With a team of experts boasting a proven track record in advancing cutting-edge therapies, they excel in seamlessly integrating with clients, offering strategic and technical support, and delivering successful outcomes.
LET'S CONNECT
Ram Mandalam, PhD
Founder and CEO
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Elisa Brunette
Regulatory and CMC
Mona Chakravarthy
Quality Assurance and Compliance
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Tim Fong, PhD
R&D and Preclinical
Development
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Martin (Marty) Geidlin, PhD
CMC and Preclinical
Development
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Joseph (Joe)
Gold, PhD
Development and Manufacturing
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Brian Hampson
Manufacturing and Automation
Kathleen Perry
Quality Systems
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Ram Mandalam
PhD
Founder and CEO
Business Strategy & Operations
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Ram is an accomplished biotechnology executive with over thirty years of experience in cell therapy and biologics development with a proven track record of leadership and execution. His experience spans business strategy and operations, technical operations, product development, GMP manufacturing and clinical/regulatory affairs.
Prior to founding Citra BioConsulting, Ram was the CEO of Cellerant Therapeutics where he led the development of a pipeline of candidates for the treatment of hematological malignancies rapidly advancing the lead program from research to late clinical stage, established a regulatory strategy for product approval and obtained FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for the lead cellular therapeutic. Under his leadership the company received over $180M in non-dilutive government contracts and grants to support product and clinical development programs. He has also held leadership positions at Geron Corporation and Aastrom Biosciences. During his tenure at the three companies, he has led research, product and clinical development programs for various cellular therapeutics.
Elisa Brunette
Regulatory and CMC
Elisa Brunette is an experienced CMC and regulatory affairs professional with over 25 years in the development of cell and gene therapies. She has successfully delivered on numerous regulatory milestones through productive interactions with the FDA and has been responsible for CMC activities such as process and analytical development, GMP manufacturing and product release.
Prior to joining Citra BioConsulting Elisa was Executive Director of Regulatory Affairs and Quality Control at Cellerant Therapeutics. Additional experience includes positions at Geron Corporation, Genitope Corporation and RPR Gencell/Applied Immune Sciences. Elisa has held roles in R&D, product development, GMP manufacturing, quality control and regulatory affairs. She has been responsible for establishing GLP controls for nonclinical safety studies, has expertise in technical writing and regulatory filing, and is experienced in government grant/contract application preparation, program development and reporting.
Elisa has been a key participant and led preparations for pre-IND, Type C, End-of-Phase and other meetings with the FDA. She has experience working in multi-disciplinary teams for the development of comprehensive meeting briefing packages to gain acceptance of development plans from FDA.
Mona Chakravarthy
Quality Assurance and Compliance
Mona Chakravarthy is a highly experienced quality consultant specializing in regulatory strategies and quality assurance for biologics, including peptides, biosimilars, and stem cell therapies, and small molecules in pharmaceutical and biotechnology industries.
Mona’s expertise spans GMP document management, quality audits, deviation reporting, CAPA, change control, vendor qualification, SOPs, and training. She has managed cross-functional teams, conducted gap analyses, and overseen project timelines. As a database architect, she has streamlined compliance systems through secure electronic databases. Mona's proficiency extends to deviations reporting, investigations, root cause analysis, and corrective actions. Additionally, she has spearheaded initiatives related to change control, vendor qualification, annual reviews, product release, stability programs, and CMO interactions. Mona Chakravarthy has established herself as a trusted advisor, driving excellence in quality assurance and regulatory compliance for her clients in the pharmaceutical and biotechnology industries.
Tim Fong
PhD
R&D and Preclinical
Development
Tim has thirty years of industry experience with broad expertise in the cell and gene therapy field. His career spans the full spectrum from building new R&D programs in a start-up environment to leading multi-functional project teams at large biotech/pharma companies.
Prior to becoming a consultant, Tim was the first Chief Scientific Officer at GenEdit. Under his guidance, the company built the in vitro and in vivo screening platform to identify novel non-viral nanoparticles with tissue and cell specific delivery properties. He transitioned to the CTO position in 2022 to focus on expanding the delivery platform to target tissues beyond the CNS space. He has held positions of increasing responsibility at Viagene, Aventis Gencell, Sangstat Corporation, BD Biosciences, Progenitor Cell Therapy, Cellerant Therapeutics, AllCells, Inc., and GenEdit. Tim has led project teams in discovery research, preclinical proof-of-concept and IND-enabling studies, and GMP manufacturing process development to successfully complete several early phase human clinical trials in cell and gene therapy.
Martin (Marty) Geidlin
PhD
CMC and Preclinical
Development
Marty Geidlin is a seasoned technical operations leader with over thirty five years of experience in the development of cell, gene, and biologics therapeutics. His experience spans all aspects of preclinical and CMC development more recently in the areas of development of CAR-T and CAR-NK immunotherapies.
Prior to becoming a consultant, Marty was the Senior Vice-President, Head of Tech Ops, at Senti Biosciences, leading the manufacturing process development (PD) of the allogeneic NK-CAR programs. Before Senti, he led the PD groups at PACT Pharma (non-viral process for generating autologous neoTcR+ T cells), Poseida (non-viral process for generating autologous CAR-T’s), and Novartis (clinical and commercial manufacturing process for Kymriahâ). In addition, he led the implementation of AAV clinical manufacturing to support the Hemophilia, LSD, and neurodegenerative disease programs while at Sangamo. Marty has been involved with regulatory filings at various stages of development including BLA.
Joseph (Joe) Gold
PhD
Development and
Manufacturing
Joseph (Joe) Gold is a highly accomplished expert in the development and manufacturing of cell therapies. In his thirty years of experience, he has led projects ranging from establishing differentiation protocols from pluripotent stem cells (PSC) for cell therapy applications to process development and GMP manufacturing of cellular and gene therapy products.
Prior to becoming a consultant, he was the Vice President of Tech Ops and Manufacturing at Catamaran Bio, developing use of nonviral methods to generate allogeneic CAR-NKs to treat solid tumors. His other experiences include five years at City of Hope producing novel cell and gene therapies for clinical trials and four years at Stanford Cardiovascular Institute, focused on cell therapies for heart disease. Prior to joining Stanford, he was at Geron directing research and preclinical development activities related to PSC derived cells for various clinical applications. He has expertise in INTERACT, pre-IND, and INDs as well as extensive experience working with CIRM and NIH-funded projects.
Brian Hampson
Manufacturing and
Automation
Brian Hampson has several decades of experience in the biotechnology industry, including over twenty five years in the development of technology and processes for manufacture of cell & gene therapy products. He has held key executive and technical management positions at Progenitor Cell Therapy (a CDMO, now Minaris) and Aastrom Biosciences (now Vericel), preceded by novel semi-automated bioreactor development at Charles River Laboratories and Corning.
Brian has been a thought leader in applying automation and closed system design to cell-based processes and was a principal leader in the development of the AastromReplicell Cell Production System, a first-of-its-kind closed, automated manufacturing platform for culture-derived cell therapy products. Brian provides strategic and technical consulting to developers of cell & gene therapy manufacturing as well as related tools & technology providers. He currently sits on the Strategic Advisory Board of the Startup Lab, a part of the Advanced Regenerative Manufacturing Institute (ARMI)/BioFab USA.
Kathleen Perry
Quality Systems
Kathy has over 25 years of experience across quality assurance, medical device certification, integrated systems development, and consumables product launches. Along with her strong technical skills, she has successfully bridged the gap between highly technical biological research and quality systems to bring cutting edge products to market.
Prior to becoming a consultant, Kathy established Quality Management Systems from the ground up at two different innovative start-up biotech companies: Mammoth Biosciences and Twist Biosciences. She has authored quality manuals/policies and developed QMS processes such as risk management, design controls, supplier quality management, and corrective and preventive action. She has conducted multiple internal and external audits and obtained ISO certifications. Her quality systems experience includes Electronic Quality Management Systems (eQMS), cGMP, and Product Lifecycle Management (PLM). At Thermo Fisher Scientific, Kathy as the R&D lead, championed the launch of NGS and genetic analysis products.
