Refocusing SPI Pharma

Published: 12-Dec-2017

Antacid, excipient and drug delivery solutions provider SPI Pharma is making changes to optimise resources, establish a more global vision and enhance its customer service offering

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Associated British Foods (ABF) has a varied portfolio of companies, ranging from Primark department stores to British Sugar and Twinings Tea to SPI Pharma. Each of the companies operates fairly independently under its own CEO. Being part of ABF is highly beneficial to SPI Pharma, as they provide resources and expertise that a midsize company such as SPI Pharma would not typically have in house.

It provides us and our customers with the best of both worlds. We have the flexibility, responsiveness and creativity of a midsize company with the depth of resources of a large company.

A strategic move

In early 2017, SPI Pharma embarked on a 10-week strategy project to design our future. We began by answering the question: “Where are we today, actually?” The questions wasn’t about where we think we are from a historical perspective or aspirationally, but where we truly are, using a critical eye, with input from across the organisation, along with extensive market data and feedback from our customers. Setting this baseline was, interestingly, the most challenging and time-consuming part of the process. Even so, in a relatively short timeframe and with the participation of approximately 30% of our employees from various disciplines and levels, along with our Voice of the Customer, we learned a great deal about our company. Most importantly, the process gave us a shared view of our opportunities and our path forward. Our strategy work led us to make some structural changes, one of which was the creation of two strategic businesses units. Prior to this, the business was managed by a shared commercial team. The two business units are Antacids & Catalysts, and Excipients & Drug Delivery Systems (EDDS).

Antacids & Catalysts: The strategy made clear that the market drivers and innovation needs for antacids and catalysts are quite different from that of the EDDS portfolio. SPI is a key player in the antacids market, and we want to grow our position and our reputation as an innovative, flexible partner to our antacids customers.

Excipients & Drug Delivery Systems:The EDDS business is focused on solving problems for our customers. With our formulation expertise, and broad portfolio of products and technologies, our team of scientists takes a solutions-based approach. They develop answers to formulation challenges that result in patient-friendly dosage forms that are designed to encourage medication adherence, including specialised paediatric and geriatric formulations that support our customers’ product lifecycle management, and allow them to derisk their projects while increasing speed to market.

Global R&D and manufacturing capabilities

SPI Pharma is a major supplier of specialty ingredients and excipients to the pharmaceutical industry, dating back more than 75 years. Headquartered in Wilmington (Delaware, USA) and with R&D and production sites in the US, France and India, we offer multiple products and platforms based on core technologies geared to the development and manufacture of patient-friendly dosage forms. Our locations include:

– two sites in Delaware, USA (antacids, vaccine adjuvants and plasticisers)
– Michigan, USA (excipients and drug delivery)
– Septemes, France (antacids and vaccine adjuvants)
– Bangalore, India (R&D).

Organisational enhancement

Another change that resulted from our strategy project was the realignment of our technical resources. SPI Pharma has technical experts located around the globe. Previously, technical development managers were a part of our commercial team, whereas product development experts were located at our R&D laboratory in Michigan, USA, and our development centre in Bangalore, India. A separate business development team was responsible for establishing partnership and licensing agreements.

These three groups are now joined together in our Applied Innovation Group, and report to Sarath Chandar in the newly created position of Chief Scientific Officer. Sarath has been with SPI Pharma for 17 years and is a true innovator. Joining the three groups under Chandar’s direction enables more co-ordination and co-operation between our technical experts. Because the three groups are now working closely together, new ideas from the market are shared directly among our development experts, facilitating rapid product development. In addition, we have reorganised with a view to becoming a more global organisation. In the past, all of our key leadership positions were located in our corporate headquarters in Delaware (USA).

This has changed with our new organisation. We have hired a new head of India, TV Ramamurthy or “Ram.” Ram will be located in our offices in Bangalore and will have responsibility for our team in India and the Asia-Pacific region. The head of the Strategic Business Unit (SBU), Antacids & Catalyst, Jon Struthers, is located in the UK, and the Global Head of Sales for the SBU EDDS, Christèle Durand, is headquartered in France.

Focus on patient-friendly formulations

Patient-friendly dosage forms (PFDFs) are intended to increase medication adherence by making it easier for patients to take their medications. In addition to being easy and convenient to take, PFDFs typically have a good taste, mouthfeel and aroma. True patient-centric formulations developed using unique technologies designed to meet these criteria can lead to improved patient outcomes. Indeed, patient-friendly dosage forms fulfil the diverse needs of today’s patients and allow formulators to be creative, developing tailored products that are highly differentiated in the marketplace.

Ease of administration is particularly important for paediatric, geriatric, non-ambulatory and mentally ill patients. In fact, concerns regarding paediatric medications have led to recent changes in regulations regarding the development and commercialisation of drugs for this patient population. Whereas in the past, clinical studies were only conducted with adults, drug developers must now develop paediatric formulations based on age-appropriate dosage forms, such as liquids, granules, chewable tablets, dispersible powders and orally disintegrating tablets (ODTs), and conduct clinical trials for these formulations. They must also demonstrate the palatability of drug products to paediatric patient populations.

Separately, there are concerns about parenteral drug products. There are challenges not only with the need for injections, which often require visits to a hospital or doctor’s office, but also with respect to the frequent need for refrigeration and a managed cold chain, which poses logistical and transportation difficulties. There is a real need for the development of delivery systems that allow the administration of drug substances, typically formulated as parenterals, in a more sustainable and accessible way.

New partnerships

A third focus of our strategy is to identify partnerships that enable SPI Pharma to quickly expand our portfolio to better address our customers’ needs, with an asset light approach. In October 2017, we announced our agreement with Noramco, a global leader in the manufacture and supply of controlled substance active pharmaceutical ingredients, to develop and license “ready-to-implement” patient-friendly drug formulations that provide convenience, compliance and efficacy for such therapeutic indications as intense pain, opioid addiction and central nervous system conditions (epilepsy, migraine, etc.). By partnering with Noramco, we are able to combine our expertise in functional excipients with their experience in APIs to develop formulation solutions that help reduce time-to-market, derisk new product development for our customers and facilitate product differentiation.

Many solutions

Active only in the pharmaceutical industry, SPI Pharma’s primary objective is to engineer functional materials that enable our customers to solve formulation problems, achieve differentiation and gain speed to market. We serve more than 55 countries with formulation innovation, technical assistance and troubleshooting support. Our products include antacid actives, excipients, tastemasking technology, drug delivery systems for tablets, fast-dissolve technologies and a variety of other creative offers for patient-friendly dosage formats.

We supply immediate release antacid actives, including multiple aluminium-, magnesium- and calcium-based products in gel, paste and powder form, plus preformulated suspensions and tablets, directly compressible calcium carbonate powders, a wide range of functional excipients for all dosage forms, and a strong line of vaccine adjuvants based on aluminium hydroxide chemistry.

SPI’s full spectrum of orally disintegrating products, services and technologies supports every stage of the drug product lifecycle. Our fully formulated and optimised Pharmaburst and Pharmasperse systems are ready to use and provide excellent organoleptic properties for any patient population. Our Actimask tastemasked ibuprofen and acetaminophen products, Effer-Soda surface-modified sodium bicarbonate and Mannogem line of mannitol excipients are designed for the formulation of multiple dosage forms. Importantly, our highly engineered materials are manufactured in dedicated pharmaceutical facilities and meet the quality standards set for active pharmaceutical ingredients (APIs).

SPI is also a formulation partner to the pharmaceutical industry. Through our Pharmasolutions drug development service, we work closely with our customers to develop drug delivery platforms and/or dosage forms on a fee-for-service basis.

Taking SPI Pharma to the next level

All of these changes are positioning SPI Pharma to bring a higher level of service and a heightened value proposition to our pharma customers. We have passionate employees who want to see the company reach the next level, and we believe our efforts will be reflected in a growing business. We are filling our pipeline with new products and actively seeking additional partners that have the same commitment to bringing value to their customers. Our goal is to develop innovative solutions.

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