Tao Feng

Oversee product development, transfer, and manufacturing for all Laekna’s pipeline products including both small molecules and antibodies.

- Drug product development, clinical manufacturing, and commercial launching of Niraparib and Omadacycline. - Commercial manufacturing facility (located at Biobay Suzhou) setup and operation - Due diligence in scientific aspects for various in-licensed programs

Lead GMP manufacturing of drug product to support clinical trials in US, Europe, Australia, Russia, and China. Specialized in oral solids including tablets, capsules, sachets, pellets,and etc. Based on clinical study requirement (dosage form, dose, delivery route, study timeline), coupled with the unique properties of drug substances (solid form, solubility, stability, physical properties), design phase appropriate formulations to support clinical studies. Gained significant exposure to specialty formulation types such as topical formulation, inhalation formulation, and liquid formulations.

Head preformulation development services at WuXi Apptec. - Provide technical leadership on discovery support, preformulation profiling of lead compounds, API salt and polymorph screening and selectionl, API crystallization process development, and PK/Tox formulation development. - Oversee preformulation lab operation and team development including facility design and expansion, reserach team building and development. - Held accountable on finanical performance of preformulation group including annual budget preparation and execution, operation key metrics design and monitor to achieve financial goals set for individal business unit. - Manage business development through actively attending industry exhibition, setup internal and external collaboration and alliance programs to promote business volume.

Manage a preformulation development group within pharmaceutical development service to support drug discovery, API manufacturing process development, and early phase formulation development.

- Completed preformulation profiling for five discovery programs to support preclinical candidate characterization for nomination into full development - Led physical form selection (salt selection and polymorph screening) for eight nominated chemical entities to select final form for API manufacturing to support GLP toxicology and FIH studies - Closely worked with engineers to design optimal manufacturing processes to ensure successful manufacturing of clinical drug supplies to support Phase I-III clinical trials

- Independently developed two high viscosity liquid formulations with comparable solubility and stability to lead formulation and characterized release profile using patented OROS system - Evaluated sustained release performance of over ten different formulations using OROS system - Solved system leaking and liquid active migration into solid engine problem and presented to senior management