Mark Brader, Ph.D.
Dr. Brader leads a formulation development group at Biogen Idec responsible for early phase and commercial biologics products. He has 20 years experience in the formulation and characterization of therapeutic proteins. Previous roles include technical positions in the pharmaceutics department at Novo Nordisk, Denmark and biopharmaceutical research and development at Eli Lilly and Company, Indianapolis where he established and led a biophysical characterization group in support of product development. His research interests include the application of biophysical analysis techniques to probe interrelationships between protein structure, stability and biopharmaceutics. Dr. Brader received his Ph.D. in inorganic chemistry from Massey University, New Zealand in 1988 and held postdoctoral positions in the department of biochemistry at the University of California at Riverside and department of chemistry at Rutgers University performing research in physical biochemistry and bioinorganic spectroscopy respectively. He also holds a graduate certificate from Purdue University in regulatory and quality compliance.
Byeong S. Chang
Dr. Byeong S. Chang is a founder of Integrity Biosolution which provides contract research and manufacturing services for the development of formulation and delivery of protein/peptide pharmaceuticals. He was an Associate Director at Department of Pharmaceutics and Drug Delivery at Amgen where he served for 12 years (1992-2003). Prior to joining Amgen, Dr. Chang was a protein formulation scientist at Cetus (1990-1992). He did his post-doctoral training in the Department of Pharmaceutical Analysis at SmithKline Beecham, after receiving his Ph.D. degree from the University of Massachusetts in 1988. Dr. Chang received a BA degree from Seoul National University in 1980.
Mary E. M. Cromwell, Ph.D.
Mary Cromwell is a Director and Senior Scientist in the Protein Analytical Chemistry Department at Genentech, a member of the Roche Group. During her first 19 years at Genentech, she developed novel formulations for cytokines and antibodies, including Avastin™. She was the Analytical Assay Subteam Leader for the Avastin™ project, and it was this experience that led her recently to shift her focus to analytical method development, validation, and protein characterization. Most recently, Mary has led a team to develop an approach to determining the Control Strategy for products utilizing Quality by Design. She was the co-founder and former chairperson of the AAPS Focus Group on Protein Aggregation and Immunogenicity and is the newly elected chair of the Biotec section within AAPS. She received a B.S. in Chemistry from West Virginia University, an M.S. in Biophysical Chemistry from the University of California-Berkeley, and a Ph.D. in Pharmaceutical Sciences from the University of Colorado-Denver.
Dominique Gouty
Dominique Gouty is the Scientific Director for Intertek-Alta Analytical Laboratory in San Diego, CA, where she directly interacts with Project Managers/Principal Investigators and Project Analysts during assay development and validation to provide guidance on the most effective route to robust and rigorous assays. As well as being a technical advisor, Dr. Gouty also ensures that all bioanalytical assays are performed according to strict GLP guidelines and validation requirements. Dr. Gouty has over 15 years experience in various disciplines ranging from Research and Development to Clinical, spanning several countries.
Anthony Manibusan
Anthony Manibusan received his B.A. in Biochemistry from Lewis & Clark College, Portland, Oregon in 2002. After graduating he joined the analytical development team at Applied Molecular Evolution/Eli Lilly supporting Phase I/II optimized protein therapeutics. Anthony is currently a Senior Research Associate with the analytics and formulation team at Ambrx, Inc applying HPLC, CE and mass spectrometric techniques to characterize proteins incorporated with novel amino acids and site-specific modifications.
Adriana Manzi, Ph.D.
Adriana Manzi Ph.D. is President & Principal Consultant at Manzi & Associates. Her consulting work focuses on recombinant proteins, dendritic cell vaccines, biosimilars, analytical method development/validation, CMC, and selection/ management of CMOs and CROs. Previously, as Sr. Director of Research for Baxter Healthcare, Dr. Manzi was responsible for the design/execution of the analytical component of bio-pharmaceuticals development leading 35 scientists supporting global programs. She interacted with regulators in the US and EU and participated in global due diligence. Earlier, Dr. Manzi was Director of Analytical Development and Quality Control at Nextran Inc., and Cytel Corporation as well as Director of the Glycobiology Core Facility at the University of California San Diego (UCSD). Dr. Manzi has lectured on chemistry and glycobiology as Assistant Professor at UCSD and Adjunct Professor at San Diego State University. She has published 28 research articles and 20 book chapters as well as articles in Bioprocess International where she is also member of the Advisory Board. Dr. Manzi also volunteers to the CONNECT Springboard Program, advising life sciences entrepreneurs as a domain expert. Dr. Manzi received a B.S. (Chemistry) / M.S. (Industrial Chemistry and Food Sciences), and Ph.D. in Organic Chemistry (summa cum laude) from the University of Buenos Aires, Argentina. She completed her Postdoctoral Research in biochemistry/glycobiology at the UCSD Cancer Center.
Curtis A. Monnig
Dr. Curtis A. Monnig is the Director of Biopharmaceuticals Method Development for Allergan. Prior to joining Allergan, he was the Sr. Director of Scientific Affairs and Project Director at Cardinal Health and Magellan Laboratories, a Senior Scientific Investigator leading the Analytical Characterization group at Amylin Pharmaceuticals and part of the Chemistry faculty at the University of California, Riverside. Dr. Monnig was a National Science Foundation Postdoctoral Fellow at the University of North Carolina Chapel Hill after receiving his Ph.D. degree in Chemistry from the Indiana University at Bloomington, and BS and MS degrees from the University of Missouri, Columbia. Dr. Monnig has 4 patents, over 34 research publications, and more than 90 presentations at national and international meetings.
Joseph Nawrocki, Ph.D.
Joseph Nawrocki graduated with his Ph.D. in analytical chemistry from the University of Florida, Gainesville, Florida in 1997. After graduation he joined the National Institutes of Health in Bethesda Maryland where he did a post-doc for four years in the area of structural characterization of biological products using mass spectrometric techniques. After completing this post-doc he moved to Worcester Massachusetts to work for Charles River Laboratories as a manager in the structural characterization department. After a period of almost two years, Joseph moved to San Diego to begin his career at the PTS division of Cardinal Health which later transitioned to Catalent Pharma Solutions. Joseph is currently the Director of the Structural Characterization and Analysis Department at Catalent Pharma Solutions where he oversees a group of nine individuals performing structural characterization on drug products including small molecules, peptides, proteins and oligonucleotides. Joseph currently lives in San Diego and enjoys many outdoor activities such as tennis, camping, SCUBA diving, swimming and photography.
Randall Nielsen, Ph.D.
Dr. Nielsen earned his Ph.D. in chemistry at the University of Arizona. Following graduate school he did postdoctoral studies at Eli Lilly and Company and evaluated a new bioanalytical tool (at that time), capillary electrophoresis, for characterization of recombinant human proteins. Next he took a job with Hybritech Inc. the first company to commercialize immunoassays using monoclonal antibodies. Dr. Nielsen hired on as part of a small research group supporting manufacturing and later transferred to product development. Hybritech was later purchased by Beckman and fully integrated into the Beckman organization. After a total of 13 years at Hybritech and Beckman, Dr. Nielsen left to join a pharmaceutical CRO, Cardinal Health (formerly Magellan Labs). The pharmaceutical division of Cardinal was later sold to Blackstone and renamed Catalent Pharma Solutions. During his 7 years at Catalent, Dr. Nielsen has worked in three areas (often at the same time): analytical methods development; formulation development, and stability. He currently manages a QC and Stability group.
John Philo
John is the V.P. and co-founder of Alliance Protein Laboratories, where he is in the laboratory analyzing aggregation nearly every day for more than 150 clients world-wide. Before co-founding A.P.L. in 1998 John spent over 6 years in Protein Chemistry at Amgen, where his primary responsibilities were protein characterization using analytical ultracentrifugation, light scattering, and calorimetry. While there he pioneered new sedimentation velocity techniques appropriate for biotechnology products and new software techniques for analysis of protein-receptor interactions by sedimentation equilibrium. Prior to working at Amgen, John was a faculty member in Molecular and Cell Biology at the University of Connecticut in Storrs for 9 years studying protein structure and function. While at U. Conn. he founded and headed the Macromolecular Characterization Facility in the Biotechnology Center and was a co-founder of the National Analytical Ultracentrifugation Facility. John was also a postdoctoral fellow at U. Conn. with Todd Schuster studying hemoglobin kinetics. He received his Ph.D. in Physics from Stanford in 1977. John has authored over 80 scientific publications including over 60 directly related to biotechnology and pharmaceutical applications.
Laura Salmeron
Graduated from University Autonomae of Guadalajara in Jalisco Mexico (1989). BS in Biochemistry and Microbiology and Medical Technologist. Has worked at BIIB for 14 years. Leads the Analytical Development Testing Group in San Diego. Provides Analytical Support to Technical Development groups using CE techniques, HPLC-MS and Bioassays. Prior to working in Biotechnology worked in Clinical Laboratories for 6 years. Owned clinical Laboratory at Hospital San Jose in Tijuana Mexico and worked in Rx Medical Laboratories in Monrovia California. Involved with CE technology for the last 12 years developing and optimizing CE methods using various platforms.
Heather Simmerman, Ph.D.
Heather K. B. Simmerman, Ph.D., is Senior Director, Quality Assurance at Halozyme, Inc., in San Diego, California. She has twenty years of industry experience in analytical development, quality control, quality assurance, and GMP compliance of clinical and commercial biotechnology and pharmaceutical products at Amgen, Amylin, Genentech, Genzyme, Halozyme, and Repligen. Her principal responsibilities have included implementing phase appropriate Quality Systems, Quality Agreements, and global laboratory standards; auditing to ensure GMP compliance; directing GMP laboratories; managing method transfers, validations, investigations, and method, product, and stability trending; and development of CMC sections for regulatory filings. She is the author of twenty-one publications and numerous conference presentations on analysis and characterization of proteins, product quality, and laboratory topics. Dr. Simmerman is a graduate of Northwestern University (B.A., Biology) and Indiana University (Ph.D., Chemistry).
Jeff Staecker, Ph.D.
Jeff obtained his Ph.D. from the University of Wisconsin in Madison and performed post-doctoral work at the Howard Hughes Institute at Vanderbilt University prior to employment in industry. Jeff’s work experience includes Abbott Labs and Beckman Coulter. He joined PPD as a lab manager in Biopharmaceutical Analysis in September 2007. Jeff’s diverse background includes R & D, QC, QA, manufacturing, and contract analytical service. Currently Jeff is the Associate Director, cGMP Operations at PPD’s Wayne, PA site.