Advising on inhalation product development
World leading advisors on inhalation science are available for our clients. With 30 years of experience each in big pharma and big generic industry, as well as 10 years of experience as consultants at Emmace, our advisors can support in the most demanding projects in the field of inhalation product development.
Our skilled experts can provide highly specialized and comprehensive support in:
Kyrre Thalberg, PhD
Senior Adviser Dr. Kyrre Thalberg has been a lead scientist in big pharma for 30 years in the field of dry powder inhalers. He will review generated data and suggest new formulation approaches to improve the overall performance and thereafter evaluate the analytical result.
Per Bäckman, PhD
Dr. Per Bäckman assists clients with the discovery and development of inhaled medicines. This includes for example: establishing in vitro-in vivo correlations in support of specifications and product design targets and IVIVC model-based batch selection for BE studies. During the last 8 years, Dr. Bäckman has focused on the application and development of computer-based models to link in vitro critical drug product attributes and clinical performance. Senior Adviser Dr. Per Bäckman has over 20 years of experience in biopharmacy and half of that time he has used the Preludium software as a superuser. Together these two experts provide unique insights and world leading knowledge in the field.
Gunilla Petersson, PhD
Dr. Gunilla Petersson brings a multidisciplinary expertise in the field of inhalation pharmaceuticals covering development of analytical testing, formulations, devices, and registration of drug products. Former member of EPAG and IPAC-RS Boards.
Pharmaceutical and Medical Device Development with focus on regulatory affairs and the CMC development process
Anna Holmberg, PhD
Dr. Anna Holmberg holds a PhD degree in Physical Chemistry and has over 20 years’ experience of pharmaceutical and medical device development with focus on regulatory affairs, product development, technical documentation, clinical and biological evaluations, and management of the CMC development process. She has experience from all classes of medical devices (class I, IIa, IIb and III).
Characterization of Inhaler Products and rAPSD
Mårten Svensson, PhD
Dr. Mårten Svensson has more than 20 years of experience in characterization of inhaler products using a wide range of techniques and instruments, Realistic Aerodynamic Particle Size Distribution (rAPSD) and dissolution testing in particular.
Lars-Magnus Bjursten, MD, PhD
Professor in Experimental Medicine Lars-Magnus Bjursten is chairing the ISO group that works on the next version of the ISO 18562 standard. He can judge the chemical components and particulate data of a medical device considering current established toxicology limits and deliver a pass/no-pass accredited decision.
Advising on inhalation product development
Our clients have the possibility to access our deep and comprehensive knowledge in inhalation product development during all stages of their product development process.
When you’re facing challenges with inhalation product development or receiving unexpected analytical results, we help you find the solutions by:
- understanding and interpreting surprising clinical data in relation to in vitro data (IVIVC) and assisting in planning the next study.
- adopting a holistic view on large DoE packages regarding manufacturing and preparation of dry powder formulations following evaluation and assistance during the next steps including a scale up.
- evaluating the toxicity level from multicomponent assay for medical devices.
