Denis Geffroy VP Business Development API and Chemical Development, Almac1. API services need to be focused towards smarter, faster and better value objectives.
The shortage of Venture Capital investment to support early phase clinical development programs over the past few years has resulted in fewer early phase clinical development projects entering Phase I. CMOs like Almac had to quickly react to this fast-changing market or face dramatic consequences. Over the past few years, Almac’s API business has continued to grow at a double digit pace, +15% last year, and forecasted to be +17% in 2013.
2. More pharmaceutical companies are looking at the whole drug development process – the API and drug product – to realize efficiencies, avoid duplication of work and shorten timelines.
At Almac, a project can start at the earliest phase of development and benefit from chemical development and physical form optimization, analytical method development, drug product manufacture and pharmacodynamic biomarker or companion diagnostic development. Undertaking these early clinical development activities can greatly help reduce attrition rate, or even reach a “project kill” decision earlier.
As compounds advance into clinical development, Almac routinely employs biocatalysis technology to greatly improve the manufacturing process, focus on cost of goods and achieve high quality product.
3. So how did Almac manage such an impressive growth within a challenging market environment?
We can attribute this success to three main factors:
- Targeting strategic partnerships with Multinational Pharmaceutical clients
Almac has built a fully integrated CMC and Clinical Supplies model over the past 5 years making it the top choice when looking for a “one stop shop” approach. Major Pharma companies are increasingly looking for synergies across all activities and to rationalize their supply chain to save time and money. This strategy has proven to be very effective as we have added three additional strategic partnerships with top 10 Pharmaceutical companies this year.
- Focus on Phase III and commercial opportunities
As early phase projects became scarce, we are targeting late phase and commercial API opportunities. As part of this strategy we increased our API manufacturing capacity: moving from 50kg scale to >500kg. Results are already striking with several Phase III and Commercial projects initiated in the past year. Today, Almac’s API business is 30% late phase and commercial projects, compared to 5% three years ago.
- Developing a collaborative model to support emerging Pharma companies
Preclinical to Phase II projects still represent the majority of Almac’s API business although currently growing at a slower pace than the Late Phase and commercial supply. Fewer early phase opportunities and fierce competition meant that Almac needed to offer more than just a manufacturing service. Through our RapiddTM offering, we provide a custom Preclinical and First in Human package, aligning customers key milestones, financial limitations and strict timelines. Almac’s early phase program also includes advice from a range of industry opinion leaders, thus further de-risking projects and avoiding common pitfalls.
4. The paradigm shift for the acceptance of biocatalysis is at the forefront of research within the fine chemicals and pharmaceutical industries.
API manufacturing is extremely competitive and meeting the smarter, faster and cheaper objectives can be satisfied through innovation and embracing new technologies. Biocatalysis is recognized as an alternative solution for solving complex chemistry problems due to its rapid implementation, economic benefits and ‘green’ credentials. The proven ability of biocatalytic technology to produce hard cost savings for pre-existing processes or to provide novel routes to access NCEs is at the forefront of Almac’s key technologies and investments. Almac has many successful projects which use biocatalysis technology to significantly reduce the number of chemical steps required for API manufacture – achieving these results gives a definite competitive edge in the marketplace versus the use of traditional chemistry processes.
APIs are increasingly classified highly potent, requiring special containment facilities to manufacture these products. Almac has been involved in highly potent API manufacturing for over 10 years, and has a strong track record which is another advantage in such a competitive space. Testament to our success in this area, we have recently completed an expansion of our manufacturing capabilities which enables us to manufacture highly potent APIs up to 500kg scale.
5. Creative solutions will help keep the development pipeline moving.
Solutions aimed at accelerating clinical development, reducing cost and attrition will address the issues preventing successful pharmaceutical development. Almac is addressing all these issues through its technology, investment and integration strategies. Additionally, embracing biocatalysis technology, investing in our solid expertise in the API manufacturing arena and integrating processes enables us to become as efficient as possible.