Accelerating digitization in cell & gene therapy manufacturing: real-world insights & practical strategies

Rebecca Street-Howard leads RoslinCT’s digital operations, bringing over a decade of experience in transforming and optimizing digital infrastructure for growth. Rebecca brings over 20 years of experience having held various positions across R&D and supply chain at GSK. Her passion for science, technology, and engineering in the pharmaceutical industry drives her commitment to advancing lifesaving medicines. With deep expertise in biopharmaceutical scale-up and launch, sterile manufacturing, and digital transformation, Rebecca has achieved industry-first innovations, including designing and delivering one of the UK’s first digital factories. She now applies this expertise to the unique challenges of industrializing cell and gene therapies, focusing on efficient, cost-effective production with a global reach. Rebecca’s experience in scale-up, global product launch for large molecules, and lean manufacturing supports RoslinCT’s mission to lead in operational excellence for advanced therapies.

Tour Ala currently serves as the IT Lead for Cell & Gene Therapy Technical Operations at Roche.  The scope of the role starts from early development, through clinical manufacturing and to commercial supply. Responsibilities include leading the IT design and road-mapping, delivery and operations for manufacturing and supply chain processes. Prior to joining Roche in February 2020, Tour Ala had an extensive career at GlaxoSmithKline from October 1988 to December 2019, holding various senior roles such as Supply Chain IT Lead,  Agile Transformation Program Lead, Digital Data and Analytics Lead, and Chief Architect for Global Manufacturing and Supply Chain. Tour Ala's work has focused on designing and developing innovative technology standards, driving agile transformations, and enhancing digital analytics capabilities within the pharmaceutical sector. Educational background includes a Higher National Diploma in Business Information Technology from Buckinghamshire New University.

Chris Baldwin is the VP, Manufacturing & Supply at Resolution Therapeutics, a Regenerative Macrophage Therapies clinical phase company. Prior to joining RTx, he was the Senior Director for Cell & Gene Therapy Supply Chain at GSK with accountable for the vein to vein supply chain for T-Cell autologous Oncology products. His team covered forecasting, logistics, labelling, Chain of Identity, apheresis collection qualification, patient scheduling and developing the cell therapy digital ecosystem. He was accountable for autologous clinical supply for multiple pilot and a pivotal registration study across North America, Europe and Australia under a Master protocol approach, and developed the patient journey and operational model for commercial supply. Chris is a champion for cross industry standardization including industry chair of a workstream for the UK’s ATTC network. In previous roles, he has lead matrix teams for CMC development and supply for complex biological products including vaccines, MAbs, biosimilars and Antibody Drug Conjugates, including Arzerra/Kesimpta, Blenrep and Arexvy. Chris holds a PhD from University of Cambridge, a Masters from University College, London and BSc from University of Kent.

Dr Nicole Mather leads IBM’s Life Sciences consulting team across UKI and EMEA, which brings world-leading business, technology, and digital capabilities to innovative pharma and growing SMEs. Building on a vision to transform the future of health for patients, her teams combine a collaborative culture, innovative approaches, and technical depth to enable business transformation. IBM combines a trustworthy approach to AI and deep experience in data & hybrid cloud infrastructure to deliver change, safely at scale. Working with IBM Research enables cutting-edge technologies and methods to be incorporated into client solutions across UKI and EMEA. As the founding Director of the Office for Life Sciences, across the Departments of Health and Social Care and Business, Energy and Industrial Strategy, Nicole shaped the policies underpinning the UK Life Science ecosystem and data environment, working across government and the private sector, including the design and evolution of the Digital Innovation Hubs and NHS genomics programmes. She led the development of the first Life Sciences Sector deal, cementing key elements of the sector-led Life Sciences Industrial Strategy. Nicole was responsible for supporting investment into the UK across Life Sciences research, health data and genomics. Prior to OLS, Nicole had over 15 years’ experience as a strategy consultant at Deloitte and Kearney. Currently, Nicole serves as a NED at the Cell & Gene Therapy Catapult and The Wellcome Genome Campus. She holds a DPhil in Neuroscience from the University of Oxford.

Peterjohn (PJ) currently leads the GxP Digital Systems Team for the gene therapy manufacturing and supply chain organization at Genentech in Philadelphia PA. Part of the Roche gene therapy innovation center, this business unit is dedicated to discovering, developing, and delivering innovative treatments for genetic diseases. Before joining Spark, PJ spent over 18 years in the biopharmaceutical industry across a variety of roles in manufacturing operations, process automation, global engineering, and enterprise data & analytics. PJ is a hyper curious leader, recognizing that "Empathy for the business process, and those who execute them is a success factor for lasting digital transformation / pharma 4.0 programs". PJ is active across several Pharma 4.0 communities, seeking to keep up with the pace of innovation, and build new connections to learn from.