SPI Pharma is a leader in antacids, specialty excipients and drug delivery systems. The company recently restructured following a strategic review of the business, establishing two dedicated business units: Antacids and Catalyst, and Excipients and Drug Delivery Systems (EDDS). We sat down with seven experts spanning the organization to discuss, from their diverse perspectives, how SPI Pharma is leveraging its existing strengths and refocusing its capabilities to provide next-level products and service going forward.
Jeanne Thoma, President and Chief Executive Officer
When I became President and CEO of SPI Pharma, I realized quickly that our people are a core strength of the organization. I found a great deal of creativity and enthusiasm that, if encouraged and channeled effectively, could provide a real competitive advantage. Also, we were spending a lot of time on the basics, the day-to-day management of the business, while neglecting the strategic vision. This led to a strategy review. To ensure that we were gathering all of the good ideas across the organization, we reached into the various departments and across our global footprint to engage the business. This greatly enriched the end result, while also making the strategy much more tangible to each person in our organization.
The strategy led to a reorganization. Previously, we had managed the business as a single organization, and, while there is strong customer overlap between the antacids and EDDS businesses, the market dynamics are quite different. We separated those businesses so that we could focus on their different strengths, market positioning and value propositions. We also created a third team, the Applied Innovation Group (AIG), which provides product development and innovation, along with technical support to both business units. We have found that it is possible to create a positive tension by empowering the innovation group and putting them on equal footing with the commercial teams in the business unit.
Another important piece in our reorganization was the formation of a support platform that includes finance, human resources, quality and regulatory, and safety, health and environment, among other teams. This platform will make it easier for us to bolt on additional business units.
By implementing a continuous improvement program in conjunction with our restructuring, we have made our processes more efficient and facilitated stronger communication across different groups. There is a real sense of collaboration taking place, which is providing knock-on benefits that we couldn’t have anticipated.
We have been getting great feedback from customers who have observed that communication and collaboration have strengthened as a result. They are pleased that the representatives we send to interact with them are specialists who can speak in great detail, not just about our products, but also about the market, the range of technologies that are available, and the innovation taking place.
We have implemented a rigorous stage-gate process that allows us to advance promising projects faster. We are looking to grow our product portfolio as well as our platform solutions. As such, we will continue to invest in formulation expertise and applications knowledge, in addition to expanding our commercial expertise.
Ultimately, we don’t want to merely provide what our customers are seeking. Instead, we want to be constantly thinking about our customers’ customers and what they need, broadening our understanding of the market and anticipating new needs, opportunities, products and applications before our customers even ask. Our focus is on making a difference — in the lives of patients, our customers, our employees and in the communities we serve.
Sarath Chandar, Chief Scientific Officer
SPI Pharma is one of the few excipient companies that not only develops new functional materials, but also offers drug and dossier development services to help our customers accelerate time to market launch. To Jeanne’s point regarding anticipation of market needs, we routinely investigate niche areas and cutting-edge applications, notably the oral delivery of large molecules.
Our overall approach to innovation is based on identifying major market trends in the pharma space grouped along five dimensions (political, socioeconomic, technology, customer strategy and regulatory) and determining which trends we can best address using our strengths and our toolkit.
We believe that we possess the right set of tools to leverage our expertise in functional platforms and enhanced APIs to deliver patient-friendly therapies to those vulnerable parts of our population who have had difficulties with existing dosage forms. For example, we are exploring sublinguals and other orally dispersible forms as a means of enhancing efficacy and creating 505(b)(2)-type applications to convert injectables into oral forms to better serve aging and pediatric populations.
One example of this is our partnership with Normaco, who have developed cannabinoids for debilitating medical conditions and antagonists to treat opioid addiction. We are working with them to combine their APIs with our EDDS platforms and formulation expertise to create efficacious dossiers that could be licensed to pharma companies.
We are looking to establish more strategic partnerships where we can synergize our strengths with those of our partners to create win–win situations. As patent cliffs have passed and generic companies are struggling to determine their next plays, we are working to develop unique dossiers and to help get products to market more quickly, a capability that appears to be rare among excipient companies.
Graeme Macleod, Global Director of R&D
Historically, SPI Pharma has been an innovator capable of generating new ideas, products and applications. In the past, we lacked an internal process through which we could channel and funnel those ideas. With the recent reorganization, we have really refocused our entire R&D culture, with the discipline of our revised processes providing the key.
Our R&D teams are primarily based in two locations — Grand Haven, Michigan and Bangalore, India — with an additional team focused on antacids in Septemes, France. With the creation of the AIG group, we have begun to integrate our capabilities across the globe and widen the scope of what our teams work on. The stage-gate process Jeanne discussed keeps all parties focused on projects and deliverables, so that we have the right combination of technical and commercial scope overseeing each stage.
At the end of the day, we are trying to identify what patients currently need and what they will need in the future. At the moment, both patient needs and regulatory guidances are trending toward more personalized, convenient and efficacious dose forms. In terms of our R&D portfolio, we are continuously determining what we need to do to provide products and applications to support these needs.
In order to enhance our customer focus as Jeanne discussed, we have placed technical development managers on each continent to investigate new opportunities for existing products and to better understand the megatrends affecting our customers and their markets. Close collaboration with customer formulators helps us create opportunities for new product and application development.
Jon Struthers, General Manager Antacids and Catalysts
In the antacids business, customers recognize the integrity we bring, in terms of product quality and level of service, as well as our flexibility and our expertise in applications. The antacids market is well established, but customer needs are changing and, as such, the format in which we deliver products is changing. We need to keep our product portfolio current to reflect those needs, which ties directly to the R&D team in France that Graeme mentioned.
Our products present a range of unique functionalities that can improve handling or reduce blending and mixing times, providing customers with clear cost-in-use benefits and increasing their margins.
The restructuring of the antacids business into a dedicated business unit gives us greater ownership over the delivery of service value, and allows us to accelerate new ideas and opportunities through the business in a much more dynamic way.
We definitely see the trend toward convenience and single-dose products. This next generation of patient-centric products will require different ingredients and formulations, requiring high concentrations of APIs, mitigating the risk of microcontamination and enhancing the patient experience, particularly regarding mouthfeel and other organoleptics. We will continue to find new ways to extend our history of innovation to develop and provide ingredients that will allow our customers to keep up with end-consumer trends, remain competitive and gain strong shares within the market.
Joe Rogus, Global Sales Manager for Antacids
SPI Pharma has long been a global leader in the antacids space, supplying more than 50 countries for decades and maintaining robust long-term relationships with our customers.
We are currently eyeing global opportunities for our calcium granulation products, particularly in Asia and Latin America, markets where calcium has not historically been popular. We are seeing demand increase for calcium smoothie products globally and are promoting our supporting products in these emerging markets. Another growing product class is compressible calcium for multivitamins or calcium/vitamin D3 mineral supplements to promote bone health in women. As Jon discussed, we are pursuing the trend toward unit doses (e.g., stick packs), as well as smaller sizes of tablets — two directions that will require higher concentrations of API. We are investigating ways to produce micronized powders to deliver on these evolving patient experience needs.
Customer feedback has been very positive for our directly compressible products (also available for aluminum/magnesium combinations), which free up capacity and allow customers to quickly go to market with a product that has already been formulated.
Coralyn Gonzalez, Global Sales Manager for EDDS
SPI Pharma has always been a customer service–oriented company, and we are finding new ways to continue this approach, working with our customers as a dependable partner and understanding their needs and market trends, particularly with regard to pediatric and geriatric applications. This is a market that directly benefits from the patient-friendly therapies Sarath discussed.
The restructuring process has increased focus on the EDDS portfolio and an understanding of where our growth is coming from. For EDDS, we created a new marketing plan and are endeavoring to implement it, working closely with the marketing team to make sure that we can access the market and reach the types of customers who will benefit from our service and expertise.
We always want customers to understand that we are looking to work together as a partner rather than merely as an ingredient supplier. What I like most about working at SPI Pharma is how flexible and agile we are as an organization, maintaining the ability to make adjustments according to customer needs.
John Creighton, Head of HSE and Corporate Responsibility
Going back many years, building close relationships with communities has been a part of the corporate culture at SPI Pharma. We have always looked to reduce energy usage and minimize our impact on the environment.
In the corporate social responsibility (CSR) world, we are seeing our customers request more information about energy use, packaging, being a good neighbor and other CSR issues. These are all areas where we have been working already, an effort that is supported by the continuous improvement initiatives my colleagues touched on.
The reorganization of SPI Pharma has put more focus on HSE and CSR and created a unified focus that supports and works as a resource for the different business units, in any area that is needed. We are overlaying our strong existing local cultures in these areas with universal standards and best practices for all business units and operations to follow, which is having a major impact on improvement.
We have gained clarity on accountability within the business: determining key areas to work on, planning and determining responsibilities and pivoting quickly if things change. We are now more disciplined about sticking to projects that are truly strategic, allocating more resources and quickly recognizing when something does not have a likely commercial benefit.
We try to remain proactive in all areas relevant to CSR and HSE and set objectives. In most cases, our CSR agenda is smoothly integrated with our other business objectives. As Jeanne stated, the people are a core strength of the organization — and this extends to the communities in which we operate.