Ms. Meissner has been working in the Biotech Field for over 15 years. She founded BioProcess Solutions in 2009, working as an independent consultant in the area of Process Development. Prior to consulting, Dagmar worked with MicroIslet Inc. as Director of Process Development on the encapsulation of human and porcine Islets of the Langerhans for a cell-based therapy for diabetes. Prior to that she worked at CP Kelco on the purification of neutraceuticals and biopolymers. Furthermore, she developed and scaled-up processes for the clinical manufacture of various therapeutics at Pacira Inc. and Biogen IDEC including AVONEXTM, DepoCytTM, and DepoMorphineTM.
Her broad knowledge base includes a variety of biologics such as cell- based therapies, proteins, antibodies, biopolymers, and liposomes. Her experience spans the spectrum of process development, from initial feasibility studies through GMP production for Phase III clinical studies including process design, optimization, and scale-up, equipment design, commissioning, validation, and technology transfer.
Ms. Sofianos is a biopharmaceutical professional with over 10+ years of experience. In 2008 she founded AS Consulting. She has worked as a consultant in the areas of process development, technical support for cell culture and viral production, assay qualification protocols, wrote NIH reports, reviewed pre-IND and IND information packages and Man- In-Plant on behalf of National Institute for Allergy and Infectious Disease (NIAID).
Prior to working as a consultant, she was the Production Manager at PaxVax, Inc., a start up vaccine Production Company. She was responsible for clean room design, cGMP equipment specs, purchase and validation, set up process and development labs, process development, hired manufacturing employees, negotiated contracts with CMO’s and initiated the cGMP doc system. During her employment at Canji, Inc., she worked with bioreactors (cell culture and viral production), automated purification equipment, scale-up and technology transfer into Manufacturing, and established a cGMP system that resulted in FDB license.
Her experience spans from engineering to manufacturing to QA.
Ms. Fan has been working as a business development professional in different industries, including the pharmaceutical industry for more than 10 years. She co-founded and serves as Vice President of Business Development of Effinity Tech, a global developer of the most efficient optimization and complex system control technology for process development in the biopharmaceutical industry and beyond. The company has helped clients to significantly reduce cost, improve production and accelerate time to market in various field such as chemical synthesis, cell culture development and fermentation.
Helena earned an MBA from Marshall School of Business in USC and a Bachelor of Medical Science and a Masters of Public Health from West China University of Medical Sciences.
Helena also serves as a Board of Director in SABPA and Co-Chair of the SABPA Entrepreneur Committee. She was Chairman of the SABPA Career and Education Committee.
Mr. Patel is a biopharmaceutical professional experienced in GMP manufacturing, process development, and facility operations since 1993. He has a broad range of practical experience in bioprocess equipment design and commissioning related to fermentation, cell culture, filtration, chromatography, CIP/SIP, process automation, viral purification, and oral dosage drug product formulation. He also has extensive hands-on experience in the start-up of three GMP production facilities including two for parenteral liposomal drug products and one for oral dosage viral vaccines. Mr. Patel earned a B.S. in Chemical Engineering from Rutgers University and an M.B.A. in Operations Management from Rutgers Graduate School of Management.