The Drug Industry Association (DIA) Annual meeting took place this year in Philadelphia, Pennsylvania, from June 25 to 30.
DZS Clinical Services launched its enhanced ClinPlus 3.1 eClinical software at DIA 2016 this week in Philadelphia, Pennsylvania.
As electronic patient reported outcomes (ePRO) become more prevalent, the adoption of Bring Your Own Device in clinical trials “won’t be far behind,” says Bracket.
After the Bial trial tragedy earlier this year, panelists gathered at DIA to discuss what went wrong and how to move forward as an industry.
endpoint has introduced its new clinical supply management tool DRIVE, which enables interactive response technology (IRT) functionality for non-IRT and investigator-sponsored trials.
Industry, academia, regulatory and government agencies, have flocked to Philadelphia, Pennsylvania for this year's DIA... Outsourcing-Pharma brings you the best of the action.
According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.
Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.
Our coverage of the BIO International Convention June 6 to 9 2016, in San Francisco, California.
The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.
Eli Lilly is conducting several experiments on the International Space Station (ISS) US National Laboratory over the next year – with several implications for pharma back on Earth.
With problems in forecasting capacity demand, biopharma is looking to a number of new models from third-party manufacturers according to Patheon.
The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.
A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.
The global contract research organization (CRO) announced the formal launch at BIO International, which takes place this week in San Francisco, CA.
The biopharmaceutical industry broke several records in 2015 – but to continue the trend will require a sustained investment from multiple stakeholders.
Strategic partners, controlling the supply chain and what happens when something goes wrong, were just three of the subjects discussed at this year's Global Contract Manufacturing summit - Europe’s largest and leading event for the contract manufacturing community - in London, UK.
BASF, one of the world’s largest chemical companies, has chosen Colorcon to distribute its Kollicoat Immediate Release (IR) tablet coatings.
Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.
Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.
The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.
A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.
Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.
Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant
Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.
When the bioprocessing world headed towards New York's Javits Center in March 2014, our team of reporters were on call to bring you the best news and views from the show floor.
Aenova says the acquisition of Haupt Pharma and Patheon’s merger with DSM are evidence of consolidation in the CMO industry, as it looks to further increase its global footprint.
Patheon and DSM’s Pharma Products merger is “highly complementary” with crossover limited to North American oral solid manufacturing growth, says DPx as it targets further growth opportunities.
Ultravox and Ringo Starr shared differing opinions of Vienna, Austria but the outsourcing clinical world assembled here to discuss the prominent issues affecting CROs at the Partnerships in Clinical Trials Congress 2013.
And amongst the lively debates around strategic partnerships, AROs, CRAs and changing regulatory needs, Outsourcing-Pharma.com sported its notepad and pen to bring you all the news as it happened.
Strategic partnerships are “the next phase” of sponsor-CRO relations, according to Parexel, and on top of saving pharma on oversight costs will reshape the industry.
Private equity will be looking to exit the CRO industry and could pose a threat to recent strong growth, according to financial experts at PCT
Trust, transparency and end-to-end participation are just some of the reasons Merck Serono says its exclusive strategic partnership with Quintiles is the “first of its kind.”
Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.
Strategic partnerships were put on trial yesterday at PCT and with a number of alliances coming up for renewal, Pfizer, Novartis, Amgen and Baxter spoke about the issues affecting a sponsor-CRO relationship.
Economic uncertainty and a bleak fiscal outlook will lead to over-regulation and increased fines in the clinical trial industry, according to an economic expert at PCT.
CROs from across Europe and beyond have gathered in Vienna, Austria this week for Partnerships in Clinical Trials' (PCT) European congress. Outsourcing-pharma.com will be covering the show live.
Are strategic alliances a positive or a negative thing for the CRO industry as a whole? In light of PCT Europe this week, we invite you to comment.
In June, Boston became more than a feeling for the CROs, services providers and regulatory experts who gathered there for the 49th annual meeting of the Drug Information Association (DIA).
Outsourcing-pharma.com was there to track down the latest news and developments. Here's what we found out.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
Outsourcing-Pharma has come to Boston, US for DIA 2013. Best promotion we've seen so far is Medidata Solutions' tie up with the Michael J. Fox Foundation. Go get a photo with a time machine and Medidata will donate in your name.
Parexel’s growth rate has slowed recently to a pace that the company can more easily keep up with than in years past, CEO Josef von Rickenbach told us at DIA’s annual meeting in Boston on Monday.
Kohlberg Kravis Roberts (KKR) has purchased PRA International for $1.3B, which is about $500M more than previous private equity owner Genstar paid in 2007.
The Global Pharmaceutical Contract Manufacturing Event (GPCM) 2013 took place in the centre of London, UK on June 25-6.
Some of the major CMOs were present, along with both big and small pharma representatives discussing best practices for selecting third-party manufacturers, the current state of the industry, quality issues, global effect and regulatory challenges.
And of course Outsourcing-Pharma.com was there too, reporting back the latest developments in the CMO world.
Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.
Pharma may be "wary of making big investments" in the protected Russian market leaving an opportunity for local CMOs, according to an industry expert.
Rebuilding 'problem' sterile manufacturing plants to modern specifications may be a better option than spending money trying to fix them according to an ex-GSK expert.
Performance monitoring should be applied equally to external manufacturing as internal operations, says Eli Lilly.
Pharma firms are returning to European and North American manufacturers as quality issues and rising costs have lost India and China some of its ‘Eastern promise,’ according to industry experts.
Roche says its hands on approach to managing sterile manufacturing partners is resulting in a safer and tighter network.
The survey was undertaken as part of the GPCM (Global Pharmaceutical Contract Manufacturing) Event held in London, UK this week involving delegates from a number...
Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.
With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).
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.
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.
The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.
Single-use technology will see more HP production brought in-house but contract manufacturers will still win-out, according to Alkermes.
The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.
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.
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.
Clinical trial enrollment can be accelerated by better understanding patients and using EHRs to inform protocol design, panelists told an Outsourcing-Pharma conference.
Companies outsourcing patient recruitment in emerging markets should have more people on the ground, according to Cutting Edge Information's Shaylyn Pike.
Companies looking to outsource patient recruitment need to think outside the box, says Cutting Edge Information’s director of research Eric Bolesh.
Outsourcing should play a vital role in any patient recruitment strategy, says Cutting Edge Information’s director of research Eric Bolesh.
Covance has announced it will collaborate on a genome sequencing project with Broad Institute to create genomic resources for a research model.
Software developer CliniWorks says data-mining is key to addressing trial sector’s “Achilles Heel,” patient recruitment.
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 Patient Recruitment says the future of patient sourcing for clinical trials lies in social media.
PPD has launched an iPhone app as part of efforts to use technology for patient recruitment and other clinical trial processes.
Technology use in clinical trials is accelerating and will have a major impact on patient recruitment and other processes, said a PCT panel.
Being proactive and re-establishing relationships with investigators are vital to boosting patient recruitment and retention, said a PCT panel.
Applying a business model based on marketing theory to clinical trials can give a consistent framework for planning and managing patient recruitment, say academics.
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
A pool of research-aware US oncology clinical investigators must be developed to ensure patient recruitment rates meet demand.
Faster patient recruitment and use of lighter packaging minimise the carbon footprint of clinical trials.
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 and Mexico recruit more patients per site than any other country where clinical trials are frequently conducted, according to EMA data.
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.
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 and national regulators must learn from each other to better understand outreach tactics and how they fit with a country’s ethics and laws.
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
Forming a strategic partnership with a CRO is one of the key steps to boosting patient recruitment, according to a report.
CRO Quintiles says Southern California Permanente Medical Group (SCPMG) partnership will improve patient recruitment and, ultimately, accelerate the drug development process.
BBK Worldwide and CROee take on Japan’s notorious “drug lag” with new partnership offering faster patient recruitment and trial site identification.
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 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.
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.
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
Central and Eastern Europeans face, with some exceptions, a higher cancer mortality risk than their western European counterparts.
Outsourcing-Pharma presents an interactive map of mortality risk for major cancers around the globe.
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.
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.
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.
Outsourcing-Pharma presents an interactive map of cancer mortality in Latin America, showing the extent of deaths from preventable diseases.
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.
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 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.
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 is to buy Clinical Force in a move that will add SaaS CTMS capabilities to its eClinical suite.
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 has combined two business units in response to shifts in R&D and is lining up takeovers to expand reach and capabilities.
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 has expanded its oncology trial services offering through its acquisition of Nexus Oncology.
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.
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
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 has extended its oncology offering after striking up an alliance with MPI Research.
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.
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.
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.
US-based Veeda Oncology has launched a new service designed to help community cancer practices manage clinical trials.
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 has leant its support to I-SPY 2, an innovative clinical trial designed to accelerate the development of treatments for breast cancer.
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 have partnered to provide biopharmaceutical developers with support for cancer trials.
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.
Sweden-based cancer drug specialist Kancera has bought Stockholm-headquartered discovery and development services provider iNovacia.
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.
A pool of research-aware US oncology clinical investigators must be developed to ensure patient recruitment rates meet demand.
US Oncology Research has added a site in Dayton, Ohio, US to its network of Phase I cancer research centres.
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.
Predictive Biomarker Sciences (PBS-Bio) is collaborating with ENDECE, Revalesio and Unibioscreen to help bring new cancer drugs to the marketplace faster.
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.
Charles River Laboratories (CRL) has added two new exclusive knockout rats to its preclinical development offering in deal with Transposagen Biopharmaceuticals.
HUYA Bioscience International will co-develop a new Chinese cancer drug, HBI-8000, with Quintiles for the “benefit of cancer patients globally.”
GSK has awarded the National Comprehensive Cancer Network (NCCN) grants worth $4m to support trials involving ofatumumab and pazopanib.
Bio Nano Consulting (BNC) says University of London School of Pharmacy deal helped land first Ph I trial formulation services contract.
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.
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
UK contract research organization (CRO) Molecular Profiles says speed to clinical is key demand driver for drug development sector.
Demand for drug discovery, development services and active pharmaceutical ingredients (APIs) were the main growth drivers in Q3 according to Wuxi Pharmatech.
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.
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.
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 is adding protein and peptide profiling to its biomarker capabilities through a strategic alliance with Proteome Sciences.
Quotient Clinical and Bend Research have teamed up to tackle solubility issues in early clinical development.
PRA International says its new bioanalytical services laboratory in Lenexa, Kansas offers clinical customers streamlined services.