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Clinerion and iClusion partner to boost the identification and recruitment of more patients into clinical trials

Clinerion’s Patient Network Explorer and iClusion’s Trial Eye platforms both connect clinical trial sponsors with networks of partner hospitals, giving trial managers the ability to include eligible patients for trials more quickly and efficiently than before. Treating physicians and patients benefit from increased treatment options and quicker access to new medical interventions.

Together, the partners’ joint mission is to increase patient participation in studies to its full potential by optimizing protocol design, enabling study sites to efficiently start up their trials locally and plan and meet realistic patient recruitment and therefore total timeline targets.

This new clinical trial optimization partnership also facilitates a total study site network activation for all trials, beyond the study sites already chosen to participate, by facilitating online referral and activation services.

iClusion makes clinical research accessible for physicians and their patients by connecting sponsors and their research protocols with research sites. Connecting all stakeholders and automating standardized local approval procedures in one networked platform accelerates total study timelines and makes innovative products available to more patients faster.

Clinerion makes real-world patient data accessible for analysis so that study protocols can be optimized with real patients in mind and real-world patient data can drive study feasibility and patient recruitment.

Both iClusion and Clinerion maintain cloud platforms which bring together participants from across the clinical study ecosystem, comprising sponsors, hospitals and clinicians, and treating physicians and patients. However, the partners offer complementary support and solutions throughout the product development process.

“Never in history has the R&D engine in pharmaceuticals been more productive, driving a pool of promising new agents,” says Edwin Klumper, CEO of iClusion. “The growing pipeline of targeted and personalized medicines puts tremendous pressure on more trials to be conducted in smaller, more well-defined patient populations. As a result, patient recruitment has become the bottleneck, nowadays, which is delaying progress and withholding many patients from the benefits of participation. I am pleased that Clinerion and iClusion are partnering to start tackling the identification and recruitment of the right patients into the right studies to bolster trial conduct and innovation.”

“Our collaboration re-emphasizes that patients are at the heart of clinical development and clinical trial conduct,” says Ian Rentsch, CEO of Clinerion. “Our combined services cover trials operations from protocol design through operational feasibility, site selection, local approvals, startup of study sites and patient recruitment. This partnership is therefore ideally positioned to optimize and advance protocols faster, reach more study sites and offer more patients the possibility to participate in research.”

Source: iClusion (press release)

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Apply now for the BIO Start-Up Stadium

Start-Up Stadium is a platform, organized at the BIO International Convention, that provides early-stage emerging companies exposure to key investors, venture philanthropy groups, strategic partners, and non-dilutive capitalists. During Start-Up Stadium, 50 selected companies have the opportunity to share their technology and value proposition to an audience of investors, analysts and strategists from across the value chain providing companies feedback and Q&A.

By participating in Start-Up Stadium, companies benefit from the exposure to investors, discounted registration fees, and complimentary access to BIO One-on-One Partnering.   

Which companies can apply for Start-Up Stadium?

Companies that have:

  • Raised less than $10M round since inception
  • Previous business pitch/competition experience (desired, not required)
  • Fewer than 20 full-time employees
  • No previous experience in BIO One-on-One Partnering at BIO events

The application deadline is 27th of March and you can apply here. You can find out more about the program of Start-Up Stadium and find the pitch presentation guide via the same application link!

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Twee nieuwe ROM’s in ontwikkeling

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Nederland is straks twee nieuwe regionale ontwikkelingsmaatschappijen (ROM’s) rijker. Staatssecretaris Mona Keijzer van het ministerie van EZK maakte op 20 februari bekend dat er in Utrecht en Flevoland ook ROM’s zullen worden opgezet. Hierdoor ontstaat een stelsel dat heel Nederland dekt.

Net zoals bij de andere ROM’s zal naast provincies, gemeentes en andere entiteiten, ook de Rijksoverheid een belang nemen in de fondsen. Het startkapitaal voor Flevoland komt daarbij neer op €16 miljoen en zal voor Utrecht €22 miljoen bedragen. Dit kapitaal zal worden aangewend voor het uitvoeren van acquisitie, business development en ondernemersfinanciering in de regio. Ondernemersfinanciering zal voornamelijk worden verstrekt als risicodragend kapitaal aan startende en innovatieve MKB’ers.

Meer informatie en een uitgebreid overzicht van de structuur van de ROM’s vind je hier terug in de Kamerbrief ‘Oprichting ROM’s in Utrecht en Flevoland’.

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EUROSTARS grant for vaccine against breast cancer

A consortium of Danish and Dutch research organisations led by AdaptVac ApS has been awarded a EUROSTARS grant for the further development of the AV001 vaccine against breast cancer. The combination of state-of-the art technologies revealed a highly immunogenic vaccine against human epidermal growth factor receptor 2 (HER2) expressed by cancer cells.

With the support of EUROSTARS, we will be able to prove safety and immunogenicity in different in vivo models, finalize the production process and prepare for further clinical development. The envisaged vaccine could be an effective tool in the treatment of patients and in the delay of recurrence. The consortium consists of AdaptVac, ExpreSion Biotechnologies, and University of Copenhagen (Denmark), and LiteVax BV and the Biomedical Primate Research Centre (the Netherlands).

Breast cancer affects more than 1.3 million worldwide annually, resulting in more than 450,000 deaths. Today, the most common treatment is based on monoclonal antibodies against HER2. Such passive immunization has some clear-cut limitations and therefore we developed a vaccine that activates patient’s own immune system to destroy HER+ cancer cells. By combining technologies from AdaptVac,  xpreSion Biotechnologies and LiteVax BV, the prototype vaccine generated strong immune responses in different animal models. In this project, we will further prove safety and immunogenicity, finalize the production processes and prepare for clinical development.

“We are particularly pleased by the strength of the consortium, bringing together expertise in vaccines, adjuvants, as well as canine and non-human primate vaccination to predict the performance in patients.

Source: Litevax

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Sanofi to create new industry leading European company to provide active pharmaceutical ingredients

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Sanofi plans to create a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API), which are the essential molecules responsible for the beneficial effects used in the composition of any drug. The project consists of creating a standalone company which would combine Sanofi’s API commercial and development activities with six of its European API production sites : Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).

With increasing medicine shortages that critically impact patient care, the new entity would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected to help in balancing the industry’s heavy reliance on API sourced from the Asian region3.

The new company would rank as the world’s second largest API company with approximately €1 billion in expected sales by 2022. It is expected to include 3,100 skilled employees and to be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.

Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said “Based on the expertise and experience built over decades within our industrial network, this new entity would help ensure a greater stability in supplying drugs to millions of patients in Europe and beyond. With this endeavor, this new entity would be agile as a standalone company, and able to unlock its growth potential, especially in capturing new third-party sales and all the opportunities of a market growing at a pace of 6 % per year4.”

By operating independently, the new entity plans to increase its sales to third parties and to expand its partnerships with other pharmaceutical companies in order to take advantage of new growth opportunities and have the ability to deftly adapt to customer needs. The new company would be uniquely positioned to benefit from its significant competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as leveraging an extensive commercial network covering more than 80 countries. 

Sanofi is fully committed to the new company’s success and intends to establish a long-term customer relationship with the new API supplier and to hold a minority stake of approximately 30% in the new company. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities, and is committed to remaining an important customer.

Source: Sanofi (press release)

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DSM to acquire Glycom to accelerate growth in Early Life Nutrition

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DSM, a global science-based company in Nutrition, Health and Sustainable Living, today announces that it has reached agreement to acquire Glycom, the world’s leading supplier of Human Milk Oligosaccharides (HMO) for an enterprise value of €765 million. This transaction represents an EV/EBITDA multiple of 20.6x based on the 2019 reported EBITDA, and around 15x based on the estimated 2021 EBITDA.

HMOs are a collection of carbohydrate structures found in human breast milk. They act as prebiotics in infants, which help to develop the desired microbial flora by serving as feed for the good bacteria in the intestine. HMOs are essential for both immune and cognitive development.

Glycom is a Danish company with more than 150 employees, founded in 2005, that pioneered the development and commercialization of HMOs for Early Life Nutrition applications. The company operates a state-of-the-art manufacturing plant in Esbjerg (Denmark) and is the only fully-integrated HMO provider in the world with its own product development, preclinical and clinical development, regulatory and large-scale production with an exciting innovation roadmap for next-generation HMOs. The company achieved €74 million of sales in 2019. These sales were pre-dominantly generated with Nestlé and Nestlé will continue to be an important customer in the future. The Nestlé contract is a mutually beneficial long-term contract with firmly committed volumes also covering the mid-term horizon.

DSM is a leading global solutions supplier to the Early Life Nutrition industry with its unique portfolio of, for example, nutritional lipids, vitamins and nutrient premixes. With the acquisition of Glycom, DSM adds HMOs to its portfolio, a novel high-growth ingredient for next generation Early Life Nutrition solutions.

This acquisition by DSM will be highly synergetic for both companies. DSM can accelerate the growth of Glycom by offering HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Early Life Nutrition customers. DSM can accelerate the HMO product development of Glycom by leveraging its strong R&D platform and clinical competencies to support Glycom’s development of next generation HMOs. DSM can furthermore introduce HMOs in other segments outside the Early Life Nutrition market, for instance for toddlers, children and adults, as well as in the medical nutrition and the pet food segments, creating additional growth potential.

Geraldine Matchett and Dimitri de Vreeze Co-CEOs of Royal DSM, commented: “We are looking forward to welcoming Glycom to DSM. Our companies have a great fit together, with a shared passion for purpose-led and science-based solutions in Nutrition & Health. This acquisition is an attractive and logical next step for DSM enabling us to provide our customers with innovative Early Life Nutrition solutions in our Human Nutrition business.”

Odd Hansen, CEO of Glycom, added: “We are excited to join DSM. This not only enables us to accelerate the growth of Glycom by adding our HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Infant Nutrition customers, it also creates leverage with DSM’s strong R&D platform and clinical competencies to support development of Glycom’s next generation HMO’s. DSM is a real great home for Glycom to reach its full potential”.

The transaction is expected to close in Q2 2020.

Source: DSM

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DCVA & RegMedXB fund launched

On February 13, during the Innovation for Health 2020 conference in Rotterdam, Focco Vijselaar, Director-General for Business and Innovation of the Ministry of Economic Affairs and Climate Policy, officially launched the ‘Fonds InvesteringsRijpe STarters’ (FIRST).

FIRST is a joint early phase investment fund of the Dutch CardioVascular Alliance (DCVA) and Regenerative Medicine Crossing Borders (RegMed XB) with a total volume of 9.5 million euros. The ministry is investing 5.5 million euros in the project, the DCVA and RegMed XB both invest 2 million euros. In addition to the FIRST fund, the partners invest in expert guidance for researchers to bring knowledge obtained by their research to patients. For this purpose, the ministry is investing an additional 2.5 million euros.

This initiative is important for Dutch patients, because of the gap that is still often found in translating results from fundamental medical research into available solutions, such as a new treatment or innovative technology. The various health foundations involved in the DCVA and RegMed XB have worked together to ensure that researchers receive support in taking the first step towards bringing their findings to the market.

The DCVA and RegMed XB are public-private partnerships that bring together the best researchers in the Netherlands in patient-driven development of new solutions aimed at preventing and curing chronic diseases such as cardiovascular disease, kidney disease, diabetes and osteoarthritis. Together with university “knowledge transfer offices”, the DCVA and RegMed XB are actively scouting for such solutions to help with the plans, team formation and initial technical and clinical evidence needed to attract other investors.

FIRST finances this first development into an “investment-ready” company based on proposals of sufficient quality and potential. The fund has an independent investment manager and committee and is managed by BioGeneration Ventures, one of the most successful venture capital firms investing in (the early phase of) European life sciences companies. After the launch, FIRST is working hard to start a first investment round this summer.

Source: Dutch CardioVascular Alliance (press release)

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Nieuwe stimuleringsregeling voor industriële biotechnologie en biobased industrie bij Biotech Campus Delft

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Vanuit het Europese Fonds voor Regionale Ontwikkeling is sinds kort een nieuwe stimuleringsregeling voor ‘Biobased Industries’ gelanceerd van in totaal € 451.750,-. De regeling bestaat uit een drietal vouchers, die individueel of in combinatie met elkaar kunnen worden aangevraagd door in de Europese Unie gevestigde MKB-ondernemingen en die ingezet kunnen worden bij Planet B.io of de Bioprocess Pilot Facility (BPF) in Delft. MKB-ondernemingen met activiteiten die bijdragen aan de transitie naar een biobased economie kunnen een aanvraag indienen voor een vestigingsvoucher, groeivoucher of pilotvoucher.

Meer informatie lees je hier.

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Innovatiekrediet 2020 van start!

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Vanaf 7 februari heeft de Rijksdienst voor Ondernemend Nederland (RVO) het aanvraagloket voor het Innovatiekrediet weer geopend. Je maakt als ondernemer aanspraak op het Innovatiekrediet als je werkt aan de technische ontwikkeling van een nieuw product, of als je bezig bent met de klinische ontwikkeling van een medicijn of apparaat.

Het budget voor 2020 is vastgesteld op €60 miljoen en is gelijk verdeeld over technische en klinische projecten. Het maximale Innovatiekrediet is per klinische aanvraag €5 miljoen en per technische aanvraag €10 miljoen.

Klik hier voor meer gedetailleerde informatie over het Innovatiekrediet.

Klik hier om te lezen hoe ondernemers het Innovatiekrediet in de praktijk ervaren.

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Neuroplast haalt € 4 miljoen op voor stamceltechnologie

Neuroplast heeft € 4 miljoen opgehaald bij investeerders om fase II/III klinisch onderzoek te starten om zogeheten ‘conditional market approval’ te verkrijgen voor de behandeling van patiënten met een dwarslaesie.

Neuroplast verkreeg de financiering van Brightlands Venture Partners en LIOF, terwijl ook bestaande aandeelhouder en informal investor Lumana Invest BV meedeed. “De financiering en ondersteuning van de investeerders stelt ons in staat om klinisch onderzoek uit te voeren in ziekenhuizen in Nederland, Denemarken, Duitsland en Spanje en om het product naar de markt te brengen”, zegt CEO Hans de Munter. Neuroplast werd in 2014 opgericht door arts Hans de Munter en neuroloog Erik Wolters. Het team van Neuroplast is onlangs uitgebreid met Juliette van den Dolder, die benoemd is als COO en lid van het managementteam. Juliette heeft 20 jaar ervaring in productie, marketing en verkoop en heeft haar expertise in biomaterialen en stamceltechnologie opgedaan in zowel de academische wereld als in de industrie. 

Neuroplast is gespecialiseerd in regeneratieve geneeskunde en heeft zich als doel gesteld om de kwaliteit van leven voor patiënten met neurodegeneratieve aandoeningen zoals een dwarslaesie te verbeteren door teruggave van de opgewerkte lichaamseigen stamcellen. Met dit humane preparaat heeft de onderneming veelbelovende preklinische resultaten behaald. Op basis daarvan heeft de Europese regelgevende instantie EMA het product de status van weesgeneesmiddel gegeven, de zogeheten orphan drug designation, hetgeen een versnelde procedure van klinisch onderzoek mogelijk maakt.   Het klinisch onderzoek zal naar verwachting in maart 2020 starten. 

“Neuroplast is een mooie combinatie van een doorbraaktechnologie met een degelijk managementteam. Het gaat om een belangrijk probleem en een grote behoefte, want een succesvolle behandeling van door een ongeluk verlamd geraakte patiënten zou het leven heel veel draaglijker maken voor henzelf en hun familie en tegelijk voor de maatschappij de lasten en kosten aanzienlijk verminderen”, aldus Marcel Kloosterman, directeur van Brightlands Venture Partners. Tys van Elk, directeur van LIOF voegt daar aan toe: “Neuroplast kan een medische doorbraak worden op het gebied van  personalized medicine. Wij zijn blij dat we met onze investering kunnen bijdragen aan deze innovatie. Neuroplast wordt een pionier in de ontwikkeling van een betere behandeling voor acute dwarslaesies”. CEO Hans de Munter voegt daar aan toe “Neuroplast wordt een belangrijke ontwikkelaar van zogeheten ATMP’s (Advanced Therapy Medicinal Products) in de regio, met een prachtig ecosysteem voor regeneratieve geneeskunde”.

Jaarlijks krijgen 24.500 mensen in Europa en de VS een traumatische dwarslaesie, meestal veroorzaakt door een ongeluk. De gevolgen voor het dagelijks leven van de patient zijn enorm en de kosten voor de maatschappij substantieel: alleen de ermee samenhangende medische kosten in Europa en de VS bedragen al meer dan  € 13 mrd.

Bron: LIOF (persbericht)

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