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European Biopharmaceutical Review

Better Together

Increased productivity within the healthcare system is a constant aim for stakeholders responsible for making investment and funding decisions. For biopharmaceutical companies, transforming clinical development to be more productive in delivering solutions can satisfy the triple aim of improved population outcomes, enhanced quality of life and reduced healthcare costs.

Historically, productivity measures for biopharma companies have centred on the number of compounds in the pipeline and their respective, expected value and probability of technical success, divided by the Increased productivity within the healthcare system is a constant aim for stakeholders responsible for making investment and funding decisions. For biopharmaceutical companies, transforming clinical development to be more productive in delivering solutions can satisfy the triple aim of improved population time-to-market and the investment required. These elements can be quantified fairly easily and the technique applied to a single compound, a company’s pipeline, or even the industry pipeline as a whole.

However, with the emergence of new drug interventions, technology solutions and holistic care programmes designed to address specific health conditions, the market is becoming increasingly personalised. This is great news for patients with unmet medical needs and, at the same time, this market structure easily lends itself to productivity improvements, given that a reduced number of end-users for a solution can mean lower revenue for developers.

Given this, there is another factor within developing medical innovation which could make a difference to productivity and which has not yet been given the consideration it deserves. This factor is collaboration. Collaboration between biopharma companies and other stakeholders in the healthcare sector could hold the key to achieving new levels of productivity. Such partnerships need to go beyond the traditional collaborative model, reaching across the entire lifecycle of a new medical intervention – both pre- and post-market. Delivered effectively, collaboration improves the probability that work carried out within the healthcare sector, and by biopharma companies in particular, delivers a positive effect – now and in the future – and therefore realises worthwhile revenue.

Opportunity Identification

Product development starts with the identification of new treatment opportunities. Creating collaborative relationships between diverse stakeholders involved in producing and using new medical solutions can help biopharma companies make more effective portfolio and target product profile decisions. Discussions with a wide range of stakeholders at the earliest possible stage can clarify the desired benefits from a solution and suggest how those benefits can be realised. However, it should be recognised that not all stakeholders within the supply chain for a medical solution are likely to – or indeed should – seek a collaborative relationship.

Partnerships with regulatory bodies are unlikely, given that such relationships could be seen to compromise the integrity of these bodies in their roles as independent monitors. It may also be argued that a close relationship with a medical provider – even in an advisory capacity – may not sit well in the context of the provider/patient relationship, where the provider must always offer the most effective solution based purely on the condition of the individual.

Collaboration between biopharma companies and payers, patient groups and new entrants, however, is workable, and can have positive outcomes for productivity. It is patients, after all, who benefit from innovative medical solutions, and payers who ultimately see value for money if a new solution is successful. Moreover, payers are in the privileged position of possessing an overview of the impact a solution has on the overall cost of healthcare delivery. By bringing this perspective into the identification of new opportunities, a project proposal can be clear as to its impact on achieving better population outcomes, improved quality of care and lowering costs.

For example, collaboration between a patient group and a biopharma company on a specific solution may result in costs being driven out of both the development cycle and final treatment. The path to creating an effective solution could be made less time-consuming and more effective, while the treatment itself could include a reduction in required supportive measures elsewhere in the treatment of patients. From their position, payers are able to measure these impacts, whereas frontline medical providers – like doctors and pharmacists – may not.

Development planning requires early input from healthcare stakeholders, be they patients, payers, providers, doctors or regulators. Vertex collaborated with the Cystic Fibrosis patient organisation during the development stage of one of its products, helping the project identify tangible benefits within the healthcare system. David Orenstein – a cystic-fibrosis specialist at the Children's Hospital of Pittsburgh and the University of Pittsburgh Medical Center, who helped conduct research – said of the project’s value: “If I can cut down their [his patients’] need for hospitalisations, or courses of antibiotics, that would be a discernible benefit” (1).

Development Strategy

A development strategy created through collaboration with others involved in the management and delivery of healthcare solutions can allow greater productivity for biopharma businesses and the healthcare sector in general. If the mix of internal and external capabilities of those involved are factored in from the start of the process, the method by which the final treatment option is created can be delivered in the best – or most productive – way.

Without collaboration, it could be argued that biopharma businesses do not fully appreciate the nature of the opportunity facing them. Without input from patients and payers, developers may be creating solutions without a complete understanding of the relevant issues and challenges. However, with collaboration, companies can mitigate this risk. Rather than working in a vacuum that may consider only the performance of a compound in scientific terms, developers can study the patient’s overall experience and the nature of the system in which a solution is delivered. In this scenario, an effective solution might not be dependent on drug performance alone, but on a combination of interventions within which biopharma can play a significant role.

In order to capitalise on this opportunity, biopharma companies should be open to the idea that their contribution may extend beyond simply delivering a compound or drug. There may be the potential to diversify in the provision of support for specific patients, but this cannot be realised if the company focuses purely on the drug element of the treatment. By engaging in a collaborative relationship, businesses can open themselves up to increased opportunities and a faster way to add value. Sean E Harper, Managing Director Executive Vice President of Research and Development at Amgen, was quoted about his company’s involvement in the Lung Master Protocol project, which involves several pharma firms: “This latest collaboration can significantly speed our understanding of targeted approaches for this complex and underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design.” He added: “It may ultimately tell us more about how best to match patients to the right treatments” (2).

Other opportunities through collaboration may come from new entrants, such as Google partnering with Alcon to develop their ‘Smart Lens’ solution. In this case, the final product is not a drug, but a piece of technology which will have a significant positive impact on the management of diabetic patients’ conditions.

Planning and Design

Providing a clear roadmap for collaborative projects is imperative if they are to be delivered more productively. New treatment options need to be described in the Target Product Profile (TPP), which defines the new treatment’s characteristics and how it will provide value for each stakeholder group.

The debate around value, however, is not a straightforward one and can present a barrier to productive collaboration. According to Quintiles’ research for Value is the Target, while biopharma’s top definition of value is ‘addressing unmet medical needs’, other stakeholders have a different perception of biopharma’s priorities (3). In total, more than 50% of US payers believe biopharma’s top definition of value is ‘potential number of patients’. Conversely, while the payer’s top definition of value is ‘degree of improved efficacy’ (an overwhelming 63% of US payers have this view), biopharma and providers believe payers wish to emphasise ‘cost compared’ with ‘existing products’ – at 45% and 62%, respectively.

All these issues can be addressed through a focus on productivity. By targeting the aims of improving population outcomes, enhancing quality of life and lowering healthcare costs, the ideas and commitment of the stakeholders can be focused and united, rather than driven apart. Gaining this unity requires skilled communications to enable each party to understand one another. Such communication may be made possible through the work of an external third party in the absence of effective in-house skills.

Getting the TPP correct is imperative for increasing productivity in the development of a new solution, because it underpins the product development necessary to obtain regulatory market authorisation and successful market access. Indeed, to enhance productivity, it is clear that the TPP must now reflect the collaborative approach being taken during product development.

Evidence Generation


One of the most crucial elements in producing a successful therapeutic for a condition is the securing of evidence. While personalised healthcare offers great opportunities for new and innovative treatments, it also presents challenges in evidence generation, notably proving the efficacy of a solution that meets the needs of a smaller patient group. There can be no doubt that the delivery of effective patient trials can be more difficult and costly in the emerging personalised medicine market. In addition, regulatory scrutiny may be heightened in order to ensure the proposed solution delivers a positive experience for those it is intended to help.

To increase productivity, it is vital that all sides appreciate each other’s view on the data generated. Quintiles’ research highlighted the scepticism with which payers regard biopharma data (3). According to their figures, 84% and 54% of US and EU payers were ‘not at all’ or ‘not very confident’ about biopharma companies’ claims regarding value. Perhaps more concerning is that 74% of US payers and 44% of EU payers were ‘not at all’ or ‘not very confident’ in the completeness and transparency of information provided by businesses to demonstrate value.

In this environment, it is imperative that evidence generated is meaningful for all stakeholders going forward. Collaboration can help with this issue – Mediguard, for example, is an online platform that provides access to anonymised or patientreported data to help companies better understand what is important to patients and how treatments have an impact on real-world outcomes.

A collaborative relationship must recognise and respect the needs of each collaborator. Gaining trust and an understanding of evidence among stakeholders requires work some time before the conclusion of any trials. By including the perspectives and ideas of market access stakeholders, key opinion leaders and even patients, it is possible to generate a clear idea of what is required evidence-wise before any investment is made in securing that evidence. Even if regulators are not directly involved in the process, their likely concerns can be factored in – giving new interventions a more straight forward passage to market. Effective collaboration offers a great opportunity to work earlier with market access entities and patients to provide treatment solutions that improve longterm population outcomes.

Good Communication

Greater transparency and trust has a positive effect on productivity as it enables a focus on what stakeholders truly consider valuable. Generating trust and transparency means creating an effective dialogue between parties based on an understanding of the processes and priorities driving each organisation. Clinical researchers may be impressed with the performance of new compounds, while end-users may be more concerned with metrics reflecting their wider quality of life experience. Both of these considerations have a place in the delivery of a new valuable solution, but neither should be expected to provide all stakeholders with the evidence they need to sanction an answer.

Continuous Learning

Increasing productivity is not a oneoff activity and collaboration is not intended to deliver a single, remarkable change, but instead should support diverse modifications wherever and whenever the opportunity arises. Biopharma companies and stakeholders should not expect collaborations to terminate when a new product reaches the marketplace, nor does the push for greater productivity end at this point. By creating an effective feedback cycle post-market, new knowledge and continuous learning can be brought into the project, helping to deliver improvements to existing techniques and the development of new opportunities. Collaboration is imperative here because the most important learnings for R&D will come from other functions within the organisation and from the external parties that were part of the last development cycle.

This learning represents a long-term commitment. There may be a shift in resources which the payer only appreciates in months and years to come. A metric such as reduced hospital admissions, for example, may not be accurately measured until some months after a solution’s introduction.

Truly effective collaborative relationships can last many years. For payers within the healthcare sector, it may be a great challenge to invest in a partnership – and indeed in a solution – when the benefits of that investment may not be seen for more than a decade. The task is made all the greater since the actual tangible outcome may not be clear at the start: the objectives of improving population outcomes, enhancing the quality of life and lowering healthcare costs are clear, but precisely how this will be achieved is not immediately obvious.

Essential Collaboration


Market conditions – in terms of medical trends and industry structure – present challenges for the biopharma industry to realise improved productivity. In this environment, collaboration with other healthcare stakeholders is essential for delivering productivity gains through a leaner and more informed development process.

Building on increased productivity that is achieved through addressing the number of compounds in development and their likely success, collaboration places the focus of innovation on the value delivered to the healthcare sector. It paves the way for biopharma companies to contribute in diverse ways for medical provision, rather than continuing to achieve value only through the development of unique drugs. Working alongside others in the healthcare sector enables biopharma to address the emerging personalised healthcare market in an effective way.

Examples of collaborative relationships are already emerging. Some firms are running Phase 3 trials to gather additional data while a drug is going through approval in an effort to meet stakeholder demands for evidence showing product value. In the US, the introduction of accountable care organisations is contributing to a shift in emphasis from volume to value in the development of solutions. This change in emphasis epitomises the mindset required to deliver better productivity among biopharma companies.

Realising the full benefits to productivity of collaborative work involves creating and maintaining a diverse range of projects and relationships with organisations throughout the healthcare system. Within this, pharma companies must realise productivity does not exist only in delivering effective new compounds, but in playing a responsive and active part alongside others, in the creation and management of effective treatments.

References

1. Visit: http://online.wsj.com/articles/ vertex-says-late-stage-cysticfibrosis- treatment-studies-meetendpoint- 1403610720
2. Visit: www.science20.com/ news_articles/amgen_joins_national_ cancer_institute_other_companies_on_ lungmap_project-138700
3. Quintiles, 2013. Visit: www.quintiles.com/ library/white-papers/value-is-the-target

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Peter Wagner is the Director of Consulting at Quintiles and has more than 12 years’ experience in assisting life sciences organisations as a consultant and manager at both a global and local level. He previously worked with Accenture, where he focused on R&D, and also served as Senior Vice President Operations and Technology in a start-up company which focused on stakeholder analytics within life sciences companies. Peter has a BMS in Finance and Economics from the Waikato Management School.

Dr Christoph Schnorr
leads Quintiles’ European Research and Development Consulting Practice, with a focus on helping biopharma create strategies and capabilities to bring medical innovation to patients. He is a doctor by training with 20 years' experience in the pharma industry. Most recently, Christoph was Head of Development Operations for a global pharma company with oversight for all development functions, including medical science and innovation, global clinical operations, the Chief Medical Office and regulatory affairs. He earned his medical degree from the University of Giessen.

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