Manfred Keller, born 1951, qualified at the University Freiburg, Germany as a pharmacist (1978) and after his doctorial thesis (1985) as a pharmacologist (1989) and a pharmacist for pharmaceutical technology (1995). He was acknowledged in 1988 as second opinion expert with the German health office on Chemistry, Manufacturing and Control (CMC) topics and has held various positions in the pharmaceutical industry as e.g. analytical laboratory manager, head of manufacturing & quality control, manager for project & business development, chief scientific officer (CSO) and executive vice president (VP) including member of the board.
He is an expert in drug delivery and contributed in his various positions on the development of many drug products and dosage forms, as for instance tablets, capsules, ointments, creams, solutions, suppositories, (nano)-suspensions and liposomes. Over the last 25 years his focus was on inhaled drug products and inhalation devices as for instance nasal sprays, pressurized metered dose inhalers (pMDIs), dry powder inhalers (DPIs), such as the Certihaler® and the electronic nebulizers eFlow® and Vibrent®. He made substantial contributions on the development of powders, solutions, suspensions, liposomes, lyophilisates for inhalation by various inhalation devices to target and optimize drug delivery.
He was responsible for strategic planning, intellectual property (IP) and budgeting as well as all development steps comprising e.g. of drug formulation, analytics, manufacturing, stability (CMC), safety & clinical trials, pharmacokinetics, regulatory, market evaluation including support for the launch of drugs and devices. About 30 patent applications and more than 200 publications (mainly posters) provide further evidence on his skills and Know-How in pharmaceutical science, inhalation systems and beyond. He contributed to develop and approve products such as Flutiform®, Cayston®, Colifin®, Mucoclear®, Vantobra®, etc.. Dr. Keller offers his vast expertise in inhalation drug delivery and therapy as an independent consultant with the goal:
Dr. Keller’s personal motivation to improve drug/device products for inhalation
Born with a lung damage characterized by fever, elevated sputum production since early childhood caused frequents stays in climatic health resorts combined by jet nebulizer and drug therapies. Irrespective hereof, my life expectancy at that time was estimated to be only about 20 years. Fortunately, at the age of about 9 years, progression in radiation technologies helped to characterize the disease as bronchiectasis.
Resection of the left lung lobe at the age of 10 years was regarded as sole choice to improve my health status. In addition, physicians recommended a continuous stay at a clean air health resort, realized by my attending of a boarding school (Kolleg St. Blasien) for 9 years located in the Black Forest. Nevertheless, frequent pneumonias required various drug therapies which culminated in my decision to become a pharmacist.
Frequent drug therapies for decades to treat the still remaining bronchiectasis, rhinosinusitis (surgery at the age of about 44) and asthma, drove my decision to focus my scientific qualifications (pharmacologist and pharmacist for pharmaceutical technology) to improve drug therapies particularly in the respiratory field with a special focus on formulations and inhalation systems.
I am also lecturing on inhaled drug therapies for asthma, COPD and other lung diseases and instruct physicians, nurses and patients how to use inhalations systems in a correct way. The latter of which, together with drug adherence is the most important problem regarding inhaled drug therapy.
The situation of being both a patient and a scientist puts me in a unique position to develop and rate drug therapies from a patient, care giver, corporate, regulatory, and investor perspective to create a win-win for all involved with the development, approval, and use of inhalation products resulting in my key message: