The Innovative Medicines Initiative -10 Years of Public-Private Collaboration.

The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Union and the European pharmaceutical industry. Born of the necessity to foster collaboration between different stakeholders in order to address growing challenges in bringing new medicines to market and the rapidly evolving healthcare landscape, IMI has successfully delivered the radical collaboration needed to address these challenges. In this article we reflect on some of the major achievements of the programme by highlighting a few of the key projects funded and the progress they have made, as well as some of the lessons learnt in delivering such an ambitious partnership. Those that drove the foundation of IMI recognized that to address these challenges required not just ambitious scientific approaches, but also an awareness of societal needs. Therefore, actors from beyond the traditional pharmaceutical research communities would be needed. One of the key successes of IMI has been to foster radical collaboration between diverse public and private partners of all types, including large pharmaceutical companies, SMEs, regulators, patient organizations and public research institutions. It has achieved this by being a neutral platform where all partners are bound by the same rights and responsibilities. Since it began there has been an evolution in the understanding of what is considered "pre-competitive," resulting in IMI projects now addressing all of the steps within the pharmaceutical development value chain. With this expansion in the types of projects supported by IMI, different actors from beyond the traditional pharmaceutical research family have been attracted to participate, enriching further the collaboration at the heart of the programme. Finally, such a complex programme brings with it challenges, and we reflect on some of the important learnings that should be applied to future collaborative models to ensure that they are as successful as possible and deliver the expected impact.

How to Harness Big Data for the Benefit of Patients.

IMI is a large public private partnership which has committed Euro 5 Billion from the European Commission, the European Pharmaceutical sector and other partners, to enable and accelerate bringing medical innovation to patients. IMI is now 10 years old and already has changed the ecosystem and way of working in developing innovative medicines across the public/private divide. Big data represents a significant piece of this investment and projects in this area are attempting to provide solutions to major challenges including: 1. Data integration from many sources across many jurisdictions and institutions and which need to be validated with regard to their quality and robustness 2. Data interfaces, for example, between research and clinical data and how to overcome the challenges around data protection and access 3. Data standards and who establishes these and how they are deployed 4. How do we scale and sustain some of the successful pilots to ensure the value of the investment? 5. How do we take advantage of the digital revolution to enable more relevant and accurate data capture in the real world? Much has been done already through IMI projects and beyond and now we need to consolidate through intelligent implementation across the European landscape. With a mixture of generic and disease specific investments, and although many challenges remain, significant progress has been made and examples of success will be described.

Global implementation of genomic medicine: We are not alone.

Around the world, innovative genomic-medicine programs capitalize on singular capabilities arising from local health care systems, cultural or political milieus, and unusual selected risk alleles or disease burdens. Such individual efforts might benefit from the sharing of approaches and lessons learned in other locales. The U.S. National Human Genome Research Institute and the National Academy of Medicine recently brought together 25 of these groups to compare projects, to examine the current state of implementation and desired near-term capabilities, and to identify opportunities for collaboration that promote the responsible practice of genomic medicine. Efforts to coalesce these groups around concrete but compelling signature projects should accelerate the responsible implementation of genomic medicine in efforts to improve clinical care worldwide.

Complications/adverse effects of maxillomandibular advancement for the treatment of OSA in regard to outcome.

OBJECTIVE: To evaluate adverse effects/postoperative complications and surgical response rate of maxillomandibular advancement for the treatment of severe obstructive sleep apnea syndrome. STUDY DESIGN: Case series with chart review. SETTING: Otolaryngology Head and Neck Surgery Department in a teaching hospital. SUBJECTS AND METHODS: A total of 59 consecutive severe sleep apnea patients underwent maxillomandibular advancement. Systemic complications were evaluated from medical charts. Functional adverse effects and cosmetic consequences were evaluated by questionnaires. The treatment outcome was assessed by polysomnography. RESULTS: Fifty patients were evaluated. They had a mean age of 46.4 +/- 9.0 years. No serious postoperative complication was observed. The most frequent local complication was mental nerve sensory loss. Most patients reported cosmetic changes. The mean apnea-hypopnea index decreased from 65.5 +/- 26.7 per hour to 14.4 +/- 14.5 per hour (P < 0.0001). Light-sleep stages were also decreased (P < 0.0001), whereas deep-sleep stages were increased (P < 0.001). CONCLUSION: Maxillomandibular advancement can induce local adverse effects and cosmetic changes, but they seem to be considered as secondary to the patients according to the surgical outcome.