Jorge Luis Vega Elias, Eng, MsC
Jorge Luis Vega Elias has been involved in the biotechnology product manufacturing field for more than 34 years as Director of the Manufacturing Direction of the Center for Genetic Engineering and Biotechnology of Havana, Cuba. He got the Chemical Engineery Degree in 1984 in the Higher Polytechnic Institute “José Antonio Echevarria” of Havana, Cuba and awarded the scientific category Agregated Researcher in 1992 and the technological category First Degree Technologist in 2002. He has published more than 25 papers in prestigious scientific journals and has issued, as chairman, several scientific lectures in scientific congress and workshops in topics related with physiological aspects of the recombinant protein expresion in bacteria, clonage, expresion and purification of human interferons, production of polysacharides from Neiseria meningitis for human vaccination, scale up of hepatitis B vaccine production process, production of pentavalent vaccine, filling and packing of biopharmaceutical products, desing and operation of multiproduct production plants, technology transference and technical evaluation of Heberprot-P production plants. He has also received and imparted multiples post-graduated courses and have been involved in collabration projects with several international scientific institutions. He is member of the Cuban Chemistry Society.
Rodolfo Valdés Véliz, PhD
Rodolfo Valdés Véliz has been involved in the monoclonal antibody field for more than 28 years as Head of Monoclonal Antibody Production Department of the Center for Genetic Engineering and Biotechnology of Havana, Cuba. He got the Bachelor in Biology Degree in 1989 and Doctor of Philosophy Degree (Biochemistry Mention) in 2008, both in Havana University. He has published more than one hundred papers in scientific journals and has issued several scientific lectures in scientific congress and workshops in topics related with monoclonal antibody production in animals, cell culture, and transgenic plants. He has also received and imparted multiples post-graduated courses and have been involved in collabration projects with other national and international scientific institutions. He is member of the Cuban Immunology Society and awarded the scientific category (Auxiliar Researcher) and technological category (First Degree Technologist) in 2013.
Keith L. Carson, ChE, MBA. Chairman of the Manufacturing and Development of Biotechnological Products
Mr. Carson has more than 35 years of experience in the design, construction, and operation of bioprocessing facilities and systems for products derived from mammalian and insect cell culture. In 2009, he established the International Society for BioProcess Technology (ISBioTech), which organizes 8 programs throughout the year on scale-up, process analysis and automation, cell banking, raw materials, and contaminant control for viral and cellular products, as well as therapeutic proteins. He founded the BioProcessing Journal in 2002, which is one of the most respected, peer-reviewed publications on the development and production of biologics, and he currently serves as its Editor-In-Chief. And in 1994, he established the Williamsburg BioProcessing Foundation (WilBio), which organized leading conferences on the scale-up and production of biologics for over 15 years. In 2001, in response to concerns about dosing, and at the request of the biotech industry and FDA, he helped organize and facilitate the production of the first viral gene vector reference material (RM) for adenovirus serotype 5 (Ad5), which is being used to validate internal reference materials and assays. He is now serving in the same capacity for a lentiviral vector RM. All of the data pertaining to the viral vector RMs is available on the ISBioTech website. He previously held senior management, technical, and marketing positions at Flow Laboratories, Endotronics, Sartorius, Fisher Controls, and Fluor Daniels. Mr. Carson holds a bachelor’s degree in chemical engineering from the University of South Alabama, and an MBA in marketing from George Washington University in Washington, DC.
Dr. Willis H. Thomas. Chairman of the Regulatory Issues for the Biotechnological Product Manufacture
Willis H. Thomas has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations. He has been in senior management for life sciences companies for the past 15 years. Dr. Thomas is adjunct faculty at the Lake Forest Graduate School of Management, International Institute for Learning and Institute of Validation Technology. His publications have received global recognition from associations such as the Project Management Institute (PMI) where he received the Cleland Award for “The Basics of Project Evaluation and Lessons Learned.” This book was an 8-year effort that enhanced the framework for the evaluation of projects using the PMBOK® Guide. He has been a featured speaker on an international basis and has received the Apex Publication Excellence Award for implementing useful tools for project management, evaluation and training.
Oscar Cruz Gutiérrez, Eng. MSc. Co-Chairman of the Manufacturing and Development of Biotechnological Products
Oscar Cruz Gutierrez is one of the Deputy Directors of Production Direction of the Center for Genetic Engineering and Biotechnology of Havana Cuba, with more than 30 years on experience in the recombinant protein production field. He got the Chemical Engineering Degree in 1997 and Master in Science Degree (Biotechnology Mention) in 2003, both in the Higher Polytechnic Institute “José Antonio Echevarria”, Cuba. Currently, he is in charge of the production of EGF, GCSF, Gamma and Alpha human IFN, Alpha 2b PEG IFN, P64K protein and HBcAg. He accumulates also experience on production process qualification by different pharmaceutical regulatory authorities and qualified personnel from Europe and Latin-America. He has participated in technology transference projects for the recombinant protein production to China and Brazil. He has also received and imparted multiple post-graduate courses and has been involved in collaboration projects with other national and international scientific institutions. He has published different papers and technical reports related with the recombinant proteins purification and validation of downstream processes. He has been also awarded with three Cuban Science Academy Prizes and granted the category of First Degree Technologist from 2008 in Cuba.
Luciano Hernandez Marrero, BSc. MSc. Co-Chairman of Regulatory Issues for the Biotechnological Product Manufacture
Luciano Hernandez Marrero is head of Regulatory Affair Group of Production Direction of the Center for Genetic Engineering and Biotechnology of Havana Cuba, with more than 30 years on experience in the recombinant protein production field. He got the Bachelor Degree in Biology in 1984 in Havana University and the Master in Science Degree (Quality of Biotechnological Productions Mention) in 2011. He performed a Diploma in Human Molecular Genetics at the DIBIT, San Rafael Hospital in Milan in 1994. He has also worked in the expression of recombinant proteins in mammalian cells, and purification and characterization of recombinant proteins espressed in bacteria. In 1994, he starts to work in the stablishment and scaling of active pharmacaeutical ingredient manufacturing processes. He has experience in the implementation of manufacturing processes in multiproduct plants and has accumulated a valued knowledge in cleaning and process validation. In parallel, he has participated in technology transference projects for the recombinant protein production to China and Iran. He has worked as GMP technical expert in Cuba and abroad and is member of author’s teams of more than 30 scientific publications, and three patents. He has been also awarded with Cuban Science Academy Prizes, National Annual Health Prize and Prize of the Cuban Office of Patent and Inventions.