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44 DRUG DISCOVERY AND DEVELOPMENT


required for a given trial by 20- 40%. Tis not only decreases the cost and time it takes to conduct a trial, but also eliminates some of the factors that make results more difficult to interpret.


For Quintiles, the focus is on the clinical development needs and goals of emerging biopharmaceutical companies.


To this end it has launched the Quintiles Emerging Biopharma Solution to improve both service delivery and the probability of product success for the sector.


“Tis new offering focuses squarely on those challenges – combining an operational model designed to meet these customers’ needs with access to Quintiles’ global infrastructure, integrated technology and therapeutic expertise,” noted Paula Brown Stafford, president of clinical development at Quintiles.


Real time data access Te idea is that this new operating model leverages Quintiles’ integrated technology platforms to provide customers with real-time data access as well as a transparent view of project performance.


In addition to providing a dedicated leader with emerging


biopharmaceutical operations expertise, the offering includes senior-level sponsorship for each customer.


“Tis level of support provides easy access to the unique expertise and nimble operational support required by these companies,” says the company.


Oncology expertise Te new offering covers all therapeutic areas and, says the company, adds to the proven oncology expertise of Novella Clinical – Quintiles’ oncology service provider for emerging biopharmaceutical customers.


Te company is recognised as a leader in Phase I and Phase II/III research among small biopharmaceutical customers and has worked with 240 of them since 2009. Its activity in this sector has more than doubled in the last year.


In collaboration news, Covance has signed a research deal with Frenova Renal Research that will seek more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).


Tis collaboration enables Covance to use its powerful analytics capabilities to conduct research on behalf of


Parexel acquires ClinIntel P


arexel has bought UK-based ClinIntel, a specialist provider of clinical randomisation and trial supply management (RTSM) services. ClinIntel’s


offerings now will be combined into Parexel’s ClinPhone RTSM suite, technology that is designed to make patient randomisation and clinical supply chain solutions more efficient. Together, the advanced RTSM technologies will


offer improved planning, forecasting and supply chain eLogistics. They will also be aimed at accelerating study start-up timelines. The entire ClinPhone RTSM suite will be available through the Perceptive MyTrials platform and as a standalone solution, and both solutions will


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be available through Parexel’s Perceptive Partner Programme. Perceptive MyTrials is one of the industry’s leading


suites of applications for managing clinical trials. Its flexible, open architecture allows partners to integrate targeted, specialised solutions within the platform. This gives their sponsor customers efficient access to clinical data and applications from a single source, allowing them to more efficiently and effectively manage critical trial activities. The idea of the Perceptive Partner Programme is to


allow CROs, technology, consulting, reseller and training companies to enhance and broaden their services


to biopharmaceutical customers by leveraging the Perceptive MyTrials eClinical platform along with clinical and technical support services. Josef von Rickenbach, chairman and CEO of Parexel,


believes that by combining the ClinIntel and ClinPhone solutions his company will be have an opportunity to further advance its position as a clinical technology leader and grow market share by bringing enhanced speed, efficiency, and simplicity to its existing RTSM offering. In a separate development, Parexel has announced


that clinical technology companies CRF Health and Clinical Ink have joined the Perceptive Partner Programme.


its biopharmaceutical clients using Frenova’s database, the world’s largest renal database with longitudinal data on more than 393,000 CKD patients and 980,000 ESRD patients.


Te goal is to improve the lives of kidney patients by looking at which treatments are most effective.


Te data will be used to better understand the burden of illness, treatment patterns, medication adherence, and comparative safety and efficacy of medical treatments in the real world.


Te collaboration will also help new drug sponsors assess protocol feasibility, select study sites, conduct targeted patient recruitment and determine optimal sample size.


Te two companies believe that this new collaboration has significant potential to support all key stakeholders, but especially dialysis patients who undergo intensive treatment three days a week and whose average life expectancy after diagnosis is five years.


Te ultimate goal is for the analyses to provide insights into ways of slowing the progression of chronic kidney disease and preventing the need


for dialysis for some patients altogether.


Adaptive trials Finally, in news from Ireland, Icon has announced that Pfizer and Roche have joined the ADDPLAN DF consortium. Te consortium was founded in 2013 by Novartis Pharma, Janssen Pharmaceuticals, Eli Lilly, and Aptiv Solutions – the latter an Icon company leading the design and implementation of adaptive trials. Te goal of the consortium is to develop methodologies and execution technologies that improve dose- selection, which remains a major barrier to resolving high failure rates in Phase III trials.


ADDPLAN DF is statistical software for the design, simulation and analysis of adaptive dose-finding trials.


Te graphical user interface supports the design process, allowing the development team to model flexible dose-response shapes and multiple design and analysis options.


Icon notes that both Pfizer’s and Roche’s decision to join the consortium comes as more companies recognise the value of adaptive design in improving decision making in exploratory development.


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