Marissa Shapiro

's (Holmdel, NJ) Chief Financial Officer, 

has also been promoted to Chief Operating Officer where in addition to managing the company's legal and human resource departments he will also oversee the day-to-day operations, provide planning and resource allocation, and advise the CEO and management team on key planning issues and business decisions. 

 (Somerset, NJ), Director of Environmental Health and Safety for Printed Components Business, will be filled by 

Working in the regulatory affairs sector in areas such as wound care, vaccine, and pharmaceutical manufacturing, 

 will use her past experience in her new position as Regulatory Affairs Manager for 

Twenty five years of experience in clinical research and business development has landed 

 a job as Vice President of Business Development for 

 (Columbus, OH) where he will develop and implement marketing and sales initiatives, and push for the company's services within oncology research and in other business areas. 

 (Lancashire, UK) has made two new additions to its team with the appointment of 

With a background of 25 years in international financial experience and 10 of those years being spent in the biotechnology industry, 

's (Paris, France) new Chief Financial Officer.  

 (Exton, PA) has made several additions to its team, including the appointment of 

, to the General Manager of CMC services and CTM manufacturing; 

, as Vice President of DMPK and bioassay for China operations; and 

 as Senior Vice President of business development.

Filling the role of Vice President of Strategic Alliances for 

 will become responsible for leading client relationship management and development efforts, as well as forging the partnership strategy for multinational expansion.

After serving as senior vice president of sales and marketing for 

's (Valley Forge, PA) AmerisourceBergen Packaging Group sister company, Anderson Packaging (Rockford, IL), 

 will now become Brecon's new Managing Director.

Vetter executives, along with Illinois Biotechnology Industry Organization and Economic Development executives, dedicate Vetter's new facility in suburban Chicago. 

Extending on a previous agreement, ICON (Dublin, Ireland) will continue to manage the clinical data management outside the United States for 

Four new task orders have been assigned to 

 (Baltimore, MD) by the FDA (Silver Spring, MD), requesting statistical analysis support and data conversion services for clinical trials.

 (Research Triangle Park, NC) with the responsibility of delivering the company's clinical pharmacology studies worldwide and across a range of therapeutic areas.

 (Princeton, NJ) to offer the company's InForm electronic data capture solution to its customers worldwide.

 (Dublin, Ireland) will enable the latter to use Medidata Grants Manager and CRO Contractor and to implement three analysis modules to further enhance its processes.

Adding four more years to a collaboration that began in 2004, 

 (Ingelheim, Germany) will continue to work together in the areas of CNS, inflammation, cardiometabolic, and respiratory diseases and because of the success in those areas will add oncology targets.

To develop six potential oncology products in 

 (Research Triangle Park, NC) will conduct Phase II proof-of-concept studies for 11 solid tumor indications.

To provide sponsors with a global network, particularly strengthening services in India, Europe, and Japan, 

 (Bangalore, India) have formed a strategic alliance.

Executive Vice President and Chief Information Officer of 

 (Research Triangle Park, NC), William Deam, has been named to 

At the 2009 Mass Technology Leadership Awards held in Boston, MA, the Mass Technology Leadership Council named 

 (Waltham, MA) the Private Sector Company of the Year.

Based on its percentage of growth and profitability over a three year period, 

 (Research Triangle Park, NC) was ranked number two at the annual Fast 50 awards, which recognize the 50 fastest growing private companies in the Triangle region of North Carolina. 

 (Paris, France) has won first prize in Deloitte's Technology Fast 50 of 2009, which ranks France's fastest growing technology companies.

Meeting the qualifying criteria of increasing revenues for the past three years as an independent, privately held, for-profit company; being headquartered in the Cincinnati regions; and having a three-year operating history, 

 (Cincinnati, OH) walked away as one of Cincinnati's 55 fastest-growing private companies for 2009.

 (Lund, Sweden) as one of the 50 best working places in Sweden.

Expanding its functional sourcing resources into Eastern Europe, 

 (Philadelphia, PA) intends on this presence to provide more cost savings for its clients.

Pivotal Laboratories, ACM Global Central Laboratory

 (York, England) is celebrating 10 years of providing central lab services throughout Europe.

 (Buckingham, England) has successfully passed its first routine inspection by The Medicines and Healthcare products Regulatory Agency (MHRA), with a report of zero critical findings, zero major findings, and only a handful of observations.

Now with advanced nuclear imaging function for cardiology clinical trials, 

 (Boston, MA) has expanded its medical imaging capabilities.

 (Cambridge, UK) has obtained a new Chinese Business License and is expanding its operations into China.

CTI Clinical Trial and Consulting Services 

CRS Clinical Research Services and CRS—Staff Leasing Services

 (Kiel, Germany) and will incorporate all of the company's employees as well as maintain CRS' headquarters.

's (Wilmington, NC) presence in the Asia Pacific market is its acquisition of 

, a large contract research organization located in China. PPD has also acquired 

, who has a presence in Beijing, which will help to expand the company into China.

 (Bromborough, England) is going to provide the company with a new headquarters and manufacturing facility located in North Wales, where it intends to create 54 new jobs with support from the Welsh Assembly Government.

The opening of a new office in Moscow, Russia, this past October will help to strengthen the CRO 

's (Bangalore, India) presence in Eastern Europe.

 (Ravensburg, Germany) has chosen Chicago as the location of its new facility based on its thriving biopharmaceutical region, established infrastructure, and talent pool of 70,000 to 80,000 professionals. 

Articles

Industry news focusing on the people and organizations who work in the clinical trials profession.

Business and People Update February 2010

						The former Vice President and Global Head of Quintiles eSolutions Business, 

, has now taken on the role of Head of Business Development for 

As the new General Manager of Pharmaceuticals for 

 will gain the responsibilities for sales and future expansion into Europe of the company's pharma businesses. 

With 25 years of successful sales and sales management experience, 

, as its new worldwide Executive Director, who will direct DIA's global operations and strategic expansion. 

 has been promoted to Director of Program Management, and 

, with the company since 2008, was promoted to Senior Director of Business Development. 

 (Munich, Germany) as a principal Consultant. 

 as Executive Vice President of Worldwide Sales.      

A multiyear agreement will put into effect the plans for 

 (Budapest, Hungary) to adopt and implement 

To provide sponsors with research and technology services for faster evaluations of treatment side effects, 

 (Kansas City, MO) have entered into an agreement.

 (New York, NY) announced a multiyear contract with 

 (New York, NY) for use of Medidata Grants Manager. 	

 (Yardley, PA) as one of the "Best Places to Work in PA" for 2009.

 (Waltham, MA) has won the 2009 Society for Clinical Data Management (SCDM) Data Driven Innovation Award competition for a joint project with customer Merck & Co.

Recognizing the company's therapeutic concept for the treatment of distinct orphan diseases, 

 (Appenzell, Switzerland) received the award for "European Orphan Diseases Entrepreneurial Company."

In acknowledgement of its contributions to medical communications, 

 (Flemington, NJ) is the 2009 recipient of the American Medical Writers Association's "Harold Swanberg Distinguished Service Award."

 (Philadelphia, PA) was honored with the award for Best New Product for its ePRO based suicidality monitoring solution at the 2009 European Outsourcing Awards.

 (Boston, MA) has officially been launched.

 (Wilmington, NC) has changed its name to 

As part of the reform of the health care system by the U.S. government, 

(Philadelphia, PA), attended a roundtable discussion with Governor of Massachusetts 

 to discuss how to promote widespread HIT adoption. 					

Launching resourcing services in Switzerland and Belgium, 

 (Basking Ridge, NJ) now provides personnel in over 50 countries.

To increase its presence in the North American market, 

 (Manchester, UK) will open a U.S. office in Boston, MA.

To accommodate demand in outsourcing of clinical supply management services,

(Craigavon, Northern Ireland) has completed a 67,000 square foot expansion to its North Carolina facility. 

 (Doylestown, PA) has released GenSight version 8.0., with features to further facilitate enterprise-wide portfolio management.

 (Waltham, MA) presents the newest version of open source electronic data capture (EDC) software for clinical trials. 					

 (San Diego) released Sages Templates Version 1.1.3, with redesigned and extended templates.

Upgrading its software in an effort to streamline supplier collaboration, 

 (Austin, TX) has released Xtended Process Control (X.PC) 5.7dm.

 (Wayne, PA) announced the release of StartingPoint 4, offering new content templates, improved functionality, and compliance with Windows 7. 

The ERT team accepts their award for Best New Product at the 2009 European Outsourcing Awards.

Business and People Update January 2010

• Formerly holding a quality management position at 

 (South Wales, UK) where he will manage a 22-person quality management team. 

• With 17 years of clinical research experience, 

 will work in the medical and clinical development division of 

 (Oldenburg, Germany) where he will perform clinical studies and prepare clinical reports for the pharmaceutical service provider. 

 (South Wales, UK) as the head of analytical services, in which he will manage 45 analytical chemists. 

• Filling the role of associate director of business development for Japan at 

 will work with the company's Japanese partner, Site Support Institute (SSI), to facilitate sales activities and improve domestic support of Japanese sponsors and sites. 

, PhD, has become the senior director of clinical statistics for 

 (Wayne, PA), where he will oversee all statistical activities and staff. 

 (Cincinnati, OH) as its new managing director of Europe and 

 will become the director of clinical operations. Both men will be located in the company's Germany office. 

• With more than nine years experience in the central laboratory industry, 

 will become the new head of business development in Europe for 

 (Durham, NC) increased productivity goals, the company has hired 

• The new clinical pharmacology unit of 

 (Dublin, Ireland), located in Omaha Nebraska, will become 

, MD, PhD, new place of work as he has been appointed the company's vice president and medical director. 

 (Dijon, France) as the Vice President of Drug Discovery, 

, PhD, will be responsible for  establishing and directing integrated drug discovery activities. 

 (Seoul, South Korea) has chosen to implement 

 (Redwood Shores, CA) Health Sciences applications, which includes the use of Oracle Remote Data Capture 4.5.3 and Oracle Clinical.

• To support the research and development for 

 (Corvallis, OR) exon skipping candidate drugs for treating Duchenne Muscular Dystrophy,

 (London, England) has collaborated with the company.

• A $145 million, five-year contract with

 (Whitehouse Station, NJ) to purchasing genomic analysis services from the company.

• The signing of a license agreement between 

 (Fort Lauderdale, FL) and a West coast clinical research organization will allow the CRO to use the company's TrialMaster solution in a technology transfer model.

• Being selected as the preferred provider for a top 10 pharmaceutical company, 

 (Washington, DC) has been awarded with several cardiac safety service contracts.

• Ranking 20th among America's fastest-growing small public companies, 

 (Waltham, MA) has moved up from 38 on last year's Fortune's Small Business 100 list.

• At the SAS Professionals Convention held this past July, 

 (Cary, NC) acknowledged a group of six from 

 (Middlesex, UK)—a niche CRO providing innovative clinical outsourced solutions—for their success in BASE SAS certification. Each person was awarded a certificate as well as £5000 worth of SAS training.

• Experiencing growth across the UK, Central and Eastern Europe, India, and South Africa, has led 

 (Manchester, England) to double its head office capacity.

 (Philadelphia, PA) to lead its global PR campaign.

 (Seattle, WA) has recently launched a newly redesigned version of its Web site.

 (Reston, VA) has recently launched CE-Dedicated FastTrack, a CE marking program intended to conduct reviews at an accelerated pace.

• With the anticipation of future growth at its Craigavon headquarters, 

(Craigavon, Northern Ireland) has the potential to create over 500 jobs during the next five years and has also acquired a 5.4 acre site.

• After changing its name from Cardinal Health to 

 (San Diego, CA), the company has taken part in a string of marketing activities, including being added to the New York Stock Exchange and ringing the bell on Wall Street.

Care Fusion's truck parked outside the NYSE. 

• The Web-based ePRO and late phase solutions company 

(Whitehouse Station, NJ) Seattle-based Gene Expression Laboratory. 

• After opening new offices in Belgium, Hungary, and Brazil, a new office in Edinburgh, Scotland, marks 

 (London, UK) fourth new office opening since the New Year.

Industry news focusing on the people and organizations who work in the clinical trials profession

Business and People Update November 2009

Sweeping regulatory and government changes are pushing pharma to do more than has been expected from them in the past. No longer is the development of a clinically proven, effective, and safe drug always enough. How do drugs compare to other's being marketed for the same therapy? How has the safety and effectiveness of this drug proven itself when used in real-life?  

This information is gaining more value and why it is becoming fundamental that companies begin to look at activities that were typically done in postmarket in earlier phases of a trial. 

Though postmarketing research is in the FDA's hands to enforce once a submission is received, "doing the right thing at the right time will reduce cost and promote better quality of care," noted Nayan Nanavati, vice president of peri-approval clinical excellence, North America for Parexel, while presenting at CBI's conference on registries and postapproval studies this past September. 

In this case, "the right thing" is more elaborate research and "the right time" is starting before the IND or NDA is submitted. 

Bringing in the idea of postapproval strategies earlier will allow for these activities to be factored into trial budgets. At the same time, gaining information from such investments makes for a more concrete foundation and better assurance for a drug. 

"In my group we are doing several safety-related studies, more than I have seen in the last 10 years," Nanavati offered. "And this shift has taken place in the last two years alone." 

If the resources are there, current trends suggest that safety-risk initiatives should be taken regardless if there is a requirement. 

The risks a drug presents should surface by the end of a Phase II trial. Acknowledging and understanding these risks while the study is still up and running enables safety-related issues to be addressed in real-time. Revisiting a trial and all the risks it presented through the entire drug development process can be taxing on a team's resources. 

"If you think of [REMS] at the end of Phase II you can start implementing tools, instead of conducting postmarketing studies at the end and having those costs," explained Jill Robinson, vice president of global safety surveillance and epidemiology for Wyeth and also a speaker at CBI's conference. 

If your drug presents a serious risk, preparation of a REMS is a wise step to take earlier on because upon submission the FDA will likely require it. 

If a drug is not considerably risky and a REMS does not seem likely to arise in a drug's foreseeable future, comparative effectiveness research is worth deliberation. It offers better insight into a drug's true effectiveness not only to treat a condition, but also how it compares to its competitors on the market. 

Similarly, patient registries also provide a unique and valuable information source for a drug's effectiveness and safety. Drugs can be evaluated for treatment of certain conditions and more specifically in various patient populations. 

"Current regulatory framework, which essentially focuses on efficacy, dictates we prove that a pharmaceutical product is proven to work better than a placebo," Nanavati explained. "The regulatory process must be optimized for there to be a way to integrate observational studies before IND submission." 

Gathering comparative effectiveness data on a drug gives sponsors an advantage, especially with the direction in which the health care reform is heading. If Obama's program follows through the prescribing process may see change because doctors will receive suggestions for what has been found to be the best drug for a particular condition. While this is intended to cut health care costs and avoid the use of ineffective drugs, it may very well cut reimbursements for sponsors. 

				With this comparative effectiveness research being collected it may become more of a factor in pharma company's go/no-go decisions.—

Implementing postmarketing strategies early on to avoid on-the-spot and costly requirements upon submission.

Preparing for Postmarket

 (Cambridge, UK) for many years, the current vice president of business operations for 

, will become the new Chairman for the organization. 

•Now the new vice president of project management for 

 will hold the responsibility of globally implementing and delivering the company's project assurance methodology, which will include developing and executing strategic plans to enhance customer service.

 (Fargo, ND), who will now manage operations, sales, and finance divisions of the company, the role of chief executive officer has been given to 

, who will now focus on business strategies and growth opportunities, including development of on-demand packaging and labeling. 

, MD, will gain the responsibility of providing clinical insight and site experience to clients and internal staff, as well as provide therapeutic training, industry white paper leadership, speak at industry conferences, and represent the company's special interest groups. 

 (West Lafayette, IN) has expanded its business development team in the United States with 

 now representing the company in Canada and the Western United States, including California, Oregon, Washington, Idaho, Nevada, Utah, Montana, Arizona, and Wyoming. 

•The former founding executive, president, and chief scientific officer of 

, PhD, is now the chief operating officer of 

Professor So Iwata, an Imperial College London scientist, accepting his Â£2 million Diamond Fellowship from the Biotechnology and Biological Sciences Research Council. 

' (New York, NY) Medidata Rave EDC solution, 

 (Basel, Switzerland) will deploy its software as its core EDC system in a phased, multiyear approach across its five disease biology areas.

As a new collaboration to support Phase I cardiac safety clinical trials, 

 (Portland, OR) Ambulo 2400 ambulatory blood pressure monitoring (ABPM) systems into its suite of offerings.

 (Redwood Shores, CA) clinical data management platform, 

 (Philadelphia, PA) has recently implemented the company's enhanced EDC application, Oracle Remote Data Capture Onsite 4.5.3.

 (Newark, DE) has entered into an alliance with 

Taiwan's Development Center for Biotechnology

 (Xizhi City, Taiwan) to provide biopharmaceutical companies with comprehensive drug development services ranging from preclinical through clinical services.

Upon a three-year agreement signed with the 

 (Philadelphia, PA) will enhance or upgrade its software products already in use at the agency as well as provide maintenance and support.

To cover such employment gaps as seasonal fluctuations, and maternity or holiday leave and to provide an additional resource option, 

 (Birmingham, UK) to implement a UK-wide temporary staff Recruitment Process Outsourcing solution.