Chamow & Associates Consultants are leaders in biopharmaceutical product development. Our skilled professionals have substantial industry experience and fully understand the challenges faced in drug development.
Our integrated team work together to provide expert advice and solutions; helping clients meet their business objectives and achieve their missions.
Process Development / Manufacturing
Bryan Monroe is a process development / 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/implemented both major remodel of facilities as well as 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 for 9 years.
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.
Regulatory Affairs and Compliance
Darlene (Dar) Rosario, B.S., MBA, RAC, 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 mid-size start up 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, Moraga, California, B.S. in Chemistry from Eastern College (University) in St. David’s, Pennsylvania and is a certified Regulatory Affairs Profession, RAC. She is an active member of RAPS and DIA. She has served on the board of director of the International Pharmaceuticals Aerosol Consortium on Regulation and Science (IPAC-RS) to advance the science of orally inhaled and nasal spray drug products.
Technical Writing and Project Management
Jennifer Bratt, Ph.D., has been employed as a Technical Writing Consultant and Project Manager at Chamow & Associates since January 2016. Jennifer assist’s Chamow & Associates Project Leaders by planning, directing, and coordinating activities of team members for designated client projects, ensuring that goals and objectives are accomplished within prescribed time frame and funding parameters.
Jennifer received her Ph.D. in Biochemistry and Molecular Biology at the University of California, Davis in 2010 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. At this time, she has published 16 peer-reviewed articles and a book chapter on these topics.
cGMP Manufacturing / 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 the generation of multi-specific T cells for the treatment of cancer. Juli was part of the team to launch 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 8000sq.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.
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 US, 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-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.
Quality Assurance / CMC Regulatory Affairs
Stephen Nava is a quality assurance/regulatory affairs professional with 24 years of experience in cGMP compliance and quality systems. Stephen is an ISO9000-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 US and ex-US 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 V.P. 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 6.5 years.
Stephen holds a B.S. in Chemistry and Mathematics from Texas A&M University.