Inhaled and Nasal Biologics/DNA Forum 2023

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, 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.