Ask the Experts: Marco Michi
Dr Marco Michi (MSc in Analytical and Physical Chemistry) is a Research Leader and Scientific Officer at Aptuit (Verona, Italy). He has 16 years of bioanalysis experience working for Pharma and CRO companies, mainly working in quantitative determinations of small molecules in a regulatory environment. In his actual position, Michi has the responsibility of the implementation of new technologies including protein analysis by utilizing mass spectrometry, problem solving, regulatory compliance and scientific overview. Michi defines the best bioanalytical processes, the new instrumentation to be purchased and new strategic investments. He also manages proposal generation, including outsourcing activities.
In what areas is the outsourced work you receive from?
Non-regulated and regulated bioanalysis for preclinical and clinical development area.
What does your organization believe is important when being selected for outsourcing?
The possibility to drive small and medium biotech thorough the development process.
What are the challenges you face when receiving outsourced work?
Dealing with consultants who may not always be entirely competent in the bioanalytical area, poor information sharing from the sponsor, signing a contract in time to keep allocated or promised slots and the shipment of reference standard in time.
Do you think the amount of outsourcing will change in the future?
Yes, as the overall research and development pipeline is continuously increasing.
What factors do you think will increase outsourcing?
Pipeline size increase, biotech proliferation, on-going big pharma ‘virtualization’ processes.
Do you think the relationship between pharma and outsourcing companies will change in the future?
Yes. The more big pharma adopts virtualization, the more they need to interact with CROs. Drug discovery and development outsourcing is also increasing and that requires a different relationship with CROs. Integrated drug development services will also increase, requiring a constant interaction between sponsors and CROs.
