Fortrea’s Post

Geography Trivia: The closest city to Toronto's antipode is Augusta, Australia. 🌏 In other words, Australia and PurMinds NeuroPharma's HQ couldn't be farther away from each other, yet, that's where the psychedelic startup company is planning its Phase 2A clinical trial. It's cool to see how professional connections and an intimate understanding of the regional regulatory environment can outweigh the sheer challenge of moving delicate drug product from one side of the planet to the other. ______ This year, I started working with one of our newest communities, Clinical Supply Leader, to talk about solving problems related to manufacturing and moving medicine for clinical trials. That's how I connected with Amy Reichelt, Ph.D., for this Q&A about PurMinds' plans to test efficacy for their botanical psilocybin, treating patients with depression who also have #Parkinsons, a world away. 🔌 Personal plug: I'm building my network of experts who want to write about clinical supply issues. If you or someone you know has insights to share, DM me!

“The positive data from our Phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program. Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well-tolerated. We are especially encouraged that the IM route produced psychedelic effects in the majority of subjects, with a short-duration psychedelic experience from a single administration of SPL028. These results for IM dosing of deuterated DMT are highly promising and will help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing.” - Doug Drysdale, Chief Executive Officer of Cybin Inc https://lnkd.in/eBgTE7Ur

Signature gathering has officially kicked off to qualify an initiative for California’s 2024 ballot that would spend $5 billion to create a state agency focused on advancing research and development of psychedelic therapies. Known as the TREAT California Act, the measure would not itself change the legal status of any substances. Rather, it would establish a state agency called the Treatment, Research, Education, Access and Therapies (TREAT) Institute, which would identify opportunities for advancing scientific research and development into the therapeutic potential of psychedelics. #psychedelics #psychedelictherapies #psychedelicreserach #psychedelicpolicy https://lnkd.in/g7DmyiSp

Start your program the right way. Our experts in #earlyclinicaldevelopment and #clinicalpharmacology set you up for #drugdevelopment efficiency with highly coordinated efforts to anticipate potential challenges, recruit the right patients, engage top investigators and design a trial that will build a platform for later-stage success.

A Psychedelic Success! 🍄🎤 We would like to commend Sofia Raitsin, PhD. for her amazing panel discussion on the Methodological Considerations for the Abuse Potential Evaluation of Psychedelics. And thanks to Dr. John Oldenhof for providing his expert support throughout the conference. BioPharma Services Inc. specializes in #Phase1 clinical trials, bioavailability, bioequivalence, First-in-Human and Human Abuse Potential Studies (#HAP). Let our world renowned Pharmacokinetics team execute your next clinical trial with confidence. . . . #clinicalresearch #clinicalstudies #clinicaltrials #cro #clinicaltrials #Biopharma #drugdevelopment #phase1 #CCALC2023 #AbusePotentialEvaluation #Psychedelics

We celebrate Clinical Trials Day on May 20! At PARTS we collaborate in more then 600 clinical trials! On May 20 in recognition of what is often considered the start of the first randomized clinical trial we are very proud to bring hope to patients. In 1747, James Lind began a clinical trial on this day to study the effects of different remedies for scurvy among sailors at sea. His research famously provided evidence of the benefits of citrus fruits to treat this disease. Clinical trials have undergone many changes since the time of James Lind, not only in respect to medical, scientific and technological advances, but also in terms of ethical and legal requirements. Regardless, clinical trials remain a critical part of drug development, as a means of generating evidence to support the regulatory decision-making for safe and effective new medicines. #Erasmusmc #science #PARTS #pathology #departmentofpathology #PARTS #ERASMUSMC

Celebrating International Clinical Trials Day with Team Raptim! Today, on International Clinical Trials Day, we take a moment to express our immense gratitude to our incredible team at Raptim Research! Your dedication, expertise, and unwavering commitment are the driving force behind successful clinical trials. Through your tireless efforts, you contribute not only to ground breaking medical advancements but also to bringing hope to patients worldwide. Thank you for making a difference! #InternationalClinicalTrialsDay #RaptimResearch #ClinicalTrials #ThankYouTeam #CRA #CRC #CRO #ClinicalOperations #DataManagement #Biostatistics #MedicalWriting

Introducing the Pα+ Library! Through our years of reporting at Psychedelic Alpha we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews. The Pα+ Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling. The inaugural deposit to the Pα+ Library introduces some of the key concepts in the matter of psychedelic REMS. It's thanks to the expertise of our Advisors like Michael Haichin, PharmD, BCMAS, who led the underlying research for this REMS note (and more in-depth reports on the matter), that we're able to produce these pieces. A link to the psychedelic REMS piece is in the comments. If you would like to access the Library, please subscribe to Pα+. (Send me a note if you would like to discuss team or corporate plans.)

"Celebrating the successful completion of the 'Principles of Clinical Pharmacology 2023-24' course from the esteemed NIHR (National Institute for Health and Care Research) 🏆 This transformative journey delved deep into the intricate world of drug development, mechanisms, and patient outcomes. This accomplishment signifies my commitment to staying at the forefront of medical advancements. Excited to apply this newfound knowledge in enhancing patient care and contributing to the ever-evolving landscape of clinical practice. 🌐💊 #ClinicalPharmacology #ContinuousGrowth #HealthcareExcellence