Chengde Zheng

1. IND application of mAbs, bispecific antibodies and ADCs in US; 2. Biological drug registration in Latin America, EU, MENA, CIS and Southeast Asia； 3. Drug re-registration and post-marketing maintenance； 4. Regulatory support for oversea customers； 5. Coordinate GMP onsite audit.

1. IND application of new mAbs in US（submitted 2 PIND and 2 IND, got 2 IND STP）, Regulatory and Clinical strategy development, IND maintance; 2. Alliance management for 4 license-in products from other countries; 3. CRO screening and operation of 1 US phase 1 trial.

1. IND application of new mAbs in US and CRO screening，PM for a US Phase 1 Trial; 2. Biological drug registration in Latin America, EU and Southeast Asia（submitted 1 NDA to BPOM Indonesia，attended 1 debate at COFEPRIS Mexico； 3. Drug re-registration and post-marketing maintenance； 4. Regulatory support for oversea customers； 5. Coordinate GMP onsite audit from foreign authorities like Ukraine, Mexico and Colombia and EU QP audit； 6. Establish DMF and CTD dossier；

1. Oversea registration of several biologics in Southeast Asia, Middle East and India; 2. Preparation of SMF, DMF and CTD. 3. Oversea re-registrations and post-marketing maintaince; 4. Involved in the self-inspection of the clinical data by CFDA； 5. Support the onsite audit by oversea authorities; 6. Deal with all registration-related issues from the oversea customers.

1. Drug registration in US, Australia and South Korea; 2. US Dietary Supplement registration; 3. Pathology project of US PhaseⅡ clinical trial; 4. Management of CROs and sites; 5. International research collaboration management; 6. Financial reconciliation of clinical trials; 7. Organize initiation meeting, unblinding meeting, exhibitions and advisory borad meeting; 8. Track the international drug code and trials.

I investigated the molecular mechanisms involved in the commitment of mesenchymal stem cells to preadipocyte.

Generation of BMP4 and BMP7 Adenoviruses as tools to explore the brown adipocyte differentiation, Research Project, Prof. Christian Wolfrum, Competence Center for Systems Physiology and Metabolic Diseases

Influence of Arabidopsis thaliana RBR1 on CaLCuV infection, Research project, Prof. Gruissem Wilhelm, Zurich-Basel Plant Science Center

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