Presented by
Management Forum
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
1-3 Dec 2021 + 3 more dates
The importance of the biotech industry has increased significantly over recent years and biotech companies now dominate the new drug pipeline. The industry is gaining momentum and advancements in biomedical science and increased innovation hold vast potential for the growth of the biotech market.
This intensive three-day course will provide an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment. The interactive programme will cover the latest advances in regulation, including biosimilars and advanced therapies, and address the role and importance of patents within biotech, including what actually can be patented.
Benefits of attending:
This course is ideal for non-scientists and scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.
It will be relevant for anyone needing either an overview or refresher, particularly those working in:
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.
Kunle 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, Kunle has been involved in the production of biopharmaceuticals for more than 30 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.
Dr Adrian Haines is the Head of Science and Technology at Sobi AG, based in Geneva, Switzerland. Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics and is extensively involved in the scientific oversight of both upstream and downstream process development, and process characteristion studies prior to regulatory filings. He joined the company (then 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 ~30 years, starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received a bachelor degree from Imperial College, London, and a PhD from St Thomas’ Hospital Medical School, University of London.
Peter O’Callaghan holds BSc and PhD degrees in Genetics from Newcastle University. Since graduation he has gained over 10 years’experience in biotechnology research and development in academia and industry, during which time he co-authored patents as well as research articles and reviews in international peer-reviewed scientific journals and books.
Since 2011 he has been woking in the New Expression Technologies group at Lonza Biologics in Cambridge. He works as an Principle Scientist where he is responsible for the development and commercial implementation of new gene expression technologies, cell lines, and tools for recombinant therapeutic protein production using CHO cell lines. He also leads R&D strategies for developing next-generation technologies and processes, in addition to supporting commercial launch and associated promotional work
Kate Smith is currently Principal Scientist, Development Services, at BioReliance, UK, part of the Merck Group. In this position she is reponsible for providing technical supprt to both colleagues adn clients on the deign, execution and interpretation of viral clearance studies. Prior to transitioning into Development services Kate was responsible for managing the team involved in the preparatino of cell banks, viral seeds stocks and production of clinical lots of virus. .
Prior to joining BioReliance Kate was 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 is Director Physico-Chem Analytics, for Fresenius-Kabi, SwissBio Sim, a post she took up in 2017. She was formerly a Director within the Biosimilar Unit of Merch Serono and 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.
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.
Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer developing manufacturing processes and analytical offerings for biological products followed by 10 years in regulatory CMC roles supporting clients with clinical development and marketing authorisation activities for large molecules and advanced therapies.
1-3 Dec 2021
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11385
Until 27 Oct
Limited places remaining
7-9 Mar 2022
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11614
Until 31 Jan
27-29 Jun 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11876
Until 23 May
28-30 Sep 2022
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11707
Until 24 Aug
The content was excellent and all presenters were clearly SMEs, who managed to explain much of the complex content in an understandable way.
Sep 29 2021
Sunil Singh 
Director, Regulink Ltd
Apr 14 2021
Excellent. Really enjoyed and learned a lot.
Anthony Barker
Director - Regulatory CMC, Home Address
Apr 14 2021
The presentations were well prepared in general and I learned a lot.
Katja Pecjak 
Director of Regulatory Affairs & QPPV, Billev farmacija vzhod d.o.o
Sep 30 2020
I felt like the three days flowed together really well, first giving a basic understanding of the biology side of these products, how they are made and then their uses.
Laura Jones
Regulatory CMC Manager, AstraZeneca
Sep 30 2020
Really interesting, and a great introduction to someone with little/no knowledge of biotechnology. Also great that it went from scientific processes through to industrial processes. Nicely laid out. Well worth the three days!
Jackie Knipe
IP Paralegal, ALBUMEDIX LTD
Apr 10 2019
Well-balanced set of topics – nothing of importance seems to have been left out. The perfect level of detail for me as a biotech program leader/manager with a non-biotech scientific background.
Sergio Freitas 
Development Program Lead, Tillotts Pharma AG
Sep 25 2019
A good general introduction that managed to make this very technical subject matter understandable to those with little scientific background, or as a refresher to those who may have graduated many years previously.
Matthew Jordan
Imerys Minerals
Sep 25 2019
The course was comprehensive and the speakers were both subject matter experts and very good presenters. I really enjoyed the three days.
Linnea Elrington
VP, Head of HR, Silence Therapeutics
Sep 25 2019
I thought it was a really interesting overview of biotechnology, from the specific scientific processes all the way through to the industry trends. I appreciated the discussion of advantages/ disadvantages and challenges of various methods and the industry as a whole, as I think this added a lot of context. This was beneficial for me when I was trying to apply what I had learned in the day to my specific company's context.
Sian Gilfillan
Marketing and Communications Associate, Albumedix
Apr 10 2019
I wanted to learn the basics of biologicals research and establishment/characterization of MCB. I also wanted to learn more on biologics manufacture and registration/filing. All of this was accomplished.
Michael Vestling 
Regulatory and Quality Manager, INTERVACC AB
Apr 10 2019
I really appreciated the course and learned a lot.
Natacha Gonzalez
CMC Dossier & Compliance Specialist, Merck
Apr 10 2019
The content and presentation were very good.
Rutger Vandiest 
Sr Director - Head of Sales, Bavarian Nordic
Sep 26 2018
Excellent course – I learned a lot despite having worked as an in-house lawyer for a CMO for almost 5 years. The speakers were highly competent, engaged, knowledgable and able to answer all of my questions (and I had quite a few). Overall, a course I can highly recommend to other in-house lawyers.
Anna Damgaard Jensen 
Head of Legal , AOP Orphan Pharma
Sep 26 2018
The course is prepared to explain biotechnology in a very clear and complete way. It is intensive and you have to be focused to follow, but it's definitely worth the effort!
Roza Puzio 
European Projects Manager, Atlanpole
Apr 25 2018
All speakers were excellent and explained complex ideas very well. Fantastic, applicable course, presented really well. Great refresher course on molecular biology.
Luisa Teixeira
Account Manager, Owen Mumford Ltd
Apr 25 2018
Very good with lots of content. Thank you!
Falk Neukirch 
CFO, Vita 34 AG
Apr 25 2018
Highly qualified speakers.
Merecedes Rodríguez Rojas 
Business Manager, CZ Veterinaria, S.A
Apr 25 2018
A good mix of speakers – the course was useful for me.
Oliver Dale
Senior Specialist, MSD
Apr 25 2018
Interesting course with good quality speakers.
Anna Sarao
Regulatory Affairs Project Manager, Servier
Apr 26 2017
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
Apr 26 2017
Very good. Broad overview. Friendly audience
Jean-Paul Chappuis
Galderma International
Apr 26 2017
Speakers - well experienced. Content - well structured presentations
Lina Cacic 
Regulatory Affairs Advisor, Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Sep 27 2017
Very good.
Rabiea Abdullah
Senior Regulatory Specialist, MSD
Sep 27 2017
Well-structured training, clear presentations and explanations.
Oliver Jungmann
Global Head Drug Substance Technical Lead, F. Hoffmann-La Roche Ltd.
Sep 27 2017
Very good course, a bit condensed, very good speakers
Erik Andersen
Associate Director, Ferring Pharmaceuticals A/S
Apr 26 2017
Course covers biopharmaceutical aspects of biotechnology thoroughly. Good presenters
Patrick John Couzens
Patent Attorney, Société des Produits Nestlé S.A.
Sep 19 2016
An excellent course! Very informative both for beginners and as a refresher.
Sarah Norton
Senior Scientific Officer, Veterinary Medicines Directorate
Apr 27 2016
I liked the course and would recommend this to work colleagues
Anna Woźniak 
Valeant Sp. z o.o. Sp. j.
Apr 27 2016
Very comprehensive and intense. Mostly interested in the science and processes, less interested in patents.
David Cooke
Analytical Science Team Leader, Pfizer Ltd
Sep 19 2016
Course was very well outlined, prepared and presented
Isaac Hanania
LL.M., Boehringer Ingelheim RCV GmbH & Co KG
Sep 19 2016
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
Sep 19 2016
Very well organised
Marjon van Dijk 
Associate Consultant Chemistry, Manufacturing & Control, Kinesis Pharma B.V
Apr 27 2016
Intense but very interesting course that takes you back to the basis of biotechnology and also provides some inside in regulations
An van Hemelrijck 
RA Consultant, PhaRA
Apr 27 2016
Good, useful, complicated
Nicolai Soberg-Hansen
Patent Administrator, Genmab A/S
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