In his role as Associate Vice President of CMC Development Operations, Derek leads the clinical manufacturing strategy for Allergan’s global biologics portfolio, spanning eyecare, CNS, GI and medical aesthetics. This includes maintaining a network of strategic partnerships that enables the development of any class of biologic drug or device at any stage. In addition, Derek is the global product development lead for Brazikumab, an anti-IL23 monoclonal antibody in late stage, global trials for Crohn’s Disease and Ulcerative Colitis. Derek began his career at Celltech-Medeva, was a co-founder of Eden Biodesign, the operator of the UK National Biomanufacturing Centre, and since the acquisition of this business by Watson Pharmaceuticals in 2010 has held a variety of roles in business development, biologics operations and product leadership within Large Pharma. Derek has been an active member of the BIA Manufacturing Advisory Committee for over 15 years and is passionate about patient centricity. He has a PhD from Liverpool University and performed post-doctoral research in Manchester University funded by the British Heart Foundation.

Steve Bates has been the CEO of the UK Bioindustry Association since 2012. He currently chairs the International Council of Biotech Associations and has been a Board member of Europabio since 2015. Steve is the visible face of the vibrant UK life sciences industry to government and media. He sits on the UK’s Life Sciences Council and Life Sciences Industrial Strategy Implementation Board. Steve has championed with government effective industrial incentives like the Biomedical Cataylst which have crowded-in private sector investment into UK SMES. He has forged links for the sector across the USA, Europe and in China. In his time at the BIA Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before the BIA, Steve worked for Genzyme and as an advisor to the UK Government of Tony Blair. He was made OBE for services to innovation in 2017.

Sharon Grimster has been an active member of the UK bioprocessing community for more than 30 years, and she feels fortunate that her career spans an amazing period in biopharmaceutical development from working in manufacturing at Celltech in the early days of large scale GMP bioprocessing, up to her current role working with ATMPs at ReNeuron. Sharon was the chair of the BIA MAC from 2003 to 2006, and worked with the BIA to implement the recommendations of the BIGT report which resulted in the formation of BioProcess UK, for which she was the first chair of the steering committee.

Prior to working at ReNeuron, Sharon held senior team roles at Celltech, Antisoma and F-star, and during her career has had responsibility for a range of development functions, including project management, CMC, , medical devices, business operations, regulatory affairs and quality.

Sharon qualified as a coach at the Henley Business School, and she is also a current member of a number of industry steering groups and committees including MMIP, MAC and ATCC industry advisory group.

Jim Faulkner joined Autolus from GlaxoSmithkline, where he spent 15 years in a series of progressively senior roles within the Biopharmaceutical R&D Unit, latterly serving as Vice President, Manufacturing and Supply within the GSK Rare Diseases unit. Jim’s role spanned all the unit’s projects and products including its ex vivo autologous gene therapy portfolio, therapeutic oligonucleotides and monoclonal antibodies. Previously Jim worked within small biotech and has also held academic posts. He received a BSc in biotechnology from the University of Leeds and a PhD in molecular biology in association with the University of Kent and has authored a number of publications and patents in the field of biopharmaceutical development.

Ed serves as SVP Manufacturing at Achilles and has more than 16 years of industry and academic experience in process development, technology transfer, GMP manufacturing and regulatory affairs in the field of cell and gene therapy. Before joining Achilles, he was the Cell Therapy Operations Manager for Europe at Orchard Therapeutics where he was responsible for establishing the supply-chain infrastructure to support cell therapy manufacturing and regulatory submissions in the US and Europe. Previously, Ed held positions at Cognate BioServices Ltd as Director for Manufacturing and in post-doctoral translational research at University College London (UCL). He holds a PhD in T cell immunology and transplantation from UCL, and an MSc in Medical Immunology from King’s College London.

Jacqueline is the Chief Clinical Officer and a board Director of the Cell and Gene Therapy Catapult, the UK’s centre for the acceleration of the translation of cell therapies towards commercialisation. Prior to this Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. Before that she held a number of post-Doctoral academic posts at the University of Edinburgh studying neuromuscular regeneration. She has considerable experience in the development, translation, clinical trial and approval of cell based medicinal products and therapies.

About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 180 employees focusing on cell and gene therapy technologies, we aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.

Nick is responsible for overseeing the BIA’s operations, ensuring that all activities are professionally delivered to the highest standard. He will be providing an organisation-wide operational perspective to, and support for, activities and projects.

He has specific responsibility for office management/facilities, financial systems/processes and credit control, company secretariat, human resources and IT/telecoms. Nick joined the BIA in October 2014, bringing with him extensive industry and not-for-profit management experience.

Prior to this role he ran the Clinical Laboratory Division of Lab21. This involved providing specialist laboratory services to the healthcare, pharmaceutical and clinical trials markets. He had management responsibility for all operations, income, laboratory and customer services and client liaison across the Group. He also has specific experience of diagnostic testing within the HIV and HCV disease areas. This was gained through building Delphic Diagnostics into a one-stop-shop for clinicians, enabling more effective patient monitoring and subsequent treatment options.

Nick also has extensive management experience within the not-for-profit sector, working for a trade body representing and building the profile of the business communication industry.

Dr Miskin joined Oxford BioMedica in 2000. He has 15 years of experience in GxP assay development, analytical testing, lentiviral based vector bioprocessing development and cGMP production. In his current role, he has overall responsibility for Oxford BioMedica’s biomanufacturing and supply activities, as well as its process development work. He is also a named inventor on several patents in the field. He holds a Bachelor of Science degree and PhD in Molecular Biology from the University of Leeds and subsequently conducted post-doctoral research at The Pirbright Institute for a number of years. He is a member of the UK BioIndustry Association Manufacturing Advisory Committee.

Alan is Professor of Biotechnology at the University of Manchester with BSc and PhD from The University of Edinburgh. He is a molecular cellular biologist and works on research programmes that seek to enhance expression and manufacture of biologics. Current grant funding includes Research Council and industrially funded projects. He is a member of the Executive Committee of the European Society for Animal Cell Technology (ESACT) and leads the multi-disciplinary Centre of Excellence in Biopharmaceuticals (COEBP) based in the Manchester Institute of Biotechnology. The COEBP links researchers from biological, chemical, chemical engineering, medical and physical sciences backgrounds, applying novel approaches to challenges of manufacture of biologics, promoting industrial-academic linkages and providing access to research technologies including high-throughput and high-content cell culture robotics. Alan was Co-Director of BioProNET, the BBSRC NIBB co-sponsored by EPSRC, promoting industrial-academic interactions across the general area of bioprocessing and, linked to BioProNET, has run several early career events including the week-long BBSRC-funded Strategic Training Awards for Research Skills (STARS) programme for development of entrepreneurial skills in bioprocessing.

Harvey joined CPI in April 2010 and is currently a Chief Technologist within the Biologics Business Unit. In his current role he has responsibility for the technical oversight on a range of both Collaborative Research and Development and commercial projects. Activities are technically diverse and include a range of analytical and automation work focused on bioprocessing and next generation products. He provides CPI with more than 25 years of experience in commercial manufacture of biopharmaceuticals and biochemicals. Prior to joining CPI, Harvey spent 18 years in the biotechnology industry in both small start-up firms and large multinationals. During this period he spent 13 years at Genzyme in a managerial role, working at the interface between R&D and manufacturing. Harvey’s knowledge extends through R&D, automation, manufacturing support and production management.

Dr Veeren Chauhan is a Nottingham Research Fellow in Bio-inspired Therapeutics in the Advanced Materials & Healthcare Technologies (AMHT) division at the School of Pharmacy, University of Nottingham. He conducts multidisciplinary research at the interface of analytical, biological and medical sciences that endeavours to produce solutions for global challenges that will diagnose, cure, prevent and alleviate the symptoms of disease.

Veeren’s research has focused on the development and application of fluorescent nanosensors, to elucidate fundamental microenvironmental biochemical processes. Fluorescent nanosensors have demonstrated their enhanced measurement capabilities to quantify pH, molecular oxygen and temperature in complex model systems, such as the nematodes Caenorhabditis elegans & Pristionchus pacificus, Saccharomyces cerevisiae, Microelectromechanical systems (MEMS) devices, and human mesenchymal stem cells (hMSCs).

These exciting findings could be readily applied to augment cell and gene therapy manufacture due to the accurate, precise real-time measurements afforded by fluorescent nanosensors.

Cath Green is Head of the Clinical Biomanufacturing Facility at the University of Oxford. As a unique GMP manufacturing facility embedded in a world-leading academic research institution, the CBF endeavours to assist basic researchers in the transition from pre-clinical studies to first in man human trials. We are currently mostly producing adenovirus vectored vaccines against major human pathogens, but also have significant experience in recombinant protein and monoclonal antibody production. The CBF holds an MIA from the MHRA for manufacture and importation of IMPs and has in house QC and QP teams to ensure our products are of the highest quality. Cath is also both an Associate Professor in the Nuffield Department of Medicine, Oxford, where she heads a research team within the Wellcome Centre for Human Genetics, and a Fellow of Exeter College, Oxford.

Kit is Strategic and Transformational Venture Manager at Fujifilm Diosynth Biotechnologies where he previously worked as a Biochemical Engineer until Lean Six Sigma was introduced in the business and he moved into R&D continuous improvement.

The adaptation of some of the tools to the lab environment was essential and subsequent Black Belt qualification has shown that R&D departments can embrace LSS. Kit has subsequently applied LSS to quality and engineering. Kit has a first degree from Nottingham University in Chemical Engineering and a PhD from Cambridge University in Chemical Engineering and is a Fellow of the Institute of Chemical Engineers. Kit has also worked in a volunteer sector where he managed a church for two years.

Andy has worked in the biopharmaceutical industry for more than 25 years. Originally trained as a molecular biologist with a Ph.D. from the University of Wales in Cardiff he has led development and manufacturing projects bringing over 50 proteins from microbial and mammalian expression systems into the clinic. He is Chief Scientific Officer for the CDMO Fujifilm Diosynth Biotechnologies, responsible for science and innovation across the company’s sites in Europe and the US.

Martin is Managing Director of Booth Welsh, an engineering services technology company. Martin has led the growth and evolution of the business to successfully embrace digitalisation within its service offering and stimulate a top-to-bottom culture of innovation.

Martin is a firm believer that embracing Industry 4.0 is as much to do with human interaction as it is to do with technology. Booth Welsh has been through a remarkable journey of positive cultural change after taking the brave decision to transform and is now reaping the rewards.

Martin is Martin is a member of the Scottish Government Life & Chemical Sciences Steering Committee and a regular speaker at future-focused industry events both in the UK and overseas.

Aimee Doole heads up the Marketing, Communications & Engagement department for Booth Welsh, an engineering services technology company. In this ever-changing industry, Aimee has helped lead the company’s strategic direction by driving innovation efforts internally and setting the promotional strategy for success within digitalisation. She is a scholar of the European Fresh Thinking Labs Workplace Innovation & Engagement programme and works across the global group to share learnings and best practice. She is a member of the Chartered Institute of Marketers and is regularly asked to speak at conferences both in the UK and internationally to share learnings on the themes of workplace innovation and culture.

With over 20 years of Life Science experience focusing on the future of manufacturing and IIOT concepts helping organisations on their digitalisation journey.
With specific focus on global strategic development of IT/OT convergence, data acquisition and analytics and factory of the future concepts Peter works with leadership to define goals and objectives to meet or exceed clients KPI’s and objectives.

Carol is the Vice President and Head of Medicine & Process Delivery (MPD) at GlaxoSmithKline. Carol’s team at GSK provide project leadership, project management, portfolio and governance support for the development and industrialisation of the physical product, manufacturing process and supply chain for all of GSK’s pharmaceutical R&D portfolio. Carol trained as a biochemical engineer, obtaining a B. Technology (Hons) degree from Massey University in New Zealand followed by a PhD in Biochemical Engineering from University College London. She has over 20 years’ experience in the pharmaceutical industry from pre-clinical through to post-launch with specific expertise in bioprocess research, development, manufacturing and industrialisation and has been involved in the development of monoclonal and domain antibodies, antibody drug conjugates, therapeutic proteins, plasmid DNA, cell and gene therapies, viral vaccines and small molecule medicines.