What discovery companies need from external partners

Introduction 

The rise in the importance of out-sourcing has been one of the most dramatic changes in the drug discovery landscape over the past 20 years, along with the shift from small molecule therapies towards alternative modalities. All but gone are the large, fully functional R&D sites employing several thousand people and in their place is a dense network of smaller, leaner organisations focused on a core technology expertise or platform and bringing in non-core activities as and when required. Virtual companies with no laboratory facilities of their own also seek to develop or commercialise their IP via external partners. Hopefully, this re-distribution of skills will lead to a more flexible, efficient working model within a more open, collaborative mind-set. Being located at the heart of one of the biggest biotech hubs in the world in Cambridge, UK I am witnessing this evolution of the market place gather pace. It seems that almost every day I find out about a new company as both small molecule and biomolecular companies thrive in and around a world class academic and medical infra-structure. It is noteworthy that now some of the CROs are the largest companies in the sector, for example employing the majority of Medicinal Chemists in the UK with individual Chemistry departments larger than those of the traditional big Pharma companies. They may be large, fully functional one-stop-shops or offer a more focussed range of services, either of general utility (e.g. ADME) or of a bespoke nature.  At the other extreme, there are consultants such as myself playing their part in the new model.

Difficult Choices 

SMEs requiring to out-source non-core drug discovery activities, or virtual companies looking to out-source entire programs, need to weigh up many factors when arriving at a choice of CRO(s). Apart from the obvious ones such as availability of appropriate services and cost, there are some less tangible considerations around such issues as communication and the optimum (synergistic even) match up in terms of company cultures. Do you want a one-stop-shop approach via a large supplier or a possibly more flexible arrangement with a smaller organisation(s) that allows you to pick and mix the support you require?

In fact, in conversations with colleagues at SMEs, there is a feeling that they may be somewhat overlooked by CROs that tend to focus on larger clients. SMEs may be seen as a higher financial risk and a shorter-term business opportunity and hence a secondary priority that are not afforded the same degree of attention or resources.  The need for extreme flexibility may present challenges to larger CROs to move fast enough when needed to get teams in place. Culturally, small companies have a tendency to keep a very close eye on operations which may lead to the CRO feeling under too close a scrutiny leading to problems with the relationship.

 Solutions 

The key solution to relationship issues is to establish a strong, single point of contact at the CRO who knows the services and projects from start to finish, works closely with the sponsor throughout listening to their problems and is empowered to make decisions.

Discovery Analytical Consulting (DAC) has established a consortium of companies to address the need for flexible drug discovery services. Via our network of providers, we provide a range of physical chemistry, in vivo efficacy, PK and bioanalytical services supported by experienced study management and consultancy including expert DMPK interpretation.

Our core values include being highly responsive to client needs. No individual part of the consortium is so big as to have forgotten how important this is. A consistent, single point of contact provides the ongoing continuity that is crucial to providing efficient support.  Above all, regular and open communication is provided at all times to ensure a successful collaboration. We recognise the headaches that can be associated with large volumes of data and will format your data to meet your reporting needs.

Services

DAC offers a range of consulting services for discovery analytical and physical chemistry, compound management and external study management, as well as practical UHPLC services for QC, method development and physical chemistry measurements.

CEM Analytical Services (CEMAS) provide high quality and robust bioanalytical solutions for drug discovery.  This can either be stand-alone bioanalytical support or integrated with a broad range of pharmacokinetic and in vivo efficacy services available through our preferred supplier Saretius Limited.

All CEMAS activities are backed by comprehensive in-house method development, validation and transfer know-how. The company has the capacity to carry out large-scale sample analysis using the following range of automated high throughput systems to analyse animal and human samples in all formats with full accreditation to GLP, GMP and GCP, where required, from discovery through to phase III clinical trials:

  • 9x AB Sciex LC-MS/MS including 4x API 5500
  • 2x Spark Holland Pharma automated SPE systems
  • 3x Agilent 6890/5973 GC-MS
  • 1x Agilent 7800 ICP-MS

Further Information

If any of the issues discussed in this article are of interest to you, please feel free to contact me directly on mark@discoveryanalyticalconsulting.com for further information.

Mark PortsmouthComment