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Inhalation and Respiratory Drug Products Summit

  • 28th – 29th September 2017
  • Germany flag Germany Berlin
  • Hotel Riu Plaza Berlin Martin-Luther-Straße 1, 10777

Vonlanthen Group of Companies will be presenting a conference that includes a multitude of different subjects within the field of Inhalation and Respiratory Drug Development.

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About

We will be discussing how we develop and design dry powder inhalers; integrate development and scale-up combination products; patient use, compliance and human factors associated with DPIs; the challenges of developing a generic inhalant product; and the analytical approaches and specifications for inhaled medicine. Our panel will be addressing these critical issues and much more over the two days, to drive new concepts and new ways of thinking among a consortium of different companies and people in the field of Respiratory and Inhalation Drug/Product Development.

Who Should Attend

Directors, Vice Presidents, Managers and Department Heads specialising in:

  • Respiratory Drug Development
  • Scientific Research
  • Inhalation Drug Delivery Inhalation Device Development and Engineering
  • Medical Devices & Injectors
  • Inhalation Product Development
  • Medical Marketing
  • Device Engineering New Delivery Technologies
  • Inhaled Dosage Systems Connective Health
  • Pulmonary Disease Metered Dose Inhaler Development
  • Respiratory Medicine Inhalation
  • Generics & Respiratory
  • Drug Delivery Innovation Respiratory Pharmacology
  • Inhalation Formulation Development
  • Inhalation Process Development Particle Characterisation
  • Marketing and Business Development
  • E-health Inhalation Drug Delivery Technologies
  • Respiratory Regulations Respiratory R&D

Key Practical Learning Points

  • Regulatory updates in the global respiratory market
  • Innovative technologies for inhalation delivery
  • Enhancing the performance of DPI
  • Integrate development and scale-up combination products
  • Device and formulation integration
  • Integrated formulation design approaches for DPI
  • Analytical approaches and specifications
  • Human factors: Design, planning and implementation

Dr. John Pritchard, UK

Director PMO & Technology, Resp. Drug Delivery, Sleep & Resp. Care

Philips

A graduate in physics from Birmingham University, John joined the UK Atomic Energy Authority in 1977, leading research into the deposition and clearance of particles in the respiratory tract. During this time, he gained a Ph.D. from the University of Essex on research into the lung deposition of tar from cigarette smoking. John moved into the pharmaceutical industry in 1991, initially with Glaxo, then with 3M and AstraZeneca. At different stages in his career he held roles in line management, project leadership, technology development and commercial product strategy. During this time, he has been associated with the launch or life-cycle management of 11 different inhaled marketed products. Since January 2011, John has been chief technology officer for Philips Respironics Drug Delivery, with global accountability for the development of advanced delivery systems for the monitoring and treatment of respiratory diseases. John has published widely in the respiratory drug delivery field, been editor to several journals, as well as having served as president of The Aerosol Society, board member for the International Society for Aerosols in Medicine and on the UK Government Committee on the Medical Effects of Airborne Pollutants. He is currently a member of the United Nations Medical Technical Options Committee, which makes recommendations on the essential use of CFC propellants, and is an editor for ‘Pharmaceutical Technology.’ Until 2015 when they were acquired, he was also a member of the Scientific Advisory Board of Prosonix.

Paul Johnson, UK

Inhaled Product Platform Lead

GSK R&D

Paul is a senior director at GSK R&D Ltd and is currently the Inhaled Product Platform Lead. Paul completed his BSc Hons in Applied Chemisty at Hatfield Polytechnic (now Hertfordshire University) in the 1980s whilst working as analytical chemist at Merck Sharp and Dohme. He joined GSK in the early 1990s and lead various analytical chemistry and formulation teams in the UK, and US before becoming focussed on inhaled product development in the late 1990s. He led the MDI technology group within GSK to enable the development of GSK HFA-134a pMDI products, authuring a number of patents of solution pMDI formulations and fluoronated MDI compontents. In the early 2000s Paul led CMC teams responsible for the early development of a number of inhaled NCEs before leading the CMC development of Relvar/Breo Ellipta and subsequently leading the portfolio of GSK Ellipta products from candidate selection through to launch and lifecycle management. More recently Paul has been leading GSKs efforts to seek, identify and develop inhaled product platforms tailored towards enhancing customer experience, generating incremental value and ensuring quality throughout the supply chain for GSK’s current and future portfolio.

Dr. Elisa Le Floch, FR

Business Development & Marketing Manager

Clariant

Dr. Elisa Le Floch, has been with Clariant Medical Specialties since 2011. She is responsible for business development and marketing in the healthcare packaging segment. She is in charge of EQ-PAK® & ADP® solutions, dedicated products to control the humidity level inside the inhalation packaging. Prior to working for Clariant, she held the role of brand manager in the pharmaceutical industry. Elisa holds a Pharm. D from Nantes University, complete by a certificate in conception & molecule synthesis with a therapeutic interest. She has pursued a marketing master from HEC Paris.

Mark Milton-Edwards, UK

Global Commercial Senior Director

Teva

Mark Milton-Edwards, global commercial senior director, has been employed by Teva for 10 years with responsibility for global branding and commer­cial strategy specific to respiratory and inhaled brands, including the global launch of the Spiromax®/RespiClick® dry-powder inhaler. Mark is currently responsible for product and health solutions within digital health. Mark is a native to Britain but lived and worked abroad for 11 years in Japan, Den­mark and Sweden. He held various positions throughout those countries, including VP of sales and marketing, strategic planning and business devel­opment and global brand lead. Mark first graduated in aeronautical sciences and later completed his MBA at Durham University, UK. During his career, he has led inhaler development teams through engineering definition, CMC characterisation, clinical evidence generation and ultimately to successful launch. Two of these products have been approved as either medical device (510K/CE) or NDA/sNDA products. Mark has numerous patents granted and pending in the area of electronic communications, inhaled pharmaceutical development and respiratory physiological function.

Dr. Stefan Leiner, DE

Chemical-Pharmaceutical Expert

Boehringer Ingelheim

Dr. Stefan Leiner is a pharmacist by training and joined Boehringer Ingelheim in Germany in 1987. After a couple of years in manufacture, pharmaceutical and analytical development, he focussed on inhalation forms. He is responsible for the scientific standard of the module 3 of marketing authorisation applications. He authored the quality overall summaries for a lot of Boehringer Ingelheim’s inhalation developments. Stefan represents Boehringer Ingelheim in the Inter­national Pharmaceutical Aerosol Consortium – Regulation and Science (IPAC-RS) and was chair of that organisation. He was a member of the development group of the ISO 20072 Standard on ‘Aerosol Drug Delivery Devices.’ He is active in pharmacopeias.

Dr. Frank Thielmann, CH

PMO & Operational Excellence Platform Leader, Biologics

Novartis

Dr. Thielmann graduated from University of Duesseldorf, Germany in 1996 with a diploma in chemistry. This was followed by a Ph.D. in physical chemistry in 1998 in the area of materials characterisation. Frank then worked for a private materials testing institute in Hannover, Germany before joining Surface Measurement Systems UK (SMS) in 2000. He stayed with SMS for eight years in different roles including global head of application science. In this role, he was heavily in- volved in the development of novel characterisation methods for the challenges in the modern (bio)pharmaceutical industry with focus on solid dosage forms. Frank joined Novartis Pharma (Basel, Switzerland) in July 2007 as formulation lab head. From August 2009 until February 2011, he managed the inhalation & device development group at the Horsham site, UK. Upon his return to Basel, he took on the responsibility for the local inhalation technology platform until February 2012. Subsequently, he joined Novartis Technical Operations where he was leading the setup of a new inhalation manufacturing facility and the transfer of the corresponding portfolio. In December 2016, Frank joined the Biologics Technical Development & Manufacturing department as the lead for PMO & op- erational excellence. Dr. Thielmann is member of the Steering Committee of the Material Science Focus Group in the British Academy of Pharmaceutical Sciences. He is an author and co-author of more than 25 articles in peer reviewed journals as well as author and co-author of more than 50 oral presentations at international conferences and seminars and over 100 scientific posters.

Dr. Holger Memmesheimer, DE

Head of Quality – Chemistry (API); Former Head of Resp. Drug Delivery

Boehringer Ingelheim

Dr. Holger Memmesheimer studied chemistry at the University of Kaiser­slautern. Following the completion of his Ph.D. in organic chemistry and some post-doctoral studies in the UK, he started his industrial career at Shell (later American Cyanamid) in 1993, working on Agrochemicals (En­vironmental Chemistry and Chemical Process Development). In 2000, he joined Boehringer Ingelheim as head of an analytical laboratory in R&D. In 2003, he was appointed as a director, with responsibility for drug product analytics and formulation development of Respimat® and metered- dose inhaler projects. In 2010, he took responsibility for all analytical functions in respect to the development of inhalative dosage forms. From 2013 to 2014, he was in charge of the respiratory drug delivery department, which includes the disciplines drug product analytics, formulation and process development, device and packaging development. Since 2015, he is re­sponsible for the quality unit chemical production (API) in operations.

Paul Smith, UK

Functional Manager, Inhalation Toxicology

Charles River Laboratories Edinburgh Ltd.

Paul has over 30 years of experience in the inhalation toxicology area, gaining his knowledge at 4 contract research organisations (CRO) and has 8 publications to his name. He was the head of inhalation toxicology at his 2 previous CRO’s and managed study director and inhalation technical teams of up to 22 staff for over a decade. Paul is a highly experienced inhalation toxicologist and has worked on a range of chemical and pharmaceutical studies through to 2 years’ carcinogenicity studies. Paul is a committee member of the Association of Inhalation Toxicologists and held the post of chairman from 2009-2011.

Dr. Gerhard Scheuch, DE

CEO

GS BIO-INHALATION

Gerhard Scheuch is recently founder and chief executive officer (CEO) of GS-Bio-Inhalation GmbH which is a pulmonary consulting company. He was the founder and chief executive officer (CEO) of Activaero GmbH from 1998 and president of Activaero America Inc. until the acquisition of Activaero by Vectura in 2014. Activaero was a respiratory area specialist focusing on the development of drug-device combination products for the treatment of severe pulmonary diseases. Dr Scheuch was also founder and CEO (1998−2004) of Inamed Research GmbH, a respiratory CRO. He has worked as a senior scientist at Helmholtz Centre Munich Research Centre for Environment and Health (1992−1998) and as an engineer at GSF National Research Centre for Environment and Health in Frankfurt, Germany (1980−1992). Dr. Scheuch’s research interests include deposition and distribution of inhaled aerosols in the human respiratory tract, mucociliary clearance mechanisms in the airways, and drug delivery to the human lungs to treat pulmonary diseases. He has a particular interest in rare and severe diseases, including severe asthma, cystic fibrosis, alveolar proteinosis and pulmonary arterial hypertension. He has published over 150 scientific articles on aerosol and lung research. He is also a member of the expert panel of the European Medical Agency (EMA) and more recently, Dr Scheuch was involved in developing the guidelines on orally inhaled products (OIP-Guideline). From 1999 until 2013, he was member of the Board of the International Society for Aerosols in Medicine (ISAM) and served as president from 2007 until 2013.

Antoine Laut, FR

Key Account Manager pMDI

Aptar

Antoine’s background is in mechanical engineering with a speciality in polymers & composite materials. He completed his technical background with a Master’s degree in project management. After various positions in quality assurance & project management for the automotive industry, he joined Aptar Pharma 10 years ago where he led the development & industrialization of various MDI and DPI devices. During these missions, from concept to commercialized product, he went through multiple patient studies and applied “Design for Manufacture” & “Quality by Design” principles. Antoine is now Key Account Manager at AptarPharma.

Dr. João Ventura Fernandes, PT

Business Development Manager

Hovione Technology

He is a mechanical engineer with 10 years of experience in product design across the aerospace and pharmaceutical industries; having worked previously at Volvo Aero, Rolls-Royce jet engines and having been with Hovione during the last 3 years in developing the Inhalation Device Business. He is a researcher, inventor and author of patents. Currently, he is the business development manager of Hovione Technology Limited, a company fully dedicated to development and commercialisation of Hovione’s inhalation device portfolio.

Dr. Sven Stegemann, DE

Director Pharmaceutical Business Development at Capsugel

Professor for Patient Centric Drug Development and Manufacturing at Graz University of Technology

Prof. Dr. Sven Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Over the course of his 18-year career at Capsugel, Dr. Stegemann has worked as an advisor to major pharmaceutical companies on ways to improve the design, development, and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, Dr. Stegemann’s focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Dr. Stegemann is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as the founder and president of the Geriatric Medicine Society.

Nathalie Heuzé-Vourc’h, FR

Head of Research

INSERM

Dr. Nathalie Heuzé-Vourc’h (Ph.D., INSERM CR1) is a senior research scientist at the National Institute of Biomedical Research in Tours, France. She is deputy director of a multidisciplinary team in the Research Centre for Respiratory Diseases (CEPR, INSERM U1100) dedicated to ‘Aerosoltherapy and Biologics for Respiratory Diseases’ (team 3). After graduating with her Ph.D. in oncology inFrance, she focused her research on lung diseases and obtained a postdoctoral position in the division of pulmonary and critical care medicine (Dr Steven M. Dubinett) at UCLA, California. She gained interest in biotherapeutics working in a start-up (Agensys Inc., Santa Monica, California) developing anticancer monoclonal antibodies and was recruited in 2005 by INSERM as a young research scientist to continue working on this topic. Joining Pr Patrice Diot’s research group specialising in the delivery of drugs by aerosol in Tours, offered her new perspectives on her research projects as she started investigating the local delivery of biotherapeutics through the airways. She is currently supervising several projects on the multifaceted aspects of the delivery of biotherapeutics through the airways for treatments of lung diseases, from formulation to preclinical safety, with both academic and private partners. She has published more than 50 peer-reviewed papers and book chapters. She is one of the leaders of the Laboratory of Excellence ’MabImprove’, since 2011, from the French program ‘Investments for the Future.’ She serves as a consultant to the pharma industry and is regularly invited to speak in international conferences/seminars. Moreover, she has participated in several successful projects funded by the French funding agencies (French Ministry of Defence procurement agency (DGA) Rapid grants AeroRiMac & Pneumophage) and industry (e.g. Sanofi-Genzyme).

Dr. John Pritchard, UK

Director PMO & Technology, Resp. Drug Delivery, Sleep & Resp. Care

Philips

Paul Johnson, UK

Inhaled Product Platform Lead

GSK R&D

Dr. Elisa Le Floch, FR

Business Development & Marketing Manager

Clariant

Mark Milton-Edwards, UK

Global Commercial Senior Director

Teva

Dr. Stefan Leiner, DE

Chemical-Pharmaceutical Expert

Boehringer Ingelheim

Dr. Frank Thielmann, CH

PMO & Operational Excellence Platform Leader, Biologics

Novartis

Dr. Holger Memmesheimer, DE

Head of Quality – Chemistry (API); Former Head of Resp. Drug Delivery

Boehringer Ingelheim

Paul Smith, UK

Functional Manager, Inhalation Toxicology

Charles River Laboratories Edinburgh Ltd.

Dr. Gerhard Scheuch, DE

CEO

GS BIO-INHALATION

Antoine Laut, FR

Key Account Manager pMDI

Aptar

Dr. João Ventura Fernandes, PT

Business Development Manager

Hovione Technology

Dr. Sven Stegemann, DE

Director Pharmaceutical Business Development at Capsugel

Professor for Patient Centric Drug Development and Manufacturing at Graz University of Technology

Nathalie Heuzé-Vourc’h, FR

Head of Research

INSERM

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