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

Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity < 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

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

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

CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance < 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

Biologics manufacturing, Process Development, Fermentation, CHO cells, ADC, Fusion proteins, Monoclonal antibodies, CMC regulatory < Back Li Malmberg, Ph.D. Prin. Consultant Dr. Malmberg is an accomplished CMC executive with 29 years of product development and manufacturing experience, leading aspects of technical and strategic decision making in CMC and external partnerships . She now serves as an independent consultant after extensive careers in pharmaceutical and biotech industries. Mostly recently she served as Chief Technology Officer and Senior Vice President at three biotech startups, Magenta Therapeutics, Xilio Therapeutics and DynamiCure Biotechnology where she established the CMC technical operations organization and drove technical and business strategies for CMC product development. Between 2017 and 2020, Li served as Vice President of Biologics Development and Manufacturing at Celgene where she was responsible for the global technical development and manufacturing of all Biologics clinical and commercial products. During her tenure, she built an end-to-end organization of > 150 scientist/ engineers with an over $100 MM annual budget and led the CMC development for 15 biologic clinical programs leading to the launch of REBLOZYL - first biologic marketed product at Celgene. Prior to this role, Li was Director, Head of Process Sciences at Abbvie where she built and led an organization of more than 80 scientists and engineers responsible for biologics drug development from preclinical to commercial launch. At AbbVie and Abbott Li held various technical leadership roles in R&D supporting small molecules CMC development and drug discovery. She holds a Ph.D. in Chemical Engineering from the University of Minnesota. Contact

Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions ​ < Back Marc Better, Ph.D. Prin. Consultant Dr. Better is a biotechnology professional with more than 30 years’ experience in cell therapy and biologics CMC. Most recently, Dr. Better was Senior Vice President, Product Sciences at Kite, a Gilead Company, where he led process and analytical development, process characterization and process validation activities leading to the successful US licensure of Yescarta, a first in class anti-CD19 CAR T cell therapy. Dr. Better joined Kite in Jan 2013 where he brought experience in biologics CMC; upstream, downstream, analytical and drug product development; GMP manufacturing; commercial manufacturing support; technology transfer; contract manufacturing; and regulatory interactions. Dr. Better has a record of strong business skills and technical depth. He is a strategic thinker and innovator, with a track record of technology development and continuous improvement implementation. In previous roles, Dr. Better has a proven record building high performance teams, internal and external collaborations and corporate partnerships. He is also experienced authoring and reviewing regulatory documents for global submission, and working with regulatory agencies in the US, Europe, Japan and China. His expertise also includes working with CMOs as a customer and as a provider. Prior to joining Kite, Dr. Better was Executive Director, Process Science at Boehringer Ingelheim, Executive Director, Process Development at Amgen and in key leadership roles at both Abgenix and XOMA. Dr. Better received a Ph.D. in Biochemistry from Brandeis University and holds a B.S in Microbiology from Michigan State University. Contact

Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation < Back Steven L. Cockrill, Ph.D. Sr. Consultant Dr. Cockrill brings over 20 years of biotherapeutic commercialization experience from first-in-human through licensure and post-marketing filing support. His expertise lies in the advancement of various product modalities including traditional biologics (recombinant glycoproteins, monoclonal antibodies, Fc-fusion proteins) from mammalian and microbial expression systems, gene therapies (PEGylated antisense oligonucleotides), and microbiome-based live bacterial therapeutics from the perspective of analytical development, quality control, and oversight of external contract organizations for testing, development, and manufacturing operations. Prior to his consultancy, Dr. Cockrill served as head of analytical functions (Analytical Development and Quality Control) as Senior Director, Executive Director, and Vice President roles in various virtual and semi-virtual organizations. His previous responsibilities included leading efforts to develop and optimize analytical strategies and global implementation of technologies to support Amgen's future state aspirations for Quality Control. Prior to his role in Corporate Quality Control, he provided oversight of commercialization activities with respect to late-stage biologic therapeutics as a lead in Analytical Sciences and functional representative on process teams at Amgen. Before Amgen, he had roles at Sigma-Aldrich Biotechnology and Tanox, supporting method development and characterization of various protein therapeutics. Dr. Cockrill holds a B.Sc . in Chemistry from the University of York, England and a Ph.D. in Chemistry from Texas A&M University. Contact

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

Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions < Back Greg C. Flynn, Ph.D. Prin. Consultant Dr. Flynn has over 20 years of experience in development and characterization of biologics, recombinant proteins, monoclonal antibodies, biosimilars and ADCs. That experience includes extensive development, qualification and validation of analytical methods and efforts to understand and control critical quality attributes for protein therapeutics. He has held key roles in the development and implementation of Quality by Design principles at Amgen. Implementation of Quality by Design included contributing towards and reviewing many regulatory filings. He has more than 50 scientific publications, including dozens focusing on the safety and efficacy of product quality attributes on protein therapeutics. Previous experience includes scientific project team leadership, technology development leadership, process team leadership, and formulation development. Prior to joining Pharmefex, Dr. Flynn worked at Amgen for 13 years in a number of capacities, most recently as Scientific Director of Attribute Sciences. Prior to joining Amgen, he was a Senior Scientist at Baxter, Inc. and was a faculty member of the Chemistry Department and member of the Institute of Molecular Biology at the University of Oregon. He holds a Ph.D. in Chemistry (Biochemistry) from the University of California, Santa Barbara and was a Postdoctoral Fellow at Princeton University. Contact