Deerfield
About Deerfield

Launched in 1994, Deerfield Management Company is an investment firm dedicated to advancing healthcare through information, investment, and philanthropy—all toward the end goal of cures for disease, improved quality of life, and reduced cost of care.

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Investment

Supporting companies across the healthcare ecosystem with flexible funding models…

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Information

Delivering market research to the Deerfield team, its portfolio companies and other partners.

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Philanthropy

A New York City-based not-for-profit devoted to advancing innovative health care initiatives.

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Portfolio Companies

Deerfield generally maintains a combined portfolio of more than 150 private and public investments across the life science, medical device, diagnostic, digital health and health service industries at all stages of evolution from start-up to mature company.

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Research Collaborations

Deerfield partners with leading academic research centers, providing critical funding and expertise to further sustain and accelerate the commercialization of discoveries toward meaningful societal impact by advancing cures for disease.

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Strategic Partners

As a strategic partner, Deerfield offers capital, scientific expertise, business operating support, and unique access to innovation.

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Deerfield Foundation

The Deerfield Foundation is a New York City-based not-for-profit organization whose mission is to improve health, accelerate innovation and promote human equity.

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Cure Campus

Cure is a 12-story innovations campus in New York City that intends to bring together innovators from academia, government, industry, and the not-for-profit sectors to advance human health and accelerate the fight against disease.

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Cure Programming

Cure has a series of expert lectures intended to advance thought in healthcare, management, innovation, policy, and other relevant subjects. This fosters growth and education for those at Cure and its guests.

Events at the Cure

Deerfield and EuropaBio Publish a Report on Regulatory and HTA Scientific Advice for Small and Medium Enterprises

NEW YORK & BRUSSELS–(BUSINESS WIRE)– EuropaBio, the European Association for Bioindustries, and the Deerfield Institute have partnered to carry out a survey on the current state of regulatory and health technology assessment (HTA) advice with a special focus on small and medium sized enterprises (SMEs). The findings suggest early regulatory scientific and HTA advice may help SMEs to better prepare and manage their clinical programs toward facilitating both regulatory approval and positive HTA recommendations,and therefore contribute to their increased competitiveness.

Main findings

“Despite agreement amongst all stakeholders that early interactions between regulatory, HTA authorities and SMEs would be positive, ensuring that these interactions actually take place is not straightforward. Given that many SMEs focus on the early stage of development and can be quite limited in terms of personnel and resources, the process of seeking such advice can be perceived as lengthy,formal, and cumbersome”, said Miriam Gargesi, Director for Healthcare Biotechnology at EuropaBio. However, the findings also show that both the authorities and the SMEs acknowledged the need to become more flexible, and to diversify and increase the number of interactions between them.

“Early dialogue activities have the potential to reduce drug development uncertainties related to regulatory and HTA assessments. While existing HTA scientific advice programs have made a good start and EuropaBio member companies have reported positive experiences so far, there are a number of other needs to be met,particularly in the areas of information, training and coordination”, said Paolo Morgese, Director of European Research for the Deerfield Institute and Chair of EuropaBio’s HTA Topic Group.

Background

Phase III clinical trials are the last and vital development step before submitting healthcare biotech products for approval. While the costs for these trials are rising, the success rate is still 50% at phase III, according to the UK’s Centre for Medicines Research. Success at phase III clinical trials is not the end of the story, as drugs will still have to go through regulatory and HTA evaluation processes before being accessible to European patients. Reviews from the European Medicines Agency, and to a larger extent from HTA authorities,have proven to be a significant challenge for biotech SMEs, often resulting in very limited access to new biotech drugs.

Against this context and the resulting significant financial burden incurred during phase III clinical trials, companies, regulatory and HTA authorities are starting to work together at earlier stages of drug development in order to make drug development more efficient. This could eventually help companies better understand what data the authorities need earlier in the process, thus leading to better designed clinical trials and fewer drugs failing at the approval stage, or not being reimbursed.

The full report is available on the websites of Deerfield (http://goo.gl/hR1aUM) and Europabio (http://goo.gl/VkdpZZ

About EuropaBio

EuropaBio is the European Association of Bio Industries. EuropaBio members are involved in research, development, testing, manufacturing and commercialization of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership, who in turn represent more than 1800 biotech SMEs.

For more information, please visit: www.europabio.org

About Deerfield

The Deerfield Institute is the research and analytics group of Deerfield, an investment organization with the mission of advancing healthcare through investment, information and philanthropy. Comprised of over 30 researchers based in the US, Switzerland and China, the Deerfield Institute focuses on analyzing the healthcare industry through many dimensions including market research, market access, biostatistics, intellectual property, clinical and regulatory evaluation.For more information on the Deerfield Institute, please visit: http://www.deerfield.com/DI

Contacts

Deerfield Management Company
Karen Heidelberger, 212-692-7140
[email protected]