Dozens of test tubes in a holder

Speaker Bios


Mark Fitchmun, President and Senior Advisor, Manufacturing Process Development and Outsource Management, Somatek, Inc.

Since founding Somatek in 2003, Mr. Fitchmun has consulted on over 40 biopharmaceutical and analytical projects including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. Mr. Fitchmun has also served as Vice President of Accelagen, a provider of enzymes for molecular biology research; Manager of Process Development at GenStar, a gene therapy company; and Group Leader at Desmos, developing new antibodies, and assays, and research methods for the study of extra cellular matrix proteins.

 

Tareq Jaber, Ph.D., Senior Supervisor, Process Evaluation, Biologics Testing Solutions, Charles River Laboratories

Tareq Jaber received his B.Sc. and M.Sc. degrees majoring in Genetics and Molecular Biology from Jordan University of Science and Technology. He joined California State University-East Bay biotechnology program, which offered an advanced training in academic and industrial research with focus on pharmaceuticals development. In 2004, Dr. Jaber joined the School of Biological Sciences' Ph.D. program at the University of Nebraska-Lincoln and his research focused on studying HIV pathogenesis and the discovery of novel proteins and small RNAs involved in Herpesviruses latency stages. In 2010, he joined University of Pennsylvania School of Dental Medicine, Department of Microbiology as a Postdoctoral Fellow and performed studies on oncogenic Herpesviruses. Dr. Jaber received extensive training in tissue culture manipulation, viral assays, protein chemistry, and molecular biology. During his career in academia, he published several peer-reviewed articles and was the recipient of various awards and Fellowships including Certificate of Research Excellence, Graduate Student Outstanding Accomplishment Award, National Institute of Health (NIH) Kirschstein National Research Service Award, Program of Excellence Award Fellowship, and the Virology Training Grant

 

Andrew Lees, Ph.D., Scientific Director, Fina Biosolutions; Associate Professor, University of Maryland, School of Medicine

Andrew Lees, Ph.D., is the founder and scientific director of Fina Biosolutions LLC, in Rockville, MD.  Dr. Lees has been teaching biochromatography for 15 years.  Dr. Lees is an expert in the chemistry of conjugate vaccines with over 20 patents to his name and an author on over 60 peer-reviewed articles. Conjugation chemistry developed by Dr. Lees is used by GSK, the Serum Institute of India, the Chengdu Institute of Biological Products and others in their Streptococcus pneumoniae and meningococcal conjugate vaccines.  

Dr. Lees is also an Associate Professor at the Center for Vaccine Development at the University of Maryland School of Medicine.  Dr. Lees was formerly Director of Protein Purification and Macromolecular Sciences at Biosynexus, Inc and Director of Vaccine Development at Virion Systems, Inc. Andrew Lees holds a BS in Chemistry from Harvey Mudd College (Claremont, CA) and a Ph.D. in Biophysics from The Johns Hopkins University (Baltimore, MD).

 

Julie Robinson, Graduate Student Research Assistant, Chemical Engineering, Rensselaer Polytechnic Institute

Julie Robinson is a fourth year PhD student under Professor Steve Cramer at Rensselaer Polytechnic Institute. Her research focuses on understanding multimodal ligand-protein interactions and the development of computational models to predict protein behavior in multimodal systems. Julie's work has been published in peer reviewed journals and she has given numerous oral and poster presentations at national and international meetings. She is the recipient of a NSF Graduate Research Fellowship and received a BS in chemical engineering from Clemson University. 

 

Darryl Sampey, Ph.D., President and CEO, BioFactura, Inc.

Darryl Sampey co-founded BioFactura in 2004 and as President and CEO manages all strategic and scientific endeavors of the Company. Before BioFactura, he led both process development and manufacturing teams at Human Genome Sciences, Inc. (HGS) honing his skills developing new biologics processes and control strategies. During his tenure with HGS, Dr. Sampey played key roles in the start-up, commissioning, and validation of the company’s first cGMP manufacturing facility and associated development laboratories. Additionally, he performed lead roles in the development, transfer, and evaluation of novel fermentation processes for cGMP clinical manufacturing. Prior to his work at HGS, Dr. Sampey gained industrial experience in the commercial research laboratory designing and optimizing fermentation and product recovery processes for novel vaccines at North American Vaccine, Inc. His work in vaccine research has since progressed to internationally-approved vaccines for whooping cough in infants and meningitis in adults. Darryl Sampey began his career in biotechnology at the University of Maryland. Dr. Sampey graduated first in his class and was awarded a Bachelor of Science in Chemical Engineering, Magna Cum Laude, and subsequently earned a Ph.D. in Bioengineering both from the University of Maryland.

 

Ben Woodard, Director, Biotechnology Research and Education Program University of Maryland

Ben began his biotech training as a student employee at the University's Bioprocess Scale-Up Facility (BSF) and upon graduation was hired, full time, as a faculty assistant. Ben has played a vital role in the continued growth of the facility and has led the development of improvements to the facility infrastructure and capabilities. In 2000, he assisted with the procurement of a $775,000 "Sunny Day Fund" award from the State of Maryland for BSF facility enhancements. His primary responsibility is to create and instruct corporate biotech training programs and directing biopharmaceutical clients regarding contract research. In his 18+ year career in biotechnology, he has trained 50+ undergraduate technicians and has placed 100 percent of those students in the local biotech workplace. In addition, he has given numerous lectures to academia, government agencies and industry on fermentation processes and biopharmaceutical production. He has created and instructed laboratory courses for a variety of undergraduate classes and mentors in the University Gemstone Program. His guest lecturers have included talks throughout the U.S., Canada and the Middle East.  Ben is a graduate of the University of Maryland with a BS in Biology and a Masters in Business Administration.

 

Xuemei He, Ph.D., R&D Manager, Process Chromatography, Bio-Rad Laboratories

Dr. Xuemei He is the manager of Chromatography Media Chemistry at Bio-Rad Laboratories. She holds a Ph.D. degree in Biological Chemistry, and has over 20 years of experience in the field of biomolecule separation and characterization. Her laboratory is concentrated on the development of new chromatography media for process-scale production of protein pharmaceuticals, with an emphasis on the removal of residual process- and product-related impurities during polishing purification stage.

 

William H. Rushton, MS, Chromatography Support Scientist, Bio-Rad Laboratories

William Rushton is a Process Chromatography Support Scientist for Bio-Rad in North America.  He obtained a M.S in Biomedical Sciences from Philadelphia College of Osteopathic Medicine in 2005 and his B.S in Biology from St. Joseph’s University in 1994. Prior to Bio-Rad he worked at Centocor (wholly owned subsidiary of Johnson and Johnson) from 1997-2007 in the Process Development Group. While there he worked on ReoPro®, Remicade® and developed the downstream purification processes for Simponi® and Stellara®. In 2007 he joined Charles River Laboratories as the manager of the Process Evaluation/Validation group performing viral clearance studies for Pharmaceutical and Bio-Tech companies. Upon leaving Charles River in 2009, he supported the BLA filing and post marketing activities for Xiaflex® at Auxilium Pharmaceuticals as a Senior Scientist in the Process Development group. His work resulted in development of highly purified versions of the collagenases to improve analytical assay sensitivity as well as column validation work.

 

Mark A. Snyder, Ph.D., R&D Manager, Process Chromatography Applications, Bio-Rad Laboratories

Dr. Mark A. Snyder is Manager of the Process R&D Applications Group in the Process Chromatography Division of Bio-Rad Laboratories. He received a B.S. from the Massachusetts Institute of Technology and his Ph.D. in biochemistry at the University of California, Berkeley. He has been responsible for many developed processes, including Bayer’s current-generation licensed recombinant Factor VIII purification process. He is experienced in process troubleshooting, optimization and validation. His work has been published in numerous peer reviewed journals.

 

James M. Sulzberger, MS, Process Chromatography Specialist, Bio-Rad Laboratories

James M. Sulzberger is an American downstream purification scientist possessing an analytical development and cGMP background, with a specific interest in the modernization of biomolecule purification processes using modern membrane and chromatography technologies.  He obtained his MS in Chemistry with a focus in Separation Sciences in 2017 from Northeastern Illinois University and a BS in Biology from the University of Illinois Chicago in 2007.  Jim joined Bio-Rad Laboratories in 2016, and is currently a Process Chromatography Consultant, where he uses his knowledge in downstream process development to suggest and develop purification processes with clients facing unique biomolecule purification challenges.  Prior to Bio-Rad, Jim was a Chemist at Celgene Corporation from 2008-2012 where he performed FDA investigations and developed, validated, and transferred HPLC and UPLC methods for the analysis of nanoparticle albumin bound (nab) paclitaxel based metastatic breast cancer therapeutic, Abraxane™.  In 2012, he joined Adello Biologics as a Scientist III (formerly known as TPI), where he worked on development of downstream process and analytical development for biosimilar versions of filgrastim (GCSF), pegfilgrastim, interferon beta-1b, adalimumab, and rituximab.  Most recent to joining Bio-Rad, Jim was a Senior Scientist -Purification at Pall Corporation from 2013-2016.   While at Pall, he performed process development studies and scale-up support for tangential flow filtration, membrane filtration, virus filtration, membrane chromatography, chromatography for antibodies, recombinant proteins, plasma proteins, viruses, and virus like particles from a diverse array of expression systems  such as bacterial, mammalian, plant, plasma, and transient transfection virus systems.