How can virtual pharma companies’ de-risk new product launches?
The big pharma companies and well-established pharma companies who are existing in the pharma industry for a long time are already the expertise of the whole pharma journey. They are well-aware of the operations that go beyond science such as regulatory processes, clinical trials, and manufacturing right through to marketing, supply chain design, sales, distribution, and other post-launch activities. Contrary to this, virtual pharma companies that are comparatively small and innovation-powered have to rely upon or partner with bigger pharma players to get their product into the market. However, the scenario is changing as virtual pharma companies are taking it into their own hands to market their products and handle new product launches.
They now have to deal with the two key obstacles already mastered by big pharma: bringing their product through all the steps towards a successful market launch and setting up an entire supply chain with all the commitments that are important to these activities. Therefore, virtual pharmaceutical companies will need access to a wide spectrum of skilled and professional support in the core areas of scientific research, specific knowledge of the disease domain, clinical trials, and regulatory affairs. They will need access to wider market expertise covering tactics of finance, accounting, legal, intellectual property, and commercial strategy. It is also necessary to have access to vital functional elements, such as production, supply chain, marketing, sales, order-to-cash, distribution, and new demands introduced by the continuing evolution of the supply chain.
Virtual pharma companies have to mitigate many risks and challenges if they want to give their product the finest, successful, and proper launch and adoption. This can be done with the best expertise, dynamic network, and ensuring no gaps between timing, scope, and risk. So how to make your new product launch a success not only for the product but also for the pharma company?
A detailed project plan is the crucial starting point for any successful new product launch, from an initial concept, drug production, and phase 1 clinical trials, right through to regulatory enforcement, product delivery, and post-marketing surveillance trials. It should be completely detailed and account for all criteria and performance. It should also ensure that sufficient timings and interdependencies are represented, which is a market launch scenario with many moving parts and major uncertainties pose a specific challenge.
Calculating the known, unknown risks
Of course, this is nothing new; the risks involved with selling every new medication are well-documented. It may not prove to be safe or successful, or because you did not have the full picture, which is a problem facing many smaller virtual pharma companies, you may have skipped crucial regulatory steps in your project plan. However, several other measures are included in the practical steps of releasing your new drug on the market that may risk tripping you up. It is particularly important that the implementation and go-to-market strategy, working in a controlled setting, allows for quality processes, especially in terms of the structures you need to introduce and the partners you need to work with. This includes the collection and audit of suppliers, quality agreements, change controls, document management, validation, positions and duties, a training programme and role-based curriculum, and extensive SOPs, including handling of exceptions.
Partnership and consultation
The creation of partnerships with industry experts and key suppliers is a vital part of preparing a new product for launch, particularly for smaller, leaner operations of virtual pharma companies. Choosing a partner who has the full vision and can provide experience and talents that are at the forefront of innovations is important. You will need advisors in the short term who will help you select the right long-term partners, and these partners will become a vital part of your company in the long term. Compliance regulations have become much more complex with the introduction of serialisation and traceability standards, and consultants who trained in this field years ago do not understand more recent innovations at the appropriate level of detail now.
Meeting market-specific compliance requirements
Lastly, without completely complying with the relevant regulatory criteria, no product can enter the market. Since pharmaceutical production and distribution are so highly regulated, enforcement is a very general concept, and there are internationally agreed standards of best practise and national regulations that vary by country. Robust serialisation enforcement systems, not only with the initial specifications but also in terms of evolving regulations as they continue to change, would allow traceability, accountability and visibility of the product across the entire supply chain.
Tracking the performance
One of the digital’s great advantages is the ability to monitor and measure what works and what doesn’t. The virtual pharma company should be fitted with real-time analytics dashboards that track the success of activities against a simple collection of actionable metrics; follow the scientific path, monitor social media and online voice sharing per molecule, assess what rivals do and what best practises are evolving, KOL and HCP actions and benchmark. It would be difficult to optimise without these data-driven insights and there is a considerable risk of finding new opportunities and progressing too slowly.
Succeeding in a new product launch is all about effective and proper digital marketing. Virtual companies need to be equipped with the necessary skills and staff to engage digitally.