The biopharmaceutical industry is starting 2012 with good reason for optimism. Based on preliminary results from BioPlan Associates' 9th Annual Report and Survey of Biomanufacturing, biologics manufacturers and their vendors are spending more, demanding better technologies, and expressing greater optimism than at any time in the nine years we have been assessing this industry. This year the BioPlan study finds substantial optimism, with a 37.3% of suppliers indicating that their company did either "better" or "much better" than expected in 2011. Even more relevant, 49.4% expect they will do "better" or "much better" in 2012.  

Sales growth among vendors is a leading indicator of the overall performance of the bio/pharmaceutical industry because vendor sales are derived from demand for materials biologics production. If vendors are doing welll and are optimistic for the future, the bio/pharmaceutical industry is likely to follow. Supplier respondents indicated that, on average, sales growth is currently at approximately 14% annually, up from 13.0% in 2010 and 14.1% in 2007.  

Budgets also are a good indicator of industry strength, and budget estimates for 2012 are up strongly in areas such as acquisition of new technologies, capital equipment, and personnel training and development. Early results from the 2012 BioPlan survey projects increases in all 12 areas, except for outsourcing (see Figure 1).  

Figure 1: Average change in biomanufacturers' budgets (2009â2012). (Figure 1 is courtesy of the author) 

These overall trends are in large part resulting from global shifts that continue to drive the bio/pharmaceutical industry. Below are trends we project in 2012 specifically relating to biomanufacturing.  

 The bio/pharmaceutical industry continues to expand globally, driven by the need for prudent expansion of infrastructure, presence in new markets,  and cost savings through outsourcing and offshoring, including R&D, which is traditionally performed in established high-technology regional clusters.  

Biomanufacturing capacity also is increasing outside established markets. Although the US and Western Europe remain the leaders in biopharmaceutical manufacturing capacity, more than 37% of bioreactor capacity is operating in other parts of the world, including nearly 10% in Japan and the Pacific Rim, 9% in China, and more than 8% in India (2). Western product developers also are joining with local companies, such as in the local manufacture of vaccines. As more biopharmaceutical manufacturing is performed worldwide, product developers are working to standardize their products and manufacturing processes, which involves simplifying their manufacturing processes, so they can be reliably performed with consistent product produced even in facilities in lesser developed counties.   

 The trend toward more global standardized manufacturing is contributing to the adoption of single-use/disposable bioprocessing equipment, which allow the same manufacturing systems to be shipped and installed at multiple facilities. Some companies, with major vaccine manufacturers among the leaders, are starting to think more in terms of selling full manufacturing and technology packages, including all needed equipment and technology transfer, not just finished end-products, to foreign countries that are seeking local manufacture of vaccines for domestic distribution. Companies, such as GE and Biologics Modular, for example, are developing fully modular, drop-in-place-type, and equipment preinstalled or simply installed single-use bioprocessing-based facilities to address the interest for prepackaged biopharmaceutical manufacturing facilities.  

 In 2011, single-use/disposable bioprocessing systems further increased their dominance for the manufacture of biopharmaceuticals for preclinical R&D and clinical testing.  Single-use systems dominate noncommercial-scale biopharmaceutical manufacturing in most regions. Single-use systems are increasingly being adopted for upstream manufacturing, such as adoption of single-use bioreactors and other upstream equipment. Despite dominance within precommercialization manufacturing segments, single-use systems remain a relatively small market compared with fixed stainless-steel equipment, capturing only approximately 10% of the overall bioreactor market. Stainless steel remains the preference for commercial GMP manufacturing. In as short as 10 years (approximately about how long it takes a biopharmaceutical to reach the market), half or even more of new commercial biopharmaceutical manufacturing systems can be expected to be largely or fully single-use based. 

 Most industry attention in recent years, including blockbuster products and manufacturing technology development, has concentrated on recombinant proteins produced by mammalian cell culture. Mammalian cell-culture capacity and facilities continue to dominate worldwide biopharmaceutical manufacturing (2). Microbial manufacturing remains relatively stable with few new technologies, and few major bioprocessing equipment developers announcing novel devices. A confluence of trends, however, is contributing to increased use of microbial (i.e., bacteria, yeasts, and other fungi) host cells for recombinant-protein manufacture.   

 Companies of all sizes worldwide continue to increase their outsourcing, particularly R&D and manufacturing. These activities include increasing the use of CROs, particularly for high-throughput screening, lead identification, toxicological studies as well as greater use of CMOs for commercial manufacturing. Based on the BioPlan annual survey that evaluates 24 outsourced activities, the primary outsourced activities include product-characterization testing, with 70% of biopharmaceutical companies outsourcing at least some of this activity. Other tasks routinely outsourced include validation services (69% of biomanufacturers cited), toxicity testing (65%), analytical testing/bioassays (61.1%), and fill–finish operations (60.0%). Relatively few companies have outsourced all of their manufacturing, but nearly one-half of surveyed manufacturers expect to increase their budgets for biopharmaceutical CMO outsourcing.  

These trends are, in large part, resulting from global shifts that continue to drive the bio/pharmaceutical industry. Below are broad industry trends we project in 2012.   

 The worldwide market for biopharmaceuticals continues to expand and at a more rapid rate than for pharmaceuticals in general. The world market for biopharmaceuticals is approximately $140 billion, with approximately $100 billion involving recombinant proteins and antibodies (2). The market includes over 430 biopharmaceuticals, including over 300 recombinant proteins and antibodies that are approved in the US and/or Europe. The biopharmaceutical market has been and is expected to continue to grow about 15–18% annually, well above overall economic growth rates. This steady overall growth rate is driving much current investment in biopharmaceutical R&D. 

 Despite increasing biopharmaceutical sales, the number and rate of biopharmaceutical approvals in the US has been relatively poor in the past few years (12 biopharmaceuticals entered the US market in 2011). The 2011 approvals were even fewer in number than the relatively poor results in 2010 and 2009 (4). This weak showing for biopharmaceuticals is in contrast with FDA reporting in November 2011 near record overall pharmaceutical approvals. The 2011 FDA biopharmaceutical approvals are listed in Table 1. 

Table I: FDA full biopharmaceutical approvals in 2011.** 

Approval-related innovation and progress.

 The good news, particularly for patients and the healthcare system, is that 2011 FDA biopharmaceutical approvals involved genuine innovation and advances, with nearly all products being approved for either new indications for which no treatments were previously available or for indications for which the last product approval was granted well over a decade ago.  A record number (i.e., eight) products were approved with orphan designation. Recombinant antibodies are a leading area for biopharmaceutical development. The large number of recombinant monoclonal antibody and recombinat monoclonal antibody-like products that many companies are relying on for future products may finally be starting to enter the market.  

 Largely due to the limited markets for these orphan and other approved products, 2011 US approvals will not have as much industry economic impact as is likely needed in the long-term. Only two of the twelve approvals are expected to eventually reach blockbuster sales levels of $1 billion or more per year.  

 Illustrating the trend towards internationalization of manufacturing, a record number of four, or 33%, of newly-approved US biopharmaceuticals are manufactured outside the US—in the United Kingdom. Germany, Mexico, and Italy. These products include the first product manufactured in Latin America that received FDA approval—a scorpion venom antitoxin (equine immunoglobulin F(ab) fragments), Anascorp, manufactured by a Mexican company.   

 With patents expiring for most established, successful, biopharmaceutical products, development of biosimilars is accelerating worldwide and will change the industry landscape. This emergence of biosimilars will likely involve the entrance of many new manufacturers. Most of this activity is targeted to introducing these products in the US and European markets, but many products are being developed by foreign companies, if only initially, for marketing in lesser-regulated domestic and international markets. There will likely be multiple biosimilars (as well as biobetters and biogenerics) for each currently successful biopharmaceutical. As a result, the number of biopharmaceuticals in the market and the number of biopharmaceutical manufacturing facilities will rapidly increase, perhaps doubling in the next five years.  

Many biosimilar/biobetter/biogeneric developers are adopting state-of-the-art expression systems and other manufacturing platforms. Biosimilars are competing with products being manufactured using 20-year-old technology. Although biosimilar manufacturers will have technical advantages with newer technology, drug innovators of the the now biosimilars will have long off paid off manufacturing facilities. As a result, biosimilar/biobetter/biogeneric developers will have to compete on the basis of price and adopt aggressive cost-cutting technologies to effectively compete with the original biologic and other biosimilar manufacturers. Although over a dozen biosimilars have received European Union (EU) approval, no biologics have yet been approved as biosimilars by FDA. BioPlan analysis shows that biosimilar/biobetter companies are present in virtually every biotechnology-capable region, including Latin America, Korea, and other areas that have yet to be significantly involved in major Western biopharmaceutical markets (2). For example, of the nearly 400 organizations involved in biosimilars/biobetters development, more than  30 companies are based in India and 14 in China.   

 The worldwide economic downturn in recent years continues to affect the biopharmaceutical industry.  Yet, with continuing growth in its underlying sales revenue, the industry has managed to remain largely insulated from severe economic problems. Financial issues continue to affect most companies, including the major international (i.e., Big Pharma) companies that are the source for most biopharmaceutical R&D, with many having to deal with their most profitable products coming off patent. Spurred, however, by their interest in new, profitable products, biopharmaceutical R&D continues to increase. R&D invesment includes a record amount of more than $70 billion being invested by the pharmaceutical industry in R&D, about 90% sponsored by the largest international companies, with an increasing number and percentage of pharmaceuticals in the development pipeline being biopharmaceuticals versus chemically manufactured drugs). Biopharmaceuticals provide more exclusivity, market monopolization, and are increasingly attractive to the Big Pharma-type companies.  

One important trend, however, is the internationalization of R&D. Large international (i.e., Big Pharma) companies continue their expansion and/or off-shoring of R&D. Several  companies have announced major, multimillion, investments in new R&D centers in China, such as Merck Serono's $225 million, four-year commitment in Beijing.  

 The trend for industry mergers, acquisitions, and other corporate consolidation at all scales continued in 2011. This is particularly evident among large international companies that continue merging and purging (i.e., acquiring or merging companies and then downsizing the merged company). Some companies, such as Merck & Co., are moving from mergers/acquisitions in favor of more in-house and company-sponsored R&D. The continuing trend of pharmaceutical mergers, combined with off-shoring of certain jobs and facilities, has resulted in relatively high bio/pharmaceutical industry unemployment rates in the US.  

 Patent-infringement suits can be expected to increase, particularly as a large number of biosimilars (and biobetters and biogenerics) approach filing in the US and other major markets. Major test cases, such as 

Classen Immunotherapies versus Biogen Idec

, involve whether business methods patents include coverage of methods for determining the optimal dose of a therapeutic. Biopharmaceutical companies may soon need to consider yet another type of patent, in addition to those for composition-of-matter (e.g., sequences), formulations, uses, bioprocessing, and reference standards.    

The bio/pharmaceutical industry is emerging from the current global economic situation into 2012 with a positive outlook. The industry is spending more, becoming more efficient, and, perhaps most importantly, expressing great optimism. With sales growth of between 14 and 18% this year, we will likely continue to see additional spending in new technology, capital equipment, and hiring.  

 is president of BioPlan Associates, tel. 301.921.5979, 

8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production:  A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations

Top 1000 Global Biopharmaceutical Facilities Index

 Biopharmaceutical Products in the US and European Markets 

www.bioplanassociates.com/publications/pub_bpuseu.htm

FDA Biopharmaceutical Product Approvals and Trends, 

Articles

Outsourcing

Industry optimism is on the rise for 2012.

Biomanufacturing Outlook

 As the industry gathers this month for DCAT Week, an annual event featuring educational programs and networking opportunities for sourcing, procurement, and pharmaceutical supply-chain professionals organized by the Drug, Chemical, and Associated Technologies Association (DCAT), Patricia Van Arnum, executive editor of 

 spoke with DCAT President Joan Connolly and principal at Connovan Consulting. Connolly became president of DCAT in November 2011 and discusses key industry trends affecting pharmaceutical companies and their suppliers and the association’s focus and activities for 2012. Also, for additional insight from Joan Connolly, listen to our 

: In your capacity as DCAT president, the  trends affecting the pharmaceutical/biopharmaceutical industry and supply-chain issues  are of great importance to your member companies. What are most pressing issues affecting the pharmaceutical/biopharmaceutical industry as a whole and specifically for procurement/sourcing professionals?

 Our industry is facing significant change and constant pressure to do more, often with declining resources. A recent survey by PharmaIQ showed that 44% of employees in the pharmaceutical industry are concerned about layoffs, which may be a reasonable fear given the scale and frequency of layoff announcements in the industry. For procurement professionals, this often translates to demand for outsourcing more materials and activities as in-house resources are reduced or eliminated, but it can also increase the complexity of their role as they must now leverage external knowledge with less support from in-house technical experts. Of course, the quality and security of the drugs they support can never be compromised, so it is critical that sourcing professionals stay abreast of new regulatory developments and quality initiatives even while potentially managing a higher workload. 

In addition to declining resources, the industry is struggling to improve R&D efficiency, both to increase the probability of success in delivering new therapeutic options to patients and to reduce the overall cost of developing these therapies.  In today’s world, no organization can expect to have total knowledge within their own four walls and needs to leverage breakthrough technologies and intellectual capacity at external organizations, which could be around the block or around the globe.  For the procurement professional, this can require a different level of engagement, in a role that facilitates open dialogue and true collaboration while still respecting the intellectual property of all involved. 

Another challenge for the industry is the greater focus on pharmcoeconomics and how that is changing the way new products are evaluated and introduced to the market. Globally, governments and insurers are looking for a much greater return for their healthcare dollar, and this situation is translating to a greater emphasis on patient-targeting tools or personalized medicine. In addition to generating broad safety and efficacy data during clinical evaluations, our member companies are becoming more focused on companion diagnostics that can be approved prior to or in conjunction with a new therapy, so that physicians are able to more accurately select which patient will respond to which drug. While this can translate into a smaller market/lower demand for an individual new drug, there is a significant benefit for patients to limit exposure to drugs that would not be expected to work for their genotype. Because of an enhanced efficacy rate for patients with the correct genetic marker(s), I believe we will see more ‘kit’ launches in the future, where the companion diagnostic becomes an integral part of a successful product launch. While this challenge can be daunting from a sourcing and logistics perspective, the patient benefit is significant, so as an industry, we must deliver innovation for better health solutions as opposed to just better medicines.

 Supply-chain security and product integrity are obviously key issues for sourcing, procurement and supply-chain professionals. What specific challenges do you think sourcing and procurement professionals are facing in this area, particularly in the sourcing of raw materials and other ingredients in the pharmaceutical supply chain?  What would you identify as key initiatives/programs on an industry level that are helping to resolve some of these challenges?

 Sourcing and procurement professionals are always challenged to balance risk and reward, and that includes a clear understanding of the security of their supply chain. I think a key to this is simply knowing your supplier and not just relying on remote communications and document review, but physically seeing the manufacturing site and building a relationship with your supplier as a true business partner. In an era of compressed timelines and reduced travel budgets, it can be easy to forego a trip to a remote manufacturing location, but I think it is a mistake to select a manufacturer, regardless of a perceived cost advantage, if you are not prepared to put in the time and miles to foster a real understanding of its supply position and the overall value, including security, of its offering. 

Of course, even with the best knowledge of our suppliers, there is still a need for ongoing oversight of the supply chain itself to ensure that adulterated components can be identified and eliminated prior to use in downstream manufacturing and that misbranded products do not enter legitimate distribution chains outside of our control. The efforts of industry consortia, such as RX-360, can be instrumental in identifying vulnerable supply points, and growing collaboration between health authorities (such as he Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme [PIC/S], which FDA recently joined) also help by developing common global standards for auditing that will allow for more information-sharing between agencies, who are dealing with their own resource constraints. Track-and-trace technologies also are evolving, and while not a cure-all, can be an important tool to enhance supply chain security. DCAT is delighted to be hosting Thomas Christl, the new leader of the Office of Supply Chain Security from FDA, to our Supply Chain Security program during DCAT Week. Lt. Christl will highlight specific agency recommendations and requirements, and we hope the program will foster dialogue between FDA and our member companies to jointly address supply-chain risks. The discussion will then continue at DCAT’s annual Sourcing Summit in July, where a panel of industry experts will share their concerns and evolving solutions to secure the pharmaceutical supply chain. This is another area of significant challenge for our industry, but the public-health risk demands that we work together and in partnership with regulatory authorities to ensure that patients can trust in the quality and integrity of the drugs we provide.

: What would you identify as key accomplishments for DCAT in 2011 in terms of member services, member activities, educational programs, and membership enlargement? How many new member companies did the association add in 2011?

DCAT added 48 new member companies in 2011, and we continue to grow with an additional 65 new member companies having joined in 2012. We also increased participation levels at many DCAT educational and networking events in 2011 despite ongoing industry consolidation and continuing challenges in the broad economy. DCAT events offer a unique opportunity for our members to establish new connections and build on existing relationships to drive their business forward in a highly efficient and controlled environment, and we believe that the rising participation levels at these events are the best evidence that they represent a valuable service offering to our members.

We also continue to grow the DCAT Week attendance and engagement levels every year, and last year welcomed 1750 guests to our annual ainner at the Waldorf-Astoria. Because so many of our members now stay in New York for essentially the full week, we added a new members reception earlier in the week that generated a great response last year, and we are expecting even greater participation this year. A new DCAT Week mobile app was launched in 2011 to assist our members in getting the most out of the week both in terms of participating in the many educational programs and in helping to facilitate direct member-to-member interaction. The feedback was terrific, so we hope to build on the success of the app by broadening our virtual presence and should be able to share some of those developments in the months ahead. 

The organization also is are very interested in supporting science-education initiatives to help build the next generation of scientists and engineers that will drive our industry forward. To further this goal, last year we partnered with the National Lab Network, enabling our members to support the Goggles & Gloves campaign with donations of safety equipment to more than 100 high school classrooms.This program enables higher levels of participation in the hands-on experimentation that we hope will ignite more interest in the study of science and engineering at the university level. We also provided grants to high school science teachers who were recognized by their peers at the National Science Teacher’s Association (NSTA) as developing truly innovative and exciting approaches to science learning. The NSTA grants are supported by member fundraising through an annual charity golf tournament—last year held at the fantastic Jasna Polana course in Princeton.So in addition to supporting a great cause, it was a great time for all attendees.

Looking ahead to 2012, can you outline the association’s key goals and related activities to serve those goals?

: The purpose of the DCAT organization is to facilitate business development and foster learning among our member community. While we always see tremendous member engagement and participation during DCAT Week itself, our direct interaction with membership can wane somewhat outside of that event. We often find that our members would like to continue their discussions around topics raised during our educational programs, but simply run out of time during the event itself. A key strategic initiative for 2012 is to help harness the energy of our members and provide greater interaction outside of DCAT Week and our other “live” events and programs. To that end, we are evaluating tools to allow broader collaboration throughout the year and to foster ongoing dialogue on some of the key discussion topics broached during our “in person” events. We hope to have more information to share with our members in the coming months.

DCAT is a very special brand. We strive to offer a premier experience, but as a not-for-profit organization, we are also always cognizant of spending our membership dollars wisely and targeting our education investments in areas of strategic importance to member companies. We are very fortunate to have a strong cadre of industry volunteers on our standing Education Committee and Supply Management Committee and can also draw on the collective knowledge of our board of directors and other key association supporters whose industry knowledge and experience helps us deliver exceptional programming. So another of our key initiatives for 2012 is to ensure we leverage that deep industry knowledge to focus our programming in areas that will be most impactful to our members’ businesses. Many of our educational programs this year are focused directly on the key challenges our member companies are facing and which we earlier discussed. And many of our members are participating directly in the programming, so they have an intimate understanding of the challenges and are able to share real-life strategies and solutions in a way that is often not found in ‘for profit’ educational programs.

Of course, we always look for ways to expand our membership as well, to broaden the network of suppliers and buyers within our association. While DCAT has long been engaged with traditional pharmaceutical companies and suppliers and has grown our network within the biopharmaceutical space in recent years, we recognize that many of the newer virtual pharmaceutical companies may not be aware of the benefits of DCAT membership. For companies who do not want to build their own manufacturing capacity, DCAT offers the perfect platform to identify and connect with potential manufacturing partners, and we will be looking for ways to expand our reach to this segment of the industry in the coming years. 

: Can you explain the organizational structure of DCAT, related committees and their functions, and how they advance the goals of the organization?

: DCAT is a member-supported and member-run organization, meaning that our leadership is elected by all of our member companies, and that all members of the Executive Committee are employees of member companies.We also attempt to provide balance on the Executive to ensure that companies from both the buy and sell side of the industry and the generic and brand side of the business are represented. This helps us ensure that our leadership is able to represent the needs of all our member companies. This leadership team sets the strategy and priorities for the organization and is also responsible for overseeing the organizations finances. Fortunately, we are blessed with a highly capable Executive Director, in Margaret Timony, and a small but strong staff, who manage the organization on a day-to-day basis and always deliver such exceptional quality in our events. 

We also have a very committed group of volunteers who support the execution of DCAT strategy and initiatives by participating in standing and ad hoc committees.Standing committees include the following:

• The Education Committee focuses on identifying the educational needs of our members and delivering excellent educational programs to address those needs.
 • The Membership Committee

reaches out to qualified companies within the biopharmaceutical industry to encourage and support their application for membership.
 • The Member Services Committee helps to assess the needs of our members and deliver programs or tools to address those needs, to enhance the DCAT value proposition, and to encourage member recruitment and retention.
 • The Science Education Scholarship Committee identifies the needs of today’s students and educators in the sciences and provides assistance through a variety of organizational projects, grants, and member support.
 • The Scholarship Funding Committee is responsible for organizing, promoting, and growing participation in events that increase awareness of and generate funds for DCAT Scholarship initiatives.
 • The Supply Management Committee, made of up volunteers from the buy-side of our member community and  who deliver the Sourcing Summit program every year, specifically addresses sourcing challenges and trends.

Would you like to explain the educational programming at DCAT Week this year, which is being held Mar. 12 to 15? 

 Our programs are very diverse, and are meant to offer valuable and timely educational content as well as provide an opportunity for our members to interact with and brainstorm with their peers in the industry. Our Education Committee delivers most of the programming during DCAT week and selects topics based on key trends and issues in the industry, including some of those earlier discussed. We also will accept proposals from members who want to take advantage of the critical mass of thought leaders who attend DCAT week to address issues that have broad impact across the industry. Such was the case this year with the Supply Chain Security program, driven largely by Marty van Trieste of Amgen.

For a detailed view of the programs on offer, I would suggest that your readers go to our website, 

 but at a high level, in addition to the Supply Chain Security program mentioned above, the topics include:

Successfully Partnering Pharmaceutical Manufacturing Throughout the Product Lifecycle

, which is focused on the impact manufacturing can have on licensing valuation and success at different stages of development

which this year is focused on orphan drugs and niche products and their specific challenges for manufacturing and launch

• Excipient Supply—Managing the Cost Without Impacting the Quality,

 which is an area of increasing focus across the industry, particularly with recent incidents around drug safety that have related directly to excipient inputs

High-Potency Manufacturing Technologies to Support Today’s Innovative Pharmaceuticals

, which will review some of the technologies available to support manufacture of new targeted therapies

Generic Drug User Fees Act: Government and Industry Perspectives

, which will discuss implications of the new pay-to-play system for both generics companies and their suppliers

• Biologics Forum Understanding the Practical Complexity of the Biopharmaceutical Landscape,

 which will discuss investment drivers in the biologics-based drug industry and the latest on the regulatory pathway for biosimilars.

In conclusion, we talked a lot about the challenges that the industry faces, so I would just like to end by saying that despite these challenges, I wouldn’t want to work in any other industry. We come to work every day to help solve critical health challenges, and the therapies we develop, manufacture, and distribute really impact and improve the lives of patients. While there remains much to be done, I am confident that my colleagues in the industry are up to the challenge, and will continue to deliver innovations that improve and extend people’s lives. I will look forward to seeing many of them at the upcoming DCAT Week—where business gets done.

For additional insight from Joan Connolly, listen to our 

APIs

Joan Connolly, president of the Drug, Chemical, and Associated Technologies Association (DCAT) and principal at Connovan Consulting, examines the key issues affecting sourcing, procurement, and the pharmaceutical supply chain.

DCAT President Discusses Supply-Chain Challenges and Trends

 launched the “Amgen Science Teacher Training Initiative” in France, Germany, Ireland,  and Poland. The Amgen Science Teacher Training Initiative provides professional development for secondary school science teachers to help them incorporate hands-on inquiry-based science education in their classrooms. The initiative will focus on those teaching science, principally biology and chemistry, to students aged 12 to 18. 

Schwartz Center for Compassionate Healthcare, 

 a Boston-based nonprofit dedicated to strengthening the relationship between patients and their healthcare providers, has received a $500,000 grant from the 

 This grant will go toward the planned expansion of Schwartz Center Rounds and to support the launch of a National Consensus Project.  The Schwartz Center Rounds allow caregivers from multiple disciplines to come together on a regular basis to discuss the most challenging emotional and social issues they face in caring for patients. The National Consensus Project will convene a broad range of stakeholders to define compassionate care, develop best practices to ensure that this type of care is provided, and develop a plan to implement these core principles and best practices. 

 has established new environmental, health, and safety goals. The company wants to increase its energy efficiency worldwide by 35% by 2020, compared to its previous goal of 25%. The company also aims to reduce greenhouse-gas emissions per ton of sales product by 40%, originally set at 25%. By 2020, the company plans to cut in half the current amount of drinking water it uses for production compared to 2010. It also intends to establish sustainable water-management systems at all production sites in areas of water stress. Within the area of occupational health, BASF will measure its performance with a new, expanded indicator, the “Health Performance Index.” The index comprises five criteria: reported cases of occupational diseases, medical-emergency planning, first aid, preventive medicine, and health promotion 

 announced $7.7 million in funding for 10 new grants to identify biomarkers for diagnosing tuberculosis (TB) in low-resource settings. This new grant program, Biomarkers for the Diagnosis of Tuberculosis, supports innovative research into TB biomarkers to facilitate the development of a low-cost, simple-to-use tool that can quickly and accurately diagnose TB in developing countries. The biomarkers program is part of the Gates Foundation’s Grand Challenges in Global Health initiative, which seeks to overcome bottlenecks in creating new tools to  improve health in the developing world. The Gates Foundation is partnering on this program with the Foundation for Innovative New Diagnostics, which will help monitor the grant portfolio and supply clinical TB samples from developing countries, and the Canadian Institutes of Health Research, which is co-funding one of the grants. 

has released its corporate responsibility report using the Global Reporting Initiative framework, which is designed to help companies report on economic, environmental, and social performance. Included in the report are highlights indicating that Lilly:

•	Helped more than 227,000 people through its patient-assistance programs in 2010, a 12% increase compared to the previous year

•	Launched a physician-payment registry to help people better understand how the company works with doctors to advance research and education 

•	Introduced 229 new clinical-trial sites in US locations with diverse populations since 2008 

•	Gave approximately $430 million in global charitable contributions in 2010, including cash, products, and other in-kind donations

•	Invested its largest-ever education-focused grant ($2.5 million) in a campaign sponsored by The Mind Trust to improve public education for underserved children 

•	Launched a new five-year, $60 million commitments through The Lilly NCD Partnership and The Lilly MDR–TB Partnership to improve outcomes for underserved populations

•	Selected 200 employees to volunteer, on company time, in countries where people lack resources or access to quality healthcare

•	Decreased water intake by more than 30%  and waste to landfill by 50% compared to 2007

•	Improved energy efficiency by more than 12%, compared to 2007, and reduced corresponding greenhouse-gas emissions by more than 9%. 

 has pledged $100,000 to the American Red Cross for its tornado-disaster relief efforts. The donation will support families and communities affected by tornadoes that struck Indiana, Kentucky, Ohio, Alabama, and Georgia on March 2, 2012. In addition, through its matching gifts program, the Lilly Foundation will provide a 1:1 match of employee donations to the American Red Cross and the Salvation Army. 

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) 

 has announced an expansion of its Code of Practice to govern how companies interact with healthcare professionals, medical institutions, and patient organizations. Beyond addressing interactions, the Code now also includes high-level guiding principles for practice, a requirement for member companies to train all employees, a clear distinction between gifts, promotional aids, and items of medical utility, guidance for supporting continuing medical education, a provision on disclosure of clinical-trials information, and guidance for filing complaints. The Code continues to prohibit preapproval promotional activities for pharmaceutical products, company-sponsored entertainment at events, and providing or offering personal gifts to healthcare professionals. 

 has received the 2012 Energy Start Sustained Excellence Award from the US Environmental Protection Agency (EPA) for its continued improvement of energy performance and leadership in energy management in both the pharmaceutical and industrial sectors. Merck has been an Energy Star partner since 1995 and has been recognized by EPA for seven consecutive years,  twice as Partner of the Year and now a fifth time for Sustained Excellence. The 2012 Energy Sustained Excellence Award recognizes the accomplishments of Merck's energy-management program, including Energy Star designations earned for six manufacturing sites and three large corporate office buildings, including two at the company's headquarters campus and one building with a major data center. These efforts at the company's sites are part of a broader effort to reduce energy use and greenhouse-gas emissions. Merck has a greenhouse-gas reduction goal of 10% by 2015 from a 2009 baseline, reflecting the integration of the merger of Schering-Plough and Merck in November 2009 into one business entity. 

 with support from Merck & Co. launched the "Call My Name" national tour to help bring attention to the AIDS epidemic in African American communities in the United States through quilt-making and educational workshops. The NAMES Project Foundation is the international, nongovernmental organization that is the custodian of the AIDS Memorial Quilt and its associated document and media archive. The tour kicked off on Feb. 11, 2012 and will visit 10 US cities. 

 report that the world has met the UN Millennium Development Goal (MDG) target of halving the proportion of people without sustainable access to safe drinking water, well in advance of the MDG 2015 deadline, according to a report issued by UNICEF and WHO. Between 1990 and 2010, over two billion people gained access to improved drinking water sources, such as piped supplies and protected wells. At the end of 2010, 89% of the world’s population, or 6.1 billion people, used improved drinking water sources. This is 1% more than the 88% MDG target. A WHO-UNICEF report estimates that by 2015, 92% of the global population will have access to improved drinking water. 

In other news, a small group of global public health and influenza experts at a WHO-convened meeting reached consensus on two issues related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research with new laboratory-modified H5N1 viruses and recognition that research on naturally occurring H5N1 influenza virus must continue to protect public health. WHO convened the meeting as a first step to facilitate the discussion of differing opinions that have arisen in recent months after two research groups, one in the Netherlands and the other based in the United States, have created versions of the H5N1 influenza virus which are more transmissible in mammals than the H5N1 virus that occurs naturally. The experts at the meeting included lead researchers of the two studies, scientific journals interested in publishing the research, funders of the research, countries who provided the viruses, bioethicists and directors from several WHO collaborating-center laboratories specializing in influenza. 

, the philanthropic arm of the laboratory supply and distribution company, 

 raised $75,000 in an auction on Jan. 16, 2012, to benefit Children's National Medical Center of Washington D.C. 

CSR and Sustainability Forum

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

CSR and Sustainability in the News

In late January, 13 pharmaceutical companies, the governments of the United States, the United Kingdom, and the United Arab Emirates, the Bill & Melinda Gates Foundation, the World Bank, and other global health organizations announced a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade. An 

of pharmaceutical companies’ pledges was announced by the International Federation of Pharmaceutical Manufacturers and Associations in late January 2012. Other groups and pharmaceutical companies have further detailed public, private, and public–private efforts in combating NTD following a meeting in late January at the Royal College of Physicians in London. 

In a large, coordinated effort  to combat NTDs, the groups said that they would sustain or expand existing drug-donation programs to meet demand through 2020, share expertise and compounds to accelerate R&D of new drugs, and provide more than $785 million to support R&D efforts and strengthen drug-distribution and implementation programs. Partners also endorsed the “London Declaration on Neglected Tropical Diseases,” in which they pledged new levels of collaborative effort and tracking of progress. 

“Inspired by the World Health Organization’s 2020 Roadmap on NTDs, we believe there is a tremendous opportunity to control or eliminate at least 10 of these devastating diseases by the end of the decade,” said the London Declaration. “But no one company, organization or government can do it alone. With the right commitment, coordination and collaboration, the public and private sectors will work together to enable the more than a billion people suffering from NTDs to lead healthier and more productive lives, helping the world’s poorest build self-sufficiency.” The declaration was signed by Abbott, AstraZeneca, Bayer, Becton Dickinson, the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, the Children’s Investment Fund Foundation (CIFF), the Department for International Development (DFID) (a department of the British government), the Drugs for Neglected Diseases Initiative (DNDi), Eisai, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, the Lions Club International, Merck KGaA, Merck & Co., Mundo Sando, Novartis, Pfizer, Sanofi, the United States Agency for International Development (USAID), and the World Bank. 

These partners committed to the following: 

 • Sustain, expand, and extend programs that ensure the necessary supply of drugs and other interventions to help eradicate Guinea worm disease and help eliminate by 2020 lymphatic filariasis, leprosy, sleeping sickness (human African trypanosomiasis),  and blinding trachoma

• Sustain, expand, and extend drug-access programs to ensure the necessary supply of drugs and other interventions to help control by 2020 schistosomiasis, soil-transmitted helminthes, Chagas disease, visceral leishmaniasis, and river blindness (onchocerciasis) 

• Advance R&D through partnerships and provision of funding to find next- generation treatments and interventions for neglected diseases 

• Enhance collaboration and coordination on NTDs at national and international levels through public and private multilateral organizations 

• Enable adequate funding with endemic countries to implement NTD programs necessary to achieve these goals, supported by strong and committed health systems at the national level 

• Provide technical support, tools, and resources to support NTD-endemic countries to evaluate and monitor NTD programs 

• Provide regular updates on the progress in reaching the 2020 goals and identify remaining gaps. 

“Today, we have joined together to increase the impact of our investments and build on the tremendous progress made to date,” said Bill Gates, cochair of the Bill & Melinda Gates Foundation, in a Jan. 2012, press release. “This innovative approach must serve as a model for solving other global development challenges and will help millions of people build self-sufficiency and overcome the need for aid.” The Gates Foundation announced a five-year, $363 million commitment to support NTD product and operational research. 

 To guide the effort against NTDs, WHO unveiled a new strategy, 

Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases—A Roadmap for Implementation,

 which sets targets for what can be achieved by the end of the decade. “The efforts of WHO, researchers, partners, and the contributions of industry have changed the face of NTDs,” said WHO Director-General Dr. Margaret Chan, in the release. “These ancient diseases are now being brought to their knees with stunning speed. With the boost to this momentum being made today, I am confident almost all of these diseases can be eliminated or controlled by the end of this decade.” 

Speaking on behalf of the CEOs of the 13 pharmaceutical companies involved, Andrew Witty, CEO of GlaxoSmithKline, said, “Many companies and organizations have worked for decades to fight these horrific diseases. But no one company or organization can do it alone. Today, we pledge to work hand-in-hand to revolutionize the way we fight these diseases now and in the future,” he said in the release. With new and existing pledges totaled, companies will donate an average of 1.4 billion treatments each year to those in need, according to IFPMA. In addition, new R&D collaborative efforts and access agreements with 11 companies and the R&D organization DNDi are providing access to compound libraries. Other research tools include access to WIPO Re:Search, a database of research compounds, knowledge and expertise. 

To close the funding gap for Guinea worm eradication, Sheikh Khalifa bin Zayed Al Nahyan, president of the United Arab Emirates, the Gates Foundation, and CIFF are donating  $40 million to the Carter Center. These commitments complement an October pledge from the DFID that it would contribute £20 million ($31 million) if others come forward—part of a four-year, £195 million ($307 million) commitment to NTDs announced by DFID. 

USAID also announced an $890million appropriation by the US Congress to strengthen drug-delivery and distribution programs, building on its $212 million investment since 2006. In addition, the World Bank will extend its financing and technical support to help African countries build stronger community-health systems that will integrate NTD elimination and control, as well as work with other partners to expand a trust fund to combat river blindness to other preventable NTDs in Africa. The governments of Bangladesh, Brazil, Mozambique, and Tanzania, where NTDs are endemic, announced that they would implement integrated plans to defeat NTDs and devote political and financial resources to combat these diseases. All partners pledged accountability by exploring mechanisms to regularly track progress toward the 2020 goals. 

All companies with NTD drug-donation programs pledged to sustain or extend their programs to the end of the decade, and some pledged to increase their commitments. These commitments include the following: 

 • Sanofi, Eisai, and the Bill & Melinda Gates Foundation will work together to provide 120 million diethylcarbamazine tablets to WHO for its Global Lymphatic Filariasis Elimination program. Combined with Eisai’s donation commitment that will start in 2014, these new tablets will ensure a sufficient supply of diethylcarbamazine from 2012 through 2020. 

• Bayer will double its existing donation of nifurtimox to treat Chagas disease.

• Eisai will extend its existing donation of 2.2 billion tablets of diethylcarbamazine for lymphatic filariasis to 2020. 

• Gilead, which announced a donation of AmBisome for visceral leishmaniasis in2011, will continue its program at cost and commit to investigate and invest in technologies and processes that could reduce that cost in resource-limited countries. 

• GlaxoSmithKline will extend its existing donation of albendazole to treat soil- transmitted helminthes by providing 400 million tablets per year for an additional five years to 2020, as well as continuing its donation of 600 million tablets per year to combat lymphatic filariasis. 

• Johnson & Johnson will extend its existing donation of mebendazole for soil- transmitted helminthes by providing 200 million tablets per year to 2020. 

• Merck & Co. will continue its unlimited donation of ivermectin to combat river blindness and lymphatic filariasis (where co-endemic with river blindness), as well as discuss the use of ivermectin to combat other diseases. 

• Merck KGaA will significantly increase its annual donation of praziquantel tablets from 25 million to 250 million tablets per year, extending the program indefinitely.

• Novartis will extend its commitment to provide multidrug therapy (rifampicin, clofazimine and dapsone) to leprosy patients worldwide. 

• Pfizer will continue its donation of azithromycin for blinding trachoma until at least 2020, as well as donate the drug and placebo to a study on the reduction in mortality of children treated with azithromycin. 

• Sanofi will extend its existing donation of eflornithine, melarsoprol, and pentamidine for sleeping sickness to 2020, as well as provide logistical support to ensure that the drugs continue to reach patients at the point of care cost-free. 

Product-development partnerships under the coordination of DNDi with Abbott, Johnson & Johnson, and Pfizer are underway to develop new drugs to treat helminth infections, notably a macrofilaricide, which kills adult worms that cause river blindness and lymphatic filariasis. Abbott is conducting initial drug reformulation studies and providing scientific expertise for preclinical development with technical and supply assistance from Johnson & Johnson. If preclinical development is successful, Johnson & Johnson will cofund clinical development and collaborate with other partners, including technical support from Pfizer’s staff scientists. Johnson & Johnson would obtain regulatory approval. 

Additionally, innovative licensing or collaboration agreements with DNDi by 11 companies (Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, GlaxoSmithKline, Johnson & Johnson, MSD, Novartis, Pfizer,and Sanofi)—are in negotiation or underway for the sharing of compounds and knowledge  to generate new drugs for diseases including river blindness, lymphatic filariasis, sleeping sickness, Chagas disease, and visceral leishmaniasis, according to the release. For example, DNDi and Sanofi announced a product-development collaboration to codevelop a new drug candidate for sleeping sickness, oxaborole/SCYX-7158, in addition to fexinidazole, which is already in clinical development. 

Several major pharmaceutical companies detail their contributions for combating neglected tropical diseases.

Examining Project Work for Neglected Tropical Diseases

Contract API manufacturers and fine-chemical producers assembled in New Orleans last month for Informex, an annual trade show for custom and batch manufacturers, which was held Feb. 14–17. Below is a roundup of news from exhibitors, including an 

 with the organizers of Informex on this year’s show. 

has opened a new purpose-built $4.6-million high-potency manufacturing facility for the manufacture of formulated products and plans to upgrade its API manufacturing facilities to enabling manufacture of high-potency APIs at commercial scale. The upgrade will allow Aesica to manufacture SafeBridge Category 3 APIs and formulated products from pilot to commercial scale from two of its sites in Europe. The new facilities will enable Aesica to successfully manage high-potency API production at quantities from 1 kg to 200 kg. Further investment in API manufacturing capability in 2013 will equip Aesica to produce batch sizes up to 600 kg.

 is doubling its analytical capacity at its 240,000-ft

 North American headquarters in Souderton, Pennsylvania. The facility offers full-service, integrated clinical packaging, drug-supply management, and technology services to pharmaceutical and biotechnology clients. Almac’s additional laboratory investment will include polymorph and salt screening and solid-form development. The new facility is also equipped with a bathless dissolution apparatus for comparative dissolution studies.

In other news, Almac also has acquired two new pieces of encapsulation equipment for its North American headquarters in Souderton, Pennsylvania: the Bosch GKF 702 capsule filler with integrated KKE 1700 checkweigher. The Bosch cGMP-compliant system is able to produce 42,000 capsules per hour compared to the 2,700-4,500 output of Almac’s current machine in the United States. Further capabilities of the new equipment include powder, pellet, tablet, and placebo fill as well as multifill.

Laboratories (Tianjin) reported on the opening its new large-scale manufacturing facility, Jilin Asymchem Laboratories, in Dunhua, Jilin province, China.  Phase I completion of Dunhua’s manufacturing facility included 5000–20,000 L vessels for cGMP manufacture of raw materials to intermediates. Phase II involved completion of a second module for a total capacity of 532 m

. This site offers manufacturing as a standalone service and also back-integration for internal downstream cGMP targets to be further processed in Asymchem’s Tianjin 2 GMP facility. Phase III construction in Dunhua for a GMP API manufacturing plant is on schedule and is expected to be completed later this year. 

 has opened an industrial biotechnology and microbiology research center in Tarrytown, New York. The company uses biotechnological methods to produce products such as vitamins, enzymes, pharmaceutical intermediates, and specialties for the personal care, food and feed industries. One focus of the research laboratory work is to develop even more efficient and resource-conserving production processes. The use of metabolic engineering, or the targeted modification of metabolism, is used to enhance the efficiency of the microorganisms used in these production processes. The laboratory will also be used to develop bacterial biofilms. 

 reported in February 2012 that its Bubendorf, Switzerland, API manufacturing site had successfully an FDA cGMP inspection. The inspection was completed in September 2011. The Bubendorf site supports 160 employees and is focused on process optimization and supply of late-phase and commercial APIs and highly potent APIs. 

 has completed the acquisition of the clinical-trial supplies business of Aptuit. The transaction was previously announced in August 2011. 

 CEO Alan Shaw has resigned from the company to pursue other interests. Peter Strumph, head of the firm’s pharmaceuticals business, was named interim CEO as the company searches for a new CEO. 

, a developer of connectors, is further enhancing its DrumQuik PRO and DrumQuik PUR chemical-dispensing systems with the addition of a new tethered protective dust cover and extended shipping plug. In addition to storing and protecting the DrumQuik coupler for extended use, the tethered cover provides a place to store the drum-insert shipping plug when the coupler is connected. 

reported on InnoSyn, a route-scouting service that supports R&D as well as implementation of economical and scalable routes. The service offering includes consulting, route scouting, biocatalyst/catalyst screening, prefeasibility studies, full feasibility studies, mini-plant campaigns, and support in transfer and implementation. Various technical packages are provided for biocatalysis, homogeneous catalysis, organic chemistry and process R&D and continuous chemistry (i.e., microreactor technology). 

 recently introduced a new synthetic method for carbon-carbon bond formation as it detailed in a new brochure, "Silicon-Based Cross-Coupling Reagents." The brochure contains more than 160 references, including reviews on the formation of biaryl, styrene, diene, triene, aryl acetylene, diaryl acetylene, pyridine and enyne derivatives and Heck coupling/cross-couping cascade reaction sequences. 

reported on its cytotoxic and high-potency manufacturing facilities in Biasca, Switzerland and multiyear expansion in this area. The company’s capabilities include pilot-scale, small-scale, and commercial-scale capabilities for manufacturing highly potent APIs. It cytotoxic capabilities include isolated and dedicated cytotoxic quality control and R&D laboratories, raw-materials and finished-goods warehousing, and finishing and sampling areas. A new laboratory has been constructed exclusively for small-scale cytotoxic production, design of experiment, and initial process development. The company also has pilot-scale, small-scale, and commercial-scale capabilities for manufacturing cytotoxic small molecules.

will be held Feb. 19–22, 2013, in Anaheim, California. Highlights of the 2012 installment of Informex are discussed in a 

 have formed a partnership to manufacture Eclipse’s cancer therapeutic antibody, ET-101. Lonza will produce Phase I clinical material at its facility in Slough, England.

, a contract manufacturer of APIs, intermediates, and peptides, launched a new mobile app version of its GuarD project-management system. GuarD was developed to support customers’ participation in project planning and real-time tracking. GuarD uses the principles of critical-chain project management, which emphasizes resource availability and flexibility to maintain project timelines. GuarD allows for a detailed project plan that is viewable in an online template to provide a customer progress of its project, information on the latest task updates, expected time of completion, and other information important to the project. 

 has commenced construction of its new 24,000-ft 

 cGMP aseptic fill–finish manufacturing facility in Hunt Valley, Maryland. Targeted for completion in the fourth quarter 2012, the new facility will more than double the company’s current sterile GMP manufacture capacity. Fill–finish suites will include automated vial- and syringe-filling, inspection and labeling equipment capable of producing batch sizes of 100,000 plus units. The facility expansion follows the company’s recent FDA pre-approval inspection, which allows the company to commercially manufacture an aseptic vial in its existing Hunt Valley aseptic facility. 

 reported on its recent $350-million acquisition of BioReliance, a provider of global biopharmaceutical testing services, from Avista Capital Partners. BioReliance provides biologic, specialized toxicology and animal health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life-science companies. BioReliance employs more than 650 people and is headquartered in Rockville, Maryland, with additional operations in Glasgow and Stirling, Scotland, and sales offices in Tokyo, Japan, and Bangalore, India. The acquisition complements SAFC’s industrial media position, and its CompoZr zinc finger nuclease technology is synergistic with BioReliance's toxicology and animal-health services operations for the development of new assays, cell lines, and animal models, according to the company.

, part of Lanxess, appointed Joerg Scheider to assume management of the agrochemical and fine chemicals business line at Saltigo, effective Feb. 1, 2012. He was previously managing director of Lanxess Elastomeros do Brasil. 

Society of Chemical Manufacturers and Affiliates

 reported that several new companies joined the Bulk Pharmaceutical Task Force (BPTF), an affiliate of SOCMA in 2011. SOCMA is the trade association representing custom and batch manufacturers, including contract manufacturers of APIs and fine-chemical producers. Joining BPTF were Ampac Fine Chemicals, Cambridge Major Laboratories, DSM, Evonik, Hovione, and Polypeptide Laboratories. Created in 2002, BPTF’s primary focus is drug-ingredient quality issues, such as cGMPs and drug supply-chain safety. 

Also, in the fourth quarter of 2011, six new member companies joined SOCMA. These companies were BioChemInsights, a provider of databases of life-sciences molecules; Cardno, an environmental consulting firm; Heritage Environmental Services, another environmental firm; Inventys, a provider of organic chemicals for the pharmaceutical and agrochemical sectors; Pharmatek Laboratories, a pharmaceutical-chemistry firm, including a provider of highly potent compounds; and SARmont, a provider of medicinal chemistry and lead-optimization services. 

 reported on their partnership for custom research and manufacturing services, which was announced in October 2011. The preferred but nonexclusive partnership provides services from route scouting to commercial manufacturing. Solvias brings expertise in chemical, analytical and solid-state development, and RohnerChem brings experience in scale-up and commercial-scale custom synthesis of complex, small-molecule fine chemicals and APIs. Key capabilities from Solvias include high-throughput screening methods, which have been used in asymmetric homogeneous catalysis, CX-couplings, racemate resolutions, carbonylations, hydroformylations, biocatalysis development, and various other transformations. Solvias’ solid-state development group also is equipped to assist in developing crystallization processes, perform polymorphism studies, and provide guidance in the development of the best solid form for an API. After process optimization, which can be performed either at Solvias’ or at RohnerChem’s kilo laboratories, commercial quantities can be manufactured at RohnerChem facilities. 

Contract Manufacturing

The latest developments from contract API manufacturers and fine-chemical suppliers from Informex, held in New Orleans last month.

PTSM: Pharmaceutical Technology Sourcing and Management-03-07-2012

Biomanufacturing Outlook

DCAT President Discusses Supply-Chain Challenges and Trends

CSR and Sustainability in the News

Examining Project Work for Neglected Tropical Diseases

A Roundup of Informex