Publications

Independent

  1. Eckhardt K. Evidence-time dilemma in a pandemic with high mortality: Can outcome-driven decision making on vaccines prevent deaths? Clin Transl Sci. 2022;15(1):5-8.

In Pharma and Biotech Industry

  1. Schoedel KA, Andreas JO, Doty P, Eckhardt K, Sellers EM. Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Crossover Study Evaluating the Abuse Potential of the Antiepileptic Drug Lacosamide in Healthy Recreational Drug Users. J Clin Psychopharmacol. 2017;37(6):675-683.
  2. Bainbridge J, De Backer M, Eckhardt K, Tennigkeit F, Bongardt S, Sen D, Werhahn KJ, Shaibani A, Faught E. Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain. Epilepsia Open. 2017;2(4):415-423.
  3. Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016;87(3):314-23.
  4. Elger CE, Rademacher M, Brandt C, Elmoufti S, Dedeken P, Eckhardt K, Tennigkeit F, De Backer M. Changes in hormone and lipid levels in male patients with focal seizures when switched from carbamazepine to lacosamide as adjunctive treatment to levetiracetam: A small phase IIIb, prospective, multicenter, open-label trial. Epilepsy Behav. 2016; 62:1-5.
  5. Steinhoff BJ, Eckhardt K, Doty P, De Backer M, Brunnert M, Schulze-Bonhage A. A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures. Epilepsy Behav. 2016; 58:35-43.
  6. Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016; 57(7):1139-51.
  7. Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D'Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015;52(Pt A):165-8.
  8. Stockis A, van Lier JJ, Cawello W, Kumke T, Eckhardt K. Lack of effect of lacosamide on the pharmacokinetic and pharmacodynamic profiles of warfarin. Epilepsia. 2013;54(7):1161-6.

At Regulatory Service

  • Eckhardt K, Cremer-Schaeffer P, König J, Paeschke N. Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Feb;48(2):173-80.

In Academia

  1. Eckhardt K, Roth P, Günter T, Schmidt S, Feuerstein TJ. Differential effects of K(ATP) channel blockers on [(3)H]-noradrenaline overflow after short- and long-term exposure to (+)-oxaprotiline or desipramine. Naunyn Schmiedebergs Arch Pharmacol. 2003; 367(2):168-75.
  2. Niu HQ, Eckhardt K, Ostertag CB. Radiobiological effects of photon radiosurgery on choroid plexus cells in vitro. Minim Invasive Neurosurg. 2003;46(2):86-9.
  3. Freiman TM, Kukolja J, Heinemeyer J, Eckhardt K, Aranda H, Rominger A, Dooley DJ, Zentner J, Feuerstein TJ. Modulation of K+-evoked [3H]-noradrenaline release from rat and human brain slices by gabapentin: involvement of KATP channels. Naunyn Schmiedebergs Arch Pharmacol. 2001; 363(5):537-42.
  4. Siegle I, Fritz P, Eckhardt K, Zanger UM, Eichelbaum M. Cellular localization and regional distribution of CYP2D6 mRNA and protein expression in human brain. Pharmacogenetics. 2001;11(3):237-45.
  5. Eckhardt K, Ammon S, Hofmann U, Riebe A, Gugeler N, Mikus G. Gabapentin enhances the analgesic effect of morphine in healthy volunteers. Anesth Analg. 2000;91(1):185-91.
  6. Eckhardt K, Nevo I, Levy R, Mikus G, Eichelbaum M, Vogel Z. Morphine-related metabolites differentially activate adenylyl cyclase isozymes after acute and chronic administration. FEBS Lett. 2000; 470(3):309-14. Eckhardt K, Hufschmidt A, Feuerstein TJ. Treatment of chronic and neuropathic pain. Established amitriptyline and the new gabapentin. MMW Fortschr Med. 2000;142(38):29-30.
  7. Dilger K, Eckhardt K, Hofmann U, Kucher K, Mikus G, Eichelbaum M. Chronopharmacology of intravenous and oral modified release verapamil. Br J Clin Pharmacol. 1999;47(4):413-9.
  8. Eckhardt K, Li S, Ammon S, Schänzle G, Mikus G, Eichelbaum M. Same incidence of adverse drug events after codeine administration irrespective of the genetically determined differences in morphine formation. Pain. 1998;76(1-2):27-33.
  9. Fromm MF, Eckhardt K, Li S, Schänzle G, Hofmann U, Mikus G, Eichelbaum M. Loss of analgesic effect of morphine due to coadministration of rifampin. Pain. 1997;72(1-2):261-7.
  10. Sperker B, Mürdter TE, Schick M, Eckhardt K, Bosslet K, Kroemer HK. Interindividual variability in expression and activity of human beta-glucuronidase in liver and kidney: consequences for drug metabolism. J Pharmacol Exp Ther. 1997;281(2):914-20.

Company Information

ConEckt Consulting, founded by Dr. med. Klaus Eckhardt, MDRA, provides expert services and advice to drug developers in academia, start-ups, global pharma and biotech industry as well as for patient organisations, investors and regulatory authorities in clinical drug development and regulatory affairs.

Our focus, offering advice on evidence generation by connecting clinical insights and regulatory expertise.

Our Purpose

Expedite the provision of therapies to patients to address their unmet medical needs

Our Services

We provide independent expert services and advice in all phases of clinical drug development and regulatory affairs as well as in due diligences.

We help you define innovative and robust development strategies to generate the evidence needed for your target population.

We offer medical writing support when it comes to clinical documents for your marketing authorisation application.

We facilitate meetings with key stakeholders such as regulatory agencies, HTA agencies and payers support the preparation of necessary briefing packages containing a full development strategy.

Thus, we can support you throughout the entire clinical development of your projects taking care that you generate exactly the evidence that is required by key stakeholders, such as regulatory agencies, HTA, and payers.

Success of your Drug is Our Motivation – Better Treatments for Patients with Unmet Needs

* For further information see Klaus Eckhardt´s CV: Download it now!