Thinking commercial during drug discovery and development

When your product launches five, eight or ten years from now, what do you intend the label to read? Join Johnson & Johnson Innovation – JLABS for a dynamic symposium where experienced professionals and J&J experts explore the power of the Target Product Profile (TPP) in shaping business decisions and fostering collaboration. From target population to formulation, and benefits to payment models, our speakers will navigate the intricate landscape of drug development.

Experienced professionals and J&J experts explore :

  • How do you define the exact target population, indication and formulation?
  • Which benefits, risks and tolerability concerns are acceptable?
  • What could be unique selling points compared to future competitors?
  • What is your business model and who is going to pay, using what model?

Don’t miss out! Start-ups, early innovators and entrepreneurs are welcome to register here https://jji.jnj/briskr. We also welcome stakeholders supporting these start-ups.

ARE WE IN-SYNC?

coordination in social interactions

When humans interact, a social interaction emerges that is more than the mere sum of its parts. Far beyond simple exchanges, these interactions are symphonies of coordination and synchrony across body, language, and physiology. But what drives this synchronization, and how does it shape our relationships?

On April 24th, the Science Café will unravel these mysteries as we embark on a journey through the world of social interactions, guided by three of the field’s top specialists. Marlene Meyer (Radboud University) will kick off the evening and delve into the developmental function and nature of coordination. Then, Aslı Özyürek (Max Planck Institute for Psycholinguistics) will guide us through the fascinating realm of multimodal coordination in one-on-one interactions and Travis Wiltshire (Tilburg University) will shed light on the complexities of coordination within team dynamics. Along the way, you’re invited to tune in to the theme seamlessly, in sync with the music played by The Mule Stompers.

scientists /8pm Aslı Özyürek (MPI for Psycholinguistics), Marlene Meyer (RU) and Travis Wiltshire (TiU)

music /7.30pm  The Mule Stompers

moderator          Linda Drijvers

time                    Wednesday April 24th 2024, 7.30/8 – 10 pm
venue                 The Shamrock, Smetiusstraat 17, Nijmegen

admission          free admission (no reservation)

language            English

info                     www.sciencecafenijmegen.nl

FDA Fundamentals workshop: here’s what you missed

On Thursday, 7 March 2024, a large group of companies gathered for the FDA Fundamentals workshop. Lorry Weaver, Principal Consultant at Qserve, came to share all the ins and outs of the key expectations and processes required to achieve FDA clearance of medical devices for the US market. Let’s dive into the recap of this event!

A lot is changing in Europe when it comes to laws and regulations. From 2020, all medical devices marketed in Europe will have to comply with the European Medical Devices Regulation (MDR), even those that have been on the market for years. This will set stricter rules for the safety and traceability of medical devices. It is a daunting task that is making more and more startups curious about bringing their products to the US market.

The move to the US

The implementation of the new European regulations poses new challenges for startups. Alex Lankhorst and Egon Kunnen from AQLANE Medical: “We have a novel bioresorbable urethral implant for the treatment of female stress urinary incontinence. We are now in the MDR process. This is a tough road. It is a challenge for a small company. That is why we are looking at the FDA strategy: what does it entail, and what steps should we take? That way, we can make a proper risk-based assessment before we start.”

Orikami’s Kees Eilander agrees: “Compared to European regulations, the FDA has always been seen as a major challenge. Now it’s the other way around: startups want to try it in America first and then in Europe. You have to have a good understanding of how the game works.” Andreas Baudot of Spierings Orthopedics adds: “We make medical devices, mainly for hip surgery. I think the FDA is a bit stricter. For example, they have different requirements for labelling. So, this workshop is a good first introduction to FDA basics.”

Challenge accepted

In fact, Enzyre is already on an FDA track: “We are creating a platform to bring diagnostics to the patient, both in the hospital and at home or in the doctor’s office”, Danique Steeghs and Michael Lie tell us. “We specialise in blood clotting diseases but want to expand this to include resources for diabetes patients. We are working on a 510(k) clearance to bring our product to the US market. So it’s good to learn the basics.”

Franca Verhaegh and Josephine Dodemont say they are also exploring the possibilities at HCM Medical “We are a contract manufacturer and produce medical products for other companies. We are often asked by our customers if they want to enter the US market. So, it is useful to know what this means for us. With European registrations, a lot of responsibility lies with the product’s owner. Is this different from the FDA? For example, is there more responsibility for us as a manufacturer?”

Diving into the fundamentals

Speaker Lorry Weaver has worked in the medical device industry for 40 years, specialising in FDA. “How did I get here? It was sort of by accident. I am a trained microbiologist; I can work in a clinical laboratory. When I first came out of university looking for a job, no labs were hiring. So, a medical device manufacturer hired me. I started in the quality department. The regulatory department is closely related to that. Regulatory was my favourite. There’s no school to become a regulatory professional. You learn it by working in the industry.

5-jaar event OnePlanet Research Center

De afgelopen 5 jaar werkten we aan de toekomst van Agri, Food en Health. Sinds de start in 2019 zijn we flink gegroeid in omvang, hebben we kantoren in Wageningen en Nijmegen, zijn onze faciliteiten uitgebreid met een nieuw lab, hebben we veel mooie onderzoeksontwikkelingen in onze innovatieprogramma’s, bloeit het OpenEducation-programma en werken we samen met MKB in de regio. We kijken ernaar uit deze mijlpaal te vieren samen met onze oprichters, stakeholders en samenwerkingspartners.

In een dynamische middag kijken we terug op de resultaten, geven demonstraties van ontwikkelde producten en blikken we vooruit op een mooie toekomst.  

Aanmelden kan hier.

Programma

Locatie: Industriepark Kleefse Waard, Westervoortsedijk 73, Arnhem

Dagvoorzitter: Irene Rompa

12.00 uur Ontvangst en walking lunch

13.00 uur Plenair openingsprogramma

Tijdens dit programma onderdeel neemt dagvoorzitter Irene Rompa ons mee in 5 jaar OnePlanet Research Center. In een wervelend programma komen diverse sprekers aan het woord.

13.45 uur Pauze en bezoek van de demo markt.

Op de markt worden diverse demo’s gepresenteerd die OnePlanet Research Center de afgelopen periode heeft ontwikkeld.

14.15 uur Parallelle sessies rond Health en Agrifood

15.00 uur Pauze en bezoek van de demo markt

15.30 uur Parallelle sessies rond Environment en Open educatie

16.15 uur Pauze

16.30 uur Plenaire afsluiting

17.00 uur Afsluitende netwerkborrel

Direct aanmelden kan hier.

Workshop Cybersecurity: What the hack! You’ve been hacked, now what?

More and more often, companies fall victim to a cyberattack. Due to digital dependency, the consequences are often enormous. For an organization, it is essential to be resilient and to act quickly and adequately. How can you best protect your organization against this? What steps should be taken and who is liable? We hereby invite you to an exclusive event in collaboration with our partner Poelmann van den Broek Advocaten. After this event, you will know exactly which steps to take to defend your organization against cyberattacks. Some practical examples will be discussed.

In this workshop you will learn:

  • Who is responsible for security & backups;
  • Who is liable in case of poor security or lack of backups;
  • What to do in case of a hack?
  • Tips for IT contracts.

Speakers:

  • Valerie Lipman, Poelmann van den Broek, Partner & lawyer, a lawyer at Poelmann van den Broek since 2012, specialised in commercial contracts, IT and IP.
  • Jan Willem van Aken, Poelmann van den Broek, lawyer at Poelmann van den Broek since 2023, specialised in commercial contracts, IT and IP.

Don’t miss out! Join us on May 21!

Location

Meet&Greet in Building M, Noviotech Campus Nijmegen. Transistorweg 5.
 
Good to know
The workshop is facilitated in English. Participation in the workshop is free for everyone, including drinks and bites. However, for cancellations within 24 hours prior to the event, we will charge a fee of 15 euros (excluding VAT) to cover expenses.

A few days before the event we will send an email from marion.schouten@briskr.nl with more detailed info on the workshop (you might need to check your spam box or add our email to your trusted contacts).

Digital Science & Innovation Day

Join us for an enriching half-day experience in Leiden as Benchling and Kadans Science Partner host the Digital Science & Innovation Day, a free event dedicated to R&D Digital Transformation.

Explore the forefront of life sciences digitalisation as we gather influential biotech organisations in the region. Benefit from the wisdom shared by thought leaders, covering topics such as the latest trends, challenges, and success stories in modernising R&D.

Don’t miss this prime opportunity to get new insights on the lab of the future and connect with industry peers to foster innovation in the region.

More information and registration.

SMB network meeting: How to attract talent in Health and Hightech (cancelled)

In an era where the demand for specialized talent far exceeds supply, the battle to attract and retain skilled professionals has intensified, especially in the critical sectors of Health and HighTech. As small and medium-sized businesses (SMBs) strive to compete in these competitive markets, the question looms large: How do we attract the talent necessary to innovate and thrive?

This meeting is dedicated to unraveling the complexities of the current talent shortage and exploring strategic approaches to talent acquisition and retention. We aim to look beyond conventional hiring practices and consider innovative perspectives on jobs, work, and talent identification.

We invite our network interested in the future of talent acquisition in the Health and HighTech industries to join us for a session of insightful discussions and networking. Together, let’s discover how we can adapt, innovate, and succeed in attracting the talent that will drive your businesses forward.

Don’t miss this opportunity to gain valuable insights about Gen Z and strategies to overcome the talent challenge in today’s competitive landscape. See you there!

Speakers
Renate Bouwman, The Economic Board Arnhem-Nijmegen, Human Capital; Working together for a labour market that works! 

In this region, entrepreneurs, knowledge institutions and government are working together on the talent needed for the transitions in the care, technology and energy sectors. Make your contribution to these initiatives and join in as talent or as an entrepreneur!

Angelique Driessens, 3sense; Collaboration Between Different Generations in the Workplace: Tips for Success

Working well with colleagues isn’t always a breeze, especially when they’ve grown up in different times. Millennials and Baby Boomers, for example, have pretty different work styles. As a manager, you’ve got a mix of at least three generations on your team. How do you make sure they all work together smoothly?

Sanne Pas, Kracht Recruitment; Recruiting with your community!

A recruitment platform that makes hiring more accessible, efficient, and cost-effective for all community members. How? By running effective recruitment campaigns and building a shared talent pool. There are countless reasons why that one applicant may not be the right fit at the moment. But imagine if you could also see the applicants from your neighbours? How many more talented people could we connect to this region?

Live event
This event will be organized in a live setting at Noviotech Campus in Nijmegen (building M, Meet&Greet area). A few days before the event we will send an email with practical information on directions/parking (sender = marion.schouten@briskr.nl). You might have to check your spam box.

Good to know
Presentations are in English & the entrance is free (registration upfront is needed though). We welcome new guests, so please feel free to pass on this invitation to relevant people in your network!

Unfortunately it is not possible anymore to register, because the meeting is cancelled due to circumstances.

Avantor® and Briskr Forge a Trailblazing Partnership to Elevate Startups and Scale-ups in Nijmegen

Avantor® and Briskr are joining forces in a game-changing partnership aimed at accelerating the growth of start-ups and scale-ups in the Nijmegen region. This collaboration embodies a shared vision of propelling innovation in the realms of health and hightech, thereby contributing to the region’s economic vitality.

Avantor®, a Fortune 500 company, is a leading life science tools company and global provider of mission-critical products and services to customers in the life sciences and advanced technology industries. From discovery to delivery, Avantor works side-by-side with scientists around the world to enable breakthroughs in medicine, healthcare, and technology at scale. Avantor’s portfolio is used in virtually every stage of the most important research, development and production activities at more than 300,000 customer locations in 180 countries. For more information, visit avantorsciences.com and find Avantor on LinkedIn, X (Twitter) and Facebook.

On the other side of this partnership, Briskr, the nurturing ground for startups and SMEs, provides a spectrum of services to address the hurdles faced by entrepreneurs in health and hightech sectors. Through Briskr’s academy program, business support, access to risk capital and validation services, startups are equipped with essential tools and knowledge to traverse the challenging landscape of the healthcare industry. Additionally, Briskr’s network of experienced healthcare innovation professionals aims to bridge the gap between healthcare needs and entrepreneurial innovations.

Together, Avantor® and Briskr will blend their distinctive strengths, creating a robust ecosystem that fosters both business growth and technological advancement. This partnership underscores a joint endeavor to nurture a flourishing innovation landscape in Nijmegen, inviting all ambitious startups and scale-ups to be part of this remarkable journey.

For more information about this partnership, please contact: Liz Fransman, Life Science Specialist  –  t +31 (0)6 89922081 – m Liz.Fransman@avantorsciences.com

Tooltronics event

Op donderdag 14 maart organiseert Tooltronics in samenwerking met fabrikanten het Tooltronics Technology Event op de NovioTech Campus, gebouw 52Nijmegen.

De modernste apparatuur staat opgesteld, beschikbaar voor ontwerp, prototyping, structuring, test, productie, reiniging, micro assemblage, bonding, en rework van boards, dies, designs en assemblages om te laten testen door de bezoekers. Hands-on live demonstraties worden gegeven. Bezoekers kunnen diverse presentaties van de fabrikanten bijwonen. Deelname aan deze leerzame dag is gratis.

Openingstijden: 9:30 – 17:00 uur
Adres: Jonkerbosplein 52, 6534 AB Nijmegen

Inschrijven kan via het inschrijfformulier

Meer informatie over de fabrikanten die hun primeurs demonstreren, vind je hier.

Nationaal Biotech Booster Event

Donderdagmiddag 14 maart 2024 staat het Eerste Nationaal Biotech Booster Event gepland. Een inspirerende bijeenkomst die plaatsvindt in de Jaarbeurs Utrecht, in congreszaal de Polar. Wij verwelkomen je graag tussen 13.30 uur en 14.00 uur. Het belooft een middag vol boeiende inzichten te worden, onder leiding van onze directeur Nettie Buitelaar. Verschillende inspirerende sprekers zullen het podium betreden en hun kennis en ervaring met ons delen.

Na een kort welkomstwoord starten we dit event met een interview met Constantijn van Oranje over het belang van valorisatie en NGF, de aansluiting met Biotech Booster en TechLeap.

Aan het woord komen verder ondermeer de volgende sprekers:

Dan Jing Wu – CEO en medeoprichter van VivArt-X, over de start van haar jonge bedrijf;

Linda Dijkshoorn – CCO & oprichter van EV Biotech, over de groei van haar bedrijf;

Jan de Kerpel – co-head corporate finance bij Van Lanschot Kempen zal zijn ervaringen delen op het gebied van financiën en bedrijfsstrategieën. 

We sluiten het officiële deel van de dag natuurlijk af met een gezellige borrel! 

Tot 14 maart in de Jaarbeurs!! Meer informatie en aanmelden.