By Imran Khan, CEO, BioGateway
Are CROs the future of R&D programmes?
R&D and CROs
The continued need for innovation and development in an ever increasingly competitive market has seen the pharmaceutical industry restructure its approach to research and development (r&d). With the pressures of patent expiry, generic competition and declining revenues to cut costs has led to an increase in outsourcing and strategic partnerships.
Contract Research Organisations (CROs) continue to build up their portfolio of services as they look to meet the demands of a growing market need for outsourced partners.
The importance of CROs aside from the exorbitant costs associated with development, they provide the advanced and integrated expertise required to help contain costs and shorten development timelines.
With the continued need for expert development strategies and protocols, it is imperative that CROs are faster, smarter and more responsive to accommodate the growing complexities and pressures to deliver innovation.
With the renewed drive for innovation, we look at Kent’s Science Network and how the CRO market responding to the demands of the ever growing Kent Science Network.
Kent Science Network
Representing over a 150 companies with over 6800 employees working within the life science sector in Kent. Kent is fast becoming a hub for innovation playing home to some of the biggest names across life sciences. This is no surprise given the world class talent available, the funding opportunities, the dedicated sites, facilities and the ease of access into Kent from both London and Europe.
Kent has developed a wealth of talent as a leader in drug research and development, diagnostics, drug manufacturing and medical devices. Whilst retaining a high level of talent from industry, Kent also boasts an excellent pool of life science graduate talent from both Kent university and Canterbury Christ Church University.
With two of the leading science parks in the UK, Kent is host to both Discovery Park and Kent Science park amongst various other incubator spaces. Offering state of the art lab spaces to support growth of organisations from start-ups to global leaders.
With the development of the High Speed rail, Kent provides quick and easy access into London to access bodies such as NICE, MHRA, The Francis Crick Institute and the Wellcome trust. Kent also provides easy access to other European life science communities with Brussels and Paris both accessible in under 2 hours through the Eurostar.
With multinational organisations within the life science sector including Pfizer, Novartis and Mylan all operating heavily out of Kent, there has been an increased need for CROs as pharma and biopharma continue to restructure their approach to r&d.
The growing life science sector in Kent has responded to the demand for outsourced research partners with CROs fast becoming a strong part of the DNA make up of Kent’s life science landscape. With both Discovery Park and Kent Science Park providing an array of analytical services and contract research facilities through companies such as Peakdale Molecular, LGC and AbBaltis, with corporate giants Charles Rivers also operating heavily out of Margate.
The growing importance of CROs to pharma and biopharma can be easily identified by looking at the exponential growth of Kent based CRO, Tetrad Discovery.
With over 20 years of experience in drug discovery and significant experience in urology, cardiovascular and safety pharmacology, current CEO Dominique Westbrook established Tetrad Discovery in 2012 at Discovery Park following the restructuring of Pfizer, Sandwich. Westbrook speaks of the growing importance of CROs to the biotech industry, ‘As we have seen in recent years, large pharma is continuing to restructure their r&d infrastructure with a growing trend of outsourcing to clinical research partners who are able to offer the clinical expertise and the flexibility required’.
Given Westbrooks background in drug discovery, this has naturally translated into the wide range of outsourced support services Tetrad Discovery provides to support the development and discovery of new drugs.
Tetrad Discovery provides a bespoke in vitro analytical solution to provide key data to address the progress of molecules through the drug discovery and development pathway.
- Tailored analysis of biological agents including Pharmacokinetics and the measurement of endogenous and exogenous proteins/peptides
- Biomarker analysis from all sources of biological samples and species
- PK/PD support
- Determination of anti-drug antibodies (ADA)
- Epitope mapping
- Functional in vitro pharmacology screens with a variety of endpoints
- Determination of functional activity of ADA.
- Histological sectioning and staining
- SDS-Page electrophoresis
The growth of Tetrad Discovery is clear indication of the shift in paradigm to a more outsourced/partner focused approach to r&d. Starting out from a limited facility out of Discovery Park, Tetrad Discovery has outgrown various previous facilities, with several expansions and recruitment drives. They now operate out of their most recent expansion at Manston Park, with larger facilities to accommodate their ever growing team of scientific experts.
Challenges facing CROs
The challenges in rising cost of delivering new drugs to patients continues to challenge industry with biopharma companies continuing to invest heavily into r&d. The primary challenges are the time and cost involved in drug development with industry looking at alternative solutions to de-risk on investment by outsourcing elements of the process to CROs positioned with the correct expertise and advanced technology to advance the research.
Despite the increase in demand for outsourced services, the increasing complexities involved with current r&d trend continues to present challenges with CROs having to be flexible to develop and grow to meet the increasing demands. With pharma continuing to focus on cost constraints and shortening development timelines without compromising quality it has driven increased business towards CROs due to the growing need for flexible solutions.
Westbrook reciprocated saying ‘it is important that CROs align their service offerings to ensure we are able to meet the growing demands of industry, with industry partners relying heavily on outsourced providers like Tetrad Discovery’
CROs are constantly looking at hiring skilled clinical researchers and new technologies to provide flexible solutions to reduce cost implications and development timelines. Tetrad currently employ clinical researchers who have worked in the pharma industry which appears to be a growing trend as pharma restructures its r&d approach, many clinical researchers who once worked within pharma are finding renewed opportunities within CROs.
The challenges posed to CROs to keep up with the growing needs is a similar challenge faced by pharma prior to their restructured approach to r&d. There is an increasing pressure to present new innovative solutions to overcome challenges which requires significant investment in developing and retaining clinical experts and similarly investing in more advanced technologies to meet deadlines and criteria’s.
Speaking to Adrian Herron, Tetrad Discovery’s operations manager ‘Clients are very specific in their brief from data requirements, accuracy of data to timelines to produce such data which inherently requires us to be flexible in our approach to ensure we are able to satisfy these needs’
There is a significant amount of responsibility placed on CROs to deliver with industry looking for partners that can deliver on their specific requirements.
Herron discusses how Tetrad Discovery have built a reputation for delivering, ‘We have a very forward thinking approach to client relationships. We work with clients to deliver the bigger picture, so we continue to identify areas of need and support for our clients to achieve their end points.’
He continued ‘We have a fantastic team of experts who offer a comprehensive consultation and look to utilise state of the art technology to ensure the highest level of accuracy and turn around for clients’.
Pharma and Biotech continue to invest heavily in advancing research programmes with applied pressures on CROs to provide the sophistication and rigor biopharma clients need.
Tetrad Discovery has recently added a range of new services and has invested significantly in state of the art equipment to support their continued growth.
Herron discusses the importance of investing in advancing their technology requirements ‘the fundamental success of a CRO is being able to consider the life cycle of a study and identify opportunities to reduce costs and turnaround times, whilst maintaining the highest level of quality possible.’
Tetrad Discovery recently invested heavily in Protein Simples multi-analyte ELISA sample reader Ella with Tetrad Discovery being the first provider in the UK to be able to offer such technology.
Protein Simples Ella completely automates ELISAs using simple plex cartridge based assays. With increased sensitivity the Ella assays are able to produce readings as low as pg/mL with zero cross reactivity with up to 72 ELISAs an hour.
Tetrad Discovery continues to invest in advanced technologies and clinical experts as changes in r&d programmes continue to move towards an integrated outsourced provider to deliver cost effective, turn around driven solutions without compromising on the high level of quality required.
The future of CROs
It is evident that CROs play an important role in the future of drug development as they integrate with sponsors by developing their capabilities to assist from early through to late stage drug development with a strong focus on partnership, collaboration and a fee based service model. Services continue to evolve as therapies become more complex with opportunities in emerging markets like Biosimilar’s providing further scope for CROs to grow to meet new demands.
The future of the CRO market looks promising and is fast becoming an integral aspect of modern day drug discovery and development.
To find out more about Ella and other Tetrad Discovery services, contact email@example.com or call 01304 763 014