshaping the journey from preclinical development to first-in-human studies.
When asked how Quotient Sciences’ integrated approach to drug development, Translational Pharmaceutics®, expedites the transition from preclinical development to clinical testing, John says:
"Quotient Sciences’ approach is integrated. In our case, integration is bringing the CDMO service world close to the CRO service world. It is horizontal integration, providing breadth of service, being both a CDMO and CRO – as well as vertical integration bringing depth of service, and deep acumen in each of the areas we support within formulation, manufacturing, and clinical testing.
Through Translational Pharmaceutics®, our integrated drug development platform, we bring formulation development, drug product manufacturing, and clinical testing into the same program of work, managed by a single project manager. That means we can manufacture batches of drug products in our facility, release them, and dose them in our clinics to trial volunteers in less than seven days.
Translational Pharmaceutics® is proven to accelerate early development studies by taking scale up of drug product and long-term stability studies off the critical path for dosing. These two aspects alone can save four to six months of time getting to the first subject, first dose."
When asked what benefits recent collaborations bring to Quotient Sciences as a company, John states:
Collaborations are one avenue that we have used this year to extend our science and services. Earlier this year, we announced a joint venture with CPI, the UK Centre of Process Innovation, to advance the development of mRNA based therapeutics.
It is known that mRNA therapies have a complex supply chain, often requiring multiple providers for synthesis, LNP formation and clean up, and sterile fill-finish let alone the cold chain requirements for these drugs.
The mRNA-based vaccines created to address the COVID-19 pandemic are a great example of how these development programs can be accelerated. However, those were unprecedented times, and normal operating modes have now for the most part returned.
The lessons-learned and pace of COVID-19 vaccine development we hope can be applied to regular therapeutics, and we know in our case Translational Pharmaceutics® has shown that kind of speed. For almost two decades, we’ve consistently shown how we can streamline the supply chain, taking a molecule from API to human-ready dosage form and through Phase I trials in accelerated time by eliminating unnecessary steps that create distance between the drug product manufacturer and the clinic. We're very excited to be working in this space to bring our Translational Pharmaceutics® platform into mRNA manufacturing.
The second collaboration is a partnership with Biorasi, a US-based CRO that is focused on global patient trials. We have made this move as a response to increasing industry trends that we've observed in terms of getting efficacy data in the first in human study. Yes, we're a contract manufacturer, but we're also a contract research organization, and we’ve built a body of work over the last 20 years running first in human studies and accelerating those programs demonstrating safety, tolerability, and pharmacokinetics in healthy volunteers.
The key question is, what about efficacy? Is the drug actually working? The trend that's starting to emerge, again, is back to having a quick win or fast fail.
By bringing patients into a first in-human study, we get to evaluate that drug during its first year of clinical development to assess whether it actually has an impact, and if not, provide our clients with the data so they can confidently choose to cease investment or pursue other paths.
Read the full Q&A article on the European Pharmaceutical Manufacturer website here.