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Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Kaela Siahpush Assoc. Consultant Kaela Siahpush is a detail oriented problem solver and specialist with 7 years of experience in biologics, and cell therapies, developing protein therapeutics, cell culture processes and technology transfers and associated regulatory filings. She has led several projects on process development and optimization, as well as process control strategy, technology transfer in start-up and major biotechnology company settings. Her experience includes designing and implementing methods, improving efficiency, yield and throughput, and product quality. Prior to consulting Kaela tested new technologies for improving CAR-T cell therapy processes at Bristol Myers Squibb. Kaela is adept at leading technical initiatives, conducting risk assessments, and authoring a broad range of technical and regulatory documents, including IND submissions, control strategies, batch records, and SOPs, ensuring compliance with FDA, EMA, and ICH guidelines. She holds a Lean Six Sigma Yellow Belt certification and is proficient in tools such as Veeva Vault, JMP, Excel and Prism. Kaela earned her Bachelor of Science in Chemical & Biological Engineering from the University of Colorado, Boulder. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Josie Hayes, Ph.D. Sr. Consultant Dr. Josie Hayes is a seasoned expert in translational medicine and predictive diagnostics, with 20 years of experience in oncology diagnosis and research. Her career spans clinical diagnostics, bioinformatics, biomarkers, and experimental molecular biology, making her a trusted leader in the field. Josie is the founder of Hayes Consulting LLC, where she provides strategic guidance on biomarker strategy and evaluation, lean translational operations, predictive and pharmacodynamic biomarkers, and assay development. Her work supports clients through all stages of drug development, from hypothesis generation to patient application. She is highly skilled in computational biology, biostatistics, real-world evidence analysis, and TCGA biomarker mining, offering insights that have directly influenced clinical decision-making. Previously, Josie held leadership positions in prominent biotech firms such as Revolution Medicines and an immuno-oncology stealth start-up, where she spearheaded translational medicine strategies, managed cross-functional teams, and contributed to clinical trial protocols, IND filings, and investigator brochures. Her work has included developing early development biomarker and companion diagnostics strategies, designing complex biomarker-related mouse clinical trials, and establishing robust RNA-seq and exome sequencing pipelines. Josie's expertise extends beyond industry roles; she has conducted postdoctoral research at UC Berkeley and UCSF, focusing on biostatistics, neurological surgery, and bioinformatics. Her academic achievements include a PhD from the University of Leeds in collaboration with Harvard Medical School, with her research yielding several highly cited publications. An accomplished author, Josie published 'Confront Cancer: Tools to Make the Right Decisions for Your Cancer,' reflecting her commitment to empowering patients with actionable knowledge. Known for her communication skills, attention to detail, honesty, leadership, and professionalism, she is also well-connected within the biotech community, fostering collaborations that ensure value for money and high-quality outcomes. Josie continues to drive innovation in biomarker discovery and clinical application, helping biotech companies bridge the gap between scientific discovery and clinical success. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < 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

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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Liz Pecan Sr. Consultant Liz Pecan is a life sciences leader with expertise in biotechnology company formation, development, and operations. Most recently, she served as Co-founder and Head of Corporate Development at a venture-backed biotechnology company spun out of the University of Pennsylvania, UCSF, and Stanford. In this role, she helped direct the company through critical early-stage milestones, including academic technology transfer, team development, and securing over $200M in Series Seed and Series A financing. As a founder, Liz established and managed key strategic functions including business development, program and alliance management, corporate finance, operations, and communications. She also oversaw the company's facilities expansion and laboratory infrastructure development. Previously, she held roles at Merck & Co., focusing on early commercial indications for Keytruda in oncology, and led strategic initiatives for oncology programs in international markets. Liz currently supports several early and mid-stage life sciences companies as a strategic advisor, focusing on fundraising, corporate development, program management, financing strategy, and business development. Her recent work spans hematology, gene therapy, cell therapy, obesity, and platform technologies. She brings significant expertise in capital strategy and resource allocation for early-stage teams. While her background is rooted in oncology and early-stage companies, Liz is agnostic on therapeutic area and modality and is open to new opportunities that align with her experience in building and scaling biotechnology companies. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Jeff Wedeking Sr. Consultant Jeff has over 30 years of experience in the Biopharmaceutical industry leading quality assurance teams in support of early stage development through well-established commercial products for biologics, small molecule, and gene therapy programs. Prior to consulting, Jeff held leadership roles at both Amgen and BMS including Site Quality Head, Director External Quality, and Quality Director over Mammalian Manufacturing Operations at Amgen’s Juncos site. Jeff has a proven track record and a broad range of experience providing support and expertise across the entire GMP Quality landscape including oversight of GMP clinical and commercial manufacturing operations, facility commissioning and qualification, batch release, quality systems development and execution, eQMS implementation, supplier quality management, GMP audits and inspections, inspection readiness prep, and regulatory submissions. Jeff holds a B.A. in Pharmacology from University of California Santa Barbara. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Jill Herendeen, PharmD Prin. Consultant Jill Herendeen is a seasoned regulatory affairs leader with more than 20 years of experience in drug development, specializing in innovative oncology therapeutics that address areas of high unmet need. She has played a pivotal role in the development and global commercialization of multiple oncology therapeutics, including Vectibix®, Opdivo®, and Imbruvica®. Her expertise spans the full spectrum of drug development—early- and late-stage programs through post-marketing—across modalities such as small molecules, biologics, cellular therapies, and companion diagnostics. Jill’s experience extends beyond regulatory sciences into pharmacovigilance, clinical operations, clinical quality assurance, program management, and alliance management, giving her a comprehensive view of the drug development lifecycle. Jill began her career at Amgen and went on to hold senior regulatory leadership positions at Bristol Myers Squibb, Pharmacyclics (acquired by AbbVie), Silverback Therapeutics, and Orca Bio. Most recently, she founded Rubicon Consulting, a regulatory consulting firm dedicated to helping biopharmaceutical companies design and execute regulatory strategies that align with their vision for product development. Through Rubicon, Jill partners with clients to navigate complex regulatory pathways and ultimately maximize patient access to innovative therapies. Jill holds a BS in Biology from Gonzaga University and a PharmD from University of Washington and completed a general medicine and oncology residency at University of North Carolina Chapel Hill and drug development fellowship at University of North Carolina Chapel Hill and GlaxoSmithKline. 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 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

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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back 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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Srini Bandi, Ph.D., M.B.A Prin. Consultant Dr. Srinivasulu (Srini) Bandi is a biopharmaceutical process development, CMC and manufacturing consultant with over 20 years of experience supporting Phase 1/2/3 development and BLA-ready manufacturing. He specializes in process development, process characterization, scale-up, technology transfer, and PPQ for biologics, nucleic acids, and high potency small molecules across microbial and mammalian platforms. Srini provides strategic leadership in CDMO selection, vendor qualification, and external manufacturing oversight, and partners closely with Quality and Regulatory teams to deliver inspection-ready, compliant CMC packages. He helps late-stage programs de-risk development, control costs, and achieve commercial readiness. Prior to joining Pharmefex, Srini held roles as Director of process development and external manufacturing at Sail Biomedicines, a clinical stage biotech company developing circular RNA based LNP-Antibody conjugates for autoimmune diseases. Prior to joining Sail Biomedicines, Srini worked as consultant and contractor roles with biotech companies developing processes, tech transfers and clinical manufacturing of pDNA, antibody and microbiome products. He also worked in BioVectra, a CDMO for 11 years at various levels primarily led the tech transfers, process development, scale-up & clinical manufacturing and supported process validation & commercial manufacturing activities. He holds a Ph.D. in Pharmaceutical Biotechnology from Andhra University, India and Executive MBA from UPEI, Canada. He also trained as a postdoctoral researcher from KAIST, South Korea and NRC, Canada. Contact