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 Karen Benson Consultant Karen has over 28 years of experience in Quality Assurance and management for biologics, antibodies, ADCs, and cell and gene therapies. Prior to her consulting career Karen served as Quality Manager and Quality Engineer with hands on engagement and oversight of change control, management of non-conformance records, annual product review, product disposition, warehouse operations, and document creation and control for recombinant proteins and vaccine products at some of the leading biopharma companies including Amgen, Sandoz, KBI Biopharma, Medtronic, Guidant Vascular and Mentor Medical. She has specialized in Quality Assurance for commercial production from raw materials through finished product distribution; however, her expertise spans Supplier Quality Management, Validation/Qualification, Change Control, Deviation/OOS Investigations, CAPA implementation, Annual Process Review, New Product Introductions, Process Improvements, and Project Management. Karen is PMP certified and holds a Six-Sigma Green belt. Karen received her B.S. in Mechanical Engineering from UC Santa Barbara, and an MBA from Webster University in Netherlands. 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 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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Kanika Chawla, Ph.D. Sr. Consultant Dr. Chawla is a strategic and accomplished CMC leader with 20 years of experience across CAR-T, cell therapy, and biologics. She brings deep expertise in process and analytical development, CMC strategy, and technical leadership from early-stage development through commercial launch. Most recently, Dr. Chawla led Process Sciences at Cargo Therapeutics, where she played a key role in shaping CMC strategy and building manufacturing and analytical platforms for multiple autologous and allogeneic CAR-T therapies across the development lifecycle, from preclinical through late-stage programs. Prior to Cargo, she served as Head of Process Sciences at ArsenalBio, where she built the Technical Operations function and led the development of a non-viral manufacturing platform and analytical methods for an innovative CAR-T cell therapy targeting solid tumors. Earlier in her career, Dr. Chawla led analytical strategy at Vir Biotechnology, contributing to the development of therapies for infectious diseases, including sotrovimab, tobevibart, and elebsiran. She began her industry career at Cellerant Therapeutics, specializing in process and analytical development for an allogeneic stem cell therapy for radiation-induced neutropenia. Dr. Chawla completed postdoctoral fellowships in Biomedical Engineering at Northwestern University and in Chemistry at UC Irvine. She holds a PhD and MS in Bioengineering from the University of California, San Diego, and a BS in Chemical Engineering from the University of New Mexico, where she was recognized as a Distinguished Young Alumna. Contact

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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Nathan Parker Sr. Consultant Nathan is a distinguished pharmaceutical quality professional with 30 years of leadership experience spanning biologics, sterile injectables, cell therapy, and small molecule manufacturing. His career reflects a strong track record of building scalable quality systems, leading high-performing teams, and guiding organizations through major regulatory milestones, operational scale-ups, and enterprise transformations. Nathan has been consulting for pharmaceutical companies for over 3 years and has provided support for facility start-ups and qualification, CDMO oversight, technology transfers, batch release, quality management system development and improvement, computer system validation and data integrity assessments, significant deviation investigations, root cause analyses, corrective/preventive action development, and inspection preparation and support. Prior to consulting, Nathan was a senior quality and operations leader for API, DS, DP, and cell therapy contract manufacturing companies. In these experiences, Nathan identified and prioritized quality improvements by utilizing risk and gap assessments, built successful teams and developed personnel through formal training programs and mentoring, developed structured approaches for deviations, change controls, laboratory investigations, and CAPA identification. Other areas of focus included data integrity, computer system validation, DP visual inspection, expedited batch release, quality backlog reduction, equipment qualification including process utilities and sterilization systems, process validation, environmental and contamination control strategies, and cleaning validation. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Richard Blackmore, Ph.D. Sr. Consultant Dr. Blackmore has over 27 years of experience in development of fermentation, purification, and chemical modification processes for human therapeutic proteins. He has extensive experience in cGMP manufacturing support, scale-down process modeling, computer-based monitoring and control and technology transfer. Dr. Blackmore has particular skills in mathematical modelling of biological processes and in Exploratory Data Analysis. Dr. Blackmore's career started at Baxter/Somatogen where he developed fermentation and purification processes for various products and managed the R&D fermentation facility. He then proceeded to Seattle Genetics where he developed and scaled up processes for monoclonal antibodies and Antibody Drug Conjugates. Subsequently Dr. Blackmore spent time at Emergent Biosolutions/Trubion where he gained experience on mono and bi-specific mAb-like bio-pharmaceuticals based on scFv fragments. Dr. Blackmore has also spent a number of years at Dendreon where he has managed upstream and downstream development organizations for antigen development as well as technical support for CMO operations and the Process Monitoring Program for Dendron’s Autologous Cellular Immunotherapy (Provenge™). Dr. Blackmore holds a Ph.D. in Biological Sciences from University of East Anglia, Norwich, U.K. and was a Postdoctoral Fellow at Cornell University, Ithaca, NY. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Xiaoyu (Sam) Hu, Ph.D. Consultant Xiaoyu (Sam) Hu, Ph.D. Dr. Xiaoyu “Sam” Hu is a biopharmaceutical Technical Operations and MSAT leader with extensive experience spanning gene and cell therapy, viral vectors, vaccines, virus-like particles (VLPs), and conjugated biologics. His expertise includes technology transfer, process characterization and validation, PPQ and commercial readiness, CDMO oversight, manufacturing troubleshooting, and lifecycle CMC strategy. At Aura Biosciences, he led sponsor-side process validation strategy for a late-stage conjugated VLP therapeutic across a multi-CDMO manufacturing network and established the company’s lifecycle process validation framework. Previously at Novavax, he led global PPQ and validation strategy across more than eight CDMOs supporting commercial vaccine supply and regulatory approvals or authorizations in more than 40 countries, and served as a Drug Substance technical and BLA lead for validation and manufacturing content. Earlier at Lonza, he led technology transfer of more than 10 viral-vector programs into GMP manufacturing, including one program that advanced to commercial manufacturing, while providing MSAT leadership for GMP campaigns, investigations, troubleshooting, CAPA, and continued process verification. Dr. Hu brings experience from both sponsor and CDMO perspectives and has partnered cross-functionally with Quality, Regulatory, Process Development, Manufacturing, and Supply Chain organizations. He holds a Ph.D. in Biomedical Genetics from the University of Rochester Medical Center. 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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Ramji Krishnan, Ph.D. Prin. Consultant Dr. Ramji Krishnan has over 25 years of experience in biologics, cell and gene therapy development, and commercialization. He began his career as a bench scientist and progressed into leadership roles spanning multiple functions, including manufacturing, regulatory sciences, process and analytical development, supply chain, and engineering. Most recently, he served as the Chief Technology Officer (CTO) at Celularity, where he was responsible for the technical development of CRISPR-based genetic engineering tools for allogeneic cell therapies, including CAR-T and CAR-NK cells. Prior to that, Dr. Krishnan led Manufacturing, MSAT and all CMC technical development for both AAV (AAV9) and autologous Hematopoietic Stem Cell (CD34+) therapies at Rocket Pharmaceuticals. In his role at Celgene, prior to its acquisition by Bristol-Myers Squibb (BMS), he was the Global Head of Biologics MSAT. Dr. Krishnan began his career at BMS, supporting product development, approval, and lifecycle activities as a technical and regulatory lead for several products, including Reblozyl, Opdivo, Myalept, Yervoy, Nulojix, Orencia IV, and Orencia Sub-Q. Dr. Krishnan's passion lies in creating positive patient outcomes through product development. He is dedicated to finding optimal solutions and helping teams collaborate strategically to achieve clinical, regulatory and commercial success. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Sunitha Lakshminarayanan Prin. Consultant Sunitha Lakshminarayanan has more than 25 years of biopharmaceutical development, manufacturing and commercialization experience across cell therapy, biologics, biosimilars, radioligand therapies, vaccines, oral solid dose products and injectables. Most recently, as CTO of Melinta Therapeutics, she led Manufacturing, Quality, Supply Chain and Technical Operations for a global commercial portfolio, driving significant improvements in cost, supply reliability and operational performance. As SVP at Actinium Pharmaceuticals, she led CMC and Technical Operations for a clinical-stage radiopharmaceutical portfolio. At Bristol Myers Squibb/Celgene, she built and led a 50-person global cell therapy Process Engineering organization and directed process validation, comparability and manufacturing readiness supporting the approvals of Breyanzi® and Abecma®. At Kashiv BioSciences, she led development and manufacturing activities for biosimilars, including the development and FDA approvals of Releuko® and Fylnetra®. Earlier roles at Progenics and BioReliance included biologics and vaccine development, clinical manufacturing and technology transfer. She holds an MBA from Northwestern University’s Kellogg School of Management, an M.S. in Chemical Engineering from Penn State University, and a B.S. in Chemical Engineering from Coimbatore Institute of Technology. Contact