CAMBRIDGE UK (2018- 03- 05) – ProteinLogic, the biomarker discovery and exploitation company has
appointed Darleen Welford as VP of Regulatory Affairs and Quality Assurance (RA/QA) to bring
valuable global regulatory expertise, and to further the company’s RA strategy.
Darleen has over 19 years’ experience in the field of In Vitro Diagnostic Medical Devices and brings
with her a variety of regulatory and quality skills across the whole product life cycle, including
experience of global product registrations, risk management, quality management systems and
clinical study management.
Before joining ProteinLogic, Darleen worked in similar roles in the IVD sector, where she has gained
experience in both start-up and more established environments. Darleen has worked closely with a
number of regulatory authorities including the FDA and has attained ISO certification, GMP
certification and successful IVD registrations globally, including in the EU, Australia, Korea and Japan.
“I am very excited to be joining ProteinLogic at this important stage of the business” said Darleen. “I
am very much looking forward to working within the ProteinLogic team to accomplish the
commercialisation of our TB diagnostics, and making a significant impact in the field of diagnostic
medicine by further realising the full potential of the ProteinLogic proprietary technology
ImmiPrint®, in line with the commercial vison of the company.”
Nicolas Huber, ProteinLogic CEO, stated: “Darleen brings an extensive breadth and depth of
knowledge of the industry, as well as excellent knowledge of the regulatory landscape, which will
play a key role in the definition of our market-access strategy. In addition, moving into a more
commercial phase of the company, Darleen will ensure the high quality of our processes and our
products will make ProteinLogic a respectable player in IVDs. It is a pleasure to be welcoming
Darleen on board, and I am more than looking forward to be working with her moving forward.”
ProteinLogic is a biomarker discovery and exploitation company developing novel diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The first product in the pipeline is a novel diagnostic blood test for tuberculosis. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in blood and other body fluids.