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.
★★★★★ "Content flow is well designed and good. [Parts I particularly liked were] process economy , Upstream... more (50)"
2-6 December 2024 »
from £1649.00
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.
This course is part of our Biopharma training courses series which aims to provide up-to-date knowledge on industry best practices and regulations surrounding biopharmaceuticals.
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. 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.
Dr Adrian Haines is a Senior Process Manager within MSAT at Sobi (Swedish Orphan Biovitrum). 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 characterisation studies prior to regulatory filings. He joined the company (then Novimmune, Switzerland, subsequently acquired by Sobi) 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 biochemistry degree from Imperial College, London, and his PhD from St Thomas’ Hospital Medical School, University of London. He is currently based in the UK.
After completing his degree in molecular biology at the University of Reading, Robert Alvarez has been at Lonza Biologics for 17 years, of which 14 were spent working in the product stability group and 2 as Head of Business Planning and Innovation within Analytical Services (AS). Most recently he has accepted a new role as Site Head of Digital Transformation spearheading Lonza’s digitilisation strategy. Within AS he was a Subject Matter Expert responsible for the design and implementation of forced degradation and formulation studies, directing stability programs for multiple products and establishing standards for stability, as well as supporting stakeholders and customers. As analytical lead for mAb and non‑mAb programs, he has provided technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including successful BLA licence applications.
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.
Marc Feary is Principal Scientist at Lonza. He has greater than 15 years’ experience in biopharmaceutical development and bioproduction, having held R&D and commercially-focused roles at Lonza Biologics facilities in Slough and Cambridge (UK). Marc holds a B.Sc. in Human Biological Sciences from Plymouth University and Ph.D. in Molecular Biology from the University of Kent.
Mardon McFarlane currently works as a Director of External Manufacturing for the gene therapy company AAVantgarde Bio. Mardon is a co-founder of a consultancy, Taxo Bioscience, that specialises in supporting pre-clinical and clinical stage biotech companies, by ensuring they make the correct, impactful decisions early in their journey to bring life-changing therapies to patients. Mardon specialises in the CMC aspect of drug discovery and has been involved in notable drug approvals during his 18+ years in the industry. His experience in the biotechnology sector started with biologics but over the last 11 years he has migrated to the cutting-edge sector of cell and gene therapy. Mardon’s career has been focused on the processing aspects of drug manufacture and has spanned process development, technology transfer, scale up and large-scale manufacturing. Mardon holds an MEng in Biochemical Engineering from University College London.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
2-6 December 2024
Live online
12:00-17:00 UK (London) (UTC+00)
13:00-18:00 Paris (UTC+01)
07:00-12:00 New York (UTC-05)
Course code 14091
Limited places remaining
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Content flow is well designed and good. [Parts I particularly liked were] process economy , Upstream and Downstream scale up.
Sep 25 2024
Arindam Gupta
Global Category Procurement Manager, Servier Monde
Sep 25 2024
Excellent, I am so please a colleague mentioned to IPI to me.
Julie Bailey
CFO, ILC Therapeutics Ltd
Sep 27 2023
I thought all the speakers were excellent. You could tell that they all really knew there subject matter and were so passionate in the way they delivered the content. Special mention has to go to Adekunle - fantastic course leader and so knowledgeable and made the 3 days very interactive.
Mark Kalinowski
Chief Financial officer, Albumedix Ltd
Sep 27 2023
The course was good and it was a pleasure to learn from the speakers. I wanted to get an overview of research and development of drugs and pharmaceuticals. I think this was achieved.
Sarah Kanna
Senior Legal Associate, Hevolution Foundation
Jun 26 2023
Very good
Jurgen Vercruysse
Business Unit Manager Drug Product, Eurofins Amatsigroup
Dec 5 2022
It was great. All speakers presented well and were knowledgeable about the Industry/topic.
Shanell Burwell
Compliance Manager Internal External Audits, Pfizer
Dec 5 2022
I have a masters in Biochemistry and have worked as a formulation scientist for 1 year so I wanted to gain more applied knowledge, and a broader understanding of the drug development process. I found the content of this webinar easy to understand and it was nice to have the information presented to me in an organised and coherent manner.
Samantha Martell
Scientist 1, Ipsen Biopharm
Sep 28 2022
All speakers were knowledgeable on their respective topics and could give explanations in detail. Overall I was satisfied with each given presentation... Personally, I enjoyed seeing the overview of product development from start to finish, and the background of the (GMP) regulations. Reasons for this is personal interest and relevance to my current job.
Christian Malonda
Process Engineer, Janssen Biologics BV
Sep 28 2022
One of the best courses I attended because the target was clear and the execution met the expectations... The whole course was well integrated to give to non specialist an overview of everything.
Tomaso Guidi
Head of Formulation and Process Development, Chiesi Farmaceutical SpA
Mar 7 2022
The level of detail and complexity was just right and I have learnt a lot and would certainly recommend this course to others. I thoroughly enjoyed the course.
Melanie Pires
Pharmaceutical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)
Sep 28 2022
Very good content considering the target population, good compromise on the level of detail, very good material and excellent speakers
Francesca Usberti
Head of Pharmaceutical Development , CHIESI FARMACEUTICI SPA
Sep 28 2022
Positive and professional
Mauro Provezza
Site Manager, Bayer Cropscience SRL
Mar 7 2022
The webinar was very good overall with very comprehensive material and understandable throughout. The speakers were very knowledgeable and were open to questions and comments and answered them very professionally.
Tomas Orn Sigurbjornsson
Sourcing Lead, Alvotech
Dec 1 2021
Excellent course with expert speakers. It is highly recommended to people who already have a background on life sciences.
Mary Malamatari
Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)
Dec 1 2021
Every speaker brought in their own experience and passion that should offer something for attendants from a variety of backgrounds and levels of detail, and certainly did for mine...Excellent content for somebody lacking a bio or chemistry background providing a clear and useful understanding of the building blocks that make up the biotech industry.
Patrick Helm
Sr. Associate Contract Management, Genmab B.V.
Sep 29 2021
The content was excellent and all presenters were clearly SMEs, who managed to explain much of the complex content in an understandable way.
Sunil Singh
Director, Regulink Ltd
Apr 14 2021
Excellent. Really enjoyed and learned a lot.
Anthony Barker
Regulatory Project Director , AstraZeneca
Dec 1 2021
I really enjoyed the course and I have already recommended it.
Paolo Gasbarrone
Principal scientist, Merck group
Apr 14 2021
The presentations were well prepared in general and I learned a lot.
Katja Pecjak
Associate Director & 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
Principal Advisor for Regulatory Affairs, 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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3 days
Typical duration
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Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
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