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Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Wendy Laderach Prin. Consultant Wendy Laderach has over 30 years of experience in various quality roles. She previously served as the Senior Vice President of Corporate Quality, Quality Site Head of External Supply, Site Quality Assurance Head and Head of Quality Control at both a Site and Corporate level. A process-oriented leader with an extensive background in operational leadership, regulatory and operational excellence, Wendy consistently balances quality, requirements, and operational needs to develop solutions which ensure optimum performance. Wendy has led global initiatives in Analytics, Regulatory Reporting, Information Technology Tool Implementation, Inspection Preparation and Process Development at her previous companies generating value through elimination of waste and generation of hard savings. She has a proven track record of results across quality assurance, quality control, operations and regulatory while also holding key leadership positions within executive teams both within company and with external partners across the globe. Wendy received her BS degree in Biochemistry, her Master’s degree in Business Administration and is certified in Data Management and Regulatory Affairs. Contact

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

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 Deepthi Kolli, Ph.D. Sr. Consultant Deepthi Kolli, Ph.D has over 15 years of cell therapy and biologics development and commercialization experience. Dr. Kolli has worked at and/or advised numerous cell and gene therapy companies on a vast array of CMC topics including development, technology transfer, CDMO selection, validation, comparability, regulatory submissions and interactions, and CMC strategy. Previously, Dr. Kolli served as Vice President of Process Sciences at ImmPACT Bio, where she led a team of scientists and engineers responsible for process development, analytical development, technology transfer, manufacturing support, quality control and overall CMC activities for bispecific CAR T cell therapeutics. Prior to joining ImmPACT Bio, she held increasing leadership roles at Sonoma Bio, Atara Bio and Charles River focusing on both autologous and allogeneic cell therapy products. She has hands on experience on various cell therapy products (CAR T, CAR Treg, CIK, CAR NK, iPSCs, HSC derived hybrid cells, Allogeneic T cells to name a few) in terms of starting cell material characterization, clinical correlations, specification setting, EOS, potency assay development, lyophilization, Quality investigations, NC/CAPA’s, and risk analysis and has presided over transfer, validation and submissions of numerous products. Dr. Kolli has extensive regulatory submissions and interactions including in the US, EU, China and Japan. Deepthi holds a Ph.D and M.S in Immunology from the National Dairy Research Institute, and a B.Sc in Biochemistry and Microbiology from Nagarjuna University in India. Contact

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