Advances in Pulmonary Delivery of Biologics

Dr Michael Song leads the Device and Packaging plus Shipping Validation function at Moderna overseeing development, submission, and on-market support activities. Prior, he has held positions as Director of Sterile Packaging at GSK and Associate Director at Takeda. Through Dr Song’s career, also formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca as well as Device, Package, and Process Engineering group at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Dr Song holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Philippe Rogueda is the Chief Business officer and a co-founder of Merxin Ltd. Merxin Ltd makes inhalers. He is an inhaled formulation expert with a global reputation and an enviable track record of developing pMDIs, DPIs, Nebules, Nasal and soft mist inhalers for both generic and originator companies. Dr Rogueda trained in Physical Chemistry at the Universities of Bordeaux (France) and Bristol (U.K.), where he obtained his PhD. He subsequently worked for AstraZeneca, Novartis, Actavis before founding Inhalation Asia (Hong Kong) and Merxin Ltd (U.K.). Merxin Ltd designs and supplies inhaler devices. We redefine Inhaler Technology: Multidose Dry Powder Inhalers, Capsule Dry Powder Inhalers, and Soft Mist Inhalers. Our soft mist inhaler MRX004 (www.mrx004.com) is spearheading a renaissance in inhaled biologics product development. Our DNA is in the pharma industry, our reputation is built on excellence. We develop inhaler devices used in local and systemic inhaled therapies. We make inhaled therapies and inhaled devices better for use from bench to commercial launch. Dr Rogueda’s current interests lie in enabling inhaled biologics. With 4 products approved and 119 assets in development in the US only, inhaled biologics is a market poised to expand. His recent publications include: Sorting through Soft Mists: Generics, Biologics and Beyond (2024), Soft Mist, Strong Impact: Enhancing Inhaled Biologics Drug Delivery (2024), Dornase Alpha Soft Mist Inhaler (2024), Soft Mist Inhalers vs Nebulisers Delivery Equivalence (2024), Transitioning pMDIs to SMIs (2023), Open File Close: A Guide To Making A Generic Triple DPI (2023).

Alessandro Cavecchi is the Head of the Pharmaceutical Technology Section within Chiesi Farmaceutici’s R&D department, holding a Magister degree in Industrial Chemistry from the University of Parma (IT). With over 20 years of experience in developing inhalation dosage forms, Alessandro has specialized expertise in Dry Powder Inhalers (DPIs) and pressurized Metered Dose Inhalers (pMDIs). In his current role, he ensures the scientific integrity and robustness of formulation and process development for the dosage forms in Chiesi Farmaceutici's R&D pipeline.Before joining Chiesi, Alessandro served as Senior Formulation Manager at Zentiva (Sanofi Generics), where he was responsible for the formulation and manufacturing development of generic inhalation products. He also worked at Novartis as a Formulation Fellow, supporting the establishment of the Breezhaler® portfolio.