Inhaled and Nasal Biologics/DNA Forum 2022

Accelerate your biopharmaceutical development with three days of conference and networking on key considerations for developing effective orally inhaled or nasal biologics or oligonucleotide therapies or vaccines

Building Effective Orally Inhaled or Nasal Products
With drug discovery programmes increasingly focused on biological drug substances for both respiratory and systemic targets, the need to develop effective solutions for nasal and inhaled delivery is becoming increasingly vital for the industry.

Biologic and DNA based modalities such as oligonucleotides, proteins, antibodies and a range of other complex forms present unique challenges for developing an effective inhaled and nasal delivery.

With a focus on networking and learning, Intertek is delighted to host this first forum on all aspects of the development of biologic drugs for respiratory delivery. Join industry leading experts for discussions on key principles, challenges, regulatory expectations, best practice and technologies involved in building effective inhaled and nasal DNA or biologic products.

Places are limited and so please register your interest to attend. Visit our event portal now.

DATE: 28-30th September 2022
VENUE: Madingley Hall, CAMBRIDGE, UK

AGENDA
Following an informal networking evening and dinner (Wed 28th September), the conference (29-30th September) will cover the key themes of fundamental development considerations for inhaled biologics, regulatory developments, formulation development, inhaled and nasal product testing, current and future trends with case studies from real-world projects. Our schedule includes these exciting talks:

PLENARY: Complex large molecules delivered to the nose and lungs by devices as a combination product. Whatever could be simpler than that!
Eddie J French PhD, TEKH Consulting Limited

Inhaled Biologics – Time to Deliver!
Professor Ben Forbes, Professor of Pharmaceutics, King's College London

Smart nebulizers, the future role of technology in respiratory care
Ulf Krüger, CEO, Pulmotree Medical GmbH

Inhaled IFN-β (SNG001) for the treatment of COVID-19 and other severe viral lung infections
Phillip Monk, Chief Scientific Officer, Synairgen Research Ltd

Inhaled Biologics: What Molecules? What Markets?
Philippe Rogueda – Co-founder and Chief Business Officer, Merxin Ltd.

Fundamentals of OINDP Testing
Mark Parry, Technical Director, Intertek

Fundamentals of DNA Medicines Testing for Inhaled and Nasal Oligonucleotide and mRNA Products
Ashleigh Wake, Intertek Pharmaceutical Services


MEET OUR SPEAKERS

Eddie French SpeakerEddie J French PhD, TEKH Consulting Limited
Eddie French is an independent pharmaceutical consultant who specializes in drug product design and development. In this role he supports medicines development programmes in biotechs, established pharma companies and philanthropic organizations.  He has a PhD is drug delivery and spent time as an academic at Bath University prior to 30 years in the pharmaceutical industry.  The majority of this time was spent with Pfizer where he spent 7 years leading their biologics formulation development team followed by 9years working in the inhaled drug delivery space. He finished his career at Pfizer as Director of Device Enabled Drug Delivery. Since then, Eddie has worked on numerous inhaled and nasal products including several with biological derived molecules.Eddie is a previous chair of the Academy of Pharmaceutical Sciences of Great Britain and its inhaled product focus group. 
 Professor Ben ForbesProfessor Ben Forbes, Professor of Pharmaceutics, King's College London
Ben Forbes is Professor of Pharmaceutics at King’s College London. He has a BPharm from King’s College London (1987) and a PhD in Drug Delivery from Strathclyde University (1996). Before doctoral studies, he worked in hospital pharmacy in London and Sydney, and for Inveresk Clinical Research in Edinburgh. He was appointed to the academic staff of King’s College London in 1997 and is a registered pharmacist in the UK. The term ‘Inhalation Biopharmaceutics’ was coined by Ben Forbes in the dying embers of the last Millennium to describe the scientific field that considers the factors that influence respiratory and systemic exposure to inhaled drugs [Ehrhardt C, Pharm Res 34: 2451–2453, 2017], and he has authored many publications in this area, including: inhaled medicine formulation, the development and application of techniques to study respiratory drug transport and metabolism, inhalation toxicology. He chairs the Scientific Advisory Committee of the Aerosol Society’s annual Drug Delivery to the Lung’s (DDL) conference.
 Ulf KruegerUlf Krüger, CEO, Pulmotree Medical GmbH
Ulf Krueger, CEO and founder of PULMOTREE. His experience in life sciences and especially in managing projects, programs and portfolios in the field of inhaled drug delivery is the basis of Pulmotree’s business. Throughout his career, Ulf has been particularly engaged in the development of transpulmonary drug delivery devices and the targeted delivery of drugs to the lungs.
In his former position as Director – Fox Nebulizer Programs at Vectura, he held responsibility for the entire sector of vibrating mesh nebulizers. Previous to that, he held various positions in the research and development department of PARI. He is a graduate biomedical engineer and a certified senior project manager (IPMA® Level B) and is a member of The Aerosol Society, the European Respiratory Society (ERS) and the International Society for Aerosols in Medicine (ISAM).
 Phillip MonkPhillip Monk, Chief Scientific Officer, Synairgen Research Ltd
Dr Phillip Monk is currently the Chief Scientific Officer at Synairgen, an AIM-listed spin-out company focused on novel therapies for the treatment of respiratory disease, founded by leading academics from the University of Southampton (Profs Holgate, Djukanovic and Davies). The company’s most advanced programme is based around the development of inhaled interferon beta (SNG001) as a broad-spectrum antiviral for the treatment and prevention of virus-induced exacerbations of respiratory disease and COVID-19. Phillip was previously Director of the Respiratory and Inflammation Biology group at Cambridge Antibody Technology (‘CAT’ now part of AstraZeneca) and led the early discovery / development of tralokinumab, an anti-IL-13 therapeutic antibody, now an approved treatment for moderate-to-severe atopic dermatitis. Prior to joining CAT, he worked at Bayer AG within the respiratory disease therapeutic area, focusing on the development of novel therapies for asthma, COPD and cystic fibrosis.
 PhillipeRogueda
Philippe Rogueda – Co-founder and Chief Business Officer, Merxin Ltd
After extensive education culminating in his PhD in Physical Chemistry Philippe joined Astra as a Pharmaceutical Scientist leading to more senior roles in AstraZeneca R&D. After this he was offered a position as Principal Fellow at Novartis to research early phase nebulisers, nasal and DPI formulations. He was engaged as Principal R&D Consultant at Kind Consumer, followed by Actavis as the Executive Director Emerging Technologies. In this role Philippe was responsible for all generic inhalation products across nasal, DPI, pMDI and nebulisers. In 2011, he co-founded Inhalation Asia, the foremost inhalation drug delivery network in Asia, producing 3 Global conferences and a 3k+ peer network. He also co-founded Merxin Ltd, a generic medical device supplier, developing and supplying the drug delivery market with standardised off-the-shelf drug delivery devices. The company launched with no external investment and within 18 months had exceeded expectations and grown to a £multimillion turnover business. Philippe also consults for Aedestra Ltd, providing strategic support, advice and guidance to drug technology companies.
 Mark ParryMark Parry, Technical Director, Intertek Pharmaceutical Services
Mark Parry has worked with Intertek Melbourn for 20 years after graduating from Cambridge University and currently works as the Technical Director supporting the wide range of analytical, formulation and product development activities across the company. Mark has worked in a range of pharmaceutical analysis and formulation development areas with a particular focus on inhaled and nasal drug products. Mostly working in the pre-approval stages, Mark’s background includes extensive experience with product and formulation development, as well as method development and validation, stability studies, and pharmaceutical development activities for a wide range of clients across the pharmaceutical industry.
 Ask Our Expert Ashleigh WakeAshleigh Wake, Business Development Director, Intertek
Following graduation, Ashleigh joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. She has a background in mass spectrometry and a career of over two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, PK studies and API/product characterisation, CMC support analytics and ICH stability studies). Ashleigh has specialized in the design and delivery of regulatory (GXP) studies relating to the physiochemical and biological activity of biomolecules including oligonucleotides, proteins, mAbs and vaccines and is currently responsible for strategic growth and business development at Intertek’s GMP compliant centre of excellence for biologics characterisation in Manchester, UK

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T: UK +44 (0)1763 261 648     |     E: bd.melbourn@intertek.com

Need help or have a question? +44 1763 261648
 

Need help or have a question?

+44 1763 261648
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+44 1763 261648