Planning Members

The following organizations contributed to the planning of the M-CERSI Conference on Patient-Focused Drug Development.

	The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways in which drugs and medical devices are developed and evaluated. It is a collaborative partnership between the Food and Drug Administration (FDA) and the Baltimore and College Park campuses of the University of Maryland.
	AstraZeneca is one of only a handful of pure-play biopharmaceutical companies to span the entire value chain of a medicine from discovery, early- and late-stage development to manufacturing and distribution, and the global commercialization of primary care, specialty care-led and specialty care medicines that transform lives. The company operates in more than 100 countries, with its innovative medicines used by millions of patients worldwide. Its primary focus is on three areas of health care: cardiovascular and metabolic disease (CVMD); oncology; and respiratory, inflammation and autoimmunity (RIA), though it is also active in the infection, neuroscience and gastrointestinal (ING) disease areas.
	Avalere is a vibrant community of innovative thinkers dedicated to solving the challenges of the health care system. The company delivers a comprehensive perspective, compelling substance, and creative solutions to help organizations make better business decisions. The company partners with stakeholders from across health care to help improve care delivery through better data, insights, and strategies. With breakthrough business intelligence tools and programs, it empowers business leaders to take action.
	Critical Path Institute (C-Path), founded in 2005 in Tucson, Arizona, is an independent, non-profit organization dedicated to bringing scientists from the FDA, industry, and academia together to collaborate and improve the drug development and regulatory process for medical products. C-Path aims to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies.
‌	Epstein Health evaluates the impacts of fast approaching scientific advances and helps direct client scientific and clinical innovation efforts and investments toward novel solutions in health care. Epstein Health creates and helps companies propel a differentiated strategy -- gaining the confidence of key constituents, including payers, clinicians and investors, and accelerating health care innovation and market access.
	The Global CEOInitiative represents an acceptance of the invitation from public authorities, domestically and internationally, to the private sector to forge robust public- private partnerships to stop Alzheimer's disease and dementia. Our vision is that the CEO Initiative becomes the leading business voice on this seminal public health issue of our time, which will have profound impact in fiscal, social and political matters as we “change the game” on Alzheimer’s.By working together and in partnership with leading non-governmental organizations and governments, the CEO Initiative will identify and pursue research, therapy development, financing, and public awareness projects of the highest priority that, when achieved, can transform the global fight to stop Alzheimer’s disease.
	Founded in 1945, Kaiser Permanente is one of the nation’s largest not-for-profit health plans, serving approximately 9.5 million members, with headquarters in Oakland, Calif. It comprises: Kaiser Foundation Hospitals and their subsidiaries, Kaiser Foundation Health Plan, Inc., and the Permanente Medical Groups. At Kaiser Permanente, physicians are responsible for medical decisions. The Permanente Medical Groups, which provide care for Kaiser Permanente members, continuously develop and refine medical practices to help ensure that care is delivered in the most efficient and effective manner possible.
	The Lora Group, LLC, provides expert regulatory and scientific advice on medical product development. The company supports activities related to labeling, medical product outcomes, research, global regulatory strategy, and advertising. It reviews medical product development strategies, protocols, endpoint measure development summaries, and regulatory submissions for compliance with regulatory requirements and standards, addressing the integration of these requirements with international health technology assessment needs. The company also reviews clinical outcome assessment development programs intended for regulatory qualification and provides training for individuals or groups in product labeling and outcomes research.
	Founded in 1920, the National Health Council (NHC) is the only organization that brings together all segments of the health community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations and businesses, the NHC's core membership includes the nation’s leading patient advocacy organizations, which control its governance. Other members include professional and membership associations, nonprofit organizations with an interest in health, and major pharmaceutical, medical device, health insurance, and biotechnology companies.
	Merck is an innovative, global healthcare leader that is committed to improving health and well-being around the world.Our product offering categories include heart and respiratory health, infectious diseases and women's health. We continue to focus our research on conditions that affect millions of people around the world - diseases like Alzheimer's, diabetes and cancer - while expanding our strengths in areas like vaccines and biologics.We also devote extensive time and energy to increasing access to medicines and vaccines through far-reaching programs that donate and deliver our products to the people who need them.At Merck, we're applying our global reach, financial strength and scientific excellence to do more of what we're passionate about: improving health and improving lives.
	The National Organization for Rare Disorders (NORD) is a unique federation of voluntary health organizations dedicated to helping people with rare "orphan" diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and service.
	The National PKU Alliance works to improve the lives of families and individuals associated with PKU through research, support, education and advocacy, while ultimately seeking a cure. The NPKUA was formed in 2008 by parents, grandparents, and individuals across the country just like you. We are the first national non-profit organization to unite adults, families, regional and statewide PKU organizations, the medical community and PKU-friendly businesses to make a difference in the lives of people with PKU.
	The National Quality Forum (NQF) is a not-for-profit, nonpartisan, membership-based organization that works to catalyze improvements in health care. Specifically, NQF: convenes working groups to foster quality improvement in both public- and private-sectors; endorses consensus standards for performance measurement; ensures that consistent, high-quality performance information is publicly available; and seeks real time feedback to ensure measures are meaningful and accurate. NQF endorsement is the gold standard for health care quality.
	Novartis provides innovative health care solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas.
	Parent Project Muscular Dystrophy (PPMD) is the largest most comprehensive nonprofit organization in the United States focused on finding a cure for Duchenne muscular dystrophy—our mission is to end Duchenne. It invests deeply in treatments for this generation of young men affected by Duchenne and in research that will benefit future generations, advocating in Washington, DC, and securing hundreds of millions of dollars in funding.
	PatientsLikeMe® is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 250,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 40 peer-reviewed research studies.
	Pfizer applies science and its global resources to bring therapies to people that extend and significantly improve their lives, striving to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. The company's global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer health care products. As one of the world's premier innovative biopharmaceutical companies, Pfizer collaborates with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world.
	With headquarters in Bridgewater, NJ, Sanofi is a global health care leader that discovers, develops, and distributes therapeutic solutions focused on patients’ needs. The company has core strengths in the field of health care with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer health care, emerging markets, animal health and the new Genzyme.
	UCB is a global biopharma focused on severe diseases with operations in approximately 40 countries. We combine biology and chemistry to make major breakthroughs. By integrating our expertise in large, antibody-based molecules and small, chemically-derived molecules, we can offer families with severe diseases and their specialist physicians the advantages of both large and small molecules to produce extraordinary breakthroughs.