Andrew Sinclair

Biopharm Services

President & Founder

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and is a Fellow of the Royal Academy of Engineering.

Gary Finka

GSK R&D

Senior Director, Drug Substance Development

 Gary Finka has over 25 years of experience within the Biopharmaceutical industry and currently holds the position of Senior Director, Drug Substance Development at GSK R&D. As part of the CMC Digital Transformation within GSK, Gary leads a Digital Grand Challenge called CMC Next Generation Workspace. This is focused on transforming GSK’s CMC laboratory workspaces and associated ways of working by simplifying the process of collecting and reusing FAIR data allowing scientists to focus on innovative science through the application of digital tools to enable the acceleration of medicines to patients. 

Jean Aucamp

Lonza

Associate Director, R&D, Biologics

Jean is an associate director in the Bio R&D organisation where he and his group are responsible for introducing new process technologies for the Mammalian Business Unit in the areas of primary separation and protein purification. In this role he collaborates with academics, CROs, SME and biopharmaceutical technology partners to develop and implement innovations, technologies and applications which meet the demands of a CDMO.

Jean holds a doctorate in Biochemical Engineering from University College London and has special interests in sustainability, in silico process development and digital manufacturing processes.

Kelly Balsom

Advent Bioservices

Vice President Operations

Kelly is a member of the Advent Bioservices senior management team responsible for overseeing the efficient and effective production of cellular therapy products, ensuring that Advent Bioservices achieves operational excellence, and delivers high-quality products to patients. Kelly oversees all aspects of manufacturing operations as well as client and stakeholder engagement.

Kelly joined Advent Bioservices from a private London Hospital where she worked as Quality Manager for their Transplant Service, and Stem Cell Laboratory Manager prior to this.  With over 20 years experience in the field of Haematology, Stem Cells and Cryostorage Kelly is considered an expert in her field and holds an MSc in Biomedical Science and a Diploma in Management and Leadership.  Kelly actively engages in ongoing CPD that positively impact both Advent Bioservices and the wider Advanced Cellular Therapies environment.

Nigel Richardson

CatSci

Director of New Modalities

Nigel completed his first degree in Chemistry and subsequent PhD in Synthetic Organic Chemistry at Exeter University, UK. Interested by the analytical chemistry challenges within his research at Exeter, his first industrial appointment was with Dow AgroSciences as an Analytical Chemist. After nine years with Dow, he moved to GSK as an Analytical Team Leader within the Chemical Development Division based in Stevenage, UK. Whilst at GSK, Nigel led the analytical activities to commercialisation for Tykerb (breast cancer medicine) and led GSK’s oligonucleotide therapy for Duchenne Muscular Dystrophy into the final stages of development and regulatory submission. He has also worked as Chemistry Lead in a team focused on novel platforms for oligonucleotide delivery. More recently, he held the position of Senior Director within the CMC Analytical Division, leading a department of 55 scientists who focused on analytical modernization and new technology introduction. In 2019, Nigel established McLean Pharma Consultancy Ltd, which focuses on CMC, analytical and oligonucleotide consultancy.

As CatSci’s Director of New Modalities, Nigel supports Argonaute RNA as Head of Regulatory Affairs and was the Principle Investigator for the OligoFLAME consortium grant proposal for the Nucleic Acid Therapeutic Accelerator (NATA) Grand Challenge to develop an alternative manufacturing platform to conventional solid phase synthesis.

Keith Foster

PFU Therapeutics

Director, Chief Scientific Officer

Dr. Keith Foster is a senior scientific executive with proven ability to establish new biotechnology companies, be responsible for generating inward investment and lead discovery programs from conception to preclinical characterization. He has deep scientific knowledge of neuromuscular, neurological, metabolic, cardiac and inflammation therapeutic areas, with over 30 years’ experience in developing gene, cell and pharmaceutical medicines

Dr. Foster is the Chief Scientific Officer for PFU Therapeutics and inventor of a technology to enhance the in vivo delivery of antisense oligonucleotides to target tissues such as muscle, heart and brain. A serial inventor and entrepreneur that has established and exited other gene medicine companies. He is passionate about the delivery of new therapeutic options to patients with unmet clinical needs and adopts a patient-centric approach coupled with a fail-fast attitude.

Dr. Foster is part of a ‘number of networks’ of excellence; has acted on the scientific editorial board of numerous scientific journals; acts as an expert reviewer for grant applications and has supported a number of scientific advisory boards for medical research charities. He holds a B.Sc. (hons) in Genetics from Queen Mary, University of London and Ph.D. in Cancer Genetics from University College London.

Jill Caswell

Almac

Senior Biology Team Leader

Dr. Jill Caswell is the Biology Technical Leader within Almac’s Biocatalysis group. After obtaining a degree in Biochemistry Jill worked in the industry producing recombinant proteins in a variety of host organisms before obtaining a PhD in 2011 through an industrial collaboration with Queen’s Univerity Belfast.

Jill’s career has focussed on recombinant enzyme expression as well as molecular biology techniques that enable enzyme engineering. She joined Almac’s Biocatalysis group in 2012 with 10 years of industry-relevant experience to bring to the biology team, helping to grow the enzyme engineering capabilities.

Kimia Witte

University of Strathclyde

Chancellor’s Fellow in Medical Device Development & Lecturer in Biomedical Engineering

Dr Kimia Witte, Chancellor’s Fellow in Medical Device Development and Lecturer in Biomedical Engineering at the University of Strathclyde, specialises in understanding the mechanosensitivity of cells during the organogenesis of connective tissues, with a particular focus on the nervous system. They are also developing Blood-Brain Barrier organoid models using microfluidics for applications in disease modelling and drug discovery.

Andrew Rutter

rutterdesign

Director

The key goal I have is to apply advanced manufacturing technologies in the field of pharmaceutical manufacture – to reduce cost, improve quality, sustainability, and produce a more agile factory.
rutterdesign is a consultancy that can help you succeed in designing your small agile factories, and the processes that go in it.

I’ve been at the forefront of building multi step continuous manufacturing lines from modular libraries of unit operations. My team built the worlds first GMP API continuous pilot plant in 2007. We developed the ideas into large molecules and oligonucleotide manufacture, branched into digital twins and augmenting design with system based models. I have explored the concepts of scale/scale out and replicated designs for medicine supply.

Now – I’m working on how to speed up the design process; creating skilled teams augmented with models and machine learning. I’m also thinking about agile spaces, and the attributes of a perfect factory.

Specialties: Continuous Processing, Process Economics and Benchmarking, Technology Strategy, Pharmacueticals, Process Modelling. Change management.

Hannah Robinson

AstraZeneca

Principal Scientist – Continuous Processing

Hannah is a chartered chemical engineer with 18 years experience in the Pharma industry, spanning manufacturing and development; innovator and CDMO; across both batch and continuous processing.

Whilst previously working at GSK, Hannah spent 10 years in the field of continuous processing, including development, industrialisation and successful registration of GSK’s first continuous API process. This involved engagement with regulatory agencies and working closely with manufacturing and quality organisations to define and implement new procedures to make commercial, GMP, continuous processing a reality.  Subsequently she led the technical development of new continuous platform technologies to expand capability for project delivery.

Her current role within Chemical Development at AstraZeneca encompasses the integration of new technologies and approaches within the core business processes, to ensure the benefits can be realised and built upon to meet the ever changing challenges to the small molecule supply chain.

Mark Talford

Innovate UK

Deputy Challenge Director – Medicines Manufacturing Challenge

Mark Talford has over 20 years of experience in research and innovation posts in industry and academia. Beginning his career as a lecturer in Chemical Engineering at the University of Bradford, Mark joined BNFL, and later British Nuclear Group, Sellafield following the closure of Bradford’s original course. As a Senior Technical Advisor to the Waste Vitrification Plants Mark was responsible for the delivery of a multi-million-pound annual programme of process improvement research from both UK and overseas contractors.

In 2006 Mark joined Britest Ltd, becoming Technical Director in 2012 and CEO in 2018. At Britest Mark was involved in the scoping and delivery of several pharma, speciality and fine chemicals collaborative innovation projects including the EU F3 Factory and SYNFLOW programmes and the UK AMSCI ReMediES and ADDoPT projects, as well as supporting a variety of pharma and non-pharma MNC’s and CDMOs develop and implement novel primary and secondary manufacturing processes using the Britest process understanding toolkit. He joined the UKRI Medicines Manufacturing Industrial Strategy Challenge Fund Team as Deputy Challenge Director in February 2021.

A chartered Chemical Engineer, Mark holds a degree in Chemical Engineering and a PhD in polymer process modelling from the University of Bradford.

John Mack

Applied Materials Pharma Group

Head of Perceptive Advanced Process Control

John is the head of the Perceptive APC product unit within Applied Materials’ APG Pharma group. His role is to lead the team that delivers software and solutions for Advanced Process Control, process monitoring and optimisation in the process industries. He is particularly interested in developing robust model-based systems to reduce process development costs and to optimise routine manufacturing. His experience includes developing solutions for many processes including: an entire paper mill, industrial boilers, and continuous pharmaceutical processes through to lab-scale crystallisers and micro-fluidic systems.

John is a Chartered Engineer with a BEng/NZCE from Auckland University and more than 20 years’ experience in the process industries.