Kinapse Life Science Consulting and Outsourcing Services White Papers

Performance Management in Medical Affairs As Medical Affairs evolves and takes a more prominent role in the development and commercialisation of medicines, it needs a more robust approach to performance management. However, Medical Affairs must first be def ined in a way that is clear to all internal stakeholders. A definition of Medical Affairs accountabilities and deliverables which is supported by robust KPIs will help to align the Medical Affairs organisation, and importantly enhance cross-functional collaboration in the achievement of the goals of the business.
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Ideas About the Future of the Innovative Pharmaceutical Industry Download our latest white paper here.
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Big Pharma R&D – thinking big, acting small The pharmaceutical industry is experiencing an extended phase of consolidation in an attempt to realise economies of scale and mitigate risks. Kinapse analysis suggests that Big Pharma might now be too big and shows how to break it into smaller operating entities to help increase R&D productivity.
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Earned Value Management, an approach for effectively managing pipeline value Life sciences R&D organisations have made advancements in managing the performance of their development projects and portfolios, yet prioritisation, resource and budget allocation, and the tracking of value creation remain hard to achieve. This article argues that life sciences R&D organisations should adopt EVM, describes the benefits of applying EVM at the project level, and explores the potential for additional benefits at the portfolio level.
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Discovery Metrics – Creating the Right Balance Metrics can be powerful tools for driving performance, but the measurement of effort and output in Discovery organisations is often felt to be in fundamental conflict with the need for the creative, unconstrained culture required to drive innovation. In addition, many would argue that Discovery metrics largely fail to yield benefits. This paper explores the reasons behind that, and looks at an approach to defining metrics that are ‘fit for purpose’.
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Internet usage of Indian General Practitioners General Practitioners (GPs) form a vital part of the medical fraternity in India and are a major part of the pharmaceutical companies’ prescriber base. A rapid development has taken place in the use of Internet by the medical fraternity in India over a past few years and pharmaceutical companies have been making a lot of efforts to use Internet as a channel to connect to GPs both for marketing their products as well as knowledge sharing. A survey was conducted involving more than 100 GPs across 3 Indian cities to evaluate opinions and perceptions of the Indian GPs on their professional use of Internet. This paper tries to analyse their opinions and provide recommendations on how the industry can further use Internet to improve their reach to GPs.
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Practical Approaches to Early Stage Life Sciences Technology Valuations Early stage partnering has become a key component of life sciences business strategy, however valuation of early stage assets is a continuous area of valuation practice. This article provides a framework for building realistic and widely accepted early stage valuations that facilitate productive transactions and form the basis for successful long-term partnerships.
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Improving Clinical Site Productivity There are a number of factors in the industry that make clinical trials more costly, more time-consuming and requiring more patients than in previous years. More than ever, sponsor companies are being pushed to deliver clinical trials quicker and more cost effectively. The purpose of this paper is to look at ways in which clinical trials can be run more effectively and thus improve productivity. The paper introduces the Kinapse Clinical Site Productivity Framework as a mechanism to evaluate seven key areas in the patient recruitment process. By assessing each key area, issues can be identified, prioritised and solutions designed and improvements made.
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Real World Development: Increasing Value for Patients The traditional drug development paradigm must change. We propose a fundamentally new approach which will create a win-win partnership between industry, academia, health authorities, health technology assessment (HTA)/health economic program (HEP) bodies and patients. We call this new approach “Real World Development” the underlying principle of which is to constantly assess the product in as close to post-marketing use as possible. Key components of this approach are the use of adaptive trial design and capitalisation of existing real world data sources. It enhances the evaluation of benefit/risk, enable earlier patient access to innovative medicines, and improve value for money.
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Discovery Innovation – Productive Partnering for Shared Success Phase II clinical development has traditionally been considered the ‘sweet spot’ for big pharma partnering deals. However our recent analysis reveals that discovery and early-stage clinical alliances are of increasing importance to big pharma’s long-term business strategy. This paper highlights the shifting industry trends responsible for the growth in earlier-stage partnering and describes how key stakeholders in the discovery space are evolving. We discuss the implications of this changing landscape for big pharma, and outline the new competences required to maximize value, mitigate risks and ultimately deliver new treatments to market.
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Insights from Close Loop Marketing Implementation Close Loop Marketing (CLM) is a new buzz word and the latest technology fancy in Pharma Marketing world after CRM in the 90s. But failing to anchor it in a thought-through business rationale could result in wasted (big) investment. CLM as a new business discipline is in fact a major change in mindset for an organisation and will have deep impact on Marketing and Sales processes (and others too) and ways of working. We have summarised different implementation perspectives and approaches from recent CLM implementations in Europe and the US. As you will see, there is no ‘one approach fits all’ but different considerations to bear in mind when thinking about Close Loop Marketing.
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Offshore Outsourcing in Regulatory Affairs and Pharmacovigilance Based on Kinapse’s direct experience, we explore the emerging environment for regulatory and pharmacovigilance offshore outsourcing within the biopharmaceutical industry and predict the evolution of sourcing from emerging markets for these skill sets. The ideas in this paper build on a Kinapse editorial, published in September 2010, which proposed that partnering between client and service provider allows cost reductions and quality benefits while creating value for both organisations.
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In With the ‘New’: A Leaner, Fitter Biosciences Sector – 2010 The biosciences sector has witnessed numerous challenges during recent years, as the global economic downturn has adversely impacted sector liquidity and undermined investor confidence. But now, as the sector begins to show signs of recovery, emerging and developing companies with innovative platforms and products have unique opportunities to build sustainable growth over the long-term. This paper outlines the leaner and fitter sector that is set to emerge from the global recession, and suggests how developing companies can position themselves to exploit the changing competitive landscape of the life sciences industry and capture significant industry value.
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What Might the Proposed NHS Reform Mean for Pharmaceutical Commercial Models? Over recent years the UK has pioneered the evolution towards payer-driven healthcare. This has created significant business shifts in both primary and secondary care, provoking a fundamental rethink of pharmaceutical commercial operating and governance models. Now, with its White Paper Equity and Excellence: Liberating the NHS2, the UK Government has signalled yet another revolution in the way healthcare is organised and delivered. Although the intent and underlying principles of the NHS reform set out in the White Paper may be laudable, the reality is likely to present major challenges both to healthcare professionals and to the pharmaceutical industry, with a high risk that the ‘new’ commercial models currently being developed and implemented will no longer be fit for purpose.
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Medical Affairs at the Centre of Life Science Innovation In today’s challenging business environment, many innovative life sciences companies are raising questions about the return on investment of internal resources and external expenditures. These questions are now being asked of Medical Affairs Leaders. It is very challenging to measure Medical Affairs ‘value’ in this way, and we see many instances of Medical Affairs investments being constrained in light of general budgetary pressures. We argue that this is a short-sighted and potentially hazardous trend as we believe that Medical Affairs capabilities must evolve to be at the centre of life sciences companies’ therapeutic innovation, product development and stakeholder interactions.
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New Commercial Realities Faced with a changing healthcare environment and the prospect of diminishing commercial returns, the pharmaceutical industry has recognised that traditional commercial models based on sales force arms races are no longer viable. In order to adapt to new commercial realities that require more complex decision-making processes and involve a greater number of stakeholders influencing at a range different levels, pharmaceutical companies must undertake a fundamental and systemic rethink of their commercial operations. This paper provides insights into the changing healthcare environment and describes how key stakeholders in the space are evolving. We discuss the key implications of this changing landscape for pharmaceutical commercial operations, and provide an actionable approach for implementation of new commercial models that considers future roles & competencies, governance and organisational structure and size.
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