505(b)(2): It’s A Different Animal
Camargo
The outsourcing services sector gathered in Madrid, Spain in October for ICSE.
The Outsourcing-pharma.com editorial team were there to track down all the breaking news and speak with the movers and shakers about the latest industry trends.
Aesica says academic partnerships are key for CMOs
UK CMO Aesica Pharmaceutical says that working with academia to access cutting edge technologies is critical for contractors that want to meet the demands of the modern drug industry.
India will stamp out "fly by night operators" in trial industry, says Gov
The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.
Single-use lets some Pharmas make own potent drugs but outsourcing demand still strong: Alkermes
Single-use technology will see more HP production brought in-house but contract manufacturers will still win-out, according to Alkermes.
Aesica ramps up HPAPI capacity to meet industry demand
The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
Cobra Biologics talks recent fill finish acquisition and future growth plans
CMO Cobra Biologics says North America is an obvious place to look at for a facility acquisition.
Finding and retaining patients for clinical trials is a major headache for the pharmaceutical industry with, according to recent data, failure to find an adequate number of people to take part being the most common reason for study failure.
Such problems, combined with the drug industry's need to improve the efficiency of clinical research, are driving more and more drugmakers to use contract research organisations (CRO) to try and accelerate the recruitment process.
With this in mind the Outsourcing-pharma.com is holding Patient Recruitment Outsourcing 2011 , a conference bringing together thought leaders in the field of outsourced patient recruitment.
The event will take a strategic look at outsourcing of patient recruitment, discussing when to outsource, who to partner with and looking at how outsourcing can overcome the challenges of working in rare indications, in global locations or engaging with patients already overwhelmed with trial information.
To whet your appetite for the event Outsourcing-pharma.com has compiled a list of recent news impacting patient recruitment. See you in September.
Social media is a must in patient recruitment, say PRO panelists
Early adopters are effectively using social media for patient recruitment and retention but in general the industry is fearful, a panelist at Patient Recruitment Outsourcing (PRO) 2011 said.
Data-backed decisions ease enrollment, PRO panelists say
Clinical trial enrollment can be accelerated by better understanding patients and using EHRs to inform protocol design, panelists told an Outsourcing-Pharma conference.
Patient Recruitment Outsourcing in emerging markets: the good, the bad, and the ugly
Companies outsourcing patient recruitment in emerging markets should have more people on the ground, according to Cutting Edge Information's Shaylyn Pike.
Patient recruitment must evolve, says Cutting Edge Information
Companies looking to outsource patient recruitment need to think outside the box, says Cutting Edge Information’s director of research Eric Bolesh.
Patient recruitment best outsourced, says market analyst
Outsourcing should play a vital role in any patient recruitment strategy, says Cutting Edge Information’s director of research Eric Bolesh.
Covance establishes more roots in complex contract pharma
Covance has announced it will collaborate on a genome sequencing project with Broad Institute to create genomic resources for a research model.
Cliniworks claims AccelFind can accelerate patient recruitment
Software developer CliniWorks says data-mining is key to addressing trial sector’s “Achilles Heel,” patient recruitment.
Realistic, evidence-based patient recruitment goals are key, Shire
An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.
Blue Chip gives social networking in patient recruitment the thumbs up
Blue Chip Patient Recruitment says the future of patient sourcing for clinical trials lies in social media.
PPD adds iPhone app to patient recruitment toolbox
PPD has launched an iPhone app as part of efforts to use technology for patient recruitment and other clinical trial processes.
Upturn in trial tech use will drive recruitment innovation
Technology use in clinical trials is accelerating and will have a major impact on patient recruitment and other processes, said a PCT panel.
Proactive planning and strong site links boost recruitment
Being proactive and re-establishing relationships with investigators are vital to boosting patient recruitment and retention, said a PCT panel.
Business & marketing tactics can boost recruitment
Applying a business model based on marketing theory to clinical trials can give a consistent framework for planning and managing patient recruitment, say academics.
Social media boosting patient recruitment, but FDA guidance needed
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
Pool of US cancer investigators needed to boost recruitment
A pool of research-aware US oncology clinical investigators must be developed to ensure patient recruitment rates meet demand.
Fast patient recruitment cuts clinical trial carbon footprint
Faster patient recruitment and use of lighter packaging minimise the carbon footprint of clinical trials.
Visualisation of trials, sites & patient recruitment, 2005-09
Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country.
Finland, Brazil & Mexico top per site recruitment; visualisation
Finland, Brazil and Mexico recruit more patients per site than any other country where clinical trials are frequently conducted, according to EMA data.
Latin American sites recruit 91% more patients than US
Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
Education of health conditions in RCTs boosts recruitment
Patient recruitment is boosted by health condition awareness strategies and financial incentives, according to research, but various methods of randomisation and consent design have no impact.
Patient recruiters & regulators educating each other as trials globalise
Patient recruiters and national regulators must learn from each other to better understand outreach tactics and how they fit with a country’s ethics and laws.
Top strategies for recruiting and retaining trial participants
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
Strategic partnerships with CROs key to patient recruitment
Forming a strategic partnership with a CRO is one of the key steps to boosting patient recruitment, according to a report.
Quintiles teams with SCPMG to boost recruitment in US
CRO Quintiles says Southern California Permanente Medical Group (SCPMG) partnership will improve patient recruitment and, ultimately, accelerate the drug development process.
BBK and CROee partner to boost recruitment in Japan
BBK Worldwide and CROee take on Japan’s notorious “drug lag” with new partnership offering faster patient recruitment and trial site identification.
PRA partners to boost recruitment in Latin America
PRA International has entered into a partnership with Oncopartners and IBPC to accelerate the planning, start-up and patient recruitment of oncology trials in Latin America.
Synexus hails recruitment for vaccine trial
Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.
Finding principal investigators crucial to recruitment; report
CROs believe that finding the right principal investigators is the hardest part of recruitment, according to a survey that adds that 80 per cent of respondents would prefer to reach enrolment goals 10 per cent quicker than cut costs by 20 per cent.
A series of graphical data articles, created by Outsourcing-Pharma, to illustrate the scale of the global cancer crisis and identify hotspots. The series was created to accompany OncologyTrialsOutsourcing , an industry first, virtual conference hosted by Outsourcing-Pharma.
J&J hunting for new CMO for Doxil
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
Interactive map shows cancer burden on CEE
Central and Eastern Europeans face, with some exceptions, a higher cancer mortality risk than their western European counterparts.
Interactive map of cancer mortality risk around the world
Outsourcing-Pharma presents an interactive map of mortality risk for major cancers around the globe.
Asia braces for cancer surge
Lung and stomach cancer are big killers in Asia, as shown by our interactive map, and there are fears the number of new cases will jump in coming years.
US cancer death rate in decline but problem areas remain
Cancer death rates are in decline in the US but, as our interactive map shows, the situation varies from site-to-site and state-to-state.
Cancer an emerging threat in Africa – interactive map
In Africa cancer is emerging as a major public health threat, the extent of which can be seen in our interactive map of the region.
Interactive map of cancer mortality risk in Latin America
Outsourcing-Pharma presents an interactive map of cancer mortality in Latin America, showing the extent of deaths from preventable diseases.
Quintiles launches silo busting data management platform at DIA
CRO Quintiles chose DIA 2011 to launch its new Infosario clinical trial data and information management system which, it says, will ‘bust’ the information silos that hamper the research process.
Celerion talks about research sector in South America
US CRO Celerion gained Brazilian National Health Surveillance Agency (Agência Nacional de Vigilancia Sanitaria ANVISA) approval for its bioanalysis labs in Lincoln, Nebraska and in Belfast, Northern Ireland.
PRA reflects on data and information management at DIA
PRA International says that the adoption of new industry standards is changing how the research sector approaches data and information management and is creating opportunities for the use of innovative technologies.
DSA talks social media in pharma at DIA 2011
Social media can play a role in ensuring that medicines are safe, but regulatory input is needed according to the Drug Safety Alliance (DSA).
Medidata to add SaaS CTMS through Clinical Force buy
Medidata is to buy Clinical Force in a move that will add SaaS CTMS capabilities to its eClinical suite.
Vendor info sharing positions trials for success; consultant
Sponsors should bring together vendors before a trial begins and have them share information and experiences that will make the project successful, said a consultant at DIA.
UBC forms new biz to meet clients changing R&D needs
UBC has combined two business units in response to shifts in R&D and is lining up takeovers to expand reach and capabilities.
Firecrest's site performance software goes mobile
Firecrest Clinical has launched a mobile version of its site management and training platform, citing investigator demand for trial in your hand solutions and sponsor demand for increased research efficiency.
Oncology is one of the most active areas of research in the pharmaceutical industry with, according to recent PhRMA figures, more than 900 new cancer drugs being developed by US companies alone.
The contract research sector has been quick to recognise this demand with barely a week going by without news of a cancer trial partnership or new oncology-focused service launch.
With this trend in mind, on July 12th Outsourcing-pharma.com is holding Oncology Trials Outsourcing an industry-first virtual conference focused on the role outsourcing can play in the successful development of cancer drugs.
Experts from Cutting Edge Information, INC Research, Quintiles and Eli Lilly will lead our webinar programme, sharing their thoughts on the important issues and instantly fielding questions from you, our online audience.
Sign up to "attend" our innovative, online only event for free here .
Ockham buys Nexus in bid to boost oncology trial offering
Ockham has expanded its oncology trial services offering through its acquisition of Nexus Oncology.
US-based START open Phase I cancer research center in Shanghai
Anti-cancer clinical trial specialist, South Texas Accelerated Therapeutics (START), has collaborated with China's largest cancer hospital to open a new Phase I cancer research center.
J&J hunting for new CMO for Doxil
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
Sareum sees hike in share prices thanks to inhibitor
Shares in drug discovery company Sareum have soared by 36 per cent after the firm announced the selection of a preclinical development candidate for its Checkpoint kinase 1 (Chk1) inhibitor programme.
vivoPharm branch out in US with MPI partnership and new Hershey office
vivoPharm has extended its oncology offering after striking up an alliance with MPI Research.
Synteract talks rescue studies at DIA 2011
Synteract says the use of non-validated data systems in clinical trials is a key driver for the ‘rescue study’ segment of the contract research sector.
SCM Pharma teams with SEP in cancer product manufacturing deal
UK-based contract manufacturing organisation (CMO) SCM Pharma has struck a deal with urology experts Speciality European Pharma (SEP) to help bring SEP's oncology product, Plenaxis, to the European market.
Changing Times: The Need For a Logical Sourcing Strategy
Sponsors need to abandon the ‘single trial, random, tactical sourcing approach’ in favour of a model flexible enough for a variety of study designs and research needs according to Eli Lilly experts Lee Scheible and Jeffrey S Kasher in this exclusive guest article.
Veeda Oncology launches virtual trial management service for cancer clinics
US-based Veeda Oncology has launched a new service designed to help community cancer practices manage clinical trials.
Quintiles in genomics partnership with PGT
Quintiles has signed a deal with Population Genetics Technologies (PGT) that, it says, will bring large-scale genomics analysis into the drug development mainstream.
Quintiles backs I-SPY-2 breast cancer trial
Quintiles has leant its support to I-SPY 2, an innovative clinical trial designed to accelerate the development of treatments for breast cancer.
VisualSonics unveils ‘revolutionary’ Vevo LAZR imaging system
VisualSonics, a high-resolution micro imaging systems manufacturer, has launched a new imaging system it claims will revolutionise cancer research.
Aptiv Solutions and Cancer Genetics team on cancer trial services
Aptiv Solutions and Cancer genetics have partnered to provide biopharmaceutical developers with support for cancer trials.
UK CROs extend preclinical cancer partnership
Preclinical Oncology Services Limited (Precos) will to work with discovery services firm Argenta Discovery on cancer drug development projects under a revised collaboration agreement announced late yesterday.
Kancera buys CRO iNovacia
Sweden-based cancer drug specialist Kancera has bought Stockholm-headquartered discovery and development services provider iNovacia.
Role for CROs as study deems cancer trials biggest risk for Pharmas
Late-stage cancer trials are the biggest challenge for pharmaceutical and biotech firms according to data presented at the Biotechnology Industry Organisation's (BIO) CEO and investor conference in Washington DC, US this week.
Pool of US cancer investigators needed to boost recruitment
A pool of research-aware US oncology clinical investigators must be developed to ensure patient recruitment rates meet demand.
Ohio site joins US Oncology Research Phase I network
US Oncology Research has added a site in Dayton, Ohio, US to its network of Phase I cancer research centres.
Christie cancer centre opens early phase trials unit to help fight cancer
The Christie cancer centre in Manchester, UK, has opened a £35m (€41m) early phase clinical trial unit to help develop new treatments for a range of cancers.
PBS-Bio inks deals to speed up cancer drug development
Predictive Biomarker Sciences (PBS-Bio) is collaborating with ENDECE, Revalesio and Unibioscreen to help bring new cancer drugs to the marketplace faster.
Horizon and Cylene to better patient selection in cancer drug development deal
Horizon Discovery will use its X-MAN human disease cell line models to identify patients likely to benefit from Cylene Pharmaceuticals’ candidate cancer drug, CX-4945.
CRL expands cancer model offering with p53 and BCrp rats
Charles River Laboratories (CRL) has added two new exclusive knockout rats to its preclinical development offering in deal with Transposagen Biopharmaceuticals.
Chinese cancer drug brings HUYA and Quintiles together
HUYA Bioscience International will co-develop a new Chinese cancer drug, HBI-8000, with Quintiles for the “benefit of cancer patients globally.”
GSK taps NCCN for cancer drug trials
GSK has awarded the National Comprehensive Cancer Network (NCCN) grants worth $4m to support trials involving ofatumumab and pazopanib.
BNC lands cancer drug formulation contract
Bio Nano Consulting (BNC) says University of London School of Pharmacy deal helped land first Ph I trial formulation services contract.
Biomarkers “indispensible” in cancer drug development, says Quintiles
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.
FDA issues cancer vaccine trial guidance
Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
The Outsourcing-pharma team went to the American Association of Pharmaceutical Scientists (AAPS) conference in New Orleans, US to cover all the breaking drug industry news and trends and speak with key pharmaceutical industry movers and shakers.
For the full list of articles click the + More button below
Molecular Profiles expands into early-development
UK contract research organization (CRO) Molecular Profiles says speed to clinical is key demand driver for drug development sector.
WuXi posts strong Q3; highlights GLP tox services at AAPS
Demand for drug discovery, development services and active pharmaceutical ingredients (APIs) were the main growth drivers in Q3 according to Wuxi Pharmatech.
SCM talks US demand for niche contracting at AAPS
SCM Pharma says demand for specialised contract manufacturing services is growing as the pharma industry focuses on niche indications, biologics and the development of potent medicines.
Industry, innovation & Viagra-stuffed teddies at AAPS
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
New analytical services biz plans growth in tough market
Newly-formed Gateway Analytical is confident its service offering, employees’ experience and ties to its parent company will allow it to grow despite a challenging operating environment.
Icon inks Proteome deal to bolster biomarker offering
Icon is adding protein and peptide profiling to its biomarker capabilities through a strategic alliance with Proteome Sciences.
Quotient and Bend discuss new collaboration at AAPS
Quotient Clinical and Bend Research have teamed up to tackle solubility issues in early clinical development.
PRA unveils new US bioanalytical lab at AAPS
PRA International says its new bioanalytical services laboratory in Lenexa, Kansas offers clinical customers streamlined services.
