Associated British Foods (ABF) and its Ingredients division (ABFI) are committed to growing their global pharmaceutical footprint. Included in this initiative are significant investments in their pharma subsidiaries — one such subsidiary of ABFI is SPI Pharma (SPI), headquartered in the US. Following a reorganization and finalization of its new growth strategy, SPI is re-engaging in innovation. As a result, SPI has created a new team called the Applied Innovation Group (AIG). AIG is entrusted with developing innovative technologies and drug formulations that will create new opportunities for pharmaceutical and nutraceutical customers worldwide, while ultimately benefiting patients.

Commitment to Growth

In January 2017, ABFI brought Jeanne Thoma on board as President and CEO of SPI and immediately embarked on the development of a new strategic direction for our company. Based on external market data, voice of customers, and input from across the organization, two strategic business units (SBUs) were created with dedicated business teams, and our global technical resources were consolidated into one group — AIG.

The two business units are Antacids & Catalysts and Excipients & Drug Delivery Systems (EDDS). SPI is one of the largest suppliers of immediate relief antacids, offering aluminum-, magnesium- and calcium-based actives. Several major brands across the globe use SPI’s antacid actives. The market drivers and innovation needs for antacids and catalysts are quite different from those of the products and services in the EDDS segment.

The EDDS business offers a broad array of products and technologies combined with customized drug formulation expertise. Products and technologies include excipients, microencapsulation technologies for taste masking and controlled-release applications, drug delivery platforms, fast-dissolve systems, effervescent products, vaccine adjuvants based on Al2(OH)3 chemistry, and a variety of other creative offerings focused on building patient-friendly dosage forms (PFDFs).

Focusing on Applied Innovation

At SPI, applied innovation means market-relevant innovations that deliver solutions to enhance convenience, compliance, and efficacy to patients (see Figure 1). To accomplish this, the AIG team is comprised of 3 distinct functions: R&D, strategic business development (BD), and technical business development. R&D works on material and drug development, while BD explores partnerships and licensing, and Technical Development Managers (TDM) interact directly with drug formulators in pharma companies. This new organization enables valuable cross-pollination and coordination amongst subject matter technical experts and customer-facing commercial folks. Market-relevant new ideas are discussed and prioritized, facilitating rapid product development.

 

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R&D

The R&D group within AIG is responsible for new product/material development (NPD), applications development/technical support (ARTS), and drug development in patient-friendly dosage forms (Pharmasolutions).

Given the number of excipients and other materials approved for use in drug formulations is finite and limited, SPI plans to work on NPD initiatives to develop innovative ideas and technologies to expand the range of highly functional excipient systems. This is accomplished by leveraging the synergies of excipient combinations through various coprocessing technologies to deliver compendial materials (looking for 1+1=3). Co-processing (co-drying, co-granulating, co-congealing, etc.) has the potential to provide additional functional benefits that aren’t realized when different excipients are simply dry-mixed together in a formulation. The NPD group also focuses on safely enhancing the performance of APIs through microencapsulation techniques to mask taste as well as adjust the release profile of the active using aqueous media instead of a solvent-based system.

All of the products in the SPI portfolio are characterized for functionality by ARTS. They focus on understanding the cause-effect relationship in excipient functionality. They also provide technical support to our customers that are using our excipients and platforms in their drug formulations.

Pharmasolutions covers dossier development for out-licensing as well as customized drug development service to meet customers’ specific needs. Our customers benefit from the ability to market specialty drug products that are highly differentiated in the marketplace. Pediatric and geriatric formulations developed and tested by SPI support our customers’ product lifecycle management, reducing risk of failure while achieving speed to market. The business model is structured on a milestone-based fee for service. Since the inception of this service, SPI has established a strong track record of helping customers successfully launch commercial drug products for treating migraine, Parkinson’s, schizophrenia, nausea, allergy, erectile dysfunction, diarrhea, smoking cessation and others in patient-centric formulations. A partial list of such products with APIs and dosage forms is available on our website: www.spipharma.com. A fully equipped drug development laboratory in India, staffed with scientists from major pharma companies, supports the Pharmasolutions initiative.

TDM

The technical development managers are regionally focused and responsible for supporting pharma customers in the US, Latin America, Europe, Middle East/Africa, and Asia-Pacific regions. Each of these technical development experts provides technical support for existing projects as well as promoting innovative ideas developed by the AIG. They work closely with the commercial team, reaching out to senior formulators around the world to identify areas in which SPI’s capabilities connect with our customers’ drug product strategies. The AIG works closely with the SBUs to ensure alignment with the business plans. Once fully developed, the technologies and products, whether developed internally or in-licensed, are transferred to the SBU’s commercial team.

 

SPI plans to work on NPD initiatives to develop innovative ideas and technologies to expand the range of highly functional excipient systems. This is accomplished by leveraging the synergies of excipient combinations through various coprocessing technologies to deliver compendial materials (looking for 1+1=3).


Strategic Business Development

BD is responsible for partnerships and licensing (in- and out-). They explore partnerships with companies that offer unique/specialty ingredients/actives that, when combined with SPI’s products and technologies as well as drug development knowledge, will enable the development of unique solutions for our customers.

The most recent example is the signing of a Letter of Intent in October 2017 with Noramco, one of the largest producers of opioid agonists and antagonists for the treatment of opiate addiction. The main focus of this agreement will be the development of unique products for treating opioid addiction by leveraging Noramco’s experience with APIs and our expertise in functional excipient platforms and specialized drug development capabilities. In addition, Noramco and SPI will be developing drugs for the treatment of CNS conditions like migraines, epilepsy and pain management, using our drug delivery technologies and Noramco’s patented synthetic cannabinoid APIs. These APIs are expected to provide the therapeutic benefits of cannabis without any of the problems or negative hallucinogenic side effects associated with consumption of tetrahydrocannabinol (THC) in cannabis.

Investing for the Future

SPI Pharma, backed by ABFI and ABF’s strong commitment to investment and growth, is focused on the development of innovative technologies, products and services that deliver functional value to our customers. Following the changes made during 2017, SPI Pharma is well positioned to meet the complex challenges faced by our pharma customers. We are developing new products using a stage-gate process and actively exploring potential partnership opportunities. Our mission is to deliver tangible benefits to our customers, who have the same commitment to bringing value to the ultimate consumer: patients. These combined efforts will enable improved quality of life for patients and ease the burden of caregivers in terms of compliant administration and accurate dosage, while enabling the growth of SPI, our customers, and our partners.