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Pharmaceutical Intellectual Property Biotech

Biotechnology for the Non-Biotechnologist

27-29 Sep 2017

GBP EUR USD
Standard 1849 2589 2884
Excluding VAT @ 20.00%

Venue: Cavendish Hotel, London

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25-27 Apr 2018

GBP EUR USD
Standard 1849 2589 2589
Excluding VAT @ 20.00%

Venue: Radisson Blu Hotel, Nice, France, Nice

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Bespoke training

We can customise this course to meet the requirements of your organisation.

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Course overview

Biotechnology for the Non-Biotechnologist, ideal for non-Scientists and Scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.

Why you should attend

  • Gain an introduction to the fundamental principles of Biotechnology
  • Improve your understanding of the key techniques used by Biotechnologists
  • Understand the importance of meeting regulatory requirements and hear about the advances being made
  • Learn how to identify potential patents, and why and how they must be protected

Who should attend

  • Quality Assurance
  • Regulatory Affairs
  • Legal and IP
  • Business Development
  • Sales and Marketing
  • Engineering
  • Finance
  • Finance
  • Training
  • Administration
  • Management

Programme Day one

Introduction to Biotechnology

  • Historical perspective
  • Diversity of biotechnology products
  • Impact on society
  • Product development overview

Introduction to Molecular Biology

  • DNA, RNA, genes, plasmids, and vectors
  • Protein synthesis – transcription and translation

Re-Expression of Proteins

  • Recombinant DNA techniques
  • Monoclonal antibodies – from mouse to human
  • Transgenic animals and plants

Development of Production Organisms

  • Transfection
  • Selection
  • Preservation

Fermentation Technology and Large Scale Production

  • Types of fermenters
  • Fermentation basics
  • Modes of operation
  • Process development

General Discussion

End of Day One and Drinks Reception

Programme Day two

  • Process Optimisation and Scale-Up
    • Scale-up strategies
    • Strain improvement
    • Media improvement
    • Process improvement
  • Analysis of Biopharmaceuticals
    • Biological activity
    • Physicochemical characterisation
    • Purity, impurities and contaminants
  • Product Recovery and Purification
    • Cell harvesting and removal
    • Clarification – intracellular and extracellular proteins
    • Chromatographic techniques
  • Formulation Design of Biopharmaceuticals
    • Factors affecting degradation
    • Choice of excipients
    • Prolonging shelf life
  • Process Economics
    • Drug development and bioprocess economics
    • Optimising bioprocess economics
    • Manufacturing make or buy
    • Future manufacturing alternatives
  • General Discussion

Programme Day three

Patenting Biotech Inventions

  • What is a patent?
  • What are the basic criteria for patentability?
  • What can be patented?
  • Can you patent genes, proteins, hybridomas, and stem cells?

Patent Workshop

  • How to recognise what is patentable
  • Drafting claims to biotech inventions
  • Maximising protection for an invention
  • Understanding the examination process
  • Enforcing patents

Regulatory Considerations of Biopharmaceuticals

  • General principles
  • Product quality and control
  • Pre-clinical safety

Application of Regulatory Principles

  • What do regulators want?
  • Specifications
  • Product characterisation
  • Assessment of process change
  • Comparability guidance and strategy

Advances in Regulation: Biosimilars

  • Comparability, equivalence and biosimilarity
  • Biosimilars guidance
  • Guidance vs Practice – a case study

Advances in Regulation: Advanced Therapies

  • Gene Therapy
  • Cell Therapy
  • Tissue Engineered Products

General Discussion

Presenters

Mark Richardson

Mark Richardson is a Pharmaceutical/Biotech Drug Development Regulatory Affairs Consultant and is also Director of Richardson Associates Regulatory Affairs Ltd. After postdoctoral research in molecular biology at the Universities of Dundee and California at Berkeley, he joined British Biotech in 1988 to work on recombinant vaccines before becoming Head of Assay Development, then Biopharmaceutical Development Manager and subsequently moving into Regulatory Affairs with responsibility for rDNA products in preclinical and clinical development.

In 1997 he moved to Groupe Fournier as Head of the Gene Therapy Development Unit to lead a European oncology clinical development programme. Joining the CRO sector in 1999, first with Orion Clinical Services and later with i3 Research, he headed the Regulatory Affairs departments providing advisory and regulatory support for global development and clinical investigation of gene and cell therapy products, recombinant proteins and monoclonal antibodies, as well as for small molecule drugs.

Philip Webber

Dr. Philip Webber obtained his first degree from Cambridge University, UK (Natural Sciences, Genetics) and then carried out research on the regulation of brain-specific genes at Warwick University, UK, where he obtained his PhD.
He qualified as a UK Chartered Patent Attorney and European Patent Attorney with Dehns (formerly Frank B. Dehn & Co.) London and Oxford, and is now a partner in their Life Sciences Group. He has a worldwide client-base including clients from the UK, Scandinavia, the US and Japan. Amongst other things, his work involves the preparation and filing of patent applications in Europe and throughout the world; acting for his clients in opposition procedures at the European Patent Office; and searching for and advising his clients on the relevance of competitors’ patents. He is an active member of the Life Sciences Committee of the UK Chartered Institute of Patent Attorneys (CIPA). He has spoken at a number of European conferences and on BBC Radio on the patenting of biotech inventions, as well as publishing a number of papers in this area.

Kate Smith

Kate Smith is currently Principal Scientist, Development Services, at BioReliance, UK. In this position she is responsible for managing the team of scientists involved in the preparation of cell banks (master and working), viral seed stocks (master and working) and production of clinical lots of virus. She was until recently a Principal Group Leader in the Purification Development Group at Lonza Biologics, plc. She has more than 18 years experience in the development, scale-up, transfer and validation of purification processes for monoclonal antibodies and recombinant proteins from mammalian cell cultures. Her area of expertise is the design and management of Viral and DNA reduction studies used to support product safety.

Alison Sykes

Alison Sykes is Associate Director Physico-Chem Analytics, Biosimilars, at Merck Serono, Geneva, a post she took up early in 2015. She was formerly Biosimilar Technical Director within Analytical Services at Lonza Biologics plc responsible for oversight and definition of all analytical activities relating to pre-clinical and clinical development of Biosimilars derived from mammalian and microbial cell culture. She had worked for Lonza for 25 years, responsible for running various different analytical teams and functions including cell culture support, method development and validation, stability and formulation and protein characterisation. She has been responsible for set-up and establishing FDA and MHRA approved laboratories and providing technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including several successful BLA licence applications. A biochemist by training, she started her career working for the National Health Service and then moved to NIBSC. Her experience here on the human side of the drug industry and the need for global standards in protein drug development helped drive her enthusiasm for detailed analysis and characterisation of safe and efficacious biopharmaceuticals.

Adekunle Onadipe

Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and characterization of mammalian and microbial cell lines for biotherapeutics and vaccines production. His group is also involved in the scale-up of bioprocesses from bench top to pilot scale bioreactors and process development for the establishment of cell banks to support the manufacture of biopharmaceutical products for early phase clinical trials. He joined Pfizer Limited in the UK in 2005 in Discovery Biology with responsibility for optimizing cell culture processes for the production of cell-based assay reagents. Prior to this he worked for 15 years at Lonza Biologics plc., in Slough UK where, as a Principal Group Leader in cell culture process development, he was responsible for constructing and developing production mammalian cell lines and culture processes, subsequently transferring them to full-scale production for clinical trials.
A microbiologist by training, he has been involved in the production of biopharmaceuticals for more than 27 years and has a broad experience of microbial and mammalian cell culture methods. He obtained his PhD in Microbiology from the University of Surrey, Guildford UK.

Adrian Haines

Dr Adrian Haines is the Section Head of Process Development Sciences at Novimmune SA, Switzerland. He leads teams of upstream and downstream development scientists who work within a CMC environment to develop, evaluate and characterise processes for the production of monoclonal antibodies and novel κλ-bodies. He has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics.
He joined Novimmune in 2015 and prior to this he worked at Lonza Biologics in the UK working on projects to develop new technologies and processes for generating manufacturing cell lines. Before that he worked for ML Laboratories/Cobra Research developing UCOE technologies for the expression of proteins in mammalian cells and at Therexsys Ltd, developing antibody targeted gene therapies. Prior to this he worked at Celltech Research Ltd, generating radiolabelling and cross-linking technologies for antibodies.
A biochemist by training, he has been involved in the protein chemistry and production of monoclonal antibodies for over 28 years starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received his bachelor degree from Imperial College, London, and his PhD from St Thomas’ Hospital Medical School, University of London.

Robert Young

Dr Robert Young is the Principal Group Leader of Lonza Biologics New Expression Technologies Group based in Cambridge, UK. He manages a group engaged in developing expression systems for the industrial production of therapeutic recombinant proteins. He received his PhD in molecular biology (1994) from King’s College London (in collaboration with Celltech Ltd, UK (now a part of UCB)), creating glycosylation mutant human IgE-Fc fragments and other components of the IgE system and expressing them in CHO-K1 and NS0 cells (using the GS expression system) for biochemical and structural studies. After extending this work as part of his first post-doctoral appointment, he embarked on a second post-doctoral position at the Laboratory of Molecular Biology (Division of Structural Studies), Cambridge, UK (1995-1998), working on the structure of the protein components of small nuclear ribonucleoprotein (snRNP) complexes. In 1998, he joined a biopharmaceutical company, Antisoma plc (London, UK) running the Protein Engineering team engaged in the expression of anti-tumour antibody-enzyme fusion proteins in mammalian cells. He left Antisoma at the end of 2004 to join Lonza Biologics, where he became a Principal Scientist in the Cell Culture Process Development (CCPD) Department. He remained there until the end of 2010 when the New Expression Technologies Group was established.

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Previous customers include...

  • Arven Ilac
  • Avecia Biotechnology Ltd
  • Becton Dickinson
  • Bergen Teknologioverforing AS
  • Cobel Darou
  • EuropaBio
  • European Patent Office
  • F. Hoffmann-La Roche Ltd
  • GALDERMA R & D
  • Galderma R&D - Les Templiers
  • Genmab A/S
  • GILROY FILTRATION LTD
  • Ipsen Pharma SAS
  • Janssen Pharmaceutica NV
  • Kinesis Pharma BV
  • KPMG
  • LFB
  • LimmaTech Biologics AG
  • Melbourn Scientific Limited
  • Novartis Pharma AG
  • Pfizer
  • Pfizer Ltd
  • Recipharm AB
  • Sagentia Limited
  • Sanofi-aventis Groupe
  • Shandon Clinical Trials Limited
  • Stephen Griggs Ltd
  • Tanatex Chemicals BV
  • The Cooperation Council For The Arab States Of The Gulf
  • UCB Pharma SA

What previous delegates say...

I really enjoyed this course, it was detailed and interesting. Speakers were very well qualified and good presenters

Jill Challis, Principal Consultant, NDA Regulatory Science Ltd

Very good. Broad overview. Friendly audience

Jean-Paul Chappuis, , Galderma International

Very positive opinion - content very clear - interaction with speakers was fruitful - Good to have each day a summary of what was learnt the day before

Vanessa Brousset, Manager Europe, Galderma R&D