BioLabs’ Post

Patient access to effective and affordable medicines is the goal that brings all ATMP stakeholders together. Products in clinical use prior to these regulations have slowly died out due to a disconnect in clinical and commercial needs. The EMA is recognising the need for supporting hospital driven product development, where market approved medicines do not exist for a patient group. This ATMP world tour 2024 session is hosted by Peter Tropp from Region Örebro län (Örebro University Hospital) and we are very pleased to have Manel Juan from Hospital Clínic de Barcelona presenting. This duo will address the needs of the volume of patients outside of the clinical trial eligibility criteria of existing market approved ATMPs and in using hospital GMP functions to fill the gap where commercial options are not possible. The session also begins to explore the implications of obtaining autologous start material 'under duress' and the ownership of these autologous cells and data. We look forward to a lively discussion with access to effective and affordable medicines for patients in focus. https://lnkd.in/ggS_UR6V

For those attending our RAPS DC/Baltimore Chapter FDA Panel & Summer Mixer event on July 9th, please see the information in this post for some important details. KNOW BEFORE YOU GO We look forward to seeing you at the RAPS DC/Baltimore Chapter FDA Panel & Summer Mixer event hosted by Arnold and Porter on July 9th! Arnold and Porter is located at 601 Massachusetts Ave NW, Washington, D.C. 20001 We are providing transportation guidance below. Please note that there will be road closures due to a NATO Summit occurring at the Convention Center. Details and a link to an interactive map are provided below. In addition, a map of road closures is attached. We recommend using public transportation to travel to the event. Transportation Guidance Metro - Walking Guests using the Metro should exit the Gallery Place/Chinatown Metro Station. The Mt. Vernon Square/7th Street Convention Center Metro Station will be closed. The quickest route to 601 Mass will be to exit the metro station on 7th Street, walking north towards Massachusetts Avenue. When you get to Massachusetts Avenue, cross the street and turn right, walking away from the park towards 6th Street. Please use the 601 Massachyusetts Avenue entrance in the middle of the building. Please do not use the K Street entrance. This door will be locked at all times.   Guest Parking Instructions The parking garage at 601 Mass Avenue is located on 6th Street, between Massachusetts Avenue and K Street. All drivers must park inside the Arnold & Porter dedicated parking area inside the gate arms on P3. Please pull a ticket at the main entry gate and proceed to the Arnold & Porter dedicated area inside the P3 gate. Drive up to the P3 gate arm and it will open automatically. If the gate does not open, please scan your ticket to enter. Please park in any open space. Please use the garage elevators to go to the G level/Ground Floor. Arrival and Check-in All attendees should check in with security at the lobby desk. You will then be escorted by Arnold and Porter staff to the event location. Please stop by the even registration desk when and pick up your name badge. PLEASE BE AWARE of NATO Summit Event Occurring in D.C. on July 9th.  The United States is hosting the 2024 NATO Summit at the Walter E. Washington Convention Center. The summit will impact vehicular traffic, pedestrians, and public transportation to Arnold & Porter. However, there should be no issues entering the Arnold and Porter building garage or lobby. You may view an interactive map of road closures here.  HOST CONTACT INFORMATION We look forward to hosting you soon at Arnold & Porter. For questions or issues with transportation on July 9th, please contact Christina Purpura of Arnold and Porter at: Email: christina.purpura@arnoldporter.com Phone: 202.942.6496. https://lnkd.in/e_EQxNzt

Join ERGOMED Group TODAY at Outsourcing in Clinical Trials Europe 2024! 💡 Discover how Ergomed solutions can optimize your operations at Booth #80. Our Clinical Research experts, Marijana Prodan and Alba Peña Paris, along with PrimeVigilance 's Iwona Kmicikiewicz, joined by our commercial team of Bernd Saynisch and Aleksandra Marinkovic, are available to answer any queries you may have. Looking forward to continuing discussions today! #ClinicalResearch #OCTEurope2024 #Barcelona

Take a look at this! 👀 In honour of the Summer Olympics, we hosted our own inspired event yesterday. Our lawn turned into an Olympic playground - with fewer world records and more laugh-out-loud moments! It was a fun twist on Olympic glory, where our coworkers "transformed" into Olympian athletes for an epic tug-of-war showdown, and three-legged race, among the many activities. They might not have broken any world records, but they definitely broke the laughter barrier! Big shoutout to all the “athletes” who participated and made the afternoon an unforgettable one! Thanks also to our fantastic social committee for organizing this event. Whether you were a gold medalist or just there for the fun, your spirit and teamwork were the real winners today. 🎉 Check out some snapshots of the action-packed afternoon and see if there’s a future "Olympian" among us! 😉🏃♂️🏃♀️ Just as our team brought their A-game to this event, our world-renowned Pharmacokinetics team brings the same level of commitment, precision, and teamwork to every clinical trial we conduct. Whether it’s #Phase1, Bioavailability, Bioequivalence, First-in-Human, or Psychedelic Clinical Trials, you can expect a gold medal performance from us every time. But don't worry – we promise to leave the potato sack races and egg tosses at home! 🥇 . . . #clinicalresearch #clinicalstudies #clinicaltrials #bioanalsysis #cro #clinicaltrials #Biopharma #drugdevelopment #genericdrugs #biotech #pharmaceuticalindustry #clinicalresearch #olympics

Check Out Our List of Upcoming Industry Events 🌎🖥️👥🖱️🌎🖥️👥🖱️🌎🖥️👥🖱️ #IndustryEvents #MedicalDevices #HealthCare #Sustainability #ISO #FDA #Biocompatibility #Microbiology #Sterilization #Chemistry #Toxicology #Cannabis #TattooInk #Cosmetics #Testing #Regulatory #MicroBioConsulting https://wix.to/rhT8HoG

Check Out Your Upcoming Industry Events 🖊️🗓️ We are continuously adding and updating the list with links on our website. Click to find more! 👇 https://wix.to/zdksGqb #IndustryEvents #Webinars #Conferences #MedDevice #MedTech #Cannabis #Consulting #Biocompatibility #Sterilization #Microbiology #Chemistry #Toxicology #MicroBioConsulting

OccamPoint Webinar is excited to announce our next webinar on Nov 20, 2024: The Power of Real World Evidence: Accelerating Approvals In Global Markets. Setareh Aria Williams PhD CMPP, President & CEO of Star Biopharma Consulting, will share a case study featuring the use of #RWE from a US-approved product to secure the #approval of a new drug in the European Union (EU). The marketing authorization application (#MAA) incorporated data from one pivotal #clinicaltrial, #postmarketing data from the U.S. market, and a #realworldeffectiveness and #cardiovascular safety study. The successful use of RWE in this instance addressed a critical data gap, ultimately leading to the drug's approval in the EU. An HEOR industry veteran with 20+ years of in-house #pharmaceutical industry experience, Setareh Williams leads Star Biopharma Consulting. This #womanowned business generates robust real-world evidence to meet the rigorous demands of regulators, payers, and healthcare practitioners to inform decisions regarding research design, and the best source of data to meet stakeholders' needs in a timely and efficient manner. Register at the link below to learn more about this powerful application on November 20. Thank you to our sponsors for making these events possible: Clinical Research Strategies, LLC, Keliomics, Stat4ward and Telperian Inc #clinicalresearch, #biotechnology, #pharmaceutical, Julia Varshavsky, Ph.D.,Katie Rapp, Sheila Babnis, Greg Ball, Beth Brinsdon, Mark G. Eller, Susan Gibson, Dean Gittleman, Shuguang Huang, Chinglin Lai, Rick Landin, Lucia Mokres, Corsee Sanders, Ph.D., Winifred Wu, Yi Wang, PhD, MBA, CLP, Peng Yang, Rezi Zawadzki, Daniel Hargrove https://lnkd.in/gE8Tc5D9

Step into a world of unparalleled growth and opportunity at 35th Annual European Pharma Congress Set to take place on March 10-11, 2025 Rome, Italy. This premier event offers a dynamic platform for professional advancement and industry innovation. Here’s why you should seize this opportunity. Expand Your Knowledge Base Enhance Your Skillset Enhance Your Professional Profile Join a Global Community   #PharmaEurope2025 #CallForProposals # #IndustryExperts #ProfessionalDevelopment #NetworkingOpportunities #SubmitYourProposal #SuccessStories

Last Friday, I was privileged to witness the 100th anniversary of Roche in Belgium. It was an absolute honor to be a keynote speaker at their celebration event, and the perfect moment to take a step back and reflect on Roche's remarkable journey, and their enduring commitment to advancing healthcare in Belgium. I was inspired to see how they too have been at the forefront of addressing critical healthcare challenges with their innovations in diagnostics and medicines. It reminds me that pharma and biotech companies might have different approaches - sometimes as partners, sometimes as competitors - but we’re always united by our commitment to transforming patient outcomes and improving quality of life. Prevention, early diagnosis and rapid access to innovative treatments: it’s what keeps us moving forward, and it’s our industry’s responsibility to society. So, I echo today’s call for faster and easier access to innovation for patients, and for an effective healthcare spending. We’ll need a stable policy and investment climate and we need to move away from silos. I heard a clear call for policies, frameworks, and infrastructure to ensure that high quality data can be securely shared between stakeholders and across projects to enable personalized care. It’s a critical knot to untangle, as it’s a cornerstone for future-proof healthcare. As we look to the future together, I’m confident that collaborations between industry leaders like Roche, innovative biotech companies like Galapagos, and Belgium’s world-class academic centers will continue to drive progress and shape the future of healthcare - in Belgium and beyond – provided that we can operate in a stable and supportive climate for innovation. Congratulations once again to Roche Belgium & Luxembourg and Roche Diagnostics Belgium on this momentous milestone. Here's to the next hundred years of advancing healthcare together! #CloseTheHealthcareGap #Roche100yinBE #PioneeringForPatients