SWG Proposal

The Scientific Working Group is a strategic advisory group whose objective is to support the EBPMN association in multiple areas, such as the development of programs and projects in general, like webinars, definition and content creation with a global scope.

 

 

Members

 

Dr. Ebrahim Mohamed, Biovac Institute, South Africa

Is a Synthetic Organic Chemist by training with 15 years’ experience in pharmaceuticals with expertise covering business development, product development, technology transfers, process optimizations, and cGMP.

After completing his Ph.D. from the University of Cape Town in 2009, he joined the Science and Innovation (S&I) Department at the Biovac Institute (BIOVAC) where he established his expertise in the development of glycoconjugate vaccines. As Group Leader he currently manages all the CMC related activities with the Science and Innovation department. He has accumulated experience in both inward and outward bound technology transfers of clinical vaccine candidates and commercial products. His responsibilities have expanded further to include support to manufacturing operations at Biovac.

In 2015 Ebrahim became a key member of the secretariat team of the African Vaccine Manufacturing Initiative (AVMI) where he has played a pivotal part in assisting with the coordination of the AVMI Vaccine Manufacturing and Procurement in Africa (VMPA) study. He was elected as a member of the board, representing the Southern African Region in 2016. Ebrahim has published several publications in reputable peer-reviewed journals.

Mr. Cleber Augusto Gomes, Instituto Butantan, Brazil

Mr.  Cleber Augusto Gomes is the Regulatory Affairs coordinator - post-licensing of Instituto Butantan.   Cleber Gomes has been working at Butantan for over 8 years. He is responsible for the regulatory activities regarding Instituto Butantan's portfolio products, post-licensing, vaccines, and sera.  Cleber Gomes has a bachelor's degree in Pharmacy. 

Ms. Fabiana Belasco Guilhen Olivier, Instituto Butantan, Brazil

Ms. Olivier serves as Production Manager of Monoclonal Antibodies at Instituto Butantan. Olivier has been working at Butantan for over 22 years and has assumed responsibilities in several other areas related to vaccines production. She holds a degree in Chemistry from Mackenzie University and a Master's degree in Biotechnology from the Public University of São Paulo (USP).

Mrs. Yi O Cho, Instituto Butantan, Brazil

Mrs. Yi O Cho is the Regulatory Affairs manager of Instituto Butantan, since 2019. Mrs. Cho has more than 20 years of experience in regulatory field working for big pharma companies like Baxter, Novartis, Sanofi. She's responsible for all aspects of regulatory environment, for the new development products of Butantan's portfolio, vaccines and sera. This responsibility also includes management of the GMP requests, as well as export affairs affecting IB's products. Yi O Cho has a bachelor degree in Pharmacy and Biochemistry, post-graduation in Industrial administration, an MBA Project management and is currently seeking a master degree in Biotechnology and Bioprocesses.

Dwun-Hou (Tom) Chen,

Dr. Dwun-Hou (Tom) Chen, Founder & President of BioTEC Consulting LLC., has more

than 28 years’ experience in biotech industry. He held various leadership roles at biopharmaceutical companies including Prometic BioTherapeutics Inc. (2006-2019), The American Red Cross (2003-2006) and EntreMed Inc. (1999-2003).

At Prometic, Dr. Chen served as Vice President, later, as Senior Vice President managed product development for its plasma-derived therapeutics as well as business development with an emphasis on Asia Pacific region.

Prior to joining Prometic, Dr. Chen was Director of the Process Development of Plasma Derivatives Department at The American Red Cross. He was responsible in developing a novel platform technology for plasma fractionation.

Prior to the American Red Cross, Dr. Chen was Director of the Pharmaceutical Sciences at EntreMed Inc., he oversaw process and assay developments for in-house projects and co-managed manufacturing activities at CDMOs for lead candidate drugs.

Other work experiences included Principal Scientist at Genetics Institute, Group Leader of the Protein Chemistry group at MetaMorphix, Inc., and Manager of the Protein Core Facility at Regeneron Pharmaceuticals, Inc. Furthermore, served as consultant for over a dozen non-profit organizations and companies in US, China, and Taiwan since 2004, projects include recombinant protein therapeutics and vaccines.

Dr. Chen received a BSc in Chemistry from Tamkang University, Taiwan, a PhD in Biochemistry from Auburn University, USA, and post-doctoral research at the Wistar Institute and University of Pennsylvania.

Dr. Sarmad Hanif, TechInvention, India

Dr. Sarmad Hanif is a Sr. Research Scientist at TechInvention Lifecare Pvt. Ltd. He is a Ph.D. in Biochemistry having 10+ years of cross-disciplinary research experience, covering microbiology, molecular biology, and bioprocess technology. He is proficient in the discovery, design, and development of upstream and downstream processes for bacterial and viral vaccines. He is also Skilled in the design and development of serological-based immunoassays for Immunogenicity assessment of vaccine candidates.

Ms. Shaily Sethi, TechInvention, India

In her current capacity as Head Regulatory Affairs as TechInvention, Shaily is leading quite a few strategic regulatory in-licensing and out-licensing projects in the arena of Vaccines & Biologics and pharmaceuticals. Shaily is an accomplished pharma regulatory professional having 19 years of diverse work experience of creating patient and stakeholder value and expanding horizonts in healthcare in Indian (Reliance Life Sciences) and MNC Pharma organizations (GSK, Bayer and Abbott). Proven track record od successfully firming and executing novel regulatory strategies. Shaily is a pharmacist with a Master of Pharmacy in Pharmaceutical Sciences from BITS, Pilani.