2019 was an exciting year for the clinical trial and medical community with some major breakthroughs and news. Here are the top 5 groundbreaking happenings that caught our attention this past year.
Continuing High FDA Approvals
2019 was a great year for drug approvals by the FDA. Although down from the previous record breaking 59 approvals in 2018, this year still saw a whopping 48 drugs approved.1 Some of these approvals included treatments for cancers, sickle cell disease, and cystic fibrosis2 and 21 orphan drugs for the treatment of rare diseases.3 This spells good things for 2020 with growing opportunities for pharmaceutical and biotechnology firms.
First CRISPR Clinical Trials See Success
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) also got a boost in 2019 with success seen in patients treated for sickle cell disease and beta-thalassemia with gene edited bone marrow.4 This is finally some proof of its potential for clinical treatments and promises more revolutionary medical usages in the future.
AI and Big Data a New Horizon in Drug Development
The rise of big data and AI machine learning has also begun to shape the world of medical research and healthcare. Drug development using this technology has emerged in pharmaceutical and biotech companies to speed up the process.4 AI technology has also been utilized to identify ideal candidates for clinical trials to increase recruitment rates.4 This is particularly useful when recruiting for rare disease studies due to the low number of potential participants. You can read more about the difficulties faced by rare disease clinical trials in our previous blog post.
Cannabis Treatments Continuing Innovation
Of course we have to mention the continuing boom in cannabis-based drugs in Canada since the recreational legalization in October 2018. Although medically legal since 20015, the recreational legalization brought further interest in developing everyday products including edibles, topicals, and extracts.6 This increased consumer interest has sparked more clinical trials including treating children with Autism Spectrum Disorder using cannabidiol.7
Psychedelic Shrooms for Treatment of Depression
Similar to the success seen by the medical marijuana industry, the FDA gave the green light to clinical trials using Psilocybin, or magic mushrooms, for UK patients with treatment-resistant depression.8 This was cited as the ?largest controlled study of psilocybin to date? and shows the changing views towards previously demonized treatments.8 The successful results of this clinical trial suggest that a novel treatment for serious depression is on the horizon.
With such an exciting year for clinical trials and medical advancements in 2019, Bay Area Research Logistics is excited to see 2020 be an even more successful year. Our expertise in planning, packaging, labeling, storage, and distribution can contribute to the clinical development of 2020. Contact us to learn more.
1 Gardner, Jonathan. ?5 Trends to Watch at the FDA in 2020.? BioPharma Dive, January 9, 2020. https://www.biopharmadive.com/news/5-trends-to-watch-at-the-fda-in-2020/570077/.
2 ?Novel Drug Approvals for 2019.? U.S. Food and Drug Administration. FDA. Accessed January 13, 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019.
3 Brennan, Zachary. ?FDA: 2019 Continues Uptick in Orphan Drug Approvals.? Regulatory Affairs Professionals Society (RAPS). Regulatory Affairs Professionals Society (RAPS), January 6, 2020. https://www.raps.org/news-and-articles/news-articles/2020/1/fda-2019-continues-uptick-in-orphan-drug-approval.
4 Breindl, Anette, Karen Carey, Michael Fitzhugh, Lee Landenberger, Randy Osborne, Alfred Romann, Cormac Sheridan , and Peter Winter. ?Year in Review: From Capital Markets to CRISPR, 2019 a Pretty Good Year for Biopharma.? BioWorld RSS. BioWorld, December 30, 2019. https://www.bioworld.com/articles/432068-year-in-review-from-capital-markets-to-crispr-2019-a-pretty-good-year-for-biopharma.
5 ?Understanding the New Access to Cannabis for Medical Purposes Regulations.? Government of Canada. Government of Canada, September 30, 2016. https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/understanding-new-access-to-cannabis-for-medical-purposes-regulations.html.
6 ?What You Need to Know about Cannabis.? Government of Canada. Government of Canada, October 17, 2019. https://www.canada.ca/en/services/health/campaigns/cannabis/canadians.html.
7 Barchel, Dana, Orit Stolar, Tal De-Haan, Tomer Ziv-Baran, Naama Saban, Danny Or Fuchs, Gideon Koren, and Matitiahu Berkovitch. ?Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-Morbidities.? Frontiers in Pharmacology 9, no. 1521 (January 9, 2019). https://doi.org/10.3389/fphar.2018.01521.
8 Bergland, Christopher. ?Psilocybin: Four Important Takeaways from a Clinical Trial.? Psychology Today. Sussex Publishers, December 14, 2019. https://www.psychologytoday.com/ca/blog/the-athletes-way/201912/psilocybin-four-important-takeaways-clinical-trial.