Dalton Pharma Services, a contract development and manufacturing organisation (CDMO) offers expertise in drug discovery, formulation and process development, custom synthesis, and GMP manufacturing services. Lu Rahman spoke to CEO, Peter Pekos about the company’s ongoing expertise.
LR: The company has experience supplying the needs of the orphan drug field – how can Dalton help with orphan drug innovation and how much opportunity do you see in this market?
PP: Dalton can help with orphan drug innovation through our cGMP API manufacturing and sterile or solid dose manufacturing capabilities. We have extensively contributed to the development of an Artesunate containing anti-malarial orphan drug for the US military, which recently received FDA approval. Our expertise in dosing sterile powders in vials, which is being used to treat a rare type of severe and complex malaria, is critical for those seriously afflicted as injection is the only viable method for drug administration. Ultimately, Dalton was successful in producing enough vials to serve the market for this form of malaria.
With more than 7000 orphan diseases affecting an estimated 30 million people worldwide, and in combination with the introduction of monetary incentives and regulatory relaxations in recent years, the opportunity in this market is experiencing significant growth. Incentives including tax credits, lower hurdles to approval, lower marketing costs, longer exclusivity, premium pricing, favourable reimbursement, and shorter regulatory pathways, among others, further contribute to growth in this market.
LR: Tell us about the work you have done with the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan on a Covid-19 vaccine. Where are you with that project?
Dalton is a leader in sterile manufacturing which is a critical requirement in the development of vaccines. We manufacture different types of RNA biopolymers, and one of the RNA molecules is used as an adjuvant in vaccine development. We’ve been manufacturing various versions of VIDO’s developmental vaccines over the last ten years thanks to a long-standing relationship and are now focusing on its Covid-19 initiative. This is an exciting project as the vaccine recently received Health Canada authorisation for early phase clinical trials. Like other companies supporting the global Covid-19 initiative, Dalton is doing in months what would typically take years. It is a race against time and we are adapting our capabilities to expedite this process.
LR: On that note, how has the last year been for Dalton and how have you dealt with and reacted to the pandemic?
PP: Dalton has not slowed down in light of the pandemic. In fact, these circumstances have pushed us to expand our capabilities in support of initiatives such as Covid-19 vaccine development programs and the manufacturing of Covid-19 test kits. For instance, we have been able to quickly and effectively adapt our liquid filling capabilities to manufacture a component of Covid-19 test kits. The test tubes produced at Dalton contain a transport medium that inactivates the Covid-19 virus at the point of collection. One of the big challenges with testing for infectious diseases is that once a sample is taken, it’s considered biohazardous. Therefore, caution is essential at this stage as there is an important biological sample on the tip of the swab. The transport medium Dalton has manufactured therefore allows these patient test samples to be safely and accurately processed by clinical labs. We have been producing 100,000 tubes per week and are actively working to scale up and supply hundreds of thousands of these viral transport medium tubes which deactivate infectious agents to supply the needs of Canada, as well as other countries.
LR: How important is collaboration to the business and can you share any examples of recent successes?
PP: At Dalton, collaboration is essential to our growth and success. As a B2B CDMO, we support clients at different stages of drug development to accelerate their drug discovery programs. We offer support from inception, to cGMP manufacturing through our integrated drug discovery, development and manufacturing capabilities reducing timelines and cost through all phases of development and manufacturing.
As an example of our collaborative efforts, we recently acquired two licenses under the Canadian Cannabis Act and Regulations; a Cannabis Drug License (CDL) and a Standard Processing License (SPL). Acquisition of these licenses has allowed us to support many initiatives in the cannabis space including Ontario-based Cardiol Therapeutics. We have collaborated with Cardiol in the clinical and commercial development of cannabis related products for therapeutic use and supported them in the development and manufacture of Cortalex, an oral pharmaceutical Cannabidiol.
LR: As a Canadian company, where do you see the challenges and opportunities in the drug discovery and development market?
PP: Currently, 70% of Dalton’s overall revenues are from pharmaceutical/biopharmaceutical companies located outside of Canada, with 80% of this foreign business originating in the United States, and most of the remaining 20% originating from the EU and India.
As a Canadian CDMO, we have a great export advantage over a US CDMO due to the existence of a mutual recognition agreement (MRA), whereby Health Canada registration of a facility allows direct export to Europe, Australia, and other markets. This has allowed us to become a leading CDMO for global distribution of cGMP API, cGMP sterile fill/finish or aseptic liquid and powder finished products.
Our location provides geopolitical stability, adherence to high ethical standards, geological stability, as well as a high standard for regulatory compliance with Health Canada as our governing body. These factors minimise risks surrounding ethics, culture, infrastructure support, regulatory compliance, and IP protection. This enhances our ability to support our clients’ requirements for excellence and security of supply. Dalton benefits from Canada’s reputation as a reliable and stable jurisdiction for pharmaceutical manufacturing. Being located next to the largest and most important pharmaceutical market in the world is an additional reason why Canada is a great place for drug development and manufacturing.
LR : Where do you see future innovation in drug development?
PP: The psychotropic drug market is a niche and innovative new area for us. The use of psychedelics for the treatment of previously untreatable debilitating mental illnesses is a rapidly growing area in drug discovery and development. There is a substantial body of evidence that shows these drugs can have positive life changing results. We are licensed to supply the active drug ingredient, the formulation of the drug product, as well as the dosage form.
LR: The company’s mission is to be ‘a leading partner in the development and manufacture of medicines and drugs for a healthier world. How do you go about this?
PP: Dalton’s range of integrated services from formulation/process development to API and solid & sterile finish dose manufacturing, more than 30 years of expertise, emphasis on quality, reliability, speed, flexibility and a valued employee culture – all in one centralised location, – are key attributes for the continued success of our ability to accelerate our clients drug development programs.
Clients have always been our main focus – we are responsive, adaptable, and flexible in our collaborative efforts and hare proud to have delivered on many technically challenging projects within a highly regulated framework. Our success has been a combination of experience, technical skills, expertise, a creative environment and a passion to succeed.
Volume 22, Issue 2 – Spring 2021
Peter Pekos is co-founder and CEO of Dalton Pharma Services, established in 1986. He has managed its growth into a leading supplier of drug development and manufacturing services to the global pharmaceutical industry. Pekos has founded several companies, and is a board member for biotechs, not-for-profits, as well as academic institutions.