Robert Metcalf, Ph.D.
Vice President, Global Regulatory Affairs – US & Global Medical QualityRobert is Vice President, Global Regulatory Affairs – US and Global Medical Quality. He is responsible for interactions with the FDA supporting new drug development and marketed products, including US product labeling, advertising and promotion, and regulatory policy. Robert also has responsibility for, global label management, global submission management, and global Chemistry, Manufacturing and Control for Lilly. He also has responsibility for the Quality organizations supporting clinical development, regulatory, and product safety.
Afte...
Source: PHRMA - November 11, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Marc Boutin on PDUFA
An astute marketer will tell you that success of any product is dependent on the wants and needs of the end user. In health care, we need a similar mindset. By collaborating with patients early in drug development, there is an opportunity to improve the success rates in the preclinical stage of the development, which could ultimately accelerate the delivery of new treatments to patients and enhance patient adherence to their treatment plans. The end result will be a win for all stakeholders.
To effectively integrate the patient voice throughout the research and regulatory processes, we need to first develop a consistent de...
Source: PHRMA - November 11, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Marc M. Boutin, J.D.
Executive Vice President & Chief Operating OfficerMarc Boutin is the executive vice president and chief operating officer of the National Health Council, an organization that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
In addition to overseeing financial management and operations at the National Health Council, Boutin builds consensus among member patient advocacy organizations enabling them to speak with one voice on systemic health research and health care policy initiatives...
Source: PHRMA - November 11, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Andrew MacCalla on Ebola
Over the past several years, Direct Relief has been privileged to work with and support several deeply dedicated partners in Liberia and Sierra Leone working hard and thoughtfully to expand and improve health services for people and build back the health systems that were decimated by civil wars that ended a decade ago. Of the many severe, chronic problems their efforts were seeking to address, the Ebola virus was not among them.  When Ebola arrived, Direct Relief’s partner organizations were on the front lines of what has since become the worst, deadliest outbreak in history.  They asked for help, and Direct Relief ...
Source: PHRMA - October 31, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Andrew MacCalla
Director of International Programs and Emergency ResponseAndrew MacCalla has been the primary coordinator of Direct Relief’s Haiti response – the largest humanitarian effort since the organization was founded in 1948 – managing on the ground efforts and collaborating with more than 100 Haitian health facilities, as well as the Haitian Ministry of Health. Since 2010, Direct Relief has provided life-saving medications and supplies valued at over $70 million wholesale. He has worked at Direct Relief for five years with a short break to earn a Master's Degree in Public Policy and Management from the University of Melbour...
Source: PHRMA - October 31, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Erin Mullen on Rx Response
Rx Response is composed of members that span the bio-pharmaceutical supply chain, and so any kind of public health emergency probably will involve most, if not all, of the components of that supply chain. In the case of emerging infectious disease, there are biotech and pharmaceutical manufacturers doing the research and testing for innovative new treatments and vaccines, and producing the approved products that are used for current treatment or prevention; distributors ensuring the efficient storage, delivery, and inventory management of those products; and pharmacies and other healthcare facilities providing the clinical...
Source: PHRMA - October 31, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Erin Mullen
Executive DirectorDr. Erin Mullen is the Executive Director of Rx Response and an Associate Vice President, IT & Operations for the Pharmaceutical Researchers and Manufacturers of America (PhRMA). She also holds a Clinical Assistant Professor appointment with the University of Maryland School of Pharmacy. She is a disaster responder, serving as a reservist in the National Disaster Medical System (NDMS) and volunteer with the District of Columbia Medical Reserve Corps.
Prior to joining PhRMA, Dr. Mullen practiced community pharmacy and was the first Public Health Preparedness Pharmacist for the Florida Department of Hea...
Source: PHRMA - October 31, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Paul Stoffels on Ebola
Stepping Up Our Response to Ebola
Less than 100 years ago, little could be done to combat global epidemics. In 1917, Spanish influenza swept the world quickly and 50 million people died. Science and medicine significantly lagged behind medical need. The World Health Organization (WHO) and other global health authorities weren’t yet formed to help coordinate a response. And governments were without options.
Since then, innovation in R&D has significantly advanced vaccine research and production. Today, we are faced with the threat of a new global epidemic—the Ebola virus. The global health community must work in loc...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Paul Stoffels, M.D.
Chief Scientific OfficerPaul Stoffels, M.D., is the Chief Scientific Officer, Johnson & Johnson, and Worldwide Chairman, Pharmaceuticals. As Chief Scientific Officer, he works with the R&D leaders across Johnson & Johnson to set the enterprise-wide innovation agenda. Dr. Stoffels serves as a member of the Executive Committee and the Management Committee and has more than 20 years of global health and pharmaceutical experience. He chairs the company’s Worldwide Research & Development Council, and provides oversight to Johnson & Johnson Development Corporation, the Johnson & Johnson innovations ce...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
John P. Howe III, M.D.
President and CEOJohn P. Howe III, M.D., is President and CEO of Project HOPE, a global health and humanitarian assistance organization. Founded in 1958, Project HOPE (Health Opportunities for People Everywhere) is dedicated to delivering sustainable improvements in health care around the world. Identifiable to many by the SS HOPE, the world’s first peacetime hospital ship, Project HOPE now conducts land-based health programs and has five practice areas including infectious diseases, non-communicable diseases, women’s and children’s health, humanitarian assistance & disaster relief, and health systems strengtheni...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
John P Howe on Ebola
The Ebola Outbreak: How Public-Private Partnerships Search for Solutions in Sierra Leone
When natural disasters or medical crises erupt around the globe, like the Ebola outbreak, it’s not unusual for my phone to ring at any hour of the day or night. A government leader or foreign ambassador in Washington calls with an appeal for help because the rudimentary health systems of many nations in the developing world don’t have the capacity to respond to major health crises. Although always composed and articulate, the voices I hear on the phone convey the urgency and grave concern that is seizing their countries backÂ...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Donna Altenpohl on Ebola
Ebola response is a model of collaboration
The constant stream of photos and reports about Ebola from West Africa tragically illustrate the speed at which disease can spread, devastating communities and reshaping daily life. GSK is working with many partners at an unprecedented speed and with passionate focus to try to develop a vaccine to limit the total number of deaths from this epidemic and future outbreaks. While the current crisis is our focus, there also are lessons for the future: US health and security can be threatened by events half a world away and the global community is not fully prepared for such disease out...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Donna Altenpohl
Vice President of Public PolicyDonna Altenpohl is Vice President of Public Policy for GlaxoSmithKline, one of the nation’s leading pharmaceutical firms. In her role, she and her team are responsible for developing and executing the company’s public policy strategy, as well as evaluating the implications of health care reform to the life sciences industry.
Donna joined GSK in 2006 as an Executive Account Manager for the Employer Segment. In 2008, she was promoted to Account Vice President of the Center for Medicare and Medicaid Services Team, which was enlarged to include HHS in 2009. Donna has deep experience in the he...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
mark mosely on ebola
Ebola: Lesson learned for future response
Ebola is a virulent virus killing well over half of the people it infects. This Ebola outbreak is the worst we’ve seen in recent history and caught West African countries, and the many other nations who love and support (including the U.S.), off guard. So what can we do to better prepare for future infectious disease outbreaks?
A key factor in MAP International’s swift response to the outbreak in March, 2014 was the fact that we had extensive inventories of personal protection suits (PPEs) as well as appropriate medicines and supplies on hand and ready to deploy. USAID had ...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
Mark Mosely
VP of Global Essential Medicines, Supplies and Services For two decades, Mark has worked to bring health and hope to those in need in +50 countries; from sustainable health development to disaster relief; from armed conflicts including Rwanda and Bosnia to 12 UN defined complex humanitarian emergencies such as Indonesia’s tsunami and Sudan’s Hunger Triangle. Serving 10 of those years at MAP in senior management positions, Mosely manages provision of donated and purchased medicines, logistics services, and supply chain / public health consulting to MAP and its partners ranging from UN World Health Organization to nation...
Source: PHRMA - October 30, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news
