Yousuf Mohiuddin Mohammed

- Manage implementation of quality standards, processes, tools and systems used in conducting due diligence(DD)/integration for in licensing, merger & acquisition and out-partnering projects across GxP areas.

• Biopharmazeutische und klinische Experte und der Ansprechpartner für die Abteilung Geschäftsentwicklung / Lizenzen (BD&L) • Sicherstellung, dass nur Dossiers und Zulassungen mit qualifizierten klinischen Studien gekauft werden, die geeignet sind, in den Ländern von Interesse Zulassungen zu beantragen und eine rechtzeitige Vermarktung zu gewährleisten

- Managing, writing, supporting and ensuring quality of medical writing projects for biosimilar products. - Acting as a project medical writer providing complete support for a biosimilar product. - Writing clinical CTD modules 2.5, 2.7.2, 2.7.3 and 2.7.4 and clinical study reports. - Managing and coordinating external CRO's for medical writing projects.

I worked in Prof. Baumesiter group on a project to purify and crystallize one of the subunits of 26S proteasome. This subunit is one of the targets of proteasome inhibiton as it is belived to have de-ubiqinitating activity and determining its structure would greatly facilitate drug designs. To overcome hurdles faced during purification of soluble S. cerevisiae 26S proteasome subunit due to protein crystallization, a new project was initiated to have nanobodies selected against 26S proteasome subunit.

I was responsible for preparing clinical study reports involving pharmacokinetic, pharamcodynamic (biomarker), efficacy and safety data in human patients/subjects in oncology therapeutic area, Summary Efficacy and Safety Documents, Risk Management Plans in Oncology therapeutic area. In addition I was also responsible for reviewing Report Analysis Plan and clinical documents.

I was responsible for preparing clinical study reports involving pharmacokinetic, efficacy and safety data in the Diabetes and Oncology therapeutic area for a Danish Client. I was responsible for attending the study related meetings in Denmark for close to 3 years and I was also involved in the preparation of investigator presentations.

I was responsible for writing Pharmacokinetic Protocols and Study Reports involving HIV drugs, Gastroenterology therapeutic areas and antibiotics drugs.

Responsible for writing Pharmacokinetic Protocols and Study Reports mainly for HIV drugs and Gastroenterology therapeutics drugs. I was involved in pharmacokinetic analysis through WinNonlin® software and also played an important support role to bio-analytical department for pharmacokinetic data generation. In addition, I have good knowledge of PK analysis software WinNonlin® and SAS®.

Oncology, Research management and scientific Conduct, applied epidemiology and biostatistics, molecular biology Cell biology and genetics, physiology essential laboratory techniques in theory and practice, disease processes (molecular, cellular and physiological changes).

Clinical Pharmacy, Pharmacotherapeutics, Hospital Pharmacy, Pharmaceutical Analysis.

Pharmacology, Pharmaceutics, Pharmaceutical Analysis, Medicinal Chemistry, Biotechnology, Biochemistry, Pharmacognosy, Clinical and Hospital Pharmacy.