Search Results

< Back Supply chain resilience is becoming a manufacturing footprint decision Jan 12, 2026 As we've discussed previously, the FDA’s Manufacturing PreCheck pilot is designed to strengthen domestic drug production by providing early, proactive regulatory feedback on pharmaceutical manufacturing facilities, and to speed up readiness before official product applications are submitted. Combined with tariff pressure and geopolitical uncertainty, it pushes companies to reevaluate their manufacturing location, partners, and long-term strategy. Recent discussions around onshoring and the FDA’s PreCheck initiative are sharpening the focus on quality systems, inspection readiness, and supply chain resilience, with an emphasis on protecting intellectual property by keeping manufacturing closer to home. As a result, onshoring and domestic capacity are moving rapidly into active planning. At Pharmefex, this has shaped how we approach CDMO partnerships , including relationships with U.S.-based manufacturers. Experience across large CMO programs shows how tariffs, logistics constraints, and shifting trade conditions can introduce delays and cost pressure. Bringing production closer to market provides a more stable foundation for execution and regulatory readiness. Pharmefex focuses on exactly this space . We support teams in selecting and managing CDMOs, structuring development strategy, and preparing regulatory submissions such as INDs and BLAs. Schedule an intro call at www.pharmefex.com to learn more. #CMC #Biotech #Pharma #SupplyChain #Manufacturing #CDMO #RegulatoryStrategy #Pharmefex #Consulting #Management Industry perspective on FDA PreCheck and onshoring https://www.linkedin.com/pulse/10-takeaways-from-fda-precheck-meeting-onshoring-drug-stockhausen-lrgqe/ Sources FDA Manufacturing PreCheck Pilot Program https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program Advancing quality in drug products https://www.pharmtech.com/view/advancing-quality-in-drug-products Previous Next

< Back CDMO strategy is one of the most important levers in CMC Jan 5, 2026 Across industry in the drug development space, especially in small and mid-size biopharma, CMC-related conversations often shift to outsourcing. Avoid the overhead when funding or approval isn’t guaranteed, and instead hire the right experts at the right time, for the context needed, before you meet challenges you’re not ready for. 🡪 In the commercialization phase this proves critical – and too often is overlooked or underestimated – until it is too late. The real challenge is how to select the right partner, structure the relationship, and maintain control over timelines, tech transfer, and quality. In practice, many of the issues we see are not technical, but structural: • Contracts that don’t allow for changes as programs evolve• Misalignment during tech transfer that slows development or regulatory later on• Limited auditing of CDMOs, leading to gaps in QMS and GMP readiness• Batch failures and delays that drive avoidable cost and timeline pressure At Pharmefex, we work closely with teams throughout the full CDMO lifecycle. That includes drafting and reviewing contracts with future stages in mind, supporting partner selection and audits, and helping manage the relationship as development progresses. Experience shows that outcomes depend heavily on how these partnerships are established and maintained over time. Clear expectations, strong governance, and early alignment tend to make the difference as programs move forward. Professional CMC support makes all the difference, contact us at Pharmefex.com to learn more. #CMC #CDMO #QMS #QualityAssurance #Biotech #Pharma #DrugDevelopment #Manufacturing #TechTransfer #RegulatoryStrategy #Pharmefex #PharmefexConsulting Previous Next

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 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. Prin. 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 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 Marc Better, Ph.D. Prin. 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 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 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 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 Heather Kenny Sr. Consultant Heather has over 24 years of Quality Assurance experience supporting cell therapy and biologics at large multinational biopharmaceutical companies, small scale start-up companies, and multinational Contract Development and Manufacturing Organizations. Leveraging her background at Amgen, Atara, and FujiFilm Diosynth Biotechnologies, Heather brings extensive expertise in containment, risk reduction, and organizational skills to support businesses in achieving compliance and operational excellence. Her current efforts are informed by a comprehensive background in quality assurance and regulatory affairs. With over a decade of experience in Pharmaceutical Quality Systems and Quality Management Systems, Heather has contributed to process optimization, risk management, and inspection readiness across global organizations. Her mission is to drive compliance, enhance operational efficiency, and ensure that regulatory standards are consistently met. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Zahbea Saund Sr. Consultant Zahbea is a seasoned professional with extensive expertise in CMC program leadership and CDMO management. Her career spans over 30 years in biopharma and she has a proven track record in leading cross-functional teams, managing the complexities of drug development, scenario planning and aligning teams to achieve program and corporate goals. Zahbea’s experience spans the entire product development lifecycle across biologics, cell and gene therapy, biosimilars and vaccines. She is a highly collaborative strategic thinker with a focus on execution and driving results. She excels at building relationships with and amongst team members and is passionate about bringing teams together to define and align on a path forward to meet program goals and deliverables. As an innate problem solver and holistic thinker, she drives teams to assess multiple scenarios and incorporate contingencies and mitigations into a program plan. Zahbea strives for and drives success by maintaining positive team dynamics and ensuring the infrastructure/ business practices support the aligned upon plan for successful product development. Zahbea has worked at Amgen, Lyell Immunopharma, Bill & Melinda Gates Foundation and Novavax. She holds a B.S. in Biology from UCLA, and certifications in clinical trials, mediation, decision making and coaching from UW. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Elijah Tan Prin. Consultant Mr. Tan has over 25 years of experience in the biotechnology/pharmaceutical industry, with close to 2 decades of biologics and biopharmaceutical CMC regulatory experience. Since starting his consulting career in 2017, Mr. Tan has advised numerous cell and gene therapy, biosimilar, and novel biologic clients on a wide range of CMC topics and provided services such as regulatory strategy consultations, global submissions, health authority interactions, and CMC gap assessments. He has spearheaded regulatory strategies, significantly contributed to 9 BLA and 2 EU MAA approvals, and supported more than 40 investigational biological products, including monoclonal antibodies, bi- and tri-specifics, gene-edited autologous therapies, mRNA/lipid nanoparticle products, oncolytic viruses, and antibody-drug conjugates across different stages of clinical development. Before consulting, Mr. Tan held senior leadership positions in regulatory affairs at Coherus Biosciences, Genentech/Roche, and Biogen, where he was responsible for global CMC regulatory strategies, health authority negotiations, and successful product approvals. He also has hands-on experience in pharmaceutical development, analytical chemistry, quality assurance, regulatory compliance, and quality systems implementation from his earlier career at Vertex Pharmaceuticals and Merck. Mr. Tan is US-RAC and EU-RAC certified and holds an M.S. in Pharmaceutical Quality Assurance/Regulatory Affairs from Temple University and a B.S. in Chemistry from West Chester University. 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 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 Aaron Pilling, Ph.D. Sr. Consultant Dr. Aaron Pilling is an experienced professional with nearly 20 years of expertise in biologics process design. He has provided technical leadership over a wide range of molecule types and has been involved in multiple stages of development and commercialization. Aaron started his career at Cook Pharmica, where he helped to establish and build the mammalian cell culture process development team. Later, he transitioned to Amgen and supported multiple end-to-end late-stage antibody and biosimilar programs through process characterization, technology transfer, control strategy development, manufacturing, and commercialization. At KBI Biopharma, Aaron was Senior Director, head of the process development, responsible for cell line development, upstream, solubilization/refold, and downstream process design for integrated client programs. In this role, he was responsible for new client engagement, business development/sales, proposal development, technology and innovation efforts, and launching new CDMO service offerings. Aaron is an expert on CDMO organizations, their strengths, weaknesses, and areas of specialization. He can lead large cross-functional technical teams towards coordinated common goals and intentions. Technically, he is a subject matter expert in process design - early to late stage, process characterization, mammalian and microbial expression products, risk assessment methodologies, control strategy design, technology transfer, analytical comparability evaluations, and contamination investigations (Viral, Microbial, Bacteriophage). Aaron received a PhD in Molecular, Cell, and Developmental Biology from Indiana University and did Post-Doctoral Research at the University of Pennsylvania. 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 Douglas Smith Sr. Consultant Mr. Smith has over 35 years of biologics and cell therapy development, validation, and commercialization experience, including foundational career tenure at Amgen. Since transitioning into senior advisory roles, he has guided numerous small biotech and startup companies through the critical evolution from clinical-stage operations to full system maturity. A Chemical Engineer by training, Mr. Smith brings a rigorous, data-driven approach to CMC strategy, technology transfer, and process optimization, holding professional certifications in Lean Six Sigma, GMP Auditing, and Artificial Intelligence. He specializes in bridging foundational engineering principles with modern advancements in eQMS digital transformation to implement fit-for-purpose infrastructure that ensures data integrity and operational readiness. His hands-on expertise spans the entire product lifecycle for MABs and advanced Cell Therapies (CAR-T), from Master Cell Bank (MCB) establishment through Process Performance Qualification (PPQ) runs, Fill/Finish operations, and global Shipping Qualification. As a specialist, he has presided over the successful validation and tech transfer of numerous products while authoring CMC sections for global regulatory submissions. He holds a Bachelor of Science in Chemical Engineering from the University of Iowa. 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