Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Patricia Van Arnum

Excipients play an important role in pharmaceutical formulations by adding functionality or facilitating the processing of a drug product. Several excipient manufacturers are planning or recently expanded production capacity, have made acquisitions, or have partnered to broaden their product portfolios and related service offerings. 

Ashland Specialty Ingredients recently added low-viscosity, pharmaceutical-grade polyvinyl pyrrolidone (PVP) capacity for its Plasdone excipients at its manufacturing facility in Calvert City, Kentucky. PVP is a synthetic polymer used as a tablet binder. Ashland currently produces PVP at its manufacturing facilities in Calvert City, Kentucky, and Texas City, Texas. 

In January 2012, Ashland also announced that it planned to expand production of Polyplasdone crosslinked polyvinylpyrrolidone (PVPP) at its manufacturing facility in Texas City. The company plans to complete the addition of a new PVPP production unit at the site by late 2013. Polyplasdone PVPP is a synthetic polymer used as a tablet disintegrant and drug-dissolution aid. The company says it expects steady growth in PVPP driven by an industry need for formulation ingredients that improve the dissolution of poorly soluble drugs and growth in emerging markets generated by increased demand for generic-drug products and consumer demographics. In August 2011, Ashland acquired International Specialty Products, an excipient producer and manufacturer of the Plasdone and Polyplasone products.  

In October 2011, Ashland Specialty Ingredients launched three new commercial grades of Benecel hypromellose (HPMC) excipients for the formulation of matrix tablets. These commercial grades (HPMC K250 PH PRM, HPMC K750 PH PRM, and HPMC K1500 PH PRM) of intermediate-molecular-weight polymers are designed to provide more predictable controlled-release profiles compared with blending legacy grades of HPMC. HPMC is used in hydrophilic matrix systems. Molecular weight plays a key role in dictating drug release, so formulators select specific molecular weight grades based on drug solubility and desired release profile, which often required blending different grades of HPMC. The new grades eliminate the need for such blending. 

Meanwhile, Univar formed an agreement with Dow Corning in March 2012 for the US distribution of its silicone-based products, including pharmaceutical excipients, process aids, and fluids for siliconization. The agreement includes the United States and Puerto Rico and is an extension of the companies' existing partnership in Canada. Univar will sell a range of Dow Corning branded products, including simethicones, dimethicones, medical antifoams, and specialty fluids. The products are used in a variety of end-use applications, formulations, and manufacturing processes. 

BASF launched a new packaging system, PeroXeal, last October, to protect its pharmaceutical excipient, Kollidon, which is based on polyvinylpyrrolidine, against contact with oxygen and subsequent oxidation. The system makes it possible to reduce the level of peroxide of Kollidon, thereby making the excipient suitable for use in oxygen-sensitive formulations. The PeroXeal packaging system consists of a multilayered and heat-sealed plastic film used as inner packaging material. The new packaging has been introduced for most Kollidon products at the company's Ludwigshafen and Minden, Germany, sites. BASF will offer all grades of the Kollidon line with the new technology starting by the end of 2013. 

Personalized dosing: the next outgrowth for personalized medicines			

Also in October, BASF and Colorcon formed a collaboration for the development of future film-coating systems using BASF's Kollicoat SmartSeal 30D and new Colorcon preformulated additives. Colorcon developed a preformulated additive system for use with Kollicoat SmartSeal 30D to enable efficient preparation and application of this polymer in taste-masking applications. The preformulated additive lowers the number of materials to be dispensed by 50% and reduces the preparation time by almost 40%, according to the companies.  

BASF launched Kollicoat Smartseal 30 D, an aqueous dispersion of a film-forming polymer with taste-masking and moisture-barrier applications in 2011. The excipient is highly impermeable to water vapor, which helps preserve the potency of sensitive active ingredients, according to the company. The polymer is stable in saliva and specifically soluble in gastric juice. These properties allow for effective protection from unpleasant taste in the patient's mouth and rapid release and onset of active ingredient action in the stomach. 

Also in 2011, Dow Polyglycols, Surfactants & Fluids, a business unit of Dow Chemical, announced it is expanding capacity for Carbowax Sentry solid-grade polyethylene glycols, which are used as pharmaceutical excipients, APIs (i.e., laxatives) and in personal-care products.  The company announced the expansion last October with the expansion slated to begin in 2012 to support global supply.  

In late 2010, the chemical company Celanese launched VitalDose, an ethylene vinyl acetate (EVA) polymer-based excipient for controlled-release pharmaceutical applications. The EVA-based excipients can be used in the design of transdermal, subcutaneous implant, and mucosal insert dosage forms.  

On the acquisition front, DMV–Fonterra Excipients GmbH & Co. KG, the 50–50 joint venture for pharmaceutical excipients between the Dutch dairy company Royal Friesland Campina and the New Zealand dairy company Fonterra, acquired the business and assets of Brahmar Cellulose Private Limited (BCPL) in 20011. The move positions the company in pharmaceutical microcrystalline cellulose and sodium carboxyl methylcellulose.  

Evonik completed the acquisition of SurModics Pharmaceuticals, a subsidiary of SurModics, in late 2011. The acquisition gives Evonik ownership of SurModics' parenteral dosage forms services and bioresorbable polymers business. The new business includes two facilities for the development and manufacturing of polymers and drug-delivery systems in Birmingham, Alabama. Formulation approaches used with the bioresorbable polymers include bioresorbable microparticles, nanoparticles, liposomes, implants, and other polymer-based configurations. Evonik is a producer of functional pharmaceutical excipients, which includes coatings and matrix systems for controlled release of APIs in tablets and other oral dosage forms through its Eudragit product line. In 2011, Evonik acquired the Resomer polymer business from Boehringer Ingelheim. These polymers are used for controlled release injectables, bioresorbable implants and medical devices. 

In May 2011, Avantor Performance Chemicals opened a new pharmaceutical formulation application laboratory in Sinnar Nashik, Maharashtra, India, with its partner RanQ Remedies. The new laboratory is used to characterize excipients, perform functional testing, develop and characterize drug formulations, and support customer applications and product implementation. In terms of excipients, RanQ has a position in microcrystalline cellulose and sodium starch glycolate and also has expertise in developing premixed and other application-focused pharmaceutical excipients that result in a homogenous mix and coprocessed excipients. 

In Ireland, FMC completed an expansion of its microcrystalline cellulose plant in Cork. Production from the final phase of the expansion began in March 2011 and increased FMC's global capacity by 25% for pharmaceutical- and food-grade microcrystalline cellulose. FMC operates another microcrystalline cellulose plant in Newark, Delaware. In March 2011, Grace Davison Discovery Sciences, part of W.R. Grace & Co., opened a new technical service knowledge center in Southern India for customers in the pharmaceutical and biotechnology industries. 

Excipients also are an important area for regulation and related standards. Several recent developments include the launch of EXCiPACT, a draft FDA guidance to limit use of certain phthalate-based excipients, and proposed revisions to European excipients guidelines on labeling with respect to pediatric provisions. 

 In late January 2012, EXCiPACT, a new, voluntary international certification scheme, was launched. It was designed and developed to ensure that cGMP and current good distribution practices (cGDP) standards are being used in the manufacture and supply of pharmaceutical excipients. The scheme is a product of a mulitstakeholder effort, which included participation from the European Fine Chemicals Group (EFCG), the International Pharmaceuticals Excipients Council (IPEC) of the Americas, IPEC–Europe, the European Association of Chemicals Distributors,  and the Pharmaceutical Quality Group.  

The EXCiPACT scheme provides independent certification of manufacturers and suppliers of pharmaceutical excipients as a means of ensuring patient safety through supplier quality while minimizing overall supply-chain costs. The EXCiPACT standards act as annexes to ISO standards 9001, 19011, and 17021. Suppliers who do not hold ISO 9001 certification will be able to obtain an equivalent certificate through the forthcoming US national standard (ANSI–NSF 363), which also uses the EXCiPACT cGMP and cGDP standards, according to an EFCG analysis. 

 In March 2012, FDA issued a draft guidance 

Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products 

to provide the Center for Drug Evaluation and Research's thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) (1). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products. The draft guidance does not address the use of DBP or DEHP in other types of FDA-regulated products or exposure to DBP or DEHP due to the presence of any of these compounds as an impurity, including as a result of leaching from packaging materials. The comment period for the draft guidance ends May 31, 2012.  

Phthalates are found in certain pharmaceutical formulations, primarily as a plasticizer in enteric coatings of solid oral drug products to maintain flexibility (1). According to FDA's draft guidance, DBP and DEHP have been shown to be developmental and reproductive toxicants in laboratory animals. While the data in humans are less clear, epidemiological studies suggest that certain phthalates may affect reproductive and developmental outcomes. Although the human data are limited, FDA has determined that there is evidence that exposure to DBP and DEHP from pharmaceuticals presents a potential risk of developmental and reproductive toxicity and suggests that safer excipient alternatives to DBP and DEHP are available and should be used (1).  

 In March 2012, EMA issued a concept paper to gain public input regarding revisions to its excipient guidelines on labeling and packaging to include safety concerns for pediatric populations and pregnant women (2). The current excipient guideline was last revised in July 2003 and does not address safety concerns regarding excipients as they relate to pediatric populations as had been addressed in other European regulations covering pediatric populations for pharmaceuticals (3, 4). 

				 "It is important to note that the safety of excipients can affect children differently than adults due to the ongoing organ development and incomplete maturation depending on the age," stated EMA in its concept paper (2). EMA also noted in its concept paper that pregnant women are not covered in the excipient guidelines and that "safety labeling is needed for products intended for use in this population to ensure the safety of the unborn child(ren)" (2). 			

The public comment period ends at the end of May 2012. EMA also said in its concept paper that the labeling of several excipients are specified for a limited number of routes of administration and additional routes of administration need to be added. Also, the guidelines need to be expanded to include additional excipients (2). The draft revised guideline is expected to be released for a six-month month external consultation in the third quarter of 2013 to the first quarter of 2014. After the external consultation, the final guideline is expected to be available within 6–12 months. 

 485 Route One South, Bldg F, First Floor,  Iselin, NJ 08830 tel. 732.346.3072,  

raft Guidance for Industry: Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability

Concept Paper on the Need for Revision of the Guideline on Excipients in the Label and Package Leaflet of Medicinal Products for Human Use 

Guidelines: Medicinal Products for Human Use: Safety, Environment and Information: Excipients in the Label and Package Leaflet of Medicinal Products for Human Use

Articles

Excipient manufacturers expand production capacity and partner to broaden their offerings.

Expanding Excipient Portfolios

Selecting the optimal route of administration and formulation for a drug is crucial to ensure its clinical and commercial success. As pharmaceutical companies face competitive challenges from generic-drug incursion and reduced R&D productivity from their pipelines, strategies for more efficiently bringing drugs to market and for managing the product life cycle of new and existing drug products is vital. 

IMAGE COURTESY OF CATALENT PHARMA SOLUTIONS 

Formulation scientists are important participants in realizing these goals. To gain a better understanding of the technical challenges and solutions in drug delivery, 

 gained feedback through an industry survey, the 

Catalent–Pharmaceutical Technology Landscape Drug Delivery Survey. 

The survey examined key issues in formulation development and drug delivery overall and for oral product forms specifically (1). The survey showed that bioavailability and solubility were top technical concerns and that partnering strategies were important approaches for addressing technical challenges and concerns in resource allocation. 

Figure 1: How would you evaluate the following challenges when developing a drug formulation? 

The survey showed that decisions on the route of administration are made early in the drug-development process. Once a route of administration has been decided, formulation scientists face a myriad of issues. Chief among them is the overall safety of the drug product. More than three-fourths of  respondents regard safety as "very significant" and 17% regard it as "significant" (see Figure 1). Developing the appropriate therapeutic and delivery profile was the second leading challenge. Almost 91% of respondents identified developing the appropriate therapeutic and delivery profile as "very significant" or "significant" (see Figure 1). Other key findings from the survey (see Figure 1) showed:  

89% of respondents regarded bioavailability as "very significant" or "significant" 

86% said solubility was a "very significant" or "significant" challenge in formulation development.  

The survey also asked respondents what their chief concerns were in drug development. Key findings (see Figure 2) showed that:  

Costs and budgetary concerns was the number one concern, with 73% of respondents identifying it as such 

63% cited project delays as a chief concern

50% cited limited time for formulation development as a key challenge.

Figure 2: What are your chief concerns when encountering challenges in drug development?  

How do companies address these challenges? Partnerships in various forms were identified as important tools. Key findings from the survey (see Figure 3) showed:  

51% of respondents have used third-party providers of formulation technologies/development

50% have formed partnerships with academia 

38% have worked with a drug-development or drug-delivery provider 

27% have accessed a network of contract partners (see Figure 3). 

Figure 3: Which of the following has your company done to solve drug delivery and formulation challenges?  

Increasing R&D internally also was another popular option, with more than half of respondents using this strategy. A cross-functional approach, applied both externally and internally, was also a popular choice. Forty percent of respondents said they have used open collaboration and brainstorm sessions as a way to resolve challenges in drug delivery and formulation (see Figure 3). 

The survey also asked how new drug-delivery technologies and solutions were typically introduced into a company. Almost two-thirds of respondents said new technologies are introduced through their companies' internal R&D department, the leading way by which new technologies are introduced. Partnerships also constitute an important vehicle for gaining access to and knowledge of drug-delivery technologies. With respect to partnerships, the survey showed that:  

43% of respondents said new technology is introduced into their companies by an outsourcing service provider

More than one-third introduce technologies through academic research

Almost one third use collaboration and brainstorm sessions

Almost one-quarter use key opinion leaders and advisory boards. 

A majority of survey respondents were primarily involved with oral solid dosage forms, and approximately 40% were primarily involved with parenteral forms. For those involved with oral solid dosage forms, tablets were the most active area of focus. More than 70% of respondents involved with oral solid dosage forms are currently working on a project involving tablets or expect to have a project involving tablets in the future. Powder-filled capsules and combination products were the next leading areas of current and planned project work.  

As in drug-delivery and formulation development overall, bioavailability and solubility were major challenges identified by respondents working with oral solid dosage forms. Three-fourths of respondents identified bioavailability as a current or past challenge. Dissolution, stability, and drug-release profile also were key issues. Dissolution was cited as a current or past challenge by 78% of respondents, closely followed by solubility (77%), stability (76%), and drug-release profile (71%).   

Given these challenges, the survey asked respondents to evaluate available technologies in resolving these problems for oral dosage forms. Dissolution, which was ranked as the number one challenge, was also an area in which respondents felt that existing technology was fairly good. One quarter of respondents said current technology was "excellent," and 43.7% said available technologies were "very good." Respondents also were fairly positive about the utility of existing technologies for resolving problems in solubility and bioavailability. Almost one quarter of the respondents said that technologies for addressing solubility were "excellent" and 38.6% said they were "very good." Bioavailability, however, was more challenging. Only 17.7% of respondents said that technologies for addressing bioavailability were "excellent," and nearly 26% said the technologies were "very good."  

The survey also asked respondents to evaluate technologies for specific dosage/product forms. There was large satisfaction with technologies for the mainstay of oral solid dosage forms, traditional tablets. Nearly three-fourths of respondents said technologies for tablets were "excellent" or "very good." The survey also showed that:  

54% of respondents said that technologies for matrix tablets were "excellent" or "very good" 

53% said that technology for fast-dissolving or orally disintegrating tablets were "excellent" or "very good."

In addressing problems of bioavailability and solubility, "there are two dimensions to which to address solubility of poorly soluble drugs, the drug substance and drug product," says Kurt Nielsen, PhD and senior vice-president, innovation and growth with Catalent Pharma Solutions, in commenting on the survey results. With respect to the drug substance, he points to various solutions, such as optimizing the salt form or solid-state form (i.e., polymorph or co-crystal). Slight modifications to the drug substance also can be made to improve solubility, such as converting the drug to a prodrug, or by reducing the particle size of the drug substance, explains Nielsen.   

With respect to the drug product, Nielsen says that various methods can improve solubility, ranging from straightforward strategies, such as solubilizing agents (e.g., surfactants and polymers) to more complex solutions where site-specific drug release is required to address such issues as poor stability of the drug in the stomach or pre-systematic metabolism in certain locations in the gastrointestinal tract. As with the drug substance, particle engineering can be used to not only optimize solubility but also to modify or control the release of the drug, he adds. In sum, these strategies seek to address the key aspects of solubility, permeability, and site of absorption.  

On a dosage form level, various approaches may be used. "Liquid-based dosage forms, such as softgels, dispersion-based dosage forms through hot-melt or spray-dried dispersions, and drug layering and coating can be used to improve solubility and bioavailability of oral dosage forms," says Nielsen. If bioavailability is still a problem, other routes of administration, such as transdermal, buccal, and sublingual drug delivery can be considered.   

Catalent–Pharmaceutical Technology Landscape Drug Delivery Survey

A recent survey examines the industry's views on the chief challenges and technologies in drug delivery and formulation development.

Gaining a Pulse on Formulation and Drug Delivery Challenges and Technologies

GlaxoSmithKline (GSK) plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines. The company announced selection of Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK for almost 40 years. Investment also will also be made at the company’s two manufacturing sites in Scotland at Montrose and Irvine.

GSK’s announcement follows plans by the UK government to implement a “patent box” to encourage investment in R&D and related manufacturing in the UK by introducing a lower rate of corporation tax on profits generated from UK-owned intellectual property. “The introduction of the patent box has transformed the way in which we view the UK as a location for new investments, ensuring that the medicines of the future will not only be discovered, but can also continue to be made here in Britain,” said GSK’s CEO Andrew Witty, in a Mar. 22, 2012, 

. “Consequently, we can confirm that we will build GSK’s first new UK factory for almost 40 years and that we will make other substantial capital investments in our British manufacturing base. In total, this will create up to 1000 new jobs over the lifetime of the projects. We are also actively considering other investments in our UK manufacturing network, which would create further jobs and reinforce the UK’s international competitiveness and as a world leader in life sciences.”

Following a feasibility study conducted through 2011, GSK said it will locate a new £350 million ($559 million) biopharmaceutical manufacturing facility in Ulverston, Cumbria. Four existing GSK sites across the UK were assessed—Barnard Castle and Ulverston in northern England and Irvine and Montrose in Scotland—with consideration of factors such as sterile-processing skills, technical capability, and existing links with local suppliers and academic partners. Detailed planning and design of the new facility will begin now with an anticipated start date for construction of 2014–2015, dependent on portfolio timing and obtaining necessary planning and related consents. Once construction starts, it is likely to take at least six years before the plant is fully operational, according to GSK.

GSK announced it is considering further significant manufacturing investment at Ulverston which could double the total investment at the site to approximately £700 million ($1.1 billion). GSK also announced that it will invest more than £100 million ($160 million) in its two manufacturing sites in Scotland. This investment includes new funding at Montrose to enable the manufacture of key materials for GSK’s portfolio of respiratory medicines. Investment will also be made at Montrose to produce aluminium adjuvants used in the manufacture of vaccines. This investment will be the first time a UK GSK site will participate in the company’s vaccine-manufacturing supply chain. At Irvine, GSK will increase production capacity for antibiotics, reflecting growing demand for these medicines in emerging markets.

GSK will also invest in sustainable green-energy production and environmentally friendly manufacturing technologies at both sites. The company is making other investments totaling £80 million ($128 million) at its sites in Ware in Hertfordshire to increase manufacturing capacity for its respiratory-inhalation device and at Barnard Castle in County Durham to establish a dermatology-manufacturing center of excellence.

Overall, GSK employs around 15,000 people in the UK, including almost 6000 in manufacturing.

GlaxoSmithKline plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines. The company announced selection of Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK for almost 40 years.

GlaxoSmithKline Plans Biopharmaceutical Manufacturing Investment in the UK

Unite, Britain and Ireland’s largest trade union with 1.5 million members, said it will fight the closure of Sanofi’s pharmaceutical manufacturing facility in Newcastle-upon-Tyne in northeast England. Last week, Sanofi announced the closure of the facility, which employs 450 people and makes solid dose oral drugs mainly for the UK and European markets.

“The way the workforce and the union were advised this site is to close is completely unacceptable,” said Unite National Officer Linda McCulloch in a Mar. 15, 2012, Unite 

. “There was no prior warning and no consultation. This would never have been allowed to happen in other EU countries such as France or Germany. The company would have been expected to work with the union to explore ways to keep the site open.”

Sanofi plans to close the Fawdon manufacturing center in Newcastle-upon-Tyne by mid-2015. The company cited adverse economic conditions, including generic-drug competition, which has contributed to a fall in demand and production volumes at the facility. 

“Employees at the site have been notified of the proposal (Mar. 14th) and a process of collective consultation with employee representatives is now underway,” said Sanofi in a prepared statement. “We will support our people in every way we can to best manage the impact of this announcement and to help them through the consultation process and beyond.”

“Unite is going to fight this closure,” said McCulloch in the statement. “This company has benefited from the commitment of the local community for decades. We now expect the company to sit down with the union to explore every avenue possible to keep manufacturing at this site. The workforce at the company deserves better than being told at a moment’s notice that the site is to close and then being sent home. ‘We are appalled at the way this has been handled—there has been scant regard for the hard working and skilled workforce.”

Unite, Britain and Ireland's largest trade union with 1.5 million members, said it will fight the closure of Sanofi's pharmaceutical manufacturing facility in Newcastle-upon-Tyne in northeast England. Last week, Sanofi announced the closure of the facility, which employs 450 people and makes solid-dose oral drugs mainly for the UK and European markets.

UK Union to Fight Closure of Sanofi UK Manufacturing Facility

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.

, SOCMA said that up to 40% of all drugs Americans take are imported, and up to 80% of the APS in those drugs come from foreign sources. The Government Accountability Office says it would take FDA nine years to inspect all foreign facilities, according to the SOCMA statement.

“Since 2006, BPTF has been advocating for increased resources for the FDA in order to conduct more inspections of foreign drug ingredient manufacturers,” said BPTF Chair Patty Benson, quality assurance director at SAFC, according to the SOCMA release. “This legislation will go a long way in safeguarding our drug supply and result in greater scrutiny of drug manufacturing in high-risk regions of the globe.” 

Last year, BPTF and other industry groups negotiated generic-drug user fees with FDA at an annual cost to industry of nearly $300 million. According to SOCMA, the goal is to hold all players contributing to the US generic-drug system to the same inspection standards, achieve inspection frequency parity, expedite the availability of more affordable, high-quality generic drugs and enhance FDA’s ability to identify and track registration of contributors involved in each drug product sold in the United States. Goals established in the negotiations include a decrease in the time it takes the FDA to review and act on new drug applications, from 31 months to 10 months. The time it takes to get a generic drug approved has nearly doubled, and FDA’s resources have not kept up with the increasing number of applications, with the greatest increase coming from foreign facilities, according to the SOCMA statement.

The Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.

SOCMA Issues Support for Generic-Drug User Fees

 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 

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.