- Independent consultant with a primary focus on inhalation drug products and devices to target the treatment of diseases affecting the lower and upper respiratory tract.
Former job positions
- Chief Scientific officer and executive vice president with PARI Pharma, Starnberg, Germany
- Head of aerosols and inhalation with SkyePharma /JAGO, Muttenz, Switzerland
- Head of product development and pharmaceuticals with ratiopharm, Ulm, Germany
- Free Lance with Alcon Pharma, Freiburg, Germany
- Laboratory manger of G.A. Brenner, Alpirsbach, Germany a former subsidiary of A.H. Robins, Richmond, USA
- University Freiburg, Germany
- University Tübingen, Germany
Biographic sketch of Manfred Keller, PhD [DOWNLOAD PDF]
Manfred Keller 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 hold 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). 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 20 years he focused 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 nebulizers for the treatment of lower and upper respiratory diseases, such as 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 in order to improve both, product or device acceptance and patient’s quality of life. 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-issues, safety & clinical trials, pharmacokinetics, regulatory, market evaluation including marketing support 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, e.g. drug delivery, inhalation systems, patient and market needs any beyond. He is offering now his vast expertise as an independent consultant with the goal: "Adding value to Your business".
June 2011 until today: Owner of Keller Pharmaconsult, Munich, Germany
Expert in drug delivery with a special focus on drug formulations and inhalation devices, such as nebulizers, dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs) and nasal sprays to treat upper and lower respiratory diseases, such as Asthma, COPD, Cystic Fibrosis, Bronchiectasis, Bronchiolitis obliterans, sinonasal disorders, allergies, Mastocytosis, etc. Knowledge on all aspects important for successful product development comprising of development of drug formulations, device selection and interaction, regulatory demands, pharmacokinetics, safety and clinical studies, manufacturing, CMC-, market issues & competition including reimbursement. He was involved in the development and approval of many generic products e.g. doxycyclin capsules, ibuprofen gel, xylometazolin nasal spray, etc. and novel drug products, e.g. Geomatrix® control release tablets, such as Dilacor® (diltiazem), HFA-MDIs, such as Pulmicort® (budesonide) and Flutiform (fluticasone & formoterol), the DPI (Certihaler®), products for aerosolization via the electronoc nebulizer eFlow®, such as hypertonic saline (Mucoclear®), the peptide antibiotic colistin (Colifin®), the monobactam antibiotic aztreonam lysinate (Cayston®), the aminoglycoside antibiotic tobramyicin, glycopyrrolate solution, liposomal ciclosporine, etc..
June 2000 - March, 2011: Chief Scientific Officer and Executive Vice President with PARI Pharma, Starnberg Germany
Building of the pharmaceutical business unit of the PARI Aerosol Research Institute which became later PARI Pharma. I was involved in the development of inhalation formulations, their physical and chemical characterization with jet and electronic nebulizers for pulmonary and paranasal drug delivery (PARI jet nebs, Sinus, eFlow and Vibrent) comprisng all development steps until submission and approval of drug products, such as Ambroxol, Mucoclear®, Colifin®. Comprehensive support was provided on the development of Aztreonam-lysinate (Cayston®), high concentrated solutions of tobramycin, levofloxacin, azithromycin, liposomal ciclosporine A, budeonide nano-suspension, alpha antitrypsin on behalf of various clients, such as Corus Pharma, Gilead, Transave, Verus Pharma, Mpex, Kamada, etc.
January 1989 - May 2000: Head of aerosols and inhalation with JAO and later Skye Pharma, Muttenz, Switzerland
Support on the final development and registration of Dilacor® XR and Madopar® XR, controlled release tablets based on the proprietary Geomatrix® Technology. Thereafter, building of the aerosol business unit within JAGO Pharma to facilitate the development of HFA pMDIs, such as salbutamol, budesonide, formoterol, fluticasone plus formoterol (Flutiform®), etc holding simultaneously postions as head of manufacturing and quality control. Support in manufacturing of preservative free pump systems, such as Bepanthen® nasal and topical spray on behalf of Roche Pharmaceuticals. Development of the Certihaler®, a multi-dose dry powder inhaler including humidity protected powder formulations for administration of drugs, such as formoterol, budesonide, tiotropium-bromide, etc. Co-inventor on patents related to HFA and powder formulations including the Certihaler® DPI.
November 1985 - December 1988: Head of product development and licensing, ratiopharm, Ulm, Germany
Planning and support on the development of up to about 100 generic drug products comprising of different pharmaceutical application forms, such as solids (tablets, capsules), semi-solid (ointments, creams) and liquids (solutions, suspensions for oral, nasal, topical and parenteral administration. Licensing in of products and building of one of the largest generic product pipeline and platforms in Germany. Support on the strategic concept to build in addition the hospital and OTC business of ratiopharm products.
Education and qualifications of Manfred Keller PhD
1971: Abitur (A-level exam) at the Jesuit Kolleg St. Blasien, Germany
1971-1973: Pharmacy internship at the Rosgarten Pharmacy Konstanz, Germany
1973-1975: Study of chemistry at the university Tuebingen, Germany
1975-1978: Pharmacy school University Freiburg, Germany
1978: State exam
1980-1985: PhD thesis at the Pharmacologcial Institute of the University Freiburg, Germany
1985: Qualification as doctor rerum naturalium (PhD)
1990: Qualification as Pharmacologist by the German Society of Pharmacology and Toxicology (DGPT)
1995: Qualification as a pharmacist for pharmaceutical technology