Author´s Name: Mathini Ilancheran
Job Title: Senior Research Analyst
Company: Beroe Inc
Location: India
LinkedIn Profile: http://in.linkedin.com/pub/mathini-ilancheran/44/a28/976
Website: http://www.beroeinc.com/
Procurement quote: Think Continuous Procurement Intelligence, Evaluate Supply Chain Risk, Design Right Operating Model and Drive Savings
Introduction: With a combined background of Lifescience, engineering and management, I am highly passionate in applying my research & analytical skills in understanding the Pharma R&D vertical. As an experienced procurement analyst, I specialize in understanding the market scenario and industry dynamics across the globe in outsourcing arena. My analysis on specific clinical research service segments has enabled large pharma companies in their strategic decisions on service outsourcing contracts. My career involves regular interaction and networking with 100+ suppliers in clinical categories, keeping track of all the innovations in the market related to procurement of R&D services.
Top 5 Early Phase Clinical Trial Market Trends that will continue to Impact 2014
- Sharp Jump in M&A Deals
Increase in outsourcing of early phase clinical trials stirred suppliers to expand their capabilities through M&A’s which accounted to greater than 60% when compared to 2012. Specialized early phase trials is driving the need for specialist CROs focusing on a particular therapeutic area. This triggered established suppliers in the industry to acquire specialist players for the conduct of trials.
- CRO – Academic Institution Collaboration’s Propels Unit on Demand Model
Collaboration between CRO, Academic universities and Hospitals was seen to drive research and development within clinical research and also increase the access to trial volunteers for various therapeutic areas. By being a part of an academic hospital, CROs have introduced a new model called ‘The Unit on Demand’ wherein Phase I unit is setup within the hospital. This enables tapping into a larger number of early stage patients, thereby increasing recruitment rate and saving time for sponsor.
- Innovative Sourcing Practice: ‘Strategic Insourcing’
Big pharma and CROs mainly engage through a project-based contract model, which contributes to an estimated adoption rate of 50%. However, the industry is facing a transformation wherein strategic partnership through insourcing of resources is coming into place between big pharma and CROs, as an initiative to drive flexibility, reduce costs, and extends expertise.
- Adoption of Adaptive Clinical Trials Impact on Specialist CROs
Specialty CROs such as Da Vita Clinical, Profil Institute etc., focusing on a particular therapeutic area for phase I trials saw increased demand from both pharma and global CROs. This trend was driven by the growing demand from big pharma for adaptive clinical trials and increased need for access to specialized patient populations for early phase trial conduct.
- Emerging Market Uncertainties
The regulatory stringency in emerging markets over the conduct of early phase trials have intervened the CROs to shut down units rather than incurring loss in their early development service revenues. A recent event seen was Quintiles shutting down their early phase unit in India.
References:
http://www.outsourcing-pharma.com/
http://nextbigfuture.com/2007/12/biomarkers-and-adaptive-clinical-trials.html
Glossary:
CRO – Contract Research Organisation
PK/PD – Pharmacokinetics / Pharmacodynamics
M&A – Mergers & Acquisitions