Speed to Clinic & Market Approaches
First in Human Strategies
Reaching first in human studies quickly is often critical, especially for companies with investor milestones tied to clinical dosing. Of equal importance is the creation of a formulation and dosage form that will give the candidate its best chance at success. A poorly formulated drug product can lead to poor outcomes or challenging manufacturing processes, which may result in termination of the project, longer timelines, and higher costs.
Austin Pharmaceutics and Manufacturing’s First in Human Strategies is an accelerated development and manufacturing offering for NCEs transitioning from preclinical to Phase I clinical testing. We offer several technologies to expedite product development for first in human clinical testing, including:
- API in Bottle
- Blend in Bottle
- Blend in Capsule
- Suspensions for Clinical Compounding
In as little as 16 weeks, we can manufacture and release your phase appropriate dose form.
When conventional formulations are not enough to achieve targeted in-vivo performance, Austin Pharmaceutics and Manufacturing offers several solutions, including bioavailability enhancement strategies for poorly soluble drugs and controlled release development. Our goal is to match the best solution with the physiochemical characteristics of the molecule and your corporate goals, timeline, and budget. Click here to learn more.
Accelerated Approval Programs
Accelerated regulatory approval programs, such as orphan, fast track, and breakthrough indications, allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. The demand for these treatments remains and the pharmaceutical industry is meeting that challenge. The percentage of novel drugs using accelerated approval pathways continues to grow year over year. However, due to the accelerated timelines, it is important to ensure speed to market, scalability, and product quality.
Our dose form development and manufacturing expertise combined with our client-centric approach makes Austin Pharmaceutics and Manufacturing a unique partner for the development of accelerated approval products. These projects not only require development expertise, but also an ability to meet their rapid timelines. Our goal is to create a formulation, manufacturing process and analytical methods which enable accelerated timelines, while also ensuring an appropriate and scalable dosage form to de-risk your path to the market.
Each drug candidate is unique, as is each Company’s corporate goals. Our goal is to match the best development strategy with our clients’ needs, timelines and budget. Austin Pharmaceutics and Manufacturing expertise in formulation and process development, and sense of urgency, help ensure projects will progress quickly. And our flexible scheduling, dedicated project management and size means you will not be ignored due to larger scale projects.
Contact Us today to learn how AustinPx can support your first in human and accelerated approval candidates with our Speed to Clinic and Market Approaches.