Healthcare & Pharmaceutical Awards 2019

74 GHP / 2019 Healthcare & Pharmaceutical Awards , Emphascience Inc. Emphascience Inc.: Best Pharmaceutical R&D Company - New York Award-winning Emphascience, Inc. is a private pharmaceutical company, focused on developing novel formulations of proven drug products to address unmet medical needs in the treatment of pain, cancer, infections, andmany fatal and debilitating diseases. We share an insight into the work the firmundertakes in this vital sector and how it aims to drive life- extending developments throughout the pharmaceutical space. Thanks to its vast industry expertise in the design and development of complex dosage forms, Emphascience has come to be a respected name in the pharmaceutical research and development market. Since it first began, the firm has been focused on the reformulation and optimization of drug products, creating innovative solutions to a variety of existing issues. After all, a pharmaceutical product formulation comprises both, active and inactive ingredients, in the finished product. More than just being a means to package and deliver the drug to a patient, they become an environment that is meant to protect and promote the preferred characteristics of the active ingredient. In a way, similar to how the environment at a school can help nurture and turn the attention of its pupils to education. Pharmaceutical product formulations can protect the drug from chemical degradation, improve the rate and extent of delivery to its site of action, increase patient acceptance, or improve compliance of a treatment. By redesigning the composition of existing medicines, whose pharmacological and therapeutic efficacy have already been established in the clinic and in practice, the path to market is one of the surest and fastest, and considerably less risky or costly compared to a new chemical entity. In most cases, this means that no new clinical studies to establish safety and efficacy. Yet, the novelty of the formulations and drug delivery strategies developed by Emphascience offer, in most cases, the possibility of patent-protection, differentiated branding, exclusive market presence and faster market entry than a typical generic product. Bolstered by its emphasis on science, creativity, and energy for limitless exploration, the Emphascience team is passionately committed to offer newer, safer, more exciting therapeutic options to all stakeholders of healthy lives. Since innovative formulations designed by Emphascience are based on molecular-level interactions of the active with its immediate environment (product composition), the concepts and technologies that work for one drug are often applicable to other drugs with similar structures. This approach leads to multiple product concepts within a very short period of time. In the last six years, Emphascience has built upon some outstanding technical successes to develop a sizeable pipeline of differentiated products for commercialization. For example, a strategy developed by Emphascience to slow down deamidation of some peptides and protein-based actives has been effectively used for the design of a room-temperature-stable, ready-to-use injectable for a drug used to treat serious, acute conditions that would otherwise be lyophilized (freeze-dried) or frozen below -20°C. For many high potency drugs, in addition to chemical instability, often the loss of potency due to selective sorption on the container is a challenge. Emphascience has developed a simple solution to prevent loss due to adsorption for various large and some small-molecule drugs without changing the container type or the chemical structure of the active. Other technical successes achieved by Emphascience include antioxidant free, chelator-free formulations for drugs that are susceptible to oxidation; stable, heat- sterilized, ready-to-use sterile solutions for injections that require cold-chain, or freeze- drying, or cannot be terminally sterilized; product compositions that are safe and suitable for very young children; long-acting drugs that do not require frequent dosing. Work is in progress to improve products that cause significant injection-site pain, or severe allergic, anaphylactic reactions, and these developments will drive even greater success for the firm. Emphascience’s current business model is to conceive and design creative new pharmaceutical product concepts and turn them into innovative, scaleable formulations in a research laboratory setting, before licensing the knowhow and technology to pharmaceutical corporations for development and scale-up under good-manufacturing- practices (GMP),, followed by registration, regulatory filing and marketing. Unlike large pharmaceutical corporations, early explorations of product concepts are not limited by clinical or commercial expectations. Yet, once successfully designed, the products are selected for licensing only if they satisfy both clinical and commercial acceptance-criteria. Such research-focused setting affords flexibility and allows innovation to thrive. In the future,