Biopharmaceutical specialists to help you navigate the most demanding projects
CMC Experts at Your Service
Under the leadership of Steven Chamow, a well-known scientist and author, Chamow & Associates brings together accomplished industry leaders in the different aspects of biopharmaceutical product development. Our skilled associates provide you with their substantial industry experience and in-depth understanding of the drug development challenges you face. We work with and for you, providing advice and solutions to help you achieve project success.
"Steve Chamow has assembled a team of skilled experts on which we continue to rely for advice. Their personal extensive knowledge and background in all aspects of CMC were crucial for our first and timely IND submission."
Ute Schellenberger, SVP Protein Science at Teneobio
Our Featured Associates
FOUNDER AND PRINCIPAL CONSULTANT
SUPPLY CHAIN AND MANUFACTURING
David Banks is an expert in manufacturing and supply chain with over 25 years of pharmaceutical industry experience. He held positions of increasing responsibility at several companies, including GSK (as SmithKline Beecham), Roche (as Syntex), Johnson & Johnson (as Alza), and Gilead (as CV Therapeutics). David had leadership roles in ten pharmaceutical product launches. His areas of expertise include supply chain strategy from conceptualization through implementation, product development, commercial product production management, planning, materials and distribution management, and executive management.
David directly managed the supply chains necessary for sourcing raw materials and drug substance, as well as the manufacturing processes required for commercial production for a variety of products including orals, nasal sprays, injectables, transdermals, drug/device combinations, and controlled release products. Additionally, he has experience with being both a CMO supplying most of the major pharmaceutical companies and directly managing his own production and distribution chains.
David holds a B.S. in engineering from Tennessee Tech University, an M.B.A. from East Tennessee State University and an M.S. in finance from the University of San Francisco.
TECHNICAL WRITING AND PROJECT MANAGEMENT
Jennifer Bratt assists Chamow & Associates project leaders by planning, directing, and coordinating activities of team members for designated client projects. Since 2016, she has ensured that goals and objectives are accomplished within prescribed time-frame and funding parameters as a project manager.
Jennifer received her Ph.D. in biochemistry and molecular biology at the University of California, Davis and continued to work as a postdoctoral fellow focusing on translational research in the field of lung inflammatory conditions, including asthma and ambient particulate exposure, specializing in enzyme biochemistry, lung physiology, and metabolic regulatory pathways. Jennifer has published 16 peer-reviewed articles and a book chapter on these topics.
cGMP MANUFACTURING AND QUALITY CONTROL
Juli DeGraw is a biotechnology specialist with more than 30 years’ scientific bench-to-bedside translational experience in the development of vaccines, therapeutic monoclonal antibodies, and cell-based immunotherapies.
While at Johnson & Johnson (Janssen), she was co-inventor on eleven issued patents and co-developer of a novel platform technology for generating multispecific T cells for the treatment of cancer. Juli was part of the team that launched Johnson & Johnson’s first clinical manufacturing facility, which produced and released patient-specific product completing four Ph I/II clinical studies in advanced-stage melanoma. As associate director of scientific research, Juli was responsible for target identification and development of new indications. In her role as head of quality control, she developed, qualified, and executed test methods for real-time product release of an autologous cell-based cancer immunotherapeutic. In her most recent position, Juli was director and qualified person (QP) for the Centre Hospitalier Universitaire Vaudois (CHUV)/ Clinical Manufacturing Facility (CMF) in Lausanne, Switzerland. As CMF project leader, she managed the conceptual design and development plan of an 8000-sq.ft. GMP facility to support the production of multiple autologous cell and gene therapy products. She has expertise in process development, analytical assay development, and tech transfer.
Juli holds a B.A. in biochemistry and cell biology from the University of California, San Diego.
Antibody Engineering and Expression
Arnie Horwitz, Ph.D., is a research scientist and manager with over 30 years experience in the biotechnology industry directing teams responsible for cloning, expression and characterization of a variety of recombinant proteins in microbial and mammalian systems and for engineering of antibodies for reduced immunogenicity and improved manufacturability. He also has served as project lead for two preclinical stage programs and has participated in numerous project teams. He is an author on 45 peer-reviewed publications or book chapters and is an inventor on 50 US and 11 European patents.
During his time at INGENE, a startup biotech company, he developed a system for secreting IgG and Fab from yeast resulting in a PNAS publication. He also developed Fd and light chain modules for Fab, Fab’ and Fab’2 secretion from E. coli resulting in issued patents and Science and PNAS publications. During his time at XOMA Corporation (which acquired INGENE in 1990), Arnie was involved in implementation of XOMA’s antibody humanization technology, optimization of the permanent mammalian expression system resulting in issued patents and development of CHO cell lines expressing a number of antibodies and other proteins.
As a consultant, Arnie has provided services to a number of companies, with a focus on antibody engineering and expression, improving cell line development and upstream processes for increased protein production, supporting antibody discovery activities, supporting outsourced activities and providing technical guidance for CMC and patents.
Arnie received his BA in biology from University of California, Riverside, his Ph.D. in microbiology from The Pennsylvania State University and completed a postdoctoral fellowship in molecular genetics at the University of California, Los Angeles.
CMC OUTSOURCING AND PARTNERSHIP MANAGEMENT
Tracy Kinjerski is a global business operations professional with over 15 years of experience in the biopharmaceutical industry. She possesses extensive expertise in the biologics CDMO sector, including cell culture, microbial, gene therapy/virology. Tracy has supported business operations as companies transition between business models, delivering revenue growth and profitability for private and publicly traded companies through strategic planning, business operations, financial acumen, industry partnerships and board memberships, marketing, project management, business development, and P&L oversight. Previously, she served as Vice President, Business Operations at Avid Bioservices where she transitioned the company into a full service CDMO model, successfully impacting corporate profitability in 18 months post-transition. Tracy has also worked in business development roles at AGCBiologics, Fujifilm Diosynth, Althea Technologies and Avecia Biologics.
Tracy holds a B.A. Biology and a M.S. Biomedical Sciences, Molecular Biology with a concentration in Virology from Hood College.
CMC REGULATORY AFFAIRS
Wendy Lin has twenty years of professional, multidisciplinary biotech and pharmaceutical experience, focusing on regulatory affairs, quality, process development, and manufacturing. She has successfully led and designed global development strategies for regulatory, clinical, CMC, and companion devices for over 30 early-to-late-stage programs across oncology, infectious disease, immunology, and inflammation indications. Previously, Wendy served on the executive leadership team as head of development sciences at AbbVie Inc. in South San Francisco, CA where she was responsible for all CMC and regulatory initiatives, as well as the overarching strategic direction and functional area operations.
Wendy attended University of California, Berkeley, receiving a B.S. in chemical engineering and a B.A. in mathematics.
Process Development and Manufacturing
Bryan Monroe is a process development and manufacturing professional who has been employed in the biotech industry for nearly 30 years. During his career, Bryan has worked on a wide array of successful drug candidates including insulin, Factor X, Tretten®, NovoSeven®, Recothrom®, Orencia®, Nulojix®, and Provenge®, as well as diagnostic kits for HIV-1, HIV-2, and HTLV-3. His role in these programs included development, optimization, scale-up, and transfer of recombinant protein expression processes in yeast, E.coli, insect cells, and mammalian cells. Bryan also has extensive experience in basal and feed media development and optimization, utilizing a variety of technologies to better understand cellular metabolism as it relates to protein expression processes in both fed-batch and perfusion modes. Bryan has managed, designed, and implemented major facility remodels and green-field construction of new facilities for both process development and clinical manufacturing.
As a consultant, Bryan has contributed to the successful scale-up and/or transfer of more than 90 unique therapeutic programs throughout the global market, targeting more efficient processes, reduced time to clinical investigation, cost of goods improvements, and the development of robust expression platforms.
Bryan held the position of manufacturing engineering development associate at Genetic Systems®, senior research scientist at Bristol-Myers Squibb, process development group leader at ZymoGenetics/Novo Nordisk, process development/clinical manufacturing manager at Dendreon® and senior process science fellow (a customer-consultative role) at Life Technologies.
Bryan holds a B.S. in virology and marine biology from the University of Puget Sound and a technology management certificate from the University of Washington.
Quality Assurance and CMC Regulatory Affairs
Stephen Nava is a quality assurance and regulatory affairs professional with 24 years of experience in cGMP compliance and quality systems. Stephen is an ISO 9000-trained auditor with a solid foundation in worldwide quality and regulatory requirements and a thorough knowledge of cGMP guidelines. His experience includes auditing vendors for phase-appropriate clinical development through mock-PAI readiness. Over his career, he has completed more than 100 audits across intermediates/key starting materials, drug substance, parenteral, solid oral dosage, topical, and medical device manufacturing operations within the United States, Europe, China, Japan, Southeast Asia, and India. His experience includes both small molecules and biologics, including monoclonal antibodies. He has managed quality assurance/regulatory affairs departments, developed and implemented phase-appropriate quality systems, managed supply chains, provided CMC regulatory submission strategy for both U.S. and ex-U.S. dossiers, authored modules 2 and 3 for INDs, IMPDs, NDAs and MAAs in eCTD format and provided oversight for project technology transfer of manufacturing/analytical operations.
In addition to consulting, Stephen currently holds the position of vice president, quality assurance, compliance and regulatory affairs at Sunesis Pharmaceuticals, Inc. Prior to that, he was director, regulatory affairs/quality assurance at BiPar Sciences, Inc., a wholly owned subsidiary of Sanofi, for more than six years.
Stephen holds a B.S. in chemistry and mathematics from Texas A&M University.
Quality Assurance and CMC Regulatory Affairs
Joyce Reyes is a professional with 20 years of manufacturing, regulatory affairs and quality assurance experience. Joyce has extensive experience in small molecules, recombinant protein (fermentation and cell culture: monoclonal antibodies, enzymes, peptibodies, and biosimilars), cell/gene therapy and viral production processes, as well as auditing various CDMOs/CTLs/CROs.
Joyce held positions in quality, regulatory affairs, supply chain and CMC project management, both as a consultant and full-time employee.
Joyce holds a B.A. from St. Mary’s College of California and a master’s degree in health law from the University of California, San Diego/California Western School of Law. She also holds her Regulatory Affairs Certification (RAC).
Regulatory Affairs and Compliance
Darlene (Dar) Rosario is an experienced regulatory affairs and compliance professional with over 25 years in the research and development of drugs and biopharmaceuticals. She has extensive experience in oncology and inhalation combination products among other therapeutic areas and products, including pain, CV, diabetes, inflammation, and immunotherapy. Dar has worked with industry leaders such as GlaxoWellcome (GSK) and Chiron (Novartis) and small to midsize startup companies supporting and leading global program, regulatory, and compliance activities. Her expertise includes, program management, CMC, developing and implementing regulatory strategies, representing regulatory on project teams, interacting with regulatory agencies such as FDA and EMA, preparing and leading agency meetings, generating required documentation for IND/CTA and NDA/MAA submissions including amendments, supplements and post-approval maintenance, and identifying and mitigating regulatory and compliance risks. She has led PAI inspections and created and maintained quality units.
Dar holds an MBA from St. Mary’s College, a B.S. in chemistry from Eastern College (University) , and her Regulatory Affairs Certification (RAC). She is an active member of the Regulatory Affairs Professionals Society (RAPS) and Drug Information Association (DIA). She has served on the board of directors of the International Pharmaceuticals Aerosol Consortium on Regulation and Science (IPAC-RS) to advance the science of orally inhaled and nasal spray drug products.
CMC technical, formulation and delivery
Sangita Seshadri, Ph.D., is an expert in drug formulation and delivery. She provides expertise and technical leadership in strategic development and commercialization of traditional and novel platform and product-specific dosage forms and delivery systems.
With 20 years of industrial experience at companies such as Nektar Therapeutics and Juvaris BioTherapeutics, Sangita’s focus is to deliver robust, commercially viable formulation and process solutions for dry powder, solid and liquid small molecule, peptide, and protein drug products.
As a senior consultant, Sangita has worked with U.S., Japanese and European pharmaceutical companies involving early-to-late-phase macromolecules and small molecules. Her responsibilities spanned API manufacturing, formulation development, analytical method development, process transfer to CDMOs, auditing CDMOs and CROs, authoring CMC sections for INDs and participating in face-to-face FDA reviews.
Sangita holds a Ph.D. in chemistry from the University of California, Santa Cruz, an M.S. in chemistry from San Jose State University, and B.Sc. and M.S. in biochemistry from the University of Bombay, India.
Mary K. Shean
Operations and Project Management
Mary K. Shean is an operations professional with over 25 years of research and drug development experience. She has served as global project manager for Avastin, Perjeta, and Procysbi and global project leader/life-cycle leader for Revlimid, Amrubicin, Xermelo, and Procysbi. Mary has managed over 150 oncology, inflammation, metabolic, dermatology, and infectious disease projects worldwide, ranging from early development to post launch.
With over 23 years of project leadership and management experience for small- to large-size companies, Mary has built departments, program/portfolio management capabilities, and infrastructure. She has supported multiple regulatory filings, agency engagements, and due diligence efforts, as well as evaluation of potential in-licensing opportunities. Mary also holds expertise in alliance management and risk management components, managing the relationship within the contractual confines, setting up governance and decision making, managing/leading the joint steering committee, and facilitating conflict resolution between parties. She also provides feedback on the language and potential impact at the time of a proposed collaboration. Her experience spans multiple therapeutic areas, platforms, and routes of administration. In addition, Mary testified before the U.S. Congress and successfully lobbied to streamline the drug-approval process, expand access to experimental drugs for the terminally ill, and establish off-protocol pathways, resulting in the provisions in the FDA Modernization Act of 1997.
Mary K. Shean holds a B.A. in biological anthropology and anatomy from Duke University with a certificate in genetics. She serves on the New Managers Boot Camp panel for the UC Berkeley Haas School of Business. For over a decade, Mary was a board member and national representative for the Leukemia and Lymphoma Society and Lymphoma Research Foundation (formerly Cure for Lymphoma).