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 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 Bruce Kerwin, Ph.D. Exec. Consultant Dr. Kerwin has 30 years of leadership experience in industry developing drug products for biologics. He is a recognized expert in protein formulation and drug product design. During his career he has developed formulations and designed development strategies for multiple products from pre-clinical to commercial including Kineret, Aranesp and Imlygic. Bruce was formerly a Scientific Director at Amgen, VP of Drug Product Design at Just-Evotec Biologics and SVP of Process and Product Development at Umoja. He has led numerous drug product development teams and scientific research teams developing novel solutions to formulation problems such as high viscosity, high concentration, co-formulation of proteins, protein aggregation and formulation of viruses for subcutaneous, intravenous, intrathecal intravitreal and device delivery technologies. Work on large and small volume parenteral formulations included recombinant hemoglobin, cytokines, monoclonal antibodies, antibody drug conjugates, PEGylated proteins, glycosylated and non-glycosylated proteins, oncolytic viruses and lentivirus. As an integral member of multiple product teams he has also written drug product sections for multiple regulatory documents, participated in writing FDA pre-meeting documents and in-person FDA meetings. Bruce received his Ph.D. at the University of California at Davis followed by a Postdoctoral Fellowship at Washington State University. He has over 60 scientific publications, 14 patents and multiple invited lectures at international scientific conferences. He is currently a Scientific Advisor for Coriolis Pharma and a member of the editorial advisory board for the Journal of Pharmaceutical Science. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Thomas W. Arroll, Ph.D. Sr. Consultant Dr Arroll has over 20 years of industry experience developing and implementing cell-based and immunoassays to support process development, GXP potency release and stability testing. Through his experience leading development, GLP and GMP laboratories Dr. Arroll has gained deep knowledge of the technical and operational requirements to effectively implement robust and reproducible potency assays in the GXP environment. With an academic background in immunology Dr. Arroll has strong expertise in the development of bioassays to support drugs with immuno-oncology modalities including T cell activation, checkpoint inhibition and Fc-mediated effector functions. In addition to his experience leading potency and impurities assay groups he has served as CMC Team lead for multiple clinical stage programs responsible for process development, internal and external manufacturing and clinical drug product supply. Dr. Arroll is the Owner and Principal Consultant of Seawolf CMC Consulting, a firm focused on providing strategic and technical guidance on the development and implementation of drug potency release and biological characterization assays for the support of CMC activities. Prior to joining Pharmafex Dr. Arroll was Director of Potency and Impurities Assays at Seattle Genetics as well as leader of Potency and Biological Characterization functions at Amgen. Dr. Arroll received his PhD from the University of Washington (UW) School of Public Health and was a Postdoctoral Fellow in Immunology at the UW Howard Hughes Medical Institute. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Julie Shi, Ph.D. Consultant Dr. Julie Shi has over 8 years of experience in the biotech industry, specializing in cell and gene therapy development. She has held key technical leadership roles at Juno Therapeutics, Bristol Myers Squibb, and Sana Biotechnology, contributing to the advancement of autologous and allogeneic CAR-T and TCR-T cell therapy programs. Julie combines deep scientific expertise in non-viral gene delivery technologies, including lipid nanoparticles, gene editing, and transposons, with a proven track record of developing scalable and clinically relevant manufacturing processes. Her work spans early-stage research through pivotal process development, where she has been instrumental in driving the advancement of novel gene and cell therapies. Julie has contributed to regulatory submissions, including authoring technical reports in support of IND filings, and has played a central role in advancing multiple programs through the development pipeline. She has also led technical due diligence efforts and developed technology roadmaps, providing strategic insights for investment and pipeline decisions. Julie holds a patent for a lipid nanoparticle formulation process, has authored several publications, and has been invited to speak at conferences to share her expertise in gene delivery technologies for cell therapy. As a data-driven leader, Julie is skilled at implementing data analysis workflows to optimize manufacturing processes. She utilizes QbD approaches, including Design of Experiments (DOE) methodology, to ensure process robustness and accelerate the transition from R&D to commercial-scale production. Her leadership experience includes building and managing cross-functional teams, establishing new process development labs, and driving tech transfer and process optimization efforts. She holds a BS in Chemical Engineering from MIT and earned her PhD in Bioengineering from the University of Washington, where she focused on non-viral gene delivery, and completed a postdoctoral fellowship at the University of Toronto on peptide drug delivery systems. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Sesha Srinivasachari Principal Consultant Sesha Srinivasachari is a seasoned biopharmaceutical professional with 27+ years of experience in all phases of clinical development through roles in Manufacturing, Supply Chain, Quality, Program Leadership and Project Management. Sesha has a strong cGMP manufacturing background in biologics, cell therapies, combination products and peptides in both drug substance and drug product unit operations. Most recently, he was a Vice President at Kyverna Therapeutics, where he was the Program Lead for their autologous CD-19 CAR-T program. Prior to that, he was the Head of Manufacturing and Supply chain at Kyverna. Prior to Kyverna, he served in various capacities within technical operations in companies such as Genentech, Intarcia and Dermira. Sesha is experienced in managing CMOs / CDMOs, leading internal clinical and commercial manufacturing teams, leading capital projects, technology transfers, late-stage development, process validation and process optimization / operational excellence (LEAN, Six Sigma, Value Stream mapping). Sesha is well versed with CMC strategies and regulatory filings (IND, BLA, CTA, NDA) for multiple modalities. Sesha has experience in interactions with regulatory agencies and leading regulatory inspections. Sesha has an MBA from Haas School of Business (UC Berkeley) and holds a Bachelor of Engineering degree from Madurai Kamaraj University, India. 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 Christoph Kahl, Ph.D. Sr. Consultant Dr. Christoph Kahl has more than 20 years of experience in cell & gene therapy and vaccine development across industry and academia. After starting out as a Scientist at GenVec, he held leadership roles at OHSU, Atara Biotherapeutics, Amgen, and most recently Vir Biotechnology. Dr. Kahl brings a deep scientific expertise from a wide range of viral vector systems combined with a proven track record of translating complex gene delivery systems into clinically relevant and scalable production processes and validated assays. He has worked on programs spanning R&D and early-stage development, contributing to INDs and regulatory submissions, and helping to advance Ebvallo™, the world’s first approved allogeneic T-cell immunotherapy, through pivotal trials and enabling PPQ/BLA. His extensive responsibilities have encompassed process and platform development, design, optimization for manufacturability, process analytical technology (PAT) and data management, characterization; cell line development; analytical method development, qualification, and validation; adventitious agent testing, comparability, CMC strategy, and structured data initiatives for regulatory. Always at the forefront of science and technology, Dr. Kahl has spearheaded novel methods, instrumentation, data analytics and modeling, and has an extensive record of publications and patent applications. He earned his Ph.D. at Indiana University and completed a postdoctoral fellowship at the University of Southern California, where he focused on advancing lentiviral vector platforms and cell therapy technologies for pioneering clinical trials. Dr. Kahl is experienced in technology transfers and establishing contracts and partnerships with US-domestic and international CDMOs/CTOs, fluent in multiple languages (English, German, and Polish), and is passionate about addressing unmet medical needs across the globe. 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