Source: PTSM: Pharmaceutical Technology Sourcing and Management
Issue 10,Volume 9
A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
In an effort to increase the number of minority investigators in clinical research, Eli Lilly and the Center for Drug Development and Clinical Trials at Roswell Park Cancer Institute have formed a new collaborative training program specifically tailored to this growing group of investigators. The partnership will include a three-day clinical research workshop, "Reducing Cancer Disparities Through the Training of a Diverse Workforce," for minority physicians across the country. Workshops will begin in spring 2014 and will run through 2016.
According to an Eli Lilly press release, there are approximately 10,400 oncologists in the United States, but approximately 1 to 2% are African American and approximately 2 to 3% are Hispanic. The goal of the new initiative is to train 75 to 150 oncologists in the conduct of clinical trials. The goals of the workshop include: enhancing clinical research in minority and underserved populations through development of a cadre of well-trained minority investigators; educating participants about the principles of good clinical trial design and providing the necessary tools required to conduct trials that are relevant to minorities and under-represented populations; guiding participants to identify various challenges of clinical research, particularly in minority and underserved populations, and providing advice and education on how to overcome these challenges; providing ongoing mentorship to young minority investigators through career-long relationships with workshop faculty; and reducing cancer health disparities through increased clinical research targeting minority and underserved populations. Organizers are targeting minority physicians and senior fellows who have cancer-related subspecialties in medical, hematologic, radiation, pediatric, surgical, and gynecologic oncology. Faculty in the first five years of their academic appointments and those working full-time at an academic institution or practice with a track record of enrolling patients in cancer clinical trials may apply to participate in the workshop.
GlaxoSmithKline (GSK) it has increased its commitment to the GAVI Alliance to provide vaccines to developing countries. The company will provide an additional 240 million doses of Synflorix to developing countries over the next 10 years to help protect up to 80 million more children from pneumococcal diseases such as meningitis and pneumonia. GSK has committed to provide the additional 240 million doses of Synflorix to GAVI at $3.40 per dose. To date, more than 50 million doses of the vaccine have been delivered to GAVI countries, including Uganda, Mozambique, Madagascar, Kenya, Ethiopia, and Pakistan. Zambia is the most recent country to include the vaccine in its national immunization programme under the AMC in July 2013.
The additional commitment builds on the 480 million doses of the vaccine that GSK has already committed to GAVI through the Advance Market Commitment (AMC) framework, which is designed to bring heavily discounted vaccines to children living in the developing world. GSK provides GAVI with a several vaccines, including Synflorix which protects against pneumococcal disease; Rotarix, which is a vaccine for rotavirus, a common cause of diarrhea; Cervarix, which helps protect against cervical cancer caused by human papilloma virus; and a combined vaccination for diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae Type b, With this new vaccine supply agreement extension, GSK is committed to provide more than 850 million vaccine doses that will help protect up to 300 million children and adolescent girls in the developing world from these diseases by 2024.
Novartis has invited 60 students from international universities in 21 countries to its headquarters in Switzerland for the International Biotechnology Leadership Camp (BioCamp). Over the course of three days, students will gain first-hand experience of starting a biotechnology company as well as developing and launching an innovative healthcare product. This year's BioCamp focuses on the company's innovation efforts in new business approaches to the healthcare industry. Some of the company's g outcome-based business models include collaborations with payors on pricing arrangements, patient-compliance programs as well as online support and education.
In other news, Novartis formed a development and licensing agreement with Biological E Limited (BioE), a biopharmaceutical company based in India, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions. Under the license, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval, and distribution in the developing world. The typhoid vaccine (Vi-CRM197) has achieved proof of concept, had successful Phase II results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once proof of concept is completed through early, small-scale studies in humans to determine safety and immunogenicity.
Pfizer has signed a new supply agreement with the GAVI Alliance regarding the signing of a new supply agreement for Pfizer to provide additional doses of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), the company’s 13-valent pneumococcal conjugate vaccine, for use in infants and young children to help protect against pneumococcal disease in developing countries under the terms of the Advanced Market Commitment (AMC). Under the terms of the new supply agreement, Pfizer has committed to supply the United Nations Children's Fund (UNICEF) with up to 260 million doses of Prevenar 13, at a reduced tail price, over the course of the agreement period (through 2025). This amount is in addition to 480 million doses of the vaccine already committed through the first two supply agreements. The tail price is the reduced price per dose set by the manufacturer and paid by GAVI; the remaining amount is paid by the AMC. Pfizer will offer Prevenar 13 through the AMC at the reduced price of $3.40 per dose for the remainder of this year, at which time the price will further decrease to $3.30 per dose for the remainder of the agreement. This pricing will apply to doses purchased under all AMC supply agreements.
Pfizer entered into the first supply agreement to participate in the AMC in March 2010, and then expanded its commitment through a second supply agreement in 2011, pledging to supply Prevenar 13 through 2023. Since Pfizer’s original agreement with the AMC in 2010, more than 20 countries have introduced Prevenar 13 into their immunization programs, and pneumococcal vaccines are expected to reach more than 50 GAVI-supported countries by 2015.
The Medicines Patent Pool and Roche have formed an agreement to increase access to Roche’s Valcyte (valganciclovir), a key medicine to treat cytomegalovirus (CMV). CMV is a viral infection that can result in loss of vision and greater risk of death in people living with HIV. This infection affects around 1 in 10 people living with HIV in low-and middle-income countries. The supply agreement between the Medicines Patent Pool and Roche will improve access to Valcyte– by making it up to 90% cheaper in 138 developing and emerging countries than it is currently available. The Medicines Patent Pool and Roche will consider adding more countries to the initial scope if there is a need and will also explore licensing and technology transfer as a second step to help local production of Valcyte and increase access to Valcyte in developing countries.
Sanofi Pasteur, the vaccines division of Sanofi, reports that one of its quadrivalent vaccines to prevent invasive meningococcal disease has been prequalified by the World Health Organization (WHO). The prequalification procedure accepts Menomune vaccine for purchase by United Nations Agencies. The UNICEF supply division has been notified of Menomune vaccine’s acceptance by the WHO. The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines meet WHO recommendations on quality, safety and efficacy, including compliance with WHO’s recommended standards for GMP and good clinical practice. This Menomune vaccine prequalification was performed through a streamlined procedure in which the WHO worked closely with FDA.
Menomune vaccine is designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W 135 for use in persons two years of age and older. It is the first quadrivalent meningococcal vaccine prequalified by the WHO. The WHO notification to UNICEF states that following the evaluation of consistency of final product characteristics, GMP, and quality system audits of the manufacturing facilities, and followup of implementation of recommendations made by WHO reviewers during the evaluation, the Menomune vaccine is acceptable. It is manufactured at Sanofi’s facility in Pennsylvania.