Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

Sustainability is about more than going green. When it comes to business strategy, it also includes social and corporate governance, according to a definition from consulting firm Brandlogic and investment analytics firm CRD Analytics. The companies recently released a survey about the real and perceived sustainability efforts of the top 100 companies around the world. The goal of the 

Sustainability Leadership Report: Measuring Perception vs. Reality

 is for industry to use the identified gaps between real and perceived sustainability efforts to improve corporate performance.  

The good news is that the pharmaceutical/healthcare industry, one of nine sectors included in the survey, is leading the way in corporate sustainability. Other sectors included consumer, energy, financials, industrials and transportation, information technology, materials and mining, and telecommunications and Internet. The study authors used data from survey participants to establish a sustainability IQ matrix which groups companies into one of four areas: laggards (low perception, low reality), promoters (high perception, low reality), challengers (low perception, high reality), and leaders (high perception, high reality). Groups are based on real and perceived scores, both of which incorporate key performance indicators such as the company's environmental emissions, social diversity, and corporate vision. 

Abbott Laboratories, AstraZeneca, Bayer, GlaxoSmithKline, Johnson & Johnson, Merck, Novo Nordisk, and Pfizer all ranked in the "leader" category. Roche fell into the "challenger" category; BASF fell into the "promoter" category; and no one from pharma ended up in the "laggard" field. 

The industry's activities in environmental, social, and corporate governance come as no surprise. The most nascent goal of the drug-manufacturing world is to improve health, and ultimately, to improve lives. More and more, industry is realizing that social, environmental, and governance sustainability initiatives—and not just its products—can help it achieve this goal. 

Articles

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

Pharma Leads in Sustainability

GlaxoSmithKline (GSK) has been leading several industry efforts during the past decade to improve healthcare among developing-country populations. In 2001, the company dedicated a research and development (R&D) facility in Tres Cantos, Spain, to developing new treatments to combat diseases in the developing world. GSK now operates an open laboratory at the facility, which offers researchers from around the world a place to collaborate on new medicines for neglected diseases.  

GSK also offers preferential pricing as well as not-for-profit pricing of its antiretrovirals (ARVs) to developing nations which helps to improve access to the needed drugs. The program reaches 69 of the world's poorest countries. In addition, approximately 75% of the company's manufactured vaccines are sold to developing countries on a tiered-pricing plan. 

GSK has established community investment activities and partnerships that foster healthcare practices in places such as sub-Saharan Africa, Asia, and South America, and has launched several partnerships aimed at finding solutions for global healthcare problems. 

 "Developing countries face multiple issues on a systemic basis that negatively affect health outcomes for their citizens," says Jon Pender, vice-president for intellectual property and access at GSK, about the company's global healthcare efforts. "Fundamentally, poverty both makes people sicker and makes it harder to tackle healthcare challenges. Many people living in poverty do not have enough food or clean water. In this context, a healthcare system may exist only in name or only in isolated pockets within a country. For example, Africa suffers 24% of the global disease burden yet has only 3% of the world's health workers and 1% of the world's health budget with which to tackle it. There is no way you can get those numbers to add up to adequate healthcare provision. Together, the public and private sectors and civil society have helped to galvanize more resources for global health and reduce the barriers to access to medicines. GSK sees itself as a part of this movement and is specifically addressing issues where our talents and resources can be deployed to maximum benefit." 

A major challenge with regard to developing and delivering needed medicines to developing countries and neglected populations has to do with the long-standing reality of the economics behind R&D, adds Pender. He points out that developing a new medicine or vaccine typically takes 10 to 12 years and costs around $1 billion, including the costs of failures. Traditionally, the lack of a viable commercial return on this investment for diseases that are not prevalent in industrialized markets meant that little research was conducted on these diseases. Today, however, more attention is being paid to previously neglected diseases, such as tuberculosis (TB) and malaria, and new approaches that share the risks and costs of R&D are being pursued, he says. Through product-development partnerships with organizations, such as the PATH Malaria Vaccine Initiative (MVI) and the TB Alliance, the pharmaceutical industry is developing new tools to combat theses diseases.  

The past two years have been particularly important for GSK in this regard. In addition to establishing the open research laboratory in Spain, in 2010, GSK made available to the public more than 13,000 potential malaria targets to help scientists globally focus on finding a malaria treatment. The company is also working with PATH–MVI and the Bill & Melinda Gates Foundation to develop a vaccine against malaria. The vaccine is in Phase III clinical trials at 11 sites across seven countries in Africa. 

The company also established an R&D unit focused on developing late-stage products and formulations for diseases that affect populations in the emerging markets. Other pharma companies are involved, including Amgen, which is working with GSK to make its osteoporosis medicine, denosumab, available in developing countries. Gilead is partnering with GSK to make its drug for hepatitis B, tenofivir, available in China. India's Dr. Reddy's and GSK worked together to move two new cardiovascular branded generic drugs for developing-country populations into development. The R&D unit, meanwhile, has four ongoing late-stage projects in respiratory disease, urology, dermatology, and cardiovascular disease. These projects involve working with regions and countries to understand fully the local needs and to tailor clinical trials to those needs. 

The registration of new medicines in many of these targeted countries, however, can be costly, complex, and time-consuming, says Pender. "Too often, regulatory authorities do not have sufficient capacity to deal effectively with numerous and complex product registrations. A possible solution would be the creation of a harmonized registration system that several countries with the same disease priorities can adhere to." 

In an attempt to improve this situation, GSK established a dedicated Developing Countries and Market Access operating unit in July 2010. One of the unit's goals is to increase patient access to key medicines and vaccines.  

The recently created Advance Market Commitment (AMC), pioneered by the Global Alliance for Vaccines and Immunization (GAVI), offers another financing mechanism to ensure more sustainability in vaccine manufacturing and supply for the developing world. Recently, GSK agreed to supply up to 300 million doses of its pneumococcal vaccine for a period of 10 years to countries that are part of GAVI as part of the first global AMC for the pharmaceutical industry. Pfizer has made a similar commitment for its vaccine.  

Another challenge faced by the healthcare industry globally is the infrastructure that exists in many developing countries, including poor distribution networks and a lack hospitals, clinics, and healthcare professionals. Political issues often compound these barriers, meaning that even when there is funding, there is little action, says Pender. "In middle-income countries, the health system may be more developed, but wide ranges in income mean that many poor people at the lower rungs of the income ladder are not able to access healthcare," he adds. The needs to strengthen health systems and reduce inequities are becoming more visible, and much more can be done to increase access to life-saving services, says Pender. 

In the least developed countries (LDCs), the challenge of improving healthcare and access to medicines is even more difficult. Earlier this year, therefore, GSK formed a partnership with AMREF, CARE International UK, and Save the Children to help reinvest 20% of the company's profits made in LDCs back into projects that strengthen the healthcare infrastructure in those countries. The money will go toward programs that improve health outcomes by supporting frontline health workers who operate in these countries.  

Since 2009, GSK also has committed to significantly reducing its prices for patented medicines in the LDCs. The company's goal is to reduce prices to no more than 25% of their price in the United Kingdom.  

Going forward, GSK plans to continue and add to these global healthcare efforts. "All these initiatives commit us to continuing to work closely with the global community and to ensuring the necessary resources and political will are in place to make partnerships work," says Pender. "Partnerships that combine the resources and expertise of companies, governments, international agencies, academic institutions, NGOs and communities, are a central component to our global health approach. From GSK's perspective as a global company, we believe this is not only the right thing to do but makes good business sense. By working with others to find logical and sustainable solutions for the long-term, we can achieve more for patients than we can alone," he adds. 

GSK Works in Developing Nations to Improve Everything from Research to Roads.

Global Healthcare on the Ground: GlaxoSmithKline's Efforts

FDA released a new strategy on June 20, 2011, that is aimed at meeting the challenges posed by rapidly rising imports (they’ve quadrupled since 2000) of FDA-regulated products and the growing complexity of the pharmaceutical supply chain. A report titled “

Pathway to Global Product Safety and Quality

,” calls for four key changes to protect consumers: 

FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality

The coalitions of regulators will develop international data-information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets 

FDA will build in additional information-gathering and analysis capabilities with an increased focus on risk analytics and information technology

FDA increasingly will leverage the efforts of public and private third parties and industry, and allocate FDA resources based on risk.

“Global production of FDA-regulated goods has exploded over the past 10 years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their US production facilities, making the distinction between domestic and imported products obsolete,” said FDA Commissioner Margaret A. Hamburg in the announcement. “There has been a perfect storm—more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

In terms of how the new strategy and changing manufacturing environment will affect the pharmaceutical industry in the future, FDA’s announcement notes the following:

“Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.

Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical US manufacturing company relies on more than 35 different contract manufacturers around the world. 

Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.

Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.”

The strategy builds on recent agency efforts to increase the number of foreign inspections it conducts and to collaborate more with global regulatory authorities by, for instance, joining the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

FDA released a new strategy on that is aimed at meeting the challenges posed by rapidly rising imports of FDA-regulated products and the growing complexity of the pharmaceutical supply chain.

New FDA Strategy to Tackle Imports, Supply Chain

The FDA Center for Drug Evaluation and Research’s Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with 

 by the agency press office.
 
 Specifically, the Office of Compliance will be elevated to a “Super Office.”  Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

“Given CDER/OC’s expanding role, size, and importance in achieving the Agency’s mission of safeguarding the US drug supply, this structural transition makes a great deal of sense,” wrote Woodcock. “The reorganization will enable Compliance to align its scientific, technical, and legal capabilities with closely related program areas, leveraging our resources and maximizing its ability to achieve its public health mission.  CDER/OC’s responsibilities include ensuring compliance with requirements relating to good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS [risk evaluation and mitigation systems], drug labeling, drug approval, drug importation, and supply chain integrity, among many others.”

The new Super Office will have three primary functions:  risk science, intelligence, and prioritization; policy and communication; and organizational strategy, which involves strategic planning, organizational development, and quality management systems.  “These are key components of a high-functioning, policy-driven, risk-based organization, and their elevation and integration in the CDER/OC structure promises to help CDER/OC to continue to evolve and grow,” wrote Woodcock.  

As part of the reorganization, Deborah Autor, who has been leading the Office of Compliance, will take on the role of Acting Director of the new Compliance Super Office. The staff will be realigned according to critical functions within the new and existing program areas. The Super Office will still be called the Office of Compliance.
 

For a visual of the new structure, view a 

. Otherwise, the structure is outlined below.
 
 
 The Office of Compliance Super Office

Office of Drug Security, Integrity & Recalls
 •	Division of Import Operations & Recalls 
 •	Recalls Coordination Branch 
 •	Import Operations Branch 
•	Division of Supply Chain Integrity 

Office of Manufacturing & Product Quality 
 •	Division of International Drug Quality 
 •	International Compliance Branch 1 
 •	International Compliance Branch 2 
 •	Division of Domestic Drug Quality 
 •	Domestic Compliance Branch 1 
 •	Domestic Compliance Branch 2 
 •	Division of Policy, Collaboration & Data Operations 
 •	Drug Surveillance and Data Reporting Branch 
 •	Regulatory Policy and Collaboration Branch 
 •	Division of Good Manufacturing Practice (GMP) Assessment 
 •	Biotech Manufacturing Assessment Branch 
 •	New Drug Manufacturing Assessment Branch 
 •	Generic Drug Manufacturing Assessment Branch 

Office of Scientific Investigations
 •	Division of Bioequivalence (BEQ) and Good Laboratory Practice (GLP) Compliance 
 •	Bioequivalence (BEQ) Branch 
 •	Good Laboratory Practice (GLP) Branch 
 •	Division of Good Clinical Practice (GCP) Compliance 
 •	GCP Enforcement Branch 
 •	GCP Assessment Branch 
 •	Division of Safety Compliance 
 •	Post Market Safety Branch 
 •	Human Subject Protection Branch 

Office of Unapproved Drugs & Labeling Compliance
 •	Division of Prescription Drugs 
 •	Prescription Drugs Branch 
 •	Compounding and Pharmacy Practices Branch 
 •	Division of Non-Prescription Drugs & Health Fraud 
 •	Over-the-Counter Drugs Branch 
 •	Health Fraud and Consumer Outreach Branch 

CDER Director Janet Woodcock announces reorganization.

FDA Office of Compliance to Become a Super Office

New drugs, vaccines, and diagnostics are desperately needed for millions that suffer from infectious diseases in developing countries. The challenges of meeting this need are endless, but leaders at the Biotechnology Industry Organization (BIO) and BIO Ventures for Global Health are optimistic. 

"The fact is, that while challenges are tremendous, they are not insurmountable," said Lila Feisee, BIO's vice-president for global intellectual property policy. "The goal of getting products to the people who need them is a shared goal. It's the approach that varies, and respect for each approach is crucial in order to have progress in this area."  

BIO is taking a few approaches of its own. In May 2010, the organization developed a policy statement to educate its members about how they can improve access to medicines outside of their own borders. One approach encourages companies to use creative strategies when entering into license agreements with commercial and noncommercial entities for their inventions. Examples of creative strategies would include considering licensees in the developing world as well as facilitating sublicensing agreements and incentives that are designed to improve access to drugs in the developing world. Another approach highlights the importance of working to identify compounds or technologies that can have useful application in the developing world, rather than focusing only on research and development of drugs only for the broader marketplace. 

BIO is also educating its members about the whole picture, so to speak, with regard to increasing access to drugs in the developing world. Says Feisee, "The greatest challenges in improving health outcomes in the developing world are not related to the availability of health products, though clearly more can be done in this area, but are related in large measure to the lack of adequate infrastructure (e.g., trained personnel, roads and hospitals, and legal and regulatory policies) and distribution capability in the developing world. It is not simply enough to make or manufacture a product. There are many products both on and off patent that are available for many existing developing world diseases. But in many instances, the products cannot get to where they are most needed due to inadequate roads and delivery systems, or when they do reach their destination, there is no way of monitoring their uptake due to the lack of trained healthcare professionals or consistently available clinics or hospitals." 

She notes that local governments and NGOs are the best entities to handle these types of infrastructure problems, and that they can also encourage early-stage research domestically. The global biotech industry can be of assistance in helping to develop medicines that require little or no follow up monitoring (e.g., single dosage formulations, sustained release formulations), or products that are temperature-stable, says Feisee. "Several of our companies are already working to address some of these types of concerns.... Agricultural biotechnology companies, for example, are helping to increase food security and nutrition throughout the world, and BIO's industrial and environmental companies are working on developing new ways to purify water and clean the environment."  

BIO also has been working with BIO Ventures for Global Health, which was spun out of BIO in 2004 with the help of a Gates Foundation grant.  BVGH's mission is to save lives by accelerating the development of novel drugs, vaccines, and diagnostics coming from the biotechnology industry to address the unmet medical needs of the developing world. According to BVGH's CEO Melinda Moree, "People want to help other people—the desire is there to help save the lives of people in poor countries." Although the desire is there, the financial incentives are harder to find.  According to Moree, "It's mostly poor people who suffer from these diseases and there is little market to drive the investment needed. This lack of commercial incentive has resulted in a very slow pace of drug development for these diseases." 

BVGH has been heavily involved in the implementation of FDA's Priority Review Voucher (PRV) Program, which creates an incentive for investment in the development of new drugs and vaccines for neglected tropical diseases, such as malaria, tuberculosis, and intestinal worms. The agency grants a PRV to the sponsor of a newly approved drug or vaccine for these diseases. The voucher applies to accelerate the review of any other drug. A voucher can save a company several months of FDA review time, which for a blockbuster product could be worth up to hundreds of millions of dollars. 

This resource savings is important especially because recent economic times  have led to a shortage of investments in new medical treatments.  A way to correct this market failure, according to BVGH, is to reduce the risk companies face both by providing additional information to illuminate market demand, and by providing new incentives to motivate investment in global health. BVGH is developing a pay-for-success prize to address these needs. Countries and donors have to work together to prioritize and identify demand, says Moree, so that they can work within the health systems to deliver new products and higher quality of care to those who need it most.  

In March 2011, BVGH released an updated Global Health Primer, which provides online information about familiar drug targets and vaccine technologies associated with developed world diseases and those associated with relevant neglected diseases. Product needs and opportunities are listed for disease-specific profiles. "By connecting the dots between neglected disease product needs and biological pathways and technologies that are well known to the biopharmaceutical industry, this new release of the Global Health Primer provides not just a rich source of information but also a roadmap for action in the neglected disease space," says Moree. 

This month, June 2011, BIO and BVGH are cohosting the Partnering for Global Health Forum in Washington, DC, which will be colocated with the 2011 BIO International Convention. The forum will bring together leaders from global health, biopharmaceutical, academic, government, and donor communities, and funders supporting global health R&D. Presentations will feature speakers developing and funding technologies and products that will save lives in the developing world. Francis Collins, director of the National Institutes of Health, will provide the keynote address on how ground-breaking biotechnology innovations can serve the health needs of the world's poorest. Collins oversees the work of the largest supporter of biomedical research in the world, spanning the spectrum from basic to clinical research. He is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project. More details are available online at 

A Focus on Creative Strategies to Help the Developing World.

Global Healthcare on the Ground: BIO and BIO Ventures for Global Health

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a 

FDA approved 65 new biopharmaceuticals between 2000 and 2009, up from 39 approvals during the 1990s, and 13 in the 1980s. Of those new approvals overall, FDA approvals of recombinant protein products increased from 54% in the 1980s to 57% in the 2000s. In addition, the study showed that approvals of new biopharmaceuticals in the 2000s were more evenly distributed in six therapeutic categories, compared to those of the 1980s and 1990s.

At the same time, however, the average combined clinical and approval phase time for biopharmaceuticals rose to 95 months during the 2000s, up from 77 months in the 1990s. According to Reichert, that means drug manufacturers will need to “further streamline the development process to assure greater consistency across compounds and within disease areas.”

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.