Ari Siggaard Knoph’s Post

Exploring strategic options for Europe 🇪🇺 with your an #orphandrug? Reach out to Eva Cruz de Castro to meet at #jpm2024 to explore a partnership with Avanzanite Bioscience. License or Exclusive Distribution. We've founded to Avanzanite Bioscience with a mission of boosting #orphandrug access (patient objective) and unlocking their full potential in European markets (commercial objective). You should particularly meet Eva Cruz de Castro if you face challenges in Europe. Perhaps, there are very few patients that could use your medicine. Or the market access issues are overwhelming. Or simply, you only have a bandwith to go to to 2-3 countries at launch. Whatever is the trouble, we love challenges. Our confidence is not superficial. We have an unrivalled track record in market access and market development. And we will make sure that all back-end operations are running smoothly - distribution, pharmacovigilance, medical information, quality, compliance etc.

‘Read the enclosed leaflet carefully before taking this medicine’ - how many times have we read and heard this sentence? 💊 Every time we take a drug, we come across a lengthy leaflet with a long list of possible side effects and the conditions under which it would be best to avoid taking the drug. Well, to date this is necessary when considering that each treatment is developed on a sample of participants that leaves insufficient room for diversity while considering a limited number of characteristics… But when manufacturers begin to implement #virtualpatients in trials, enabling an inclusive, detailed and less time-consuming drug development procedure, it will no longer be needed. Contact us at [email protected] to learn more about how we will make #personalizedtreatments that work for everyone a reality! #medicalinnovation #virtualhumantwins

🚀 Introducing RegWhiz: Navigating the Labyrinth of Biopharma Regulation 🧬 I am thrilled to announce the launch of RegWhiz on Medium! As a Regulatory Affairs professional with a passion for genetic engineering, I believe in the power of knowledge to drive meaningful change. RegWhiz is designed to be your go-to source for insights at the intersection of regulatory affairs and advancements in the biopharma space. In my first article, I delve into the importance of informed regulatory guidance in the rapidly evolving field of medical innovation. With a focus on rare diseases and new biopharma advancements, RegWhiz aims to shine a light on the intricate processes that turn research into life-saving treatments. 🔍 What to Expect: Weekly in-depth articles and case studies, Updates on regulatory news and rare disease advancements, Networking events and podcasts featuring industry experts Join me on this journey as we navigate the complexities and celebrate the triumphs of this unique field. Your insights and participation are what make this community thrive. 📖 Read the full article on Medium Thank you for being a part of RegWhiz—where every detail matters, and every voice counts. #RegWhiz #Biopharma #RegulatoryAffairs #GeneticEngineering #RareDiseases #MedicalInnovation #KnowledgeIsPower

Attending the Pharmaconex conference could be the perfect opportunity for you to meet potential investors in the pharma market and establish better cooperation. This could lead to improved future trends and higher quality products, ultimately enhancing the quality of life for patients. Don't miss out on this chance to connect with like-minded professionals and make a real impact in the industry. #pharmaconex2023 #PharmaMarket #Investors #Cooperation #QualityofLife #Patients

🌟 Announcement: I will be presenting at PHUSE US Connect 2024! 🌟 I am thrilled to share that on Monday, February 26th, I'll have the honor of presenting at PHUSE alongside industry giants Peter Van Reusel and David Iberson-Hurst. We are set to take the stage in the “Digital Data Flow – From Vision to Reality” session stream, a topic that is crucial to transform and advance pharmaceutical research and drive efficiency! Join us as we explore the forefront of digital data flow in clinical research, aiming to bring vision to reality. This session is a must-attend for anyone passionate about the future of clinical trials and the transformative potential of digital protocols. Looking forward to seeing you there and engaging in rich discussions about our shared digital future in healthcare! 📅 Session Details: ++ Location: Salon B ++ Time: 11:00 AM - 12:30 PM 🔍 Presentation Highlights: ++ Peter Van Reusel will enlighten us with “DS01: ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality.” ++ David Iberson-Hurst is set to present “DS02: The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs.” ++ As for myself (William Qubeck), I'll be presenting “DS03: Digital Protocol Vision … How Digital Information Can Transform and Automate Our Processes.” #phuse #ClinicalData #DataScience #Biostatistics #ClinicalTrials #PharmaceuticalIndustry #HealthcareInnovation #DigitalHealth #RegulatoryAffairs #Biotech #DataStandards #eClinical #HealthcareData #ClinicalResearch #InnovationInHealth #DigitalDataFlow #ClinicalStandards #Innovation #cdisc #transcelerate

To continue to see and hear just how much #TrialHub is empowering Sponsors and CROs to make decisions with positive outcomes when planning and conducting their studies bring great joy... To see how much we have accomplished as a team this year (more to come on that topic shortly! 😁 ) also brings reasons to be cheerful. But for now, check out the link in the comments below👇 to see a real example of how TrialHub... - Reduced time spent conducting manual research to identify and suggest additional countries for a Rare Disease study by 50% ✅ - Provided the crucial insights needed to determine country strategies for a Rare Disease Clinical Trial ✅ - Boosted efficiency and access to hard-to-find or time-consuming insights such as the Standard of Care landscape, drug reimbursement, patient pathway and more ✅ - Supplied accurate, pre-validated data in real-time that can be trusted ✅ Would you like to level up your organisation's access to validated real-time data insights as we roll into 2024? #clinicalresearch #clinicaltrials #success #successstory #data #rarediseaseresearch #pharma #biotech #clinicalresearchorganisations

If you want well-informed data-driven decisions...

What a fabulous meeting  #cgmesa23 was. I got to reconnect with old friends, meet some in-person for the first time, and make totally new ones. And I’m not alone: 50% of respondents in DeciBio’s attendee survey cited connections and seeing old friends as their highlight. Other important updates and topics covered included: •Automation – manufacturing processes are rapidly being streamlined and automated to address a number of hurdles in the successful rollout of #advancedtherapies (Cellares’ splashy releases don’t hurt either!) •Delivery – one of the primary limiters of advanced therapeutics today. We need to get beyond #LNPs to be able to have a greater #clinical impact •Regulatory – the FDA is rapidly learning and growing to stay on top of #biopharma developments. An “exponential learning curve” is how Sumit Verma put it. This is not to create a “permissive” agency (thanks, Philip Cyr for the phrasing), but one that takes appropriate risks •Payors – How will insurers pay for therapies that in some cases are functional cures? We need better models and a rethinking of this paradigm to get away from the present network that has a “negative innovation bias” according to Bob Smith, Pfizer Here's to 2024 in Phoenix! #celltherapy #genetherapy #precisionmedicine #biotech

Welcome to Week 19 of 52 Weeks of WOW: Word of the Week Wednesdays Word of the Week: PLENARY SESSION Plenary Sessions: The main event where all paths converge, showcasing esteemed speakers and critical announcements to every conference participant. Why is this important? Plenaries set the stage for collective inspiration and unity, offering a shared experience that fuels the conference's momentum. What does the planner need to do? Curate captivating content and select high-profile speakers who resonate with the conference theme and engage the diverse audience. How can planners apply it? Elevate the conference atmosphere by orchestrating Plenary Sessions that captivate, inform, and inspire attendees from start to finish. Key takeaway: Plenary Sessions are the heartbeat of the conference, uniting attendees in a shared journey of discovery and empowerment. #52WeeksofWOW #MEDiC #MEDiCseries #pharma #biotech #medicalmeetings #mmp #eventsindustry #meetingsandevents #eventprofs #medcomms #medicalcommunications #medicaleducation