Entrepreneurs that move from research to clinical development phases and beyond go into a very regulated area with options as well as pitfalls. Chances of success are increased significantly if a company is aware of all this and more good medicines will reach the patients that way. Ozack wants to increase progress by infusing our knowledge to navigate the regulatory maze through development of medicine within all phases of drug development. We will • work out regulatory strategies with the company to choose the best route and mitigate risk • glue clinical, nonclinical, and CMC data together into a well understood story • ensure successful liaising with Health Authorities as partners rather than opponents
Eksternt link til Ozack ApS
Ole Maaløes Vej 3
Copenhagen N, Cphg. 2200, DK
Ozack ApS genopslog dette
Let's celebrate what we do best: partnerships. Join me at BIO-Europe, November 4–6, 2024, in Stockholm, Sweden, where the event marks 30 years of facilitating partnerships. Register here: https://lnkd.in/dBNBb6js Informa Connect
Appreciated the opportunity today to meet many EMA Regulators in person in Amsterdam! SMEs are encouraged to grab the opportunity to listen, learn and discuss directly with the regulators in Europe at the EMA premises.
We are hosting the #SME Info Day on 18 October. Join us to gain crucial regulatory insights and unlock your company's full potential for innovation! 💡 Why attend? - Explore EMA’s resources for small and medium enterprises (SMEs) and the various support tools available for medicine development - Get updates on topics such as scientific advice, clinical trials, medical devices, the new EU HTA regulation, the new EMA fee regulation and medicine shortages - Network with industry peers and EMA officials. If you attend the event in person don’t hesitate to engage with EMA staff during the lunch break. 📍 Where: virtual & in-person at EMA’s office, Amsterdam To watch the live broadcast 👉https://lnkd.in/eqrsesVM #PharmaSMEs #VetSMEs #EMAEvents
Niiice with successful biotech spin-outs from Aarhus University in Denmark!
Great catch Commit Biologics and great match Mikkel Wandahl Pedersen!
Why seek advice from one or two National Regulatory Agencies in EU and not directly EMA? Well..... 💡 National Advice offers the opportunity to meet, discuss and receive extra helpful advice. EMA Advice is usually written procedure only. 💡 Your Clinical Trial Applications in EU are approved per country by the national agencies and NOT EMA. 💡 Clarifying expectations to increase the likelihood of success of the clinical trial in your lead country is achieved through national advice.
A very interesting webinar by FDA (CDER), on the ICH M12 Drug-Drug Interaction Studies Final Guidance, for small businesses, was attended @Pramo Muttucumaru on 9 October 2024. Key takeaways were: * Drug-drug interactions (DDIs) may occur when patients take more than 1 medication. Therefore, it is important to conduct in-vitro DDI assessments early in development, ideally before patients are enrolled into clinical studies * Further to the outcome from in-vitro DDI assessments, clinical evaluation should then be conducted, tailored based on the specific drug, intended patient population and the therapeutic context Attended by over 7000 participants, this webinar covered the first globally harmonised regulatory guidance on the assessment of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. A systematic approach was described, including in vitro evaluation, clinical studies, predictive modelling, study interpretation, risk assessment and risk management.
🎬 A face-to-face (FTF) meeting between FDA and industry is now defined as either in-person or virtual with cameras on. This includes all PDUFA, BsUFA, and OMUFA meeting types. 💡All meetings have a hybrid component. 💡During in-person FTF meetings (with a hybrid component), FDA staff who will be involved in the discussion of the questions are expected to attend in person. 💡FDA recommends that for hybrid meetings “observers” (those not expected or likely to directly participate in the discussion) join the meeting virtually.
Regulatory Do’s and Don’ts Tips from #FDA, for small businesses was shared by FDA and NIH on a very interesting webinar, attended Pramo Muttucumaru. Key takeaways were: 💡 Prepare and inform yourself by reading the relevant FDA and ICH guidance documents before you seek advice 💡 Engage early with FDA 💡 There is a wealth of available resources to help small businesses with effective early development of drug Attended by over 6000 participants, the webinar covered the main #CMC, #nonclinical and #clinical #IND requirements for First in Human oncology studies and cell and gene therapy products, and medical devices.
Go talk to the FDA early - also when you develop a combination product for US (comprised of any combination of a drug, device, and/or biological product)! Take aways by https://www.ozack.dk/ from this final guidance: 💡 Lead center at FDA can be defined by requesting from OCP (combination@fda.gov) 💡 All interactions should go through the lead center for the combination product 💡 Very nice high-level table (appendix 1 and 2 in the guidance) of possible interaction mechanisms with FDA
Need support in better understanding when to contact the Agency during preclinical development of your early stage anticancer-therapeutics, devices, and diagnostics? 👂 Check out this opportunity on September 4th to receive an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH. #oncology #FDA