Increased use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, according to Pacific Biometrics (PBI) that turned its operating income from loss to profit in fiscal 2009.
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving efficiencies.
US CRO Health Decision says the new “Monitor View” module for its HD360 trial management system makes assessing study site performance an easier and more cost effective process.
West has opened its first manufacturing facility in China to meet rising demand but the process has taken since 2006 and been “very tedious”, its president of West Asia Pacific told Outsourcing-Pharma.
The Chao Center for Industrial Pharmacy and contract manufacturing is to donate $360,000 worth of the antibiotic Seromycin to the Global Health Committee’s fight against multidrug rtesistant tuberculosis (MDR-TB) in Cambodia and Ethiopia.
ethica Clinical has added biomarker data analysis technology to its roster of services in a C$1.25m (€782,899) deal with fellow Canadian CRO Matrix Pharma.
Quintiles has opened its expanded facility near Edinburgh, Scotland, which has doubled its central lab capacity with the intention of improving the CRO’s service offering in Europe.
GATC Biotech has expanded its human genome sequencing services and, having performed a pilot study, is “amazed” by the potential the techniques have for cancer research and diagnostics.
Improved access to data and the ability for users to share comments are among the features added to latest version of Veracity, an electronic data capture (EDC) system from Kika Clinical Solutions.
Portugese CMO Hovione has had its captisol manufacturing contract extended until 2019 in a new agreement with US specialty drugmaker CyDex Pharmaceuticals.
LGC Standards has made the “next logical step” in its “concerted effort” to expand internationally by opening an office in St Petersburg, Russia, less than six months after it moved into China.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.
Funding increases have failed to boost pharma drug development productivity and, with budgets tightening, the industry must revise its operations to improve output, according to a research paper.
Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, Gillian Corken, head of Quintiles in Africa, told Outsourcing-Pharma.
Market intelligence giant IMS Health has extended its KPO market and sales analytics offering and signed a new collaboration deal with Indian IT contracting group Tata Consultancy Services (TCS).
A totally outsourced model of discovery is “probably valid”, according to a report that believes pharma must overhaul its operations because its business model is in danger of becoming “irrelevant”.
Lab Research (LRI) aims to boost its Korean presence in a new agency deal with Safe Chemicals that, CEO Luc Mainville says, will meet growing demand for large molecule contract R&D.
Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.
Novasep’s API manufacturing facility in Le Mans, France has been certified under the potent compound safety programme run by occupational health and safety specialist SafeBridge Consultants.
QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of health (DoH), according to unit president Vincent Yen.
Pharma companies can cut the risk of taking a TKI into Phase I by using the HemoRANK in vitro test, according to ReachBio that has developed the assay to evaluate a molecules clinical hematotoxicity.
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.
Revenues from Pall’s biopharmaceuticals division grew in fiscal 2009, excluding foreign currency changes, with the company benefiting from the “thriving market” for vaccines and expanding adoption of single-use systems.
Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.
Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a deal for preclinical safety testing.
Orasi Medical claims CROs and pharmas can cut the cost and length of Alzheimer’s trials, and improve accuracy, by using its brain function measuring service, which is now being promoted in Japan.
US firms Xybion Medical Systems and Locus Technology say their new animal management and data analysis partnership will help streamline preclinical development and reduce research costs.
Dishman is pushing ahead with its international expansion, increasing efforts to win contracts in the US and Japan and nearing completion of a facility Shanghai, China, which is the first it has built outside of India.
Hyderabad, India-based Makro Care says its GCP “helpdesk” website has already proved to be an invaluable information source for contract research organisations (CRO), investigators and pharma trial sponsors.
Biotechs that partner or outsource in emerging markets are better equipped to innovate and prosper, according to research that warns “if you are not in Shanghai, Mumbai, or Dubai, watch out".
The new partnership with Indian CRO Abridge Clinical Research (ACR) is a unique collaboration offering cost efficient and timely trial solutions according to Global Pharmaceutical Services (GPSI) spokesperson Keith Russell.
Russia-based CRO SynRG has cut the time to prepare a detailed proposal from two weeks to two hours, giving the company a competitive advantage over its rivals, and established a presence in the US to target small to mid-sized companies.
US contract research organisation (CRO) Advion BioServices has expanded its biomarker business in an effort to meet growing industry demand for pharmacological analysis.
The outsourcing “market is poised to return to healthier growth rates in 2010”, according to the president of MDS Pharma Services who also told Outsourcing-Pharma that CROs will play an increasingly important role in drug development.
Aushon BioSystems has added laboratory and manufacturing capacity to its corporate headquarters to meet rising demand from clinical trials for some of its protein biomarker services.
Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.
With Lonza and JLL competing over Patheon Outsourcing-Pharma looks at what the CMO offers to a prospective buyer, analysing its global manufacturing capacity and backlog using interactive maps and graphs.
Encorium has outlined plans to specialise in vaccines, which it believes is an area it can be more flexible than big CROs, and inked a swine flu deal as part of $8.7m (€6m) of new contracts.
Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.
New multi-million dollar R&D contracts with top three pharma and biotech players go someway to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.
CRO Averion is planning to become a private company to reduce expenditure on auditor fees, which could realise savings of $805,000 (€561,000), and allow management to better focus on long-term goals.
