Dr Wolfram Kremers

Founder, Senior Clinical Research Scientist

Lahn Pharma Services GmbH

Dietkircher Weg 9
65549 Limburg/Lahn

+49 (2224) 9807050
w.kremers@lahn-ps.com

Profile

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
Career History
Lahn Pharma Services GmbH, Limburg a.d. Lahn, Germany
Since 09/2018
Founder, Senior Clinical Research Scientist
Mundipharma Research GmbH & Co KG, Limburg, Germany
01/2016 - 09/2018
Senior Clinical Research Scientist
  • 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)
Mundipharma Research GmbH & Co KG, Limburg, Germany
07/2012 - 12/2015
Clinical Science Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany
03/2005 - 06/2012
Clinical Research Scientist
Amts-Apotheke zum Engel, Weilburg/Lahn, Germany
09/2004 – 02/2005
Pharmacist
Studies & Education
University Duisburg, Essen, Germany
04/2007 - 03/2009
Master of Pharmaceutical Medicine

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   

Philipps-University, Marburg, Germany
05/2001 - 06/2004
Experimental work of the Dissertation

Department of Pharmacy
Institute of pharmacology and toxicology    

Philipps-University, Marburg, Germany
12/2001
Approbation in Pharmacy
Philipps-University, Marburg, Germany
11/2000 - 10/2001
Practical Year
  • Experimental work of the Dissertation
  • Pharmacy
Philipps-University, Marburg, Germany
1995 - 2000
Study of Pharmacy
Retirement home St. Josef, Übach-Palenberg, Germany
1994 - 1995
Alternative Civilian Service
Carolus-Magnus Gymnasium, Übach-Palenberg, Germany
1984 - 1994
Abitur
Training

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

Publications

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. 

Poster/Abstracts

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    

Professional Skills
Good clinical practice
Broad knowledge of clinical studies
Phase I - Phase III
Global regulatory affairs
Project management
Language Skills
German
Native speaker
English
C2 - Advanced International Business English
Latin
Basic Skills
IT Skills
MS-Office
Expert knowledge