PhD in Pharmacology, Master in Pharmaceutical medicine
More than 10 years experience in clinical development
- Planning/Conduct global clinical Phase I – III studies
5 Phase II studies
10 Phase III studies - Key opinion leader (KOL) management
- Writing of study related documents
Study protocols (Phase II – Phase IV)
Investigator brochure (IB)
Clinical study reports (CSR) - Medical/Scientific support of clinical studies
Medical monitoring/patient data reviews
Case Report Form (CRF), Statistical Analysis Plan (SAP), Table Listing Graphs (TLG) - Regulatory Affairs Support, incl. RTQ (Europe, USA, Amerika, Australia, Asia,…)
CTD Modules 2.5 and 2.7
Response to questions procedures
Preparation/attending scientific advice (e.g. BfArM, FDA, EMA, PMDA) - Due diligence
- Strategic discussion (CDP development)
- Study set-up (Phase I – III): Protocol writing, EC/CA submission, IB development
- Conduct Phase: Data Reviews, Medical Monitoring
- Terminal Phase: SAP involvement, CSR writing
- Global regulatory procedures involvement (CTD writing, RtQ)
- Renewal Procedures
- Scientific Advice Preparation (e.g. briefing package)
- Product Life Cycle (PSUR, DSUR)
- Due diligence
- Publications (Abstracts, Poster)
Title of Thesis: Optimisation of processes for the compilation of submission documents for getting Marketing Authorisation of a NCE (New Chemical Entity) and also for the preparation of day 50 or day 75 for the MRP, respectively day 100 for the DCP
Department of Pharmacy
Institute of pharmacology and toxicology
- Experimental work of the Dissertation
- Pharmacy
Basic Knowledge in Oncology
(Forum Insitut für Managment GmbH)
National HTA Assessment and value Assessment in Europe
(Forum Insitut für Managment GmbH)
Healthcare Managment & Market Access Lehrgang
(Forum Insitut für Managment GmbH)
Führen ohne Vorgesetztenfunktion
(Forum Insitut für Managment GmbH)
Upsalla WHO Drug coding User conferences
Basis Leadership Training
(February 2017)
Presentation Skills
Masterclass on statistics
English course
SOPs
Dupoiron D, Stachowiak A, Loewenstein O, Ellery A, Kremers W, Bosse B, Hopp M
A phase III randomized controlled study on the efficacy and improved bowel function of prolonged-release (PR) oxycodone-naloxone (up to 160/80 mg daily) vs oxycodone PR.
Eur J Pain. 2017 Jun 22. doi: 10.1002/ejp.1054.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5600007/
Dupoiron D, Stachowiak A, Loewenstein O, Ellery A, Kremers W, Bosse B, Hopp M
Long-term efficacy and safety of oxycodone-naloxone prolonged-release formulation (up to 180/90 mg daily) – results of the open-label extension phase of a phase III multicenter, multiple-dose, randomized, controlled study.
Eur J Pain. 2017 May 4. doi: 10.1002/ejp.1050.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5655918/
Löwenstein O, Leyendecker P, Hopp M, Schutter U, Rogers PD, Uhl R, Bond S, Kremers W, Nichols T, Krain B, Reimer K
Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: a randomised controlled trial
Expert Opin Pharmacother. 2009 Mar;10(4):531-43
Simpson K, Leyendecker P, Hopp M, Müller-Lissner S, Löwenstrein O, De Andres J, Troy Ferrarons J, Bosse B, Krain B, Nichols T, Kremers W, Reimer K
Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain
Curr Med Res Opin. 2008 Dec;24(12):3503-12
Culmsee C, Junker V, Thal S, Kremers W, Maier S, Schneider HJ, Pleasnila N, Krieglstein J
Enantio-selective effects of clenbuterol in cultured neurons and astrocytes, and in a mouse model of cerebral ischemia.
Eur J Pharmacol 2007 Aug 3
Galoyan AA, Krieglstein J, Klumpp S, Danielian KE, Galoian KA, Kremers W, Bezirganyan KB, Davtyan TK
Effect of Hypothalamic Proline-Rich Peptide (PRP-1) on Neuronal and Bone Marrow Cell Apoptosis.
Neurochem Res 2007 Jun 5
Culmsee C, Junker V, Kremers W, Thal S, Pleasnila N, Krieglstein J
Combination therapy in ischemic stroke: synergistic neuroprotective effects of memantine and clenbuterol.
Stroke 2004 May; 35(5):1197-202.
Bowel Function Index: Evaluating opioid-induced constipation in patients with moderate-to-severe pain from culturally and geographically diverse countries
Hanaoka K, Coffin B, Emmanuel A, Bosse B, Kremers W, Hopp M
2016 IASP (International Association for the study of pain)
Observational, multicentre study evaluating the Bowel Function Index for constipation in Asian countries
Date H, Cho E, Gao Y, Ho K, Lin W, Bosse B, Kremers W, Hopp M
2016 IASP (International Association for the study of pain)
Long-term safety and efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) up to a maximum daily dose of 180/90 mg – results from a phase III multicenter, multiple-dose, randomized, controlled study with an open-label extension phase
Janecki M, Loewenstein O, Dupoiron D, Ellery A, Kremers W, Bosse B, Hopp M
2016 IASP (International Association for the study of pain)
Safety and efficacy of oxycodone/naloxone prolonged release (OXN PR) tablets in daily doses up to OXN180/90 mg in cancer patients – results from a phase III multicenter, multiple-dose, randomized, controlled study with an open-label extension phase
Hopp M, Loewenstein O, Leppert W, Kremers W, Bosse B, Ahmedzai S
2016 IASP (International Association for the study of pain)
Long-term pain relief with high-dose Oxycodone/Naloxone prolonged release formulation (OXN PR)
Löwenstein OT, Stachowiak A, Ellery A, Bosse B, Kremers W, Hopp M
2015 EFIC (European Federation of IASP Chapters)
Bladder function and quality of life benefits of prolonged-release Oxycodone/Naloxone (OXN PR) in patients with bladder pain syndrome (BPS)
Goebell P, Baranowski A, van Ophofen A, Zámecník L, Hopp M, Kremers W
2015 EFIC (European Federation of IASP Chapters)
Safety and analgesic efficacy of prolonged-release Oxycodone/Naloxone (OXNPR) in patients suffering from severe pain due to bladder pain syndrome (BPS)
Goebell P, Baranowski A, van Ophofen A, Zámecník L, Hopp M, Kremers W
2015 EFIC (European Federation of IASP Chapters)
Oxycodone/naloxone prolonged-release tablets (OXN PR) are well tolerated and efficacious in long-term treatment of cancer-related pain
Leppert W, Kremers W, Bosse B, Hopp M, Leyendecker P
2013 EAPC (European Association of Palliative Care)
A pooled analysis to assess the long-term efficacy and safety of oxycodone/naloxone prolonged-release in patients suffering from non-malignant pain
Loewenstein O, Kremers W, Bosse B, Hopp M, Leyendecker P
2012 WIP (World Institute of Pain)
A post-hoc analyses to assess analgesic efficacy and safety of oxycodone/naloxone prolonged-release in patients suffering from pain due to osteoarthritis
Lux E A, Kremers W, Bosse B, Hopp M, Leyendecker P
2012 WIP (World Institute of Pain)
Long-term efficacy and safety of oxycodone and naloxone in a prolonged-release (PR) fixed combination in patients with chronic pain
Lux E A, Leyendecker P, Hopp M, Bosse B, Kremers W, Krain B, Olway H, Bredenbröker D, Reimer K
2012 International Conference on Opioids, 10-12 June, Boston
Efficacy and Safety of oxycodone/naloxone prolonged-release tablets (OXN PR) in patients suffering from severe pain due to a Failed back Surgery Syndrome
Lux E A, Krain B, Kremers W, Bosse B, Hopp M, Leyendecker P
2012 IASP (International Association for the study of pain)
A subgroup-analysis to assess the efficacy and safety of oxycodone/naloxone prolonged-release tablets (OXN PR) following a direct switch from different opioids
Leppert W, Kremers W, Bosse B, Hopp M, Leyendecker P
2012 IASP (International Association for the study of pain)
A randomized, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in subjects with moderate to severe, chronic cancer pain
Ahmedzai S, Kremers W, Bosse B, Hopp M, Reimer K
2011 EAPC (European Association of Palliative Care)
Long-term efficacy and safety of the fixed combination oxycodone and naloxone prolonged release (PR) in patients with chronic malignant pain
Leppert W, Ahmedzai S, Uhl R, Kremers W, Hopp M
2011 EFIC (European Federation of IASP Chapters)
Efficacy and safety of oxycodone and naloxone prolonged-release (PR) in patients suffering from chronic pain due to Osteoarthritis
Loewenstein O, Airaksinen O, Krain B, Uhl R, Kremers W, Hopp M
2011 EFIC (European Federation of IASP Chapters)
Long-term efficacy and safety of oxycodone and naloxone in a prolonged release (PR) fixed combination tablet in elderly (> 65 years) patients with chronic non-malignant pain
Lux E A, Leyendecker P, Kremers W, Bosse B, Hopp M, Reimer K
2010 EUGMS (European Union Geriatric Medicine Society)
Long-term efficacy, safety and quality of life of oxycodone and naloxone in a prolonged release (PR) fixed combination tablet in patients with chronic pain
Lux E A, Kremers W, Leyendecker P
2010 IASP (International Association for the study of pain)
Long-term Efficacy and Safety of Oxycodone and Naloxone in a Prolonged Release (PR) Fixed Combination in Patients with Chronic Pain
Lux E A, Leyendecker P, Hopp M, Bosse B, Kremers W, Krain B, Olway H, Bredenbroeker D, Reimer K
2009 EFIC (European Federation of IASP Chapters)
Efficacy and safety of oxycodone and naloxone in a prolonged release (PR) fixed combination tablet in elderly (> 65 years) patients with moderate to severe chronic pain
Lux E A, Leyendecker P, Kremers W, Bosse B, Hopp M, Reimer K
2009 IAGG World Congress of Gerontology and Geriatrics