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 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 Zahbea Saund Sr. Consultant Zahbea is a seasoned professional with extensive expertise in CMC program leadership and CDMO management. Her career spans over 30 years in biopharma and she has a proven track record in leading cross-functional teams, managing the complexities of drug development, scenario planning and aligning teams to achieve program and corporate goals. Zahbea’s experience spans the entire product development lifecycle across biologics, cell and gene therapy, biosimilars and vaccines. She is a highly collaborative strategic thinker with a focus on execution and driving results. She excels at building relationships with and amongst team members and is passionate about bringing teams together to define and align on a path forward to meet program goals and deliverables. As an innate problem solver and holistic thinker, she drives teams to assess multiple scenarios and incorporate contingencies and mitigations into a program plan. Zahbea strives for and drives success by maintaining positive team dynamics and ensuring the infrastructure/ business practices support the aligned upon plan for successful product development. Zahbea has worked at Amgen, Lyell Immunopharma, Bill & Melinda Gates Foundation and Novavax. She holds a B.S. in Biology from UCLA, and certifications in clinical trials, mediation, decision making and coaching from UW. 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 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 Navid Ghaffari Consultant Navid Ghaffari is a results-driven biotechnology expert with a proven track record in advancing cell and gene therapy from discovery to commercialization. In over 11 years of experience, Navid has led several projects on process development and optimization, as well as process control strategy, technology transfer, and life cycle management in start-up and major pharmaceutical companies. Before starting his consulting career, in his most recent role as associate director of technology transfer and life cycle management, Navid led the technical transfer of a new CAR-T drug product for Phase II clinical development to a US-based Bristol Myers Squibb’s manufacturing facility. While working with the Manufacturing, Manufacturing Science & Technology (MSAT), Supply Chain, Quality Assurance, Quality Control, Business Operations, and Regulatory Affairs teams Navid ensured a seamless technology transfer on an aggressive timeline to meet the company’s needs. Prior to Bristol Myers Squibb, Navid held roles at Sartorius AG and Lyell Immunopharma, as a Scientist, allowing him to gain in-depth and hands-on knowledge of bioreactor and cell culture operations from automated small-scale bioreactors (Ambr 15 and 250) to bench-top, pilot scale, and large-scale manufacturing bioreactors. Navid possesses strong working knowledge of both stirred tank (STR) and Rocking Motion (RM) bioreactors. In addition, he has surveyed and studied several technologies in every aspect of immune-cell therapy processing including selection technologies, activation, genetic modification (transduction and transfection), cell expansion, process analytical technologies (PATs), final drug product formulation, and cryopreservation. With a strong background in statistical and multivariate analysis as well as Design of Experiments (DoE), Navid is highly skilled in data driven problem-solving and root cause analysis. In collaboration with the Bio-statistics team at Juno Therapeutics, Navid drafted the Statistical Process Control (SPC). Navid holds a Master of Applied Science (MASc) degree in Chemical and Biological Engineering from the University of British Columbia. Contact

Offering Consultation for Cell and Gene Therapies, Biologics, Antibodies, ADCs, Biosimilars, Virology, and Non-Viral Gene delivery. < Back Elijah Tan Prin. Consultant Mr. Tan has over 25 years of experience in the biotechnology/pharmaceutical industry, with close to 2 decades of biologics and biopharmaceutical CMC regulatory experience. Since starting his consulting career in 2017, Mr. Tan has advised numerous cell and gene therapy, biosimilar, and novel biologic clients on a wide range of CMC topics and provided services such as regulatory strategy consultations, global submissions, health authority interactions, and CMC gap assessments. He has spearheaded regulatory strategies, significantly contributed to 9 BLA and 2 EU MAA approvals, and supported more than 40 investigational biological products, including monoclonal antibodies, bi- and tri-specifics, gene-edited autologous therapies, mRNA/lipid nanoparticle products, oncolytic viruses, and antibody-drug conjugates across different stages of clinical development. Before consulting, Mr. Tan held senior leadership positions in regulatory affairs at Coherus Biosciences, Genentech/Roche, and Biogen, where he was responsible for global CMC regulatory strategies, health authority negotiations, and successful product approvals. He also has hands-on experience in pharmaceutical development, analytical chemistry, quality assurance, regulatory compliance, and quality systems implementation from his earlier career at Vertex Pharmaceuticals and Merck. Mr. Tan is US-RAC and EU-RAC certified and holds an M.S. in Pharmaceutical Quality Assurance/Regulatory Affairs from Temple University and a B.S. in Chemistry from West Chester 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 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 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

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 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