Exploring Drug Delivery Solutions with Kashiv Pharma

By: Shekerah Primus On Tuesday March 13^th, iJOBS visited Kashiv Pharma, a small company located on the former Sanofi campus in Bridgewater, NJ. From its humble beginnings 6 years ago with only 8 employees, Kashiv has grown exponentially, becoming a very successful company with ~130 employees.  The founders named Kashiv after two of their children, emerging with a unique name that not only has deep personal roots, but also invokes the Indian God Shiv: a powerful God who lives at the top of a mountain. The effect is: “here greatness is born.” This deep pride in their company was showcased throughout the visit. The site visit began with warm welcomes from security as well as HR representatives, who got us settled into the meeting room with coffee and goodies to sustain us as we waited for presenters to begin. Presentations were given by three executives who shared with us the key aspects of their company, from product choice to commercialization. This was followed by a short lunch with various scientists and other team members and culminated with a tour of their labs and manufacturing plant. The meeting room—called “the party room” by some—sported golden streamers from the ceiling and is apparently where the frequent company celebrations occur. I can already taste the delicious Indian food! Other beloved employee pastimes include ping-pong tournaments in the break-room, and intensely competitive games of laser tag. Throughout the entire experience, employees expressed their love of working for a small company, which has a family feel and gives them the opportunity to shine, as well as their deep pride and belief in the work they are doing. The first speaker was Charmaine Maskarenas, the Director of Human Resources, who gave us a brief overview of the company. Kashiv focuses primarily on Research and Development. Specifically, they develop innovative formulations to improve drug delivery.  One area of interest that she highlighted was their efforts to combat the opioid epidemic through their Abuse Deterrent Overdose Protection Technology (ADOPT^TM). This technology focuses on reformulating drugs to make them difficult to liquefy for intravenous, or crush for intranasal, and other types of abuse. While the company is Research and Development-driven, most of their work is Chemistry-related, and they tend to contract out the biology work. Indeed, the rows upon rows of HPLC and GC machines, and solubility tests in progress in the two labs we visited highlight the key role of chemistry in their R&D pipeline. Additionally, with their focus on research, they currently do limited manufacturing at their facility; instead, they work with external vendors for commercialization of the products they’ve developed thus far. Their facility is capable of supporting large-scale manufacturing, however, so they plan to make full use of it as the company continues to grow. In fact, our tour group commented on how quiet it was in the manufacturing facility, with many large machines wrapped up tightly in clean rooms, awaiting safety inspections. It won’t be quiet for long! Charmaine ended with an inviting smile saying, “we’re always looking for wonderful new talent.” So to all you job seekers out there, let your resumes shine! Charmaine handed it off to Pavan Handa, the Chief Business Officer, who expounded the business model and mission of the company and gave an in-depth accounting of their key technologies. Pavan explained that their business model, which has propelled Kashiv’s growth, is to focus on technology. The company secures continued advancements by searching out and accumulating new talent for method development…hint hint job-seekers.  Their premier mission is to provide improved versions of known medicines. To accomplish this, they have developed technologies to improve drug delivery in different ways, such as increased solubility, site-specific release and fast action.  The trademarked acronyms representing these technologies are just as cool as their functions: LOAD^TM (Long Acting Depot), a long-acting subcutaneous or intramuscular injection, can be used to control the symptoms of chronic diseases, thereby improving patients’ quality of life. FAST^TM (Fast Acting Sublingual Technology): allows for rapid onset of medicinal action. ENCORE^TM (Enhanced Absorption Controlled Release): is time-release technology, that targets site-specific absorption of medicines, thereby improving patient compliance and reducing the necessary dose. And BIOMAXX formulation technologies improve the efficacy of poorly soluble and impermeable drugs by maximizing their bioavailability. Pavan also explained how Kashiv’s expertise in drug delivery gives them the ability to develop complex generics, making specialty drugs more affordable. The head of Regulatory Affairs rounded out the presentations. A distinguished scientist in her own right, Dr. Harpreet Sandhu has more than 25 years of industry experience as a formulator. Harpreet explained that other than commercialization, the main hindrance to the growth of small pharma companies is the substantial investment that goes into drug discovery, and the length of time between investment and returns—some drugs can take up to 20 years to go to market. She also outlined the numerous pitfalls that can occur: from the early discovery phase, through clinical trials and FDA approval to commercialization, highlighting the need for companies like Kashiv to make improvements on drugs that have already undergone this extensive approval process. As such, the product research team at Kashiv takes into consideration not only the needs of the market when picking new drugs for their pipeline, but they also evaluate their R&D strengths to determine whether they can improve the drug in some way, (enhance solubility, stability, permeability etc), to ultimately increase patient compliance. Improved versions of these drugs go through a much faster route to approval, since extensive studies of the active ingredient have already been done. This drug category, called 505(b)2 is cost-effective for the company and beneficial for patients. Overall, I found the Kashiv site visit enjoyable. The company has very interesting projects and is actively growing. If you’re interested in the business or research of formulation science and drug delivery, and prefer the close-knit atmosphere of a small company, Kashiv may be right for you. Junior Editor/Senior Editor: Monal Mehta/Aminat Saliu Musah