External Advisory Board

Narendra Bam has more than 20 years of experience leading various biopharmaceutical research and development groups. He joined SmithKline Beecham as an investigator in 1995, and has held various roles of increasing responsibility in platform technologies and science, pharmaceutical development, process development and biopharm discovery. His current role involves managing a group of world class scientists in US and UK responsible for developing cell lines, process, product, and analytical methods of all biopharmaceuticals in the GSK R&D portfolio. He has numerous publications, book chapters, and patents in the field of protein formulation and characterization. He chairs the Biopharm CMC Steering committee and is a member of the GSK R&D Inclusion Council. He lectures at University of Maryland in a Biotechnology graduate course.

John Bodek has over 27 years of experience in the biopharmaceutical industry in early, and late stage process development and commercial support of both mammalian and microbial products, including: tech transfer, process validation, regulatory writing conjugates, microbiome and plasmid products and commercial product support. He also worked on technology development and alliance management efforts. He serves as an Scientific Integrator on several Janssen product development teams. Previously John worked on process development support and tech transfers at GlaxoSmithKline. He received is JD from Widener University School of Law in Delaware and his BS in Biochemistry from The Pennsylvania State University.

John enjoys researching and evaluating novel therapeutic technologies in connection with his project development. He is in the Mentoring program at Janssen and supervises several Janssen personnel.

Christopher Cowan, Ph.D. is the head of the Purification Development group in Preclinical Manufacturing Process Development (PMPD) at Regeneron Pharmaceuticals, Inc. located in Tarrytown, New York. Dr. Cowan received his B.S. in chemical engineering at the Pennsylvania State University and his M.S. and Ph.D. at the University of Maryland - Baltimore County. Current position responsibilities include:

• Reagent/candidate production to support Regeneron’s pipeline
• Preclinical purification development
• Clinical-stage purification development
• Commercial-stage purification development
• Process development for Antibody Drug Conjugates (ADCs) including process chemistry, bioconjugation and supporting bioanalytics
• Establishment of ultra-scale down empirical models and in silico modeling
• Process Automation

Mandar Dixit has over 16 years of experience in filtration and separation technologies. He currently supports the North American biopharmaceutical market for filtration technologies, with a focus on sterilizing grade filters and prefilters. He is a member of PDA and ISPE. Mr. Dixit has co-authored papers in trade journals on prefiltration as well as filter optimization and scale-up studies.

Sharyn Farnsworth is Director for Upstream Process Development at FUJIFILM Diosynth Biotechnologies. She has over 26 years of experience in the process development and scale up of multiple cell lines including CHO, Sp2/0, NS0, HEK, SF9, and SF21 from 2-L to 20000-L volumes. Sharyn is Global SME for Insect Cell Culture processes and single-use manufacturing at FUJIFILM Diosynth Biotechnologies which include development activities, transfer in and scale up into GMP manufacturing, Process Characterization and Commercialization activities. She successfully completed the implementation of single-use technologies into GMP Manufacturing at FUJIFILM Diosynth Biotechnologies driving the expansion of the company and played an integral role in the characterization of these technologies through k_La studies at all scales.

Jace is a chemical engineer with a background in biopharmaceutical drug substance development and manufacturing sciences. He started his career in the Merck Manufacturing Division at Danville, PA supporting new process implementation, changeover and validation for multiple synthetic antibiotics. After finishing a PhD with Prof. Erik Fernandez at the University of Virginia, he worked for Genentech in South San Francisco developing purification processes for early phase monoclonal antibodies as well as conjugation processes for antibody-drug conjugates. From there, Jace moved to Eli Lilly in Indianapolis where he did late phase biologics development and went on to management roles in purification process development and pilot plant operations. Jace is currently Senior Director of CMC Science, Product Development Science and Technology at Abbvie in North Chicago.

Emily Greenhagen has been working in industrial biotechnology for 13 years. After studying biology at MIT, she joined Microbia (now DSM) as a molecular biologist. While at Microbia, she moved into fermentation process development and has since contributed to development of over 10 different processes across five different organisms at Microbia, and then biofuels companies Qteros and Novogy. Emily joined Ginkgo Bioworks in April of 2015 to build out the fermentation team, establishing a team of seven fermentation engineers, covering over 15 projects, across seven different organisms. As a number of projects advanced toward late stage development, she moved to Head of Deployment in the summer of 2017, where she manages a cross functional team including Process Development & Engineering, Quality Assurance/Quality Control, and late stage Project Management.

Mary Jane Guy is a dynamic global leader with over 20 years of experience in the biotechnology and pharmaceutical industries. She currently serves as the Head of Sales for the MidAtlantic/South Region at Sartorius Stedim North America, Inc. Mary Jane holds a master's degree in molecular biology and began her career as a scientist at GlaxoSmithKline. She transitioned into sales, working with companies like Wave Biotech, GE Healthcare LifeSciences, SAFC, MilliporeSigma as well as Sartorius.

Douglas Lee is the Senior Vice President for Global Plasma Product Development (PPD) at CSL Behring. For more than 25 years, Doug has worked in R&D in various capacities of biological product development at companies including CSL, Eli Lilly, Bayer, Talecris Biotherapeutics, and Grifols. Prior to moving to the biopharmaceutical industry, Doug was a post-doctoral fellow at the National Institutes of Health. Doug received his PhD in Biochemistry from Medical College of Virginia and holds both a Bachelor of Science and Master of Science from East Carolina University.

Raghu Shivappa has over 10 years of experience in the biopharmaceutical industry in process development, tech transfer, process validation, technical support, and contract manufacturing of recombinant biologics and vaccines. He joined Janssen R&D to lead teams and drive strategy for development of innovative solutions for cell culture process development and manufacturing. He also serves as an upstream technical lead on Janssen product development teams. Previously Raghu worked on process development, tech transfers, and contract manufacturing at Novartis Vaccines, KBI Biopharma, and Fujifilm Diosynth Biotechnologies. He received is PhD in Molecular Virology from the University of Maryland College Park.

Raghu enjoys interacting with the biotechnology community including students and currently represents Janssen on the Industry Advisory Board (IAB) of the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) which is an industry and academia consortium head quartered at Johns Hopkins University. He has supervised interns and co-ops from several universities and trained them to be well prepared for the jobs in the biopharmaceutical industry.

Ken Walsh is a Senior Director of Business Operations for R&D at CSL Behring. Ken has worked in pharmaceutical R&D for 10 years holding various Business Operational roles supporting the areas of Clinical and Process Development. Prior to CSL Behring, Ken held roles in automation engineering and domestic & international financial controlling within the Industry and Healthineers Sectors at Siemens. Ken received his M.B.A. from Pennsylvania State University as well as his Bachelor of Science in Mechanical Engineering.