Recently, the EU-sponsored Vaccines and InfecTious diseases in the Ageing popuLation (VITAL) project was launched. VITAL will address – in a public-private consortium – the challenges of infections in the elderly and the potential of infection prevention by vaccination.
Within the VITALproject, which will run from 2019-2023, University Medical Center (UMC) Utrecht will be the managing entity and scientific lead. The € 12.4 million project is sponsored by the European Union’s Innovative Medicines Initiative (IMI) with a grant of € 5.5 million which will be matched by grants in total of € 6.9 million from the European Federation of Pharmaceutical Industries Associations (EFPIA). The consortium academic leader is prof. dr. Debbie van Baarle, professor of Immunology of Vaccinations at UMC Utrecht and Head of the Department of Immune Mechanisms at the Centre for Immunology of Infectious Diseases and Vaccines at the National Institute of Health and the Environment (RIVM) in the Netherlands.
Multidisciplinary approach
Through a multidisciplinary public-private approach, VITAL will generate health, economic and societal benefits by mapping the disease burden of infectious diseases to be prevented by vaccines, Investigate immunity to infections and vaccinations in the aging population, calculate the clinical and economic consequences of possible vaccination strategies in different age and risk groups, and develop teaching tools for stakeholders.
The program is in line with recent recommendations from the European Council to strengthen cooperation against vaccine-preventable diseases by working on cross-border vaccination programs and develop research and development studies for better understanding the benefit of life-long vaccination impact[1].
Debbie van Baarle explains: “An aging immune system is known to cause increased infection rates in elderly people. Prevention of infectious diseases in the elderly through vaccination is a requirement to promote healthy ageing in this growing population. Our main challenge, in close collaboration with our EFPIA partners, is to overcome the reduced immune responsiveness of this age group by improving the efficacy of vaccines and to identify new vaccination strategies to protect elderly people from infectious diseases.”
Burden of infectious diseases
Due to demographic developments, the population of elderly increases in size every year. Older people are more vulnerable to infectious diseases because their immune system becomes weaker with increasing age. As a consequence, an increasing burden of infections in the elderly is observed. Avoiding such infections by vaccination should delay, reduce, or avoid the exposure to institutionalized health care. In order to achieve optimal vaccination strategies for elderly or better protect elderly against infectious diseases, better insights are needed on how the overall process of ageing, exposure to infection, and immune response to vaccination, is developing and evolving.
Public-private Partnership
The partners in the international VITAL project include 7 academic research groups, 7 public health institutes, 3 private consultancy partners and 7 pharmaceutical industries with long-standing experience in epidemiology, health economy, clinical trials, immunology and public health.
Project details
Name: VITAL – Vaccines and InfecTious diseases in the Ageing popuLation
Start date: January 1, 2019
Duration: 60 months
Budget: €12.4mio
Coordination: University Medical Center (UMC) Utrecht
VITAL partners
Academic research groups: University Medical Center Utrecht (the Netherlands), University Medical Center Groningen (the Netherlands), University of Innsbruck (Austria), Imperial College London (United Kingdom), University College London (United Kingdom), University of Ferrara (Italy), University Jean Monnet (France)
Public health institutes: National Institute for Public Health and the Environment (the Netherlands), Norwegian Institute for Public Health (Norway), INSERM: French National Institute of Health and Medical Research (France), Statens Serum Institute (Denmark), Centre National de la Recherche Scientifique (France), Instituto Superiore di Sanita (Italy), FISABIO: Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica de la Comunitat Valencian (Spain)
Private partners: P95 (Belgium), Syreon Health Institute (Hungary), Mihailovic Health Analytics (Serbia), Glaxo SmithKline Biologicals (Belgium), Pfizer (United Kingdom), Sanofi Pasteur (France), Merck Sharp & Dohme, (USA), Janssen Vaccines & Prevention (the Netherlands), bioMerieux (France), Vaccines Europe/EFPIA.
Ncardia, a leading provider of human iPSC-derived cell-based assays and services for drug discovery and development, announced the launch of their DiscoverHIT drug screening platform. The new service enables researchers to access human disease-relevant biology earlier in the drug discovery process with the goal of bringing better medicines to patients faster. The DiscoverHIT Platform is a phenotypic drug screening platform composed of four integrated modules:
Disease models: Genetic and induced human iPSC-derived cardiac and neural disease models
Large-scale manufacturing: Controlled bioreactor-based manufacturing to enable batch sizes compatible with high-throughput screening (HTS)
Customized assay development: Generation and validation of disease-relevant assays with clinically relevant readouts
High-throughput screening: Robust HTS using qualified disease assays in combination with high content data acquisition and analysis
“Ncardia enables discovery with efficacy in mind from the start. To realize this, drug developers need validated human iPSC products at scale, disease models, the right assay systems and high throughput screening. We’ve brought these components together in the DiscoverHIT platform.” stated Stefan Braam, CEO of Ncardia.
In addition to the four core modules of DiscoverHIT, Ncardia also offers access to a comprehensive compound library, scientific consultation, and the company’s newly founded training center, Ncardia Academy.
SMS-oncology, a full-service contract research organization (CRO) solely dedicated to oncology drug development, today reports a continuous strong company growth in 2018. The growth comprises an increase in both revenue and employment base.
To accommodate future growth, SMS-oncology strengthened its management team by promoting Ms. Eveline Verheijen to Chief Operating Officer (COO) per January 2019. Ms. Verheijen has over thirteen years of experience in the field of oncology clinical operations, and held operational roles at Bayer and GSK before joining SMS-oncology. In her seven years at SMS-oncology, Ms. Verheijen contributed to the development of the company, and helped it become one of the key players in the field of oncology drug development.
Ms. Verheijen is excited to continue to build and implement the strategy of the company in her new position as COO: “The year 2018 was a great year in which we initiated numerous clinical trials, of which many involve the most innovative (immuno-)oncology drugs and advanced therapy medicinal products (ATMPs). Clinical trials with anti-cancer compounds remain the most challenging of its kind. The growth we see in our company, both through new clients as well as repeat business, reflects the need for the oncology expertise we have to offer.”
The Oncology Drug Development Affairs department of SMS-oncology provides the oncology expertise needed to successfully design and conduct oncology trials. The company appointed Ms. Inka Pawlitzky, PhD, as department Director. Dr. Pawlitzky brings over 18 years of oncology and immunology research experience in both academia and industry.
With the growing number of trials and a challenging clinical landscape, SMS-oncology is excited and proud to have initiated a dedicated Patient Inclusion department. The department led by Ms. Wendy Onstenk, MD PhD, will focus on improving recruitment strategies. Before joining SMS-oncology, Dr. Onstenk was Chief Medical Officer (CMO) at Hartwig Medical Foundation.
Ms. Philine van den Tol, Chief Executive Officer (CEO) at SMS-oncology: “Industry research shows that a large group of eligible patients is not included in clinical trials. With our dedicated department, we are keen to overcome barriers hampering optimal patient recruitment and to support clinical investigators in such a way that recruitment of all eligible patients becomes a reality.”
Furthermore, SMS-oncology is spreading its geographical footprint by expanding its local presence in Germany, Spain and the Nordics.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2019-02-01 17:42:352019-02-05 17:45:16SMS-oncology reports strong growth in 2018, appointment of COO and future plans← #nieuws
Charles River and Toxys have entered into an agreement to offer access to ToxTracker® in North America. ToxTracker is a suite of assays that allow rapid carcinogenicity toxicity hazard identification in novel and existing drugs, chemicals, and other substances.
With an extremely high level of sensitivity and specificity, ToxTracker can be used to quickly screen chemicals for genotoxicity. By combining multiple biomarkers, ToxTracker provides mechanistic insight into undesired properties of compounds.
The assay identifies a chemical’s increased cancer risk through both traditional markers, such as DNA damage, and alternative Modes-of-Action, including oxidative stress, protein misfolding, and general cellular stress. For Charles River’s clients, utilization of the ToxTracker assay can help mitigate risk of regulatory rejection by demonstrating the exact mechanism of genotoxicity.
ToxTracker has been extensively validated using reference compound libraries recommended by the United States Environmental Protection Agency’s Toxicity Forecaster (ToxCast) and the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM). Through this validation, ToxTracker has shown a very high sensitivity (94%) and specificity (95%) for the detection of genotoxic compounds.Additionally, ToxTracker’s versatility in identifying unsafe compounds provides applications across the pharmaceutical, agrochemical and consumer product industries.
“We are proud to work with Toxys to expand our portfolio of genetic toxicology assays. By providing our clients with access to the ToxTracker assays, we are improving their ability to deliver safe, effective compounds.” –Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment of Charles River
“When looking for a company to provide ToxTracker to the North American market, Charles River was an easy choice. Their deep industry knowledge and experience, coupled with an already robust portfolio of toxicology services, makes them the ideal partner for our innovative assays. We are excited to work together to bring ToxTracker to a wider audience.” –Giel Hendriks, CEO of Toxys
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2019-01-30 17:13:332019-02-05 17:14:06Charles River and Toxys Enter Agreement to offer ToxTracker® in North America← #nieuws
MSD announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for the prevention of IPD in adults. Both indications are currently being studied in Phase 3 clinical trials.
The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of this Breakthrough Therapy Designation include more intensive guidance from FDA on an efficient drug development program, access to a scientific liaison to help accelerate review time and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
The FDA’s decision was informed in part by immunogenicity data from two studies. Study 005 was a Phase 1/2, multicentre, randomized, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of a new formulation of V114 in healthy adults and infants. Study 008 was a proof of concept, Phase 2, pediatric trial to confirm the results from Study 005 in a larger population of infants. In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines.
“We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine,” said Dr. Nicholas Kartsonis, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories. “The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2019-01-30 07:31:142019-02-06 07:34:57MSD Receives Breakthrough Therapy Designation from FDA for Vaccine← #nieuws
Afgelopen donderdag vierde HollandBIO samen leden en relaties haar eerste lustrum tijdens het Year Event in hartje Amsterdam. Hét leukste event van de Nederlandse biotech sector stond wederom bol van innovatie, inspirerend ondernemerschap en een gezonde dosis humor.
De openingsvideo maakte in een klap duidelijk hoe de life sciences sector vandaag al bijdraagt aan een duurzame en gezonde samenleving, welke innovaties er in het verschiet liggen en de belangrijke rol van HollandBIO om de obstakels weg te ruimen die biotech frontrunners op hun weg van lab naar maatschappij tegenkomen.
De speech van HollandBIO’s Annemiek sloot naadloos aan. Trots blikte zij terug op de eerste vijf jaar HollandBIO, waarin de vereniging vele successen op haar naam mocht schrijven, maar waaruit ook bleek dat er nog veel werk aan de winkel is. En natuurlijk vooruit: ook de komende vijf jaar gaat HollandBIO er weer vol enthousiasme tegenaan om de weg te effenen voor biotech innovaties. Daarbij is de hulp van onze achterban onmisbaar. Annemiek riep de aanwezigen op om toch vooral de spotlight op te zoeken en onze mooie sector smoel te geven: “Be good & tell it!”.
Anant Murthy, van Alnylam Pharmaceuticals, demonstreerde vervolgens hoe je dat doet: je verhaal vertellen. Als koploper in de ontwikkeling van een nieuwe generatie geneesmiddelen gebaseerd op RNA-technologie, legde Alnylam een verbluffende reis vol pieken en dalen af. Na meer dan zestien jaar pionieren, is nu eindelijk hun eerste behandeling binnen bereik van patiënten met polyneuropathie. En die eerste therapie opent de poort naar de toekomst, waarin Alnylam vele levens van patiënten met zeldzame genetische aandoeningen kan gaan verbeteren.
En ook Daan Luining van Meatable, liet zien hoe je Annemieks advies in de praktijk brengt. Een toekomstdroom om – zonder schuldgevoel – van te watertanden: 100% echt en smakelijk vlees zonder dat er ook maar één dier voor heeft moeten lijden. Als CTO bij startup Meatable pioniert Daan aan de frontlinie van de kweekvlees revolutie. Een wereld van ongekende mogelijkheden, waar we bij HollandBIO reikhalzend naar uitkijken.
Als kers op de taart trakteerde Op Sterk Water de aanwezigen op een magistraal staaltje improvisatiecabaret. De feestelijke stemming werd voortgezet tijdens diner en op de dansvloer. Geniet nog even na met de prachtige foto’s van Nils van Houts.
Medische technologie voor het eerder opsporen, monitoren en beter behandelen van hart- en vaatziekten is hard nodig. Technologische innovatie levert een belangrijke bijdrage aan een betere gezondheid. Deze innovaties zorgen voor kosteneffectiviteit en maken een persoonlijkere zorg mogelijk. Een zorg die is toegespitst op de wensen en mogelijkheden van het individu. Daarom investeren de Hartstichting, ZonMw en NWO in ‘Hart voor duurzame zorg’, een gezamenlijke subsidieoproep met een totale omvang van vijf miljoen euro. Heb je een briljant idee voor een nieuwe medische technologie? Of brengt je bestaande experimentele technologie naar de kliniek? Dien dan uiterlijk 9 april een voorstel in.
Het Amerikaanse DuPont gaat zijn in Leiden gevestigde biotechnologie-activiteiten stevig uitbreiden. DuPont sleutelt in Leiden aan door micro-organismen gemaakte enzymen. Die vinden hun weg naar onder meer (vaat-)wasmiddelen, voedingsmiddelen en diervoeding. Het gaat dan bijvoorbeeld om enzymen die wassen op lagere temperaturen mogelijk maken en daarmee helpen om energie te besparen. De groei van deze activiteiten leidt nu tot een nieuwe investering van €30 mln, bestemd voor de opening van een nieuw en groter kantoor in 2020 en een groei van het aantal werknemers van 130 naar ruim 200.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00Hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandbio2019-01-29 18:10:572019-01-29 18:10:57DuPont breidt biotech activiteiten uit in Leiden← #nieuws
DSM gaat een samenwerking aan met zijn Chinese branchegenoot Nenter voor de productie van vitamine E. Het Nederlandse speciaalchemie- en biotechnologiebedrijf wordt voor 75 procent eigenaar van de joint venture, Nenter voor het overige deel. Dat maakte DSM deze week bekend. Daarnaast kondigde het bedrijf een investering van ongeveer 135 miljoen euro aan in het samenwerkingsverband, dat eigenaar wordt van enkele productiefaciliteiten van Nenter in China. Nenter leverde al aan DSM.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00Hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandbio2019-01-29 18:09:042019-01-29 18:09:04DSM gaat samenwerking aan voor vitamine E← #nieuws
Van het telen van bananen in Nederland tot rubber producerende paardenbloemen, met gerichte veredeling is alles mogelijk. Dat is ook hard nodig want de ziekten en plagen die onze gewassen belagen, veranderen voortdurend en ook het weer wordt steeds grilliger. Maar voor gerichte ontwikkeling van de juiste planten is eerst een grondige kennis van die plant nodig. Dagblad Trouw gaf afgelopen week de eer aan KeyGene uit Wageningen om dit proces uit te leggen. Zo analyseren dataspecialisten eerst de genetische achtergrond van de plant en combineren die kennis met die vam de groei- en bloeiwijze onder verschillende weersomstandigheden. Op basis daarvan ontwikkelen de plantenveredelaars via slimme kruisingen nieuwe plantenrassen of variëteiten. Met de nieuwste gene-editing technieken zou dit veel sneller kunnen gaan, maar helaas ziet Europa deze als een vorm van genetische modificatie. Keygene-directeur Arjen van Tunen geeft aan dat daarmee de tijdswinst uit die snellere veredeling niet opweegt tegen het langdurige, onzekere en kostbare toelatingstraject. Ook bij HollandBIO vinden we dit een gemiste kans, want Europa zet zich daarmee buitenspel in het voldoen aan de vraag naar steeds gezondere en duurzaam geteelde groenten en fruit.
VITAL European Project Kicks Off
Gezondheid, InnovatieklimaatRecently, the EU-sponsored Vaccines and InfecTious diseases in the Ageing popuLation (VITAL) project was launched. VITAL will address – in a public-private consortium – the challenges of infections in the elderly and the potential of infection prevention by vaccination.
Within the VITAL project, which will run from 2019-2023, University Medical Center (UMC) Utrecht will be the managing entity and scientific lead. The € 12.4 million project is sponsored by the European Union’s Innovative Medicines Initiative (IMI) with a grant of € 5.5 million which will be matched by grants in total of € 6.9 million from the European Federation of Pharmaceutical Industries Associations (EFPIA). The consortium academic leader is prof. dr. Debbie van Baarle, professor of Immunology of Vaccinations at UMC Utrecht and Head of the Department of Immune Mechanisms at the Centre for Immunology of Infectious Diseases and Vaccines at the National Institute of Health and the Environment (RIVM) in the Netherlands.
Multidisciplinary approach
Through a multidisciplinary public-private approach, VITAL will generate health, economic and societal benefits by mapping the disease burden of infectious diseases to be prevented by vaccines, Investigate immunity to infections and vaccinations in the aging population, calculate the clinical and economic consequences of possible vaccination strategies in different age and risk groups, and develop teaching tools for stakeholders.
The program is in line with recent recommendations from the European Council to strengthen cooperation against vaccine-preventable diseases by working on cross-border vaccination programs and develop research and development studies for better understanding the benefit of life-long vaccination impact[1].
Debbie van Baarle explains: “An aging immune system is known to cause increased infection rates in elderly people. Prevention of infectious diseases in the elderly through vaccination is a requirement to promote healthy ageing in this growing population. Our main challenge, in close collaboration with our EFPIA partners, is to overcome the reduced immune responsiveness of this age group by improving the efficacy of vaccines and to identify new vaccination strategies to protect elderly people from infectious diseases.”
Burden of infectious diseases
Due to demographic developments, the population of elderly increases in size every year. Older people are more vulnerable to infectious diseases because their immune system becomes weaker with increasing age. As a consequence, an increasing burden of infections in the elderly is observed. Avoiding such infections by vaccination should delay, reduce, or avoid the exposure to institutionalized health care. In order to achieve optimal vaccination strategies for elderly or better protect elderly against infectious diseases, better insights are needed on how the overall process of ageing, exposure to infection, and immune response to vaccination, is developing and evolving.
Public-private Partnership
The partners in the international VITAL project include 7 academic research groups, 7 public health institutes, 3 private consultancy partners and 7 pharmaceutical industries with long-standing experience in epidemiology, health economy, clinical trials, immunology and public health.
Project details
Name: VITAL – Vaccines and InfecTious diseases in the Ageing popuLation
Start date: January 1, 2019
Duration: 60 months
Budget: €12.4mio
Coordination: University Medical Center (UMC) Utrecht
VITAL partners
Academic research groups: University Medical Center Utrecht (the Netherlands), University Medical Center Groningen (the Netherlands), University of Innsbruck (Austria), Imperial College London (United Kingdom), University College London (United Kingdom), University of Ferrara (Italy), University Jean Monnet (France)
Public health institutes: National Institute for Public Health and the Environment (the Netherlands), Norwegian Institute for Public Health (Norway), INSERM: French National Institute of Health and Medical Research (France), Statens Serum Institute (Denmark), Centre National de la Recherche Scientifique (France), Instituto Superiore di Sanita (Italy), FISABIO: Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica de la Comunitat Valencian (Spain)
Private partners: P95 (Belgium), Syreon Health Institute (Hungary), Mihailovic Health Analytics (Serbia), Glaxo SmithKline Biologicals (Belgium), Pfizer (United Kingdom), Sanofi Pasteur (France), Merck Sharp & Dohme, (USA), Janssen Vaccines & Prevention (the Netherlands), bioMerieux (France), Vaccines Europe/EFPIA.
Ncardia Launches iPSC-Based Phenotypic Screening Service
Gezondheid, InnovatieklimaatNcardia, a leading provider of human iPSC-derived cell-based assays and services for drug discovery and development, announced the launch of their DiscoverHIT drug screening platform. The new service enables researchers to access human disease-relevant biology earlier in the drug discovery process with the goal of bringing better medicines to patients faster. The DiscoverHIT Platform is a phenotypic drug screening platform composed of four integrated modules:
“Ncardia enables discovery with efficacy in mind from the start. To realize this, drug developers need validated human iPSC products at scale, disease models, the right assay systems and high throughput screening. We’ve brought these components together in the DiscoverHIT platform.” stated Stefan Braam, CEO of Ncardia.
In addition to the four core modules of DiscoverHIT, Ncardia also offers access to a comprehensive compound library, scientific consultation, and the company’s newly founded training center, Ncardia Academy.
Learn more @ DiscoverHIT Platform
Source: Ncardia
SMS-oncology reports strong growth in 2018, appointment of COO and future plans
InnovatieklimaatSMS-oncology, a full-service contract research organization (CRO) solely dedicated to oncology drug development, today reports a continuous strong company growth in 2018. The growth comprises an increase in both revenue and employment base.
To accommodate future growth, SMS-oncology strengthened its management team by promoting Ms. Eveline Verheijen to Chief Operating Officer (COO) per January 2019. Ms. Verheijen has over thirteen years of experience in the field of oncology clinical operations, and held operational roles at Bayer and GSK before joining SMS-oncology. In her seven years at SMS-oncology, Ms. Verheijen contributed to the development of the company, and helped it become one of the key players in the field of oncology drug development.
Ms. Verheijen is excited to continue to build and implement the strategy of the company in her new position as COO: “The year 2018 was a great year in which we initiated numerous clinical trials, of which many involve the most innovative (immuno-)oncology drugs and advanced therapy medicinal products (ATMPs). Clinical trials with anti-cancer compounds remain the most challenging of its kind. The growth we see in our company, both through new clients as well as repeat business, reflects the need for the oncology expertise we have to offer.”
The Oncology Drug Development Affairs department of SMS-oncology provides the oncology expertise needed to successfully design and conduct oncology trials. The company appointed Ms. Inka Pawlitzky, PhD, as department Director. Dr. Pawlitzky brings over 18 years of oncology and immunology research experience in both academia and industry.
With the growing number of trials and a challenging clinical landscape, SMS-oncology is excited and proud to have initiated a dedicated Patient Inclusion department. The department led by Ms. Wendy Onstenk, MD PhD, will focus on improving recruitment strategies. Before joining SMS-oncology, Dr. Onstenk was Chief Medical Officer (CMO) at Hartwig Medical Foundation.
Ms. Philine van den Tol, Chief Executive Officer (CEO) at SMS-oncology: “Industry research shows that a large group of eligible patients is not included in clinical trials. With our dedicated department, we are keen to overcome barriers hampering optimal patient recruitment and to support clinical investigators in such a way that recruitment of all eligible patients becomes a reality.”
Furthermore, SMS-oncology is spreading its geographical footprint by expanding its local presence in Germany, Spain and the Nordics.
Source: SMS-oncology
Charles River and Toxys Enter Agreement to offer ToxTracker® in North America
InnovatieklimaatCharles River and Toxys have entered into an agreement to offer access to ToxTracker® in North America. ToxTracker is a suite of assays that allow rapid carcinogenicity toxicity hazard identification in novel and existing drugs, chemicals, and other substances.
With an extremely high level of sensitivity and specificity, ToxTracker can be used to quickly screen chemicals for genotoxicity. By combining multiple biomarkers, ToxTracker provides mechanistic insight into undesired properties of compounds.
The assay identifies a chemical’s increased cancer risk through both traditional markers, such as DNA damage, and alternative Modes-of-Action, including oxidative stress, protein misfolding, and general cellular stress. For Charles River’s clients, utilization of the ToxTracker assay can help mitigate risk of regulatory rejection by demonstrating the exact mechanism of genotoxicity.
ToxTracker has been extensively validated using reference compound libraries recommended by the United States Environmental Protection Agency’s Toxicity Forecaster (ToxCast) and the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM). Through this validation, ToxTracker has shown a very high sensitivity (94%) and specificity (95%) for the detection of genotoxic compounds.Additionally, ToxTracker’s versatility in identifying unsafe compounds provides applications across the pharmaceutical, agrochemical and consumer product industries.
“We are proud to work with Toxys to expand our portfolio of genetic toxicology assays. By providing our clients with access to the ToxTracker assays, we are improving their ability to deliver safe, effective compounds.” –Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment of Charles River
“When looking for a company to provide ToxTracker to the North American market, Charles River was an easy choice. Their deep industry knowledge and experience, coupled with an already robust portfolio of toxicology services, makes them the ideal partner for our innovative assays. We are excited to work together to bring ToxTracker to a wider audience.” –Giel Hendriks, CEO of Toxys
Source: Toxys
MSD Receives Breakthrough Therapy Designation from FDA for Vaccine
GezondheidMSD announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for the prevention of IPD in adults. Both indications are currently being studied in Phase 3 clinical trials.
The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of this Breakthrough Therapy Designation include more intensive guidance from FDA on an efficient drug development program, access to a scientific liaison to help accelerate review time and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
The FDA’s decision was informed in part by immunogenicity data from two studies. Study 005 was a Phase 1/2, multicentre, randomized, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of a new formulation of V114 in healthy adults and infants. Study 008 was a proof of concept, Phase 2, pediatric trial to confirm the results from Study 005 in a larger population of infants. In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines.
“We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine,” said Dr. Nicholas Kartsonis, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories. “The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”
Source: MSD
HollandBIO Year Event viert biotech innovatie
Hollandbio, UitgelichtAfgelopen donderdag vierde HollandBIO samen leden en relaties haar eerste lustrum tijdens het Year Event in hartje Amsterdam. Hét leukste event van de Nederlandse biotech sector stond wederom bol van innovatie, inspirerend ondernemerschap en een gezonde dosis humor.
De openingsvideo maakte in een klap duidelijk hoe de life sciences sector vandaag al bijdraagt aan een duurzame en gezonde samenleving, welke innovaties er in het verschiet liggen en de belangrijke rol van HollandBIO om de obstakels weg te ruimen die biotech frontrunners op hun weg van lab naar maatschappij tegenkomen.
De speech van HollandBIO’s Annemiek sloot naadloos aan. Trots blikte zij terug op de eerste vijf jaar HollandBIO, waarin de vereniging vele successen op haar naam mocht schrijven, maar waaruit ook bleek dat er nog veel werk aan de winkel is. En natuurlijk vooruit: ook de komende vijf jaar gaat HollandBIO er weer vol enthousiasme tegenaan om de weg te effenen voor biotech innovaties. Daarbij is de hulp van onze achterban onmisbaar. Annemiek riep de aanwezigen op om toch vooral de spotlight op te zoeken en onze mooie sector smoel te geven: “Be good & tell it!”.
Anant Murthy, van Alnylam Pharmaceuticals, demonstreerde vervolgens hoe je dat doet: je verhaal vertellen. Als koploper in de ontwikkeling van een nieuwe generatie geneesmiddelen gebaseerd op RNA-technologie, legde Alnylam een verbluffende reis vol pieken en dalen af. Na meer dan zestien jaar pionieren, is nu eindelijk hun eerste behandeling binnen bereik van patiënten met polyneuropathie. En die eerste therapie opent de poort naar de toekomst, waarin Alnylam vele levens van patiënten met zeldzame genetische aandoeningen kan gaan verbeteren.
En ook Daan Luining van Meatable, liet zien hoe je Annemieks advies in de praktijk brengt. Een toekomstdroom om – zonder schuldgevoel – van te watertanden: 100% echt en smakelijk vlees zonder dat er ook maar één dier voor heeft moeten lijden. Als CTO bij startup Meatable pioniert Daan aan de frontlinie van de kweekvlees revolutie. Een wereld van ongekende mogelijkheden, waar we bij HollandBIO reikhalzend naar uitkijken.
Als kers op de taart trakteerde Op Sterk Water de aanwezigen op een magistraal staaltje improvisatiecabaret. De feestelijke stemming werd voortgezet tijdens diner en op de dansvloer. Geniet nog even na met de prachtige foto’s van Nils van Houts.
Subsidieoproep ‘Hart voor Duurzame zorg’
IJzersterk innovatieklimaat, InnovatieklimaatMedische technologie voor het eerder opsporen, monitoren en beter behandelen van hart- en vaatziekten is hard nodig. Technologische innovatie levert een belangrijke bijdrage aan een betere gezondheid. Deze innovaties zorgen voor kosteneffectiviteit en maken een persoonlijkere zorg mogelijk. Een zorg die is toegespitst op de wensen en mogelijkheden van het individu. Daarom investeren de Hartstichting, ZonMw en NWO in ‘Hart voor duurzame zorg’, een gezamenlijke subsidieoproep met een totale omvang van vijf miljoen euro. Heb je een briljant idee voor een nieuwe medische technologie? Of brengt je bestaande experimentele technologie naar de kliniek? Dien dan uiterlijk 9 april een voorstel in.
Lees hier verder voor meer informatie: https://www.zonmw.nl/nl/subsidies/openstaande-subsidieoproepen/detail/item/hart-voor-duurzame-zorg/
DuPont breidt biotech activiteiten uit in Leiden
IJzersterk innovatieklimaat, InnovatieklimaatHet Amerikaanse DuPont gaat zijn in Leiden gevestigde biotechnologie-activiteiten stevig uitbreiden. DuPont sleutelt in Leiden aan door micro-organismen gemaakte enzymen. Die vinden hun weg naar onder meer (vaat-)wasmiddelen, voedingsmiddelen en diervoeding. Het gaat dan bijvoorbeeld om enzymen die wassen op lagere temperaturen mogelijk maken en daarmee helpen om energie te besparen. De groei van deze activiteiten leidt nu tot een nieuwe investering van €30 mln, bestemd voor de opening van een nieuw en groter kantoor in 2020 en een groei van het aantal werknemers van 130 naar ruim 200.
Bron (inlog nodig): https://fd.nl/ondernemen/1286856/dupont-verdubbelt-bedrijfscapaciteit-op-leiden-bioscience-park
DSM gaat samenwerking aan voor vitamine E
Voedsel en materialenDSM gaat een samenwerking aan met zijn Chinese branchegenoot Nenter voor de productie van vitamine E. Het Nederlandse speciaalchemie- en biotechnologiebedrijf wordt voor 75 procent eigenaar van de joint venture, Nenter voor het overige deel. Dat maakte DSM deze week bekend. Daarnaast kondigde het bedrijf een investering van ongeveer 135 miljoen euro aan in het samenwerkingsverband, dat eigenaar wordt van enkele productiefaciliteiten van Nenter in China. Nenter leverde al aan DSM.
Bron: https://www.telegraaf.nl/financieel/3081239/dsm-gaat-samenwerking-aan-voor-vitamine-e
Van Nederbanaan tot paardenbloemrubber
Wereld mét toekomst, Voedsel en materialenVan het telen van bananen in Nederland tot rubber producerende paardenbloemen, met gerichte veredeling is alles mogelijk. Dat is ook hard nodig want de ziekten en plagen die onze gewassen belagen, veranderen voortdurend en ook het weer wordt steeds grilliger. Maar voor gerichte ontwikkeling van de juiste planten is eerst een grondige kennis van die plant nodig. Dagblad Trouw gaf afgelopen week de eer aan KeyGene uit Wageningen om dit proces uit te leggen. Zo analyseren dataspecialisten eerst de genetische achtergrond van de plant en combineren die kennis met die vam de groei- en bloeiwijze onder verschillende weersomstandigheden. Op basis daarvan ontwikkelen de plantenveredelaars via slimme kruisingen nieuwe plantenrassen of variëteiten. Met de nieuwste gene-editing technieken zou dit veel sneller kunnen gaan, maar helaas ziet Europa deze als een vorm van genetische modificatie. Keygene-directeur Arjen van Tunen geeft aan dat daarmee de tijdswinst uit die snellere veredeling niet opweegt tegen het langdurige, onzekere en kostbare toelatingstraject. Ook bij HollandBIO vinden we dit een gemiste kans, want Europa zet zich daarmee buitenspel in het voldoen aan de vraag naar steeds gezondere en duurzaam geteelde groenten en fruit.
Lees het hele artikel hier terug: https://www.trouw.nl/home/bij-keygene-maken-ze-meloenen-nog-gezonder-en-mooier~a014a340/