Working out how to guide your company into the personalized medicine future can be a daunting, even overwhelming task - perhaps best to put it on hold…. But since President Obama announced to the US and the world in 2015 that personalized medicine (PM) was the way to go, it’s time to admit that this is really happening and it would be wise not to ignore it any longer.
Diaceutics has been on top of PM since its early beginnings so we recognise the pharmaceutical industry’s need to understand diagnostic development, planning and commercialization. We also appreciate how much there is to think about because getting ready for PM involves every aspect of your business, from partnering deals and engaging with laboratories to educating stakeholders and funding to support test adoption.
We are happy to share our knowledge regarding the importance and the potential impact of diagnostics, so we’ve broken the process of becoming PM-ready into nine steps, helping to prevent what can often be a last minute panic attack.
1. Establishing a Robust Diagnostic Development and Commercialization Strategy on Time
To avoid lagging behind with the diagnostic strategy, pharma should start developing the commercialization strategy 18 months before launch, invest time and effort to keep track of a Target Test Profile and engage in early dialogue with third parties, as you never know how long everything will take.
2. Integrating and Aligning the Diagnostic Strategy with the Drug Strategy
Assume the asset will need a diagnostic test. Pharma and diagnostic companies should together ask ‘How do we want to position the diagnostic test?’, then develop a diagnostic strategy with feasible milestones. At the same time the diagnostic and drug strategies should be fully aligned for a simultaneous launch, helped by the Target Test Profile, a key planning document.
3. Partnering and Managing Partnerships
Identify the expertise and partnerships you need for both the development and the commercialization process then select and engage a partner from a shortlist of potential companies. Manage the partnership over the long run by incorporating efficient delegation, and maintaining a coordinated dialogue.
4. The Shift Towards Patient Centricity
By reviewing the whole patient pathway, pharma can better understand the patient’s experience, identify unmet needs and improve health care quality. Without listening to patients, pharma will not be able to achieve patient centricity. Putting the patient at the centre of the discussion is already happening and is a feasible task that is not likely to require change to the whole company strategy.
5. Pharma Communication and Education for Stakeholders
Educating stakeholders according to their ‘needs’ is essential. Physicians need a clear message and the knowledge to confidently discuss a new drug and diagnostic otherwise the test will not get adopted. While patients are educated partly by the physician, they’ll also look for direct information about their treatment or diagnostic test. It can take many of us a long time to adapt to new ways and ideas, but a transition can be eased by clear instructions.
6. Funding a Diagnostic Test at Launch to Ensure Test Adoption
Funding a new diagnostic test according to market requirements is a great way to drive test adoption in the market, particularly in Europe, where each country has a different way of covering the costs. However, subsidizing a test at launch may be a good strategy but so is a carefully planned exit. If pharma suddenly stops subsidizing testing without alternative reimbursement in place, laboratories are likely to stop using the test.
7. Engaging with Laboratories
Defining the lab footprint before the launch is essential for having the test ready in all territories and ensuring the right number of labs are ready to run the test from the day of launch. If pharma engages and leverages laboratories it could remove some introductory hurdles, such as the test set-up, the costs of implementation and selection of the test method/platform. Good communication about the test and its protocol is also important for the lab and can drive test and drug adoption.
8. Ensure Diverse Internal Capabilities in a Personalized Medicine Pharma Company
Pharma companies need to develop the right internal capabilities to work on both the drug and the diagnostic development and commercialization processes. Some pharma companies, like Roche, go one step further and become experts in diagnostics, but partnering is another way to fill any gaps. Partnering to develop an assay, or leveraging another company’s expertise in measuring the laboratory and testing landscape, could build strength across the organization.
9. Budget Allocation for Diagnostic Development and Commercialization
Pharma should be aware that in order to compete with the leaders in PM it will need ample budgets for the diagnostic development and commercialization process. An early financial impact assessment can determine the budget to spend on pre-launch and launch activities. It may only be the diagnostic division that is making the investment but the whole company has to realise the importance of the diagnostic strategy in driving PM.
Diaceutics can provide expert consultation that supports your efforts to move at a healthy pace towards a PM-ready future and Labceutics can ease your lab network implementation.
Webinar - Which Pharma Companies Are Ready For Precision Medicine in 2017: Benchmarking, Financial Risks and Predictions, December 14th, 11am ET