Can you provide us with an overview of Ascendia?

Ascendia Pharmaceuticals is a nine-year-old specialty pharmaceutical CDMO that provides custom sterile and non-sterile enabling formulations along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product development, as well as OTCs and nutraceuticals.  The company has put together a suite of unique technologies and IP platforms to develop all dosage forms for new product development and GMP clinical trial materials. 

What have been the keys to Ascendia’s rapid growth over the past three years?

In the early stages, Ascendia distinguished itself as experts in poorly soluble molecules, which are about 60% of the new drug pipeline under development. The technologies and IP platforms that our founder and CEO Jim Huang put together not only differentiate us in the marketplace to bolster product IP, but they also allow us to work seamlessly with virtually every dosage form that is available. This flexibility is really important when we deliver on our promise to clients with formulations to the clinic and are able to quickly pivot to the next dosage form that is patient-centric and comports to our client’s goal of maximizing market potential. In the past two years, our technical prowess, service-oriented culture and flexibility have begun to make the impossible possible for many companies. Building our reputation one project at a time, many of these clients have anointed Ascendia as a “Partner of Choice” because of the successes we’ve achieved for them, where perhaps others have fallen short.

Can you provide an example that illustrates Ascendia’s effectiveness in helping clients?

In the past two years we’ve had the privilege to work with several fast-growing startups and big pharma clients.  One client that was moving very quickly with an anticancer product that was working well for patients who had undergone multiple rounds of chemotherapy. Unfortunately, it required 50 to 60 pills per day, which was nearly as painful as the disease state itself and not tolerable.  The company was about to lose their funding because it was not a viable option for these patients, despite the dire straits, they were in. Ascendia was able to improve the bioavailability and decrease the dose to 10 to 12 pills per dosing, which has provided for the project to continue with funding. Furthermore, the product’s success has enabled the company to secure additional funding to support Ascendia’s formulation development of an IV and ophthalmic. Ascendia’s successes have added significant value to customer product portfolios and pipelines such that multiple projects with a client are becoming the “new normal” and “bread and butter”.

What are the most important considerations for companies hoping for a successful development program?

 Don’t hope!  Go with the best and get it right the first time.  More time equates to delayed approvals, more money being spent and opportunity loss for patients in the commercial market. It has been well described that big pharma has been killing projects earlier so they can reallocate resources and go forward with the most promising compounds and formulations.  It is even more important for a company that has a molecule and is focusing in rare disease to get it done right the first time in as robust a formulation as possible. Many CDMO’s and companies have formulation capabilities, but when the product runs into a snag or an issue, who has the domain expertise to solve those problems with a partner? Who has the tribal knowledge to share about the molecule itself (that they are passionate about) to move through those issues quickly and efficiently? That is something that requires not only the tactical prowess, but the employees and culture how they interact to collaborate with these domain experts who are passionate about their molecules.

What is Ascendia’s long-term vision?

Ascendia has been bootstrapping for the past nine years with a friends and family round. Our growth strategy includes a strategic partner and we are pleased to have just announced that we received a growth PE investment from the esteemed Signet Healthcare Partners to grow and expand our people, capabilities and facilities to meet and exceed customer expectations from early to late state development.