Christoph Krähenbühl outlines five considerations for virtual pharmaceutical companies when launching a new drug product.
Virtual pharma companies characterised by small, agile and innovation-led operations have traditionally partnered with – or even been absorbed by – much bigger players to get their product to market.
Relying on the resources and expertise of these partners is an essential part of the virtual pharma journey beyond pure science – from getting through regulatory processes, clinical trials and manufacturing right through to marketing, supply chain design, sales, distribution and other post-launch activities.
Increasingly, however, virtual pharma operations are seeking to take their products to market by themselves, rather than out-licensing them to big pharma. For companies whose focus has been on science and clinical trials, there are entirely new risks and challenges involved in taking specialty drugs, biopharmaceuticals and drug/device combinations to market in this way. Essentially, they now have to deal with the two main challenges that big pharma has already mastered: getting their product through all the steps to a successful market launch and establishing an entire supply chain with all the obligations that are required for these activities.
Virtual pharma companies need access to a vast range of experienced and professional support in the core areas of scientific discovery, specific disease-domain knowledge, clinical trials and regulatory affairs. They also need access to broader business knowledge spanning financials, tax, legal, intellectual property tactics and commercial strategy, as well as the essential practical elements including manufacturing, marketing, sales, order-to-cash, distribution and new demands introduced by the ongoing evolution of the supply chain.
To achieve this without building an in-house organisation – which would defy the objective – virtual pharma companies must work with a complex range of external expert resources, whose composition will also change over time as the programme unfolds.
This presents its own challenges, such as how to ensure the best and most current expertise is made available, how to manage a complex and dynamic network of external experts effectively and how to ensure there are no gaps in terms of scope, timing and risk.
With this in mind – and against the backdrop of ever-tightening regulations and requirements taking place throughout Europe and North America – how can virtual pharma companies mitigate some of these risks to give their product the best chance of successful launch and adoption?
1. Robust project planning
From an initial idea, drug development and Phase I clinical trials, right through to regulatory compliance, product distribution and post-marketing surveillance trials, a comprehensive project plan is the critical starting point for an effective product launch.
Any project plan must be fully comprehensive and account for every requirement and outcome. It should also ensure that the appropriate timings and interdependencies are reflected, which presents a particular challenge in a market launch scenario with many moving parts and significant uncertainties.
Sometimes, pharma companies rely on previous project plans that worked for a different product 10 years ago, but these plans are unlikely to cover the many changes and regulatory requirements that have happened since that time, or the essential tasks that virtual pharma companies may not have been made aware of. Particularly critical is the early identification of the steps that have a long lead time and reflecting them in a launch plan. Experience shows that serialisation and traceability swim, for example, which takes a project from strategy to sustainability, will take an absolute minimum of nine months.
Any project plan must be fully comprehensive and account for every requirement and outcome”
It is therefore essential that virtual pharma companies begin to think about the compliance aspects from a serialisation and traceability perspective during the early stages of Phase III, allowing 12 to 18 months to complete this process.
By mapping out key deadlines for when various stages should happen at different phases of a project lifecycle, as well as outlining all potential costs involved at every phase, virtual pharma companies can plan effectively, measure progress and mitigate the costly delays that can often occur without these factors in place.
2. De-risking the ‘known unknowns’
When it comes to getting a new product to market, small businesses cannot afford to have any unexpected surprises. This is one of the main reasons why a robust project plan is so important. If this is not in place, pharma companies may underestimate the costs involved in bringing in mission-critical partners or meeting key requirements, without which they cannot launch.
This is nothing new, of course; the risks involved in getting any new drug to market are well-documented. It may not prove to be safe or effective or critical regulatory steps may have been missed in that project plan, a challenge facing a lot of smaller companies in virtual pharma.
However, the practical steps of launching a new drug on the market involves numerous other steps that must be successfully navigated. Operating in a regulated environment, it is especially critical that the implementation and go-to-market plan enables quality processes; particularly in terms of the systems that need to be implemented and the partners that need to be engaged with. This includes vendor selection and audit, quality agreements, change controls, document management, validation, roles and responsibilities, a training programme and role-based curriculum and comprehensive standard operating procedures (SOPs) including exceptions handling.
3. Forming solid partnerships
Forming partnerships with industry experts and key suppliers is a vital part of preparing a new product for launch, particularly for virtual pharma companies running smaller, leaner operations. In the short term, consultants can help identity the right long-term partners and in the long-term, these partners will become a critical part of the business.
The cost of bringing in outside expertise can be significant, but without this expertise, products are unlikely to ever reach commercialisation and investing in an external consultancy to fill in the gaps early remains minimal compared with the potential cost of a major setback further along. It is therefore critical to choose a partner who can offer the expertise and skills that are at the cutting edge of developments.
It is important to note, however, that with the advent of serialisation and traceability requirements, compliance regulations have become even more complicated and consultants who specialised in this area years ago may not now understand more recent developments at the required level of detail.
Ultimately, without meeting all these requirements, companies simply cannot launch – whether they are looking to commercialise one product or 100 – so having the right partnerships in place is essential.
4. Effective systems integration
The integration of partners and processes across a multitude of business areas is vital to achieving effective commercialisation. From a contract manufacturer and compliance partner to the government systems needed for reporting, companies need to set up and operate fully functional and highly responsive systems and processes.
Serialisation databases must also be able to communicate seamlessly”
One of the most important elements of integration is having a traceability system that is able to communicate efficiently, effectively and without interruption to and from partners. Since all these elements are contracted out by virtual pharma companies, it is even more critical that every system is connected.
Serialisation databases must also be able to communicate seamlessly to the upstream contract manufacturers and downstream partners such as third-party logistics providers and distributors. Given the nature of advanced therapeutical products, these often involve specialised supply chains and add-on services that will require the support of partners with the right expertise and capabilities.
5. Meeting market-specific compliance requirements
Finally, no product can reach market without fully complying with the applicable regulatory requirements. However, compliance is a vastly general term because pharmaceutical manufacture and distribution is so heavily regulated and there are globally accepted best practice standards and national legislation requirements that differ by region.
The most recent expansion in compliance obligations has developed around medicines traceability requirements – in particular, the two main markets of Europe, regulated by the EU Falsified Medicines Directive (FMD) and the US, regulated by the Drug Supply Chain Security Act (DSCSA).
Achieving a state of compliance presents a challenge, not least due to the number of hidden complexities between these markets. Yet compliance does not end at product launch. Pharma companies will still be subject to regular inspections, even after going into full production.
Robust serialisation compliance systems will enable traceability, transparency and visibility of the product throughout the entire supply chain – not only with the initial requirements, but also in terms of the changing rules as they continue to evolve.
Therefore, working with the right partner in each of these areas will give virtual pharma companies every chance of a successful market launch.
About the author
Christoph Krähenbühl is the Senior Director at Excellis Europe and has been involved in serialisation projects since 2006, as Global Serialisation Project Manager and Product Security Manager at AstraZeneca. He has been a long-time member of the EFPIA industry task forces, working with the European Medicines Verification Organisation since 2009.