Earlier this year, the Scottish contract manufacturing organization (CMO) Symbiosis Pharmaceutical Services, made a US appointment to help grow the company’s growing commercial interests in the country.
As the new US Business Development Manager, Dr. Scullion will support an increased demand for the company’s sterile filling services from biotech companies.
To learn more, Outsourcing-Pharma.com talked with Dr. Scullion about his new role in the company and where he thinks the industry is headed.
Outsourcing-Pharma.com: What type of experience do you have, and how will this knowledge strengthen Symbiosis?
Dr. Thomas Scullion: Since gaining a PhD in neuropharmacology, I have spent the majority of my career within the life science industry across both the public and private sectors. Having worked for the world’s largest drug discovery CRO, I have knowledge of the challenges faced by drug developers from pre-clinical through to clinical stage.
During this time, I was completely immersed in the pre-clinical services industry and much of the research that underpins drug development. Having built strong relationships within the biotech industry (ranging from spin-out to mid-size pharma), I will use my knowledge to foster long-term relationships with Symbiosis's customers, based on mutual success.
Outsourcing-Pharma.com: Based on the industry today, where do you think it’s headed in the next year? The next five years?
Dr. Thomas Scullion: The outsourcing sector will no doubt continue to grow over the next five years and is showing no signs of slowing down. In a recent survey among CMOs, 73% said they are experiencing increased demand for their outsourced services in 2016 compared to 2015.
We expect this to continue, with particular growth in the parenteral manufacturing space coming from biopharma companies as they begin to progress new drug products thanks to an increase in funding.
Despite the demand for services, due to the substantial barriers to entry and increasing quality demands in parenteral manufacturing, we don’t expect to see many new players entering the market.
While many CMOs continue to expand their offerings, there will continue to be demand for niche manufacturing services from specialist providers that can offer the flexibility needed to meet increasingly tight timescales in the drug development pipeline.
Outsourcing-Pharma.com: How will Symbiosis Pharmaceutical Services work to meet the increased demand for its sterile filling services from biotech companies?
Dr. Thomas Scullion: As a company the ability of Symbiosis to offer rapid access to manufacturing slots in order to help clients meet tight clinical deadlines sets us apart from the crowd. In order to sustain our world class service levels and meet increased demand for sterile filling services from biotech companies globally, we have recruited significantly over the last year in project management and production to ensure we have the right people and skills in place to support Symbiosis through the next phase of its development.
We are also currently undertaking a major investment at our sterile filling facility to ensure continued compliance with the latest existing and emerging regulatory guidelines.
Outsourcing-Pharma.com: What is driving this surge in demand?
Dr. Thomas Scullion: The level of overall growth in the biotech sector is driving a surge in demand for aseptically-prepared parenteral drug products. There is a positive investor climate in the biotech space, which is facilitating the development of new biological drugs, increasing the depth of an industry-wide drug pipeline and fuelling the demand for outsourced manufacturing services to bring products to clinical trial stage in as short a time as possible.
As a result, we are finding that many biotechs are looking for flexible, small scale and specialist aseptic CMO partners that can deliver on challenging timelines and to tight budgets, meeting both investor and drug developer expectations.
In particular, we are experiencing increased demand from US companies who are undertaking clinical trials in Europe. By choosing to use a GMP manufacturer based in the EU market, they can ensure effective compliance with the QP standards required to release a drug product for clinical use in Europe while, in tandem, generating clinical supplies for US trials at the same time as a result of the regulatory strength of Symbiosis.
Outsourcing-Pharma.com: What are some of the most significant changes you’ve witnessed in the industry?
Dr. Thomas Scullion: Aside from the growth of the biotech sector, we have witnessed a number of notable changes. There is evidence of consolidation in the CMO landscape, with a number of high profile mergers and acquisitions having taken place. This has reduced the choice that drug developers have when selecting a CMO to work with who can assist with the manufacture of their promising molecule.
As we move forward, the industry is going to consist of fewer small CMOs that can deliver the specialist skills and operational flexibility needed to move biotech and pharma companies through the clinical development stages in a speedy and agile manner.
In contrast, larger CMOs are looking to extend their offering to align with the ‘one-stop-shop’ service provider model. Arguably this is a move back towards the all-under-one-roof organizational model, which existed within big pharma companies before the advent of modern drug development outsourcing. Ironically, this principle was rejected by big pharma companies to minimize inefficiency and mitigate fixed cost.