As at 20 February, 2017, the PharmaLex Group, a leading specialist provider of development consulting and scientific affairs, regulatory affairs, pharmacovigilance as well as quality and compliance services, has enhanced its regulatory team with the further addition of a highly experienced biosimilar professional.
Zabin (Zeb) Younes joins PharmaLex as Associate Director, Regulatory Affairs CMC. Zeb has more than 15 years of experience in the biopharmaceutical/biosimilar development lifecycle, from proof of concept through to, and beyond commercialisation.
This includes both laboratory and desk-based experience in process development, purification, formulation, method development, characterisation, validation, forced degradation, comparability, release and stability testing.
Zeb’s experience is wide-ranging and includes preparing and leading the execution of numerous CMC regulatory strategies, authoring regulatory submissions including BLA/MAA/IMPD/IND/PIP/Orphan Designation Applications, as well as leading more than 10 recent scientific advice packages (EMA and European national).
Zeb has extensive experience with a range of monoclonal antibody (mAb) and mAb derivative biosimilars, including those for Humira, Avastin, Leucentis and Enbrel. In addition to these molecules, Zeb has also worked on biosimilars for Neupogen, Neulasta, Epo and Clexane.
Her experience includes the development and implementation of global regulatory strategies, presubmission activities, scientific advice and dossier writing with main focus on EU/US followed by Canada and Australia. She also has some supportive experience in preparing dossiers for Japan, India and other regions of the world.
In addition, she also has more than ten years of management experience and has set up and managed research teams, GMP testing laboratories and operations, developed and implemented lean systems to increase operational efficiency and have participated and led MHRA/FDA and corporate audits.
Her product specialisms are vaccines (recombinant protein adjuvented, live attenuated bacterial, viral vectors), therapeutics (mAbs and derivatives, other recombinant proteins) and ATMP (somatic cell therapy products, tissue engineering products).
Zeb holds a 1st Class BSc (Hons) in medical biochemistry. Zeb is based in the UK and joins PharmaLex from ERA Consulting in the UK, where she was Associate Director ERA/Acting Director ERS.
“We are aware that biosimilars continue to be a key area for many biopharmaceutical companies and are continuing to strengthen our team to ensure we remain a leading service provider and Zeb comes to us with a wealth of experience,” explained Dr Thomas Dobmeyer, CEO PharmaLex.
“Enhancing our service lines with experts who are at the top of their industry, is a key attraction for our clients,” added Dr Tilo Netzer, CEO PharmaLex. “It allows us to provide instant access to specialist knowledge helping clients to reduce timelines,” he explained.
The PharmaLex Group now has more than 650 employees, with 25 offices in 13 countries and more than 600 satisfied clients worldwide.