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  • SAVE THE DATE

    Join us in Cardiff on 29 and 30 November 2017

  • SAVE THE DATE

    Join us in Cardiff on 29 and 30 November 217

Programnme

Tuesday 22 November

19.00 - 21.00

Join us at the Sky Lounge, Vermont Hotel for an informal evening of networking ahead of the conference.  Ideal for those arriving early in Newcastle. The evening is kindly supported by SAFC.

Places are limited.

Wednesday 23 November

09.00 - 09.35

Refreshments, networking, exhibition and partnering

09.35 - 09.50

Welcome

Fergal O'Brien
Director of Biologics, Centre for Process Innovation

09.50 - 10.00

BIA update

Nick Gardiner
Chief Operating Officer, BIA

10.00 - 11.30

Medicines Manufacturing in the UK

In this exciting opening session, Ian McCubbin will launch an action plan proposed by a joint Ministerial / Industry Taskforce to cement Advanced Therapy manufacturing in the UK for the benefit of patients and the economy. The taskforce was launched by the Medicines Manufacturing Industry Partnership (MMIP) in March 2016 to secure the future of manufacturing advanced therapies in the UK. This will be followed by case studies to celebrate a selection of recent major investments in UK manufacturing.

Launch of the Advanced Therapy Manufacturing Taskforce Action Plan

Ian McCubbin
Senior Vice President North America, Japan and Global Pharma Supply, GlaxoSmithKline

The potential impact of the Taskforce recommendations on a UK T-cell therapy SME

Autolus™ is a private biopharmaceutical company, focused on the development and commercialisation of engineered T-cell immunotherapy products with extreme efficacy in the treatment of life-threatening cancers. This presentation will examine the potential impact the MMIP Advanced Therapies Manufacturing Taskforce recommendations could have on their UK manufacturing investment.

Dr Jim Faulkner
Head of Manufacturing, Autolus

Lentiviral vector manufacturing strategies to supply the market

  • There are a number of very promising lentiviral based gene and cell therapies currently in development, with the closest to the market being CAR-T cells (e.g. CTL019, a CD19 targeting CAR-T cell approach being developed by Novartis)
  • To secure a robust supply chain for both OXB products and those of its partners including Novartis, the company has invested significantly in the UK in terms of both facilities and process development / scale-up
  • This talk will provide a summary of the approaches taken by OXB in order to support current and future demand for lentiviral vectors of appropriate quality to advance clinical trials and supply the future market

Dr James Miskin
Chief Technical Officer, Oxford BioMedica

Why did ReNeuron invest in a UK manufacturing facility?

ReNeuron moved its operations to South Wales in 2016 following the Welsh Government’s commitment to build an ATMP research, development and manufacturing facility in the region for late stage clinical and commercial product requirements. This presentation will look into reasons behind the company’s decision to move to Wales and expand operations, including manufacturing in the UK

Sharon Grimster
General Manager, Wales, ReNeuron 

11.30 - 12.00

 Refreshment, networking, exhibition and partnering

12.00 - 12.15

Richard Wilson Impact Award

Presented by

Dr Stephen Ward
Chief Operating Officer, Cell and Gene Therapy Catapult, and Chair of BIA Manufacturing Advisory Committee

12.15 - 13.15

Young Researchers poster flash presentations

In this fast-moving session kindly supported by Pall Life Sciences, we hear from 15 young researchers as they give a snapshot of their work and poster which is on display in the main exhibition area.

Chair
Dr Peter Levison
Senior Marketing Director - Downstream Processing, Pall Life Sciences 

13.15 - 14.30

Lunch, networking, exhibition and partnering

14.30 - 16.00

Workshops

14.30 - 16.00

Current analytical challenges across the medicine manufacturing space

The aim of this workshop will be to provide a forum to discuss these challenges and their implication for the medicines manufacturing space.

Analytical challenges for manufacturing medicines come from several directions which include:

  • Therapies being developed involve increasingly complex molecular entities, including bispecific antibodies, gene therapy products and whole cell therapies. They all provide new and novel analytical challenges in order to support development and manufacture
  • Advanced manufacturing approaches such as continuous processing, distributed manufacture etc aim to increase access to medicines and present new challenges for analytics
  • Building quality into a product through Quality by Design approaches requires characterisation and deep understanding which are only achievable by measurement

Chair
Dr John Liddell
Consultant, JML Biotechnology Consulting 

Professor Paul Dalby
Co-Director, EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, UCL

Professor Melissa Hanna-Brown
European Head and Analytical Sciences, Pfizer Global Research and Development

Dr Damian Marshall
Head of Analytical Development, Cell and Gene Therapy Catapult

Medicines manufacturing and supply innovation

This session aims to focus on cutting edge technologies and innovation that improve the manufacture and supply of medicines.  A vision for the future of pharmaceutical supply chains will be presented and company case studies on innovation in automation and downstream processing will be delivered. Discussion of implementing such approaches within a regulatory framework will also take place.

Chair
Dr Mark Bustard
Specialist, Medicines Manufacturing, KTN 

Contextualised data and digital readiness – a perspective on Industry 4.0

As the requirements for flexibility in product manufacture increases the demand on data capture and the systems that support this also increase. Having the capability to analyse meaningful and accurate quality critical, real-time data which gives a true representation of a products manufacture is and will continue to be an essential part of the overall production process. This presentation looks at some of the opportunities and challenges faced when looking to implement an increased level of digital readiness and also some of the values it can bring.

Simon Barnes
Director, High Speed Sustainable Manufacturing Institute

Alan Johnston
Technical Business Manager, Booth Welsh

Addressing industrial needs for cost effective MAb purification with a new range of Protein A agarose resins

One way to address the high costs of clinical trials is to use a less expensive Protein A resin designed specifically for early phase clinical trials and subsequently switch to a resin designed for manufacturing if the product makes it through phases 1 and 2. Another area of increasing interest is the subject of second sourcing. This presentation details a comparability study conducted in high-throughput format to support the strategy of switching resin between phase 2 and 3. The three resins evaluated are based on the same base matrix and immobilization chemistry and differ only in the type and amount of immobilized Protein A. The study was supported by Perkin Elmer and Alvotech Biopharmaceuticals.

Hans Johansson
Application Manager, Purolite

Perspectives on Future Pharmaceutical Supply Chains

This presentation will introduce Project Remedies, a £23 million pre-competitive collaborative research programme involving leading Pharmaceutical firms. The presentation will explore how new production processes, smart packaging and the progressive digitalisation of supply chains may transform future healtcare. 

Dr Jagjit Singh Sra
Head, Centre for International Manufacturing, University of Cambridge

MHRA Support for Innovation

This presentation will explain how the MHRA Innovation Office helps organisations that are developing innovative medicines, medical devices or using novel manufacturing processes navigate the regulatory procedures so they can progress their products or technologies.

Ian Rees
Manager for the Inspectorate Strategy and Innovation Unit, Medicines and Healthcare products Regulatory Agency

 

Gene Therapy Resurgence

Process industrialisation is at the heart of the resurgent gene therapy sector. The workshop is a fantastic opportunity to hear from a panel of world-recognised experts, all UK based, about the challenges they face with various virus backbones around process scale-up; limitations in current analytical technologies; GMP capacity and operating challenges.

Chair
Dr Stephen Ward
Chief Operating Officer, Cell and Gene Therapy Catapult, and Chair of BIA Manufacturing Advisory Committee

Panel
Julian Hanak
Vice President Manufacturing and CMC, NightstaRx

Professor Michael Linden
Vice President, Gene Therapy, Pfizer

Professor Adrian Thrasher
Professor of Paediatric Immunology, Great Ormond Street Institute of Child Health, UCL

16.00 - 16.30

Refreshments, networking, exhibition and partnering

16.30 - 17.00

Outputs from workshops

In this session, we will hear from workshop chairs on the feedback and outcomes from their workshop

17.00 - 17.30

Peter Dunnill Award Lecture

Processing priorities of the future – lessons learnt and future challenges

The biopharmaceutical industry has made huge strides over the past 40 years in achieving more efficient processes and  in the delivery of life saving and life-changing drugs. Peter Dunnill was an inspirational thinker and innovator in the bioprocessing space. This talk will look at how Peter influenced my own research career and touch upon a series of innovations Peter created which are now coming back into play at manufacturing scale including continuous chromatography and precipitation which have attracted renewed attention decades after the first published studies. Future trends in processing will be discussed especially focusing on the challenges that the manufacture of targeted therapies and personalised medicines will pose for the bioprocess engineer.

Professor Nigel Titchener-Hooker
Dean of the Faculty of Engineering Sciences, UCL

17.45 - 17.50

Summary and close of day one

19.00 - 22.30

Delegates are invited to join us at the Discovery Musuem in Newcastle for an informal networking drinks reception followed by evening dinner in the Great Hall

08.45 - 14.30

Thursday 24 November

08.45 - 09.15

Refreshments, networking, exhibition and partnering

09.15 - 10.45

Next generation antibody molecules

Chair
Dr Paul Varley
Vice President, Science and Collaborations and Biopharmaceutical Development (Cambridge) and Site Lead MedImmune

Beyond Antibodies
With the stunning success of Monoclonal Antibodies as a product class Industry is developing next generation products, which build on previous experience and provide even great potential as medicines.  This talk will introduce some of these developments, the rationale for their development and associated bioprocessing challenges.   

Dr Paul Varley, MedImmune
Vice President, Science and Collaborations and Biopharmaceutical Development (Cambridge) Site Lead, MedImmune

The rapidly growing pipeline of Antibody Drug Conjugates (ADCs) requires a toolbox approach to problem solving and the safe development of this complex product class
During the past decade the ADC pipeline has grown significantly from only 8 distinct ADCs in clinical development in 2008, to over 60 in 2016. Whilst early targets were primarily focused towards the treatment of haematological disorders, the generation of newer ultra-potent toxins and, more recently, improved tumour penetration through alternative scaffolds has accelerated the growth in ADC discovery programmes, especially for the treatment of more difficult to treat solid tumours.This expanding pipeline has been mirrored by an increasing number of majors with an ADC focus as well as the need for the capabilities and capacities to manufacture. 

Since ADCs are, by their very nature, complex 3-part jigsaws, combining antibodies (whole or fragments) with potent toxins added via conjugation chemistries and appropriate linkers, this presentation will focus on the current challenges including those which impact on patient safety and the requirements for the manufacture of this multi-stream and complex API.

Dr Dave Simpson
Chief Executive Officer, Glythera

Bispecific Antibodies:  New Opportunities for Novel Therapies
The ability to combine two binding specificities into one antibody has increased the potential for antibody therapies with the potential to generate synergistic effects compared to combination therapies with decreased toxicity and lower development and manufacturing costs.  This presentation will review the main approaches for bispecific platforms as well as the therapeutic opportunities and the process development requirements.

Dr Mike Davies
Vice President, Protein Sciences, F-star Biotechnology

soloMERsTM; Site-specific therapeutic biologics for the treatment of inflammatory disease
soloMERs are the smallest naturally occurring binding domains at only 11 kDa. Their remarkable stability combined with small size makes them perfect candidates for novel routes of administration challenging the existing needle-based treatments for antibodies. Elasmogen is developing anti-inflammatory soloMERs for the treatment of ocular disease but also have collaborations in the world of ADCs. Given these are new antibody-like molecules, challenges remain in the development process from candidate to final drug. This talk will introduce these domains, discuss their therapeutic potential and also look at the downstream bioprocessing questions that arise when dealing with a new class of drug.

Dr Caroline Barelle
Chief Executive Officer, Elasmogen

10.45 - 11.15

Refreshments, networking, exhibition and partnering

11.15 - 13.15

Technologies to deliver the future

Chair
Dr Chris Dowle
Director of Future Business, Centre for Process Innovation

Developing Synthetic Promoters for Bioprocessing Applications
Synpromics develops promoters that can be designed to control constitutive or inducible gene expression in any eukaryotic system, enhancing protein levels to further improve biopharmaceutical manufacturing processes and produce protein with the correct post-translational modifications. In this presentation, Dr Roberts will give an update on the company's latest technological advances in Bioprocessing.

Dr Michael L Roberts
Founder and Chief Scientific Officer, Synpromics

Nanoencapsulation of membrane proteins for drug discovery and more

Membrane proteins are some of the most attractive targets for drug discovery efforts, but studies of these exquisite molecules have lagged significantly behind those of soluble proteins due to the challenge of extraction and purification in an active form. Historically, detergents have offered limited success, but a new alternative approach to membrane protein extraction, using disc-shaped SMA lipid nanoparticles (SMALPs) will be offered in this presentation.

Professor Tim Dafforn
Professor of Biotechnology, University of Birmingham and Chief Scientific Advisor, BEIS

Brilliant machines, big data analytics, industrial internet and Bioprocessing
Today 3b people worldwide are connected to the consumer internet. New capabilities drove massive change in the way we are interacting, how we are purchasing goods, how we are watching movies. By 2020 there will be 30b machines connected to the industrial internet and this will transform the way people and machines interact by using data and analytics to drive efficiency, accelerate productivity and achieve operational excellence. We will discuss how this change will positively impact the BioPharma industry. In BioProcess case studies, we will show how the combination of brilliant machines with best-in-class data science delivers valuable new insights that were never beforepossible.

Dr Dirk Voelkel
Chief Technology Officer, Innovation and Analytics Life Science, GE Healthcare Life Sciences

Progress towards automated continuous biologics production with real time release
Advances in the development of the fully automated next generation continuous bioprocessing platform will be discussed.  This will include the integration of multi attribute PAT methods to the automated single use process and how it enables product attribute control with real time release. The regulatory and quality strategies will be discussed including methodologies for batch definition and perturbation analysis.  

Dr David Pollard
Executive Director, BioProcess Technologies and Expression BioProcess Development, Merck Research Laboratories, MSD  

13.15 - 13.20

Announcement of Young Researcher Poster Prize Competition

13.20 - 13.30

Steve Bates
Chief Executive Officer, BIA

13.30 - 14.30

Lunch, networking, exhibition and partnering