Switzerland-based inVentiv Health Communications/Europe (iHCE), an inVentiv Health company, is opening its new operational headquarters in London to serve as a hub for all European offices and support the rapid growth of the company’s consolidated communications business.

Created in August 2011, iHCE focuses on building a “super agency” governed by a single management philosophy that collaborates among inVentiv’s advertising, public relations, public policy, market access, medical education, marketing, branding and digital services. The new hub will enable iHCE to create teams that view problems from multiple perspectives and then draw upon the needed expertise.

Separately, inVentiv Health launched MySTRO, a multichannel marketing and sales solutions company with offices in Colorado and New Jersey. MySTRO provides sales force support, telephone and remote personal selling, print and direct mail, sample accountability and compliance services. MySTRO brings together two legacy inVentiv businesses: Promotech and PRS Franklin.

MySTRO has introduced Reptivate, a virtual detailing product using digital technology to accelerate and enhance direct-to-healthcare provider interactions and increase prescription growth while keeping cost levels low for clients. Reptivate’s integration with MySTRO’s call center CRM and sample inventory management systems include promotional offer solicitation, fulfillment and sample accountability.

In addition, Reptivate—a Web-based tool—allows doctors to receive the same medical information from MySTRO’s call center staff in a virtual environment as they would from sales representatives who meet with physicians in person.

AmerisourceBergen has agreed to purchase World Courier Group, a privately held global specialty transportation and logistics provider for the biopharmaceutical industry, for $520 million in cash.

Stamford, Conn.-based World Courier, which provides transportation, storage and distribution services for multinational biopharmaceutical clinical trials in addition to other end markets, will become a new operating segment within AmerisourceBergen.

World Courier’s president Wayne B. Heyland will continue in his position, reporting directly to AmerisourceBergen president and CEO Steven H. Collis.

AmerisourceBergen services healthcare providers and pharmaceutical manufacturers, providing drug distribution and related services to reduce costs and improve patient outcomes. Its services range from pharmacy automation and pharmaceutical packaging to reimbursement and pharmaceutical consulting services. Headquartered in Valley Forge, Penn., it has $80 billion in annual revenue and approximately 11,000 employees.

World Courier’s annual revenues are expected to be approximately $500 million in calendar year 2012. It has over 137 offices, 13 GMP-compliant storage depots and 2,500 employees in 52 countries.

ASLAN Pharmaceuticals has selected PharmaNet/i3, inVentiv Health’s clinical segment, as a strategic partner supporting the development of its oncology portfolio in Asia and conducting phase I and phase II clinical trials for two of ASLAN’s compounds.

PharmaNet/i3 has been conducting clinical studies for innovative oncology products since 1996 and has on-staff oncologists dedicated to developing cancer treatments. It has extensive experience in developing a variety of cytotoxic chemotherapies, monoclonal antibodies, pathway inhibitors and therapeutic vaccines. More than 400 local, regional and global oncology clinical trials have been awarded to PharmaNet/i3 in the past five years, including more than a dozen registration programs, seven of which resulted in NDA/MAA approvals.

Australia-based CRO CPR Pharma Services will open Singapore’s first bio-analytical laboratory. CPR said the Singapore clinical trials market is expected to grow to over $166 million by 2015—with more than 80% of trials being of international origin.

Yet, to date, there has not been a locally-based, accredited provider of bio-analytical services to support the country’s growing clinical trials and R&D markets.

"Singapore is a hub to multi-national pharmaceutical companies. It has an impressive research environment and a great infrastructure, which attracts early-stage clinical trials," said CPR’s CEO Jason Valentine, adding that the lab is expected to employ 15 technicians over the next three years and bring millions of dollars into the Singapore economy.

The lab was built and is expected to be utilized by CPR’s strategic partner, Singapore-based pre-clinical services company Maccine Pte. The strategic partnership with CPR brought a much-needed facility to the Asian region, said Maccine’s CEO Leigh Berryman. “We have been sending samples for analysis to laboratories in Europe and the U.S., which is both costly and time consuming and has an inherent risk in shipping. Now these samples can be analyzed right here in Singapore,” he said.

Valentine said the Singapore lab is the first paperless laboratory in the region. Phase I and II clinical trials are increasing in Singapore due to a strategic governmental focus on early-stage clinical trials and investments made by major pharmaceutical companies such as Pfizer, GlaxoSmithKline and Eli Lilly.

In 2010, Roche announced a $134 million translational medical research hub in Singapore. Pfizer, Merck and Eli Lilly have joined forces to create the Asian Cancer Research Group to accelerate research into lung and gastric cancers in Asia.

The Singapore government is strategically targeting specific therapeutic areas for its CRO sector, including oncology. Singapore is home to three public and three commercial phase I clinical trial sites.

Launched in 2009 after a spinoff from the University of South Australia in 2006, CPR has grown rapidly in early-stage clinical trial work. In 2010, CPR’s Adelaide facilities were the first existing laboratory to have an FDA audit. “The FDA audit and approval are really the gold standard,” said Valentine, “and is a huge selling point from a global competitiveness perspective.”

Lincoln, Neb.-based Celerion, a provider of early-stage drug development solutions, and Ricerca Biosciences, which offer discovery, preclinical and development services, have formed "The Biosimilars Alliance" focused on preclinical and early clinical assessment of biologics manufactured by a new supplier.

The market for biosimilars is forecast to grow from $2.4 billion in 2012 to $44 billion by 2020. While there has been an established pathway for the approval of biosimilar products in Europe for several years, the FDA has only recently issued its guidances. The foundation now exists for development of newly sourced versions of some of the most effective treatments that have emerged from medical research in the last 20 years.

The Biosimilars Alliance offers all of the specialized services required to perform early assessment of the viability of a potential biosimilar product, before beginning costly multi-center comparator studies in target patient populations, including in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies to support CTAs and INDs.

The Biosimilars Alliance also provides access to bioanalytical assay development to enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modeling, immunogenicity screening during clinical studies and the regulatory and integrated project management support to ensure timely results for strategic decision-making.

Over the last decade, nonprofit pharmaceutical companies and product development partnerships have been launched to focus on neglected diseases. But because no nonprofit CROs have existed to assist with trials, they have had to pay commercial CROs market rates for their work. But now, Ellen Morgan, co-founder and former president and CEO of CRO Synteract, has launched Public Health Alliance for Clinical Trials, or PHACT, the first-ever dedicated, U.S.-based nonprofit CRO.

Its purpose is to conduct clinical trials for biotech and pharmaceutical products to treat diseases disproportionately affecting the poorest people in developing countries. The plan is to offer traditional CRO services for 40% to 60% less than the average for-profit CRO would charge. Morgan said PHACT will attempt this with a combination of training and employing local professionals for trials, rather than flying in personnel from the U.S., and using as much technology as possible to streamline processes and keep overhead down.

Morgan, who so far is financing the effort herself, launched PHACT with partners Christian Sacher, founder and CEO of Munich, Germany-based, 100-employee CRO Verum; and Ghana-born Yaw Asare-Aboagye, a biostatistician and long-time advocate for clinical trials in developing countries.

PHACT’s focus, Morgan said, is to build operations in areas where the need exists but CRO infrastructure is lacking. Initially the organization also will collaborate with local CROs in other developing countries as appropriate.

Through Verum, San Diego, Calif.-based PHACT has capabilities throughout Eastern Europe and opened an office in Dhaka, Bangladesh, in late 2011. Early this year, it opened an office in Accra, Ghana.

Morgan said she hopes to attract nonprofit drug companies; the nonprofit arms of for-profit pharma companies; and product development partnerships, or PDPs, nonprofit entities that partner with pharma companies to work on drugs for neglected diseases.

It used to be that pharmaceutical companies would develop drugs and then hope payers would eventually add them to their formularies. But today that relationship between sponsor (or CRO) and payer is becoming far more sophisticated, with sponsors increasingly meeting with payers during the drug development process to test the waters.

CRO Quintiles wanted to know how this is changing the way in which sponsors and CROs do business, and commissioned research, forecasting and analysis firm Economist Intelligence Unit (EIU) to survey senior executives in the life sciences industry.

The result: the majority of 399 executives surveyed said they had made at least one change to their business models to better demonstrate value to payers; 82% said they made a change to R&D strategy; and 78% said they changed their commercial strategy.

Asked what steps their companies had taken during the last three years, the top three responses were: increased collaboration with external commercial and non-commercial partners; sought out new market opportunities in which value is easier to demonstrate (e.g., products addressing conditions with few existing competitors); and changed focus from the cost of the products themselves to the cost implications of how the products fit into the overall treatment.

John Doyle, senior vice president of Quintiles Consulting, said while the industry tries to figure out how best to work with payers, he’s seeing a few key trends emerge. Those conducting trials are starting to ask payers how they could change their trials to make the results more meaningful in the real world, Doyle said.

"For instance, do we need to make a comparison with some gold standard drugs so we can differentiate our product?" he said. "It’s no longer about promotion; it’s about differentiation."

In recent years, Doyle said, “reimbursability” has become a key factor in evaluating companies, and pharma has taken note.

To help biopharmaceutical companies navigate the complexities of the Asia market, Quintiles has launched two services—Strategic Drug Development and Consulting at Quintiles—to bolster the probability of success in developing and commercializing new medications in the region.

Strategic Drug Development was designated specifically to help biopharma companies design and implement strategies that take into account the Asia product commercialization opportunity and regulatory hurdles in advance of the standardized development process.

The Consulting at Quintiles practice in Asia helps customers navigate the New Health by linking business strategy, industry expertise and data-driven insights within six practice areas across regulatory, clinical and commercial.

Covance will increase its annual capital IT spending by $25 million this year and another $25 million next year. That adds up to a total of nearly $90 million in 2012 and $115 million in 2013, an increase in IT spending of 17% and 18%, respectively.

The investments include a new clinical trial management system and a new electronic trial master file, as well as upgrades necessary to consolidate 34 data centers down to three. The first release of the new clinical tools is slated for the third quarter of 2012, the company said.

The timing, however, is not the best for Covance. These large sums need to be spent at the same time Covance announced that weak demand for toxicology services in Europe is negatively affecting the company’s early development results. In the fourth quarter, Covance cut 5% of headcount at its European toxicology unit.

NHS Research Scotland (NRS) and CRO PPD have formed an alliance designed to increase the amount of clinical research conducted in Scotland, accelerate the development of new medical therapies and enhance healthcare treatment options for the people of Scotland.

PPD will work closely with the major health boards across Scotland to further reduce study start-up times, streamline regulatory approval processes, increase the number of patients recruited for clinical trials and ensure the availability of resources and training to increase the number of physicians and support staff conducting research.

The initiative covers a broad range of phase I-III trials across multiple therapeutic areas, as well as biosimilar and post-approval studies. A significant percentage of Scotland's 5.3 million people have participated in a clinical trial, and Scotland has a high incidence and prevalence of diseases in key therapeutic areas of focus in clinical research.

PPD's team of more than 300 professionals in Bellshill, Lanarkshire, offers expertise in clinical management, data management, project management, pharmacovigilance, biostatistics and quality assurance.

"Scotland's intellectual and technical resources, coupled with recent advances in streamlining processes for conducting clinical research, make Scotland an extremely attractive location for clinical research," said Roger Newbery, Ph.D., PPD's vice president of clinical management for Europe, the Middle East and Africa.

Charles River Laboratories has launched Eureka, an online community for scientists "to explore, connect and share big ideas." The site profiles scientific professionals at Charles River Labs and welcomes industry experts to share their research and opinions on industry topics and questions.

The site also includes podcasts, videos and blog postings. According to Charles River Labs, "Eureka aims to stimulate your thinking and pique your curiosity. We want you to think, re-think and share in our Eureka moments."

The company said it is in the initial stages of building the online community and is also active on Facebook, Twitter, LinkedIn and YouTube.

Parexel International has established an alliance with University Hospitals Bristol National Health Service (NHS) Foundation Trust (UH Bristol), one of the largest specialist teaching and research hospital trusts in the U.K.

"UH Bristol is an ideal alliance for us because of its experience in conducting clinical research, access to substantial patient populations and work across multiple therapeutic areas," said Sy Pretorius, M.D., M.S., M.B.A., corporate vice president and worldwide head of early phase for Parexel. "Our focus is to provide more efficient delivery of better, faster go/no-go decisions."

UH Bristol, the region’s largest provider of medical and dental teaching, is a leading research center and one of the largest acute NHS trusts in the country. It employs over 7,900 and delivers over 100 different clinical services from a group of nine hospitals in the city.

Parexel assists clients with complex early-phase trial design and execution from first-in-human (FIH) through proof-of-concept. It has hospital-based units in the U.S., Europe and South Africa as well as a network of alliance sites.

Sunnyvale, Calif.-based CRO ProTrials Research has created a wholly owned subsidiary to help meet its sponsors’ increasing needs for multi-national, multi-site clinical trials. Based in the U.K., ProTrials Global will help manage ongoing clinical trials in Italy, Spain and the U.K., and will be responsible for additional growth in Europe.

"With ProTrials Global based in the U.K., we are in a stronger position to help sponsors simultaneously conduct clinical trials in North America and Europe and guide them in the different complexities for conducting clinical research abroad," said Jodi Andrews, co-founder and CEO of ProTrials.

Founded in 1996, ProTrials Research is a specialized CRO with regional clinical research associates and project managers based throughout North America, Canada and Europe.

There’s a new twist on the clinical trials industry’s booming partnership trend: A three-way strategic alliance forged by a biotech company and a CRO, actively looking for a pharma company to complete the trio.

Devised by biotechnology firm Intarcia Therapeutics of Hayward, Calif., to speed development of its type 2 diabetes drug, the plan has Quintiles handling the global trials for the drug and also buying into it. The two would then join in finding a high-level third partner with experience in the diabetes realm that eventually would handle sales.

"We feel like this is the next step in the evolution of the industry,” said Chip Gillooly, vice president of Quintiles’ Capital Solutions group, which worked on the alliance. "It allows biotechs to innovate, it allows CROs like us to put the strategy and execution together, and it allows pharma to find the most appropriate ways to deliver needed drugs to populations around the world."

Gillooly said this type of arrangement helps trim out the waste that can sometimes occur if the CRO doesn’t own a piece of the drug and isn’t particularly motivated to finish the trials quickly and efficiently, or if a pharma company buys into a biotech drug and then doesn’t move very expeditiously on it.

This is one of the largest operational-risk partnerships in Quintiles’ history, said Gillooly. The CRO has provided risk capital around the product itself; if the product succeeds, Quintiles will receive a return on investment. Quintiles will be working on five phase III trials running in parallel, as well as a cardiovascular outcomes study, each two to four years in length. But the alliance could continue beyond that. "We hope we’re partners in perpetuity," he said.

Meanwhile, Quintiles is in talks with other biotechs and pharma companies about forging more such relationships.

"The traditional model, we feel, is vulnerable, if not broken,” said Gillooly. "A pharma or biotech company simply tells you what to do. The CRO isn’t usually incented to see that the programs are executed properly. I think we have to find ways to build a new ecosystem where we’re all incented to bring products through development as efficiently as possible."

If all goes well, Intarcia’s ITCA 650 would be the first and only once-yearly injection-free therapy for the treatment of type 2 diabetes, which affects 350 million people. Start-up activities have already begun for the trials, and Quintiles is working toward initiating patient enrollment in the current quarter.

Signaling its plan to expand its business model in the Pacific Rim and build a global presence as a large imaging and cardiac safety core lab, CoreLab Partners is opening of an office in Tokyo under the wholly owned subsidiary CoreLab Partners Japan.

"This expanded presence is a natural extension of our geographic reach and global strategy to serve our growing base of multinational biopharma companies operating in the region and will complement our operational capability which was established in Shanghai, China over a decade ago,” said CoreLab Partners’ president and CEO, Dr. Mike Woehler.

CoreLab Partners currently has a business alliance in Japan with Suzuken, which markets its cardiac safety services.

Quintiles is opening a business process outsourcing (BPO) and project management center of excellence in Dalian, China, a major city with a multilingual workforce and location ideally suited to serve the Japanese, Chinese and South Korean biopharmaceutical markets.

The Dalian office will provide data management, medical writing, biostatistics, pharmacovigilance, post-marketing safety surveillance and back-office support for administrative functions for global and local biopharma companies. The office also will support clinical operations for study sites in northeast China.

Dalian’s strategic location and talent pool will allow Quintiles to provide clinical services in English, Japanese, Korean and Mandarin (the local workforce is multilingual and has a cultural understanding of its neighboring countries), a valuable offering for both North Asian and global customers seeking to expand in the region or who want to ensure business continuity through resource diversification.

"Following the success of Quintiles’ Bangalore BPO center, which has over 1,000 people supporting global studies, the Dalian Center of Excellence will provide a North Asia support structure for our growing business in Japan, Korea and China," said Anand Tharmaratnam, senior vice president and head of Asia markets for Quintiles.

Quintiles anticipates growing the Dalian center to 500 staff in the next several years once all services are fully established. It will be the company’s fourth hub office in greater China (in addition to Beijing, Shanghai and Hong Kong).

CRO Icon has signed a strategic partnership with Shire Specialty Pharmaceuticals to serve as the sole global provider of central laboratory services and one of two strategic partners for clinical development services.

The partnership will allow Shire to utilize Icon’s central labs’ extensive test menu from its global network of laboratories. As partner in clinical development, Icon also will provide Shire with services including clinical trial monitoring, ethics and regulatory submissions, site and country feasibility, medical management and medical data review, site and study team support and project management.

Quintiles has formed a Digital Patient unit that brings together the company’s online communities and digital expertise to directly engage patients.

The goal is to provide patients with information to better manage their personal health and to provide them with opportunities to participate in clinical research, observational studies and programs to better manage their conditions.

"Today, patients are as likely to seek information online about personal health as they are about the weather,” says David Coman, senior vice president at Quintiles and head of its new Digital Patient unit. "By unifying our digital patient resources, we will be better able to deliver proper content to patients while providing our customers with a more efficient channel to find the appropriate people who may be interested in participating in clinical, observational or disease management programs."

Quintiles’ new Digital Patient unit has the ability to recruit patients by combing for patients seeking information to manage their health, and its two patient communities, www.MediGuard.org and www.ClinicalResearch.com.