our team
Dr. Mohammad El-Kalay
Mohammad El-Kalay is a Technical Operations executive who has spent his career building the manufacturing and quality foundations behind some of the most advanced therapies in Cell & Gene Therapy. From early-stage start-ups to late-stage clinical and commercial programmes, he has led the technical work that turns promising science into therapies that can actually reach patients — process and analytical development, CMC strategy, tech transfer, CDMO partnerships, quality systems, and regulatory submissions to the FDA and PMDA.
His work spans a remarkable range of modalities, with particular depth in iPSC-derived cell therapies across NK cells, macrophages, and microglia, alongside AAV gene therapy vectors, transposon-based CAR-T, MSC-based treatments, and neural stem cell programmes. He built Technical Operations functions from the ground up at companies like Shoreline Biosciences and Savanna Biotherapeutics, led CMC for a Notch-1 gene-modified MSC therapy through Phase III at SanBio, and managed AAV vector manufacturing across multiple clinical assets at Sangamo Therapeutics. Two of the products he’s contributed to have reached commercial approval: Prochymal, an allogeneic MSC therapy for graft-versus-host disease, and CELLector, a stem cell purification device.
Mohammad also co-founded EyeCyte, where as President and CEO he raised seed funding from Pfizer and secured a term sheet from Santen Pharmaceuticals to advance cell-based and peptide therapies for retinal disease.
Today, he works as an independent Technical Operations and CMC consultant, currently advising CytoHub on their allogeneic iPSC-derived cardiomyocyte programme. He holds a BSc (Hons) in Chemical Engineering and a PhD in Biomedical Engineering, both from the University of Strathclyde, Glasgow.
Dr. Geoffrey Stephens
Geoffrey Stephens, PhD, MBA, is a seasoned biotech executive with over 25 years of experience bridging science and business across both large pharma and innovative startups. With deep expertise in immunology, cell therapy, and bioinformatics, he has led cross-functional teams through the full spectrum of drug development — from discovery to IND and commercialization — in autoimmune disease, oncology, and inflammation.
He began his scientific career with early training at the NIH/NIAID, and has since built a proven track record of scientific leadership:
- At AstraZeneca/MedImmune, he led biologics discovery teams, advancing multiple programs in the autoimmune pipeline and playing a key role in the development and approval of **Benralizumab (Fasenra®)** for asthma.
- As Head of Process Development at Tessa Therapeutics, he helped drive CD30-CAR-T therapies toward RMAT (FDA) and PRIME (EMA) designation for lymphoma.
- At Immatics, he directed Product Science efforts focused on TCR-T cell therapies for solid tumors.
Geoffrey also co-founded Cellcion, where he served as Chief Scientific Officer, developing AI-powered tools to decode complex immunological networks. Today, he continues to integrate science and technology to push the frontiers of cell therapy innovation.
Areas of expertise: CAR-T, TCR-T, regulatory T cells, biologics, process development, molecular biology, GMP manufacturing, and advanced data analytics.
Sibylle Hauser
Her international professional career spans over 25 years in global Pharma, including Boehringer Mannheim/Roche for 9 years, emerging Biotech and contract manufacturing with a successful track record in corporate business development, in-licensing, fundraising, strategic planning, and international commercialization including a US biopharmaceutical product launch. Her roles in the past years focused on the capital access and fundraising side with an emphasis on Cell- and Gene Therapy technologies as well as Precision Medicine. In her current role at Open Biopharma Research & Training Institute she is leveraging her experience in the CGT and diagnostic space. Former roles include Executive Director, Innovation & Entrepreneurship at California Life Sciences with a focus on connecting Innovators with Seed and series A capital and organizing an Investor Partnering event in 2023. Prior to this role she has been Strategic Advisor – Life Sciences at Richtr Financial Studio broadening her expertise in the due diligence process of early-stage funding rounds.
Her passion, experience and expertise in supporting first-time founders in accessing and securing capital led her to start and chair the Women In Bio-Entrepreneur Center. From 9/2018 through 5/2022 she connected and enrolled over 90 female founders with innovative life sciences technologies across the US.
She is a member of the Board of Directors at SiVEC Biotechnologies as well as a member of the Investment Committee of the Gates Center for Regenerative Medicine at University of Colorado Anschutz Medical Campus.
Dr. Savita Nair
Savita Nair, PhD, is a scientific leader in biopharmaceutical analytical development, specializing in immunoassay strategy and CMC for gene and cell therapies. With over 15 years of experience spanning early research to commercialization, she has built and led analytical teams at Sangamo Therapeutics, Merck, Atrin Pharmaceuticals, and Fox Chase Cancer Center. Dr. Nair’s work transforms scientific innovation into real-world therapies by driving the development, validation, and regulatory strategy for potency, antigenicity, and identity assays that support product quality and safety. Her expertise encompasses method development, tech transfer, CRO/CDMO partnerships, and regulatory submissions across multiple stages of drug development. Her passion for science and commitment to empowering others make her a respected leader, both professionally and in her community, earning her a 2023 HBA Rising Star Award in Healthcare Leadership.
Dr. Shesh Sharma
Shesh Sharma, PhD, MBA is a biotech leader and management consultant with significant experience driving business transformation and scaling operations across high-growth startups and Fortune 100 biotech companies. Over the past decade, he has partnered with early- and late-stage CGT organizations across autologous, allogeneic, and iNK (iPSC) platforms—supporting programs from preclinical development through commercialization.
He works closely with executive teams to design fit-for-purpose organizations, architect scalable operating strategies, build and lead high-performing teams, and deploy AI-enabled manufacturing and supply chain capabilities—driving efficiency, cost discipline, and execution at scale through advanced analytics and automation. His experience includes strategic sourcing of direct and indirect materials (>$1B spend) with double-digit savings delivery, as well as CDMO partnership management and technology transfer to enable reliable, scalable operations. He brings a proven ability to connect strategy to execution—aligning operations, technology, and procurement with critical business, capital, and regulatory milestones..
In parallel, he supports founders and investors on operational diligence, investor positioning, and fundraising—bringing an operator’s lens to company building. He also contributes to industry thought leadership, with published insights on CGT commercialization, strategic sourcing, and biotech board composition and governance.
Earlier in his career, he held leadership roles at top-tier consulting firms, including Kearney and PRTM.
He is currently building a venture platform focused on enabling technologies that simplify the drug development process, reduce costs, and accelerate time to market.