Centre for Human Drug Research - CHDR.nl http://www.chdr.nl Het laatste nieuws van CHDR Copyright 2012CHDR 2012-04-27T17:19:56+02:00 Hoogste punt CHDR gebouw bereikt http://www.chdr.nl/default.asp?id=778&nieuwsid=160 CHDR verricht onderzoek naar de effecten van nieuwe geneesmiddelen bij patiënten en gezonde proefpersonen voor farmaceutische industrieën vanuit de hele wereld en werkt samen met het LUMC. In CHDR worden ook promovendi en studenten van de UL opgeleid.  De nieuwe onderzoeksafdeling is een van de grootste van Europa en een van de weinigen in de wereld geassocieerd met een universiteit.

De directeur van CHDR, Prof dr Adam Cohen stipte nog eens het belang van goed geneesmiddelonderzoek aan om snel en efficiënt zorg te dragen voor het beschikbaar komen van geneesmiddelen voor de ziektes waar nog geen goede behandelingen voor zijn.

Nadere inlichtingen bij:

Marieke van den Bosch
Business development manager van CHDR
071-5246400
bd@chdr.nl
http://www.chdr.nl

CEPEZED
http://www.cepezed.nl/

Leiden Bio Science Park
http://www.leidenbiosciencepark.nl/

DuPrie
http://www.duprie.nl

]]> CHDR verricht onderzoek naar de effecten van nieuwe geneesmiddelen bij patiënten en gezonde proefpersonen voor farmaceutische industrieën vanuit de hele wereld en werkt samen met het LUMC. In CHDR worden ook promovendi en studenten van de UL opgeleid.  De nieuwe onderzoeksafdeling is een van de grootste van Europa en een van de weinigen in de wereld geassocieerd met een universiteit.

De directeur van CHDR, Prof dr Adam Cohen stipte nog eens het belang van goed geneesmiddelonderzoek aan om snel en efficiënt zorg te dragen voor het beschikbaar komen van geneesmiddelen voor de ziektes waar nog geen goede behandelingen voor zijn.

Nadere inlichtingen bij:

Marieke van den Bosch
Business development manager van CHDR
071-5246400
bd@chdr.nl
http://www.chdr.nl

CEPEZED
http://www.cepezed.nl/

Leiden Bio Science Park
http://www.leidenbiosciencepark.nl/

DuPrie
http://www.duprie.nl

]]> 2012-04-27T17:19:56+02:00 CHDR Newsletter March 2012 http://www.chdr.nl/default.asp?id=778&nieuwsid=158

CHDR Newsletter March 2012

 

Promasys Newsletter
In February 2012 Promasys launched a new version of a clinical data management and EDC software suite. Furthermore it unveils some features of the future Promasys iPad app.
More information

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. Together with our partner ABL, CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Side event Bio-Europe Spring: Life sciences community in Leiden
Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

Side event Bio-Europe Spring: Alzheimer Center
Life Sciences Center Amsterdam is proudly hosting a lightning session entitled ‘Drug Development, Imaging, and Clinical Trials in Alzheimer Disease’, chaired by Dr. Philip Scheltens, Director of the Alzheimer Center at Amsterdam’s VU University Medical Center (VUmc).
Read more


Trials & Techniques

Induction of psychomimetic symptoms with ketamine
In addition to the THC-challenge model that we are developing for psychosis (Liem-Moolenaar et al. 2010, Kleinloog et al. submitted), we performed a trial where S(+)-ketamine was used to induce psychomimetic symptoms as a potential model for psychosis and antipsychotic drug action. Different target concentrations were tested and we found that ketamine can induce a robust, dose-dependent increase on different subscales of the Positive and Negative Syndrome Scale (PANSS) and different tests of the NeuroCart (e.g. smooth pursuit eye movements, adaptive tracking). Although many (side-)effects of ketamine were observed, these were mostly mild and dose-related.
Daniël Kleinloog

Population for Drug Abuse Liability studies
CHDR has performed many studies where healthy volunteers who had to be mild cannabis users were recruited. The subjects in these studies were compared to subjects who participated in other studies, to assess their suitability as a population for drug abuse liability studies. Mild cannabis users were found to be more flexible and open to new experiences than other healthy volunteers. They are also somewhat less cooperative and adherent to social standards, which was associated with a mildly reduced compliance to study procedures. Our experience with recruiting mild cannabis users, the different personality traits and a compliance to study procedures that is expected to be improved compared to a population of polydrug abusers (current standard drug abuse liability studies) makes a strong argument for the use of mild cannabis users in drug abuse liability studies.
Daniël Kleinloog

Posters, Presentations & Publications

PhD-Thesis: Human pharmacology of current and new treatments for schizophrenia
At the 8th of March Marieke Liem-Moolenaar successfully defended her PhD thesis "Human pharmacology of current and new treatments for schizophrenia".
Together, the studies described in this thesis give an impression of the current drug development in schizophrenia, show different ways of studying human pharmacology and provide examples how human pharmacology can be applied in an early stage of drug development in healthy volunteers.
Download Thesis or Recieve a Hardcopy
Marieke Liem-Moolenaar


Involvement of the endocannabinoid system in reward processing in the human brain.
van Hell HH, Jager G, Bossong MG, Brouwer A, Jansma JM, Zuurman L, van Gerven J, Kahn RS, Ramsey NF.
Psychopharmacology (Berl). 2012; 219: 981-990
fMRI has been used to investigate the role of the eCB system in reward processing in humans by examining the effect of the eCB agonist Δ(9)-tetrahydrocannabinol (THC) on reward-related brain activity. Results suggest a role for the eCB system in the appreciation of rewards.

Pharmacokinetics and central nervous system effects of the novel dopamine D3 receptor antagonist GSK598809 and intravenous alcohol infusion at pseudo-steady state.
Te Beek ET, Zoethout RW, Bani MS, Andorn A, Iavarone L, Klaassen ES, Fina P, van Gerven JM.
J Psychopharmacol. 2012; 26: 303-314
 In a blinded, randomized, placebo-controlled study, effects of a single oral dose of a novel dopamine D3 receptor antagonist were evaluated in healthy volunteers. Pharmacokinetics, central nervous system (CNS) effects and potential for interaction with alcohol were evaluated, using an alcohol infusion paradigm and CHDR’s NeuroCart CNS test battery. After co-administration with alcohol, effects of GSK598809 are mainly additive and the combination is well tolerated in healthy volunteers.


The effects of TPA023, a GABAA α 2,3 subtype-selective partial agonist, on essential tremor in comparison to alcohol.
de Haas SL, Zoethout RW, Van Dyck K, Smet MD, Rosen LB, Murphy MG, Gottesdiener KM, Schoemaker RC, Cohen AF, van Gerven JM.
J Psychopharmacol. 2012; 26: 282-291
The effects of 2 mg TPA023, a GABA(A) α2,3 subtype-selective partial agonist, on essential tremor (ET) were compared to the effects of a stable alcohol level (0.6 g/L) and placebo in nine patients with ET. This study showed that treatment with an α2,3 subunit-selective GABA(A) partial agonist was less effective than a stable level of alcohol in reducing ET symptoms. These results provide no support for a therapeutic role of TPA023 in the suppression of ET symptoms.

Effects of Δ9-Tetrahydrocannabinol Administration on Human Encoding and Recall Memory Function: A Pharmacological fMRI Study.
Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF.
J Cogn Neurosci. 2012; 24: 588-599.
In this study, we examined the effects of perturbation of the eCB system on memory function during both encoding and recall. We performed a pharmacological MRI study with a placebo-controlled, crossover design, investigating the effects of THC inhalation on associative memory-related brain function in 13 healthy volunteers.


The effects of a novel histamine-3 receptor inverse agonist on essential tremor in comparison to stable levels of alcohol.
Zoethout RW, Iannone R, Bloem BR, Palcza J, Murphy G, Chodakewitz J, Buntinx A, Gottesdiener K, Marsilio S, Rosen L, van Dyck K, Louis ED, Cohen AF, Schoemaker RC, Tokita S, Sato N, Koblan KS, Hargreaves RH, Renger JJ, van Gerven JM.
J Psychopharmacol. 2012; 26: 292-302
A steady state of alcohol significantly diminished tremor as assessed by laboratory tremorography, portable tremorography and clinical ratings compared with placebo. A high single MK-0249 dose was not effective in reducing tremor, but caused significant effects on the Leeds Sleep Evaluation Questionnaire and the Choice Reaction Time test.


 

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]>

CHDR Newsletter March 2012

 

Promasys Newsletter
In February 2012 Promasys launched a new version of a clinical data management and EDC software suite. Furthermore it unveils some features of the future Promasys iPad app.
More information

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. Together with our partner ABL, CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Side event Bio-Europe Spring: Life sciences community in Leiden
Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

Side event Bio-Europe Spring: Alzheimer Center
Life Sciences Center Amsterdam is proudly hosting a lightning session entitled ‘Drug Development, Imaging, and Clinical Trials in Alzheimer Disease’, chaired by Dr. Philip Scheltens, Director of the Alzheimer Center at Amsterdam’s VU University Medical Center (VUmc).
Read more


Trials & Techniques

Induction of psychomimetic symptoms with ketamine
In addition to the THC-challenge model that we are developing for psychosis (Liem-Moolenaar et al. 2010, Kleinloog et al. submitted), we performed a trial where S(+)-ketamine was used to induce psychomimetic symptoms as a potential model for psychosis and antipsychotic drug action. Different target concentrations were tested and we found that ketamine can induce a robust, dose-dependent increase on different subscales of the Positive and Negative Syndrome Scale (PANSS) and different tests of the NeuroCart (e.g. smooth pursuit eye movements, adaptive tracking). Although many (side-)effects of ketamine were observed, these were mostly mild and dose-related.
Daniël Kleinloog

Population for Drug Abuse Liability studies
CHDR has performed many studies where healthy volunteers who had to be mild cannabis users were recruited. The subjects in these studies were compared to subjects who participated in other studies, to assess their suitability as a population for drug abuse liability studies. Mild cannabis users were found to be more flexible and open to new experiences than other healthy volunteers. They are also somewhat less cooperative and adherent to social standards, which was associated with a mildly reduced compliance to study procedures. Our experience with recruiting mild cannabis users, the different personality traits and a compliance to study procedures that is expected to be improved compared to a population of polydrug abusers (current standard drug abuse liability studies) makes a strong argument for the use of mild cannabis users in drug abuse liability studies.
Daniël Kleinloog

Posters, Presentations & Publications

PhD-Thesis: Human pharmacology of current and new treatments for schizophrenia
At the 8th of March Marieke Liem-Moolenaar successfully defended her PhD thesis "Human pharmacology of current and new treatments for schizophrenia".
Together, the studies described in this thesis give an impression of the current drug development in schizophrenia, show different ways of studying human pharmacology and provide examples how human pharmacology can be applied in an early stage of drug development in healthy volunteers.
Download Thesis or Recieve a Hardcopy
Marieke Liem-Moolenaar


Involvement of the endocannabinoid system in reward processing in the human brain.
van Hell HH, Jager G, Bossong MG, Brouwer A, Jansma JM, Zuurman L, van Gerven J, Kahn RS, Ramsey NF.
Psychopharmacology (Berl). 2012; 219: 981-990
fMRI has been used to investigate the role of the eCB system in reward processing in humans by examining the effect of the eCB agonist Δ(9)-tetrahydrocannabinol (THC) on reward-related brain activity. Results suggest a role for the eCB system in the appreciation of rewards.

Pharmacokinetics and central nervous system effects of the novel dopamine D3 receptor antagonist GSK598809 and intravenous alcohol infusion at pseudo-steady state.
Te Beek ET, Zoethout RW, Bani MS, Andorn A, Iavarone L, Klaassen ES, Fina P, van Gerven JM.
J Psychopharmacol. 2012; 26: 303-314
 In a blinded, randomized, placebo-controlled study, effects of a single oral dose of a novel dopamine D3 receptor antagonist were evaluated in healthy volunteers. Pharmacokinetics, central nervous system (CNS) effects and potential for interaction with alcohol were evaluated, using an alcohol infusion paradigm and CHDR’s NeuroCart CNS test battery. After co-administration with alcohol, effects of GSK598809 are mainly additive and the combination is well tolerated in healthy volunteers.


The effects of TPA023, a GABAA α 2,3 subtype-selective partial agonist, on essential tremor in comparison to alcohol.
de Haas SL, Zoethout RW, Van Dyck K, Smet MD, Rosen LB, Murphy MG, Gottesdiener KM, Schoemaker RC, Cohen AF, van Gerven JM.
J Psychopharmacol. 2012; 26: 282-291
The effects of 2 mg TPA023, a GABA(A) α2,3 subtype-selective partial agonist, on essential tremor (ET) were compared to the effects of a stable alcohol level (0.6 g/L) and placebo in nine patients with ET. This study showed that treatment with an α2,3 subunit-selective GABA(A) partial agonist was less effective than a stable level of alcohol in reducing ET symptoms. These results provide no support for a therapeutic role of TPA023 in the suppression of ET symptoms.

Effects of Δ9-Tetrahydrocannabinol Administration on Human Encoding and Recall Memory Function: A Pharmacological fMRI Study.
Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF.
J Cogn Neurosci. 2012; 24: 588-599.
In this study, we examined the effects of perturbation of the eCB system on memory function during both encoding and recall. We performed a pharmacological MRI study with a placebo-controlled, crossover design, investigating the effects of THC inhalation on associative memory-related brain function in 13 healthy volunteers.


The effects of a novel histamine-3 receptor inverse agonist on essential tremor in comparison to stable levels of alcohol.
Zoethout RW, Iannone R, Bloem BR, Palcza J, Murphy G, Chodakewitz J, Buntinx A, Gottesdiener K, Marsilio S, Rosen L, van Dyck K, Louis ED, Cohen AF, Schoemaker RC, Tokita S, Sato N, Koblan KS, Hargreaves RH, Renger JJ, van Gerven JM.
J Psychopharmacol. 2012; 26: 292-302
A steady state of alcohol significantly diminished tremor as assessed by laboratory tremorography, portable tremorography and clinical ratings compared with placebo. A high single MK-0249 dose was not effective in reducing tremor, but caused significant effects on the Leeds Sleep Evaluation Questionnaire and the Choice Reaction Time test.


 

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]> 2012-03-30T17:19:56+02:00 PhD-Thesis by Marieke Liem-Moolenaar http://www.chdr.nl/default.asp?id=778&nieuwsid=159

At the 8th of March Marieke Liem-Moolenaar successfully defended her PhD thesis "Human pharmacology of current and new treatments for schizophrenia".

In this thesis the human pharmacology (the interaction between a drug and human) of current and new drugs for schizophrenia is discussed. Schizophrenia is one of the most debilitating psychiatric disorders and affects 1-1.5% of the world population. It usually occurs in young adults and remains present throughout life.

The studies in this thesis together give an impression of the current drug development in schizophrenia, show different ways of studying human pharmacology and provide examples how human pharmacology can be applied in an early stage of drug development in healthy volunteers.

The investigated compounds show that the main pharmacological focus in this area has shifted from psychosis to improvement of individual negative or cognitive symptom complexes, from direct receptor inhibition to indirect receptor modulation, and from single drug strategies to combination therapies, each targeted at different symptoms.

We have tried to create a pharmacological fingerprint of the investigated compounds by making use of an intensive CNS test battery to measure effects in different functional domains of the brain and additional ‘tools’ (i.e. positive controls, dose escalation, PK-PD modeling and pharmacological challenge tests) to improve the reliability of the tests.

This diversity of drug development strategies and range of neurotransmitters in schizophrenia reflects the increasing complexity of neuropharmacological hypotheses in this field. Despite these difficulties, incremental changes in drug characteristics and treatment strategies may well lead to the introduction of new classes or combinations of drugs in the future.

More information to Download Thesis or Recieve a Hardcopy

]]>

At the 8th of March Marieke Liem-Moolenaar successfully defended her PhD thesis "Human pharmacology of current and new treatments for schizophrenia".

In this thesis the human pharmacology (the interaction between a drug and human) of current and new drugs for schizophrenia is discussed. Schizophrenia is one of the most debilitating psychiatric disorders and affects 1-1.5% of the world population. It usually occurs in young adults and remains present throughout life.

The studies in this thesis together give an impression of the current drug development in schizophrenia, show different ways of studying human pharmacology and provide examples how human pharmacology can be applied in an early stage of drug development in healthy volunteers.

The investigated compounds show that the main pharmacological focus in this area has shifted from psychosis to improvement of individual negative or cognitive symptom complexes, from direct receptor inhibition to indirect receptor modulation, and from single drug strategies to combination therapies, each targeted at different symptoms.

We have tried to create a pharmacological fingerprint of the investigated compounds by making use of an intensive CNS test battery to measure effects in different functional domains of the brain and additional ‘tools’ (i.e. positive controls, dose escalation, PK-PD modeling and pharmacological challenge tests) to improve the reliability of the tests.

This diversity of drug development strategies and range of neurotransmitters in schizophrenia reflects the increasing complexity of neuropharmacological hypotheses in this field. Despite these difficulties, incremental changes in drug characteristics and treatment strategies may well lead to the introduction of new classes or combinations of drugs in the future.

More information to Download Thesis or Recieve a Hardcopy

]]> 2012-03-30T17:19:56+02:00 Promasys Newsletter February 2012 http://www.chdr.nl/default.asp?id=778&nieuwsid=152 Dear reader, 

Please Click Here to read the Promasys newsletter of February 2012. It highlights our newest software release, Promasys version 6.2.

It unveils some features of the Promasys iPad app under development. It introduces our new customers and briefly describes our customer support services in Japan.

We hope you will enjoy reading it. Please feel free to share the newsletter with interested colleagues or friends.

 

About PROMASYS

PROMASYS: integrated CDMS and EDC 

Promasys® is an integrated clinical data management and EDC system that brings quality and efficiency to your clinical data capture and data management processes. On top of industry standard data management functionality -which is available to the users without having to do any programming- Promasys offers rich reporting and  work flow support solutions, like automatic distribution of subject recruitment progress reports, automatic generation of bar-coded sample tube labels, work lists, data listings and SAS data sets, etc. 

Some of Promasys' main features include:

  • easy setup of new trials; use templates and recyclable trial design elements
  • paper CRFs, EDC screens, forms and labels are all generated from the clinical database design
  • build edit checks without programming
  • manual queries and system generated batch queries
  • full audit trail compliant with 21 CFR part 11
  • electronic signatures
  • set & forget access control, dynamic access rights management through the Study Life Cycle
]]> Dear reader, 

Please Click Here to read the Promasys newsletter of February 2012. It highlights our newest software release, Promasys version 6.2.

It unveils some features of the Promasys iPad app under development. It introduces our new customers and briefly describes our customer support services in Japan.

We hope you will enjoy reading it. Please feel free to share the newsletter with interested colleagues or friends.

 

About PROMASYS

PROMASYS: integrated CDMS and EDC 

Promasys® is an integrated clinical data management and EDC system that brings quality and efficiency to your clinical data capture and data management processes. On top of industry standard data management functionality -which is available to the users without having to do any programming- Promasys offers rich reporting and  work flow support solutions, like automatic distribution of subject recruitment progress reports, automatic generation of bar-coded sample tube labels, work lists, data listings and SAS data sets, etc. 

Some of Promasys' main features include:

  • easy setup of new trials; use templates and recyclable trial design elements
  • paper CRFs, EDC screens, forms and labels are all generated from the clinical database design
  • build edit checks without programming
  • manual queries and system generated batch queries
  • full audit trail compliant with 21 CFR part 11
  • electronic signatures
  • set & forget access control, dynamic access rights management through the Study Life Cycle
]]> 2012-02-28T17:19:56+02:00 Visit Alzheimer Center http://www.chdr.nl/default.asp?id=778&nieuwsid=151 22 March 2012: 12.00 – 14.00 h, lunch served

Alzheimer Disease presents challenges on many fronts; the complexity of diagnosis, clinical management, and the continuing unfulfilled search for effective therapy signals that we need to adopt new ways of cooperating to make progress. In this spirit, Life Sciences Center Amsterdam is proudly hosting a lightning session entitled ‘Drug Development, Imaging, and Clinical Trials in Alzheimer Disease’, chaired by Dr. Philip Scheltens, Director of the Alzheimer Center at Amsterdam’s VU University Medical Center (VUmc).

We will bring together in one room experts from key elements of drug development and clinical trial value chain within AD, including:

·         VUmc’s first-in-man trials capability in AD therapeutics, in conjunction with CHDR

·         Full integration with Imaging Center VUmc, which offers radionuclide labeling, toxicology and pharmacokinetics, full GMP lab capabilities, PET Tracer development, and combined PET/MRI

·         Intimate linkage with EATRIS (European Advanced Translational Research InfraStructure in Medicine) headquartered at VUmc

·         Blood-brain barrier delivery companies

·         AD compound companies

·         Multiple ongoing Phase I/II/III trials in AD

·         A large and very well characterized patient population of AD, especially early onset AD

·         Extensive AD biology research, coupled with Neuroscience Campus Amsterdam and beyond

 

VUmc is a conveniently located a short distance away not only from BIO-Europe conference hotels but also Schiphol Airport.

Please note – in the interest of maintaining a tight focus for this short duration and intimate event, RSVP’s will be prioritized according to direct contribution to the discussion. For this reason, LSCA may respectfully decline RSVP’s from upstream or downstream service providers.

Please RSVP to bd@chdr.nl

]]> 22 March 2012: 12.00 – 14.00 h, lunch served

Alzheimer Disease presents challenges on many fronts; the complexity of diagnosis, clinical management, and the continuing unfulfilled search for effective therapy signals that we need to adopt new ways of cooperating to make progress. In this spirit, Life Sciences Center Amsterdam is proudly hosting a lightning session entitled ‘Drug Development, Imaging, and Clinical Trials in Alzheimer Disease’, chaired by Dr. Philip Scheltens, Director of the Alzheimer Center at Amsterdam’s VU University Medical Center (VUmc).

We will bring together in one room experts from key elements of drug development and clinical trial value chain within AD, including:

·         VUmc’s first-in-man trials capability in AD therapeutics, in conjunction with CHDR

·         Full integration with Imaging Center VUmc, which offers radionuclide labeling, toxicology and pharmacokinetics, full GMP lab capabilities, PET Tracer development, and combined PET/MRI

·         Intimate linkage with EATRIS (European Advanced Translational Research InfraStructure in Medicine) headquartered at VUmc

·         Blood-brain barrier delivery companies

·         AD compound companies

·         Multiple ongoing Phase I/II/III trials in AD

·         A large and very well characterized patient population of AD, especially early onset AD

·         Extensive AD biology research, coupled with Neuroscience Campus Amsterdam and beyond

 

VUmc is a conveniently located a short distance away not only from BIO-Europe conference hotels but also Schiphol Airport.

Please note – in the interest of maintaining a tight focus for this short duration and intimate event, RSVP’s will be prioritized according to direct contribution to the discussion. For this reason, LSCA may respectfully decline RSVP’s from upstream or downstream service providers.

Please RSVP to bd@chdr.nl

]]> 2012-02-24T17:19:56+02:00 Bio-Europe Spring, 19-21 March 2012, Amsterdam http://www.chdr.nl/default.asp?id=778&nieuwsid=148 Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

]]> Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

]]> 2012-01-30T17:19:56+02:00 Bibliometric research performance profile http://www.chdr.nl/default.asp?id=778&nieuwsid=149 Bibliometric research performance profile

Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.

The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.




Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]> Bibliometric research performance profile

Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.

The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.




Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]> 2012-01-30T17:19:56+02:00 CHDR Newsletter January 2012 http://www.chdr.nl/default.asp?id=778&nieuwsid=150

CHDR Newsletter January 2012

 


TNO and CHDR join forces in the area of food related clinical trials
TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.
The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.
More information

CHDR donation to 3FM Serious Request
Last year in December, CHDR has donated EUR5000 to 3FM Serious Request which is a yearly project by Dutch radio station 3FM.  Three   DJ’s confine themselves without food to a temporary, transparent radio studio for seven days to collect money for projects of The Red Cross. The proceeds are meant to help mothers in war/conflict zones around the world with essential, basic things like shelter, medical assistance and first aid supplies such as food, water, soap and kitchen utensils. Moreover The Red Cross helps mothers to create their own income and to search for relatives.
More information on Serious Request

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

 Trials & Techniques

Anti-coagulant interaction study
To investigate the potential interaction on coagulation between an approved muscle relaxant, which is used in the clinic post-surgically, and anticoagulants enoxaparin or unfractionated heparin, the standard parameters APTT, PT and anti-Xa are investigated in a trial with young healthy males. In addition, APTT will be assessed on ex vivo spiked blood samples with muscle relaxant and/or anticoagulant in various concentrations to facilitate a robust PK-PD model. Based on this model the anticoagulant activity in case of alternative, not clinically evaluated, dosing scenarios of anticoagulant and muscle relaxant may be simulated.
Annelieke Kruithof

Pro-cholinergic drug in a scopolamine model in healthy elderly volunteers
A proof-of-pharmacology study has started with a new pro-cholinergic drug, that will be tested in combination with an already registered cholinesterase inhibitor. It is hypothesized that the combination of these drugs reduces the symptoms of Alzheimer's Disease better than either compound alone. Different dose combinations will be tested in healthy elderly volunteers who will be co-administered with scopolamine to induce temporary symptoms of memory loss and attention deficit. With this study we expect to be able to select an optimal study design for a phase II/III study in patients with Alzheimer's Disease.
Anne Catrien Baakman

UVB Pain model
The range of tests available for testing analgesics is expanding. Validation of an UVB-induced, inflammatory pain test and paradigm for measure evoked potentials is currently underway. In collaboration with the NeuroSIPE group, methodology for measuring small nerve fibre dysfunction, which can result in neuropathic pain, is also being developed. This will add to the already used pain tests including thermal pain, cold pressor, electrical and mechanical pain as well as and a paradigm for measuring DNIC.
Justin Hay

Biosimilars
The development of biosimilars is rapidly increasing and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

Posters, Presentations & Publications

PhD-Defence Anthracycline-induced cardiotoxicity
At the 17th of January Freerk Broeyer successfully defended his PhD thesis "Anthracycline-induced cardiotoxicity, a pathophysiology based approach for early detection and protective strategies". In this thesis he explored his research on possible biomarkers for anthracyclin-induced cardiotoxicity and the use of a potentially protective agent in healthy volunteers and patients with breast carcinoma.
More information


Bibliometric research performance profile
Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.
This increased output was accompanied by a similar increase in quality. The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.
Ingrid de Visser




 

Modulation of vasoactivity and platelet aggregation by selective 5-HT receptor antagonism in humans.
J Cardiovasc Pharmacol. 2011; 58 :575-80.
Moerland M, Kemme M, Dijkmans A, Bergougnan L, Burggraaf J.
The vasoactive and antiplatelet effects of the combined 5-HT1B and 5-HT2A receptor blocker SL65.0472-00 were investigated in humans to elucidate the functional involvement of these receptors. SL65.0472-00 has potent antagonistic effect on 5-HT-induced vasoconstriction and platelet aggregation but not on sumatriptan-induced vasoconstriction. This suggests that in humans, SL65.0472-00 is a 5-HT2A blocker without clear 5-HT1B antagonistic activity.

  

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to newsletter

]]>

CHDR Newsletter January 2012

 


TNO and CHDR join forces in the area of food related clinical trials
TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.
The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.
More information

CHDR donation to 3FM Serious Request
Last year in December, CHDR has donated EUR5000 to 3FM Serious Request which is a yearly project by Dutch radio station 3FM.  Three   DJ’s confine themselves without food to a temporary, transparent radio studio for seven days to collect money for projects of The Red Cross. The proceeds are meant to help mothers in war/conflict zones around the world with essential, basic things like shelter, medical assistance and first aid supplies such as food, water, soap and kitchen utensils. Moreover The Red Cross helps mothers to create their own income and to search for relatives.
More information on Serious Request

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

 Trials & Techniques

Anti-coagulant interaction study
To investigate the potential interaction on coagulation between an approved muscle relaxant, which is used in the clinic post-surgically, and anticoagulants enoxaparin or unfractionated heparin, the standard parameters APTT, PT and anti-Xa are investigated in a trial with young healthy males. In addition, APTT will be assessed on ex vivo spiked blood samples with muscle relaxant and/or anticoagulant in various concentrations to facilitate a robust PK-PD model. Based on this model the anticoagulant activity in case of alternative, not clinically evaluated, dosing scenarios of anticoagulant and muscle relaxant may be simulated.
Annelieke Kruithof

Pro-cholinergic drug in a scopolamine model in healthy elderly volunteers
A proof-of-pharmacology study has started with a new pro-cholinergic drug, that will be tested in combination with an already registered cholinesterase inhibitor. It is hypothesized that the combination of these drugs reduces the symptoms of Alzheimer's Disease better than either compound alone. Different dose combinations will be tested in healthy elderly volunteers who will be co-administered with scopolamine to induce temporary symptoms of memory loss and attention deficit. With this study we expect to be able to select an optimal study design for a phase II/III study in patients with Alzheimer's Disease.
Anne Catrien Baakman

UVB Pain model
The range of tests available for testing analgesics is expanding. Validation of an UVB-induced, inflammatory pain test and paradigm for measure evoked potentials is currently underway. In collaboration with the NeuroSIPE group, methodology for measuring small nerve fibre dysfunction, which can result in neuropathic pain, is also being developed. This will add to the already used pain tests including thermal pain, cold pressor, electrical and mechanical pain as well as and a paradigm for measuring DNIC.
Justin Hay

Biosimilars
The development of biosimilars is rapidly increasing and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

Posters, Presentations & Publications

PhD-Defence Anthracycline-induced cardiotoxicity
At the 17th of January Freerk Broeyer successfully defended his PhD thesis "Anthracycline-induced cardiotoxicity, a pathophysiology based approach for early detection and protective strategies". In this thesis he explored his research on possible biomarkers for anthracyclin-induced cardiotoxicity and the use of a potentially protective agent in healthy volunteers and patients with breast carcinoma.
More information


Bibliometric research performance profile
Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.
This increased output was accompanied by a similar increase in quality. The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.
Ingrid de Visser




 

Modulation of vasoactivity and platelet aggregation by selective 5-HT receptor antagonism in humans.
J Cardiovasc Pharmacol. 2011; 58 :575-80.
Moerland M, Kemme M, Dijkmans A, Bergougnan L, Burggraaf J.
The vasoactive and antiplatelet effects of the combined 5-HT1B and 5-HT2A receptor blocker SL65.0472-00 were investigated in humans to elucidate the functional involvement of these receptors. SL65.0472-00 has potent antagonistic effect on 5-HT-induced vasoconstriction and platelet aggregation but not on sumatriptan-induced vasoconstriction. This suggests that in humans, SL65.0472-00 is a 5-HT2A blocker without clear 5-HT1B antagonistic activity.

  

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to newsletter

]]> 2012-01-30T17:19:56+02:00 TNO and CHDR join forces in the area of food related clinical trials http://www.chdr.nl/default.asp?id=778&nieuwsid=147

TNO and CHDR join forces in the area of food related clinical trials
24 January 2012

TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.

In the current market for food development, the combined experience, expertise and assets from food research and pharma related clinical trials leads to a new proposition to the food industry that includes above-standard quality and cost efficiency and an innovative approach to research projects, which will help our customers to drive their development programs forward with increased focus and speed.

The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.

Further important assets of the alliance comprise:

  • Unique human capital, highly experienced staff with expertise in numerous indications
  • Experience in both food and pharma clinical trials
  • Wide range of validated biomarkers
  • Possibility to use microdosing and microtracers
  • Leading combination of academic expertise and operational experience
  • A large database of volunteers in several age ranges
  • Compliance with ICH GCP embedded in a QA system
  • 21 CFR part 11 compliant data management system.

 

About TNO

TNO is an independent innovation organisation. TNO connects people and knowledge to create innovations that sustainably boost the competitive strength of industry and the welfare of society. TNO’s more than 3500 professionals work on practicable knowledge and solutions for the problems of global scarcity. TNO focuses its efforts on seven themes: Healthy Living, Industrial Innovation, Energy/Geological Survey of the Netherlands, Transport and Mobility, Built Environment, Information Society, and Safety, Defence and Security.

Over the years, TNO has built a track record in clinical trials, working with all major food manufacturers, both in food innovation, preclinical and clinical studies. Furthermore, TNO is solidly anchored in innovative health-research consortia, enabling customers to tap into the newest insights.

More information:

CHDR
Prof. dr. Adam Cohen
CEO
E bd@chdr.nl
T +31 71 5246 400


TNO
Dr. Jeroen Groot
Research Manager
T +31 88 866 2399

]]>

TNO and CHDR join forces in the area of food related clinical trials
24 January 2012

TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.

In the current market for food development, the combined experience, expertise and assets from food research and pharma related clinical trials leads to a new proposition to the food industry that includes above-standard quality and cost efficiency and an innovative approach to research projects, which will help our customers to drive their development programs forward with increased focus and speed.

The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.

Further important assets of the alliance comprise:

  • Unique human capital, highly experienced staff with expertise in numerous indications
  • Experience in both food and pharma clinical trials
  • Wide range of validated biomarkers
  • Possibility to use microdosing and microtracers
  • Leading combination of academic expertise and operational experience
  • A large database of volunteers in several age ranges
  • Compliance with ICH GCP embedded in a QA system
  • 21 CFR part 11 compliant data management system.

 

About TNO

TNO is an independent innovation organisation. TNO connects people and knowledge to create innovations that sustainably boost the competitive strength of industry and the welfare of society. TNO’s more than 3500 professionals work on practicable knowledge and solutions for the problems of global scarcity. TNO focuses its efforts on seven themes: Healthy Living, Industrial Innovation, Energy/Geological Survey of the Netherlands, Transport and Mobility, Built Environment, Information Society, and Safety, Defence and Security.

Over the years, TNO has built a track record in clinical trials, working with all major food manufacturers, both in food innovation, preclinical and clinical studies. Furthermore, TNO is solidly anchored in innovative health-research consortia, enabling customers to tap into the newest insights.

More information:

CHDR
Prof. dr. Adam Cohen
CEO
E bd@chdr.nl
T +31 71 5246 400


TNO
Dr. Jeroen Groot
Research Manager
T +31 88 866 2399

]]> 2012-01-24T17:19:56+02:00 CHDR Newsletter Winter 2011 http://www.chdr.nl/default.asp?id=778&nieuwsid=145

CHDR Newsletter Winter 2011

 

 
 
New Research Director: Pierre Peeters
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 


Introduction course to Population PK and PK/PD modeling with NONMEM
This hands-on course lectured by dr. Jan Freijer on December 7-9 is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.
Registration is closed; a new course will be given next year.


E-Learning Pharmacology Database TRC hits the two million
In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’.
Read More or visit TRC via  http://coo.lumc.nl/TRC.



Trials & Techniques

Biosimilars
Biosimilars are increasingly developed and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

New analgesic compound for the treatment of neuropathic pain
A multiple ascending dose study has started with a new analgesic compound for the treatment of neuropathic pain. In this study, 24 patients with sciatica are enrolled and randomized to receive three doses of this new compound or placebo. Safety, tolerability and efficacy will be assessed using CHDR's PainCart to profile the analgesic effects of this compound on multiple pain mechanisms.
Pieter Okkerse


Innovative approach to improve renal function in diabetic patients
A proof-of-pharmacology trial has started in which a novel drug is being tested in diabetic patients. The drug is under development for the treatment of albuminuria as frequently observed in diabetes. Preclinical work and earlier human studies demonstrated that this compound potentially limits renal damage and improves glycemic control by inhibiting the infiltration of proinflammatory monocytes into tissues. This new treatment modality may help in diabetic nephropathy, a condition that is currently not optimally controlled in many patients.
Joannes Reijers


FIH of a new exploratory hypnotic agent
CHDR's Neurocart will be used in a FIH dose escalation study to test the PK, safety, PD and side effect profile of a potential new drug for insomnia. This investigational drug addressing a novel mechanism of action, will be profiled using several NeuroCart pharmacodynamic parameters. Escalation to the next dose level will be determined using tolerability and PD data of the previous dose level. The trial also includes an active reference crossover cohort to assist dose finding and compare side effects for further phase II studies. This informative trial is expected to facilitate shorter development time lines towards phase III.
Helene van Gorsel



Posters, Presentations & Publications

BPS Winter Meeting Symposium
Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
Register via this link


A literature review on pharmacological sensitivity of human experimental hyperalgesic pain models.
Human experimental pain models are often used in early phase drug development to identify the efficacy of novel and existing drugs. Hyperalgesia and allodynia can be experimentally induced to mimic symptoms of inflammatory or neuropathic pain by exposure to UV-B, capsaicin or a thermal burn.
Guido van Amerongen


A meta-analysis of pharmacodynamic testing with the NeuroCart used in the early phase drug development of CNS depressant agents.
These results show that by using a range of CNS tests, drugs can be profiled with unique CNS 'fingerprints', reflecting their distinct mechanism of action. This information can be used as a frame of reference to determine the pharmacological activity of new compounds during early development.
Justin Hay


Introduction to haemostasis from a pharmacodynamic perspective.
Kluft C, Burggraaf J.
Br J Clin Pharmacol 2011; 72: 538-546
Biochemical characterization of the haemostatic system has advanced significantly in the past decades. Many examples are available to show that traditional general methods of clotting and lysis do not provide the information that is desired. The conclusion is reached that there is a need for integrated or global methods or sets of methods that reflect the complexity and individual status appropriately and allow the practitioner to judge the effects of interventions and their individual aspects.


The Perception and Pharmacokinetics of a 20-mg Dose of Escitalopram Orodispersible Tablets in a Relative Bioavailability Study in Healthy Men.
Nilausen DØ, Zuiker RG, van Gerven J.
Clin Ther. 2011; 33: 1492-1502.
Rapidly dissolving oral (orodispersible) drug formulations have been developed to overcome problems related to swallowing. The aim of this study was to compare the bioavailability of orodispersible and conventional immediate-release (IR) escitalopram tablets. In this small study population of fasting healthy male volunteers, 2 × 10-mg ODTs or 1 × 20-mg ODT and 2 × 10-mg conventional IR escitalopram tablets met the regulatory criteria for assumed bioequivalence.


Acute effects of MDMA (3,4-methylenedioxymethamphetamine) on EEG oscillations: alone and in combination with ethanol or THC (delta-9-tetrahydrocannabinol).
Lansbergen MM, Dumont GJ, van Gerven JM, Buitelaar JK, Verkes RJ.
Psychopharmacology. 2011; 213: 745-756
The aim of the present study was to investigate whether co-administration of alcohol or THC with MDMA differentially affects ongoing electroencephalogram (EEG) oscillations compared to the administration of each drug alone. The findings indicate that the combined intake of MDMA and THC, but not of MDMA and alcohol, affects ongoing EEG oscillations differently than the sum of either one drug alone. Changes in ongoing EEG oscillations may be related to the impaired task performance that has often been reported after drug intake.


Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials.
Pronker E, Geerts BF, Cohen A, Pieterse H.
Br J Clin Pharmacol. 2011 ;71:467-70. 
Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data man agement.

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

]]>

CHDR Newsletter Winter 2011

 

 
 
New Research Director: Pierre Peeters
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 


Introduction course to Population PK and PK/PD modeling with NONMEM
This hands-on course lectured by dr. Jan Freijer on December 7-9 is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.
Registration is closed; a new course will be given next year.


E-Learning Pharmacology Database TRC hits the two million
In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’.
Read More or visit TRC via  http://coo.lumc.nl/TRC.



Trials & Techniques

Biosimilars
Biosimilars are increasingly developed and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

New analgesic compound for the treatment of neuropathic pain
A multiple ascending dose study has started with a new analgesic compound for the treatment of neuropathic pain. In this study, 24 patients with sciatica are enrolled and randomized to receive three doses of this new compound or placebo. Safety, tolerability and efficacy will be assessed using CHDR's PainCart to profile the analgesic effects of this compound on multiple pain mechanisms.
Pieter Okkerse


Innovative approach to improve renal function in diabetic patients
A proof-of-pharmacology trial has started in which a novel drug is being tested in diabetic patients. The drug is under development for the treatment of albuminuria as frequently observed in diabetes. Preclinical work and earlier human studies demonstrated that this compound potentially limits renal damage and improves glycemic control by inhibiting the infiltration of proinflammatory monocytes into tissues. This new treatment modality may help in diabetic nephropathy, a condition that is currently not optimally controlled in many patients.
Joannes Reijers


FIH of a new exploratory hypnotic agent
CHDR's Neurocart will be used in a FIH dose escalation study to test the PK, safety, PD and side effect profile of a potential new drug for insomnia. This investigational drug addressing a novel mechanism of action, will be profiled using several NeuroCart pharmacodynamic parameters. Escalation to the next dose level will be determined using tolerability and PD data of the previous dose level. The trial also includes an active reference crossover cohort to assist dose finding and compare side effects for further phase II studies. This informative trial is expected to facilitate shorter development time lines towards phase III.
Helene van Gorsel



Posters, Presentations & Publications

BPS Winter Meeting Symposium
Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
Register via this link


A literature review on pharmacological sensitivity of human experimental hyperalgesic pain models.
Human experimental pain models are often used in early phase drug development to identify the efficacy of novel and existing drugs. Hyperalgesia and allodynia can be experimentally induced to mimic symptoms of inflammatory or neuropathic pain by exposure to UV-B, capsaicin or a thermal burn.
Guido van Amerongen


A meta-analysis of pharmacodynamic testing with the NeuroCart used in the early phase drug development of CNS depressant agents.
These results show that by using a range of CNS tests, drugs can be profiled with unique CNS 'fingerprints', reflecting their distinct mechanism of action. This information can be used as a frame of reference to determine the pharmacological activity of new compounds during early development.
Justin Hay


Introduction to haemostasis from a pharmacodynamic perspective.
Kluft C, Burggraaf J.
Br J Clin Pharmacol 2011; 72: 538-546
Biochemical characterization of the haemostatic system has advanced significantly in the past decades. Many examples are available to show that traditional general methods of clotting and lysis do not provide the information that is desired. The conclusion is reached that there is a need for integrated or global methods or sets of methods that reflect the complexity and individual status appropriately and allow the practitioner to judge the effects of interventions and their individual aspects.


The Perception and Pharmacokinetics of a 20-mg Dose of Escitalopram Orodispersible Tablets in a Relative Bioavailability Study in Healthy Men.
Nilausen DØ, Zuiker RG, van Gerven J.
Clin Ther. 2011; 33: 1492-1502.
Rapidly dissolving oral (orodispersible) drug formulations have been developed to overcome problems related to swallowing. The aim of this study was to compare the bioavailability of orodispersible and conventional immediate-release (IR) escitalopram tablets. In this small study population of fasting healthy male volunteers, 2 × 10-mg ODTs or 1 × 20-mg ODT and 2 × 10-mg conventional IR escitalopram tablets met the regulatory criteria for assumed bioequivalence.


Acute effects of MDMA (3,4-methylenedioxymethamphetamine) on EEG oscillations: alone and in combination with ethanol or THC (delta-9-tetrahydrocannabinol).
Lansbergen MM, Dumont GJ, van Gerven JM, Buitelaar JK, Verkes RJ.
Psychopharmacology. 2011; 213: 745-756
The aim of the present study was to investigate whether co-administration of alcohol or THC with MDMA differentially affects ongoing electroencephalogram (EEG) oscillations compared to the administration of each drug alone. The findings indicate that the combined intake of MDMA and THC, but not of MDMA and alcohol, affects ongoing EEG oscillations differently than the sum of either one drug alone. Changes in ongoing EEG oscillations may be related to the impaired task performance that has often been reported after drug intake.


Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials.
Pronker E, Geerts BF, Cohen A, Pieterse H.
Br J Clin Pharmacol. 2011 ;71:467-70. 
Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data man agement.

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

]]> 2011-12-02T17:19:56+02:00