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 Teri Aldrich, Ph.D. Sr. Consultant Dr. Aldrich has over 30 years of experience in developing mammalian and microbial cell lines for the expression of monoclonal antibodies, bispecific molecules, and cytokines. Her upstream process development experience spans from preclinical research through process characterization and successful transfer to manufacturing. She has authored CMC documentation for regulatory submissions and streamlined technical reporting by creating standardized templates. Before joining Pharmefex, Dr. Aldrich served as Principal Scientist at ZymoGenetics, a Bristol-Myers Squibb company, where she led teams focused on microbial strain development, mammalian cell line engineering, and process characterization. Her earlier roles at Amgen and Immunex involved designing mammalian expression vectors and generating production cell lines. At Panlabs, Inc., she expanded her repertoire by expressing therapeutic proteins in fungal systems. Dr. Aldrich earned her Ph.D. in Microbiology and Immunology from the University of Illinois at Chicago. She completed postdoctoral training in Genetics at the University of Washington in Seattle, supported by a National Research Service Award from the National Institute of General Medical Sciences. 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 Jeffrey McGrew, Ph.D. Sr. Consultant Dr. McGrew has over 30 years of experience developing expression systems, cell culture processes and associated regulatory filings. During his career he implemented methods to speed development of biologics, engineered molecules and cell lines, and developed fed-batch and perfusion processes. Dr. McGrew has experience optimizing expression of monoclonal antibodies, bispecific antibodies, Fc-fusions, biosimilars and cytokines. Prior to joining Pharmefex, Dr. McGrew was Director of Cell Line and Upstream Process Development at Just-Evotec Biologics where he was responsible for developing multiple engineered cell lines, expression vectors, proprietary media and perfusion processes. Prior to joining Just-Evotec, Dr. McGrew spent nearly 20 years at Amgen and Immunex in a number of capacities including cell line, process, and technology development as well as leading molecule development teams. He received his Ph.D. from the University of Massachusetts and completed a post-doctoral training at the Dana Farber Cancer Institute and the University of Washington. He holds numerous patents and is the author of more than 20 scientific publications. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Rajesh G. Beri, Ph.D. Prin. Consultant Dr. Beri has over 30 years’ experience in the Biotech Industry, starting as a bench scientist with Lonza Biologics in 1996 and progressing to Executive Level Leadership positions at Senda Biosciences and Goodwin Biotech, prior to launching his consulting career. During his career, Rajesh has managed over 70 biologics projects from pre-clinical through commercial approval and has played a key role in approval and life cycle management of leading biologics products such as YERVOY®, ORENCIA®, OPDIVO®, ARZERRA®, BENLYSTA®, SOLIRIS® and StrenSIQ®. He has established and led development, manufacturing sciences, technical operations and CMC functions at several organizations while promoting a culture of technical excellence and quality compliance. His teams have supported manufacturing, supply chain, engineering, quality, regulatory and business development functions. Dr. Beri has a strong track record of active participation at industry events with over 20 presentations and 5 publications, 2 granted patents and 1 patent pending approval. He has been a key steering committee member of Biophorum Operations group (BPOG), contributing to the publication of white papers covering Characterization, Validation and Continued Monitoring of Biologics and a Technology Roadmap for Biomanufacturing. Based on his experience, Dr. Beri is well positioned to assist pharma and biotech companies with a broad range of technical, operational, and strategic expertise in development and manufacturing of multiple product modalities manufactured using both mammalian and microbial expression systems such as recombinant proteins, monoclonal antibodies, ADC’s, mRNA, and Lipid nanoparticles. Rajesh’s expertise spans from cell line generation to drug product manufacturing and packaging, and from pre-clinical through post approval and the associated regulatory interactions. Dr. Beri received his Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology, Mumbai, India and his Masters, and Doctorate degrees in Chemical Engineering from Worcester Polytechnic Institute. Contact

Pharmefex team serves clients that include pharmaceutical and biotechnology companies worldwide. In particular, we specialize in assisting companies to accelerate the development and approval of recombinant proteins and cellular and immunotherapy products. Our Team Xiaoyu (Sam) Hu, Ph.D. Consultant Process Validation, PPQ, MSAT, Technology Transfer, Viral Vectors, Vaccines, Biologics, CMC, External Manufacturing, Regulatory, Commercial Readiness Read More Marc Better, Ph.D. Exec. Consultant Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions Read More Rajesh G. Beri, Ph.D. Prin. Consultant Process & Analytical Development, Technology Transfer, GMP Manufacturing, Cell Culture, Microbial Fermentation, Antibodies, ADC’s, mRNA and LNPs Read More Deepthi Kolli, Ph.D. Sr. Consultant Cell therapy & Biologics, Process & Analytical Development, Technology Transfer, CDMO selection & Oversight, AI Implementation, Regulatory Submissions Read More Aaron Pilling, Ph.D. Sr. Consultant Process Design, Process Development, CMC, Biologics, CDMO Selection & Management, Process Characterization Read More Anna Maruca Assoc. Consultant Project Management, Operations, Biologics and Small Molecules, Process Optimization, Alliance Management, Business Development Read More Liz Pecan Sr. Consultant Business Development, Corporate Development, Seed Funding, Series A & B financing, Alliance Management, Corporate Finance Read More Jeffrey McGrew, Ph.D. Sr. Consultant Biologics Development & Manufacturing, Expression Systems, Cell Banking, Biosimilar Development, Upstream Read More Julie Shi, Ph.D. Consultant Cell and Gene Therapy, Allogeneic CAR-T, Process Development, Lipid Nanoparticles, Due Diligence, Technology Roadmap Read More Gaya Ratnaswamy, Ph.D. Sr. Consultant Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization Read More Edward N. Pedersen Process Architect Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis Read More Steven L. Cockrill, Ph.D. Prin. Consultant Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation Read More Josie Hayes, Ph.D. Sr. Consultant Biomarker Strategy, Discovery, Validation, & Drug Development, Multi-Omics & Companion Diagnostics, Personalized Medicine Read More Jamie Jamshidi Sr. Consultant Clinical Trial GCP Oversight & Audit, GMP, GCP & GLP Compliance, QA & QC for biologics & small molecules, PAI, GxP QMS, Regulatory Operations Read More Nathan Parker Sr. Consultant API, DS, DP cGMP Manufacturing, Quality Assurance, QMS, QRM, Inspection Readiness & Risk Management, Facility & Process Qualification Read More Klaus Beck, MD/Ph.D. Prin. Consultant Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing Read More Sunitha Lakshminarayanan Prin. Consultant Regulatory CMC, Technical Investigations, Due Diligence, Technology Transfer, Process Validation, Comparability Read More Li Malmberg, Ph.D. Prin. Consultant Biologics manufacturing, Process Development, Fermentation, CHO cells, ADC, Fusion proteins, Monoclonal antibodies, CMC regulatory Read More Ramji Krishnan, Ph.D. Prin. Consultant Cell & Gene Therapy, Regulatory Strategy, Process Characterization & Validation, FDA Inspection Readiness, PAI, Biologics Read More Deisy Corredor, Ph.D., RAC Sr. Consultant Process Development, Technology Transfer, CMC Regulatory, CDMO Management, Due Diligence, Facility Fit, Risk Assessment and management Read More Kaela Siahpush Assoc. Consultant Cell Therapy Development, Risk Assessment, Technical Document Authorship & Management, Cell Culture, Project Management Read More Beth Brown, Ph.D. Prin. Consultant Drug Product Development, Global Regulatory CMC, Technology Transfer, CDMO Selection, Technical Program Leadership, Strategic Planning Read More Christoph Kahl, Ph.D. Sr. Consultant Cell & Gene Therapy, Viral Vectors, Vaccines, Process & Analytical Development, Tech Transfer, CDMO/CTO management, CMC Strategy Read More Pranhitha Reddy, Ph.D. Prin. Consultant Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions Read More Steve D. Hughes, Ph.D. Sr. Consultant Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management Read More Sara Cook, Ph.D. Sr. Consultant CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance Read More Reza Movafaghi, MBA Sr. Consultant Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations Management Read More John P. Gabrielson, Ph.D. Sr. Consultant Biologics & Biosimilars, ADCs & multi-specific proteins, Analytical and formulation development, Comparability & Similarity Studies, Regulatory submissions Read More Wendy Laderach Prin. Consultant Quality Assurance, Biologics & combo. products, Inspection prep. & mgmt., Supplier mgmt., Quality Systems, Analytics & commercialization Read More Heather Kenny Sr. Consultant Quality Management Systems, Inspection Readiness & Support, Risk Management, Remediation, Pharmaceutical Quality Systems Read More Douglas Smith Sr. Consultant Quality Assurance, QMS, Validation, Shipping Qualification, Audits, Cell Therapy & Biologics, Sterile Fill/Finish & Aseptic Processing, Technology Transfer, Due Diligence Read More Jill Herendeen, PharmD Prin. Consultant Regulatory Strategy & Roadmap, Health Authority Interactions, Clinical Trial Design, Cell and Gene Therapy, Biologics Read More Ali R Siahpush, Ph.D. President Cell Therapy & Biologics, Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy Read More Kanika Chawla, Ph.D. Sr. Consultant Cell Therapy & Biologics, Drug Substance & Drug Product Development, CMC strategy, Process & Method Validation, Regulatory Submissions Read More Srini Bandi, Ph.D., M.B.A Prin. Consultant Nucleic acids, RNA, Microbial derived biologics, Process Development, Process Validation, Technology Transfer, CDMO selection, CDMO management & oversight Read More Mohammad El Kalay, Ph.D. Prin. Consultant Cell and Gene Therapy, Technical Operations, CMC, Process Development, Regulatory Filings, CDMO oversight Read More Zahbea Saund Sr. Consultant Program Leadership & Execution, CDMO Management, Portfolio Management, Strategy Development, Operational Excellence Read More Sesha Srinivasachari Principal Consultant cGMP Manufacturing, Aseptic Processing, Technology Transfer, Supplier & Supply Chain Management, Sales & Operations Planning, Program Management Read More Richard Blackmore, Ph.D. Sr. Consultant Biologics, Biologics Process Design, Microbial Process Development, Statistical Data Analysis, Statistical Design Of Experiments Read More Teri Aldrich, Ph.D. Sr. Consultant Biologics & Cytokines, Mammalian & Microbial Cell Line Development, Cell Banking & Testing, Technical Writing, Regulatory Submissions Read More Bruce Kerwin, Ph.D. Exec. Consultant Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors Read More Navid Ghaffari Consultant Cell and Gene Therapy, CAR-T, Technology Transfer, Process Characterization, Process Control, Life Cycle Management Read More Thomas W. Arroll, Ph.D. Sr. Consultant Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity Read More Kuldip Sra, Ph.D. Sr. Consultant Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation Read More Jeff Wedeking Sr. Consultant Quality Assurance, Quality Control, Quality system, GMP Audits & Inspections, PAI, Regulatory Requirements Read More Karen Benson Consultant Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management Read More Elijah Tan Prin. Consultant Regulatory CMC strategy, Global regulatory submissions, Briefing books, Due diligence, Advanced Biologics, Recombinant biologics, Combination products Read More

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 Steve D. Hughes, Ph.D. Sr. Consultant Dr. Hughes has over 21 years of experience in biopharmaceutical and cellular therapy product development, ranging across multiple disciplines of manufacturing, research and development. From his most recent experience leading the process development team at Dendreon, he has extensive experience in development of cellular therapeutic products, and in supporting commercial phase production using risk assessment methodology and experimental models to evaluate potential process changes or improvements. Dr. Hughes’ experience also includes pharmacology, toxicology and project management/leadership. His pharma career began at Zymogenetics, where he started in early-stage research followed by a series of roles in pharmacology, toxicology and product development teams. Dr. Hughes then began work at Dendreon in 2010, where he led a cellular therapy product development team and managed early-stage development projects. He then took the role of leading the team responsible for support and innovation of the manufacturing process for Dendreon’s Autologous Cellular Immunotherapy product Provenge™, an activated cell therapy approved to treat metastatic prostate cancer. In this role, he directed a number of initiatives aimed at improving manufacturing process performance, including adaptation of closed system processing solutions, investigation and resolution of process yield trends, and continuous improvement initiatives such as streamlining process monitoring operations. Dr. Hughes holds a Ph.D in Biochemistry from the University of Texas Southwestern Medical Center in Dallas, TX and was a Postdoctoral Fellow at Lawrence Berkeley National Laboratory Life Sciences Division and Human Genome Center in Berkeley, CA. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Klaus Beck, MD/Ph.D. Prin. Consultant Klaus is a physician and scientist with 30 years of industry experience, in roles with increasing leadership responsibility in the US, Japan and the Asia-Pacific Region as well as Europe, Middle East and Africa – working across the R&D commercialization spectrum, spanning from discovery, translational and clinical research to launch, medical affairs and maintenance, plus global business development and licensing. Klaus worked at Genentech, Amgen, Elan, AstraZeneca and Merck & Co in local, regional and global roles. Klaus’ most recent full-time role was as Chief Medical Officer and Senior Vice President for Organon & Co (a women’s health-focused company, spun out of Merck & Co) where he had direct organizational responsibility for Global Clinical Development and Pharmacovigilance & Clinical Safety Science. Klaus led or was a key contributor to the creation of all corporate governance processes and review bodies at Organon and served as co-chair on two strategic priority Franchise teams, i.e. Women’s Health and Fertility and he chaired the R&D Review Committee, i.e. the most senior technical/medical decision-making body within Organon. Klaus has extensive product commercialization experience, having supported the launch and maintenance of several new products in the US and Japan. He has successfully led international teams (up to 850 colleagues) with a budget of up to $250MM and he has overseen (and in most cases initiated) extensive organizational change initiatives including building large cross-functional teams (from initiation to 350 staff) as well as significantly downsizing and reorienting existing teams. He has successful crisis management experience during the COVID-19 pandemic as Europe, Middle East, Africa and Canada Medical Affairs lead for Merck & Co and as Japan R&D Lead at AstraZeneca KK during and following the Tohoku/Fukushima Daiichi disaster. Klaus holds MD/PhD degrees (“Approbation als Arzt” in Germany; PhD in pharmacology) from the University of Heidelberg, Germany and a PhD degree (neuroscience) from University of Southern California in Los Angeles. He is a US and German dual citizen. He is fluent in English and German, with basic skills in French, Spanish and Japanese. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Jamie Jamshidi Sr. Consultant Jamie Jamshidi is a quality and regulatory operations expert with over 35 years of experience in the biotech and pharmaceutical industry, specializing in GxP compliance, Quality Management Systems, and regulatory affairs across the full product lifecycle. Since 2014, she has served as founder and principal of GxP Council, Inc., where she acts as interim Head of Quality Unit, Regulatory Operations Lead, and Chief Compliance Officer for start-up companies, supporting clients from pre-clinical development through market launch and commercialization. Her career includes a decade as Vice President of Quality and Regulatory Affairs at Karyopharm Therapeutics, where she built the QA/QC and regulatory infrastructure from the ground up, oversaw global regulatory filings (EU, Canada, USA), and managed NDA/MAA submissions. Prior to Karyopharm, she was CEO and President of Quality & Regulatory Management (QRM) and PQC Bioscience, Inc., providing consulting services to pharmaceutical and biotech start-ups. She spent 18 years at Amgen, where she held progressive roles in Quality Assurance — including QA Supervisor in Microbiology, QA Auditor, Compliance Team Leader in Clinical Manufacturing, and Senior Manager of Small Molecule Quality — and contributed to the launch of Amgen's first two commercial products, Epogen® and Neupogen®, and the approval of Sensipar®. Jamie is a recognized speaker and trainer on GxP quality systems, clinical trial quality, FDA inspection preparation, and QU roles and responsibilities. She holds certifications in pharmaceutical education, quality auditing, and analytical method validation. Contact

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 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