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Pharmefex 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 Clients Pharmefex partners with pharmaceutical and biotechnology companies worldwide, helping them accelerate the development and regulatory approval of recombinant proteins, cellular therapies, and immunotherapy products. Our clients range from innovative start-ups to global corporations. Over the past decade, we have successfully supported more than 128 clients across the globe, contributing to over 17 regulatory submissions and securing 5 commercial approvals. Renowned for delivering high-quality results across diverse markets, Pharmefex specializes in Chemistry, Manufacturing, and Controls (CMC) support while offering deep expertise in key areas critical to product development and regulatory success. Early Stage Support Process and analytical method development consulting CMO Selection & Oversight CMC Strategy Development RFP generation for CRO/CDMO selection Transfer from academic labs to CMOs Technical/CMC guidance Project/program management Outsourcing Risk assessments Phase Appropriate Quality Systems, investigations and quality audits Statistical design and analysis Late Stage Support Inspection Preparation and Management Compliance audits, gap assessments and remediation QA, QC, Qualification & Validation Technology transfer, scale-up & manufacturing Regulatory documents (IND, BLA, & other protocols) authoring and submission Product and process characterization study design Process and method validation Product comparability Quality by Design

Pharmefex consulting, founded in 2014, focuses on technical and CMC related consulting for cell therapy, recombinant proteins and biosimilars About Pharmefex Founded in 2014 in Bellevue Washington, Pharmefex Consulting provides expert technical, regulatory, and compliance services to clients around the world. Through a multidisciplinary approach, Pharmefex helps organizations to streamline product development, accelerate time to market, reduce cost of goods, and prevent and resolve compliance problems for recombinant proteins, and cellular immunotherapy products. The company deploys decades of experience to deliver top-quality results for a diverse base of global clients, including pharmaceutical and biotechnology companies and the law firms that serve them. Our hands on experience with commercialization and commercial production of Cellular Immunotherapy products sets us apart from others. We specialize in helping cell therapy and immunotherapy companies seamlessly accelerate their products to market and achieve higher profitability and to avoid costly mistakes in this quickly emerging field. Our Clients Our Team

Contact Pharmefex for pharmaceutical manufacturing outsourcing, CMC and technical Support of Your Biologics or Cell & Gene Therapy Product Phone: 425-818-1046 Email: info@pharmefex.com Address: Bellevue, Wa 98006

Support for Cell & Gene Therapy, Biosimilars, ADCs, Antibodies and Recombinant Proteins offered by Pharmefex. Products We Support Our consultants have the breadth and depth of experience to support a wide range of products to suit your needs. Contact us today to learn what we can do for you. Monoclonal Antibodies, Fragments, or ADCs Development of antibodies to target specific receptors as a means of controlling biological pathways has become increasingly more common as a therapeutic avenue for managing various diseases. Whether you are developing an antibody (IgG1, 2, 3, or 4) or antibody fragment to directly treat an indication, or are using an ADC to deliver an agent, we have the know how to help you navigate from start to finish in the fastest and most efficient manner. Cell and Gene Therapy Products, Viral Vectors The number of cell and gene therapy products in development continues to grow. These products offer tremendous promise for the treatment of grievous illness, yet each type of product presents unique challenges. We have hands on experience with multitude of cell and gene therapy products and have dealt with and solved the problems many developers don't yet know they have. Put our experience to work for you and avoid the costly mistakes and delayed timelines. Recombinant Proteins With decades of combined experience in the development, transfer and commercialization of protein based therapeutics, we can help you with all your needs. We have the expertise to support you from early stage discovery and expression vector design, creating relevant animal models, PK/PD and tox, through the latter stages of scale up, technology transfer, GMP manufacture, validation, and risk assessments, all the way through to your regulatory filings. Biosimilars Recent changes in the regulations have made development and commercialization of biosimilars a practical reality. We are now starting to see approval of these products in various markets. Yet too often the complexities of the development of biosimilars are underestimated, causing significantly increased costs and delays. How do you take advantage of the accelerated pathway to approval? Let us assist you in getting it right the first time.

< Back Why Including Pregnant Women in Clinical Trials Is Essential for Ethical and Effective Drug Development Jun 12, 2025 Introduction Pregnant and breastfeeding individuals have long been excluded from clinical research—an exclusion rooted in historical ethical concerns and perceived risk. Yet this protective stance has unintentionally led to a dangerous information gap: most drugs on the market lack sufficient data to guide safe and effective use during pregnancy or lactation. The newly released ICH E21 guideline offers a framework to change this. It aims to standardize global efforts to include and retain pregnant and breastfeeding participants in clinical trials when scientifically and ethically appropriate—supporting more equitable, evidence-based care. What’s Missing in Current Clinical Research Today, most clinical trials exclude pregnant individuals outright, even when the drug in question is likely to be used by this population after approval. As a result: Over 90% of medications approved in the U.S. between 2000 and 2010 lack pregnancy-specific safety data. Drug labels often provide warnings but little actionable guidance for clinicians treating pregnant patients. Dosing regimens are rarely optimized for pregnancy , despite known physiological changes that alter how drugs are processed in the body. Post-marketing surveillance systems are inconsistent and underutilized , limiting the ability to gather real-world safety data. This lack of evidence contributes to unnecessary risk, conservative treatment decisions, and missed opportunities for intervention—especially in chronic, infectious, and life-threatening conditions where medication use during pregnancy is unavoidable. What the ICH E21 Guideline Recommends ICH E21 outlines a science-based, ethically grounded approach to improving inclusion of pregnant and breastfeeding people in clinical development. The guideline recommends: Evaluating whether inclusion is scientifically appropriate as early as possible in the development lifecycle. Replacing automatic exclusion with careful, dynamic risk-benefit assessments based on available data and the potential for therapeutic use in pregnancy. Designing trials that include appropriate safety monitoring and tailored consent processes. Using supplemental data sources , including registries, modeling, and post-marketing surveillance to strengthen findings. Promoting regulatory harmonization across regions to support global alignment in ethics and expectations. This shift moves the industry away from blanket exclusion and toward a more thoughtful, transparent standard that protects participants while enabling better data generation. The Role of Biopharma and Clinical Teams Implementing ICH E21 will require collaboration across the drug development ecosystem. Biopharmaceutical sponsors, CROs, and site investigators must work together to evaluate when and how to include pregnant individuals, develop appropriate protocols, and align with ethics boards and regulators on safe participation. This guidance also has strategic implications. As regulators move toward global alignment on inclusion standards, companies that proactively address these expectations will be better positioned for smoother approvals, stronger safety data, and broader access post-launch. Conclusion The historical exclusion of pregnant and breastfeeding individuals from clinical trials has left a significant evidence gap in how we treat one of the most medically vulnerable populations. The ICH E21 guideline marks a necessary turning point—one that prioritizes equity, scientific rigor, and ethical responsibility. At Pharmefex, we support our clients in adapting to evolving regulatory landscapes like ICH E21 through strategic guidance, regulatory insight, and cross-functional compliance planning. Together, we can drive a more inclusive and evidence-informed future for drug development. Previous Next

Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation < Back Kuldip Sra, Ph.D. Sr. Consultant Dr. Kuldip Sra has over 30 years of experience of working in Biotech and Biopharma companies. Over his extended experience, Dr. Sra has worked on CMC product developments for Vaccines, C&G Therapy, Crispr Gene editing, Mabs and Vectors. During his career, he has worked on commercialization of 5 approved drugs and worked on over 15 INDs/IMPDs submissions. He has written CMC sections for briefing documents, INDs, BLA, CTAs, and has written responses and justifications to Regulatory agencies’ inquiries. Most recently Kuldip served as Executive Director of Late-Stage Development at Crispr Therapeutics where he led both analytical and Quality control functions for allogenic and autologous clinical drug products (in C&G products, Hematology, RegenMed modalities). Prior to Crispr, he was QC Director at Kite managing clinical lot release & raw material testing and environmental monitoring groups. At Kite, Dr. Sra worked on Kite’s two commercial products: Yescarta and Tecartus. His contributions were critical to significantly reducing QC release from 6 weeks to < 1 week (reduction of >80% in time of release). Kuldip worked for 15 years in Aviron/MedImmune/AstraZeneca in various capacities. He was involved in commercialization of three vaccine drug products and has designed and executed product comparability protocol for Vaccine drug products manufactured in Europe and in the US. He obtained an MS and PhD degrees in Biochemistry from Seton Hall University in Biochemistry and B.Sc . with Honors from Panjab University, India. Contact

Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors < Back Bruce Kerwin, Ph.D. Prin. 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

Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management < 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

Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing < 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

Cell & Gene Therapy, Viral Vectors, Vaccines, Process & Analytical Development, Tech Transfer, CDMO/CTO management, CMC Strategy < 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

Process Design, Process Development, CMC, Biologics, CDMO Selection & Management, Process Characterization < 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

Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations Management < Back Reza Movafaghi, MBA Sr. Consultant Reza Movafaghi has more than 20 years of experience in biologics & advanced therapies. Most recently, he was Head of Manufacturing Operations with Thermo Fisher. Prior to Thermo Fisher, he served in various leadership roles within technical operations in companies such as Teva, Baxter Biosciences, and Allergan. He has extensive technical experience in process optimization, cGMP manufacturing, and technical operations in biologics clinical & commercial manufacturing. He is also experienced in new cGMP biologics production facility build out and technology transfer to/from foreign and domestic sites. Reza has hands on experience in manufacturing technical operations, design space, continuous process verification, process optimizations, FMEA/PFMEA, maintenance, change control & management, and CAPA investigations using Six Sigma DMAIC lean operational excellence methodology. He has been a cGMP manufacturing operational lead SME for worldwide regulatory agency inspections. Reza has an MBA from University of Maryland and holds a B.S. degree in Biochemistry from California State University, Fullerton. Contact