On the road

(Image: iStock/shironosov)

DIA 2016

endpoint releases new global supply management tool

By Melissa Fassbender

endpoint has introduced its new clinical supply management tool DRIVE, which enables interactive response technology (IRT) functionality for non-IRT and investigator-sponsored trials.

(Image: iStock)

DIA 2016

Survey: paperless TMF advantages and progress

By Melissa Fassbender

According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.

The SpaceX Dragon spacecraft nears the International Space Station during the CRS-8 mission to deliver experiments and supplies to the International Space Station. (Image credit: NASA)

Dispatches from BIO 2016

Drug development in space: how microgravity enables pharma

By Melissa Fassbender

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.

(Image: iStock)

Dispatches from BIO 2016

BioDuro launches as CDMO at BIO International

By Melissa Fassbender

The global contract research organization (CRO) announced the formal launch at BIO International, which takes place this week in San Francisco, CA.

The state of investment: 'biotech is up'

Dispatches from BIO 2016

The state of investment: 'biotech is up'

By Melissa Fassbender

The biopharmaceutical industry broke several records in 2015 – but to continue the trend will require a sustained investment from multiple stakeholders.

For big pharma, ten is the magic number of CMOs says ex-GSK Director

Dispatches from the GPCM Conference, London, UK

For big pharma, ten is the magic number of CMOs says ex-GSK Director

By Dan Stanton

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.

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

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

By Dan Stanton

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.

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

Dispatches from DIA

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

By Zachary Brennan

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.

Boston, yesterday

Dispatches from DIA

DIA delegates welcome Cloudy forecast

By Gareth Macdonald

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

Dispatches from DIA

China, Taiwan Begin Shift to Regulatory Convergence

By Zachary Brennan

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.

Medidata and Fox Foundation team for DIA

update

Backlog to the Future: DIA 2013 in pictures

By Gareth Macdonald

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

Dispatches from DIA 2013

Parexel CEO: Growth Rate Slowing to Manageable Pace

By Zachary Brennan

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

Private Equity Snatches PRA for $1.3B

By Zachary Brennan

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.

Western CMOs Hold Advantages Over East, says PTI

Western CMOs Hold Advantages Over East, says PTI

By Dan Stanton

Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).

Aesica says academic partnerships are key for CMOs

News from CPhI

Aesica says academic partnerships are key for CMOs

By Gareth Macdonald

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.