Dr Walkiria Schlindwein
Associate Professor of Pharmaceutics at Leicester School of Pharmacy
Walkiria graduated as Chemical Engineer in 1984 (First-class) from the Federal University of Rio de Janeiro, UFRJ, Brazil. She obtained her MSc (Distinction) in Polymer Science and Technology from the Institute of Macromolecules of the UFRJ, Brazil in 1986, PhD in Chemistry from the Department of Chemistry of the University of Leicester, England, in 1990, and DSc in Chemistry from the UFRJ in 1992.
She has over 20 years of experience in academia and is currently Associate Professor of Pharmaceutics at the Leicester School of Pharmacy. Her current research projects are in the areas of pharmaceutical formulations with interest in integrating quality by design in continuous pharmaceutical product development and manufacture. Walkiria is the programme leader of two Postgraduate courses in Pharmaceutical Quality by Design (QbD) and a key member of the academic teaching staff. She oversees all aspects of the distance learning programme including curriculum development, assessment, recruitment and support of students. In addition, she has a strong research interest in the science underpinning QbD and has developed collaborations with numerous organisations that are active in this field. She is member of the Academy for Pharmaceutical Sciences Regulatory Focus Group and of the Continuous Manufacturing and Advanced Crystallisation (CMAC) International Advisory Board.
Professor Dana Brown
Pro Vice-Chancellor/Dean, Faculty of Business and Law
Principal, Leicester Castle Business School
Professor Dana Brown joined De Montfort University (DMU) in March 2016 as the founding Principal of Leicester Castle Business School (LCBS). Raised by her mother in America with her father in England, Dana’s life and career has spanned the two countries and beyond. While completing her BA in Political Science and Slavic Languages at Rutgers University in New Jersey, she spent a year at Exeter University and a further year on Exeter’s Russian language programme in Moscow. After completing her BA, Dana was awarded a Rhodes Scholarship to study for the MPhil in Russian and East European Studies at St. Antony’s College, Oxford University. She later earned her PhD in Political Science from the Massachusetts Institute of Technology (MIT), completing a dissertation on the intersection of market and social reform in former Soviet countries. Dana has worked in and closely with business, starting in high school when she had the opportunity work alongside a former chief executive of F.W. Woolworth during the launch a new start-up retail venture. She was also amongst the first employees of Amazon.com, where she worked as Senior Manager of Operations in the period leading up to the company’s IPO. At MIT, she was part of an initiative of Sloan School of Management that invited executives from the global clothing and footwear industries to participate in emerging discussions about labour issues in global supply chains. She has worked with several companies in executive education and has supervised a number of student entrepreneurship projects, many of which have been launched into successful businesses. Dana is married to Nils and has three young daughters, Petra, Greta and Annika. Her family provides her with inspiration and support in everything she does.
Dr Line Lundsberg
Lundsberg Consulting Ltd and Global technology Partner within NNE
Line Lundsberg, PhD, runs her own consultancy business Lundsberg Consulting Ltd, supporting clients in developing and manufacturing pharmaceutical products and has a role as Global technology Partner within NNE, a global pharma engineering company. She has spent more than 20 years within the pharmaceutical Industry (API & Drug Product Development and Manufacturing). She is specialised in the science and risk-based concept of Pharmaceutical Development and Manufacturing including Quality by Design (QbD), Process Analytical Technology (PAT), Process Validation lifecycle (PV), Good Manufacturing Practise (GMP), Quality Risk Management (QRM), Pharma 4.0 and the related regulatory and compliance aspects.
Line holds a BSc in Mathematics, an MSc in Physics and a PhD in Chemistry on NIR spectroscopy.
Line has worked with innovator and generic companies, both global and national, developing and implementing QbD strategies, QbD programmes, QbD tools, QRM, GMP, PV and Advanced Control Strategies based on Real Time Release Testing (RTRT) including QbD based regulatory submissions of new product applications (MAA, NDA, ANDA). Lately she has been involved in Pharma 4.0 projects.
Line was a co-developer of the QbD MSc course organised by Leicester School of Pharmacy, De Montfort University (DMU), UK, and have recently together with DMU and Wiley contributed to the book: ‘Pharmaceutical Quality by Design: A practical approach’
Dr Luisa Freitas dos Santos
Vice President, Product Development and Supply, GSK R&D
Luisa Freitas dos Santos, PhD, CEng, FIChemE is head of Target to Patient Supply Chain and interim head of Product and Process Engineering within Product Development and Supply (PDS), GSK R&D. She is and responsible for delivery of an integrated Discovery and Clinical Supply Chain supporting all R&D small molecule and biopharm clinical studies from FTIH to Phase IV. She is also interim leader of Product and Process Engineering supporting process development and optimisation of manufacturing processes and devices. In addition Luisa is a Senior Fellow and co-chair of the GSK Fellow Council.
Luisa has extensive CMC (Chemistry, Manufacturing and Controls) pharmaceutical development experience within GSK and considerable experience externally in technology development and transfer including being a co-founder of a spin out company based on her own PhD chemical engineering research at Imperial College London.
Within GSK Luisa has had a variety of Portfolio delivery leadership roles across almost all areas of Product Development and Supply (PDS) including process chemistry, process engineering, continuous processing, particle sciences, modelling, analytical sciences, and more recently clinical supply chain management. She has led multidisciplinary global teams across 8 R&D sites in 5 countries responsible for CMC development from pre candidate selection to commercial manufacturing and has extensive regulatory and technology transfer experience. During her 22 years at GSK she has been involved in the late phase development of more than 50 new medicines.
Luisa has published > 50 peer reviewed research papers, presented work at >100 conferences and technical seminars, and received numerous internal and external awards. Luisa is a Chartered Engineer and Fellow of the Institution of Chemical Engineers.
Dr Indra Joshi
Digital Health and AI Clinical Lead (NHS England)
Indra is an emergency medicine doctor who is the clinical lead for NHS England’s Empower the Person Portfolio, which aims to create a citizen-friendly digital interface for the NHS. She admits that the NHS is having to play catch-up in parts with the digital world, but says creating a digital NHS service that is fully inclusive, and that citizens trust, takes time. Her role is to empower patients and citizens to improve their own experience of the NHS, and taking care of their own health
Dr. Csaba Sinka
Associate Professor at the University of Leicester
Csaba Sinka is an Associate Professor at the University of Leicester. Previous to academia he worked for 6 years for Merck in the US and UK in pharmaceutical formulation design and process development. Dr. Sinka’s research is in the field of mechanics of granular and porous materials including (i) constitutive model development and numerical implementation for powder compaction, (ii) powder flow with focus on powder-air interactions and fine and cohesive powders; (iii) contact laws between particles involving large deformation, compressible plasticity, impact, particle breakage and adhesive contact; (iv) modelling of particle transformations for powder processing. Dr. Sinka’s group works also on coupled and multi-physics modelling problems for droplet drying, drug delivery systems and additive manufacturing using Finite Element Analysis and Discrete Element Modelling coupled with Computational Fluid Mechanics. Dr. Sinka is the PI of the EPSRC funded multi-institutional project “Virtual Formulation Laboratory for prediction and optimisation of manufacturability of advanced solids based formulations”. He actively collaborates with industry on a wide range of projects involving complex formulated products including pharmaceuticals, food and detergents. His research is included in the USP.
Dr Yash Sabharwal
Co-founder and CEO of CherryCircle Software, Inc
An accomplished entrepreneur, Yash has over 20 years of experience with establishing and growing technology-based life science companies. He is formally trained as an optical engineer with an emphasis in biomedical and medical imaging technologies. Yash co-founded his first company, Optical Insights in 1997. Optical Insights was a leader in the development and manufacting of spectral imaging systems for fluorescence microscopy, high-throughput screening (HTS), and high-content screend (HCS). He led the optical design and software development efforts as well as managing financial operations from early stage inception to the sale of the company to Roper Industries in 2005.
In 2010, Yash moved to Austin, Texas, and joined the technical co-founders of Xeris Pharmaceuticals to formally launch the company in 2011. From 2011 to 2014, Yash served as COO and CFO at Xeris building the operational infrastructure and leading fundraising efforts. Over this period, Xeris raised over $20M in private capital and $5M in non-dilutive funding. From 2015 to 2016, he focused on his COO role managing pharmaceutical manufacturing operations while continuing to assist with the next stage of fundraising which yielded another $40M in private investment and $10M in non-dilutive funding. Having successfully grown Xeris to a point of financial and operational stability, Yash left in September 2016 to focus on new projects. Xeris is now a public company listed on the Nasdaq.
Yash is currently co-founder and CEO of CherryCircle Software, Inc. which has developed QbDVision, a cloud-based software solution for product lifecycle management of pharmaceuticals and medical devices. QbDVision promotes quality-by-design and data integrity by integrating risk-based requirements managemet, process development, and data analytics under a single platform.
Yash has a B.S. in Optics from the University of Rochester and an M.S. and Ph.D. in Optical Sciences from the University of Arizona. He is actively involved in the life sciences community in Austin including the new Dell Medical School at the University of Texas. He loves living in Austin, Texas and working with and mentoring the creative entrepreneurs of this wonderful city.
Dr Andrea Johnston
CMAC EPSRC Centre Manager
Andrea Johnston is Programme Manager at CMAC, the EPSRC Future Manufacturing Research Hub in Continuous Manufacturing and Advanced Crystallisation based at the Technology and Innovation Centre, University of Strathclyde.
Andrea’s scientific research expertise is in solid-state chemistry, crystallisation and developing automated crystallisation screening protocols in conjunction with using multivariate analysis tools to determine the influence of crystallisation conditions and other factors on solid-state structure and properties. Andrea’s enthusiasm for ML and AI in this field of science stemmed from her days as a Senior Research Fellow on the CPOSS project, Control and Prediction of the Organic Solid-State.
Andrea oversees all aspects of research and operations in CMAC Future Manufacturing Research Hub and is responsible for programme coordination and integration will all collaborators. She is on the EPSRC Connected Everything Network Plus Executive Group and MMIP skills workstream.
Professor Kendall Pitt
Senior Technical Director in Global Manufacturing and Supply for GlaxoSmithKline
Kendal Pitt, Ph.D (London University), B.Pharm (University of Nottingham), is a Senior Technical Director in Global Manufacturing and Supply for GlaxoSmithKline based at Ware, UK. He is a Fellow of the Royal Pharmaceutical Society (FRPharmS) and a Fellow of the Academy of Pharmaceutical Sciences (FAPS). Kendal has worked in the Pharmaceutical Industry for over 30 years, with Wellcome Foundation Ltd., Roche Pharmaceuticals and more recently for Merck. He has headed groups in both the United States and Great Britain and has led project teams responsible for the successful filing and launch of both tablets and freeze-dried oral dosage forms. Primary research interests are in powder compaction, powder flow and granulation process optimisation, including the use of compaction simulators in tablet and capsule product development. He has additionally published in the areas of formulation and design for nasal delivery of pharmaceuticals and on statistical design of experiments, and has co-authored chapters on formulation, tabletting and on strength testing.
Professor Melissa Hanna-Brown
Associate Research Fellow, Pfizer UK
Professor Hanna-Brown is based at Pfizer’s UK research centre in Sandwich, Kent and is part of Pfizer’s Technology & Innovation team. She and her colleagues work closely with external organisations to bring the best technologies and organisations together to accelerate medicines development timelines. She is also playing an active role in promoting gender parity and Diversity & Inclusion (D&I) at her company. Writing in Pfizer’s 2018 Gender Pay Gap Report, Professor Hanna-Brown commented: “To sustain and promote our inclusive culture, we need everyone to play a part. We want to see every UK colleague setting a D&I goal in 2018. This will help us collectively achieve a level playing field for all colleagues. It’s the right thing to do socially, morally and for the success of our company.”
Dr Ross Breckenridge
CEO of NANOGAP Therapeutics
Ross was a clinical academic in the UK, as a clinical pharmacologist, before becoming CEO of Silver Creek Pharmaceuticals in San Francisco, USA. He recently returned to the UK to start up a new biotech, NANOGAP Therapeutics, based in London, Spain and San Francisco.
Dr Helen Barker
Head of Pharmaceutical Development at Reneo Pharma
Pharmaceutical Scientist and Business Leader, with 20+ years of experience in the development of pharmaceutical & healthcare programs. A strong track record of delivery, working collaboratively with large pharmaceutical companies (Novartis, Pfizer); SMEs (Reneo, Ziarco); non-profit organisations (APS); and academia (Oxford).
Passionate about combining business strategy & scientific expertise to deliver medicines to patients and lead biopharmaceutical organisations to success. Proven success in the development of innovative strategies and the timely delivery of projects to key milestones.
Particular expertise in infectious diseases, dermal & respiratory therapeutic areas.
Core interests include the development of novel healthcare solutions, business strategy development, supporting emerging pharmaceutical scientist leaders, and patient and public involvement in research.
Dr Alastair Coupe
Senior Director, Drug Product Design, Pharmaceutical Sciences, Pfizer Ltd, Sandwich UK
Alastair joined Pfizer in 1995 and over the past 20 years has worked on a wide range of drug products (e.g Tikosyn, Vfend, Sutent, Macugen, Celzentry, Toviaz and Bosulif) and drug delivery technologies (Vfend IV, Caduet, Norvasc ODT and Viagra ODT) including IR and MR tablets and capsules, parenteral and oral liquid products and inhalation dosage forms. In addition, he has presented CMC packages at EMEA, FDA and PMDA (Japan). Alastair is currently responsible for Formulation and Process Development in Sandwich. As a leader, he has run groups ranging from 2 to 150+ including GMP Clinical Supplies manufacturing, paediatric and inhalation development. Alastair is currently leading the Innovate UK cross industry/academia collaborative R&D project “Accelerating paediatric development through smart design and predictive science”. He is also a Management Board member for the University of Nottingham/UCL CDT in Advanced and Targeted Therapeutics and a member of the Academy for Pharmaceutical Sciences Regulatory Focus Group Steering Committee. He received a B.Pharm. (1st Class) in Pharmacy (1987) and a Ph.D in Drug Delivery (Nottingham University, 1991).
Dr Colm Reddington
Unit Manager (Cardiovascular and Diabetes), MHRA
A pharmacist with a strong background in CMC regulatory affairs, currently leading a team of experienced clinical (MDs), non clinical (Toxicologists), pharmaceutical (Pharmacists) and scientific professionals within licensing division of MHRA. Experience includes assessment and oversight of European (centralised, DCP, MRP) and national UK applications for new active substances and generic products. Involvement in numerous Scientific Advice meetings as chair and assessor, together with participation in European CHMP scientific advice and joint MHRA/NICE scientific advice meetings. Scientific interest includes pharmaceutical Quality by Design and novel manufacturing processes/technologies.
Operational management includes performance and budget management, volume forecasting, representing Licensing Division on internal MHRA groups and external audits.
Project management tasks include various improvement projects, participation as customer rep. on projects and mentoring lean six sigma green belt improvement projects.
Dr Helen Muirhead
Senior Vice President Respiratory Medicines at GMPharma Limited
Helen now is an independent Respiratory Medicine Expert, acting as a consultant after 30 years with GSK in both R&D and Manufacturing. Helen is also now involved in teaching at Universities and supports Lung Disease charities. In GSK, Helen headed up the Respiratory Centre of Excellence during the late stages of Product Development through Regulatory Filing and Commercial Launch and supply of new Medicines – in the Ellipta Portfolio (Including the recent Trelegy, triple drug therapy). Helen was also responsible for the classic and establish brands; the existing Diskus Portfolio (Including Advair).
Professor Mike Hannay
Managing Director East Midlands Academic health Science Network (EMAHSN) and Chair of the AHSN Network
Mike has more than 25 years’ experience of working in the pharmaceutical industry, with an excellent track record of building collaboration with healthcare and academia. He joined EMAHSN in July 2016 from ThermoFisher Scientific, where he had worked since 2013 as Vice President for the UK BioPharma Services Division. That role built upon his significant experience both nationally and internationally, including Vice President of Medicines Development at AstraZeneca. In his role with EMAHSN, Mike leads the organisation in helping to address some of the biggest health challenges facing the region. Mike is currently Chair of the National AHSN Network, a collaboration of England’s 15 AHSNs.
Professor Gordon Muirhead
President of GMPharma Limited, a Pharmaceutical Consultancy
He is a Pharmacist and has worked in the Pharmaceutical Industry – in senior Manufacturing, Operations, General Management and Development global roles – for over 30 years and is a Fellow of the Royal Pharmaceutical Society (FRPharmS).
Previously, Gordon was Vice President of Global New Medicines Introduction within the Global Manufacturing and Supply division of GlaxoSmithKline (GSK) for 12 years. In this time GSK Filed, Launched and Transfered a significant number of new medicines, new combination medicines, and new drug-device combinations… from multiple sites. Prior to this role, he was Head of Global Process Technologies within Product Development, R&D, GSK to advance Process Analytical Technologies (PAT), Quality by Design (QbD) and Secondary Continuous Processing within that company. Gordon was one of the first Senior Fellows in GSK Manufacturing and is now the first GSK Emeritus Senior Fellow. Gordon is also Visiting Professor of Pharmaceutics within the Leicester School of Pharmacy at De Montfort University with a particular research interest into the practical application of a Rapid Adaptive Continuous development and commercial manufacturing platform, underpinned by QbD and PAT. Described as “an Engineer, trapped in the body of a Pharmacist”… Gordon is also an Associate Fellow of the Institute of Chemical Engineers (AFIChemE). He is also active in STEM initiatives, to help inspire the next generations of engineers and scientists. He is the proud grandfather of two grand-daughters; Abbie (13) and Lily (9), and learns from them both… all the time. An ex-professional musician, Gordon still believes he can become a famous Rock Star and has a Recording Studio and a bank of guitars ready for that big break!