Inhaled and Nasal Biologics/DNA Forum 2023

Join us for a ground-breaking and insightful forum on inhaled and nasal biologics development: Two days of cutting-edge talks and networking opportunities with leaders in this complex area of inhaled biologics and inhaled vaccine development. Don't miss out - Tickets are limited and so register now!

2nd Annual Inhaled & Nasal Biologics/DNA Forum
28-29th September 2023 | Cambridge, UK 

As drug discovery programs place greater emphasis on biologic drug substances for both local respiratory and systemic targets, the need to develop effective solutions for nasal and inhaled biologics delivery is becoming increasingly important for the industry. Respiratory administration of biologics and DNA modalities pose distinct obstacles. Developers must carefully balance various factors, including product performance, manufacturability, regulatory risk, and commercial considerations when designing a product.

This year's conference, centred around the theme of "Building Effective Products," features world-renowned industry leaders who will share the latest insights and case studies in the field of inhaled or nasal biologics and inhaled vaccine development with real-world case studies to stimulate discussion.

    Join industry-leading experts for two days of conference and networking. Grab your seat as a key stakeholder in this growing industry community now. 

    Places are limited - please register now.



    Wednesday, September 27th 2023 - Networking and Optional Lab Tour

    • Intertek Laboratory Tour (optional), Intertek Melbourn, Cambridgeshire, 2 pm
    • Networking drinks reception, Hinxton Hall, 5.30 pm 

    Thursday, 28th September 2023 - Day 1 of Conference

    • Keynote Speaker: Igor Gonda, Founder and CEO, Respidex LLC

      Inhaled biologics: What can we learn from Pulmozyme success 30 years later?
      Pulmozyme was the first and so far the only approved inhaled recombinant human protein. It was launched in record time of 4 years from cloning the molecule, despite no prior regulatory precedents. Many believed that this success heralded entry of many new inhaled biologics both for treatment of respiratory diseases as well as a non-invasive route of administration of macromolecules. The debacle of inhaled insulin brought the field to a screeching halt. This talk will discuss the lessons learned that include the key criteria for the choice of the target product profile for inhaled biologics and the tools needed to develop successfully such products.
    • Session 1: Learnings from Real-World Case Studies
    • Session 2: Choosing The Right Drug Delivery Device 
    • Panel Discussion
    • Networking Drinks 5:30 pm
    • Evening: Conference Dinner

    Friday, 29th September 2023 - Day 2 of Conference

    • Session 3: Designing An Appropriate Formulation
    • Session 4: Regulatory-Driven Test Requirements
    • Conference Close

    Meet Our Speakers

     Igor Gonda Keynote Speaker
    Keynote Speaker: Igor Gonda, Founder and CEO, Respidex LLC

    Inhaled biologics: What can we learn from Pulmozyme's success 30 years later?
    Igor Gonda is the founder of Respidex LLC – a consulting firm assisting pharmaceutical companies in corporate strategy, including R&D program design, collaborations with patient advocacy groups, regulatory process, intellectual property management, financing and business development. He is a Principal Consultant for Scendea - a product development and regulatory consulting practice. He was previously in various executive roles (Chief Scientific Officer, CEO and President) at Aradigm Corporation – a US company developing inhalation therapies for the prevention and treatment of serious respiratory and systemic diseases.
    Igor conducted health-related aerosol research and product development at Genentech Inc. (USA) and at universities in the UK, USA and Australia. He was also the CEO and Managing Director of the transdermal company Acrux Ltd in Australia. His current research interests include cancer prevention and treatment using inhaled small molecules and biologics. He has both past and current company Board experience in USA and Australia.
    Igor has over 120 US patents and patent applications. He published over a hundred papers. He received the British Pharmaceutical Society Astra-Zeneca Industrial Achievement Award and the Thomas T. Mercer Joint Prize of the International Society for Aerosols in Medicine and the American Association for Aerosol Research, for Excellence in Pharmaceutical Aerosols and Inhalable Materials. Igor graduated in Chemistry and received PhD in Physical Chemistry from the University of Leeds, England.
     Gunilla Petersson HCmed Innovations

    Gunilla Petersson, Ph.D., Chief Scientific Officer (CSO), HCmed Innovations Co., Ltd.

    Mesh Devices Beyond Small Molecules – Challenges and Opportunities

    Former Science and Innovation Director of Inhaled Drug Delivery at AstraZeneca, Dr. Petersson has more than 29 years of experience in the pharmaceutical industry. Affiliated to the Innovation Strategies and External Liaison segment, in most recent years, she dedicated herself to novel technology scouting, due diligence activities, and scientific marketing. During her extended and successful professional career, Dr. Petersson has also focused on inhaled medicines, medical devices (inhalers), pharmaceutical research, quality by design, and regulatory documentation, accumulating a vast number of connections with global pharmaceutical companies and renowned experts in the field.
     Ross Blezard DFE PharmaRoss Blezard Product Application Specialist Biopharma and Inhalation.
    The Role of Excipients in the Future of Pulmonary Drug Delivery

    Ross Blezard is a Product and Application Specialist for Inhalation and Biopharma at DFE Pharma. A physicist by education, Ross began his career in inhalation and transdermal delivery as a formulator. After leaving his position as head of formulation development at a UK-based CDMO, Ross worked as a senior scientist in material sciences specializing in size and solid state characterisation techniques. In 2019 Ross joined DFE Pharma, where he has supported inhalation and biopharmaceutical customers with their technical challenges.
     Mathieu EpardaudMathieu Epardaud, PhD
    Senior scientist @ INRAe
    Co-founder and Scientific consultant @ LoValTech
    Challenges and Opportunities of a Mucosal Platform for Nasal Vaccination

    An immunologist specialized in immunotherapies and vaccinology, Mathieu Epardaud joined the BioMAP team of the joined Unit UMR ISP 1282 (Tours University – INRAE) in 2018 to contribute to the development of anti-cancer immunotherapies and to develop strategies for mucosal vaccine platforms.

    He previously contributed to research on (1) preclinical model for studying the immunopathology of tuberculosis in the same UMR (Tours, France), (2) cancer immunotherapy at the Dana Farber Cancer Institute & Harvard Medical School (Boston, USA) and ( 3) systemic vs mucosal immune response within another INRAe unit (Jouy en Josas, France).

    Mathieu Epardaud participates in the intranasal vaccine development platform project and is one of the founders in January 2022 of the start-up LoValTech, for which he holds a position of scientific consultant, in particular for the preclinical studies and the development of the intranasal delivery system.
     Bruce HamiltonBruce Hamilton, PhD
    Drug Development Team Leader, Early Phase Development Solutions
    Labcorp Early Development Laboratories Limited
    Non-clinical development of inhaled biopharmaceuticals and newer classes of compounds compared to inhaled NCEs

    Bruce has more than 25 years of pharmaceutical research and development experience working within large pharma and biotechs. His current role is managing a team of Drug Development Leaders who provide Labcorps’ clients with scientific and regulatory advice and who work across the range of pharmaceutical products including biological therapies (mAbs, cells, genes), oligonucleotides, vaccines and NCEs. Before joining Labcorp, Bruce was Director New Product Development at Abcam and has also held previous positions with Medimmune, Bicycle Therapeutics, GlaxoSmithKline, and Astex Therapeutics. He has been responsible for end-to-end delivery (from compound selection to completion of IND enabling studies/initiation of clinical testing) of three compounds as well as assisting many progress through intermediate milestones. He is adept at managing risk and timelines to accelerate drug development, prioritize resources and maximize the potential for commercial value. During his time with Labcorp he has been the assigned DDL responsible for one inhaled protein therapy as well as producing strategies for the development of multiple others.
     David Coleman Labcorp ForumDavid Coleman
    Drug Development Leader, Inhaled Drug Development,
    Labcorp Early Development Laboratories Limited
    Non-clinical development of inhaled biopharmaceuticals and newer classes of compounds compared to inhaled NCEs

    David Coleman has over 20 years of experience conducting toxicology studies and is an expert in all aspects of nonclinical safety testing required to support locally or systemically administered pharmaceuticals (NCEs and large molecule biotherapeutics). As part of Labcorp’s Early Phase Development Solutions team, he provides scientific advice and oversight for clients’ preclinical programs. His professional highlights include four years of experience in drug development strategy in a CRO environment, dealing with a broad range of modalities. He has also overseen several first-in-human enabling programs that have been reviewed by regulatory agencies and proceeded to phase I trials. David presents regularly on the regulations and strategies essential for nonclinical development, addressing both external and internal audiences.
     Prof Cees van RijnProfessor Cees van Rijn
    Senior Researcher, University of Amsterdam and
    Director IPR at Medspray B.V.
    Aerosolization of Biologics by Different Soft Mist and Nebulizer Technologies

    Prof. Van Rijn has been working as senior researcher and director of Intellectual Property Rights (IPR) at Medspray B.V. since 2012. As IPR Director, he is responsible for the company’s innovation policy. From 2007 to 2017, he was professor by special appointment of MicroSystem and Nano Technology at Wageningen University & Research (WUR). He has set up several nanotechnology companies, including Nanomi and Vycap, and has initiated a range of public-private research projects with the business community. He studied Physics at Vrije Universiteit Amsterdam and obtained his doctorate at Leiden University. Van Rijn has published a large number of academic articles in peer-reviewed journals. The work he recently conducted into aerosols – with several collaborators, including UvA physicist Daniel Bonn – made world news. It was partly on the basis of their publication in The Lancet Respiratory Medicine that the World Health Organization (WHO), among others, pointed to the possible role played by aerosols in the transmission of the coronavirus and the importance of good ventilation in public spaces.
     Professor Ben ForbesProfessor Ben Forbes
    Professor of Pharmaceutics
    King's College London
    Development of mRNA Formulations for Inhaled Drug Delivery

    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.
     Jacob HarkerJacob Harker
    BnL Pharma Solutions
    Inhaled Oxytocin, Bringing safer Childbirth to Women in Need

    Jacob is a consultant and formulator, with some 20 years’ experience in developing drug device combination products. He has a passion for novel formulation technologies and developing dry powder oral and nasal inhalers. During his career as formulation chemist and product development specialist, Jacob worked at Pfizer, AsteraZeneca and Circassia, before starting his own consultancy in 2018. He now works with a variety of companies to help develop their respiratory assets.
     Pete LambertPete Lambert
    Director, Program Management
    Monash Institute of Pharmaceutical Sciences
    Inhaled Oxytocin, Bringing safer Childbirth to Women in Need

    Originally trained as a pharmacist in the UK, Pete Lambert has 20 years experience in drug development in the pharma industry, primarily focusing on inhaled and intranasal delivery systems. In 2010 he transitioned to working in global public health, completing his Masters in HIV Management at Stellenbosch University, South Africa, and joining Monash Institute of Pharmaceutical Sciences (MIPS) in Melbourne, Australia in 2012. He currently leads the Inhaled Oxytocin project, is the founder and director of the Monash Quality of Medicines Initiative and co-coordinates the Global Health Therapeutic Program Area at MIPS.
     Kaoutar KristouKaoutar Kristou
    Area Sales Manager Northern EU, Aptar Pharma Rx
    Aptar Pharma Rx
    Nasal Device Optimization: Balancing Formulation and Patient Needs

    Kaoutar Kristou is Sales Area Manager UK & Northern Europe within Aptar Pharma’s Prescription division where she is responsible for driving a portfolio of Nasal and Pulmonary drug combination product opportunities, with a specific focus on new nasal delivery technologies. Kaoutar is a Scientist by training. Driven by innovation and science, she has been active in drug developments and Bioanalytical activities related to vaccines and biologics. Her interest lies in supporting the development of innovative combination products treatments with Aptar drug delivery devices, balancing formulation, technology, and commercial potential.
     Ashleigh Wake DirectorAshleigh Wake
    Business Development Director
    DNA Medicine Testing for Inhaled and Nasal Oligonucleotide and mRNA Products

    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 centres across Europe including the centre of excellence for biologics characterisation in Manchester, UK.



    The registration fee per attendee is shown below. This includes the conference registration, accommodation at Hinxton Hall if required, the conference dinner and networking drinks.

    RateIncl. 2 nights' accommodationIncl. 1 night accommodationNo accommodation required
    Standard Rate (from 1 June 2023)£449£399£349

    Hinxton Hall, Cambridge, UK

    Set within a one-hundred-acre estate bordering the River Cam, Hinxton Hall Conference Centre is located on the Wellcome Genome Campus, alongside research institutions that are at the forefront of the genomics revolution.

    Hinxton Hall is 25 minutes from the centre of Cambridge, and a mere 60 minutes from London and accessible from Heathrow, Luton and Gatwick airports and is only 20 minutes from London Stansted Airport. The hall is easily accessible from the M11. For GPS please use: CB10 1SA.

    The Intertek team will book accommodation on your behalf if you indicate that you require a room during registration. 

    QUESTIONS? Please contact us: 
    T: UK +44 (0)1763 261 648     |     E: 


    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 was delighted to host the first forum on all aspects of the development of biologic drugs for respiratory delivery which took place at Madingley Hall, Cambridge from 28-30 September 2022. 

    We thank all of our industry leading experts who joined us for discussions on key principles, challenges, regulatory expectations, best practice and technologies involved in building effective inhaled and nasal DNA or biologic product. The agenda included these 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


    Need help or have a question? +44 1763 261648