1. A knowledgeable executive with demonstrated success in the pharmaceutical industry and most relevant experience in drug development and manufacture management. Participated in 5 NDAs from process development to market launch. Three of them became blockbuster drugs.2. Management experiences in innovation, generic and CRO/CMO drug industries with15 years on API cGMP manufacture. Extensive experience in senior leadership capacity, including direct responsibility for both internal and external initiatives. 3. In-depth knowledge on international regulatory affair and relevant China policy on drug development and manufacture including registration and EHS. Fluency in both English and Chinese.
Chinagene Co., Ltd.
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Chief Executive OfficerChinagene Co., Ltd. Oct 2021 - PresentIn charge of overall operation of a innovation company which is leading in gene therapy.1. Led teams to accomplish Phase II clinical trials for the leading pipeline.2. Obtained 3 INDs.3. Secured funding of US$35 million.
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Chief Executive OfficerZhongke Biopharma Co., Ltd. Aug 2014 - Jul 2021In charge of overall operation of the company.1. Accomplished the market launch for the rabies vaccine. Annual sales reached US$25 million.2. Led teams to carry out Phase III clinical trials for one small molecule cancer therapy.3. Directed BD team to finalize 3 license-in projects.4. Initiated 7 first-in-class pre-clinical research.5. Accomplished 3 generic filing. Annual sales reached US$12 million.
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Vice PresidentHuahai Pharmaceutical Co, Ltd. May 2011 - Jul 2014Lead and manage 5 API and advanced intermediate production plants located in Zhejiang and Jiangsu provinces. Direct responsibility for production plan, cost control, quality control, tech transfer, process development and environmental trend. Total revenue: US$258 million.1. Accomplished annual production plan with revenue reached US$3 billion.2. Led Process R&D to accomplish 87 process development projects with US$16 million contribution on cost saving.3. Passed 2 FDA and 1 BGV GMP audits with zero deficient.4. Initiated the construction of a state-of-art process R&D center with various technology platforms including a new solid state lab, enzymatic catalyst lab, crystallization lab, etc.5. Developed new CMO business, accomplished 5 CMO projects with US$22 million revenue.
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Director Of Process DepartmentWuxi Apptec, Ltd. Jul 2009 - Apr 2011Responsible for technical aspect of CMO projects including production management, process R&D, cost control, organization structure. Responsible for customer relationship including business development and customer quality audit.1. Accomplished 87 projects, including advanced intermediate production and cGMP batches for clinical trials. Total revenue US$30 million.2. Assisted customers to accomplish 10 CMC package for FDA filings.3. quality system audit and led quality improvement program. Established API quality specification, including purity, impurity profile, impurity structure elucidation, physical properties.4. Participate 24 times business negotiations. Received 5 times quality audits from big pharmaceutical companies and once CFDA GMP audit.5. Initiated new SOP program.6. Participated API commercial manufacture plant validation.
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Senior Scientist Of Process R&D DepartmentGilead Sciences, Ltd. Jun 1998 - Jun 2009Responsibility for process development, tech transfer, API manufacture to support market launch and commercial production.1. Led team to accomplish 5 antiviral NDA (Viread, Emtriva, Hepsera, Truvada and Atripla) filings and 10 IND filings. Viread, Truvada and Atripla achieved blockbuster status in the market with annual sale of US$2 billion, US$3.1 billion and US$3.5 billion, respectively.2. Managed API cGMP production to support clinical studies and accomplished 16 API process development projects.3. Participated 50 million budget pilot plant construction, provided tech support and conducted cGMP validation batch.4. Provided tech support for outside production partnership, assisted them to achieve 250-ton production capability for Viread.5. Assisted the sourcing effort on supply chain saving US$30 million cost on raw materials.6. Employee of the Year (2005).
Kevin Chen Education Details
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Chemistry -
Eastern Illinois UniversityOrganic Synthesis -
Wuhan UniversityChemistry
Frequently Asked Questions about Kevin Chen
What company does Kevin Chen work for?
Kevin Chen works for Chinagene Co., Ltd.
What is Kevin Chen's role at the current company?
Kevin Chen's current role is Chief Executive Officer | Pharmaceutical Industry.
What schools did Kevin Chen attend?
Kevin Chen attended Purdue University, Eastern Illinois University, Wuhan University.
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