The PharmaLex Group, a specialist provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance services, and Pharmacovigilance has enhanced its regulatory team with the further addition of a highly experienced biosimilar professional.
Zabin Younes joins PharmaLex as Associate Director of Regulatory Affairs CMC. Younes has more than 15 years’ experience in the biopharmaceutical / biosimilar development lifecycle, from proof-of-concept through to, and beyond commercialisation.
Younes’ experience is wide ranging and includes preparing and leading the execution of numerous chemistry manufacturing and controls (CMC) regulatory strategies, authoring regulatory submissions including BLA / MAA / IMPD / IND / PIP / Orphan Designation Applications, as well as leading over 10 recent scientific advice packages (EMA and European national).
Dr Thomas Dobmeyer, CEO at PharmaLex, said: “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.”
Younes 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, Younes has also worked on biosimilars for: Neupogen, Neulasta, Epo and Clexane.
Her experience includes the development and implementation of global regulatory strategies, pre-submission 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.
Younes 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 has 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 ATMPs (somatic cell therapy products, tissue engineering products).
Younes holds a 1st Class BSc (Hons) in Medical Biochemistry.
Dr Tilo Netzer, CEO at PharmaLex, said: “Enhancing our service lines with experts who are at the top of their industry, is a key attraction for our clients. It allows us to provide instant access to specialist knowledge helping clients to reduce timelines.”