Professor in Pharmaceutics
& Biopharmaceutics

Trinity College Dublin

In-person

Carsten is Professor in Pharmaceutics and Biopharmaceutics and Fellow at Trinity College Dublin. He also holds an Adjunct Professorship at the University of Southern California. His research is focused on lung drug disposition and pulmonary epithelial transport. Moreover, he is interested in molecular origins of airways disease. Carsten has edited 1 book and (co-) authored >100 peer- reviewed publications and over 250 abstracts. He is the recipient of honours and awards from German Pharmaceutical Society (DPhG), American Physiological Society and Galenus Foundation. Carsten serves as Associate Editor of Journal of Aerosol Medicine and Pulmonary Drug Delivery and Section Editor of European Journal of Pharmaceutical Sciences and is a member of the Editorial Boards of European Journal of Pharmaceutics and Biopharmaceutics, Journal of Pharma- ceutical Sciences, Pharmaceutics, and Pharmaceutical Research.

Global Lead of Inhalation Sciences and Engineering

Labcorp Drug Development

In-person

Simon joined the company in 1999 as an inhalation study analyst and was promoted quickly within
the Aerosol Technology and Analysis section. When the section expanded and divided in 2003 into
inhalation chemistry and aerosol technology, Simon was promoted to the role of Head of Aerosol
Technology with managerial responsibility for the aerosol In 2009, he took managerial responsibility
for the inhalation engineering services group. The inhalation engineering services groups designs,
prototypes and manufactures custom made inhalation equipment for all sites within the organisation.

In July 2017, Simon took on the additional responsibility of being part of the Toxicology Operations
Management as a Team Leader of the inhalation study management team with line management
responsibility for Study Managers and Trainee Study Managers in the Inhalation Studies Group.
In this role, Simon is responsible for all aerosol technology aspects including of the overall
interpretation and reporting of the inhalation studies including safety pharmacology and ADME at
the Huntingdon site.

In 2019, Simon’s role expanded to his current role where he has global responsibility of all studies
conducted at inhalation sites across the Covance portfolio including line management responsibility
for the Aerosol and Inhalation technologists at the Somerset site.

Simon obtained his degree from the University of Dundee in Chemistry (1996) and gained his PhD
in Heterogeneous Catalysis from the University of Glasgow (2000) using high-pressure gas flow and
chromatography. Simon lectures at the University of Surrey as part of the MSc Toxicology course on
inhalation dosing, techniques and methodology, is the Vice Chairman of the Association of Inhalation
Toxicologists, a committee member of the British Standard Institution on Nanotechnologies and has
produced over 100 publications

Senior Principal Scientist Oncology & External Supply Small Molecules, Europe

Takeda GmbH

In-person

Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design.
He shares several years of experience in the Pharmaceutical Industry, providing scientific leadership
to govern the formulation and manufacturing strategies for drug product development programs
during clinical stages, including their scalability and validation for commercial use. Currently,
Dr. Drumond is responsible for the technical management and leadership of commercial manufacturing activities at different Contract Manufacturing Organizations (CMOs) for an established
portfolio of Takeda products within the EMEA region.

Chief Executive Officer

PULMOTREE

In-person

Ulf Krueger, Chief Executive Officer 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 pulmonary 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).

Business Development Manager

H&T Presspart

In-person

With a strong pharmaceutical and analytical background, Jacqueline Green currently works as
Global Business Development Manager at H&T Presspart, providing technical expertise and support
on every aspect of metered-dose inhalers with a specific focus on plasma treated metered-dose
inhaler cans and sustainability in the MDI market.

Inventor and Founder

1nhaler

Don Smith is the inventor of the 1nhaler, a revolutionary, single dose, dry powder inhaler, designed
to deliver a global impact through a simpler, more convenient, user-focused approach to inhaler
design. Don runs the business alongside partner and Commercial Director Lisa McMyn, with
support from an experienced team of respiratory industry experts, including Harro Höfliger

Product Application Specialist: Biopharma & Inhalation

DFE Pharma

In-person

Ross Blezard has 13 year experience in the pharmaceutical and biopharmaceutical industries. He held the position of head of formulation development for a UK based CDMO specializing in inhalation and transdermal drug delivery. During his career Ross has worked in the UK, US, Germany and is now based in the Netherlands.

In 2019 Ross joined DFE Pharma as a product application specialist inhalation and biopharmaceutical customers.

Senior Scientist – Advanced Products & Delivery

Research Center Pharmaceutical Engineering GmbH

In-person

Milica Stankovic–Brandl (PhD., Dipl. Pharm) received her Pharmacy diploma in 2007 in Nis, Serbia. Afterward, she obtained PhD. from the University of Groningen, The Netherlands (RUG), Department of Pharmaceutical Technology and Biopharmacy. Since 2013, Milica has been working as a senior scientist at Research Center Pharmaceutical Engineering GmbH (RCPE) in Graz, Austria, in the Area of Advanced Products and Delivery.

To this date, her research is compiling different formulation development areas, including formulations for inhalation, polymeric–based subcutaneous long–acting pharmaceuticals, and solid and liquid biopharmaceuticals. Her interest and work include spectra from small molecules to biologics (peptides and proteins). In the development of DPI’s, her research interest mainly covers capsule–based dry powder Inhalers (DPI’s) and strategies toimprove aerosolization but also to understand the role and the relationship between capsule material, formulation, and device for successful inhalation performance.

Independent Consultant

In-person

Having worked for more than 15 years in 3 of the largest Argentine Companies in the Pharmaceutical Industry, I was able to acquire the skills both to develop and validate analytical methodologies, and to write technical documentation. In 2018 these skills led me to lead the inhalation products project, specifically for DPIs.

Managing Director

Paul Johnson Consulting Limited

In-person

Paul Johnson is an independent consultant specialising in the pharmaceutical development of inhalation drug delivery systems. He has provided consultancy services to both NCE and generic drug development companies since 2018. Prior to this Paul gained 20 years of experience in leading the CMC aspects of much of GSK’s respiratory portfolio, including leading Relvar Ellipta from early research to registration, launch and lifecycle management.

Account Executive – Inhalation

Catalent

In-person

Patrick Goncalves, Account Executive, Business Development – Inhalation & Nasals, has over 8 years’ experience of pharmaceutical industry, with extensive expertise in Dry powder Inhalation. In his current role, he is responsible for growing the Inhalation & Nasal business in Europe. Patrick joined Catalent from Harro Höfliger where he held various sales and project management roles, and most recently was a Senior Sales Manager for Inhalation Technologies overseeing all dry powder inhalation projects. Patrick holds a Bachelor Industrial engineering from the University of Esslingen and an MBA in Sales Engineering from the Universityof Kaiserslautern.

Head of New Modalities Pharmaceutical Development

Nanopharm

In-person

Irene Rossi is the Head of New Modalities Pharmaceutical Development at Nanopharm, an Aptar Company. Irene obtained a MSc in Pharmaceutical Chemistry and Technology in 2014 and a PhD in Drugs, Biomolecules and Health Products at the Food and Drug Department, University of Parma (Italy) in 2019. She joined Nanopharm in 2019 and she currently leads a group focused on the development of new technologies for OINDP products. Her main research area is the production, optimization and characteri-zation of powders and liquid formulations for nasal and inhalation containing small (i.e. antibiotics) or large molecules (i.e. protein). Up to date, Irene has submitted and published 6 original papers, a patent application on the development of a dry powder for pulmonary vaccination and she presented her work at more than 20 international conferences.

Senior Director – Pharmaceutical Development & Technical Operations

Acorda Therapeutics

In-person

Michael Tauber is Senior Director of Pharmaceutical Development and Technical Operations at Acorda Therapeutics. Since 2002, he has worked in various areas of pharmaceutical development including early and late stage development, pre-formulation and formulation for solid oral development, formulation and scale up of spray dried engineered particles for inhalation delivery and management of CMC related activities supporting the development and commercialization of Inbrija®. Additionally Michael has servedat the solid state chemistry technical lead on numerous projects over the years and had established solid state labs as well as instructed many peers on this topic. More recently he has managed all aspects of the extractables and leachables program for Inbrija® through NDA/MAA approval. Michael holds a B.S in Chemistry from UMass Boston and an M.S. in Chemistry from Northeastern University.

Head of Health Solutions – Digital Health

Teva Pharmaceuticals

In-person

Mark is responsible for the Respiratory Health Solutions within Digital Health at TEVA Pharmaceuticals. Over fourteen years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positionsincluding R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

Principal Consultant – MedTech

PA Consultingaceuticals

In-person

Mark is responsible for the Respiratory Health Solutions within Digital Health at TEVA Pharmaceuticals. Over fourteen years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positionsincluding R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.