4^thInternational Conference on Drug Discovery, Designing Chemistry and Pharmaceutical Analysis June 27-28, 2018 Vancouver, British Columbia, Canada

Alan Low is a Pharmacist, Clinical Associate Professor with the Faculty of Pharmaceutical Sciences at the University of British Columbia, Primary Care Pharmacist and Pharmacy Lead at BioPro Biologics Pharmacy, and Manager of Medical Affairs and Government Affairs at Servier. He supports the GI Society acting as the role of Board Advisor and volunteers on professional committees. Dr Low has experience in a wide variety of health and administrative settings including patient care in the hospital, outpatient clinics, and research. He has led a number of provincial initiatives in pharmacy both in British Columbia and Alberta with a focus on leveraging pharmacists’ expertise to improve patient outcomes. Alan is a Certifi ed Clinical Densitometrist (CCD) and the co-author of newly released “The Osteoporosis Book, 4th Edition: Bone Health” and has authored numerous publications and articles in scientifi c and health journals, including being a co-founding Co-Editor of the Pharmacy Management in Canada textbook. His interests lie in innovative approaches to improve patient’s well-being and resolve medical needs as they relate to drug therapy working in collaboration with specialist physicians, primary care physicians and allied healthcare practitioners.

Patient acceptance of biosimilars over innovator biologics continues to be marginal in many parts of the world. Biologics are complex drugs which are created using recombinant DNA technology. Developing identical copies of these molecules is not possible. Unlike generic versions of chemical molecules which are the same as the innovator version, the process of manufacturing biologic molecules by nature means the molecules produced by diff erent manufacturers are not alike. After patent expiry of an innovator biologic, a manufacturer is legally able to produce and market a biosimilar of the innovator biologic, however, production details and manufacturing processes are not released by the originator. Th erefore, a biosimilar is a biological product that is similar to the innovator version and has no clinically meaningful diff erences as shown by structural comparisons and clinical trials comparing the products. A biosimilar is demonstrated to be similar to its reference product by extensive analysis and studies comparing characteristics such as purity, chemical activity, potency and bioactivity. Minor differences between the reference product and the biosimilar product in clinically inactive components are acceptable. These minor diff erences are a normal occurrence during the manufacturing process for both innovator products and biosimilars. The regulatory authorities control and monitor lot-to-lot diff erences in the production of these medicines. Pharmacokinetic and pharmacodynamic studies are carried out to assess the comparability of the responses by human patients, including assessment of clinical immunogenicity. Th e duration, level and detail of clinical trials is abbreviated which allows for a lower development cost. When a patient is prescribed a biosimilar, they are unaware of the implications of that treatment. Often, the patient is not provided with a complete explanation of the choice of therapy selected for the patient’s condition and treatment. Without appropriate patient-centered guidance and education, most patients may perceive a biosimilar is not as effective as the innovator biologic. Even more concerning is the patient who agrees to begin therapy with a biosimilar and then is told by a friend or relative that they are not receiving an originator drug which casts doubt and changes expectations of the therapy’s effi cacy and side eff ects. Many of these patients may return to the physicians asking for an innovator biologic. This scenario can be signifi cantly improved with the involvement of pharmacists who can help educate and guide the patient as well as help ensure the patient adheres to the drug therapy and the care plan. Pharmacists can help patients understand the complexities of these biologic therapies and also navigate the payment process.

Application of biopharmaceutical concepts to formulation development has revolutionized strategy for dosage form design. Nanotechnology has become an essential element of pharmaceutical sciences and fi nds multiple applications in drug delivery systems in enhancing therapeutic performance of drugs. Many of the current “Nano” drug delivery systems are pedigree of conventional dosage forms like Nano suspensions, Nano emulsions, and Nano micelles. Nano suspension is an approach to deliver water insoluble and poorly bioavailable drugs by reducing size to submicron range. Th ereby its dissolution rate is increased and hence the bioavailability, where drug dissolution rate is the limiting factor. Nano emulsions are O/W or W/O emulsion, having droplet size from 20-200 nm that are transparent and do not have the tendency to coalesce. Nano emulsions show great aesthetic appeal and skin feel and fi nd their application in transdermal delivery of drugs, topical application for systemic drug delivery, oral delivery of proteins and delivering drugs through parenteral and intranasal routes. Nano micelles are self-assembling Nano sized (usually with particle size within a range of 10 to 100 nm) colloidal dispersions with a hydrophobic core and hydrophilic shell. Th ese are currently used as pharmaceutical carriers for solubilizing hydrophobic drugs and provide drug delivery platform to be exploited for multiple routes of administration. All of these nano formulations combine the advantage of maximizing therapeutic benefi ts with minimized side eff ects and improved safety, since they have enormous potential of being targeted at cellular level. Th is review describes various facets of nano drug delivery systems in relation to formulation, characterization, potential benefi ts and risks, and pharmaceutical applications in drug delivery.