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Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Anna Maruca Assoc. Consultant Anna specializes in program management and strategy, coordinating technical teams and external partners to deliver complex biotech and healthcare initiatives. She has led virtual small molecule development programs and supported biologics manufacturing for mAbs, Fabs, bispecifics, and platforms incorporating unnatural amino acids, while also guiding early-stage startups in program strategy and go-to-market operations. She combines technical fluency with a talent for organizing and aligning cross-functional teams. Anna is known for building integrated project plans, diving into technical details when needed, and implementing systems that streamline collaboration and execution. Anna has worked at Emano Metrics, Rezolute Bio, Absci, and Oregon Health & Science University. She holds a B.S. in Biology (Cell & Molecular emphasis, Chemistry minor) from Western Washington University, and has completed Project Management Professional training. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Sara Cook, Ph.D. Sr. Consultant Dr. Cook is the visionary founder of IliaCook Statistical Consulting, specializing in helping clients in Vaccine and Adjuvant Development, Gene Therapy, Cell Therapy, Immunotherapy, CMO, and CRO fields meet their business requirements. With a deep understanding of process statistics, Sara provides invaluable support to nonclinical functions, including Upstream and Downstream Process Development, Technical Transfer, Manufacturing, Scale-up, Quality Control, Analytical Development, Formulations, and informatics groups. Her expertise in advanced statistical and data analytics ensures the highest standards of quality and efficacy. Sara's statistical methods have proven instrumental in optimization of processes, assays, and formulations, for example leading in doubling the expiry of a product and increasing manufacturing titer by 23%. As the former head of Data Science and CMC Statistics at Novavax, Sara empowered global business units, implemented data-driven strategies, and delivered proactive insights for faster decision-making. Her proven track record includes establishing data governance programs, leading high-value initiatives, and enhancing performance through innovative solutions. With a Ph.D. in Chemical Engineering and extensive industry experience, Sara is a trusted advisor in process optimization, analytical development, and more. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Richard Blackmore, Ph.D. Sr. Consultant Dr. Blackmore has over 27 years of experience in development of fermentation, purification, and chemical modification processes for human therapeutic proteins. He has extensive experience in cGMP manufacturing support, scale-down process modeling, computer-based monitoring and control and technology transfer. Dr. Blackmore has particular skills in mathematical modelling of biological processes and in Exploratory Data Analysis. Dr. Blackmore's career started at Baxter/Somatogen where he developed fermentation and purification processes for various products and managed the R&D fermentation facility. He then proceeded to Seattle Genetics where he developed and scaled up processes for monoclonal antibodies and Antibody Drug Conjugates. Subsequently Dr. Blackmore spent time at Emergent Biosolutions/Trubion where he gained experience on mono and bi-specific mAb-like bio-pharmaceuticals based on scFv fragments. Dr. Blackmore has also spent a number of years at Dendreon where he has managed upstream and downstream development organizations for antigen development as well as technical support for CMO operations and the Process Monitoring Program for Dendron’s Autologous Cellular Immunotherapy (Provenge™). Dr. Blackmore holds a Ph.D. in Biological Sciences from University of East Anglia, Norwich, U.K. and was a Postdoctoral Fellow at Cornell University, Ithaca, NY. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Ali R Siahpush, Ph.D. President Dr. Siahpush has over 29 years of cell therapy and biologics development and commercialization experience. Since founding Pharmefex in 2014, Dr. Siahpush has advised numerous cell and gene therapy clients on a vast array of CMC topics including development, technology transfer, CMO selection, validation, comparability, regulatory submissions and interactions, and CMC strategy. Prior to creating Pharmefex, Dr. Siahpush was Vice President of Product Development and Manufacturing Science at Dendreon, a pioneer in cell therapy development and commercialization, where he was responsible for early and late stage product development, and support of Dendreon’s commercial manufacturing for Provenge®. Prior to joining Dendreon, Dr. Siahpush spent nearly 20 years at Amgen in a number of capacities spanning process development, product development, technology transfer, supply chain management, program management, acquisition integration and organizational redesign culminating as Executive Director of global process development. Dr. Siahpush also has hands on experience in protein formulation and fill/finish, lyophilization, downstream development, protein derivatization, Quality investigations, NC/CAPA’s, and risk analysis and has presided over transfer, validation and approval of numerous products both within and outside of the contiguous United States. He holds a Ph.D. in Biochemical Engineering from University of Michigan, Ann Arbor. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Wendy Laderach Prin. Consultant Wendy Laderach has over 30 years of experience in various quality roles. She previously served as the Senior Vice President of Corporate Quality, Quality Site Head of External Supply, Site Quality Assurance Head and Head of Quality Control at both a Site and Corporate level. A process-oriented leader with an extensive background in operational leadership, regulatory and operational excellence, Wendy consistently balances quality, requirements, and operational needs to develop solutions which ensure optimum performance. Wendy has led global initiatives in Analytics, Regulatory Reporting, Information Technology Tool Implementation, Inspection Preparation and Process Development at her previous companies generating value through elimination of waste and generation of hard savings. She has a proven track record of results across quality assurance, quality control, operations and regulatory while also holding key leadership positions within executive teams both within company and with external partners across the globe. Wendy received her BS degree in Biochemistry, her Master’s degree in Business Administration and is certified in Data Management and Regulatory Affairs. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Pranhitha Reddy, Ph.D. Prin. Consultant Dr. Reddy has over 28 years of experience in designing and developing protein therapeutics, expression vectors, mammalian cell lines, cell culture processes and technology transfers and associated regulatory filings. Over the course of her career she has developed an in depth knowledge of raw material supply and manufacturing technical support for biologics, monoclonal antibodies, antibody-drug conjugates, biosimilars and viral vectors. Her experience includes setting up GMP and non-GMP laboratories, designing and implementing methods and work-flows to accelerate timelines, optimize yields, improve efficiency and throughput, and control product quality. She holds certifications in Clinical Trials, and in Regulatory Affairs from University of Washington, and a certification in statistical design from the SAS Institute. Dr. Reddy is also the founder of Gene to BLA Consulting. Prior to joining Pharmefex, Dr. Reddy served as Director of Cell Sciences at Seattle Genetics, Scientific Director, Principal Investigator and Head of GMP biosafety at Amgen, and in a variety of different capacities at Immunex Corp. Prior to joining Immunex, Dr. Reddy was a Research Fellow at the Fred Hutchinson Cancer Research Center, Seattle, and a Postdoctoral Fellow at MIT, Cambridge. She holds a Ph.D. in Biochemistry from Brandeis University, Waltham, MA. She holds numerous patents and has authored more than 30 publications. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Kaela Siahpush Assoc. Consultant Kaela Siahpush is a detail oriented problem solver and specialist with 7 years of experience in biologics, and cell therapies, developing protein therapeutics, cell culture processes and technology transfers and associated regulatory filings. She has led several projects on process development and optimization, as well as process control strategy, technology transfer in start-up and major biotechnology company settings. Her experience includes designing and implementing methods, improving efficiency, yield and throughput, and product quality. Prior to consulting Kaela tested new technologies for improving CAR-T cell therapy processes at Bristol Myers Squibb. Kaela is adept at leading technical initiatives, conducting risk assessments, and authoring a broad range of technical and regulatory documents, including IND submissions, control strategies, batch records, and SOPs, ensuring compliance with FDA, EMA, and ICH guidelines. She holds a Lean Six Sigma Yellow Belt certification and is proficient in tools such as Veeva Vault, JMP, Excel and Prism. Kaela earned her Bachelor of Science in Chemical & Biological Engineering from the University of Colorado, Boulder. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Josie Hayes, Ph.D. Sr. Consultant Dr. Josie Hayes is a seasoned expert in translational medicine and predictive diagnostics, with 20 years of experience in oncology diagnosis and research. Her career spans clinical diagnostics, bioinformatics, biomarkers, and experimental molecular biology, making her a trusted leader in the field. Josie is the founder of Hayes Consulting LLC, where she provides strategic guidance on biomarker strategy and evaluation, lean translational operations, predictive and pharmacodynamic biomarkers, and assay development. Her work supports clients through all stages of drug development, from hypothesis generation to patient application. She is highly skilled in computational biology, biostatistics, real-world evidence analysis, and TCGA biomarker mining, offering insights that have directly influenced clinical decision-making. Previously, Josie held leadership positions in prominent biotech firms such as Revolution Medicines and an immuno-oncology stealth start-up, where she spearheaded translational medicine strategies, managed cross-functional teams, and contributed to clinical trial protocols, IND filings, and investigator brochures. Her work has included developing early development biomarker and companion diagnostics strategies, designing complex biomarker-related mouse clinical trials, and establishing robust RNA-seq and exome sequencing pipelines. Josie's expertise extends beyond industry roles; she has conducted postdoctoral research at UC Berkeley and UCSF, focusing on biostatistics, neurological surgery, and bioinformatics. Her academic achievements include a PhD from the University of Leeds in collaboration with Harvard Medical School, with her research yielding several highly cited publications. An accomplished author, Josie published 'Confront Cancer: Tools to Make the Right Decisions for Your Cancer,' reflecting her commitment to empowering patients with actionable knowledge. Known for her communication skills, attention to detail, honesty, leadership, and professionalism, she is also well-connected within the biotech community, fostering collaborations that ensure value for money and high-quality outcomes. Josie continues to drive innovation in biomarker discovery and clinical application, helping biotech companies bridge the gap between scientific discovery and clinical success. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Gaya Ratnaswamy, Ph.D. Sr. Consultant Dr. Ratnaswamy has over 20 years of experience in the development of parenteral formulations, drug products and analytical methods for a variety of biologics, antibodies, antibody-drug conjugates (ADCs), recombinant proteins and biosimilars. Prior to joining Pharmefex, Dr. Ratnaswamy served as Director of Analytical and Formulation Development at Agensys Inc, a subsidiary of Astellas Inc for 8 years. She was a key contributor to the development of enfortumab vedotin, an antibody-drug conjugate that has been granted priority review from the FDA. Prior to Agensys, she worked at Amgen Inc for 10 years in the Process and Product Development group where she developed platform formulations for early-stage molecules as well as formulations and lyophilization processes for late-stage products. Dr Ratnaswamy has extensive experience in protein formulation, fill/finish, lyophilization process development, technology transfers to CMOs, analytical comparability, analytical method development, qualifications and transfers to CROs. She also has experience with developing CMC strategy, project planning and authoring regulatory documents. Dr. Ratnaswamy obtained a Ph.D in Chemistry from Brandeis University working on protein structure determination and completed post-doctoral fellowships at Princeton University and The Scripps Research Institute focusing on the biophysical characterization of proteins. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back John P. Gabrielson, Ph.D. Sr. Consultant Dr. John Gabrielson has over 20 years of experience developing biologics. Prior to joining Pharmefex, John was Senior Vice President of Pharmaceutical Development at Sidewinder Therapeutics, executing the company's CMC strategy. Prior to Sidewinder, he launched Similis Bio as SVP of Biosimilars at JSR Life Sciences. At KBI Biopharma, he served as SVP of Analytical and Formulation Sciences, leading a team of 400 scientists and overseeing analytical support for over 100 client programs. In 2015, John co-founded Elion Labs, where as President and CEO, he shaped the company's strategy and executed its business plan. John’s extensive experience also includes leadership roles at Amgen, where he directed an analytical organization focused on developing and validating analytical methods for biologics, from late-stage clinical trials through post-market approval. Throughout his career, John has been at the forefront of advancing analytical methods in biopharmaceuticals, evidenced by his numerous publications, invited presentations, and patent. He brings a deep understanding of the complexities of biologics development across many modalities, including development of enzymes, therapeutic antibodies, multi-specific proteins, biosimilars and antibody drug conjugates. A seasoned leader, John has a proven track record of building and scaling successful organizations and a passion for driving innovation. He holds a Ph.D. in Chemical Engineering from the University of Colorado, Boulder. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Deisy Corredor, Ph.D., RAC Sr. Consultant Deisy is a results-driven CMC Leader with over a decade of extensive experience in CMC strategy and bio-process development. She is an expert in cell culture and downstream process development, process optimization, scale-up/down, process characterization, controllability, and technology transfer. Deisy recently worked leading cross-functional biologic platforms teams within Sanofi -Aventis, as US Head of Bio-process Engineering. With a deep understanding of CMC strategy and PD, she spearheaded the initial technology transfer and scale-up of leading molecules to internal Mfg and external CDMOs, while guiding process development of innovative biologics and contributing as author and reviewer of two successful IND and IMPD submissions of therapeutic proteins. Prior to her tenure, Deisy worked as Sr. Director of PD and CMC at Synthorx Pharmaceuticals, leading the design and transfer of leading molecules to external CDMOs , work that supported the successful acquisition of Synthorx by Sanofi-Aventis. She also served as Product Leader in Development for IVDR genotyping devices at Illumina, and as Upstream Group Leader at Pfenex Pharmaceuticals where she also co-authored a successful BLA submission of biosimilars. Deisy is a trusted advisor based on her specialization in PD using Quality by Design tools, and CMC activities within cGMP environments ensuring strict compliance with ICH and FDA requirements. Deisy has a PhD in Biological Engineering from KSU, and a BSc in Chemical Engineering. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Deepthi Kolli, Ph.D. Sr. Consultant Deepthi Kolli, Ph.D has over 15 years of cell therapy and biologics development and commercialization experience. Dr. Kolli has worked at and/or advised numerous cell and gene therapy companies on a vast array of CMC topics including development, technology transfer, CDMO selection, validation, comparability, regulatory submissions and interactions, and CMC strategy. Previously, Dr. Kolli served as Vice President of Process Sciences at ImmPACT Bio, where she led a team of scientists and engineers responsible for process development, analytical development, technology transfer, manufacturing support, quality control and overall CMC activities for bispecific CAR T cell therapeutics. Prior to joining ImmPACT Bio, she held increasing leadership roles at Sonoma Bio, Atara Bio and Charles River focusing on both autologous and allogeneic cell therapy products. She has hands on experience on various cell therapy products (CAR T, CAR Treg, CIK, CAR NK, iPSCs, HSC derived hybrid cells, Allogeneic T cells to name a few) in terms of starting cell material characterization, clinical correlations, specification setting, EOS, potency assay development, lyophilization, Quality investigations, NC/CAPA’s, and risk analysis and has presided over transfer, validation and submissions of numerous products. Dr. Kolli has extensive regulatory submissions and interactions including in the US, EU, China and Japan. Deepthi holds a Ph.D and M.S in Immunology from the National Dairy Research Institute, and a B.Sc in Biochemistry and Microbiology from Nagarjuna University in India. Contact