Chris Baldwin

Leading the Cell Therapy Manufacturing and Supply Chain function

Secondment (6 month part time) to establish the new Digital Biological Twin unit lead to support clinical development of drug pipelines and contribute to preclinical development programs within GSK. Exploiting patient derived organoids, the DBT unit will apply a multimodality analytical approach, plus machine learning models which are coupled with paired patient-derived data feedback, to improve cancer patient risk stratification as well as to predict future targeted and/or immuno-therapy susceptibilities. Building synergy and collaboration between new unit and KCL scientists within the GSK-King's College London (KCL) Translational Oncology Research Hub, an exclusive research collaboration between GSK and the Comprehensive Cancer Centre at KCL. Provide functional and strategic linkages between the GSK Digital biological twin unit and other units (e.g. AI/ML, EMU, Clinical Development, Clinical Operations, Functional genomics, proteomics, Clinical Imaging) working together towards improving patient stratification of clinical treatments using GSK assets, alone or in combination with standard of care treatments

Leading the Cell and Gene Therapy Supply Chain global team to enable GSK’s expansion into Oncology Cell Therapies. Encompassing vein-to-vein supply chain from apheresis to infusion including Patient Operations, Apheresis/Tissue Operations, Cell Therapy digital ecosystem (including Patient management/scheduling & CoI/CoC software), and Global logistics. Support definition for Target Product Profile and Commercial Vision. Co-lead on project to define Cell Therapy commercial patient journey, site on-boarding, and defining internal commercial playbook. Engaged with multiple site advisory boards to ensure optimal cell therapy experience for treatment centers. Successfully delivered cell therapy supply for Lete-cel pivotal clinical trial (NCT03967223) and second generation trials (NCT04526509). Developed FDA and EMA briefing documents to support regulatory scientific advice requests. GSK lead on CGT cross industry standardisation efforts including SCB (https://www.standardscoordinatingbody.org/) and ATTC (https://www.theattcnetwork.co.uk/). Regular presenter and panel member at CAR-TCR and Supply Chain & Logistics for Cell Therapy Summit. Preparation for CGT Catapult supply including HTA licensing requirements for import of apheresis starting materials. Lead the CMC Business Development project for the transfer of NY-ESO from GSK to Adptimmune.

Leading the Cell and Gene Therapy Supply Chain global team to enable GSK’s expansion into Oncology Cell Therapies. Includes vein-to-vein supply chain from apheresis to infusion including on-boarding, personalised cell supply chain coordination, electronic cell tracking, specialist and cryo-logistics, warehousing and managing supply of raw materials.

Leading the Cell and Gene Therapy Supply Chain global team to enable GSK’s expansion into Oncology Cell Therapies. Includes vein-to-vein supply chain from apheresis to infusion including on-boarding, personalised cell supply chain coordination, electronic cell tracking, specialist and cryo-logistics, warehousing and managing supply of raw materials. Co-lead for project to define the optimal clinical patient journey and develop commercial patient journey.

Building and Leading the new Rockville Vaccine Technical Development Leader group to enable progression of adjuvanted Respiratory Syncytial Virus vaccine (now commercialized as Arexvy) and Self Amplifying mRNA vaccine development programs.

Lead delivery of Biopharmaceutical CMC matrix team (Late phase Oncology). Arzerra/Ofatumumab CMC divestment and implementation lead for GSK-Novartis transaction. Developed CMC/Supply strategy following divestment of Arzerra indications and subsequent divestment of Autoimmune indications (now commercialised as Kesimpta). Immuno-oncology portfolio development strategy and supply chain strategy lead. Developed CMC/Supply chain strategy for BCMA antibody-drug conjugate (now commercialized as Blenrep)

Biopharm CMC project leadership (JCR partnered Biosimilar Programs including JR-051)

Prepare CMC sections (all phases) for INDs, IMPDs and CTD-Mod3 packages for hand off to Therapy area regulatory. Manage the matrix submission writing process. Prepare CMC RTQs for submission. Develop CMC Reg strategy for development programs.

Led Process Dev team for GMP Tech Transfer and validation for attenuated microbial lyophilized Typhoid vaccine

Process Development (Fermentation and Primary recovery) for Pegylated Antibody Fragment Drug (commercialized as Cimzia)

Fermentation studies for the production of Arachidonic acid by filamentous fungus Mortierella alpina