The pharmaceutical landscape is considered an area where major scientific advances have been made in developing new therapies and medicines to help patients. While much of the success achieved in pharmaceuticals is important for recognition, there is also another aspect to pharma. That of the strategic decisions/collaboration made throughout the entire process of transforming a viable compound into a marketable product.
Pharmaceutical companies today have increased expectations on how well they can find and subsequently secure the rights to promising pharmaceuticals (product), source clinical trial materials for testing their products, and appropriately prepare for the manufacture of their respective product(s). The need for a company to be able to perform these three functions efficiently has created a new operational environment for pharmaceutical organizations in that leaders of those organizations must have a broader view, and thus a more integrated approach to managing (1) business development; (2) source of clinical supply; and (3) planning to manufacture.
By operating these three important functional (and/or departmental) areas together, an organization will have a significant competitive advantage.
Three major elements are referred to as the cornerstones of this transformation:
- Pharmaceutical Licensing Services
- Source of Comparator Drugs
- API Contract Manufacturing & Pharma Contract Companies
Each element plays a critical role; however, combined, they provide a framework that enables increased efficiencies across various elements, departments, and finance, ultimately reducing development timeframes and increasing sustainable global development and commercial success.
This blog will discuss how these sequentially related strategies create a new model for the pharmaceutical operation, thus requiring forward-thinking pharmaceutical organizations’ to treat all three as components of a single growth engine versus three independent functions.
The New Reality of Pharmaceutical Competition
The pharmaceutical industry has changed substantially over the last decade. The rise in research costs, increasing complexity of the regulatory environment, global supply chain interruptions and growing patient expectations have caused companies to rethink their traditional business models. Inevitably, companies are no longer able to depend on long development times and localised supply chains.
Today’s companies must:
- Get to market quicker.
- Minimise their operational risk.
- Maximise development costs.
- Ensure the continuity of supply.
- Remain in compliance with the regulators in the various jurisdictions where they sell their products.
- Efficiently increase the number of products they have for sale.
To do these things successfully takes more than just scientific knowledge. It will require strategic alignment across each stage of the pharmaceutical value chain.
Companies that have integrated licensing, clinical supply, and manufacturing strategies at the earliest stages of their pharmaceutical value chain typically get a substantial competitive advantage when compared to companies that have kept these activities separate.
Why are Strategic Partnerships Crucially Important Now?
Many pharmaceutical companies have historically kept as many pharmaceutical activities in-house as possible. While that gave these companies more control, it also resulted in limiting their ability of these companies to be good at all pharmaceutical activities.
Because of the specialisation of the pharmaceutical business today and the globalisation of the pharmaceutical business, few companies can be good at all aspects of the pharmaceutical industry.
Strategic partnerships have become the foundation for growth in the pharmaceutical business.
More and more companies are partnering with:
- Licensing experts
- Clinical supply experts
- Manufacturing partners
- Regulatory compliance consultants
- Logistics providers
- Quality assurance experts
Through these types of partnerships, companies can access the expertise, infrastructure and market knowledge needed to be successful in the pharmaceutical business without having to invest years developing the infrastructure in their own companies.
Licensing as a Tool for Global Expansion
The common challenge faced by practically all pharmaceutical companies is how to efficiently and effectively enter new markets.
In many instances, launching a product in a new and unknown market also entails navigating different and complex regulatory systems, associating with and learning from local healthcare stakeholders, and establishing a means through which to distribute products in that region.
Licensing has proven to be an effective method for entering new markets. By establishing relationships with an existing regional company, a pharmaceutical company gains a foothold in that market, while at the same time benefiting from the local company’s operational experience and capabilities.
The advantages of licensing are many:
- Faster time to market
- Reduced investments in infrastructure
- Improved regulatory navigation
- Access to established distribution channels
- Greater commercial scalability
As global healthcare markets continue to develop and change, the licensing strategy for industries engaged in drug development will become less of an optional or ancillary strategy and instead, more of a critical and essential strategy to remaining competitive.
The Critical Link b/w Licensing & Clinical Development
Upon completing a licensing agreement, there will likely be additional operational requirements that will require immediate attention.
For example, when a pharmaceutical company licenses the rights to develop or commercialize a pharmaceutical product, the company may be required to conduct clinical research in order to obtain regulatory approval, to expand the label of the product or to meet market-specific requirements.
This means that reliable clinical supply planning is of the utmost importance to conduct clinical trials in an efficient manner. One of the key components to successful planning in this process is the ability to obtain comparator drugs. Without these drugs, the execution of clinical trials may be delayed or conducted in an insecure manner.
The connection between the licensing strategy and clinical supply planning strategy is why they must be aligned from the very beginning.
Risk Mitigation Through Proactive Comparator Planning
Most delays in clinical studies originate from insufficient preparation, not because of research obstacles.
By addressing comparator requirements early on, organizations can:
- Considerably improve study readiness
- Significantly minimize sourcing disruptions
- Assure supply continuity
- Considerably better at managing expenses
- Improve regulatory compliance
More companies are building comparator planning into their product development strategy during study protocol development as opposed to after starting their studies. This proactive method creates additional flexibility and enhances operational resilience.
The Global Aspect of Comparator Procurement
As there are progressively more multinational clinical studies, the sourcing of products typically extends to several markets.
When seeking products for patients, the majority of sponsors will access products from all of the following regions of the world:
- North America
- Europe
- Asia-Pacific
- Emerging healthcare environments
When procuring products on an international basis, many additional components come into play, such as:
- Regulations surrounding import and export activities.
- Customs documentation flow.
- Regional variations in products.
- Timelines for the transportation of the product.
- Product supply chain security.
Companies with a strong sourcing network will typically be in a better position to support complicated international studies.
The Evolution of API Manufacturing
Pharmaceutical products all start with the same ingredient: Active Pharmaceutical Ingredients (APIs).
APIs have become much more complex to produce in today’s environment. Producing a modern API entails creating several things, including:
- Complexity of synthesis processes
- Enhanced analytical methods
- Special containment systems
- Meeting strict quality standards
- Optimizing processes
The accelerating pace of new therapies has meant that manufacturing individual products becomes progressively harder.
Pharmaceutical companies that work with experienced manufacturers will have access to technology capabilities that may be otherwise difficult to develop within the company.
This frees up resources to be used for R&D, commercialization, and strategic growth.
Quality is a Key Competency
Quality in the manufacturing of pharmaceutical products should not only be an expectation from Health Canada and/or FDA, but actually a core component of any organization who manufactures pharmaceuticals.
A single experience of poor product quality can result in any of the following consequences:
- Action taken against you by regulatory bodies
- Any product recall
- A disruption in your sales/revenue
- Negative impact on your company’s reputation
- Delay in your ability to meet your customers’ needs
Leading manufacturers invest in process validation, data integrity systems, a continual improvement program, and advanced monitoring technologies. Companies that are assessing manufacturing partners should evaluate the quality assurance culture of a prospective manufacturer as closely as they evaluate technical capabilities.
A strong quality assurance foundation is indicative of a high potential for a successful long-term partnership.
Final Thoughts
Patient access to innovation depends on the creation of a coordinated approach that connects business development, clinical operations, and manufacturing. Companies that leverage a strong pharma licensing service can create opportunities that accelerate growth in their portfolios; companies that source comparator drugs effectively can ensure both clinical trial integrity and timeline performance, while companies that provide strategic API contract manufacturing solutions or pharma contracts can partner with them to ensure successful market launch.
As these three pillars work together, pharmaceutical businesses experience more than just operational efficiency; they develop speed, agility, risk reduction, and increased confidence competing in an evolving, complex global marketplace. Through the continued influence of the pharma industry, companies leveraging integrated planning and strategic collaboration will be positioned to create long-term impact through continued innovation and patient-centric access to therapy while building sustainable business growth for the future.