How-To: Make Regulatory Outsourcing Effective for Pharma, Biotech Industries
A decline in revenues from approved products and rising competition in generics is placing added pressure on resources at all pharmaceutical, biotechnology and medical device companies. Company resources continue to decrease and approval processes and post-approval requirements have become more complex.
Outsourcing can provide a solution and deliver a competitive advantage for companies that lack the resources or expertise to guide a product to approval. Companies, however, need to ensure the outsourcing partner they choose will fit within their current business structure.
According to a white paper recently published by the Cardinal Health Regulatory Sciences team, there are four key factors that can help pharmaceutical and biotech companies become successful in choosing an effective regulatory outsourcing partner.
Know When to Consider Outsourcing
Shortage of employees is one of the primary reasons companies choose to outsource during the regulatory approval process. Additionally, a company may have more products in development than internal staff is available to guide to approval in a timely manner.
External staff can alleviate both of these issues by handling routine regulatory maintenance so internal staff can focus their attention on high-priority development programs.
Partnering with regulatory experts can also save valuable time and unnecessary work; especially if there have been recent changes to regulations. By using such experts on an “as-needed” basis, costs can be minimized rather than keeping individuals on staff long-term.
Determine What Functions are Best Outsourced
While entire pharmaceutical, biologic, or device development processes can be outsourced, companies generally outsource either discrete processes, such as clinical trials, or those that require a high level of expertise, such as regulatory affair processes or the formulation of development processes.
Both consultative and tactical functions are good candidates for outsourcing, according to the report. From a consultative viewpoint, the right partner can advise a company on strategic and specific information that regulatory agencies will be expecting to see in a submission.
Tactical functions, such as CMC and medical writing, are also prime candidates for outsourcing. Regulatory documents and scientific communications require a high level of precision and adherence to format, which may be best left to an experienced partner.
Learn How Your Company Can Benefit
Outsourcing provides companies with a plethora of benefits from flexibility, on-demand capacity and anticipating and preventing obstacles.
In times of need, a company can augment or add a new team when work levels are high. This helps keep budgets in line but also allows companies to bring in the exact skills required for a specific project at any given time.
In addition to augmenting staff, outsourcing also allows companies to add to their capacity when products require resources unexpectedly. Regulatory consultants can often step in and resolve unforeseen outcomes or late-breaking changes that may affect a product’s development cycle.
Regulatory scientists understand the entire research and development continuum, which allows them to build the required components into research so the study design, resulting data and documentation are appropriate prior to submission. They can also review nonclinical, clinical, CMC and compliance documents and use their expertise to anticipate any new requirements that may pose challenges.
Select the Right Partner
The right strategic partner will work with a company to ensure that the regulatory product is brought in at the appropriate time and work towards the company’s goal. By starting early, discussing the process and setting checkpoints, both the company and the partner can establish a long-term relationship and smooth collaboration.
It is important to ask questions about a partner’s background, track record and experience. A partner who lacks the expertise required for approval or who fails to deliver on time can result in a costly operation. The right partner should also have experience in the entire development process to foresee and prevent any issues from arising.
Ideally, companies should seek a partner who can become an extension of their organization.
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.