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Summary The aging population in the U.S. and other developed countries has led to a large increase in the number of patients suffering from degenerative diseases. Transplantation surgery has been a successful therapeutic option for certain patients; however, the availability of suitable donor organs and tissues significantly limits the number of patients who can benefit from this approach. Regenerative medicine has witnessed numerous recent and spectacular advances, making the repair or replacement of dysfunctional organs and tissues an achievable goal. Public‐private partnerships and government policies and incentives would further catalyze the development of universally available donor tissues, resulting in broad medical and economic benefits. This article describes a Regenerative Medicine Grand Challenge that the Alliance for Regenerative Medicine recently shared with the White House's Office of Science and Technology Policy in response to a White House call to action in scientific disciplines suggesting that the development of “universal donor tissues” should be designated as a Regenerative Medicine Grand Challenge. Such a designation would raise national awareness of the potential of regenerative medicine to address the unmet needs of many diseases and would stimulate the scientific partnerships and investments in technology needed to expedite this goal. Here we outline key policy changes and technological challenges that must be addressed to achieve the promise of a major breakthrough in the treatment of degenerative disease. A nationalized effort and commitment to develop universal donor tissues could realize this goal within 10 years and along the way result in significant innovation in manufacturing technologies. Significance Regenerative therapies, in which dysfunctional or degenerating cells, tissues, or organs are repaired or replaced, have the potential to cure chronic degenerative diseases. Such treatments are limited by a shortage of donor organs and tissues and the need for immune suppression to prevent rejection. This article proposes a 21st Century Grand Challenge that would address this significant medical need by coordinating a national effort to convene the multidisciplinary expertise needed to manufacture functional and engraftable cells, tissues, or organs that could be made available to any patient without significant risk of rejection—so‐called universal donor tissues.

A ccording to the Skin Cancer Foundation, more than 3.5 million skin cancers and 76,000 melanomas are diagnosed each year in the United States, and, on average, one person dies from melanoma every hour. As with most diseases, the best way to fight melanoma is to prevent it. Unfortunately, the latest sunscreen ingredients that can help to reduce the risk of melanoma and other skin cancers have languished for decades awaiting approval from the US Food and Drug Administration (FDA). The ultraviolet (UV) filters in sunscreen work by absorbing, reflecting or scattering the UV light emitted by the Sun. UVA radiation, which represents roughly 90% of UV radiation, can accelerate skin ageing, cause skin damage and create a risk of skin cancer by damaging DNA. The other component, UVB, leads to sunburn and also increases the risk of skin cancer. The most effective protection blocks both UVA and UVB. But ingredients delayed by the FDA approval process would provide additional options, especially for UVA protection. The active ingredients used in sunscreens are regulated by the FDA as drugs. But the FDA has not approved an over-the-counter sunscreen ingredient since 1999. In 2002, it created a new pathway to market for non-prescription ingredients, such as sunscreens, that allowed manufacturers to use data from other countries to establish that a product is safe and effective. To qualify for this 'time and extent application' (TEA) process, the company must establish that a product is approved in at least one comparable country and that it has been in use for at least five years in sufficient quantity. The TEA process was designed to streamline the review of new ingredients, and the FDA said that it expected to complete the evaluation of sunscreen ingredients within 90-180 days. Protect the USA from UVA The United States does not have access to the latest sunscreens. The Sunscreen Innovation Act could set that right, says Michael J. Werner.

Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials. This is especially true when developing cell-based therapies, which pose unique challenges to demonstrating safety and effectiveness. There are numerous opportunities for developers of a new cell therapy to interact with the regulatory agency, through both formal and informal processes. It is important to understand how to maximize the productivity of dialogue with the FDA and develop an effective regulatory strategy. This article provides an overview of the types of interactions with the FDA that are available throughout the regulatory process. This article also notes some common pitfalls to avoid and directs readers to additional references and resources to help inform cell therapy researchers and product developers and enable successful regulatory interactions. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:825-832

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