MAC-Team

Open Innovation & Pharma and biotechs

Article Index

funnelBusiness anc collaboration models are changing in the pharmaceutical and biotechs sector. Open Innovation enters the play with strength.
Being involved in both, in Open innovation and in Biotechs/Pharmaceutical projects, MAC-Team here proposes an outlook of various initiatives in the field.
You can start on Open Innovation, Open source ... aproaches at different levels depending on your strengths, your capacity in leveraging informaiton. You are not obliged to put everything on a plate right from start. you need a clear strategy on that. But, the most successful or fast developing actors are often the ones able to go in the direction of open innovation 2.0. This has been especially true outside the Pharmceutical sector, but this pharmaceutical/biotech sector is now confronted to a suffocating business model. This sector is now going for new business approaches and open innovation is a leading one.
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As presented by the IFPMA "International Federation of Pharmaceutical Manufacturers & Associations", the pharmaceutical industry is increasingly using collaborative innovation models to overcome challenges in the research of new medicines for diseases affecting both the developed and developing world:

  • The medicine development process is becoming increasingly challenging and in order to address this, industry is thinking creatively about how to innovate more effectively.
  • Companies are increasingly working in partnerships and actively seeking expertise or technology from outside the company.
  • New collaborative platforms are facilitating research on "mainstream" diseases, "orphan diseases" and "neglected diseases".
  • In order to facilitate sustainable innovation, a collaborative platform needs to be voluntary, encourage Intellectual Property (IP) owners to contribute to the scheme and be flexible enough to adapt to a variety of different circumstances.

The medicine development process is becoming an increasingly expensive and difficult. An ever-stricter regulatory environment, coupled with new technological challenges is forcing industry to think creatively about its innovation and business models. In order to meet these new challenges, the pharmaceutical industry is working in collaboration with different players throughout the research and development cycle of new products.

This improved collaboration is taking place in many different ways. Companies are increasingly working in partnerships and licensing in and out technologies and knowledge instead of developing and keeping them in-house. This facilitates the dissemination of technologies and know-how to a much wider scientific community, while allowing industry to incorporate promising external research to its knowledge pool. This collaboration can take place amongst a large range of partners, like academia, public research institutions, Product Development Partnerships (PDPs) and small, medium and large biopharmaceutical companies.

In the innovative financing ways for the development of pharmaceutical products, IFPMA presents several kinds, two of them relating to the Product Develoment Partnerships (PDPs) and to the "Orphan Drug"-type mechanisms:

  • Product Development Partnerships (PDPs)
    A recent approach that has helped to increase R&D for neglected diseases is the product development partnership (PDP) model, in which stakeholders from the private, and non-profit public sectors may work together. Indeed, the majority of industry R&D projects for diseases of the developing world now involve collaboration with PDPs. Companies provide the R&D, technology, manufacturing and distribution expertise, with funding and logistical contributions from partners, such as governments or philanthropic organizations. Academic institutions are also involved in providing research capabilities and disease area knowledge. This cooperative tool is a crucial link in the process of bringing new discoveries to patients, particularly for those diseases that affect neglected populations, where there is little commercial investment.
  • "Orphan Drug"-type Mechanisms
    In the US, the EU and several other countries, "Orphan Drug Acts" have produced impressive results in terms of new drugs made available in disease areas where the number of patients is small and the return on R&D investment insufficient. Legislation or other mechanisms similar in spirit to these "Orphan Drug Acts", (e.g. the US Priority Review Voucher Scheme) could provide a favorable framework of financing incentives to increase R&D for drugs targeting diseases of the developing world. Such a package could include R&D tax credits, research grants, lower regulatory fees, or fast-track approval.

Even if it is not on their full business activities, several of the "big" labs clearly implemented an open innovation attitude on several dimensions:

Open Innovation and Learning cycles by Lilly
what is open innovation (by Lilly) learning cycles (by Lilly)

 


SourceIFPMA "International Federation of Pharmaceutical Manufacturers & Associations"


 


Call for proposals on "personalising health care" directly requiring "open innovation"

H2020-PHC-2015-single-stage, Sub call of: H2020-PHC-2014-2015, Deadline Date: 2015-04-21 17:00:00 (Brussels local time), Total Call Budget: €162,000,000.

Topic:

Self-management of health and disease and patient empowerment supported by ICT PHC-27-2015.
Specific challenge: Empowering citizens and patients to manage their own health and disease can result in more cost-effective healthcare systems by enabling the management of chronic diseases outside institutions, improving health outcomes, and by encouraging healthy citizens to remain so. Several clinical situations would be prevented or better monitored and managed with the participation of the patient him or herself. Care sciences may complement the medical perspective without increasing the cost.

This requires research into socio-economic and environmental factors and cultural values, behavioural and social models, attitudes and aspirations in relation to personalised health technologies, mobile and/or portable and other new tools, co-operative ICTs, new diagnostics, sensors and devices (including software) for monitoring and personalised services and interventions which promote a healthy lifestyle, wellbeing, mental health, prevention and self-care, improved citizen/healthcare professional interaction and personalised programmes for disease management.

Support for knowledge infrastructures is also required. Implementation of programs or applications for different target populations to capture gender- and age-dependent differences in health, behaviour and handling of devices is encouraged.

This topic is a continuation of PHC 26 – 2014) giving more and different opportunities to develop solutions and services for self-management of health and diseases.

Scope:

Solutions should be developed and tested with the use of open innovation platforms such as large scale demonstrators for health and service innovation. Gender and ethical issues should be duly considered. Proposals should involve health procurers and support them in their efforts to lower costs, and reduce difficulties associated with limited numbers of health professionals by utilising the capacity and potential of the patient as a co-producer of health. Proposals should use pre-commercial procurement to maximise the engagement of innovation in healthcare organisations following the community building and road-mapping activity in the seventh framework programme call 10 CSA on innovation in health procurement.

Proposals should aim to empower patients to manage their pre-existing conditions. Health management will be addressed holistically, including healthy lifestyle interlinked with disease management, placing the patient in the centre and putting increased emphasis on health education, secondary prevention and self-management of individual conditions, including co-morbidities.

Proposals should address all of the following elements a) personalised guidance to patients based on their profiles and the use of wearable/portable devices and improved individual/healthcare-professional interaction, b) engagement of patients as active members in managing their diseases, in particular addressing chronic diseases, co-morbidities, treatment adherence, rehabilitation, self-diagnostics and self-care and c) decision support systems interoperable and/or maintaining integrity with electronic health records.

The Commission considers that proposals requesting a contribution from the EU of between EUR 3 and 5 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:

  • Improving the participation of the patient in the care process.
  • Improving the management of a disease by reducing the number of severe episodes and complications.
  • Increasing the level of education and adherence of individuals, patients and care givers related to application of ICT for personalised care.
  • Improved interaction between patients, their relatives, providers of health-, social-, and informal care givers.
  • Strengthened evidence base on health outcomes, quality of life, care efficiency gains and economic benefits from the use of ICT in new care models.
  • Reinforced medical knowledge with respect to efficient management of comorbidities.
  • Increased confidence in decision support systems for disease/patient management.
  • Involvement of health care providers/authorities with increased commitment in the deployment of innovative services empowering the patient.

Type of action: Pre-commercial procurement co-fund actions.

 

Innovative Medicines Initiative 2 (IMI 2)

On 10 July 2013, the European Commission released its proposal for the Innovative Medicines Initiative 2 (IMI 2), which will have the goal of developing next generation vaccines, medicines and treatments, such as new antibiotics. The European Commission's proposal is now being discussed by the European Parliament and the EU Member States.

In particular, IMI 2 aims to deliver:
a 30% better success rate in clinical trials of priority medicines identified by the WHO;
clinical proof of concept in immunological, respiratory, neurological and neurodegenerative diseases in just five years;
new and approved diagnostic markers for four of these diseases and at least two new medicines which could either be new antibiotics or new therapies for Alzheimer's disease.

What's new?

  • Common rules for all of Horizon 2020.
  • Partners in IMI 2 projects will benefit from simplifications introduced in Horizon 2020. Derogations for IMI will be limited to industry commitments (large industrial partners will not receive EU funding), and the intellectual property (IP) rules, which are designed to promote an open innovation model and the exploitation of results.
  • Lighter financial rules.
  • Option for other industrial partners to contribute in kind.

Budget
The total budget proposed for IMI 2 is €3.45 billion. The EU will contribute up to €1.725 billion of this from Horizon 2020, the next EU research and innovation framework programme. EFPIA, the European Federation of Pharmaceutical Industries and Associations, will commit €1.5 billion in in kind contributions. In addition, other life science industries may contribute a further €225 million if they decide to join IMI 2 as members or as partners in individual projects.

Duration
IMI 2 is expected to start in 2014 and will run for 10 years.


Other relevant articles:



  • by Fleming Europe
    Short interviews at the conference on Open Innovation in Pharmaceutical


Presentation of the first Innovative Medicines Initiative (IMI), the largest public-private partnership in health
(see above about IMI 2, in the call for proposals section)


Prezi presentation: From IMI-1 to IMI-2 : One step further: from invention, through innovation, to benefits for patients
(see above about IMI 2, in the call for proposals section)


Attachments:
Download this file (Assembling_the_RD_puzzle_FINAL.pdf)Assembling_the_RD_puzzle_FINAL.pdf[Assembling the pharmaceutical R&D puzzle for needs in the developing world (Putgatch Consilium 2012)]1148 kB
Download this file (CEWG_Report_5_April_2012.pdf)CEWG_Report_5_April_2012.pdf[Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (WHO - 2012)]1341 kB
Download this file (oidd_potential_path_ctmc.pdf)oidd_potential_path_ctmc.pdf[Open Innovation Drug Discovery (OIDD): A Potential Path to Novel Therapeutic Chemical Space (by Lilly)]1033 kB
Access this URL (https://openinnovation.lilly.com/dd/science-of-open-innovation/relevant-publications.html)relevant-publications.html[Publications by Lilly on Open Innovation Drug Discovery]0 kB
Download this file (Open-innovation-a-new-paradigm-for-industry-academia-collaboration.pdf)Open-innovation-a-new-paradigm-for-industry-academia-collaboration.pdf[Open innovation: a new paradigm for industry-academia collaboration, by Paul-Peter Tak, Senior Vice President, Head, Immuno Inflammation Therapy Area, GSK, UK (2013)]2861 kB
Access this URL (http://www.ncbi.nlm.nih.gov/pmc/?term=%22open+innovation%22)pmc[Search on \"open Innovation \" in the journal \"Open Medicine\"]0 kB
Access this URL (http://www.osdd.net)www.osdd.net[OSDD - Open Source Drug Discovery]40 kB