14 GHP / Biotechnology Awards 2018 , Drawing on more than 25 years’ experience in clinical pharmacology research, Altasciences offers quality solutions to biopharmaceutical companies across the world, to support both traditional and adaptive designs involving healthy normal volunteers and patient populations. Working closely with its sponsors, Altasciences is a contract research organization (CRO) that is constantly looking for ways to improve its range of services to meet the expanding needs of clients; this has led to Altasciences’ development of specialized and complex offerings, including human abuse liability/potential trials, early cardiac safety assessments, driving simulation studies, cognitive testing, smoking evaluation, biologics and biosimilars testing, and renal/ hepatic impairment studies. Dr. Wood explores these developments in more detail and highlights how the company is adapting around the latest advancements it is seeing in the clinical research market. “Currently, Altasciences is focused on clinical pharmacology studies, an area we have been working in for over two decades. Originally, Altasciences mostly worked on pharmacokinetic studies to look at how new BI180004 Best Early Phase CRO - North America With facilities in both the U.S. and Canada, Altasciences Clinical Research offers comprehensive Phase I/II drug development, including the full array of support services, such as small and large molecule bioanalysis, datamanagement, medical writing and biostatistics. We spoke to Dr. GrahamWood, Chief Research and Development Officer at Altasciences, to learnmore about the firmand the vast array of services and solutions it has to offer. compounds are absorbed and then eliminated from the body. However, over the last 15 years, we have been moving more and more into assessing the pharmacodynamics of new compounds, either by using biomarkers or other measures of the compound’s efficacy. To help further expand our access to patient populations we recruit and the procedures we perform, we have been very active in forming partnerships with local hospitals and private clinics. This increases access to patient populations in key therapeutic areas, such as renally-impaired patients. Innovation is at the core of how Altasciences designs and conducts clinical studies, allowing us to provide sponsors with the data to establish the safety of their product, and in many cases, data on the potential efficacy of their product,” as Dr. Wood has emphasised. “Altasciences has been at the forefront in conducting research on cannabinoid-based products for over 10 years. In fact, we have run over 30 studies on different cannabinoids or with patients using cannabis. This is why Altasciences was recently approached by a sponsor, Tetra Bio-Pharma, to help them develop their cannabis product for drug submission. Tetra Bio- Pharma is developing the world’s first cannabis extract that will be submitted for approval as a botanical drug for the treatment of neuropathic and breakthrough pain. The drug product is a whole plant extract of cannabis that is smoked with a titanium pipe. Altasciences was able to show that the product is safe and well tolerated. Furthermore, we demonstrated that the very fast delivery of the drug, as demonstrated by the Cmax in less than 10 minutes, should allow for much faster pain relief. This will fill a gap in the treatment of breakthrough pain since the onset of action might be up to two times faster than what is currently used. With regards to the future, we plan to further develop the different types of pharmacodymanic assessments we can do. Having the clinical expertise to collect the samples, combined with the bioanalytical expertise to analyse them, allows us to design, conduct and evaluate the data that can give sponsors great insight into the effectiveness of their compounds. A good example is in the emerging area of oligonucleotides that are being developed as drugs. We have experience in dosing in our clinical studies using small inhibitory RNAs (siRNA) that are designed to lower the production of the Company: Altasciences Clinical Research Contact: Amy Sikora Address: 575 Armand-Frappier Blvd., Laval, QC, H7V 4B3, Canada Phone: 001 450 973 6077 Website: www.altasciences.com target protein. Our bioanalytical laboratory also has a lot of experience in measuring siRNA in the blood to establish the pharmacokinetics. Furthermore, we have very good experience in measuring change in the target proteins, or other downstream effects, to examine the pharmacodynamics.” Fundamentally, Altasciences offers all of the services of a large CRO, but with a hands- on, flexible and customized approach. The company works as an extension of their clients, as partners, sharing valuable information to ensure the best solution is provided, and proactively identifies any obstacles to avoid delays and extra costs, including determining the ideal strategies to recruit healthy normal volunteers and patient populations. This pioneering, innovative approach will remain Altasciences’ continued focus as it looks to the future.