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Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Beth Brown, Ph.D. Prin. Consultant Dr. Brown has over 30 years’ experience in pharmaceutical product, process, and analytical development and commercialization of 40+ diverse product lines. She has led programs for small organic molecules, oligonucleotides, peptides, mAbs, cell and gene therapy, microbial restoration therapy, adenovector and protein/adjuvant vaccines, and drug/device combination products. She has been the primary author of Module 1, 2 and 3 CMC global regulatory documents (FDA, HC, EMA, MHRA, TGA, Medsafe, PMDA) including leadership of IND, ANDA, NDA, BLA, EUA, MAA and PMA submissions, briefing packages, change control regulatory assessments, and RFI rapid response teams. Beth has performed CTO activities including due diligence library design, regulatory pathway strategy, patent assessments, creation of target product profiles and business plans, including pitch decks and documents to support investor funding. She has led CDMO/OTL selection, created procedures for supplier identification/selection and managed outsourced technical transfer programs. She holds a Ph.D. in Pharmaceutics from University of Michigan, Ann Arbor and a B.S. in Pharmacy (Pharmacist) from Purdue University, West Lafayette. Contact

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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Mohammad El Kalay, Ph.D. Prin. Consultant Entrepreneurial Technical Operations senior executive with over 30 years of professional leadership and expertise that spans start-up to late-stage Cell & Gene Therapy companies. Extensive experience building Technical Operations teams that have successfully completed CMC requirements supporting Phase I through Phase III to early product commercialization. Experience interacting with and filing numerous regulatory packages with FDA as well international regulatory agencies. Extensive experience selecting and managing CDMO, including overseeing Tech Transfer of manufacturing process and analytical assays to USA and internationally based CDMOs. Contributed in development of two approved products: AIS’ stem cell purification device, CELLector and, Osiris’ GvHD mesenchymal stem cell product, Prochymal. Mohammad holds a BSc. in Chemical Engineering, and MSc and PhD in Biomedical Engineering from Strathclyde University, Glasgow, Scotland, UK. Contact

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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Julie Shi, Ph.D. Consultant Dr. Julie Shi has over 8 years of experience in the biotech industry, specializing in cell and gene therapy development. She has held key technical leadership roles at Juno Therapeutics, Bristol Myers Squibb, and Sana Biotechnology, contributing to the advancement of autologous and allogeneic CAR-T and TCR-T cell therapy programs. Julie combines deep scientific expertise in non-viral gene delivery technologies, including lipid nanoparticles, gene editing, and transposons, with a proven track record of developing scalable and clinically relevant manufacturing processes. Her work spans early-stage research through pivotal process development, where she has been instrumental in driving the advancement of novel gene and cell therapies. Julie has contributed to regulatory submissions, including authoring technical reports in support of IND filings, and has played a central role in advancing multiple programs through the development pipeline. She has also led technical due diligence efforts and developed technology roadmaps, providing strategic insights for investment and pipeline decisions. Julie holds a patent for a lipid nanoparticle formulation process, has authored several publications, and has been invited to speak at conferences to share her expertise in gene delivery technologies for cell therapy. As a data-driven leader, Julie is skilled at implementing data analysis workflows to optimize manufacturing processes. She utilizes QbD approaches, including Design of Experiments (DOE) methodology, to ensure process robustness and accelerate the transition from R&D to commercial-scale production. Her leadership experience includes building and managing cross-functional teams, establishing new process development labs, and driving tech transfer and process optimization efforts. She holds a BS in Chemical Engineering from MIT and earned her PhD in Bioengineering from the University of Washington, where she focused on non-viral gene delivery, and completed a postdoctoral fellowship at the University of Toronto on peptide drug delivery systems. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Steven L. Cockrill, Ph.D. Prin. 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

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Edward N. Pedersen Process Architect Mr Pedersen has over 40 years of experience in the design and management of facility projects for biologics, biopharmaceuticals, cell and gene therapy, antibodies and biosimilars. His experience spans site evaluation, concept design through construction, building code analysis, construction site technical support and project management for labs, warehouse, administrative, utilities and site security systems. He has worked with the numerous teams as Process Architect and Master Planner to interpret PFDs for equipment needed, the sequence and space for unit operations, and the product material inputs and utilities, inclusive of considerations for adjacencies of unit operations with layouts as well as FDA regulatory requirements. Mr. Pedersen has extensive experience in programming of API, primary and secondary manufacturing, lab module requirements for R&D, macro bench scale-up, stability, virology, pharm/tox, immunology/cell biology, microbiology, chemical, pharmaceutics, genetics, combinatorial chemistry, analytical microbiological, trace-level radio isotopes, robotics, QA/QC, raw material sampling and testing labs. Ed is a member of the American Institute of Architects, the International Code Council and ISPE where he has completed courses in cGMP, GLP, barrier technologies/potent compounds, aseptic processing and biotechnology facility design as well as serving as past local chapter board member, program committee chairman, newsletter editor and presenter at various national chapter forums. Ed received his Bachelor of Architectural degree from Pratt Institute and his commission in the USNR upon graduation where he served as Asst Public Works officer in the Seabee base in Gulfport, MS. After completing military service he attended Columbia University and with a MS in Urban Planning. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Rajesh G. Beri, Ph.D. Prin. Consultant Dr. Beri has over 30 years’ experience in the Biotech Industry, starting as a bench scientist with Lonza Biologics in 1996 and progressing to Executive Level Leadership positions at Senda Biosciences and Goodwin Biotech, prior to launching his consulting career. During his career, Rajesh has managed over 70 biologics projects from pre-clinical through commercial approval and has played a key role in approval and life cycle management of leading biologics products such as YERVOY®, ORENCIA®, OPDIVO®, ARZERRA®, BENLYSTA®, SOLIRIS® and StrenSIQ®. He has established and led development, manufacturing sciences, technical operations and CMC functions at several organizations while promoting a culture of technical excellence and quality compliance. His teams have supported manufacturing, supply chain, engineering, quality, regulatory and business development functions. Dr. Beri has a strong track record of active participation at industry events with over 20 presentations and 5 publications, 2 granted patents and 1 patent pending approval. He has been a key steering committee member of Biophorum Operations group (BPOG), contributing to the publication of white papers covering Characterization, Validation and Continued Monitoring of Biologics and a Technology Roadmap for Biomanufacturing. Based on his experience, Dr. Beri is well positioned to assist pharma and biotech companies with a broad range of technical, operational, and strategic expertise in development and manufacturing of multiple product modalities manufactured using both mammalian and microbial expression systems such as recombinant proteins, monoclonal antibodies, ADC’s, mRNA, and Lipid nanoparticles. Rajesh’s expertise spans from cell line generation to drug product manufacturing and packaging, and from pre-clinical through post approval and the associated regulatory interactions. Dr. Beri received his Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology, Mumbai, India and his Masters, and Doctorate degrees in Chemical Engineering from Worcester Polytechnic Institute. 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 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

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

Reach goals using expertise in CMC , Technical Outsourcing, and project management. Trust our consulting firm for solutions tailored to your needs in Cell & Gene Therapy and more. Our Expertise Regardless of your need in product areas including therapeutic proteins, monoclonal antibodies, biosimilars, or cell therapies, our broad range of services can help enhance your company's value every step of the way from early stage development to approval, launch and commercialization. Product, Process & Analytical Development Our extensive product, process and analytical development experience enables us to help you transition your products from discovery to the clinic and to market faster and with less expense and risk. Whether your product is in pre-clinical development, clinical trials, or already on the market, we can help increase its value by identifying opportunities for yield improvement, enhanced product quality, ease of scalability, greater process robustness, cost reductions, and reduced processing times. Read More Outsourcing and Supply Chain Management Pharmefex offers comprehensive CMC outsourcing and supply chain management services to help you develop outsourcing strategies that meet your needs and requirements throughout all stages of your product's lifecycle. During product development, we can manage all activities including cell line development, cell bank preparation and testing, process development, analytical method development, and formulation development. Read More Risk Management Whether you are using Quality Risk Managment as part of your overall development strategy, or using the various tools and techniques to identify your CQA's, prioritize your studies, conduct root cause investigations, or improve the effectiveness and efficiency of your processes, Pharmefex has the expertise to help you from start to finish. Why take a risk when it comes to risk management? Contact us today to find out how we can help you. Read More Manufacturing Strategy & Operations Pharmefex is devoted to helping you make sound operational decisions to support all your manufacturing, outsourcing, and facility requirements. We can help you manage outsourcing projects, implement strategies to build an optimal development and manufacturing organization, effectively communicate your CMC strategy, and efficiently manage your workflow to accelerate development of your products. Read More Quality And Regulatory Pharmefex supports all of your quality and CMC regulatory requirements through the design and implementation of quality systems appropriate for the stage of your product. We can prepare and review standard operating procedures, phase-appropriate product specifications, and process or method qualification protocols. We specialize in writing, reviewing and negotiating Quality Agreements with your contractor(s) to ensure that they are comprehensive and protect your investment. Read More Program Management Pharmefex offers comprehensive and dynamic project planning and management services to keep your development and commercialization programs on time and within budget. Our team can help you integrate all of your product development requirements into comprehensive playbooks that provide seamless roadmaps for efficient management of your product development programs from the initial identification of a new product candidate through clinical trials and commercialization. Read More