Dr. Wolfram Kremers

Geschäftsführer, Leitender klinischer Forscher

Lahn Pharma Services GmbH

Dietkircher Weg 9
65549 Limburg/Lahn

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

Profil

Promotion in Pharmakologie, Master in pharmazeutischer Medizin

Mehr als 10 Jahre Erfahrung in der klinischen Entwicklung

  • Planung / Durchführung globaler klinischer Studien der Phase I - III
    5 Phase II Studien
    10 Phase III Studien
    Meinungsführer Management
  • Key opinion leader (KOL) 
  • Verfassen von studienbezogenen Dokumenten
  • Studien Protokolle (Phase II - Phase IV)
    Investigator Brochure (IB)
    Klinische Studienberichte (CSR)
  • Medizinische und wissenschaftliche Unterstützung bei klinischen Studien
  • Medizinische Überwachung und Überprüfung der Patientendaten
    Case Report (CRF), Statistische Analyse Pläne (SAP), Tabellenlistendiagramme (TLG)
  • Globale regulatorische Verfahren, inkl. RTQ (Europe, USA, Amerika, Australia, Asien,...)
    CTD Module 2.5 and 2.7
    Antwort auf Verfahrensfragen
    Vorbereitung und Durchführung wissenschaftlicher Beratungen (BfArM, FDA, EMA, PMDA)
  • Due diligence
Berufserfahrung
Lahn Pharma Services GmbH, Limburg a.d. Lahn, Germany
Seit 09/2018
Geschäftsführer, Senior Clinical Research Scientist
Mundipharma Research GmbH & Co KG, Limburg, Germany
01/2016 - 09/2018
Senior Clinical Research Scientist
  • Strategische Diskussion (CDP Entwicklung)
  • Studienaufbau (Phase I – III)
    Protokollierung, Einreichen von EC/CA, IB Entwicklung
  • Durchführungsphase: Datenüberprüfung, medizinische Überwachung
  • Terminal Phase: SAP Mitwirkung, CSR Abfassung
  • Umsetzung globaler Regulierungsverfahren (CTD Abfassung, RtQ)
  • Verlängerungsverfahren
  • Vorbereitung wissenschaftlicher Mitteilungen (z.B. Briefings, Präsentationen)
  • Produkt Lebenszyklus (PSUR, DSUR)
  • Due diligence
  • Veröffentlichungen (Zusammenfassungen, 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
Apotheker
Studies & Education
University Duisburg, Essen, Germany
04/2007 - 03/2009
Master der pharmazeutischen Medizin

Title der 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
Experimentelle Doktorarbeit

Abteilung für Pharmazie
Institut für Pharmakologie und Toxikologie

Philipps-University, Marburg, Germany
12/2001
Approbation in der Pharmazie
Philipps-University, Marburg, Germany
11/2000 - 10/2001
Praktisches Jahr
  • Experimentelle Arbeit für die Doktorarbeit
  • Apotheke
Philipps-University, Marburg, Germany
1995 - 2000
Studium der Pharmazie
Altenheim St. Josef, Übach-Palenberg, Germany
1994 - 1995
Zivildienst
Carolus-Magnus Gymnasium, Übach-Palenberg, Germany
1984 - 1994
Abitur
Training

Grundlagen in Onkologie
(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 Führungstraining
(February 2017)

Presentation Skills

Masterklasse für Statistik

Englisch Kurs

SOPs

Veröffentlichungen

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    

Professionelle Fähigkeiten
Klinische Praxis
Breites Wissen über klinische Studien
Phase I - Phase III
Globale regulatorische Angelegenheiten
Projektmanagement
Sprachkenntnisse
Deutsch
Muttersprache
English
C2 - Fortgeschrittenes internationales Business-Englisch
Latein
Basis Wissen
IT Kenntnisse
MS-Office
Expert knowledge