SAFC, a member of the Sigma-Aldrich Group, has announced a $4.5 million capacity expansion program at its SAFC Pharma high-potency API (HPAPI) facility in Madison, WI. The program will add cGMP pilot plant and kilo lab capacity and complement the new XRPD (X-ray Powder Diffraction) analytical equipment for advanced solid form testing, which the company expects to be operational this month. The expansion is scheduled to start in early 2008.

SAFC is adding two 400-liter cGMP pilot plant reactors and two 100-liter cGMP portable jacketed reactors into a 1200-sq.-ft. large-scale kilo lab. The addition will enable larger-scale chromatography for process purification. The company also installed and qualified a Bruker D8 Advance X-ray Diffractometer for solid-form testing and analysis, providing U.S. customers with on-site cGMP and XRPD analysis of potent compounds. Rapid sample testing at the Madison site combines with data analysis and evaluation performed at SAFC Pharmorphix facilities in the U.K.

SAFC Pharmorphix specializes in solid-form research and is completing a multi-phase, $1.2 million expansion program at its labs. SAFC president, Frank Wicks, commented, “As regulatory requirements align with the increasing complexity of drugs, solid-form testing, analysis and optimization are becoming key elements in the drug development process. Additional and enhanced capabilities at SAFC Pharma’s Madison facility mark a timely expansion to the scope and value of our HPAPI offering and are reflective of SAFC’s ability to support its customers throughout the drug development cycle.”

Merck's NDA for Cordaptive (ER niacin/laropiprant), formerly known as MK-0524A, has been accepted for review by the FDA. Cordaptive is an investigational drug containing Merck's extended-release niacin and laropiprant, a flushing pathway inhibitor designed to reduce flushing associated with niacin treatment.

The application supports the use of Cordaptive, either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol (LDL-C or "bad" cholesterol), low HDL cholesterol (HDL-C or "good" cholesterol) and elevated triglycerides levels. All are conditions associated with increased risk of heart disease.

Merck anticipates FDA action in 2Q2008. The company is also moving forward with filings outside the U.S.

AAIPharma, Inc. has entered a multi-year alliance agreement with Phase Forward. Under the terms of the contract, AAIPharma will offer services centered around two Phase Forward products as part of its solution set: the InForm Integrated Trial Management (ITM) electronic data capture (EDC) system and the Clintrial clinical data management product that can be used to collect, manage and review electronic and paper-based study data.

"After an intense review process we felt Phase Forward's dedicated services organization, combined with its trusted product set, made our decision an easy one," said Anne Wiles, senior vice president, data systems and processes, AAIPharma. "The company's flexible partner program will allow us to expand and customize our offerings at a pace that best suits our growing organization, as well as our clients. As EDC adoption continues, it is important that we offer the technology that sponsors view as an industry standard, while also supporting those clients requiring a solution that supports both electronic and paper-based trials. Phase Forward remains the vendor of choice for organizations at every stage of EDC implementation."

"CROs continue to play a critical role in bringing the efficiencies of electronic data capture and management to clinical trials, and will ultimately help move the industry further along the adoption continuum over the next several years," said Bob Weiler, chief executive officer and president, Phase Forward. "Collaboratively, we believe we can help biopharmaceutical and medical device firms realize the full benefits of EDC, and we look forward to working with AAIPharma in pursuing this goal."

Catalent Pharma Solutions, Inc. and ALK-Abello A/S have signed an agreement that will expand Zydis production capacity dedicated to ALK-Abello's immunotherapy products. Under the agreement, ALK-Abello will fund a new production line for current and future tablet-based allergy products, which will be based at Catalent's Swindon, UK facility. Commercial production on the new line is expected to begin in 2010.

ALK-Abello has launched Grazax, a tablet-based vaccine against grass pollen allergy, using Catalent's Zydis oral dissolving tablet technology, and Catalent is currently producing the Zydis formulation of Grazax in the Swindon facility.

"We are pleased to have reached this next important step in our relationship with ALK-Abello, which began more than four years ago," commented Thomas Stuart, group president of oral technologies for Catalent. "The clinical success of Grazax demonstrates that protein-based products such as allergens can be taken orally by patients rather than via injection, and we believe Zydis provides unique advantages to deliver these and other types of novel compounds. We look forward to supporting the further success of Grazax and additional ALK-Abello immunotherapy products."

"We are pleased to have reached this agreement with Catalent to provide important new production capacity, which we believe will be required to meet the expected future demand for our tablet-based allergy vaccines," said Jens Bager, president and chief executive officer of ALK-Abello. "We appreciate the consistent performance and dedication of the Catalent team in Swindon, and the valuable contribution the team and the Zydis technology is making to our product."

PDL BioPharma, Inc., following a business and portfolio review, has changed its strategic focus to the discovery and development of novel antibodies in oncology and select immunological diseases. According to a company statement, it will realign its organization this fall to support its new strategy.

As a result of this new strategic focus, which does not include cardiovascular disease, PDL plans to sell its commercial assets, including its Cardene, Retavase and IV Busulfex products, as well as the ularitide development-stage cardiovascular product. Also, following a recent Data Monitoring Committee evaluation of data from the ongoing RESTORE 1 trial, the company has decided to terminate the Nuvion (visilizumab) phase III program in ulcerative colitis due to insufficient efficacy and an inferior safety profile.

BioReliance Corp. has launched iNet, an IT system that enables customers to submit test article details via controlled and secure Internet access from any location worldwide. Clients can view the status of current and past studies, view expected completion dates, download reports, and allow colleagues to view testing status—all in one online environment and in real-time, according to the company.

Tim Derrington, president and chief executive officer of BioReliance, stated, “Our customers are now armed with a web-enabled application that offers a precise picture of their project’s current and future status. We look forward to greatly expanding our iNet user base in the upcoming months and continuing to develop and integrate new technologies that will enhance our customers’ service experiences with BioReliance.”

Judith Apshago, senior director of global IT, added, “A lot of effort was placed into making iNet user-friendly, secure and compliant. As a result, preliminary users have navigated through the submission process with little difficulty. In addition, we have implemented multiple layers of security both on the front end and the back end to create an extremely secure online environment that validates users and ensures data integrity.”

iNet is compliant with 21 CFR Part 11 for user authentication, and data exchange over the web is protected by VeriSign. It's compatible with both Windows and Mac operating systems.

Charles River Laboratories International has plans to build a new facility in Sherbrooke, Quebec, to support its preclinical services business. The new facility, which will be located in the company's newly constructed Sherbrooke Biomedical Park, will provide drug discovery and development services to the pharma/biopharma industries.

The new facility will be approximately 300,000 sq. ft., 25% of which will be constructed in a first phase that is scheduled to open in 1Q2009. Construction of the remaining phases will be based on market demand. The Sherbrooke facility will employ 1,000 people who will work with the staff of 1,600 currently located in the company's Montreal facility.

James C. Foster, chairman, president and chief executive officer of Charles River Laboratories said, "We are very pleased to add this new project to our Preclinical Services expansion program. As customers choose strategic outsourcing as a means to improve the drug development process, they are increasingly turning to Charles River for our scientific expertise and the high-quality preclinical services we provide. This new facility will enable us to continue to support that demand from our global customers."

"Our goal was to identify a location similar to Montreal, equally convenient for our customers, where we could situate this new facility. Sherbrooke is ideal for many reasons, including its proximity to world-class educational institutions offering well-educated laboratory and life sciences graduates, as well as opportunities for collaborations and access to cutting-edge technology," said Christopher Perkin, corporate vice president and president, Canadian Preclinical Services. "We greatly appreciate the assistance of the government of Quebec, which is supporting this project, as we support our customers' efforts to bring drugs to market faster and more cost effectively."

Pfizer has licensed non-exclusive, worldwide rights to Xoma Ltd.'s bacterial cell expression (BCE) technology for phage display and other research, development and manufacturing of antibody products.

Under the terms of the agreement, Xoma will receive an upfront cash payment of $30 million and milestone, royalty and other fees on future sales of all products subject to this license, including products currently in late-stage clinical development.

Steven Engle, chief executive officer and president of Xoma, said, "This agreement provides clear validation of Xoma's antibody research and affirms Xoma's ability to capitalize on the value of our patented technologies. We continue to execute our strategy of using our technologies to generate high-margin revenue in support of our programs, including our proprietary product pipeline. We are very pleased that Pfizer has chosen to incorporate our BCE technology into their global drug development effort, and we look forward to what we anticipate will be a mutually beneficial relationship.

"BCE is an enabling technology for antibody phage display discovery and for the manufacture of bacterially expressed therapeutic antibody products," Mr. Engle continued. "It is a proven technology for commercially significant therapeutic antibodies as demonstrated by the approval of Lucentis for wet age-related macular degeneration. With more than 45 license agreements in place, BCE continues to be a seminal enabling technology in antibody discovery and production."

Schering-Plough/Merck Pharmaceuticals' (SPM) NDA for loratadine/montelukast has been accepted by the FDA for review. The drug is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.

SPM is seeking marketing approval of loratadine/montelukast for treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion. If approved the medicine would be marketed as a prescription treatment by Schering-Plough/Merck Pharmaceuticals, a joint venture between Schering-Plough and Merck & Co.

NovaQuest, the strategic partnering group of Quintiles Transnational, has made a strategic investment in Topigen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in respiratory disorders.  The investment, part of a private placement of $25 million in the Montreal-based company, is intended to helps Topigen accelerate its Phase II lead-product clinical programs.  NovaQuest and Quintiles first provided strategic product development advice to the company three years ago, and the relationship has since evolved into an integrated development partnership.

Patricia Lamothe, Topigen's chief financial officer, said, "The ability to access NovaQuest's clinical expertise and Quintiles' development capabilities is a tremendous benefit to our company as we continue to advance our product candidates for significant breakthroughs in the treatment of respiratory diseases."

NovaQuest vice president Ben Cons, Ph.D., added, "Having been very active in 2006, with 16 strategic investments, our focus now is to create fewer but larger partnerships.  We're seeking high potential biotechs -- those with excellent pipelines and strong management teams."

In November NovaQuest made a strategic investment in Canadian biotech company BioMS Medical Corp., a developer of treatments for multiple sclerosis.  For all of 2006, NovaQuest participated as a minority investor in funding rounds that raised a total of $342 million for 16 emerging biotechnology companies worldwide.

Hani S. Zaki has been appointed vice president and general manager of Periapproval Services for Covance, Inc.  Mr. Zaki will be responsible for managing large research studies on the use of pharmaceuticals in real world clinical practice.

Prior to coming to Covance Mr. Zaki was with PharmaNet for nine years where he served as vice president of business development, leading the company's global efforts to build its Phase IIIb and Phase IV research business.  Prior to joining PharmaNet, Mr. Zaki spent more than 16 years working in both clinical research and commercial roles on the client side.  After early career experience in data management at Schering-Plough and in clinical operations with Bristol-Myers, Mr. Zaki was with Rhone-Poulenc Rorer (RPR, now sanofi-aventis) where he headed the U.S. anti-infective clinical operations group.  While at RPR, he was also a part of Dermik Laboratories' licensing and market development group with sales & marketing responsibilities for several ex-U.S. markets.

"The market for Periapproval Services is likely to accelerate further as manufacturers seek to optimize sales of their in-line products and regulatory changes prompt a heightened need for safety studies," said Luis Gutierrez, president of Covance Commercialization Services.  "Mr. Zaki's depth of experience and track record identifying and developing new business opportunities will help to expand our efforts to maximize the delivery of integrated service offerings to our clients and our overall share of this growing market," he added.

Pfizer and Bristol-Myers Squibb have finalized their collaboration agreement to research, develop and commercialize DGAT-1 inhibitors. Pfizer's DGAT- 1 discovery program includes advanced preclinical compounds with potential applications for the treatment of metabolic disorders, including obesity and diabetes. The program also includes DGAT-1 inhibitors in-licensed by Pfizer from Bayer Pharmaceuticals in June 2006, including a preclinical compound (known as PF-04415060 or BAY 74-4113) originally discovered by Bayer.

The Pfizer/BMS collaboration was announced in April 2007. Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities.

"The worldwide incidence of metabolic disorders is increasing rapidly, and complications from diabetes and obesity are leading causes of disability and mortality globally. DGAT-1 inhibitors have shown promise in pre-clinical testing, and this research program has potential to yield several compounds that may improve treatment options for patients," said Elliott Sigal, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "This collaboration underscores the company's commitment to investing in research and development, and reflects our strategy to identify partnerships that complement our own research efforts to enhance our innovative pipeline."

Gene Logic, Inc. has entered into a drug repositioning and development agreement with Merck Serono to seek alternative development paths for several Merck Serono drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety.
   
Under the agreement Gene Logic will receive success-based milestones and royalties similar to those paid for development-stage in-licensing deals. Gene Logic also has the option gain exclusive license to any drug candidate it identifies that Merck Serono chooses not to develop. If Gene Logic obtains such a license, Merck Serono would be entitled to receive success-based milestone and royalty payments.
   
Gene Logic's Drug Repositioning Program offers the potential for pharmaceutical partners to bolster their pipelines with high-quality drug candidates that originated from their own R&D efforts. The program evaluates drug candidates for potential use across a wide range of disease indications by applying a diverse set of drug discovery technologies.
   
Charles L. Dimmler, III, Gene Logic's chief executive officer and president, said, "Merck Serono is a world leader in reproductive health and has strong market positions in several other therapeutic areas. We look forward to applying our Drug Repositioning Program to complement their internal efforts to determine new uses for their clinical-stage, de-prioritized drug candidates. Our partnership with Merck Serono is our seventh drug development agreement, further substantiating the industry's recognition of our systematic approach to identifying novel therapeutic indications for drug candidates."

MedImmune has opened a new, state-of-the-art pilot lab facility at its Gaithersburg site headquarters. The facility features the latest equipment and process automation systems and will support the company's clinical product pipeline with additional capacity and flexibility.

MedImmune, David M. Mott, president and chief executive officer, stated, "Completing this new facility is an important milestone, signaling our continued growth and success as a world-class biopharmaceuticals company. The opening of this facility, alongside the expansion work underway on our new biologics facility in Frederick, Maryland, reaffirms our leadership role within the state's biotechnology industry and demonstrates our ongoing commitment to the region."

The new pilot lab's 5,000 liters of bioreactor capacity increases production capabilities four-fold. The expanded facility enables the company to produce clinical trial materials at a greater scale and in larger quantities, helping with the testing of potential new products.

"This substantial increase in MedImmune's clinical production infrastructure supports our robust pipeline of product candidates," said Gail Folena-Wasserman, Ph.D., senior vice president, development. "The pilot lab facility is intended to meet our current and future needs, not just through its increased capacity but also through design flexibility, which efficiently allows us to produce multiple clinical products in the same space. We can drive efficiency and meet rigorous quality standards by incorporating the latest technology, including an advanced process control system."

Bengt Danielsson, M.D., Ph.D., has been appointed vice president, PharmaNet Consulting. He joins the company from the Swedish Medical Product Agency where he served as scientific director/professor in pharmacology and toxicology for the past three years. During that time he also served as a member and the EU Pharmacology and Toxicology representative of the EMEA/CHMP Innovative Medicine Task Force group and a member and Swedish representative of the CHMP/EU Safety and CHMP/EU Cell-based Products working parties. Dr. Danielsson previously worked for Astra AB and AstraZeneca where he served as global director, clinical interface support and global science leader, reproductive toxicology.
   
"We are extremely pleased to have someone of Dr. Danielsson's stature join PharmaNet Development Group," commented Dr. James Burns, senior vice president, PharmaNet Consulting. "He adds to an already impressive team of experts in our drug development consulting practice, which includes a number of senior former-FDA officials, and will bring significant technical and regulatory experience to assist our clients who are developing products in Europe."

Pro-Pharmaceuticals, Inc. has retained Camargo Pharmaceutical Services to provide strategic regulatory support for the company’s 505(b)(2) submissions for Davanat with the FDA. Camargo’s regulatory support includes the preparation and submission of NDAs, aNDAs, and 505(b)(2) NDAs to help expedite the regulatory submission and approval process for clients.

"Our goal is to get Davanat to market in a timely manner with multiple chemotherapy drugs," stated David Platt, Ph.D., chief executive officer, Pro-Pharmaceuticals, Inc. "We submitted pre-clinical and clinical data to the FDA that demonstrates Davanat improves 5-FU. In other preclinical studies, Davanat also improved activity of FDA-approved chemotherapeutics, such as Irinotecan, Oxaliplatin, Cisplatin, Avastin, Taxol and Doxorubicin.”

The company has submitted data to begin 505(b)(2) filings for Davanat as a functional excipient to be co-administered intravenously with 5-FU to treat cancer. The functional excipients are important as a drug target delivery to reduce toxicity and/or increase efficacy.

Cephalon, Inc. has signed an agreement to acquire the North American rights to Amrix (cyclobenzaprine hydrochloride extended-release capsules) from ECR Pharmaceuticals for $100 million cash. ECR is eligible to receive future cash payments based on the achievement of certain milestones.

The FDA approved two dosage strengths of Amrix (15 mg and 30 mg) in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Cephalon expects to launch the product in the U.S. early in the fourth quarter.

"Amrix is an excellent strategic fit with our current sales organization, providing us with a second product that is complementary to many pain relievers used today," said Robert Roche, executive vice president, Worldwide Pharmaceutical Operations. "Cyclobenzaprine HCl is the most widely prescribed muscle relaxant in the U.S., representing 37% of the 45 million prescriptions for muscle relaxants written in 2006, according to IMS. Amrix has convenient once-daily dosing and a side effect profile that includes very low rates of sedation which will provide physicians and patients an attractive alternative to current therapies."

GPC Biotech AG is restructuring and will reduce its U.S. staff by 46 employees (approximately 15%) with reductions in the commercialization, drug development and general and administrative groups. The company also announced that Martine George, M.D. will succeed Marcel Rozencweig, M.D. as senior vice president, drug development and chief medical officer and will assume leadership of the company's drug development team. Dr. Rozencweig will assume the position of senior vice president, clinical science and drug evaluation to focus on new drug development in-licensing opportunities.

Bernd R. Seizinger, M.D., Ph.D., chief executive officer, said, "The decision to reduce staff has been a very difficult one to make, particularly since we have been able to build and grow such stellar teams. However, these decisions were necessary as we focus on moving the company forward and planning for our future."

Dr. Seizinger remarked that GPC will "intensify efforts to in-license promising compounds" and also plans to re-file its NDA for cancer treatment satraplatin.

Dr. George joined the company as senior vice president, clinical development in the spring of 2006 with more than 15 years of experience at major pharmaceutical companies, as well as several years in an academic position as a medical oncologist. Prior to joining the company, Dr. George was senior vice president, head of oncology at Johnson & Johnson Pharmaceutical Research and Development. Previously, she held a number of executive positions in the areas of clinical and medical affairs, including at Rhone-Poulenc Rorer (now part of Sanofi-Aventis), Sandoz Pharmaceuticals (now Novartis) and American Cyanamid (now Wyeth).

The company plans to reduce certain ongoing activities and will halt further financial commitments to its 1D09C3 monoclonal antibody and cell cycle inhibitors programs. The company plans to continue ongoing satraplatin trials, including the SPERA expanded access program.

Frank A. D'Amelio has been named senior vice president and chief financial officer of Pfizer, effective in mid-September. Mr. D'Amelio is a senior executive with almost three decades of operating and financial experience at AT&T, Lucent Technologies and Alcatel-Lucent, including serving as chief operating officer and chief financial officer at Lucent.

Mr. D'Amelio is currently senior executive vice president, integration and chief administrative officer at Alcatel-Lucent. He will join Pfizer's executive leadership team and report to Jeff Kindler, Pfizer's chairman and chief executive officer. He will have responsibility for all aspects of the company's finances, including treasury, tax, the controller's division and investor development. He succeeds Alan Levin, who announced plans to retire from Pfizer in May.

"We are very pleased that an executive with Frank's skills, integrity, global experience and proven leadership is joining our management team," said Mr. Kindler. "Through almost three decades . . . Frank was a senior executive in global companies undergoing the kind of rapid and complex changes we have undertaken at Pfizer in response to our own rapidly changing markets.

Mr. D'Amelio began his career in 1979 at AT&T Bell Labs, where he held various financial, accounting and general management positions. He also served as vice president and chief financial officer of Lucent's Network Systems Business and in 1996, he helped establish the financial structure of the new Lucent company. Prior to being named executive vice president, administration and chief financial officer of Lucent in May 2001, Mr. D'Amelio was group president of Lucent's Switching Solutions Group, where he led the manufacturing, R&D, marketing and product management of Lucent's switching, access and applications software businesses.

In early 2006 Mr. D'Amelio was appointed Lucent's chief operating officer, responsible for leading the operations of the business including sales, the product groups, the services business, the supply chain, IT operations and labor relations. After Lucent merged with Alcatel later in 2006, Mr. D'Amelio was appointed senior executive vice president, integration and chief administrative officer.

Pfizer broke ground on a $50 million expansion at its Chesterfield campus that reflects the company's increased investment in biopharmaceuticals. The expansion doubles the size of a pilot plant that produces protein-based, injectable biologic drugs for clinical trials.

"We're relative novices at this, but we've got some really exciting things early on in the pipeline," said John LaMattina, Pfizer's outgoing head of global R&D. Pfizer currently has four biologics in Phase I trials, eight in Phase II, and a lung cancer treatment that is advancing into Phase III trials.

The expansion includes the addition of fermenters, bioreactors and other equipment used to grow, purify and isolate proteins. The site will enable the company to increase quantities of a single biologic needed for later-stage clinical trials, and to work on more projects simultaneously. The facility is expected to be operational by mid-2010.

Jeff Kindler, Pfizer's president and chief executive, commented that small molecules remain Pfizer's core strength. "But we believe biologics offer significant, promising R&D opportunities that we need to pursue, and we are intent on doing so," he said. "We're looking at various ways to really jump-start our activities in that area."

Hugo Stephenson, M.D. has been appointed president of iGuard, for Quintiles Transnational Corp., effective immediately. Dr. Stephenson will lead the company's new service that offers personalized safety information and alerts to patients taking prescription drugs. He reports to Stephen DeCherney, M.D., senior vice president and chief innovation officer.

Dr. Stephenson previously served as senior vice president of Quintiles' strategic research and safety services since 2003. Dr. Stephenson was the founder of Health Research Solutions, an Australian strategic research service provider acquired by Quintiles in 2002. He has a particular interest in strategic epidemiology and risk management, and he works closely with senior industry strategists to promote the use of strategic research activities to support advances in pharmaceutical research.

"We're capitalizing on Hugo's expertise in the area of risk management and the demand for consumer involvement in monitoring the safety of drugs that are on the market," said Dr. DeCherney.

ImClone Systems, Inc. received approval from the FDA for a second facility to manufacture Erbitux. This new 250,000-sq.-ft. multi-suite manufacturing facility, referred to as "BB50", more than doubles the company's total production capacity for Erbitux.

"The FDA approval of BB50 represents the culmination of ImClone's efforts over the last several years to establish this state-of-the-art facility. This now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward," said Richard P. Crowley, senior vice president, biopharmaceutical operations of ImClone Systems. "Together, our two manufacturing facilities provide us with the capacity to produce Erbitux and future products for worldwide development and commercialization, and serve to support our initiatives for the long-term growth and success of ImClone."

Construction of BB50 was completed in 4Q2005. This facility is designed to contain three distinct suites with a total future production capacity of as much as 110,000 liters. The initial validation of one of the suites was completed during 2Q2006 at which point the company began producing Erbitux. The other two suites at this facility will enable the company to produce Erbitux, ImClone products, or third-party products under contract manufacturing agreements, down the road. Both BB50 and BB36 are located on ImClone's Branchburg, N.J. campus.

MPI Research has appointed David Serota, Ph.D., DABT to the position of vice president, toxicology and pathology, as well as a member of the company's senior management team, and Tina Rogers, Ph.D., DABT joined the company as the associate director of research.

Dr. Serota will oversee more than 60 study directors and serve as the senior principal study director on several critical ongoing testing programs. He has more than 31 years of experience and previously served as the director of toxicology at Southern Research Institute and as director of laboratory operations at Hazleton Laboratories Vienna (now Covance). Most recently, Dr. Serota was the executive director of toxicology and senior study director at MPI Research.

"Dr. Serota's experience and innovation have set a performance precedent at MPI Research. He has played a key role in our capacity expansion projects, which have allowed us to provide our sponsors with the timely study starts they need to keep their projects moving forward. In fact, our Sponsors often actively seek his expertise," said Jim Laveglia, Ph.D., executive vice president and director of research at MPI Research. "With Dr. Serota leading our toxicology and pathology efforts, our Sponsors can look forward to continued service enhancements and operational excellence."

In her new role, Dr. Rogers will lead initiatives to enhance the targeted discovery research offerings at the company, focusing on biotherapeutics, including viral and other gene vectors as well as cell therapy. She will also concentrate on advancing specialized services and capabilities in other key areas of the company. She has more than 15 years of experience in the CRO industry and has held key leadership positions, including vice president of drug development at Southern Research Institute.

"Dr. Rogers is a knowledgeable leader with proven business acumen," said Dr. Laveglia. "Her unique combination of credentials and experience will only further strengthen our research team and efforts to provide Sponsors with timely, top-quality, and cost-effective preclinical drug development services."

Abraxis BioScience, Inc. and The Scripps Research Institute (TRSI) have entered an exclusive licensing agreement for the worldwide development and commercialization of an epothilone therapeutic for the treatment of cancer. Epothilones are a new class of microtubule-stabilizing agents, which bind to the tubulin pathway to inhibit the growth and proliferation of cancer cells.

Under the terms of the agreement, Abraxis has rights to eleven potential drug candidates for preclinical evaluation and selection of a lead candidate for clinical development. Financial terms of the agreement were not disclosed.

Abraxis will evaluate TSRI's epothilones using its nab technology platform, which uses the natural properties of the human protein albumin to transport and deliver therapeutic agents to the site of disease. The nab platform eliminates the need for toxic solvents such as Cremophor EL, which allow the administration of the anticancer agent into the bloodstream. Serious side effects have been associated with the use of solvents.

"We are excited to enter into this exclusive agreement with TRSI, which enables Abraxis to expand its rapidly growing oncology pipeline with the addition of a novel epothilone therapy," said Neil P. Desai, Ph.D., vice president of research and development at Abraxis BioScience. "Abraxis is committed to the development of progressive cancer therapeutics and we look forward to initiating studies to evaluate this new class of cancer agents with our nab platform."

"Our preliminary research suggests the epothilones targeted for development by Abraxis BioScience are some of the most potent agents in this new class of drugs," said K.C. Nicolaou, Ph.D., chair, department of chemistry at TRSI. "Abraxis has a strong track record in the development and commercialization of cancer therapeutics. We are excited about our collaboration, which will enable further study of these novel epothilone agents."

Enzon Pharmaceuticals, Inc. is selling 25% interest in its royalty from PEG-INTRON, marketed by Schering-Plough Corp. for $92.5 million to Drug Royalty Corp., Inc. (DRC). Enzon is also eligible to receive an additional one-time milestone payment of $15 million in 2012 if certain royalty recognition levels are met for PEG-INTRON. Enzon will retain a 75% interest in the PEG-INTRON royalty, as well as 100% of their other current royalties and any new royalties the company receives. Enzon plans to use a portion of the proceeds for repayment of outstanding debt due in 2008.

"Today's announcement is a result of a thorough and comprehensive evaluation of our options to extinguish our debt due in 2008," said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. "This transaction now fully removes any risk associated with repayment of the 2008 convertible note, and allows Enzon to continue to focus on its goal of building an innovative oncology company."

Enzon currently earns royalties on three marketed products that use its PEGylation platform: PEG-INTRON, Pegasys, and Macugen.

PEG-INTRON is a PEG-enhanced version of Schering-Plough's alpha interferon product, INTRON A, which is used both as a monotherapy and in combination with Rebetol (ribavirin) capsules for the treatment of chronic hepatitis C.

Alphora Research, Inc. has invested in a new pilot plant facility in an effort to increase its range of services. The company recently expanded to include a 14,000-sq.-ft. facility. The cGMP pilot plant is currently under construction and is expected to be finished by the end of the year. This facility includes 200L and 400L glass lined reactors, with temperature ranges of cryogenic (-80C) to 200C, as well as support process equipment. Support functions will include warehousing and quality control capabilities.

The company currently operates a cGMP Kilo lab facility, which has completed a number of clinical stage projects, and is currently validating one product for commercial supply. The new pilot plant will allow the company to supply larger quantities of clinical API materials and niche commercial products.

Alphora’s operations include synthetic laboratories, analytical laboratories, cGMP stability studies and cGMP kilo laboratories.

Nexgen Pharma, Inc. has acquired certain assets of The Chemins Company, Inc. located in Colorado Springs, CO. The acquisition includes 250,000 sq. ft. of manufacturing, laboratory and warehouse/distribution space.

Gary Korngold, Nexgen's executive vice president, stated, "This acquisition represents an exciting opportunity for Nexgen Pharma. We have not only expanded our capacities, but also our dosage form capabilities. The result will be increased offerings to the industry and the ability to meet the increased demands for our products and services."

Nexgen Pharma manufactures pharmaceutical and nutritional products and offers solid dose, powder or liquid pharmaceuticals, medical foods, OTC drugs and dietary supplements. The company has five facilities located in Irvine, CA, Tempe and Phoenix AZ, Colorado Springs, CO and Columbia, MO.

ARTEC, Inc. has made key appointments with the goal of initiating the production and global distribution of Tubercin and related immunostimulant medicines.

"R&D of Tubercin is complete, requiring no further refinement or alteration in terms of its formulation. Our new business associates are joining ARTEC, Inc. in order to stimulate and enforce the production of this potentially promising immunostimulant to combat HIV and Cancer," said Dr. Ronald Shinn, president and chairman of the board of directors of ARTEC. "Our board members will utilize their experience in the areas of product enterprise, contract negotiations and strategic investments to insure that the production and distribution of Tubercin will develop in a way that is internationally accessible while remaining affordable."

George E. Williams, Jr., has been appointed as director. He previously served as vice president of Hana Security Services, a company that provides civilian personnel for the U.S. Department of Defense throughout the U.S. Mr. Williams is also an experienced negotiator in working with governmental contracts throughout the world.

Rodney Watson has been appointed coordinator for ARTEC, South Africa. Mr. Watson was previously business manager for Innovative Investment Holding PPY in Johannesburg, Republic of South Africa. He is a successful business leader in South Africa along with other areas of Africa, responsible for overseeing large acquisitions and activating the funding of state-of-the-art technology projects.

Cecil Thompson will serve as coordinator for ARTEC, Bahamas. He is currently president of Certified Consultants, Inc. Mr. Thompson brings an expertise in property development funding, mining and new business ventures.

Gerry Knight, executive vice president of the company has been appointed as coordinator for the funding of special projects and will focus on the development of the South Africa and Bahamas operations.

Schwarz Pharma, a subsidiary of UCB, submitted a MAA to the EMEA for Vimpat to treat diabetic neuropathic pain and it has been accepted for review.

Vimpat is an anticonvulsant drug with a novel dual mode of action acting on CRMP-2 (collapsing response mediator protein 2) and sodium channel slow inactivation. Diabetic neuropathic pain is a common chronic pain syndrome from which approximately eleven million people with diabetes suffer. Neuropathic pain is caused by damage to a peripheral or central nerve and can lead to spontaneous sensations of pain.

An application for marketing approval for Vimpat as an adjunctive therapy for adult patients with epilepsy with partial onset seizures was accepted for review by the EMEA in May 2007. The company plans to file for approval in the U.S. in 4Q2007.

Also, clinical studies with lacosamide in additional indications such as fibromyalgia, osteoarthritis and migraine prophylaxis, have been initiated, with first results expected in 2008.

Amgen plans to reduce its headcount by 12-14% or 2,200-2,600 staff in an effort to "create operational efficiencies" and support R&D investments. These initiatives, expected to yield savings of between $1 billion - $1.3 billion in 2008, are in part, due to lower Aranesp sales. Restructuring charges are expected to be $600 - $700 million in 2007 and 2008, which includes $289 million for asset impairment and related costs reported in the second quarter.

With the restructuring, the company plans to improve its cost structure by reducing capital expenditures by approximately $1.9 billion during 2007-2008; closing certain production operations and rationalizing other facilities improve efficiencies; and determining the highest R&D priorities for future growth.

"At Amgen we have always been committed to investing in the future while squarely facing the challenges of today," said Kevin Sharer, Amgen's chairman and chief executive officer. "Recent changes in coverage rules and adjustments to Amgen's FDA approved labels for Epogen and Aranesp have and will adversely affect Amgen's revenue. These initiatives respond to that new reality by taking account of reduced revenues and appropriately lowering costs across the company. We will continue to strongly support our research efforts directed at development of new medicines for grievously ill patients. These changes will also position Amgen for success in 2008 and beyond."

Cell Therapeutics, Inc. will acquire Zevalin, the first FDA-approved radioimmunotherapy, from Biogen Idec. CTI will be responsible for marketing, sales, and development of the drug in the U.S. The drug will continue to be sold outside the U.S. by Bayer Schering under a previous agreement with Biogen Idec. Zevalin was approved by the FDA in 2002 to treat patients with relapsed indolent non-Hodgkin's lymphoma (NHL). In 2006, Biogen Idec reported $16.4 million in Zevalin sales in the U.S.

Under the terms of the agreement, CTI will pay Biogen Idec $10 million in cash, as much as $20 million more in milestone payments when the product receives approval for a first-line indication in NHL, and royalties on sales. CTI has also agreed to share the cost of certain clinical trials of Zevalin with Bayer Schering. The acquisition is subject to certain closing conditions.

"Zevalin is an effective yet underutilized drug with a favorable tolerability profile, producing high rates of complete response coupled with long-term remissions, all following just a single therapeutic dose," said Jack W. Singer, M.D., chief medical officer of CTI. "We believe the potential cost savings and practice efficiencies compared to standard combination chemotherapy will become increasingly attractive to oncology group practices in the ever-evolving reimbursement environment. We are currently planning to conduct registration-directed trials to expand the label into first-line treatment in both the aggressive and indolent NHL settings," Dr. Singer noted.

"Acquiring Zevalin returns CTI to a select group of biotech companies who market and sell a commercial product in the U.S. We see potential for substantial revenue growth for this product with additional clinical data and increased patient and physician knowledge about its potential in treating patients with NHL," said James A. Bianco, M.D., president and chief executive officer of CTI. "Importantly, in addition to the untapped revenue potential for Zevalin, it is an excellent complement to pixantrone, which is in phase III trials in similar patient populations. Ensuring this important cancer treatment remains available to patients fits into CTI's mission of making cancer more treatable."

Pharmatek Laboratories, Inc. has added cytotoxic and high-potent drug development capabilities to its pharmaceutical chemistry development services. These services include: analytical method development, preformulation testing, formulation development, manufacturing for early phase clinical trials, release testing, and stability testing and storage.

"This expansion was driven by an increase in demand for cytotoxic and high-potent drug development and manufacturing outsourcing among our clients," said Dr. Jeffrey Bibbs, chief executive officer of Pharmatek. "This added capability enables us to provide a broader level of services to our clients with cytotoxic and high-potent candidates."

The company's cytotoxic and high-potent development services will take place in a separate dedicated facility. Manufacturing capability includes two validated and licensed class 100,000 high-containment suites designed with barrier technology for cGMP manufacturing of final form drug products, with dedicated HVAC and HEPA filtration systems to ensure product containment within the suites.

Millipore Corp. expanded its agreement with Novo Nordisk to provide recombinant human insulin, a key cell culture supplement used to manufacture biologic drugs.

Under the terms of the agreement, Millipore will have exclusive worldwide rights to market and sell Novo Nordisk's recombinant human insulin, branded by Millipore as Incelligent SG and Incelligent AF, for cell culture media applications. Incelligent is an insulin product used in the production of several biologic drugs on the market. The two insulin products are manufactured in separate and independent facilities offering greater supply chain security, according to the company.

Cell culture supplements are products that help engineered cells to efficiently produce the proteins that are the basis of biologic drugs. Incelligent is available in a standard grade as well as an animal-free version that uses no animal-derived products in its manufacturing process, which helps to ease regulatory concerns for biopharmaceutical manufacturers.

The current long-term supply agreement between the two companies was extended for several years, ensuring that biopharmaceutical manufacturers will have a guaranteed, secure supply of insulin to use in the production of biologic drugs and the development of new cell lines.

Michael Troullis has been named chief financial officer, Quintiles Transnational Corp., effective immediately. Mr. Troullis had been acting chief financial officer for the past year. He will report to Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational.

Mr. Troullis joined the company in 1992 as director of finance, Europe. Prior to his appointment as acting chief financial officer, he was senior vice president and worldwide controller. Prior to joining the company, Mr. Troullis had a 10-year career with CooperVision, where he held several positions of increasing responsibility, finally as European finance director; and six years with KPMG in the UK.

"Mike's financial expertise and deep knowledge of Quintiles and our markets make him the best person to be the fourth CFO in Quintiles' 25-year history," said Mr. Gillings. "He has helped put in place the financial systems and controls needed to support Quintiles' growth from a small CRO to being the global leader in helping companies bring medicines to market faster and more efficiently."

The FDA has accepted for review GlaxoSmithKline's BLA for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain.

The BLA for the rotavirus candidate vaccine includes data from clinical trials conducted in the Americas, Europe, Asia and Africa in nearly 75,000 infants.

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.

Sancilio & Company, Inc. is expanding the analytical services offered through its FDA and DEA registered cGMP analytical chemistry lab at SCI's Riviera Beach, FL location.

Dr. Nealie Newberger, formerly of the Analytical Services Lab at SCI, is heading up business development efforts. Dr. Newberger has worked for such groups as Wyeth Ayerst Research and Vital Pharma, Inc. She obtained her Ph.D. in chemistry while working with the Marine Natural Products Group at Florida Atlantic University.

"Our team is known as the 'fire fighters' of the industry, and are ready to help pharmaceutical researchers and developers deal with the most challenging situations," said Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of Sancilio & Co. "We specialize in stability testing, shelf-life determination and trending, method development, verification and method validation. Our organization offers expert laboratory analysis using modern equipment, highly sophisticated SOPs, and a professional staff second to none. Data interpretation is performed by veterans of the industry with over 30 years of experience at executive levels. Our automated lab will report data back to the SCI client in less than 72 hours of receipt of samples using HPLC, GC, Dissolution, FTIR or TOC analysis," concluded Dr. Sancilio.

Icagen, Inc. has entered into a worldwide collaboration and licensing agreement with Pfizer for the discovery, development and commercialization of ion channel-focused therapeutics for pain and related disorders. The two companies will combine resources to identify compounds that target three ion channels. Pfizer will fund all aspects of the collaboration including the research and preclinical development efforts at Icagen and will have exclusive worldwide rights to commercialize products that result from the collaboration. Also, in connection with the collaboration Pfizer will make an equity investment in Icagen.

The ion channel targets included in the collaboration are important in the generation of electrical signals in nerve fibers that cause pain. In preclinical studies, compounds identified by Icagen have demonstrated efficacy in pain models.

"We are enthusiastic about entering into this collaboration with Pfizer," said P. Kay Wagoner, Ph.D., president and chief executive officer of Icagen. "By combining one of our multi-target ion channel pain programs with similar programs at Pfizer, we believe that together our scientific teams will be well positioned to capitalize upon this exciting therapeutic opportunity. Given that there are three different ion channel targets in the collaboration, we believe that there is a possibility for at least three unique products to emerge from this joint effort."

Under the terms of the agreement, Pfizer will provide $38 million to Icagen during the first two years of the collaboration, including an upfront license fee of $12 million, as much as $15 million through an equity commitment, and R&D funding. Icagen is also eligible to receive $359 million in research, development, regulatory and commercialization milestones for each product, as well as royalties.

EPIX Pharmaceuticals, Inc. has earned a $3 million milestone payment under its collaboration with GlaxoSmithKline related to the first of three discovery stage programs. EPIX has identified three lead candidates that will move forward into lead optimization in this first G-protein coupled receptor (GPCR) discovery program.
   
The two companies entered the multi-target collaboration in December 2006 to discover, develop and market medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases. The alliance includes EPIX's 5-HT4 partial agonist program and PRX-03140, which is in early-stage clinical development for the treatment of Alzheimer's disease. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn as much as $1.2 billion in milestones across the four GPCR programs. EPIX is also entitled to receive royalties on all product sales resulting from the collaboration. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
   
"We are extremely pleased with the progress of our collaboration with GSK," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "In addition to our joint focus on developing PRX-03140, our proprietary 5-HT4 agonist, for the treatment of Alzheimer's disease, EPIX and GSK have agreed upon the three discovery program targets and are making significant progress on each program. We are on-schedule and expect to continue moving forward to achieve key milestones across all of our collaborative programs."
   
"We have been impressed by the quality and efficiency of the lead identification process for this collaborative effort between EPIX and GSK," said Hugh Cowley, M.D., head of GSK's CEEDD. "In addition to the PRX-03140 program in Alzheimer's disease, we are moving forward with EPIX to discover and develop GPCR candidates for the treatment of a variety of diseases. This marks an initial milestone in what we expect will be a long and productive collaboration."

Dr. Hans Van Bronswijk has been appointed to the position of principal consultant for Parexel Consulting in its European Drug Development Practice. In this role, Dr. Van Bronswijk will advise clients on all aspects of clinical development and regulatory affairs with his in-depth knowledge of drug development and European Union (EU) regulatory procedures.

Dr. Van Bronswijk served on the Dutch Medicines Evaluation Board (MEB) for nine years as head of clinical assessment and was the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) member representing The Netherlands for six years. Dr. Van Bronswijk's experience also includes various positions within Novartis, most recently as global head of regulatory affairs for the transplantation and immunology business unit.

"We expect that Parexel clients will benefit from Dr. Van Bronswijk's internationally recognized drug development expertise and his unique combination of pan-European regulatory, medical, scientific, and pharmaceutical industry experience," said Dr. Alberto Grignolo, corporate vice president, Parexel Consulting. "This appointment reinforces our leadership in helping clients achieve successful international product registrations, clinical and manufacturing performance excellence, and product safety."

Patrick P. DeLuca, Ph.D., professor in the faculty of Pharmaceutical Sciences at the University of Kentucky College of Pharmacy, has been elected to serve as president-elect of the American Association of Pharmaceutical Scientists (AAPS), based in Arlington, VA. He will begin his term in November of 2007 at the AAPS Annual Meeting in San Diego, CA.

AAPS executive director, John Lisack, Jr., commented, “Dr. DeLuca has been deeply involved in the association and there is no doubt in my mind that his presidential term will more than live up to the standard of excellence that has been established by his predecessors.”

As president-elect, Dr. DeLuca will join 2008 president Karen Habucky, Ph.D.; Former president Gene Fiese, Ph.D.; Treasurer, Phil Mayer, Ph.D.; and John Lisack, Jr. on the executive committee of the AAPS executive council.

Also, Peter A. Crooks, Ph.D. and David Y. Mitchell, Ph.D., have been elected to three-year terms as AAPS members-at-large. They join Robert G. Bell, Ph.D., Patrick J. McNamara, Ph.D., and Janet C. Walkow, Ph.D. as the remaining members on the 2008 AAPS executive council.

Roche has filed an IND with the FDA for a Genmab antibody developed under the companies' collaboration. Genmab will receive a milestone payment from Roche.

Under the agreement with Roche, Genmab uses its antibody expertise and development capabilities to create human antibodies to a range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. Genmab may also obtain rights to develop products based on disease targets identified by Roche. Genmab stands to receive as much as $100 million plus royalties if all goals are reached.

"This will be the second antibody produced under our collaboration with Roche to enter the clinic and Genmab's seventh antibody to enter clinical development overall," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "Our partnership with Roche continues to bear fruit and add value to Genmab's expanding product pipeline."

Timothy Forsey, Ph.D. has been appointed principal regulatory affairs consultant at Kendle, specializing in providing regulatory affairs guidance to biotechnology customers. He will be based in the Ely, Cambridgeshire office in England and will work with customers to gain regulatory approval for marketing authorizations. Dr. Forsey will provide customers with advice on strategy and regulatory approaches to development and assist them with dossier preparation.

"As biotechnology's overall contribution to the healthcare arena continues to grow, so will the demand for outsourcing services, as new therapies move from preclinical to the clinical phases of drug development," said Melanie Bruno, Ph.D., vice president global regulatory affairs and quality. "Tim Forsey's experience with this customer group and in the regulatory environment will be a tremendous asset to our biotech and pharmaceutical customers seeking to move their new compounds from discovery to market approval," she added.

Dr. Forsey previously served as head of biologicals and the biotechnology unit for The Medicines and Healthcare products Regulatory Agency (MHRA), where he represented the UK on the Biologics Working Party of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA). He also worked as senior director, head of European regulatory affairs for Shire Human Genetic Therapies, Ltd. Prior to that, he worked for Pharmacia, Amgen, the National Institute for Biological Standards and Control and the University of London. He brings more than 30 years of pharmaceutical, governmental and research experience to his new role at Kendle.

John H. Johnson, formerly of Johnson & Johnson, has been named chief executive officer, ImClone Systems, effective August 27th. Mr. Johnson has more than two decades of executive and operational management experience in the biopharmaceutical and healthcare industries. He has held senior management positions of increasing responsibility at J&J and most recently served as company group chairman of its worldwide biopharmaceuticals unit, where he was responsible for the biotechnology, immunology and oncology commercial businesses, including Centocor, Ortho Biotech Products and the Worldwide Strategic Marketing Group.

"John has a strong track record in the biopharmaceutical industry and we are happy to have him serving as chief executive officer during this new era for ImClone," said Alexander J. Denner, Ph.D., chairman of the executive committee of ImClone Systems.

Paul Clancy has been appointed executive vice president and chief financial officer, Biogen Idec. He reports to James C. Mullen, the company's chief executive officer, and most recently served as senior vice president of finance, responsible for leading the treasury, tax, investor relations and business planning groups.

"Paul brings more than 20 years of experience in financial management and strategic business planning," Mr. Mullen said. "In his six years at Biogen Idec, he has repeatedly proven himself to be an effective and valued leader. With Paul's help, we will continue to optimize shareholder value by driving our strategic and operational plans."

Mr. Clancy has held several senior executive positions since joining the company in 2001, including vice president of business planning, portfolio management and U.S. marketing. Prior to joining the company, he spent 13 years at PepsiCo, serving in a range of financial and general management positions.

Bilcare has begun a capital investment project in an effort to enhance its global footprint and increase capacity and capabilities. The company is upgrading its packaging, storage and distribution facilities at its U.S. headquarters in Phoenixville, PA. The initial phase of the project includes an overhaul of each of the company's eight primary and 12 secondary packaging rooms.

The second phase involves the expansion of the company's nearby storage and distribution facility to 72,000 sq.-ft. and the construction of four new secondary packaging rooms. The secondary packaging rooms will be completed this month and the primary packaging rooms are scheduled for completion early in 4Q2007.

"With the sophisticated systems required to manage the production and logistics of clinical trial supplies on a global basis, our expanded and upgraded U.S. facilities combined with our strong foothold in India, UK and Singapore, leave Bilcare well-positioned to take advantage of the trend toward global clinical trials," said Vincent Santa Maria, Bilcare's global clinical services president. "These facility improvements further enhance our distribution, storage and packaging capability, and allow Bilcare to provide a higher level of quality and service to our customers as they conduct clinical trials in the U.S. and throughout Europe and Asia."

Wyeth and Solvay Pharmaceuticals received a "not approvable" letter from the FDA in response to the NDA for bifeprunox, an atypical antipsychotic for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients.

The FDA stated in the letter that bifeprunox demonstrated effectiveness in its long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The companies will meet with the FDA to discuss study design and to assess how this additional study, combined with ongoing and planned studies, might support a maintenance indication. The Agency also requested further information regarding human metabolism of bifeprunox, and additional information regarding a patient who died while participating in one of the trials.

"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," says Laurence Downey, M.D., president and chief executive officer of Solvay Pharmaceuticals, Inc. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."

"The development of bifeprunox offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy. We continue to support the development of the compound and the approach," adds Gary L. Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals.

The FDA has issued a "not approvable" letter for GlaxoSmithKline's sNDA for the 500/50 strength of Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD). Specifically, the agency questioned how the new dose compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request and determine next steps, including discussion of GSK's recent data on the reduction of exacerbations with the Advair 250/50 strength.

"We are very surprised and disappointed by this FDA decision, particularly given the outcome of the FDA advisory committee meeting earlier this year," said Katharine Knobil, M.D., vice president of respiratory clinical development for COPD at GSK. "The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward."

BASi

3Q Revenues: $12.6 million (26%)

3Q Earnings: $449,000 (loss of $1.8 million 3Q2006)

YTD Revenues: $34.8 million (+8%)

YTD Earnings: $1.1 million (loss of $1.9 million YTD2006)

Comments: Revenue growth was driven by a $2.7 million, or 34%, increase in service revenues, led by improvements in toxicology and clinical research operations. YTD growth was the result of a 10% increase in service revenues. Operating expenses in the quarter were $3 million, a decrease of $1.9 million, and were $8.4 million YTD, down $4.4 million. Expenses in 2006 included $1.3 million in write-downs of asset values at the company’s Baltimore clinic. The remainder of the decrease is the result of job cuts at the beginning of the 2007 fiscal year.

Abraxis BioScience, Inc.

2Q Revenue: $242.5 million (+51%)

2Q Earnings: $23.1 (loss of $90.8 million 2Q2006)

YTD Revenues: $454.7 million (+49%)

YTD Earnings: $34.2 (loss of $88.9 million YTD2006)

Comments: In the quarter, Abraxane revenue was up 116.7% to $78.7 million. The company recently announced plans to separate its proprietary business, Abraxis Oncology and Abraxis Research (ABI), from its hospital-based business, Abraxis Pharmaceutical Products (APP). Until the separation is complete, the company will continue to report in two segments: the ABI segment and the APP segment. ABI segment gross margin for the quarter was 92.2% compared to 86.5% in 2Q2006. R&D expenses were $15.5 million in the quarter up 5% but are expected to be to be in the range of $120 million to $130 million in 2007 as a result of acquisitions, licensing, and collaborations. Hospital-based product revenue for the APP segment in the quarter increased 32.6% to $159.3 million. This includes sales of $36.1 million from the anesthetic/analgesic products acquired from AstraZeneca in June 2006. R&D expenses were $12.9 million for the quarter up from $6 million due to the expense associated with its Puerto Rico manufacturing facility.

Merck and Neuromed Pharmaceuticals have discontinued development of NMED-160 (also known as MK-6721), a Phase II compound for the treatment of chronic pain. Their joint research collaboration will continue to evaluate other therapeutic candidates.

While no serious adverse events with the drug were observed in clinical trials, it was determined that MK-6721 does not demonstrate the "ideal pharmaceutical characteristics considered necessary to advance the compound further in development," according to a press statement.

"We are encouraged by what we've learned from MK-6721 and are continuing our productive collaboration with Merck with a focus on improving the pharmaceutical properties of our compounds to produce a best-in-class pain treatment," said Dr. Christopher Gallen, president and chief executive officer of Neuromed.

"Merck and Neuromed are committed to the further research and development of oral N-type calcium channel blockers for pain," said Dr. Darryle Schoepp, senior vice president, franchise head, Neuroscience at Merck. "Neuromed is a leader in the field of oral N-type calcium channel blockers and we are pleased with the results of our ongoing collaboration."

N-type calcium channel blockers represent a class of analgesics that are selective for calcium channels involved in pain signal transmission.

Galapagos NV's service division, BioFocus DPI, has entered into a new drug discovery collaboration with AstraZeneca, under which BioFocus will perform medicinal chemistry, computational chemistry and support biology and ADMET services for AZ's infection discovery program based in Boston. Total contract value for Galapagos will be $938,000.

This is the third collaboration between the two companies since August 2006. BioFocus DPI is also providing chemistry and supporting biology and ADME services for an AZ hit-to-lead program.

"We now have a global relationship with AstraZeneca, working with several sites based in Europe and the U.S.," said Galapagos' chief executive officer, Onno van de Stolpe. "This type of expansion fits very well with our strategy for growth of the BioFocus DPI service division."

"Our European colleagues have been pleased with the progress of the drug discovery programs ongoing with BioFocus DPI. The decision for our U.S.-based R&D to enter into this collaboration with BioFocus DPI is based on this productivity and the good working relationship between the two companies thus far," added Trevor Trust, vice president - Infection Discovery at AstraZeneca U.S.

Hospira

2Q Revenues: $869.4 million (+29.5)

2Q Earnings: $30.7 million (-43%)

YTD Revenues: $1.7 billion (+24%)

YTD Earnings: $1.3 million (-99%)

Comments: Pharmaceutical contract manufacturing revenues were $36.9 million in the quarter, down 26%, and $78 million YTD, down 23%. 2Q and YTD results include Mayne Pharma integration charges, and charges related to Hospira's manufacturing initiatives. R&D expenses were $52.5 million, up 35% in the quarter and $96 million YTD, up 37%, impacted by acquired in-process R&D related to the acquisition of Mayne Pharma.

Following yesterday's approval of HIV drug Selzentry, Pfizer chose to issue a statement regarding its clinical pipeline. The company announced that it has 47 active programs in its Phase II R&D pipeline—the largest in its history—and contends this will triple the company's Phase III portfolio by 2009.

"The growth of our Phase II cohort is encouraging progress toward meeting our target for our Phase III portfolio by 2009," said Pfizer's chairman and chief executive officer Jeff Kindler. "With the progress we are seeing in our pipeline, we are also continuing to target having a steady stream of new medicines from our internal R&D, four a year, starting in 2011. Our portfolio is very promising and focused on markets where we see substantial opportunities to meet unmet medical needs with innovative science and technology. We will continue to sharpen the focus and simplify the structure of our R&D organization so that we bring our pipeline forward to commercialization as rapidly as possible and enhance our productivity in all aspects of our clinical work."

According to the company, there are 99 total programs in development: 38 in Phase I, 47 in Phase II, 11 in Phase III and three in registration, awaiting regulatory action. Three compounds have entered Phase III, 14 have entered Phase II, and seven have entered Phase I.

Among the 47 programs in Phase II, 14 compounds were added and four were discontinued in recent months. The Phase II group covers a wide range of therapeutic areas including 20 treatments for cancer; 16 for cardiovascular, metabolic and endocrine diseases; 17 for pain and inflammation; 17 for neurological disorders and 10 for infectious diseases; as well as gastrointestinal, genitourinary, ophthalmology, dermatology and allergy/respiratory. Overall a total of 13 programs were discontinued.

The development pipeline has 14 biologic compounds, including vaccines and antibodies designed to treat cancer, rheumatoid arthritis, influenza and other serious medical conditions. The company is investing to further expand its presence in biologics and hopes to benefit from "certain development opportunities."

The number of Phase I compounds, which recently declined, now stands at 38, reflecting both transfers to Phase II and some attrition. The majority of Pfizer's Phase I compounds are targeted for trials the second half of 2007. New Molecular Entities comprise 85 of the 99 programs, with the remaining 14 covering new indications or enhancements for Lyrica, Geodon, Selzentry, Eraxis and Vfend, among others.

"In the last eight months, we have advanced 27 programs, with the loss of just 13. Our progress is especially gratifying since we are continuing to make major structural and organizational changes while we pursue all of these opportunities. We are revising the allocation of our capital so that we target the areas of greatest medical and commercial promise, and I am confident that you will see Pfizer bring forward significant new therapies to fight cancer, cardiovascular disease, neurological disorders, infections and many other conditions," said John LaMattina, president of Pfizer Global R&D, who announced his plans to retire from the company earlier this year.

Althea Technologies, Inc. has been selected by GeoVax Labs, Inc., an Atlanta-based biotechnology company, to manufacture its HIV-1 DNA (AIDS) vaccine for GeoVax’s Phase II trials, expected to begin in early 2008.

GeoVax AIDS vaccines are designed to prevent development of Acquired Immunodeficiency Disease (AIDS) caused by the HIV-1 virus by vaccinating individuals prior to the AIDS virus infection. The GeoVax vaccine regimen uses a “prime-boost strategy,” where participants receive the GeoVax HIV-1 DNA vaccine, which “primes” the immune system followed by the GeoVax HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines deliver more than 50% of the AIDS virus components but cannot cause AIDS.

Ongoing trials with GeoVax's preventive HIV/AIDS vaccine have indicated an acceptable safety profile and anti-HIV immune responses in as many as 100% of vaccine recipients.

Don Hildebrand, chief executive officer and president of GeoVax Labs, commented, “We are very pleased with our decision to use Althea as the contract manufacturer for our DNA-AIDS vaccines due to their long and well known expertise in this arena. The manufacturing of these vaccines for GeoVax’s Phase II trials is a very important step forward in our development plan and demonstrates our confidence in the future success of our AIDS vaccine program.”

Integrated Project Services (IPS) broke ground for RxElite Holdings, Inc.'s new Greenfield headquarters, distribution center and future manufacturing facility located in Nampa, ID. RxElite is engaged in the formulation and manufacture of specialty generic drug products.

The initial six-acre site includes the construction of a 76,000- sq.-ft. building designed to accommodate initial warehousing, new headquarters and distribution. Near and long-term plans allow the growth of the facility to include manufacturing at the new Nampa site, for a total of 230,000 sq.-ft. on 17 acres of land.

"IPS is the ideal partner to help execute RxElite's strategy to develop into a full-service manufacturer of a select group of GMP compliant ANDA drug products," stated Earl Sullivan, executive vice president, RxElite. "The systems we will create will set the platform for a flexible, cost-effective operation that enables both the growth of our top-line while maintaining the highest levels of service to our customers."

"We are very excited about the opportunity to support this major stepping-stone in the life cycle of RxElite," said Dave Goswami, president of IPS. "IPS is providing the technical know-how and expertise to support RxElite's aggressive goals for the design, construction, commissioning and validation of this new facility. We are committed to delivering high performance, technically complex facilities for all of our clients on time and on budget."

The FDA has approved Pfizer's Selzentry tablets, the first in a new class of oral HIV medicines in more than 10 years, according to the marketer. Selzentry blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV. Selzentry is expected to be available in the U.S. by the middle of September.

The FDA granted accelerated approval to Selzentry for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as "R5 virus."

An accelerated approval allows for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases. This approval is based on 24-week data. Longer-term data will be required before the FDA can consider traditional approval for Selzentry.

Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus' predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines.

Steven B. Engle has been named president, chief executive officer and a member of the board of directors of Xoma Ltd. Mr. Engle succeeds Jack Castello, the company's former president and chief executive officer, who announced his retirement plans earlier this year. Mr. Castello will remain with the company as non-executive chairman of the board during a transition period, expected to run through October of 2007.

"On behalf of the Xoma Board, I couldn't be more pleased that Steve has joined Xoma to serve as the company's next president and chief executive officer," said Denny Van Ness, a member of Xoma's board of directors who led the succession search. "His leadership experience in our industry, together with his expertise in therapeutic products, operations and corporate development, make him the right person to lead Xoma forward. I am confident in Steve's ability to enhance and execute the company's strategic plan to create value for Xoma shareholders."

Mr. Van Ness added, "I also want to thank Jack Castello for his strong leadership and years of service at Xoma. It is due to his efforts that Xoma is so well-positioned today. We appreciate his many contributions to the company and wish him all the best in retirement."

Mr. Engle has more than 25 years of executive leadership and biotechnology and pharmaceutical industry experience. He previously served as chairman of the board and chief executive officer of La Jolla Pharmaceutical Co. Prior to joining La Jolla, he held executive-level positions at Cygnus Therapeutic Systems and Micro Power Systems, Inc. He began his professional career with the Strategic Decisions Group and the Stanford Research Institute.

Bayer HealthCare and Nektar Therapeutics have agreed to develop and commercialize NKTR-061 (inhaled amikacin). NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality. Nektar's proprietary pulmonary technology would be employed to deliver a specially-formulated amikacin, an aminoglycoside antibiotic, for inhalation deep into the lung.

As part of this agreement, Nektar will receive milestone payments of up to $175 million associated with the successful development and commercialization of NKTR-061. This includes an upfront payment of $50 million. Folowing successful clinical and regulatory development of the product, the companies have agreed to co-promote the product in the U.S. and to share profits. For ex-U.S. sales, Nektar will receive tiered performance royalties up to a maximum of 30%.

Under the terms of the agreement, Bayer is responsible for the global clinical development, regulatory strategy, manufacturing and marketing of the product, with Nektar participating in all aspects of decision-making and governance.


"This new development agreement reinforces our commitment to fight infectious and respiratory diseases and is a natural fit with Bayer HealthCare's strategy of developing and marketing specialty pharmaceutical products," said Dr. Ulrich Kostlin, a member of the Bayer's executive committee.

Currently, NKTR-061 is being studied in Phase II trials for the adjunctive therapy of ventilated patients with hospital-acquired, Gram-negative pneumonias. These pneumonias are a serious problem afflicting patients even in the world's most advanced clinical settings and are responsible for a significant number of deaths. Increasingly, multi-drug resistant, Gram-negative bacteria have magnified the problem of hospital-acquired infection. Some 20-50 percent of patients intubated and on ventilators who acquire Gram-negative pneumonia will die. NKTR-061 (inhaled amikacin), if approved, would be administered while the patient is on the ventilator and also would allow for ongoing dosing (transition therapy) after the patient no longer requires ventilatory support.

This is the second collaboration between Bayer and Nektar. In 2005, they agreed to collaborate on the joint development of inhaled ciprofloxacin as a potential dry powder therapy for treating pseudomonal infections in patients suffering from cystic fibrosis.

Thomas B. Smith, M.D. has been named vice president, medical affairs, Kendle. Dr. Smith will develop and lead the company's new global medical affairs organization, aimed at enhancing delivery of Phase II-IV services worldwide. This team of medical directors will serve as medical and therapeutic advisors to customers in areas such as protocol design, endpoint selection and inclusion/exclusion criteria, providing a resource across the clinical development process in an effort to create efficiencies and maximize opportunities as a compound progresses through study and its lifecycle.

Dr. Smith most recently served as global medical director for Kendle, responsible for providing strategic medical and therapeutic leadership to clinical development projects with a particular emphasis in the Central Nervous System (CNS) therapeutic area.
   
Dr. Smith joined the company with 20 years of experience in clinical practice and the pharmaceutical industry, including positions as senior director, clinical R&D, at Akros Pharma, medical director, global R&D at Genzyme Corp., and associate medical director, neuroscience global pharmaceuticals R&D, at Abbott Laboratories.  
   
"This move further positions Kendle as a strategic partner for our customers across the clinical development process as they focus on maximizing the therapeutic potential for their compounds," said Candace Kendle, Pharm.D., chairman and chief executive officer. "With an increasing focus on novel drugs like TNF blockers and the multiple therapeutic possibilities these proteins bring, Kendle's Medical Affairs organization will provide a competitive advantage by offering expertise across the full therapeutic spectrum. We are thrilled to have someone of Dr. Smith’s caliber to lead the growth of this valuable resource within Kendle."

Regeneron Pharmaceuticals and Bayer HealthCare AG initiated a Phase III study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The study will compare the VEGF Trap-Eye and ranibizumab, Genentech's Lucentis, an anti-angiogenic agent approved for wet AMD. The study will be conducted for the FDA's Special Protocol Assessment (SPA).

The VIEW 1 trial is expected to enroll approximately 1,200 patients in more than 200 centers throughout the U.S. and Canada. The study will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of Lucentis administered every four weeks.

The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to Lucentis patients. After the first year of treatment, patients will continue to be treated and followed for another year.

Interim data from the ongoing Phase II trial in wet AMD demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks, compared to baseline. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well tolerated.

The two companies are collaborating on the global development of the wet AMD treatment, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market the VEGF Trap-Eye outside the U.S. and Regeneron maintains exclusive rights to the VEGF Trap-Eye in the U.S.

Dr. Jur Strobos has been appointed chief medical officer of InNexus Biotechnology, Inc. Dr. Strobos has extensive experience as director of policy research in the office of the Commissioner of the FDA and has a background in drug law, medical product development, and health care. Most recently, he was vice president of clinical research and regulatory affairs for Medicis Pharmaceutical Corp.

His areas of expertise include food and drug law, clinical study design and good manufacturing practices. He has been involved in the success of multiple drugs and devices through the FDA and will be working closely with Dr. Thomas Kindt, InNexus' chief scientific officer and previous director of Intramural Research at the National Institute of Health.

Dr. Kindt said, "Dr. Strobos joins InNexus as we prepare to launch our first pre-clinical development project. His experience is invaluable and his ability to develop our programs and articulate them to the FDA will be a critical aspect of our success."

Genzyme Corp. met its primary and secondary endpoints in a second Phase III trial of Mozobil in multiple myeloma (MM) similar to the recent trial in non-Hodgkin's lymphoma. The combined results of these two trials—in which patients with two types of cancer achieved more rapid and effective mobilization of stem cells in preparation for transplant than patients treated with current therapies—will support the drug's regulatory approval.

The randomized, double-blind, placebo-controlled trial included 302 patients undergoing a hematopoietic stem cell transplant (HSCT) for MM and examined the effectiveness of Mozobil in increasing the number of stem cells collected for a transplant. The trial then compared the stem cell yield from patients treated with Mozobil following G-CSF to patients treated with placebo following G-CSF.

In the primary efficacy endpoint, 72% of patients treated with Mozobil and G-CSF achieved the target threshold for collection, compared with 34% of patients in the G-CSF/placebo group. Like the previous trial, these results exceed the 20% absolute difference prospectively defined through the FDA's SPA as a successful result.

More than half of the patients treated with Mozobil and G-CSF reached the target cells in the first day of apheresis. By comparison, it took four days for a similar percentage of the G-CSF/placebo group to reach this threshold.

Secondary outcomes were consistent with the primary endpoint, showing a statistically significant result in favor of Mozobil. The drug was well tolerated in the trial, with the most common adverse events being mild gastrointestinal effects and redness at the site of injection.

AMRI

2Q Revenues: $49.4 million (+8%)

2Q Earnings: $4.6 million (loss of $353,000 in 2Q2006)*

YTD Revenues: $97.7 million (+10%)

YTD Earnings: $7.8 million (earnings were $1.5 million YTD2006)

Comments: Contract revenue in the quarter was $39.9 million, up 4%. Contract revenue from development and small-scale manufacturing was $10.6 million, up 25%, while large-scale manufacturing revenue was down 5% to $19.6 million. Revenue from discovery services in the quarter was $9.7 million, up 6%. YTD development and small-scale manufacturing revenues were $20.9 million, up 21% and YTD large-scale manufacturing revenues were $40.7 million, up 2%.

*2Q2006 earnings included charges of $2.2 million to reduce the carrying value of the company's former Mount Prospect Research Center.

Johnson & Johnson is restructuring and plans to reduce its global work force by 4% or approximately 4,820 jobs, in an effort to counter losses as a result of falling sales of its heart stents due to safety concerns and impending patent expirations for key drugs Risperdal and Topamax. The company expects to save $1.3 billion to $1.6 billion in 2008.

The company predicts that restructuring charges will be between $550 million and $750 million in the second half of 2007. According to the company, the restructuring primarily impacts its pharmaceuticals segments and its Cordis stent-making unit in Miami Lakes, FL. Under the restructuring, J&J will consolidate certain operations at the pharmaceuticals segment and integrate its Cordis business. J&J also plans to fire as many as 800 employees from its Alza and Scios subsidiaries.

"The actions we are taking are to ensure we've addressed the short-term pressures on the business," chief executive officer William Weldon told analysts during a conference call. "We believe we actually will be strengthening ourselves coming out of all of this."

"This type of impact is difficult but necessary," chief financial officer Dominic Caruso said, adding that J&J will use attrition and hiring freezes in certain areas of the business to lessen the impact on employees.

Abraxis BioScience, Inc. has acquired a sterile injectable manufacturing facility in Phoenix, AZ, from Watson Pharmaceuticals, Inc. This facility currently manufactures products for both Watson and third parties and is capable of manufacturing lyophilized powders, suspension products, and aqueous and oil solutions. Under the terms of the agreement, Abraxis will serve as a contract manufacturer for certain injectable products currently manufactured in this facility for a specified period of time. Financial terms were not disclosed.

This fully equipped facility is approximately 200,000 sq. ft. and includes manufacturing and chemistry and microbiology labs. Abraxis expects that this facility, along with its manufacturing facility located in Melrose Park, IL, will manufacture the company's current and future products such as Abraxane for Injectable Suspension after completion of the planned separation of its proprietary product business -- Abraxis Oncology and Abraxis Research (the new Abraxis BioScience) from its hospital-based product business -- Abraxis Pharmaceutical Products (APP).

"Subsequent to the announcement of our pending separation, we have made a concerted effort to make strategic decisions that support the long-term viability and growth of each operation," said Patrick Soon-Shiong, M.D., chief executive officer and executive chairman of Abraxis. "The acquisition of this facility will allow us to expand our cGMP manufacturing capabilities to provide the necessary infrastructure for worldwide growth of the new Abraxis BioScience."

MDS Pharma Services is expanding its Development & Regulatory Services (DRS) business in Europe and will now offer full-service DRS consulting services to support development of new drugs and biopharmaceutical products for clients in Europe. The DRS organization will also be fully integrated with consultants in the U.S. and Canada to provide product development consulting, program management, and regulatory affairs services.

"This expansion in Europe will greatly broaden our consulting capabilities in development and regulatory services," said MDS Pharma Services president David Spaight. "We will now be able to provide expertise to support our biotechnology and Asian pharmaceutical clients in the process of commercializing their products in North American and European markets."

This expansion includes the appointments of two industry experts, Didier Saur, M.D. as vice president of medical affairs, and Sarah Roberts, Ph.D. as senior director of regulatory affairs. Based near Paris, France, Dr. Saur will lead the MDS Pharma Services product development consulting, program management, and regulatory affairs services in Europe. He will also be responsible for organizing and chairing the medical advisory board for DRS. Dr. Saur has more than 20 years' experience as a physician in the pharmaceutical and contract research industry.

Dr. Roberts will be based near London and will provide regulatory affairs consulting for clients on European regulatory issues. She has more than 10 years' experience and is an oncology research specialist. Dr. Roberts has worked with the Dana Farber Cancer Institute in Boston, MA and the Gray Cancer Institute in London. She has experience with regulatory agencies in both North America and Europe, and most recently served as a director for Smart Regulatory Solutions Ltd, an independent consulting firm she established.

News from our sister sites