Innovative People

David Allen

I have been working in the pharmaceutical area for over 20 years. I have expertise in a wide range of analytical techniques involving the full spectrum of manufacturing from raw materials through finished product by working with solid dose and topical products. I’ve worked with name brand, generic, and OTC products, including controlled substances, under regulatory constraints ranging from FDA, EPA, and ICH. Nearly all experience has been in GMP and GLP environments. I was actively involved in FDA audits and compliance remediation.
Positions and responsibilities range from Chemist to Research Fellow with up to 7 direct reports. Work environments ranged from QC to manufacturing to formulation development to drug discovery.
I was consistently involved in technology identification and implementation including PAT and translation of PAT platforms to the laboratory setting. Beginning with repurposing old instrumentation for new applications, my laboratory robotics experience expanded to include the complete automation of the synthesis of compound libraries, from reactant dispensing through 100% analysis and packaging for shipment. Inventions include new methods of volume detection in liquid transfer platform; fast evaporation systems for purification of compounds; a system for analysis, chromatographic separation, and isolation of synthesis mixtures; and purification of ionic species by isoelectric focusing.
Process automation achievements include management of compound inventories, establishing quality systems, optimization of laboratory process flows, tracking of resources through barcodes and RFID tags, movement of materials release testing from laboratory to online analysis (PAT), designs of HMIs for chemists and automation platforms, and automated creation of protocols and reports. Data systems automation includes implementation of LIMS, CDS and electronic notebooks.
Naturally, documentation of the above was an integral part of the effort and included protocols, reports, SOPs, and sections for inclusion in IND / NDA submissions.
I have a doctorate in chemistry from the University of Texas at Dallas and training in a number of business related areas ranging from database administration to information mapping.