Stakeholder Perspectives: Innovation within the Biopharma Industry

  • February 2014
  • -
  • Firstword Pharma
  • -
  • 99 pages

What does innovation mean within the biopharma industry? How much you spend on R&D? How many products you bring to market? How many New Molecular Entities (NME) you have in research?

Within the biopharma industry, R&D output is at odds with R&D investment. Between 1950 and 2010, the number of new molecules (including both biologics and small molecules) brought to market by the biopharma industry, per billion dollars of R&D expenditure, fell by a factor of 100 in inflation adjusted terms. Innovation, it seems, is getting increasingly expensive while the prospect of blockbuster income to pay for it is getting rarer. Something has to change.

So...what are the issues we need to consider?

- New molecular entity (NME) output is not an accurate reflection of the state of innovation: new ways of measuring innovation within the biopharma industry are needed. Current methods of measuring NME output from either the FDA or EMA provide only a snapshot of what regulatory agencies deem approvable. The industry needs to move beyond NME output as a measure of innovation, taking into account provider, purchaser and user metrics including pipeline activity, clinical success, regulatory approval, patient access, satisfaction of unmet need and overall value to society;
- Collaboration is critical to success: Industry must leverage the experience, skills and insights from a diverse range of stakeholders such as physicians, patients and payers – this is critical to the future of innovation. But collaboration needs to be smart. Biopharma companies must collaborate only when the expected outcome adds value to society, contributes to better patient outcomes and supports commercial goals;
- Companies need to be brave: constantly mining a ‘comfort zone’ of known approaches leads to complacency and limits innovation. While many believe that all of the ‘low hanging fruit’ have been taken there is another perspective: that there is plenty of fruit left on the tree and companies just need the bravery and vision to look for them.

This FirstView advisory report – the first in a major new series – provides everyone interested in the dynamics of biopharma innovation with a robust understanding of the issues, opinions and insights that are shaping the current environment, and the events that could lead to a change in the future. Every aspect of the report is informed by expert insight gathered from 60-minute interviews with 16 key opinion leaders (KOLs), payers and senior industry executives from leading companies from across Europe and the US.

Experts share their insights on...

- The impact of innovation within biotechnology over the last 15-20 years
- A view of what a world without biologics would have looked like
- The pros and cons of biological therapies
- Where biologics have been best received and where there is still resistance
- The role that industry played, and needs to play, within the ‘innovation ecosystem’
- The important and growing roles of key stakeholder groups
- Attitudes toward innovation within industry
- New technologies and innovations that are exciting industry at the moment, and hypotheses about the future of innovation and roles in driving it forward
- This report tackles the pressing innovation issues and questions

What does biopharma innovation mean?

- Where is innovation coming from?
- How can the lessons of the last few decades be used to guide future biopharma innovation?
- What will be the future trends in biopharma innovation?
- How has biopharma innovation been measured in the past, and do new ways of measuring innovation need to be developed?
- What must biopharma companies focus on in order to remain competitive and deliver innovation that is truly valued by society?
- Which companies are currently viewed as being leaders of innovation within the pharmaceutical industry?
- What disruptive technologies and market dynamics are likely to impact the rate of innovation within the biopharma industry?
- What do KOLs, payers and industry stakeholders view as critical for biopharma companies to focus on in order to maintain shareholder returns and deliver customer value?

Whether you work in big pharma, a drug discovery company, patient advocacy group or regulatory body, this report Stakeholder Perspectives: Innovation within the Biopharma Industry provides a thought provoking assessment of how we can better cost-effectively develop and bring biopharmaceuticals to the market in a timely manner.

Report Benefits

- Understand and evaluate the current status of innovation within the biopharma industry, including the key drivers and resistors of innovation
- Get up to speed with current thinking on how innovation is measured within the biopharma industry
- Know what potential changes need to be made in terms of how innovation will be assessed in the future
- Understand clinical, payer and industry opinions of current and future market dynamics
- Appreciate what the critical opportunities biopharma companies should be investing in and how these opportunities can be realised

Selected Quotes from the Report

‘Innovation [within pharma] is a lot like a fine Swiss watch. There are multiple moving parts but if you take one part out, the watch stops. So every part in that watch is absolutely critical to the functioning of that watch in the same way that every key stakeholder group within the innovation ecosystem has a critical role. Whether it be a payer, a physician, a company, a policy maker, a scientist, etc. They all have a role to play and if they stop playing that role, the system falls over.’ Former Head of Innovation, Eli Lilly.

‘Collaboration is your key for survival for the future. You cannot always count on the old model of finding solutions inside your own company.’ Global Head of External Innovation & Strategic Partnerships, Roche.

‘If we had a shorter, faster, more efficient regulatory system, then the cost [and time taken] to complete clinical trials would go down. I think we need to re-think how it could be smarter, more efficient. At the moment, the regulatory system is set up to benefit big pharma, not smaller companies.’ Scientific Advisor, Innogen Institute.

‘My view is that biopharma companies need to be more receptive to new models of innovation, and that includes more collaborations, more discussions, sharing of data. I’m not a big believer of we [the biopharma industry] are better than everyone else and we know better, so I think that being open to the environment is really important.’ Head of Innovation at Merck Serono.

‘Do we have a secret sauce [when it comes to innovation]? I don’t know. I think it's the willingness to take a little bit of risk in that space. I think understanding that as good as we have been in the past, it wasn't enough. We knew that that landscape was clearly changing and under some great leadership, we were able to move into a completely new system. Good people like to follow good leaders so that's certainly a part of it.’ VP Strategy & Operations, Janssen R&D.

‘My personal opinion is that the time of the very, very large pharma companies is maybe already over. They're not dynamic enough to react very quickly to changing and dynamic patient needs, so smaller conglomerates of people who throw their expertise into one bucket and do that quickly might win over large pharma companies.’ Senior Manager, Boehringer Ingelheim.

Experts interviewed for this report

This report benefits from the considered insight of leading clinicians, payers and senior industry experts. These include:

KOL’s with relevant clinical, regulatory, scientific and commercial experience, scientific publications, involvement in clinical trials and their record of presenting at high profile international conferences.
Payers with relevant (and recent) experience of deciding on the reimbursement of expensive biological therapies in areas such as oncology, inflammatory conditions, orphan diseases and infectious diseases.
Senior industry executives with current (or recent) experience in innovation, strategy, business development, licensing, competitive intelligence and long-term planning.
Their names have been kept confidential to provide contributors with a secure forum in which they could share their candid opinions and views.

Key Opinion Leaders

Rheumatologist, UK
Rheumatologist, Germany
Rheumatologist, US
Oncologist, US

Payers

Director, Managed Care Organization
Former Pharmacy Director, Harvard Pilgrim Health
Director, Health Insurance (Germany)
Head of Medicines Management, CCG (UK)

Industry Experts

Former Head of Innovation at Eli Lilly
Senior Manager, Boehringer Ingelheim
Head of Innovation, Merck Serono
Scientific Advisor, Innogen Institute
VP Strategy & Operations, Janssen R&D
Global Head, Innovation & Partnerships, Roche
Two senior executives from a large EU-based biotech firm

Who should read this report, and why?

FirstView’s Stakeholder Perspectives: Innovation within the Biopharma Industry is a ‘must read’ for industry executives working in the areas of innovation strategy, business development & licensing, competitive intelligence, long-term planning, market access, R&D, partnering & alliance management, and emerging markets. Each stakeholder group will be able to use the insight delivered in the report to:

- Review aims, objectives and goals of current innovation strategy, and what (on the basis of the way the market is evolving) will be the critical success factors for future success;

- Reassess business development and licensing needs, aims and objectives to ensure that all future deals are accretive in terms of their ability to deliver innovative products to the market;

- Review external competitor strategies with a view to ensuring internal stakeholders are kept up to speed with market and competitive developments;

- Perform internal scenario analyses of various opportunities (e.g. gene therapy, regenerative medicine and technology opportunities) to see what will be needed to leverage the opportunity, and to understand what potential future business models will be needed;

- Review relationships with payers, asking the question ‘are we providing the right data to payers for our innovative products’?

- Review current clinical trial strategies to improve the effectiveness of clinical trials, making them faster, smarter and cheaper, and review regulatory strategies based on increased regulatory hurdles;

- Get a better understanding of what critical attributes are needed in partners when assessing collaborations and joint ventures;

- Engage in portfolio optimisation work in emerging markets to ensure that needs of the market are being addressed by current portfolio; if not, review opportunities to in-license, partner, divest assets.

About FirstView Reports

FirstWord’s FirstView Stakeholder Perspectives: Innovation within the Biopharma Industry is the first of a new series of authoritative analyses that focus on the drivers and resistors of innovation within the biopharma industry.

Innovation is the life blood of the industry, yet the cost of developing and bringing new products to market is spiralling. The series will forensically examine and answer fundamental questions such as:

- As the market moves away from blockbusters to ‘niche-busters’, how can industry and regulators bring new products to market that are not only safe and effective, but also affordable?
- Is the current clinical trials system still fit for purpose, or does industry and the regulators need to develop innovative, more efficient ways of establishing the clinical utility of new medicines?
- Are the advances in personalised medicine already witnessed only the tip of the iceberg, or have we seen all there is to offer in the field of stratified medicine?
- Are biosimilars set to take the market by storm and deliver on the promise of high quality, affordable biologics for all, or will the sector crumble under the weight of its own expectations?
- ‘Beyond the Pill.’ Do you have a strategy? Do you need one? And how influential will payers be when it comes to the impact of ‘beyond the pill’ solutions on biopharma revenues?
The pharmaceutical industry is on the verge of significant change. Old biopharma business models are under significant stress, and things need to change. Make sure you understand the potential strategic implications of these upcoming changes with FirstWord’s FirstView Reports!

Table Of Contents

1.Executive summary
2.Research methodology, aims and objectives
3.Innovation within the biopharma industry
3.1.A review and analysis of the defining characteristics of today’s biopharma industry, and how they are effecting innovation
3.2.The measurement and benchmarking of innovation within the biopharma industry, and some views on the key drivers and resistors of innovation
4.Key stakeholders in the innovation ecosystem
4.1.Who they are, and what their roles must be in order to drive innovation
4.2.Future perspectives on how each key stakeholder group must learn to work together more closely
5.Opportunities for biopharma companies, both now and in the future
5.1.A review and analysis of some of the key opportunities biopharma companies should be investing in to drive future growth, including ‘beyond the pill’ strategies, biosimilars, cancer immunotherapy, gene therapy, regenerative medicine, personalised medicine and networks.
6.A scenario-based analysis of potential biopharma futures
6.1An overview of scenarios, and how they can be used to analyse potential future market dynamics
6.2.The critical scenario drives of this report, and how they were devised
6.3.Four potential scenarios, with a robust review of each scenario in terms of its potential implications to the key stakeholders within the innovation ecosystem
6.4.Expert views and insight on the scenarios, and what it could mean for biopharma companies.
7.Concluding remarks

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