you are successful
in discovery?
Congrats!
then starts the cmc obstacle course
Bringing a new drug from the lab to the clinic is a completely different
process from identifying the target and molecule in the first place.
CMC is the most underappreciated aspect of the whole drug development process, but it can make or break development.
Grounded in science and regulated by governments, health care is a challenging sector. In the life of any startup, there are plenty of opportunities for fatal missteps.
But that doesn’t mean your company has to make one.
How to maintain pharmaceutical industry’s high-level standards ?
Each stage in drug development is key, not only demonstrating
proof of concept : 3biotech will support you day after day.
We are your first crash-test:
challenging, then supporting and accelerating
A stronger valuation of your innovation : #challenging to avoid drug development failures and get a clear Chemistry Manufacturing and Control strategy.
Define the best path from beginning to end : # supporting step by step from scientific ideas to innovative drugs.
Go faster from discovering drug candidate until clinical proof of concept : # accelerating the entire drug development
value chain
3Biotech development strategy
relies on 3 major pillars
SAFETY
EFFICACY
manufacturability
Safety
Prior to First in Human, the limits of safe dosing, and the specific potential advers effects of the drug must be assessed thus minimizing risks to clinical subjects as well as risks to the program development..
We help to design and conduct Pharmacology, DMPK or toxicology studies of the drug candidates to assess the potential adverse effects caused by the candidates related to the intended use of the product. A smart selection of the drug candidate not only relies on the expected efficacy of the product, but also on toxicology and pharmacology that make the safety package.
Safety
The lack of efficacy is one of the main causes of failure in drug development, at clinical phase. A large amount of work put on the nonclinical efficacy studies can greatly lower that figure. Those nonclinical efficacy studies rely on in vitro studies, among which
target engagement,
tissue cross-reactivity, immune-mediated cell killing, and other specific ex-vivo and in-vivo assays related to the Mechanism of Action (MoA). It is named “translational studies”
translating potential
drugs' on- and off-target nonclinical properties to clinical consequences in order to select the best drug candidates to move into early clinical testing.
Safety
Safety and Efficacy are not the Holy Grail. The last requirement is to develop a manufacturing process that demonstrates the quality and the consistency of the drug to be produced. The Chemistry, Manufacturing
and Controls (CMC) section
is a very important
part of a pharmaceutical clinical trial or marketing application. 25% of market authorization in the US are denied related to lacks in the CMC strategy, resulting in processes and products that couldn't meet the stanrdards requirements. Regulators need to be assured that there is consistency between the product tested during the clinical trials and commercialization batches produced years later. Therefore, an exhaustive CMC strategy must be defined in order to ensure that the product is safe, effective, and consistent between batchesacile.
