The average time to bring a new drug to market is 12 years—assuming it makes it through the rigorous regulatory hurdles. Any technology or methodology that can expedite the drug development process or increase the likelihood of FDA approval is advantageous to both companies and patients. Now, a new study from investigators at Coyne Scientific provides a unique look at a novel strategy—clinical trials in a dish (CTiD)—that bridges preclinical testing and clinical trials. Findings from the new study were published recently in SLAS Discovery, in an article entitled “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.”
“The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development,” the authors wrote. “Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs.”
This new CTiD platform allows pharmaceutical companies to test, at the population level, novel drugs on patient cells before moving into actual clinical trials. Because current preclinical strategies don’t follow this principle, CTiD offers the potential to impact drug discovery and development significantly.
Recent demonstrations have shown various human induced pluripotent stem cell-derived (hiPSCs) cell types (cardiac, neuronal, hepatic) recapitulate a specific individual’s drug response (rather than that of a generic human being) and have opened new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population.
“The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population,” the authors penned. The researchers continued, stating that CTiD “allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition.”
The concept of CTiD is to satisfy, in an in vitro setting, the defining biological truth that establishes the need for a multipatient clinical trial, which is that drug responses vary by human. CTiD studies are efficient, allow the study of a range of clinical doses, and can be executed at a fraction of the cost outside of the rigid and heavily regulated clinical testing environment.
CTiD studies are poised to revolutionize thinking about practical, immediate, and near-term applications in the field of drug discovery and development. CTiD can lead to insights that cannot be obtained so early and economically in drug development by any other approach. Although still requiring improvements and enhancements, CTiD offers to refine the selection of drugs to move into clinical development, leading to reduced attrition and enabling safe drugs that address unmet medical needs to reach patients more quickly.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-05 17:59:002018-06-12 18:03:47Speeding Drug Development with Clinical Trials in a Dish← #nieuws
Glycostem and MolMed signed a binding term sheet for the development and manufacturing of new NK cells–based allogeneic CAR (Chimeric Antigen Receptors). The Master Agreement will be finalized by September 30th, 2018.
According to the agreement, Glycostem and MolMed will collaborate on an exclusive base in developing and manufacturing engineered NK cells targeted to three tumor antigens: Glycostem will be responsible for the final product GMP manufacturing and release, while MolMed will have exclusive rights for the exploitation of the resulting products and Glycostem will receive upfront payments, milestones and royalties on the developed products.
Troels Jordansen, Glycostem CEO, commented: “We are very proud to be teaming up with one of the most innovative cellular therapy companies around and jointly develop mold-breaking products for the help of doctors and patients. The synergy between MolMed and Glycostem is tangible and we are confident it could lead to exciting results in the short term. This is also the initiation of Glycostem’s in-house development program in our new state-of-the-art facility in the Netherlands. It is out of the same facility that we expect to have GMP approval for our closed-system production system by the end of 2018. This will allow us to expand our clinical trial program and enter pivotal for oNKord early 2019.”
As of June 15th, the European Medicines Agency (EMA) starts the voluntary use of its Scientific and Regulatory Evaluation Procedure Support (S-REPS) for Orphan Drug Designation applications. From September 15th onwards, S-REPS will become mandatory for these applications, replacing the current PDF and Word form-based submission.
Application through S-REPS
S-REPS is a cloud-based end-to-end submission system. It is important to timely arrange for submission through this platform. Companies applying through S-REPS need to establish a User Account and Access Management. They should pre-register themselves through the organisations management services (OMS) in the substance, product, organisation and referential (SPOR) web-portal. In addition, their substance should be pre-registered via the EU Telematics Controlled Terms (EUTCT) list. Finally, the company needs to request a Research Product Identifier before they can draft and submit applications. To support applicants in this new process, EMA currently develops a guidebook and training videos.
S-REPS extension to PRIME and Business Pipeline Meetings
Although June 15th marks the launch of S-REPS for Orphan Drug Designations applications, EMA acknowledges that this project is the first step in the EMA’s wider digital transformation strategy. Therefore, over time, S-REPS use may be extended to other scientific regulatory processes. The next procedures in line are PRIME and Business Pipeline Meetings.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-05 12:10:542018-06-05 13:32:33EMA’s digital transformation: new Orphan Drug Designation application system← #nieuws
Een compleet ‘geel boekje’ als toegangsbewijs voor kinder- en naschoolse opvang, daar pleiten universitair docent rechtsfilosofie Roland Pierik en hoogleraar filosofie Marcel Verweij in de Volkskrant voor. Net als HollandBIO maken beide heren zich zorgen over de dalende vaccinatiegraad: “Zolang de trend van de langzaam maar zeker afnemende vaccinatiegraad niet wordt gekeerd, is het niet de vraag of mazelen ergens in Nederland gaat uitbreken, maar wanneer en waar.”
Elders in Europa zijn de eerste mazelenuitbraken al een feit. Italië, Griekenland, Frankrijk en Roemenië hebben het zelfs zwaar te verduren, zo bracht het NOS recent naar buiten. EU-wijd zijn in 2017 bijna 15 000 gevallen en 56 doden gemeld. En dat terwijl deze ziekte met een prikje te voorkomen is.
Het is daarom hoog tijd voor actie. Pierik en Verweij roepen op tot indirect overheidsingrijpen. Geen vaccinatie? Dan ook geen toegang tot kinder- en naschoolse opvang. Als de overheid deze maatregel invoert, neemt zij haar verantwoordelijkheid om kinderen, burgers en de samenleving tegen ernstige infectieziekten te beschermen. HollandBIO is erg benieuwd of de overheid gehoor geeft aan deze oproep, ook nu verschillende D66-Kamerleden hier vragen over stellen. Elke stap die bijdraagt aan een heldere visie op de bestrijding van infectieziekten is welkom.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-05 11:42:192023-09-27 16:32:23Leestip(s) – Kinder- of naschoolse opvang: mag ik je vaccinatieboekje even zien?← #nieuws
De Nederlandse hop sterft uit. Dit tot groot verdriet van de lokale bierbrouwers. Daarom zijn twee ambachtelijke brouwers samen met Hogeschool Inholland en Wageningen University, een project gestart om de sterke eigenschappen en authentieke smaak van de oude hop rassen weer in de huidige rassen te zetten. De onderzoekers ontleden eerst de genetische en chemisch samenstelling van de oude rassen. Deze kennis gebruiken ze vervolgens om weer authentieke Nederlandse hop variëteiten te maken. Haast is geboden, dus zullen de modernste veredelingsmethoden hierbij worden ingezet. HollandBIO juicht deze ambachtelijke en moderne kruisbestuiving toe en kan niet wachten om het eerste biertje te proeven!
Lees het hele originele artikel hier (alleen voor abonnees van het Parool).
The European Infrastructure for Translational Medicine (EATRIS) has formed a collaboration with GlaxoSmithKline (GSK) to deliver a clinical and scientific expert network for the development and application of innovative imaging methods for inflammatory diseases.
While existing clinical imaging tools provide useful endpoints in clinical trials, they typically lack sufficient cellular and molecular information to fully understand drug response. Imaging has the potential to interrogate inflammatory cell populations, quantitatively in different tissues. This alliance aims to unlock this potential by delivering new clinical tools. Applying imaging in information-rich, small cohort studies can provide a high, immediate impact to enhance R&D productivity: developing our understanding of disease in the patient; enriching clinical trial cohorts; measuring therapeutic response.
The imaging hub aims to achieve these goals by (1) optimising existing magnetic resonance imaging (MRI) and positron emission tomography (PET) technology for drug development; and (2) translating emerging PET and optical cell-specific probes towards the clinic. The first three projects with a focus around immune cell specific imaging have now been initiated.
The initiative creates a scientific bridge between GSK’s clinical imaging scientists and five leading European imaging and experimental medicine research institutes within the EATRIS network: Academic Medical Center Amsterdam, Radboud University Medical Center Nijmegen, University Medical Center Groningen, VU University Medical Center Amsterdam from the Netherlands, and Uppsala University and Uppsala University Hospital from Sweden. To enable experts in the alliance to fully focus on the scientific and technical challenges, EATRIS acts as portfolio manager, playing a key role in developing and administering the legal framework and operations, for optimal speed and efficiency. EATRIS will facilitate initiation of both independent and collaborative transnational projects under a master framework, with up-front auditing and quality agreements.
Anton Ussi, operations and finance director of EATRIS comments; “In Europe, EATRIS is in a unique position to construct bespoke international research collaborations from concept to execution of contracts. We are very excited about this novel collaboration format, combining GSK’s wealth of knowledge around drug development with the clinical and technical expertise from EATRIS institutions having highly specialised molecular imaging and experimental medicine capacity, all supported with dedicated coordination staff within the EATRIS central support office.”
On May 15th, MinacNed, hDMT and HollandBIO jointly organized the network meeting “Accelerating drug development using organ- & lab-on-a-chip technology”, mingling entrepreneurs with a background in biology and engineering. After three keynotes, two pitches and networking, the meeting’s take-home message was crystal clear: the fast-emerging field of organ- and lab-on-a-chip is of great value to improve the drug development trajectory, benefitting patients and society alike.
The meeting’s first keynote was brought by Claudia Beaurivage, who works as an associate scientist at Galapagos. The clinical-stage company has a growing pipeline, including its lead product filgotinib. Claudia’s research project aims to discover and validate new drug targets for Inflammatory Bowel Disease using 2D and 3D models like organoids and transwell systems. She established a microfluidic model using primary human material, offering several opportunities for readouts and generating lots of data per experiment. Although organ-on-a-chip technology can’t mimic a full human body (yet), it holds plenty of advantages compared to other models, both in vivo and in vitro. In addition, the application of the technology is not limited to the drug discovery process, but includes preclinical studies too.
Arie Reijerkerk, lead scientist at Ncardia, was the meeting’s second keynote speaker. Arie stressed the high-cost and high-risk nature of drug development. The lack of predictive preclinical models for efficacy and safety testing is one of the reasons for the low success rates. Based on human-induced pluripotent stem cells (hiPSCs), Ncardia offers a predictive and translational in vitro model, plus assays for efficacy screening. With the technology, virtually any human cell type can be generated from hiPSCs, resulting in a perfect model for efficacy screening studies. The company’s portfolio is most advanced in manufacturing beating cardiomyocytes. Common side effects of drugs in the cardiovascular space are caused by problems in ion-channels. Ncardia’s in vitro model is able to predict and study these types of side effects, resulting in an improved and faster way of drug development.
Last but not least, keynote Paul Vulto explained why Mimetas’ human tissue models contribute to better therapies. Mimetas brought cell culturing and microfluidic assays to a next level, resulting in the introduction of the company’s range of OrganoPlate-based models. Using 3D-imaging techniques, the plates enable the analysis of both healthy and diseased phenotypes. Mimetas already collaborates with big pharma and biotechs around the world, but Paul’s ultimate dream is that the OrganoPlate is used by every single lab in the world.
In addition to the keynote presentations, the program included two technology pitches, by LioniX International, a global provider of customized, integrated photonic-based, microsystem solutions and by Bronkhorst, leader in low flow fluidics handling technology.
The inspiring afternoon made it crystal clear: organ- and lab-on-a-chip technology will accelerate the development of medicines, leading to better, safer and more cost-effective medicines. While enjoying a cold drink, the attendees engaged in animated discussions. A fruitful first encounter of entrepreneurs in biotech and engineering.
Binnen het programma Translationeel Onderzoek (PTO2) zijn 2 subsidie oproepen geopend. Indienen van een projectidee kan voor ‘Bench to bedside’ projecten en Multidisciplinaire consortia.
Het doel van het programma is het versnellen van de overgang van preklinisch naar vroeg-klinisch onderzoek in de mens. Dit moeten ervoor zorgen dat kennis uit wetenschappelijk onderzoek eerder leidt tot concrete verbeteringen voor patiënten en verlaging van de ziektekosten. Beide oproepen richten zich dan ook op veiligheid en effectiviteit van nieuwe technologieën, behandelingen en medische producten die in het laboratorium zijn ontwikkeld tot de eerste toepassing bij de patiënt. Daarnaast kunnen er doorlopend aanvragen ingediend worden voor netwerksubsidies.
Bench to bedside
Bij de bench to bedside aanvragen werkt ZonMw samen met de topsector LSH en de Samenwerkende Gezondheidsfondsen (SGF). Er worden subsidies toegekend vanuit ZonMw en vanuit de topsector LSH via het uitvoerend bureau Health~Holland. In beide gevallen worden middelen vanuit de participerende gezondheidsfondsen toegevoegd. Door de krachten te bundelen kunnen beschikbare middelen efficiënter worden ingezet en kansrijke onderzoeken makkelijker de praktijk bereiken.
Budget
De financieringsgrootte is afhankelijk van de bijdrage van de deelnemende fondsen, hierdoor is het maximale subsidiebudget per project verschillend per fonds. Het minimaal aan te vragen subsidiebudget is € 300.000,-. De maximale looptijd van de projecten is 4 jaar.
Multidisciplinaire consortia
Onderzoek wordt in toenemende mate in samenwerkingsverbanden en multidisciplinair verricht. Dit levert nieuwe inzichten en innovaties op die anders niet of minder snel tot stand zouden komen. De onderzoeksvoorstellen dienen gericht te zijn op het uitwerken van een idee met een ‘proof-of-concept’, naar een klinische ‘proof-of-concept’ studie. De projecten worden ingediend en uitgevoerd door multidisciplinaire consortia en worden alleen door ZonMw gefinancierd. Binnen deze ronde is cofinanciering door bedrijven gewenst waar mogelijk en zinvol.
Budget
Het maximale budget dat per project aangevraagd kan worden is € 1.500.000,- voor een periode van maxima 6 jaar. Er kunnen in deze ronde minimaal 4 projecten worden gefinancierd.
Deadline indienen projectidee
Voor beide oproepen geldt dat de deadline voor het indienen van het projectidee 27 september 2018 is.
Netwerksubsidies
Binnen het programma is tevens een doorlopende subsidie beschikbaar gesteld om netwerkvorming te bevorderen, onderzoek en innovaties te stimuleren, (technologische) kennis met betrekking op translationeel onderzoek te vergroten en participatie van jonge onderzoekers te bevorderen. Aanvragen voor subsidies kunnen in 4 categorieën worden gedaan: een reisbeurs, geld voor een workshop/symposium, een communicatie voucher of een participatie voucher.
BiosparQ, has secured 3.4 million EUR in financing from the Dutch government. This funding comes in the form of an innovation credit, a loan from the government for innovation projects. BiosparQ. will be using this funding to accelerate the development, validation and certification of the DigiTOF platform for to the clinical market.
DigiTOF
BiosparQ is based in Leiden and develops DigiTOF, an in vitro diagnostics solution for rapid diagnostics. DigiTOF is based on MALDI-TOF Mass spectrometry applied on single bacteria isolated directly from patient material. Ease of use, turnaround time of less than 20 minutes and a low cost per test will ensure a large variety of applications. “From the start we knew that the DigiTOF has the potential to bridge the gap in clinical diagnostics between patient and treatment. Now that we have obtained the support from the Dutch government and the positive feedback from the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), we are certain that DigiTOF is the way forward. We would like to thank everyone that made it possible for BiosparQ to grow and develop into the company it is today and we look forward to working with you to realize the potential that is the DigiTOF” Gerold de Valk, CEO.
Sanofi, een wereldwijde leider op het gebied van gezondheidszorg, gaat in Nederland al zijn activiteiten en medewerkers huisvesten op één locatie in Amsterdam. Per november zullen ca. 200 medewerkers van Sanofi Gouda en 300 collega’s van de Nederlandse vestiging en het Europese hoofdkantoor van Sanofi Genzyme in Naarden hun intrek nemen in het Amsterdam Health & Technology Center (AHTC).
Amsterdam Health & Technology Center nieuwe thuisbasis Sanofi
Het nieuwe kantoor wordt de thuisbasis voor medewerkers met meer dan 20 nationaliteiten. De keuze voor het AHTC is gemaakt vanwege het creatieve en internationale karakter van Amsterdam. Dit sluit naadloos aan bij Sanofi als internationale ontwikkelaar van nieuwe geneesmiddelen en vaccins. Het AHTC ligt tegenover het Academisch Medisch Centrum (AMC) in Amsterdam-Zuidoost.
“Dat Sanofi straks letterlijk naast een plek zit waar mensen naar toe gaan voor gezondheidszorg past bij het karakter van ons bedrijf als partner in zorg voor gezondheid. Dat karakter blijkt ook uit onze investeringen in de ontwikkeling van nieuwe vaccins en geneesmiddelen. In de hoofdstad, tevens gastheer van het te vestigen European Medicines Agency (EMA), verwacht ik dat onze 500 medewerkers zich snel thuis zullen voelen”, aldus Bert de Jong, Country Chair Sanofi Nederland.
Breed scala aan zorgactiviteiten
Sanofi concentreert een breed scala aan Nederlandse activiteiten in Amsterdam: klinische ontwikkeling, registratie en activiteiten verbonden aan vaccins, zelfzorggeneesmiddelen en de therapeutische gebieden waarin Sanofi zorgoplossingen aanbiedt, zoals diabetes, cardiovasculair, zeldzame ziekten, multiple sclerose, oncologie en immunologie.
Europees hoofdkantoor Sanofi Genzyme
Met de verhuizing zal ook het Europese hoofdkantoor van Sanofi Genzyme, de Specialty Care business unit van Sanofi, gevestigd zijn in het Amsterdam Health & Technology Center. De nieuwe locatie ligt centraal en is gemakkelijk bereikbaar – ook voor buitenlandse bezoekers.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-31 13:41:042018-06-05 13:44:12Sanofi vestigt zich in Amsterdam
Speeding Drug Development with Clinical Trials in a Dish
GezondheidThe average time to bring a new drug to market is 12 years—assuming it makes it through the rigorous regulatory hurdles. Any technology or methodology that can expedite the drug development process or increase the likelihood of FDA approval is advantageous to both companies and patients. Now, a new study from investigators at Coyne Scientific provides a unique look at a novel strategy—clinical trials in a dish (CTiD)—that bridges preclinical testing and clinical trials. Findings from the new study were published recently in SLAS Discovery, in an article entitled “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.”
“The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development,” the authors wrote. “Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs.”
This new CTiD platform allows pharmaceutical companies to test, at the population level, novel drugs on patient cells before moving into actual clinical trials. Because current preclinical strategies don’t follow this principle, CTiD offers the potential to impact drug discovery and development significantly.
Recent demonstrations have shown various human induced pluripotent stem cell-derived (hiPSCs) cell types (cardiac, neuronal, hepatic) recapitulate a specific individual’s drug response (rather than that of a generic human being) and have opened new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population.
“The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population,” the authors penned. The researchers continued, stating that CTiD “allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition.”
The concept of CTiD is to satisfy, in an in vitro setting, the defining biological truth that establishes the need for a multipatient clinical trial, which is that drug responses vary by human. CTiD studies are efficient, allow the study of a range of clinical doses, and can be executed at a fraction of the cost outside of the rigid and heavily regulated clinical testing environment.
CTiD studies are poised to revolutionize thinking about practical, immediate, and near-term applications in the field of drug discovery and development. CTiD can lead to insights that cannot be obtained so early and economically in drug development by any other approach. Although still requiring improvements and enhancements, CTiD offers to refine the selection of drugs to move into clinical development, leading to reduced attrition and enabling safe drugs that address unmet medical needs to reach patients more quickly.
Source: GEN
Glycostem and MolMed collaborate on allogenic CAR-NK therapies
Gezondheid, InnovatieklimaatGlycostem and MolMed signed a binding term sheet for the development and manufacturing of new NK cells–based allogeneic CAR (Chimeric Antigen Receptors). The Master Agreement will be finalized by September 30th, 2018.
According to the agreement, Glycostem and MolMed will collaborate on an exclusive base in developing and manufacturing engineered NK cells targeted to three tumor antigens: Glycostem will be responsible for the final product GMP manufacturing and release, while MolMed will have exclusive rights for the exploitation of the resulting products and Glycostem will receive upfront payments, milestones and royalties on the developed products.
Troels Jordansen, Glycostem CEO, commented: “We are very proud to be teaming up with one of the most innovative cellular therapy companies around and jointly develop mold-breaking products for the help of doctors and patients. The synergy between MolMed and Glycostem is tangible and we are confident it could lead to exciting results in the short term. This is also the initiation of Glycostem’s in-house development program in our new state-of-the-art facility in the Netherlands. It is out of the same facility that we expect to have GMP approval for our closed-system production system by the end of 2018. This will allow us to expand our clinical trial program and enter pivotal for oNKord early 2019.”
Source: PivotPark
EMA’s digital transformation: new Orphan Drug Designation application system
Hollandbio, GezondheidAs of June 15th, the European Medicines Agency (EMA) starts the voluntary use of its Scientific and Regulatory Evaluation Procedure Support (S-REPS) for Orphan Drug Designation applications. From September 15th onwards, S-REPS will become mandatory for these applications, replacing the current PDF and Word form-based submission.
Application through S-REPS
S-REPS is a cloud-based end-to-end submission system. It is important to timely arrange for submission through this platform. Companies applying through S-REPS need to establish a User Account and Access Management. They should pre-register themselves through the organisations management services (OMS) in the substance, product, organisation and referential (SPOR) web-portal. In addition, their substance should be pre-registered via the EU Telematics Controlled Terms (EUTCT) list. Finally, the company needs to request a Research Product Identifier before they can draft and submit applications. To support applicants in this new process, EMA currently develops a guidebook and training videos.
S-REPS extension to PRIME and Business Pipeline Meetings
Although June 15th marks the launch of S-REPS for Orphan Drug Designations applications, EMA acknowledges that this project is the first step in the EMA’s wider digital transformation strategy. Therefore, over time, S-REPS use may be extended to other scientific regulatory processes. The next procedures in line are PRIME and Business Pipeline Meetings.
Leestip(s) – Kinder- of naschoolse opvang: mag ik je vaccinatieboekje even zien?
Gezondheid op maat, Hollandbio, GezondheidEen compleet ‘geel boekje’ als toegangsbewijs voor kinder- en naschoolse opvang, daar pleiten universitair docent rechtsfilosofie Roland Pierik en hoogleraar filosofie Marcel Verweij in de Volkskrant voor. Net als HollandBIO maken beide heren zich zorgen over de dalende vaccinatiegraad: “Zolang de trend van de langzaam maar zeker afnemende vaccinatiegraad niet wordt gekeerd, is het niet de vraag of mazelen ergens in Nederland gaat uitbreken, maar wanneer en waar.”
Elders in Europa zijn de eerste mazelenuitbraken al een feit. Italië, Griekenland, Frankrijk en Roemenië hebben het zelfs zwaar te verduren, zo bracht het NOS recent naar buiten. EU-wijd zijn in 2017 bijna 15 000 gevallen en 56 doden gemeld. En dat terwijl deze ziekte met een prikje te voorkomen is.
Het is daarom hoog tijd voor actie. Pierik en Verweij roepen op tot indirect overheidsingrijpen. Geen vaccinatie? Dan ook geen toegang tot kinder- en naschoolse opvang. Als de overheid deze maatregel invoert, neemt zij haar verantwoordelijkheid om kinderen, burgers en de samenleving tegen ernstige infectieziekten te beschermen. HollandBIO is erg benieuwd of de overheid gehoor geeft aan deze oproep, ook nu verschillende D66-Kamerleden hier vragen over stellen. Elke stap die bijdraagt aan een heldere visie op de bestrijding van infectieziekten is welkom.
Lees ook het opinieartikel in de Volkskrant en het achtergrondartikel van de NOS. De Kamervragen van D66 zijn hier in te zien.
Ambachtelijke bierbrouwers veredelen modern
Voedsel en materialenDe Nederlandse hop sterft uit. Dit tot groot verdriet van de lokale bierbrouwers. Daarom zijn twee ambachtelijke brouwers samen met Hogeschool Inholland en Wageningen University, een project gestart om de sterke eigenschappen en authentieke smaak van de oude hop rassen weer in de huidige rassen te zetten. De onderzoekers ontleden eerst de genetische en chemisch samenstelling van de oude rassen. Deze kennis gebruiken ze vervolgens om weer authentieke Nederlandse hop variëteiten te maken. Haast is geboden, dus zullen de modernste veredelingsmethoden hierbij worden ingezet. HollandBIO juicht deze ambachtelijke en moderne kruisbestuiving toe en kan niet wachten om het eerste biertje te proeven!
Lees het hele originele artikel hier (alleen voor abonnees van het Parool).
Novel Public-Private collaboration for imaging method development
InnovatieklimaatThe European Infrastructure for Translational Medicine (EATRIS) has formed a collaboration with GlaxoSmithKline (GSK) to deliver a clinical and scientific expert network for the development and application of innovative imaging methods for inflammatory diseases.
While existing clinical imaging tools provide useful endpoints in clinical trials, they typically lack sufficient cellular and molecular information to fully understand drug response. Imaging has the potential to interrogate inflammatory cell populations, quantitatively in different tissues. This alliance aims to unlock this potential by delivering new clinical tools. Applying imaging in information-rich, small cohort studies can provide a high, immediate impact to enhance R&D productivity: developing our understanding of disease in the patient; enriching clinical trial cohorts; measuring therapeutic response.
The imaging hub aims to achieve these goals by (1) optimising existing magnetic resonance imaging (MRI) and positron emission tomography (PET) technology for drug development; and (2) translating emerging PET and optical cell-specific probes towards the clinic. The first three projects with a focus around immune cell specific imaging have now been initiated.
The initiative creates a scientific bridge between GSK’s clinical imaging scientists and five leading European imaging and experimental medicine research institutes within the EATRIS network: Academic Medical Center Amsterdam, Radboud University Medical Center Nijmegen, University Medical Center Groningen, VU University Medical Center Amsterdam from the Netherlands, and Uppsala University and Uppsala University Hospital from Sweden. To enable experts in the alliance to fully focus on the scientific and technical challenges, EATRIS acts as portfolio manager, playing a key role in developing and administering the legal framework and operations, for optimal speed and efficiency. EATRIS will facilitate initiation of both independent and collaborative transnational projects under a master framework, with up-front auditing and quality agreements.
Anton Ussi, operations and finance director of EATRIS comments; “In Europe, EATRIS is in a unique position to construct bespoke international research collaborations from concept to execution of contracts. We are very excited about this novel collaboration format, combining GSK’s wealth of knowledge around drug development with the clinical and technical expertise from EATRIS institutions having highly specialised molecular imaging and experimental medicine capacity, all supported with dedicated coordination staff within the EATRIS central support office.”
Bright future ahead for organ- and lab-on-chip technology
HollandbioOn May 15th, MinacNed, hDMT and HollandBIO jointly organized the network meeting “Accelerating drug development using organ- & lab-on-a-chip technology”, mingling entrepreneurs with a background in biology and engineering. After three keynotes, two pitches and networking, the meeting’s take-home message was crystal clear: the fast-emerging field of organ- and lab-on-a-chip is of great value to improve the drug development trajectory, benefitting patients and society alike.
The meeting’s first keynote was brought by Claudia Beaurivage, who works as an associate scientist at Galapagos. The clinical-stage company has a growing pipeline, including its lead product filgotinib. Claudia’s research project aims to discover and validate new drug targets for Inflammatory Bowel Disease using 2D and 3D models like organoids and transwell systems. She established a microfluidic model using primary human material, offering several opportunities for readouts and generating lots of data per experiment. Although organ-on-a-chip technology can’t mimic a full human body (yet), it holds plenty of advantages compared to other models, both in vivo and in vitro. In addition, the application of the technology is not limited to the drug discovery process, but includes preclinical studies too.
Arie Reijerkerk, lead scientist at Ncardia, was the meeting’s second keynote speaker. Arie stressed the high-cost and high-risk nature of drug development. The lack of predictive preclinical models for efficacy and safety testing is one of the reasons for the low success rates. Based on human-induced pluripotent stem cells (hiPSCs), Ncardia offers a predictive and translational in vitro model, plus assays for efficacy screening. With the technology, virtually any human cell type can be generated from hiPSCs, resulting in a perfect model for efficacy screening studies. The company’s portfolio is most advanced in manufacturing beating cardiomyocytes. Common side effects of drugs in the cardiovascular space are caused by problems in ion-channels. Ncardia’s in vitro model is able to predict and study these types of side effects, resulting in an improved and faster way of drug development.
Last but not least, keynote Paul Vulto explained why Mimetas’ human tissue models contribute to better therapies. Mimetas brought cell culturing and microfluidic assays to a next level, resulting in the introduction of the company’s range of OrganoPlate-based models. Using 3D-imaging techniques, the plates enable the analysis of both healthy and diseased phenotypes. Mimetas already collaborates with big pharma and biotechs around the world, but Paul’s ultimate dream is that the OrganoPlate is used by every single lab in the world.
In addition to the keynote presentations, the program included two technology pitches, by LioniX International, a global provider of customized, integrated photonic-based, microsystem solutions and by Bronkhorst, leader in low flow fluidics handling technology.
The inspiring afternoon made it crystal clear: organ- and lab-on-a-chip technology will accelerate the development of medicines, leading to better, safer and more cost-effective medicines. While enjoying a cold drink, the attendees engaged in animated discussions. A fruitful first encounter of entrepreneurs in biotech and engineering.
Subsidierondes Translationeel onderzoek geopend voor indiening
InnovatieklimaatBinnen het programma Translationeel Onderzoek (PTO2) zijn 2 subsidie oproepen geopend. Indienen van een projectidee kan voor ‘Bench to bedside’ projecten en Multidisciplinaire consortia.
Het doel van het programma is het versnellen van de overgang van preklinisch naar vroeg-klinisch onderzoek in de mens. Dit moeten ervoor zorgen dat kennis uit wetenschappelijk onderzoek eerder leidt tot concrete verbeteringen voor patiënten en verlaging van de ziektekosten. Beide oproepen richten zich dan ook op veiligheid en effectiviteit van nieuwe technologieën, behandelingen en medische producten die in het laboratorium zijn ontwikkeld tot de eerste toepassing bij de patiënt. Daarnaast kunnen er doorlopend aanvragen ingediend worden voor netwerksubsidies.
Bench to bedside
Bij de bench to bedside aanvragen werkt ZonMw samen met de topsector LSH en de Samenwerkende Gezondheidsfondsen (SGF). Er worden subsidies toegekend vanuit ZonMw en vanuit de topsector LSH via het uitvoerend bureau Health~Holland. In beide gevallen worden middelen vanuit de participerende gezondheidsfondsen toegevoegd. Door de krachten te bundelen kunnen beschikbare middelen efficiënter worden ingezet en kansrijke onderzoeken makkelijker de praktijk bereiken.
Budget
De financieringsgrootte is afhankelijk van de bijdrage van de deelnemende fondsen, hierdoor is het maximale subsidiebudget per project verschillend per fonds. Het minimaal aan te vragen subsidiebudget is € 300.000,-. De maximale looptijd van de projecten is 4 jaar.
Multidisciplinaire consortia
Onderzoek wordt in toenemende mate in samenwerkingsverbanden en multidisciplinair verricht. Dit levert nieuwe inzichten en innovaties op die anders niet of minder snel tot stand zouden komen. De onderzoeksvoorstellen dienen gericht te zijn op het uitwerken van een idee met een ‘proof-of-concept’, naar een klinische ‘proof-of-concept’ studie. De projecten worden ingediend en uitgevoerd door multidisciplinaire consortia en worden alleen door ZonMw gefinancierd. Binnen deze ronde is cofinanciering door bedrijven gewenst waar mogelijk en zinvol.
Budget
Het maximale budget dat per project aangevraagd kan worden is € 1.500.000,- voor een periode van maxima 6 jaar. Er kunnen in deze ronde minimaal 4 projecten worden gefinancierd.
Deadline indienen projectidee
Voor beide oproepen geldt dat de deadline voor het indienen van het projectidee 27 september 2018 is.
Netwerksubsidies
Binnen het programma is tevens een doorlopende subsidie beschikbaar gesteld om netwerkvorming te bevorderen, onderzoek en innovaties te stimuleren, (technologische) kennis met betrekking op translationeel onderzoek te vergroten en participatie van jonge onderzoekers te bevorderen. Aanvragen voor subsidies kunnen in 4 categorieën worden gedaan: een reisbeurs, geld voor een workshop/symposium, een communicatie voucher of een participatie voucher.
Meer informatie
Kijk voor de gehele oproep op:
• Subsidieoproep PTO2 Bench to bedside projecten 2018
• Subsidieoproep PTO2 Multidisciplinaire consortia 2018
• Netwerksubsidies
• ZonMw thema Translationeel onderzoek
Bron: ZonMw
BiosparQ secures 3.4 million EUR
InnovatieklimaatBiosparQ, has secured 3.4 million EUR in financing from the Dutch government. This funding comes in the form of an innovation credit, a loan from the government for innovation projects. BiosparQ. will be using this funding to accelerate the development, validation and certification of the DigiTOF platform for to the clinical market.
DigiTOF
BiosparQ is based in Leiden and develops DigiTOF, an in vitro diagnostics solution for rapid diagnostics. DigiTOF is based on MALDI-TOF Mass spectrometry applied on single bacteria isolated directly from patient material. Ease of use, turnaround time of less than 20 minutes and a low cost per test will ensure a large variety of applications. “From the start we knew that the DigiTOF has the potential to bridge the gap in clinical diagnostics between patient and treatment. Now that we have obtained the support from the Dutch government and the positive feedback from the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), we are certain that DigiTOF is the way forward. We would like to thank everyone that made it possible for BiosparQ to grow and develop into the company it is today and we look forward to working with you to realize the potential that is the DigiTOF” Gerold de Valk, CEO.
Source: BiosparQ
Sanofi vestigt zich in Amsterdam
InnovatieklimaatSanofi, een wereldwijde leider op het gebied van gezondheidszorg, gaat in Nederland al zijn activiteiten en medewerkers huisvesten op één locatie in Amsterdam. Per november zullen ca. 200 medewerkers van Sanofi Gouda en 300 collega’s van de Nederlandse vestiging en het Europese hoofdkantoor van Sanofi Genzyme in Naarden hun intrek nemen in het Amsterdam Health & Technology Center (AHTC).
Amsterdam Health & Technology Center nieuwe thuisbasis Sanofi
Het nieuwe kantoor wordt de thuisbasis voor medewerkers met meer dan 20 nationaliteiten. De keuze voor het AHTC is gemaakt vanwege het creatieve en internationale karakter van Amsterdam. Dit sluit naadloos aan bij Sanofi als internationale ontwikkelaar van nieuwe geneesmiddelen en vaccins. Het AHTC ligt tegenover het Academisch Medisch Centrum (AMC) in Amsterdam-Zuidoost.
“Dat Sanofi straks letterlijk naast een plek zit waar mensen naar toe gaan voor gezondheidszorg past bij het karakter van ons bedrijf als partner in zorg voor gezondheid. Dat karakter blijkt ook uit onze investeringen in de ontwikkeling van nieuwe vaccins en geneesmiddelen. In de hoofdstad, tevens gastheer van het te vestigen European Medicines Agency (EMA), verwacht ik dat onze 500 medewerkers zich snel thuis zullen voelen”, aldus Bert de Jong, Country Chair Sanofi Nederland.
Breed scala aan zorgactiviteiten
Sanofi concentreert een breed scala aan Nederlandse activiteiten in Amsterdam: klinische ontwikkeling, registratie en activiteiten verbonden aan vaccins, zelfzorggeneesmiddelen en de therapeutische gebieden waarin Sanofi zorgoplossingen aanbiedt, zoals diabetes, cardiovasculair, zeldzame ziekten, multiple sclerose, oncologie en immunologie.
Europees hoofdkantoor Sanofi Genzyme
Met de verhuizing zal ook het Europese hoofdkantoor van Sanofi Genzyme, de Specialty Care business unit van Sanofi, gevestigd zijn in het Amsterdam Health & Technology Center. De nieuwe locatie ligt centraal en is gemakkelijk bereikbaar – ook voor buitenlandse bezoekers.
Bron: MedicalFacts