What was the decision-making process behind selecting Veeva Vault Quality Suite to harmonize Adare’s quality systems?

Bringing in Veeva Vault Quality Suite gave us a world-class platform to harmonize our quality systems across the organization, streamline our processes, and allow us — both from a training and compliance standpoint and from a quality management standpoint — to up our game in a cloud-based system. Many of our pharma clients are already familiar with Veeva, and it provides much better access to faster reporting and better diagnostic tools to ensure we are staying ahead of the curve in terms of our quality systems.

Have any areas of product development prompted more demand than others in 2022?

We are seeing demand in several key areas. Pediatrics is one great example where unpleasant taste is a major barrier to adherence and, as many companies are looking to expand into pediatrics or looking to expand their patents, we have seen increasingly more requests to support taste masking using our microencapsulation and control-released technologies. We are also seeing demand for traditional things like bioavailability and support for geriatric patients, and with the Frontida acquisition, we can leverage even more tools to support a wide range of capabilities. Pediatric and geriatric patients many times have difficulty swallowing drugs and we are using our technologies to come up with unique and creative solutions for this challenge.

What differentiates Adare’s proprietary tastes masking platforms and what is driving growth in the taste masking market?

We work on a wide range of APIs that have taste challenges such as bitterness or they need sweetening or flavoring. We have several microencapsulation technologies and capabilities to address these needs, from uniformly coating solid particles to creating a physical barrier for improving the taste or the release profile of a product.

For every challenge, we have a set of tools we can leverage to create optimized solutions beyond taste masking. For example, whether it is low solubility or high potency, we are seeing a range of different types of bioavailability challenges. Our solid-solution or solid-dispersion Diffucaps technology platform enhances solubility by preserving a drug's amorphous form, helping address the faster onset of action and minimizing food effects amongst others.

What are the challenges and opportunities for CDMOs in the US in 2023?

The changes in regulations around FDA inspections offer both challenges and opportunities. The agency is now able to do more unannounced inspections as well as more remote types of audits. We have already seen an increasing number of CDMOs, in particular in emerging markets like India, which are receiving warning letters and 483s, which is resulting in opportunities for onshoring and customers bringing back their production to US or Europe.

There continue to be general supply chain challenges, but fortunately, Adare has a global supply chain team which allowed us to continue to meet demand and not have too many difficulties along the way. In terms of funding, we have not seen any of our clients having major challenges, whether it is through IPOs, M&A, or additional fundraising. The decision-making might be slightly slower, but companies that have creative and breakthrough solutions can attain funding.

What are Adare’s main goals for 2023?

2022 was another great year for Adare Pharma. In 2023, we look forward to both organic and inorganic growth. Adare has an active investment plan and strategy that encompasses all our sites, and the company continues to invest in new capacities and capabilities to offer an even broader suite of solutions to our customers. We are currently scaling our long-acting injectable capability at our Lenexa facility in Kansas. We are also currently going through a major operational excellence initiative which is helping us to reduce costs and operate more efficiently and are also spending significant time on our ESG strategy. As these initiatives come to fruition or get to a steady state, we will then start to look at our longer-term plan which includes several M&A targets as we continue to grow the business. The client experience journey is one of our important strategies for the year, and we are off to a great start in 2023 and are looking forward to continued growth and expanding our business.