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Breaking News on Contract Research, Manufacturing & Clinical Trials

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.

Consolidation prevalent in industry, says third largest CMO

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 crossover limited, more growth targeted says DPx

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.

Parexel: Strategic partnerships are reshaping the CRO industry

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. 

Not all good news: CROs must prepare for Private Equity exit, experts say

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

Quintiles is the "arms, legs and brain" in Merck Serono's monogamous relationship

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.”

Pfizer: Active role for patients as smartphones lead way in virtual trials

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.

Oversight is key in sponsor-CRO partnerships say Pfizer and Amgen

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. 

Regulatory costs will rise, fines will increase, expert warns

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.

Ultravox wrong: Vienna 'everything' to CROs this week

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.

Readers' Survey: Are strategic alliances good for the CRO industry?

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. 

EMA Says International Collaboration and New Laws Mean Reliable API Imports

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.

CROs, Sponsors Yet to Cement Appropriate Risk-Sharing Models, Execs Say

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.

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

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.

DIA delegates welcome Cloudy forecast

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.

China, Taiwan Begin Shift to Regulatory Convergence

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.

Backlog to the Future: DIA 2013 in pictures

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 CEO: Growth Rate Slowing to Manageable Pace

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. 

Private Equity Snatches PRA for $1.3B

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.

To QbD or not to QbD? That is the Question...

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.

Russian Protectionism may Offer Chances For Local CMOs, Expert Says

Pharma may be "wary of making big investments" in the protected Russian market leaving an opportunity for local CMOs, according to an industry expert.

Plant Design Critical in Sterile Manufacturing, Expert Says

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.

Pharma Abandoning East, Returning West for CMOs say GPCM Delegates

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: Governance of CMOs Ensures Sterility, Strengthens Partnerships

Roche says its hands on approach to managing sterile manufacturing partners is resulting in a safer and tighter network.

Quality Agreement Dictates Price in Manufacturing Relationships

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' Compliance for Biologics with Nasal and Long Acting Techs

Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.

BIg Pharma's Shift from R&D Opportunity for CDMOs, Says Expert

With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.

Western CMOs Hold Advantages Over East, says PTI

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.

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.

The Outsourcing-pharma team went to the Drug Information Association (DIA) 2011 conference in Chicago, US to cover all the breaking drug industry news and trends and speak with key pharmaceutical industry movers and shakers.

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.