BioPharm International - February 2020

BioPharm-Outsourcing eBook

Issue link:

Contents of this Issue


Page 19 of 29

20 BioPharm International eBook February 2020 Building Strategic Relationships with CROs How to adopt win-win strategies and understand quality agreements for complying with cGMP. P harmaceutical and biopharmaceutical com- panies have been extensively using con- tract research organizations (CROs) to meet their challenging needs in R&D and stan- dard work for several decades. A noticeable shift occurred in outsourcing research and clinical work when Big Pharma R&D costs skyrocketed. For example, in 2012, approximately 33% of drugs in the pipelines of the top 10 pharmaceutical companies were initially developed elsewhere (1). Sponsor companies engage CROs either on a trans- actional basis or on a strategic basis. In either case, stakes are high for pharmaceutical and biophar- maceutical companies to make sure CRO work is successful. Neither selecting a reputable CRO, micro- managing CRO work, nor throwing the work over the fence leads to a successful CRO relationship. Key strategies that can lead to a win-win relation- ship include a relationship on a solid foundation (CRO selection, quality management, and clarity in expectations), soft factors (build the trust and empowerment), and project management excellence (simplifying the complex, metrics, and continuous improvement). This article discusses these strategies as well as FDA guidelines on quality agreements for the contract manufacturing arrangements for drugs. VADIMGUZHVA - STOCK.ADOBE.COM SHREEKANT KARMARKAR, PHD is president, DAT Pharma Consulting, Inc.,, Tel: 1.224.383.4493. SHREEKANT KARMARKAR Partnerships for Outsourcing Outsourcing

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - February 2020 - BioPharm-Outsourcing eBook