Pharma News in Global Health and Sustainability - Pharmaceutical Technology

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Pharma News in Global Health and Sustainability
A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 9, Issue 5

A $100,000 grant from Bristol-Myers Squibb will support a Center for Green Schools Fellow in New Jersey who will work with leaders from the state’s 586 public school districts to provide direction, training and resources toward greening school buildings. The Fellow, who will be employed by the Center for Green Schools at the US Green Building Council and placed with the New Jersey School Boards Association (NJSBA), will work with NJSBA staff to address opportunities involving facilities, curriculum, and professional development for school board members. The fellowship will focus on helping school board members improve the environmental aspects of New Jersey’s schools and increase awareness about the importance of building sustainable communities. Following a nationwide search, the Fellow is expected to begin work in June 2013. A pilot effort during the 2013-2014 academic year will concentrate on the New Brunswick and Trenton school districts, urban districts that are located near Bristol-Myers Squibb’s five campuses in Middlesex and Mercer counties in central New Jersey. The project will later expand to include districts statewide. Bristol-Myers Squibb’s grant to USGBC funds the first of three years of the fellowship.

Eli Lilly celebrated National Volunteer Week April 21-27 by sending off the first of 200 volunteers who will serve in impoverished communities throughout 2013. They are part of Connecting Hearts Abroad, Lilly's global employee volunteer program launched in 2011. Volunteer teams went to Lima, Peru, and Kilimanjaro, Tanzania. Through Connecting Hearts Abroad, Lilly has sent more than 400 employees from its operations worldwide on two-week service assignments in communities throughout Asia, Africa, Eastern Europe and Latin America. In 2013, about 200 Lilly employees from 45 countries will volunteer in impoverished communities in Brazil, Costa Rica, Ghana, Guatemala, India, Morocco, Peru, South Africa, Tanzania and Thailand.

FDA has announced the deployment of an FDA-developed Counterfeit Detection Device (CD-3) as part of a public–private partnership to identify counterfeit or substandard antimalarial medicines, including falsified products in Africa and parts of Southeast Asia. FDA has partnered with the Skoll Global Threats Fund, the US Pharmacopeia (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the multi-agency President’s Malaria Initiative (PMI), led by the US Agency for International Development (USAID).

FDA also announced it has signed a letter of intent with Corning Incorporated to refine and improve the CD-3 tool for eventual manufacture on a larger scale. The CD-3, developed by scientists at FDA’s Forensic Chemistry Center in Cincinnati, Ohio, is a handheld, battery-operated tool that illuminates a product with a variety of wavelengths of light to provide a visual comparison of an unverified product with an authentic sample, allowing inspectors to identify suspect products and remove them from the supply chain. According to FDA, the effectiveness of the tool in detecting counterfeit or substandard versions of two common anti-malarial therapies will be tested in Ghana in 2013 and 2014, and information obtained from the test in Ghana will guide a second testing program.

GlaxoSmithKline (GSK) will provide a funding injection of up to GBP 5 million ($7.85 million) from the Wellcome Trust to support its open approach to discovering and developing new treatments for diseases of the developing world. The funding will move early-stage research to the next level, to find new medicines for diseases such as tuberculosis, malaria, leishmaniasis, and sleeping sickness. Scientists will work in collaboration with GSK drug discovery experts at its facility in Tres Cantos, Madrid, where GSK’s work researching diseases of the developing world is focused, with the overarching goal of developing two high-quality experimental drugs over the next five years. GSK has been committed to an open approach to discovering new treatments for diseases of the developing world since 2010, when it created its Open Lab at a dedicated facility at Tres Cantos, Madrid. Since its establishment, the Open Lab has hosted 27 external researchers, who have worked alongside and been supported by GSK scientists on early-stage projects to identify compounds that are active against diseases affecting the developing world.

At the Global Vaccine Summit held in April, the Global Polio Eradication Initiative (GPEI) presented a six-year plan to eradicate all types of polio disease, both wild poliovirus and vaccine-derived cases, simultaneously. Global leaders and individual philanthropists pledged approximately three-quarters of the plan’s projected $5.5 billion cost over six years. They also called upon additional donors to commit up front the additional $1.5 billion needed to ensure eradication. The new plan’s budget includes the costs of reaching and vaccinating more than 250 million children multiple times every year, monitoring and surveillance in more than 70 countries, and securing the infrastructure that can benefit other health and development programs. Bill Gates, co-chair of the Bill & Melinda Gates Foundation , announced that his foundation would commit one-third of the total cost of the GPEI’s budget over the plan’s six-year implementation, for a total of $1.8 billion. The funds will be allocated with the goal of enabling the GPEI to operate effectively against all of the plan's objectives. To encourage other donors to commit the remaining funding up front, the Gates funding for 2016-2018 will be released when the GPEI secures funding that ensures the foundation’s contribution does not exceed one-third of the total budget for those years. The Polio Eradication & Endgame Strategic Plan 2013-2018 was developed by the GPEI in consultation with a broad range of stakeholders. The plan incorporates the lessons learned from India’s success becoming polio-free in early 2012 and knowledge about the risk of circulating vaccine-derived polioviruses. It also complements the tailored Emergency Action Plans being implemented since last year in the remaining polio-endemic countries (Afghanistan, Pakistan and Nigeria), including approaches in place to vaccinate children in insecure areas.

Novartis Novartis and Malaria No More, a global charity focused on ending malaria deaths, are joining forces on the Power of One campaign to help close the treatment gap and accelerate progress in the fight against malaria. Over the next three years, Novartis will support the campaign financially and also donate up to three million full courses of its pediatric antimalarial drug to match the treatments donated by the public, doubling the impact of these donations. Power of One will officially launch in the fall. Until then and to mark the announcement of this campaign, the first 10,000 people to sign up and register their interest on the Power of One website (www.Po1.org) will help provide a treatment to a child with a confirmed case of malaria in Africa.

Sanofi and PATH’s Drug Development program announced the launch of the large-scale production line of semisynthetic artemisinin at Sanofi’s Garessio site in Italy, according to an April 11, 2013 Sanofi press release. Global demand for artemisinin, the key ingredient of artemisinin-based combination therapies (ACTs), has increased since the World Health Organization identified ACTs as the most effective malaria treatment available. This semisynthetic route will allow a more consistent supply compared to the botanical supply of artemisinin.

Development of a new, commercial-scale alternative manufacturing process to produce artemisinin started nine years ago. The partnership is led by OneWorld Health, a nonprofit drug-development organization that established PATH’s Drug Development program and is funded by the Bill & Melinda Gates Foundation. The project built upon synthetic biology work by Dr. Jay Keasling at the University of California, Berkeley and involved a team of public and private partners, including Sanofi and synthetic biology innovator Amyris.

The no-profit, no-loss production model helps maintain a low price for developing countries. In the commercial process, Huvepharma in Bulgaria produces artemisinic acid through fermentation, followed by a synthetic transformation of the artemisinic acid into artemisinin via photochemistry, which will be performed at Sanofi’s Garessio site. Sanofi plans to produce 35 tons of artemisinin in 2013 and, on average, 50 to 60 tons per year by 2014, which corresponds to between 80 and 150 million ACT treatments.

In other news, Sanofi and the Drugs for Neglected Diseases initiative (DNDi) , an independent not-for-profit foundation, announce that on the occasion of World Malaria Day, more than 200 million treatments of ASAQ Winthrop have been distributed in Africa since the medication became available in 2007. ASAQ Winthrop treatment combines artesunate and amodiaquine in a fixed-dose combination, and was developed in a partnership between DNDi and Sanofi, and manufactured by Sanofi in its Zenata plant in Morocco, ASAQ Winthropis now available in most malaria-affected countries, and 90% available in Africa. It is easy to use (once-a-day dose) and is available at a price of less than $1 for adults and $0.50 for children, for three-day treatment.

Sanofi Pasteur , the vaccines division of Sanofi, will provide 1.7 billion doses of oral polio vaccine (OPV) to support the Global Polio Eradication Initiative’s (GPEI) strategy to eradicate polio in this decade. The doses of OPV will be delivered through 2017 for GPEI polio-vaccination program. In addition to OPV campaigns, the World Health Organization’s expert group on immunization (SAGE) recommends that all countries introduce at least one dose of injectable inactivated polio vaccine (IPV) in routine polio immunization programs. Sanofi Pasteur is responding to this strategy with the expansion of production capacities of IPV.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
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Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
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