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Now online: English information about CBG-ZIN Parallel Procedures Pilot

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As previously highlighted in our newsletter, the Dutch Medicines Evaluation Board (CBG-MEB) and the National Health Care Institute (Zorginstituut Nederland: ZIN) joined forces in a pilot to accelerate access to innovative medicines in the Netherlands. To inform your international colleagues and/or international affiliates about this opportunity, the information about the “CBG-ZIN Parallel Procedures pilot” is now available online.

Recently, HollandBIO and the Association of Innovative Medicines organized together with CBG-MEB and ZIN a well-attended information session about the pilot, during which Kevin Liebrand (project lead on behalf of CBG-MEB) and Pauline Pasman (project lead on behalf of ZIN) elaborated on the aim of the pilot and the prerequisites for participation. Companies were very enthusiastic about the pilot, based on the amount of questions that were asked during the session. Frequently asked questions will be combined and published online in the near future.

The pilot is a seamless fit with the HollandBIO program Faster & better from bench to bedside, where we work towards solutions that boost both health, innovation and affordability. This pilot is a first step towards a more flexible health ecosystem, where the Netherlands can achieve the full potential of tomorrow’s medicines. We are therefore very curious who will be the frontrunner of this faster & better opportunity.

More information:

The most important information about the pilot can be found here, including a link to the Interest Form – CBG-ZIN Parallel Procedures pilot. Explanation in English of the interest form can be found here. If you have any questions, you can also always contact Marit.

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HollandBIO welcomes AGILeBiotics as a new member

HollandBIO connects and supports the Dutch biotech industry. We represent over 200 companies in the field of medical, agrifood and industrial biotech. And, HollandBIO is growing steadily. Today, we are proud to welcome AGILeBiotics to the HollandBIO community!

AGILeBiotics is a spin-off company of the University of Groningen founded by the CEO Dr. Andreas A. Bastian in March 2017. The start-up is committed to contribute to the fight against bacterial resistance by bringing new therapeutic solutions to hospitalized patients. The company’s vision is to accelerate the development of novel antibiotics by employing a proprietary technology named OxaSelect on existing complex natural product-based antibiotics, which have lower risk for drug resistance. The synthetic technology gives quick access to next generation drugs with broad-spectrum activity and improved safety profile.

AGILeBiotics is about to enter the pre-clinical stage. Their pre-clinical candidates overcome drug-class related bacterial resistance and have high potency against multidrug-resistant clinical isolates belonging to the top five pathogens of WHO’s priority list. AGILeBiotics’ goal is to develop novel antibiotics for the treatment of infections with high death rate, such as ventilator-associated pneumonia (VAP) and bloodstream infections (BSI), and neonatal sepsis.

Since 2017, AGILeBiotics has successfully enquired the pre-seed and seed investment round enabling the identification of their pre-clinical candidates. Currently, AGILeBiotics is reaching out for Series A investment round to develop the antibiotic candidate until clinical Phase II.

For more information please visit AGILeBiotics website.

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Dutch Biotech Event 2019 celebrates the beauty of biotech

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The Dutch Biotech Event 2019 had it all: a great line-up, over 250 eager biotech professionals, a lovely venue and perfect weather.

During her opening speech, Annemiek Verkamman brought the festive news that HollandBIO welcomed its 200th member! Our growing member base strengthens us in our mission to maximize the contribution of biotech products to our society’s health and sustainability. And it shows that HollandBIO’s impact is bigger than ever. Of course, HollandBIO will continue what we do best: paving the way for biotech’s frontrunners by challenging the status quo.

A three decade journey in cell therapy – Arie Belldegrun

Arie Belldegrun, our first keynote speaker, took us on a dazzling, three-decade journey in cell therapy. Arie played an instrumental role in several of today’s frontrunners in biotech, such as Kite Pharma, bringing ground-breaking science from bench to bedside. And, as he is convinced that science drives innovation, Arie is always looking for the next revolution. Today, he serves as Executive Chairman & Co-Founder of Allogene Therapeutics. The company’s Allogenic CAR-T therapy may be the next big breakthrough, since more patients can be treated with engineered T-cells after a single manufacturing run. Although no one can predict the future, Arie firmly believes cell therapy holds great promise for cancer therapy. What is it that keeps him going after so many successes? It is the great fun along the way. No better way to conclude a fantastic story of a true biotech pioneer!

AmbAgon wins Venture Challenge Spring 2019

Chrétien Herben, Director at LifeSciences@Work, announced AmbAgon as the winner of the Venture Challenge Spring 2019 edition. The Venture Challenge is a 10-week programme to develop an initial idea – a breakthrough research result – into a solid business case. This edition’s winners AmbAgon aims to develop small-molecule therapeutics for breast cancer by augmenting the tumor-suppressing functions of the 14-3-3 protein. The prize includes a cheque worth €25.000.

Personal perspectives on a career in biotech – Tim Knotnerus

“It’s not about where you work, nor what you do, it’s who you work with.” And Tim Knotnerus, our second keynote speaker, worked with the best. After graduation, Tim joined Aescap, a VC fund established by Dinko Valerio. The experience to work with one of the pioneers of the Dutch biotech sector, sparked Tim’s ambition to pursue an entrepreneurial biotech career of his own. He continued his career at AM-Pharma. Together with CEO Erik van den Berg, he secured multiple funding rounds. An option to acquire deal with Pfizer was the cherry on the cake. The deal also paved the way for Tim’s next big leap in biotech: becoming CEO of AgomAb, a Belgium biotech start-up holding an exclusive license agreement from argenx. With € 21 million secured in a series A earlier this year, exciting times lie ahead for this ‘fourth-generation’ biotech star.

Lessons in leadership – John Haurum

Biotech owes its success to innovation. But how to create and sustain an innovative corporate culture? John Haurum’s keynote focused on the strong leadership it takes to pull that off. John’s former roles as CSO of Symphogen and CEO of F-Star not only made him an expert in the field of therapeutic antibodies, but also gave him hands-on experience in corporate cultures. As board member of a growing number of biotech companies, his knowledge is of great value to a new biotech generation. Guided by a Harvard Business Review article, John shared his vision on building an innovative biotech culture, stressing the apparent paradoxes involved: tolerance for failure but  intolerance for incompetence, willingness to experiment combined with rigorous discipline and collaboration that involves individual accountability. All in all, John’s presentation provided plenty of food for thought for both established as well as up-and-coming biotech leaders.

Break-out session – Critical communication

As our beautiful biotech sector is under bigger scrutiny than ever before, simply being good is no longer good enough. The need to be good and tell it, to speak up, to explain what you do and why you do it, is bigger than ever before. But in a seemingly post-fact era, and a debate driven by emotion, that might be easier said than done. Hugo van Rooijen (Janssen Pharmaceuticals) and Guus Scheefhals (DegenRx) shared their communicative views, ideas and experiences. From fact-checking as pharmacovigilance for politicians, to setting the right frame for a constructive discussion, and managing expectations among patients and other stakeholders. The session delivered a number of best practices to move forward. HollandBIO hopes the attendees will also practice what these biotech frontrunners preached!

Break-out session – Cell land gene therapy in the spotlight

Kite Pharma is one of the frontrunners in cell therapy, with the approval of Yescarta for treatment of certain types of non-Hodgkin lymphoma. At the same time, gene therapy is also booming! Guided by Kite’s Markwin Velders, two pioneering companies shared their experiences in the gene therapy world. Rudolf van Olden (Avexis) highlighted the development of Avexis’ Zolgensma, which got just approved by the FDA to treat children with SMA. The results of the initial clinical trials were spectacular, resulting in an ultra-short time to market. Thanks to the rapidly built production site, patients in the US are already being treated. Tjarda Kasteel from bluebird bio shared the fascinating story of Zynteglo, a one-time gene therapy for patients with ß-Thalassemia. Based on the exceptional clinical outcomes, Zynteglo saw a ultra-fast approval by the EMA. Because both Zynteglo and Zolgensma are ‘one time’ treatments challenging the status quo, both companies introduced correspondingly novel payment strategies. The impressive results so far make it more than justified that cell and gene therapy are in the spotlight right now.

Break-out session – Think different

During the workshop Think Different, biotech entrepreneurs Wim de Laat (BioscienZ) and Jos Seegers (MyMicroZoo) gave us a sneak peek of tomorrow’s food and how insights in your microbiome can help you make better lifestyle choices. Wim aims to serve a Christmas dinner with egg ingredients produced by fermentation of a fungus, which converts sugar from sugar beet, cane or grain into ovalbumin. If you are curious about the effect of a (G)Meal, or any other lifestyle intervention, on your microbiome, the MyMicroZoo poo-it-yourself-test from Jos will provide you with answers based on the most advanced DNA sequencing techniques. HollandBIO is already looking forward to our next teambuilding activity!

Break-out session – How to fund a biotech

A no now, doesn’t mean a no later. That was one of the lesson’s learned by Synaffix’ CEO Peter van de Sande. To secure funding to commercialize antibody-drug conjugates and build a technology platform company, Peter had to knock on many doors. You definitely need to be persistent, Xenikos CEO Ypke van Oosterhout added. Ypke’s dedication did pay-off: Xenikos closed a €30 million series B financing round last year. Edward van Weezel agreed as well. As a managing partner of venture fund BGV, he sees hundreds of projects every year. The overall success rate for companies is very low, only a few get an investment. It is worrisome that the Netherlands is losing its strong start-up position to other countries around the globe. Especially in the United States, huge amounts of risk capital is invested in very young start-ups, paving the way for growth. To stay on track, the Netherlands should invest more in innovative start-ups. Government and private investors have to work together, to bridge the gaps in the funding landscape. Until then, you had better take into account the panelists’ lessons learned: stay flexible and creative along the way, and always keep looking for solutions.

Fueled by the fascinating biotech stories and new insights, it was time to network while enjoying a refreshing drink and tasty BBQ. A great day to celebrate what biotech is all about: building a better world by combining top-notch science, true entrepreneurship and a lot of fun.

Be sure to mark the last Friday of June next year in your agenda. See you next year!

Photos by © Nils van Houts – 2019

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Staatssecretaris Blokhuis op stoom

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Staatssecretaris Blokhuis wil gezondheidswinst door vaccinaties maximaal verzilveren, zo liet hij de Tweede Kamer afgelopen week in een uitgebreide Kamerbrief weten. De Kamerbrief meldt dat de daling van de vaccinatiegraad tot staan is gebracht. Volgens Blokhuis geen reden om op zijn lauweren te rusten: “dit motiveert mij des te meer om onverminderd in te zetten op de maatregelen uit mijn brief Verder met vaccineren”. We roemden al eerder de doortastende aanpak van Blokhuis op het vaccinatiedossier. En ook nu weer is HollandBIO blij met de ambitie die uit de brief spreekt. We zetten de hoogtepunten uit de brief graag voor je op een rij.

Pneumokokkenvaccinatie voor ouderen

Vanaf het najaar van 2020 gaat de overheid ouderen wapenen tegen de pneumokokken. De Staatssecretaris neemt nu definitief het advies van de Gezondheidsraad over om 60, 65, 70 en 75 jarigen een vaccinatie aan te bieden. In eerste instantie mogen gegadigden zich bij de huisarts melden voor deze prik. Of dit de best passende aanpak is, zal na twee jaar uit een evaluatie blijken.

Werkdruk bedreigt voorspoedige implementatie van nieuwe vaccins

De werkdruk bij de jeugdgezondheidszorg (JGZ) is hoog, zo constateert Blokhuis. En dankzij de implementatie van diverse nieuwe vaccins, waarvoor de JGZ verantwoordelijk is, zal die niet snel afnemen. “De praktijk kan geen oneindige hoeveelheid wijzigingen tegelijkertijd aan”, concludeert Blokhuis. En dus liggen vertragingen bij invoer op de loer. Volgens HollandBIO is er maar één structurele oplossing: extra capaciteit en middelen. Op die manier kan de werkdruk worden verlicht en vinden al die vaccins snel hun weg naar de juiste arm.

Een verbeterde communicatiestrategie

Blokhuis wil zich nog duidelijker uitspreken vóór het belang van vaccinatie. Op verzoek van de Tweede Kamer gaat hierbij extra aandacht uit naar ervaringsverhalen. Die krijgen dan ook een prominente plek op een te ontwikkelen website, waar jong en oud terecht kunnen voor informatie en actualiteiten over vaccineren. Het RIVM werkt intussen aan een vergrote zichtbaarheid van de al bestaande website over vaccinatie. Tot slot zet de staatssecretaris extra middelen in voor aanvullende gesprekstrainingen van professionals.

Benieuwd naar de hele Kamerbrief? Lees hem hier.

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HollandBIO’s Annemiek in nieuwe campagne over Life Sciences & Health sector

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De nieuwe campagne van Mediaplanet gaat in op de meest recente ontwikkelingen binnen de Life Sciences & Health sector, of het nu gaat om de vooraanstaande positie van de Nederlandse gezondheidszorg op internationale ranglijsten of de pogingen om in Nederland een vaccin tegen kanker te ontwikkelen. In één van de interviews komt ook HollandBIO’s Annemiek aan het woord over de ontwikkelingen en uitdagingen in de cel- en gentherapie. Benieuwd naar deze en andere artikelen? Lees hier meer.

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Diervrije hamburgers en zuivel hebben de toekomst

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Een lekkere hamburger eten zonder schuldgevoel over dierenleed en milieuschade, dat willen we allemaal. Met de komst van kweekvlees komt deze toekomst steeds dichterbij. De analyse van AT Kearny, een consultancybureau, is dat in 2040 60% van de wereldwijde vleesproductie plantaardig of gekweekt zal zijn. De drijvende kracht daarachter zijn de ontwikkeling en toepassing van biotechnologie in de voedingsmiddelenindustrie. De start-ups voor de productie van veganistische en vegetarische alternatieven schieten als paddelstoelen uit de grond, ook in Nederland. Naast de productie van vlees richten deze bedrijven zich ook op andere producten zoals, zeevruchten, leer, melk, zijde, eiwit en gelatine.

Het Amerikaanse bedrijf Perfect Day Foods is het al gelukt om wei- en caseïne-eiwitten, beide bestanddelen van melk, met hulp van bacteriën te maken. De volgende uitdaging is nu om melkvet in micro-organismen te produceren. Melkvet geeft de melk namelijk smaak en structuur. Ondertussen richt Perfect Day zich op de opschaling en afzet van haar kunstmatige melkeiwitten in yoghurt, kaas en andere zuivelproducten. De hoop is dat deze producten binnen afzienbare tijd in de Amerikaanse supermarktschappen liggen.

Of we in Nederland en Europa ook volop in gaan spelen op deze fantastische toepassingen uit biotechnologie, is nog onduidelijk. Het blijft de vraag of, hoe en op welke termijn deze producten door de Europese Novel Foods wetgeving heen zullen komen. HollandBIO blijft zich in ieder geval inzetten om de drempels voor deze duurzame vindingen weg te nemen, zodat we ook in Nederland en Europa zo snel mogelijk duurzaam en diervriendelijk kunnen genieten van vlees en zuivel.

Bronnen: SingularityHub en AT Kearny

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First volunteer dosed with microneedle patch of MyLife Technologies at CHDR

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MyLife Technologies started a first-in-human study with its ceramic nanoporous MicroNeedle Arrays (npMNA) technology at Centre for Human Drug Research (CHDR) in Leiden (NL) today. npMNA patches loaded with a pharmaceutical peptide formulation are being tested in healthy volunteers

In many cases pharmaceutical peptides are parenterally administered. Existing alternatives for peptide delivery are among others intranasal sprays or subcutaneous implants. npMNA patch administration could lead to reduced peak concentrations and modified drug release and should overcome several of the drawbacks of the existing delivery routes: npMNA patches are minimally invasive, pain-free and allow for self-administration. The drug formulation is stored in the nanopores of the npMNA devices and diffuses into the patient once the npMNA patches have been applied onto the skin. Drug release rates from the nanopores can be tuned. This makes MyLife Technologies’ npMNA patches a versatile drug delivery system.

“We have entered an exciting new phase in the development of our npMNA technology”, says Pieter Jan Vos, CEO of MyLife Technologies, “We have found a valuable partner in CHDR, an experienced clinical CRO in the field of novel concepts and dermatology”.

Source: MyLife Technologies

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Trend analysis: bright future ahead for Dutch biotech

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Today, the leading global business development database Biotechgate presents its 2019 trend report for the Dutch life sciences market. The annual trend report shows that the Netherlands is on track to become a world leading life sciences cluster in 2030.

The total number of biotech companies is growing steadily to 470 in 2019. Oncology remains the most prominent therapeutic area, followed by neurology and infectious diseases. With many ground-breaking companies and world-class universities, the Netherlands is the perfect location for biopharmaceutical innovation in Europe.

Over the years, the Netherlands evolved into a fertile breeding ground for research and development. The number of products in our clinical pipeline slightly increased compared to 2018. At the moment there are 41 phase I, 49 phase II and 13 phase III studies in development. On top of that, almost 100 products are investigated in a preclinical setting. These numbers promise a bright future ahead.

HollandBIO’s managing director Annemiek Verkamman is happy to see the analysis confirms the leading position of the Dutch life sciences sector. “With top-notch scientists, outstanding research and education and great entrepreneurial spirit, we established our leading position in Europe. Add to that the recent relocation of the EMA, and it becomes clear that the Netherlands has what it takes to become one of the world’s top biotech clusters by 2030!”

Click here to go to the Dutch Life Sciences Trend Analysis 2019.

Biotechgate is a global business development database containing nearly 55,000 high-quality company profiles including company descriptions, contact information, product pipeline information, financing rounds and more. Biotechgate is owned and operated by Venture Valuation AG, a Zurich-based company specializing in independent assessment and valuation of technology-driven companies in high-growth industries.Whether you are looking to partner with a Dutch company or looking for a specific service, you’ll find the most complete overview of the Dutch life sciences sector at www.dutchbiotech.com.

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HollandBIO welcomes Amaris Consulting as new member

HollandBIO connects and supports the Dutch biotech industry. Today, we are proud to announce that Amaris Consulting has joined the HollandBIO community. Amaris is a global services and solutions provider with more than 6000 talented people located in more than 55 countries. Their diversity in capabilities and global footprint allows them to be a trusted partner to pharmaceutical, biotech and medical device companies of all sizes and help them create and capitalise on the value of their products.

About Amaris

Biotech companies are expected to deliver largest part of the pharmaceutical innovation in the coming years. At Amaris, we know innovation and understand the specific challenges you are faced with operationally and strategically. To match the dynamic needs and culture of our Biotech partners we have developed a matching integrated offering that allows for a seamless interaction and engagement at the level at which it brings most value. Partnering with us, means that you would have access to experienced teams with core knowledge of the healthcare market and scientific capabilities that would support you throughout your product’s life cycle – from the development of a product strategy that resonates with patients, payers and physicians alike to the delivery of such strategy in practice.

Our understanding of technological innovation and its applications combined with years of experience in the quality, engineering, regulatory and compliance makes us uniquely capable to optimise your organisation and environment in which you operate, ensuring enhanced efficiency and productivity. After all, having the right environment is a key prerequisite for innovation to flourish.

Finally, at Amaris we strongly believe in the role of people in tomorrow’s world. With all the technological innovations which overflow our sector, people remain a key component that drives the organisation and augment these innovations. We can help your organisation grow by supporting the development of your employees. We can help with capacity building trainings aimed at transferring knowledge and helping people to become true asset to the organisation.

For more information, visit the website of Amaris Consulting

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HollandBIO leestip: Politico slaat spijker op zijn kop

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De komst van het Europees Medicijnagentschap (EMA) naar Amsterdam kan ervoor zorgen dat de Nederlandse Life Science & Health (LSH) sector een enorme boost krijgt. Zoals staatssecretaris van Economische Zaken en Klimaat Mona Keijzer in een Kamerbrief van februari dit jaar aankondigde, versterkt het EMA ons nationale LSH-ecosysteem, maar is het essentieel dat alle partijen in de LSH-sector gezamenlijk optrekken om deze kansen te verzilveren. En daar zit hem nou net de angel.

Terwijl het ministerie van Economische Zaken en Klimaat dit momentum aan wil grijpen om meer bedrijvigheid naar ons land te halen, zendt minister Bruins van Medische Zorg tegenstrijdige signalen over het belang van innovatie uit richting de farmaceutische industrie. Eerder schreef HollandBIO al dat Nederland zichzelf in toenemende mate internationaal op de kaart zet als een bananenrepubliek als het gaat om intellectueel eigendom. Laten we in plaats daarvan alles op alles zetten om het innovatieparadijs voor life sciences te worden. Online politiek newsblog Politico slaat met een onvertaalbare titel in ieder geval de spijker op zijn kop: ‘Amsterdam has a drugs problem’. Wat ons betreft een onvervalste HollandBIO leestip!

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