Beyond scratching the surface

Head of Pharmaceutical Technology Section at Chiesi Farmaceutici with a Magister degree in Industrial Chemistry from the University of Parma (IT), Alessandro has over 20 years of experience in the development of inhalation dosage forms. Specialized in Dry Powder Inhalers (DPIs) and pressurized Metered Dose Inhalers (pMDIs), in his current role he ensures scientifically sound and robust formulation and process development of all dosage forms in the Chiesi R&D pipeline for respiratory and special care areas. Prior to joining Chiesi, Alessandro worked for Zentiva (Sanofi Generics) as Senior Formulation Manager in charge of formulation and manufacturing development of generic inhalation products, and Novartis as formulation Fellow supporting the establishment of the Breezhaler® portfolio.

Prof. Dr. Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, managing director of the section Pharmacy and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia. She also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). She also is member of the board of the research focus area KiNSIS (Kiel Nano Interface and Surface Sciences) at Kiel University. Her research interests include disperse systems and nanoparticles, stabilization of biomolecules and particle engineering in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery. She is a co-founder of the Nasal Research Focus Group, a research consortium from academia and industry focusing on nasal drug delivery.

My research interests include disperse systems and nanoparticles, stabilisation of biomolecules and particle engineering in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery. My work comprises formulation development and optimisation, functional characterisation as well as basic research exploring underlying principles in formulation and performance. Recent projects work on novel non-spherical dry powder carriers, softpellets and drug nanocrystals for high dose application of powders to the lung, mucosal vaccination via the respiratory tract, nose-to-brain delivery, the in vitro assessment of nasal excipients, the exploration of surface energy in powders for inhalation and the development of nanoparticulate drug carrier systems.

Michael Kappl studied physics from 1983-1990 at the University of Regensburg and the Technical University of Munich. From 1991 to 1996 he did his PhD thesis work in Prof. Ernst Bamberg's group at the Max-Planck-Institute of Biophysics in Frankfurt, on transport kinetics of the Na+-Ca2+exchanger membrane protein. From 1997 to 1998 he did one year of postdoctoral research at the University of Mainz in the group of Prof. Butt. From 1998 - 2000 he was working as a consultant for Windows network solutions at the Pallas Soft AG, Regensburg. He rejoined the group of Prof. Butt in August 2000 at the University of Siegen.

Since 2002 he is group leader at the MPI-P, working in the fields of surface forces, wetting and characterization of mechanical properties on the micro- and nanoscale. In addition he is heading the Focused Ion Beam Service Lab, providing service for nanostructuring, cross-sectioning of samples, preparation of TEM lamella, and 3D tomography.

His research is focused on surface forces and mechanics on nano- and microscale and wetting.

Pharmacist (Apotheker), Ph.D. in Pharmaceutics specialized in Drug Delivery of poorly soluble drugs. Professional expertise in business and science related to drug product devel-opment in start-ups, medium and global companies including own entrepreneurial experience. In depth experience with pharmaceutical excipients in particular polysorb-ates, synthesis and characterization. Since 2018 Expert Advisor for the United States Pharmacopeia (USP). Specialised in the product development of innovative drug formulations, of a variety of dosage forms, (oral, topical, ophthalmic, transdermal). Developed three products that are on the market EvoTears, EvoTears Omega and Solaraze. In addition two innovative products are in PH III in the USA. I transferred several products from lab stage to CMOs until market launch. In addition, I have relevant regulatory experience. I served as "Informationsbeauftragter" and deputy "Stufenplanbeauftragter". I hold the "Sachkundenachweis", according to §15 (German) AMG, qualifies for QP.

I co-authored 15 patent families.
Throughout my career, I licensed successfully technologies and products including nanotechnologies for poorly soluble drugs. As member of the leadership team, I was jointly responsible for four financing rounds. In addition, I served 4 years as board member at Novaliq.
In 2003, I was founder of APISPHARMA AG, a consulting firm, covering the whole value chain from idea to market, including licensing, IP and business development in the biomedical industry for innovative dosage forms, mainly active in the start-up environment.
From 2003 until 2016 I worked in the start-up environment in a variety of func-tions.
In 2013, I became CSO at Novaliq after serving 4 years as Board Member and Head of Business Development. In this function I developed the core of Novaliq IP, 10 patent families, developed a novel drug delivery technology for eye drops from concept to market launch (EvoTears
As from 2016, I started at Lonza as Senior Advisor and subsequently becoming Head Application Development Excipients in 2017, responsible for the devel-opment of an improved generation of pharmaceutical excipients, leading to 3 patent families (not published yet).
I have worked within international teams and in different cultural environments for companies throughout Europe, including Germany, Switzerland, Denmark, and Sweden. This led to an extensive network both, in industry and academia.

I am an open minded, curious and innovative personality with a high grade of dedi-cation and result orientation combined with business sense and strength for identi-fying out of the box solutions.

Francesca Buttini is currently holding an Associate Professor position at the Department of Pharmacy, University of Parma (IT) where she got the PhD title in 2004 and where now she is leading the unit dedicated to design of pharmaceutical products for inhalation. In 2014, she was appointed as Visiting Lecturer at the Institute of Pharmaceutical Science of King’s College London (UK). In 2016 she has been affiliated as Key Researcher at the Research Center Pharmaceutical Engineering (Austria).

Combining her background in pharmaceutical technology, regulatory aspects and device construction, she is leading and executing research programs aimed to deliver medicinal products that take into consideration the patient, industrial and regulatory requirements. As a result of her research achievement she obtained in 2017 the DDL Emerging Scientist Awards from the UK Aerosol Society.

Francesca Buttini is a founder of PlumeStars, an innovative SME, dedicated to development of orphan drug products to treat lung and systemic disease by inhalation therapy.