Improving access to quality medicines is an ongoing challenge in the developing world. In addition to overcoming the challenge of bringing drugs to remote or difficult-to-reach areas, there is the problem of substandard or counterfeit drugs entering the supply chain. To help address that problem, a new platform for detecting substandard and counterfeit medicines using microfluidics was recognized earlier this year with a grant through a private–public parntership 

Saving Lives at Birth:  A Grand Challenge through Development. 

Saving Lives at Birth:  A Grand Challenge through Development 

 is an initiative to improve maternal and children’s health. It was launched in March 2011 to seek innovative prevention and treatment approaches for pregnant women and newborns in rural, low-resource settings. The project is a partnership between the US Agency for International Development (USAID), the government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the World Bank. These partners provided nearly $14 million for this grant program's first round of funding and have a commitment of investing at least $50 million in projects in multiyear funding. The first call in 2011 for innovative approaches resulted in the selection of 24 solutions for award. A second call was issued in February 2012 for innovations across three domains: science and technology, service delivery, and ways to stimulate demand for healthcare services at the time of birth. The call elicited more than 500 submissions from almost 60 countries. In July 2012, The Saving Lives at Birth partners nominated 15 innovations for award. Among the innovations recognized was PharmaCheck, a new platform for detecting substandard and counterfeit medicines. 

Developed by Boston University in collaboration with the Promoting the Quality of Medicines (PQM) program, which is supported by USAID and implemented by the US Pharmacopeial Convention (USP), PharmaCheck has reached the proof of concept stage—demonstrating a quantitation linear relationship for analysis of an antimalarial medicine of interest on a microfluidic chip, according to a July 26, 2012, USP press release. The technology addresses shortcomings of current field-based, portable quality- control laboratories currently in use throughout the developing world, including the inability to precisely and accurately measure the percentage of API or other important quality attributes of medicines. The technology is expected to greatly reduce the need for confirmation of field-tested results at fully equipped quality-control laboratories.

“This technology promises to be groundbreaking in the fight against substandard and counterfeit medicines,” said Anthony Boni, pharmaceutical management specialist for USAID’s Global Health Bureau, Office of Health, Infectious Diseases and Nutrition/Health Systems Division, in the USP release. “Inexpensive, easy-to-use and effective, we expect that PharmaCheck will represent a paradigm shift in combating the scourge of poor quality medicines. One of the most exciting elements is the ability to potentially deploy this technology at point-of-use, with an ultimate vision of healthcare facilities, clinics, and hospitals using the technology to verify the quality of the medicines they receive.” 

Muhammad Zaman, associate chair for undergraduate studies, biomedical engineering and professor of biomedical engineering at Boston University is leading the development for PharmaCheck. A project summary provided by Saving Lives at Birth, explained the need for such a device to improve maternal and children’s health. Malaria affects over 50% of the populace in sub-Saharan Africa and contributes to over 200,000 newborn and 10,000 maternal deaths annually worldwide. In 2008, maternal sepsis accounted for 36,000 deaths while neonatal infection caused close to a million neonatal deaths. It is estimated that between 10–30% of drug sales are counterfeit in parts of Africa, Asia, and Latin America and between 30–50% of all anti-malarials are substandard. The primary objective of the project is to develop a device to screen for substandard anti-malarials and antibiotics, thereby improving adverse maternal and neonatal health outcomes with respect to malaria and sepsis. The researchers say there is no device to test counterfeit and substandard drugs in the field thoroughly. To this end, they see PharmaCheck as a user-friendly, cost-effective, contextual and high-throughput device capable of quantitatively measuring active ingredient concentration and drug-release profiles to quickly and accurately screen for spurious medicines. 

“Existing methods of counterfeit drug detection are bulky, qualitative, error-prone and do not take time-based measurements of drug-release kinetics, and thus do not provide information about whether therapeutic levels of the drug are reached and sustained,” noted the summary. “PharmaCheck addresses these shortcomings through affordable fluorescence, dissolution testing, which allows for highly specific and quantitative time-course measurements of drug release. PharmaCheck will offer an affordable, effective tool for local health authorities to better safeguard the efficacy of their pharmacopeia and significantly impact maternal and neonatal health outcomes in the developing world.” 

“This technology is an important breakthrough as we strive to help ensure the quality, safety and efficacy of medicines essential to treating patients suffering from malaria, tuberculosis and HIV/AIDS in developing countries around the world,” said. Patrick Lukulay, vice-president of Global Health Impact Programs for USP and director of the PQM Program, in the USP release. “This will be a very powerful tool with broad application and impact. We are very pleased to be partnering with Boston University in advancing this technology.” 

Articles

CSR and Sustainability Forum

A look at PharmaCheck, a field-based tool in development that uses microfluidic chip technology for assessing the quality of medicine in the developing world.

Using Microfluidic Chip Technology for Assessing Drug Quality

Greater market pressures have obliged pharmaceutical companies to reconsider their product-development strategies. Product innovation amidst an increasingly competitive market, inclusive of generic-drug incursion in many therapeutic areas, makes developing new drugs ever-more challenging. Orphan drugs, traditionally pursued by smaller biopharmaceutical companies, are becoming an attractive option for mid- to large-sized pharmaceutical companies.  Often supported by favorable pricing from a pharmaceutical-company perspective and filling patient demand for drugs to treat unmet medical need, orphan drugs offer good market potential. 

A recent Thomson Reuters analysis of the economics and investment case for orphan-drug development and commercialization shows that although orphan drugs target much smaller patient populations than traditional mainstream drugs, the favorable pricing for such products and other factors, such as government incentives, smaller and shorter clinical trials, extended exclusivity, and high rates of regulatory approval, make the top orphan drugs a viable alternative to mainstream drugs. Part of that opportunity also comes from the abundance of therapeutic areas for possible drug development. The Thomson Reuters report offers estimates from the National Institutes of Health and the European Organization for Rare Diseases that indicate that there are approximately 7000 rare diseases worldwide and the recognized number of such diseases increases at a rate of 250 diseases per year. 

The orphan-drug market was valued at approximately $50 billion globally at the end of 2011, according to the Thomson Reuters analysis. Spending on orphan drugs currently makes up approximately 6% of total pharmaceutical sales, assuming a total pharmaceutical market of $880 billion. The compound annual growth rate (CAGR) of the orphan-drug market between 2001 and 2010 was 25.8% compared with a CAGR of only 20.1% for a matched control group of non-orphan drugs, according to the Thomson Reuters analysis. Given these comparative growth rates and expectations that approval rates of orphan drugs will continue to be robust, the positive indicators for orphan drugs are likely to continue in the long-term. This growth is in part due to the high number of biologic-based orphan drugs, which are less vulnerable to generic-drug incursion compared to small-molecule drugs, according to the Thomson Reuters analysis. 

The Thomson Reuters analysis evaluated current and future revenue of the top-revenue generating drugs over a drug’s product lifecycle. The average present value, based on 2010 estimates, of orphan drugs was $637 million, which was on par with the average present value of non-orphan drugs of $638 million.  In looking at the value of drugs over a product’s lifetime, Lipitor (atorvastatin), Pfizer’s anticholesterol drug, was found to be the highest valued drug. It generated an estimated $197 billion over its lifetime as measured through discount potential revenue. Discount potential revenue is the discontinued peak value of a drug’s revenue over its lifetime. It is an estimate based on the value of all historical revenues and future projected revenues. The anticancer drug Rituxan (rituximab), by Roche/Genentech, is the second highest ranked drug in terms of discount potential revenue and is the only drug among the top 10 drugs that has significant sales arising from orphan-drug indications, according to the Thomson Reuters analysis.

 The economic value of rituximab shows the strength of the oncology market as a leading therapeutic area for orphan drugs. Approximately 40% of the top 10 orphan drugs are oncology drugs with an estimated average lifetime revenue potential (EALRP) of $70 billion per drug, according to the Thomson Reuters analysis. The remaining 60% of the top 10 orphan drugs have an EALRP of $41 billion per drug. 

 Following rituximab, the next highest ranked orphan drug, as measured by discount potential revenue, is the ophthalmological drug ranibizumab with discount potential revenue of $74 billion, according to the Thomson Reuters analysis. Ranked third among the top 10 orphan drugs is the human-growth hormone drug somatropin (epr) with a discount potential value of $62 billion followed by the oncology drug lenalidomide with a discount potential value of $60 billion, according to the Thomson Reuters analysis. Rounding out the top 10 orphan drugs, based on discount potential revenue, in descending order of discount potential revenues are: imatinib mesylate, filgrastim, glatiramer acetate, recombinant factor VIII;octocog alfa, bosentan monohydrate, and bortezomib, according to the analysis. 

Although orphan drugs are associated with niche therapeutic areas, their market success have been fairly robust. Of the 86 orphan drugs included in the Thomson Reuters analysis, 25 were blockbusters, representing 29% of orphan drugs. Blockbuster drugs are defined drugs with sales of more than $1 billion. That 29% was comparable to the 29%, or 83 out of 291 non-orphan drugs that were considered to be blockbusters. 

One of the benefits of orphan drugs compared with non-orphan drugs is that orphan drugs are protected by additional market exclusivity. In the United States, orphan drugs are awarded a seven-year orphan-drug exclusivity (ODE). Non-orphan new chemical entities are awarded five years of exclusivity upon approval, thereby providing orphan drugs an additional two years of market exclusivity, explains the Thomson Reuters report. The seven-year orphan exclusivity can also begin later in the product’s lifecycle if the new indication is approved after the initial launch. The exclusivity for orphan drugs, however, does not apply to non-orphan indications for a particular drug. Additionally, orphan-drug exclusivity does not have any association with patents and may or may not provide exclusivity beyond the composition of matter patent, according to the Thomson Reuters report. 

APIs

Although serving niche areas, orphan drugs offer good market opportunities for pharmaceutical companies and their suppliers.

Evaluating Market Opportunities in Orphan Drugs

Planning and decision-making for the manufacture of biopharmaceuticals are becoming more complex as companies continue to implement cost-saving efforts, including outsourcing many support and even critical tasks. Companies must make difficult strategic decisions about commercial manufacture earlier in product development. A recent BioPlan Associates analysis found that essentially all biopharmaceutical developers use outsourcing services of some kind for the manufacture of clinical or commercial supplies, process development, R&D, assay services, fill–finish, or other activities (1).  

The BioPlan survey, which included responses from 302 representatives from biopharmaceutical companies and CMOs in 29 countries, evaluated 23 key outsourcing areas in biomanufacturing (1). The study showed that companies are incorporating outsourcing as a manufacturing strategy rather than as an ad hoc method of adding flexible capacity or to simply eliminate overhead costs associated with lower value production activities. Data also show a spike in the percentage of biopharmaceutical companies projecting outsourcing of analytical testing, validation services, and fill–finish activities. 

The BioPlan study further evaluated how companies are addressing cost issues in biopharmaceutical manufacturing. The survey identified activities biomanufacturers undertake to reduce costs. The study showed that outsourcing activities ranked in the bottom quarter of measured factors to reduce costs although outsourcing increased slightly for certain functions as a strategy for cost-containment during the past 12 months (see

). There was an increase in respondents using outsourcing of jobs in manufacturing to cut costs: 14.5% in 2012, up from 11.8% in 2011. Approximately 13% of respondents outsourced jobs in process development and 8.8% did in R&D. An equal number of respondents (9.4%) reported outsourcing manufacturing activities to domestic and nondomestic service providers. (see 

Figure 1: Outsourcing actions taken by biomanufacturers to reduce costs at facilities during the past 12 months. (ALL FIGURES ARE COURTESY OF THE AUTHOR) 

The survey showed clear evidence that budgets are bouncing back in all areas in 2012, except outsourced manufacturing.  The uptick in areas other than outsourcing represents a change from two years ago when budgets decreased in areas ranging from production, hiring new scientific staff, and new facility construction.  

The survey also separately asked respondents to indicate how their outsourcing in R&D and manufacturing will change during the next 12 months. On average, future outsourcing at individual facilities will see moderate overall increases for all types of outsourcing not just manufacturing (9.3% during the next 12 months). These increases are more heavily distributed on key outsourcing areas (see 

) rather than broadly seen as increases across all operations.  

Figure 2: Select outsourcing activities projected to be done at significantly higher levels. 

The survey evaluated 24 different areas associated with outsourced operations and asked respondents which activities will be outsourced "more often" during the next 24 months. More than one-third (35.4%) expect to increase outsourcing of analytical testing/bioassays. BioPlan believes much of this increase relates to product characterization, including for biosimilars.   

Validation services was the area where respondents predicted the highest rate of increase (32.3% indicated high rates in outsourcing in 2012, compared with 22.1% in 2011 and 23.8% in 2010). Also, 26.2% of biomanufacturers predict they will outsource significantly more fill–finish operations during the next 24 months compared with 23% in 2011, and 25% in 2010. Other areas of outsourcing growth include: API biologics manufacturing,cell-line development, testing for lot release,and toxicity testing. Some recent decreases in predictions for outsourcing growth are in: downstream production operations, testing/product characterization, media optimization; upstream production operations, regulatory services, upstream process development; and testing cell-line stability. 

The biopharmaceutical industry continues to focus on productivity, efficiency, getting more out of existing internal resources, and maximizing performance from their provider relationships. Although outsourcing can improve overall efficiency and reduce costs, the management of relationships continues to be challenging and necessitates CMO/CRO flexibility to meet clients' shifting needs. Data from this study shows that CMOs are expanding their manufacturing competence through the use of novel technologies, single-use/disposable bioreactors, and other differentiated bioprocessing services. Improved services are resulting in increased adaptability, lower costs, faster turnaround, and higher yields, thereby offering more choice for biopharmaceutical companies. At the same time, the costs for using CMOs for product manufacturing are becoming slightly more competitive.  

 is president of BioPlan Associates, tel. 301.921.5979, 

9th Annual Report and Survey of Biopharmaceutical Manufacturers 

Outsourcing

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Gauging Biopharm Outsourcing

On Oct. 1, 2012, the Generic Drug User Fee Act (GDUFA), which was signed into law by President Barack Obama on July 9, 2012, goes into effect and provides important changes for generic-drug manufacturers and producers of generic APIs. The law imposes generic-drug user fees, payable by producers of generic finished drugs and APIs, to provide additional funding to FDA to improve the regulatory review process, including inspections for drug-manufacturing facilities, for generic drugs. These measures, which are supported by the generic-drug and fine-chemical industries, are intended to speed the delivery and ensure the quality of generic drugs (1). 

 
Under the GDUFA, FDA will receive $299 million annually (adjusted for inflation) during the five-year authorization of GDUFA from Oct. 1, 2013 to Sept. 30, 2017 (i.e., fiscal year [FY] 2013 to FY 2017) (2). The user fees required by the GDUFA are: 
 • A one-time fee for original abbreviated new drug applications (ANDAs) pending on Oct. 1, 2012 (also known as backlog applications)
 • Annual fees for API and final dosage-form facilities
 • Fees for new ANDAs and prior approval supplements (PASs)
 • A one-time fee for drug master files (DMFs) (1). 


Seventy percent of the GDUFA fees will be derived from annual facility fees for facilities producing or pending review to produce APIs or finished dosage forms for a generic-drug application, and approximately 30% of the user fees will be derived from one-time application fees (DMF fees and ANDA and PAS fees). Overall fees were structured to reflect the respective weight in the supply chain, so that 80% of the fees are paid by finished dosage form manufacturers and 20% by API manufacturers. In the first year of the program, $50 million of the total GDUFA user-fee funding will be generated by the one-time backlog fee for ANDAs pending (except for ANDAs that are pending but have received tentative approval) on Oct. 1, 2012. Overall, it is estimated that FDA will receive the funding through approximately 750 ANDAs per year submitted electronically, 750 PASs, 350 newly referenced DMFs per year, and 2000 facilities associated with ANDAs (2).


With the additional funding provided by generic-drug user fees under the GDUFA, FDA is obligated to meet certain performance goals with respect to its regulatory review of generic drugs. The GDUFA outlines goals in five main program areas.
  • 

 By the end of FY 2017, FDA will review and act on 90% of complete electronic ANDAs within 10 months after the date of submission. Certain amended applications may have differing metrics.  
  • 

 FDA will review and act on 90% of all ANDAs, ANDA amendments, and ANDA PASs of current review status (whether electronic, paper, or hybrid) pending on Oct. 1, 2012, by the end of FY 2017.
 • 

 FDA will conduct risk-adjusted biennial cGMP surveillance inspections of generic API and generic finished dosage form manufacturers, with the goal of achieving parity of inspection frequency between foreign and domestic firms in FY 2017.
 • Efficiency enhancements: FDA will implement various efficiency enhancements, which include efforts by industry and FDA to populate and maintain databases as necessary for facilities, fee assessments, efficiency, and other enhancements. FDA also will make DMF- and inspection-based enhancements as well as create a current chemistry manufacturing, and controls (CMC) records database to aid in the efficiency of reviews and inspections.
 • 

: FDA will continue or begin various regulatory-science initiatives. Some key issues are continuing quality-by-design initiatives for generic drugs, including developing science-based recommendations for product development, raw material, API and process controls, and life-cycle management of complex dosage forms (e.g., orally inhaled drug products and modified-release dosage forms). Another key goal is to develop a risk-based understanding of potential adverse impacts to drug-product quality resulting from changes in API manufacturing and controls. This effort will aid in the ability to predict the potential impact manufacturing changes will have on product quality, so manufacturers can target assessments and controls on high-risk areas and regulators can focus their reviews on these areas (2).


Industry response to the GDUFA has been largely positive with groups, such as the Generic Pharmaceutical Association (GPhA), the European Fine Chemicals Group (EFCG), and the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufactures & Affiliates (SOCMA), supporting the passage of the GDUFA and offering input throughout the legislative process. 

“The historic user-fee legislation—the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act—will provide FDA with additional resources and ensure all participants in the US generic-drug system, whether US-based or foreign, comply with our country’s strict quality standards,” said Ralph G. Neas, president and CEO of GPhA, in a July 9, 2012, GPhA press release. The new fees are expected to reduce the average review time for most generic-drug applications by nearly two years—from more than 30 months today to 10 months by the end of the program’s fifth year, according to GPhA, and will provide increased funding for generic-drug manufacturer facility inspections.

For fine-chemical and API producers, one of the key provisions of the GDUFA is the adoption of a risk-based inspection process to achieve parity in facility inspection between US and foreign manufacturers, a point made by FDA Commissioner Margaret Hamburg earlier this year (3). “Under the GDUFA, FDA will also ensure that manufacturers—foreign or domestic—who participate in the US generic drug market are held to the same, consistent, high quality standard,” said Hamburg at the GPhA Annual Meeting on Feb. 23, 2012 (3). “We will conduct risk-adjusted biennial surveillance inspections of all generic API and finished form manufacturers—with the goal of achieving parity of inspection frequency between foreign and domestic firms by year five. Having the resources to undertake these regular inspections will level the playing field for foreign and domestic manufacturers...”(3).

The fine-chemicals industry agrees. “The Congressionally mandated inspection frequency of every two years has been very difficult to achieve due to insufficient resources within FDA and the rapid globalization of generic-drug manufacturing,” says BPTF Executive Director John DiLoreto. “While US facilities have been inspected approximately every 2.5 years, many foreign facilities have never been inspected at all. Successful implementation of the GDUFA will result in the identification and registration of all drug-production facilities,” he explains. “Previously, FDA even had difficulty determining how many facilities were producing generic drugs that enter the supply chain every day,” he said. By the end of the first five years of the GDUFA, it is expected that all foreign and domestic facilities will be inspected at the same nominal rate of every two years. “This will level the playing field for foreign and domestic producers and establish a balance in drug quality by ensuring that all manufacturers are implementing cGMPs,” says DiLoreto.

Under the GDUFA, FDA will conduct risk-adjusted biennial cGMP surveillance inspections of generic API and generic finished dosage-form manufacturers, with the goal of achieving parity of inspection frequency between foreign and domestic firms in FY 2017. FDA will prioritize inspections of establishments associated with ANDAs that are otherwise approvable or eligible for tentative approval except for an outstanding inspection, as well as establishments associated with ANDAs that have not been inspected previously. In appropriate circumstances, FDA can rely on a routine surveillance inspection in lieu of an application-specific inspection. Generally, FDA relies on a previous inspection of a finished product site occurring within two years of the cGMP evaluation for a pending application, three years for an API site or a control testing laboratory, and four years for a packaging-only site (2). There are exceptions to this general practice, which are usually related to the nature of the drug being processed or the complexity of the associated processing operations. Under the GDUFA, FDA intends to continue the practice of using a risk-based assessment in determining the length of time since the last inspection, guided by a two-year cycle for finished dosage product sites and a three-year cycle for API sites with consideration of the type of finished product or API in the application. For making decisions about pending applications for which FDA does not have current inspection information within the time period indicated, FDA may use previous FDA inspection information and/or use inspection information from another regulatory authority as appropriate (2). 

 “Risk-based inspections will have a positive effect on FDA and generic-drug manufacturers,” says DiLoreto. “In managing resources most efficiently, FDA will be able to focus on those manufacturers having the most difficulty in implementing and maintaining quality drug-production programs. Manufacturing facilities that have never been inspected will be considered high risk, and manufacturers with a history of active successful quality programs will be considered to be lower risk,” he explains. 

Carla Vozone, business development director at Hovione and industry representative of the EFCG during the negotiation process for the GDUFA, also points to the benefit of the GDUFA in “correcting the mismatch that existed in the inspection schedule and the actual supply chain.” Although approximately 80% of APIs for drugs marketed in the US come from India or China, inspections of drug-manufacturing facilities in these countries are not proportional to these levels, explains Vozone. “Parity in inspections is critical to ensure safety of generic medicines,” she says. She also points to the value in the provisions of the GDUFA that provide for a risk-adjusted surveillance inspections system to prioritize inspections of higher-risk facilities. 

Also of significance is increased authority for FDA to deal with low-quality and counterfeit drugs. “Prior to the GDUFA, FDA had little authority to prevent low-quality and counterfeit drugs from entering the supply chain,” explains DiLoreto. As of Oct. 1, 2012, FDA will have the authority to consider misbranded any drugs not produced in a registered and inspected manufacturing facility. All drugs considered misbranded may be destroyed rather that returned so they will not be allowed to enter the supply chain through different supply chain channels, he explains.

As the quality bar for generic drugs and APIs are raised under the GDUFA, the supply chain for generic drugs also may be affected, notes Vozone. “Generic-drug manufacturers will have to do a risk assessment of their supply chains,” she says. Issues, such as increasing secondary sourcing or further evaluations of existing suppliers, will come into play. She also notes that the amount of the user fees, which are still being  determined, will oblige producers to evaluate their cost structures for supplying a given generic API, and as a result, certain producers may exit the market for that product or the sector. These issues will be important to take into consideration in the sourcing strategies for generic-drug manufacturers. 


1. FDA, “Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794,”  Federal Register 77 (144), 43844–43846  (2012). 
2. FDA, 

 Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 

(Rockville, MD), July 7, 2012, www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf, accessed Aug. 15, 2012. 
3. M. Hamburg, “Challenges and Opportunities for the Generic Drug Industry Remarks,” presented at the GPhA Annual Meeting, Orlando, FL, Feb. 23, 2012. 

Supply Chain

The Generic Drug User Fee Act seeks to improve and enhance regulatory activities, including achieving parity of inspections between foreign and domestic drug-manufacturing sites for both finished dosage forms and APIs of generic drugs.

Moving to Risk-Based Inspections

Innovation in parenteral drug delivery often comes from the device itself to enable ease of use and greater patient compliance. Several recent developments in parenteral drug delivery involve thin-wall needles for prefilled syringes, an auto-injector with audio and visual functionality, and an improved self-injection system. 

In late July, BD Medical, a segment of BD (Becton, Dickinson and Company), launched the BD Hyflow needle, a 27-gauge thin-wall needle designed for use with BD’s prefillable syringe systems. The optimized inner diameter of the BD Hyflow needle enables injection of highly viscous drug formulations without the use of a larger needle that could be more painful for the patient, according to the company.

The BD Hyflow needle increases flow to facilitate use with auto-injectors and infusors. The new needle technology also reduces the pressure required to inject, a crucial attribute for patients with dexterity limitations and facilitates patient use and compliance. The needle technology represents an alternative to larger needle-gauge systems. BD says the product is one of several the company plans to launch over the next 18 months to enhance the performance of prefilled-syringe systems. 

 Auto-injector with audio and visual functionality 

Drug Delivery

A roundup of the latest developments for drug delivery of parenteral drugs.

Drug Delivery Insights: Injectable Drugs

 has selected 40 undergraduate and graduate students living with cystic fibrosis (CF) to each receive a $2500 CFCareForward Scholarship for use during the 2012–2013 academic year. Recipients were chosen based on their academic merits, community involvement, and creativity and will now compete for two additional scholarships for a total award of $20,000 each. Until Sept. 11, 2012, the public is invited to vote at help determine this year’s 

Thriving Undergraduate and Graduate Student 

 has announced $1.6 million in grants to four healthcare institutions in India that will help improve diabetes education, prevention, and care as well as increase healthcare worker capacity in rural and tribal areas and among the urban poor. The International Diabetes Foundation (IDF) reports that 61.26 million people in India are diagnosed with Type 2 diabetes, ranking India second only to China in total cases and third behind the United States (10.9%) and China (9.3%) in terms of prevalence. By 2030, India will have 101.2 million people with Type 2 diabetes, IDF projects. Through its 

 initiative, Bristol-Myers Squibb has awarded grants to the Mamta Health Institute for Mother and Child in New Delhi, All India Institute of Diabetes and Research in Naranpura,  Swasthya Diabetes Hospital in Ahmedabad, and Sanjivani Health and Relief Committee in Ahmedabad. Since its launch in November 2010, the 

 program has awarded $32.57 million in grants to 17 organizations in 23 states and the District of Columbia in the United States, $1.23 million to two organizations in China, and $1.6 million to four organizations in India. The total commitment is $115 million through 2014. 

 a provider of packaging and packaging solutions, has introduced Shellpak Renew, a new package that features a tear-resistant, recyclable outer carton, an easy-slide blister, and an integrated calendar for patients to track their medications. The new sustainable Shellpak Renew packaging has a smaller footprint requiring less shelf space. The outer carton is made of the company’s Natralock, an environmentally friendly paperboard-based packaging solution that maximizes the use of recyclable materials and minimizes waste. The package also contains enhanced adherence features, including color-coded spine labels to help distinguish among drugs, and easy-open, child-resistant push buttons. 

 through its Ministry of Health and supported by 

 has announced the launch of a national vaccination program with Merck’s cervical cancer vaccine Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16 and 18] vaccine, recombinant] for girls 9 to 13 years of age in 12 districts throughout the country.  Through an agreement with Merck, the vaccination program will be implemented with 460,000 doses of Gardasil donated to 12 districts in Uganda during a two-year period, enough to vaccinate approximately 140,000 eligible girls in 12 districts.  The program represents the first phase of Uganda's national rollout plan for human papillomavirus vaccination. (HPV). 

 The initiative in Uganda follows the launch in April 2011 of a cervical cancer prevention program in Rwanda incorporating both HPV vaccination and HPV testing. In its initial year, an estimated 93% of eligible girls 12 to 15 years of age in Rwanda were vaccinated with three doses of Gardasil.  Also, in 2010 Merck partnered with the Royal Government of Bhutan and the Australian Cervical Cancer Foundation to launch a six-year national vaccination program with Gardasil for girls and young women between the ages of 12 and 18 in Bhutan.  Merck provided Gardasil at no cost in the first year and for the remaining five years is providing it at an access price at which Merck will not profit. In 2009, Merck also announced a partnership with Qiagen focused on increasing access to HPV vaccination and HPV DNA testing in resource-poor areas of the world. 

 held its annual International Biotechnology Leadership Camp (BioCamp), a three-day seminar that brought biotechnology and business experts together with 60 university students from 21 countries and territories. This year’s Novartis BioCamp emphasized increased access to healthcare and the importance of R&D in emerging markets and how the company is expanding its global reach in clinical development. 

 reported that it achieved its five-year public goal of reducing greenhouse gas emissions by 20% after only four years. As a result of this effort, the company achieved $85 million in annualized project savings. To help reach this goal, more than 1500 energy-conservation and utility projects designed to improve efficiency and promote environmental sustainability were implemented along with other initiatives that reduced product packaging and increased use of renewable energy sources. 

 and the Lucerne Festival, a musical festival, are renewing their partnership in the Roche Commissions cultural program. Since the program was launched in 2003, Roche has commissioned an orchestral work from a renowned composer. Since 2006, the program has taken place in a two-year cycle. In the future, the Lucerne Festival will be the exclusive partner of the Roche Commissions. From 2003 to 2012, Roche Commissions had been run by Roche and three cultural institutions: the Lucerne Festival, Carnegie Hall, and the Cleveland Orchestra. As in the past, a new work will be premiered every two years at the Lucerne Festival. Under the renewed partnership, Roche will be the resident sponsor of the Lucerne Festival in the summer and a resident partner of the Lucerne Festival Academy from 2013 onwards. Roche and the Lucerne Festival also are launching the Roche Young Commissions. Every two years, alternating with the existing Roche Commissions program, two young composers will be commissioned to write orchestral works that will premiere at the Lucerne Festival, for the first time in 2015. The Roche Young Commissions awardees will have two years to complete their compositions. 

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

PTSM: Pharmaceutical Technology Sourcing and Management-09-05-2012

Using Microfluidic Chip Technology for Assessing Drug Quality

Evaluating Market Opportunities in Orphan Drugs

Gauging Biopharm Outsourcing

Moving to Risk-Based Inspections

Drug Delivery Insights: Injectable Drugs

CSR and Sustainability in the News