Regulatory affairs

FDA aims to expedite coronavirus diagnostics

11-Mar-2020 By Jenni Spinner

The agency has issued a new policy intended to speed availability of diagnostic tests for the potentially deadly virus.

Judge: Feds must open trial data access

03-Mar-2020 By Jenni Spinner

A judge has ruled in favor of parties seeking to broaden access to federal clinical trial information, helping close a long-standing loophole.

Female participation up, diversity rates down in 2019 approved drugs’ trials

26-Feb-2020 By Vassia Barba

US FDA’s 2019 Drugs Trials Snapshots show female participation in clinical trials of the drugs approved during the past year increased, although ethnic diversity remains an issue.

'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost

19-Feb-2020 By Nick Taylor

President Trump proposes extra cash for US FDA to address “significant problems at many inspected outsourcing facilities.”

FDA allows research animals to enter retirement

11-Feb-2020 By Staff Reporter

Animals used in lab research can be made available for adoption, after their involvement in research at US FDA facilities.

The potential of blockchain for clinical trials

29-Jan-2020 By Ben Hargreaves

Due to the imperative for secure communication between stakeholders organizing clinical trials, a recent report suggests that blockchain technology could be a ‘perfect’ solution.

PharSafer adopts Oracle’s cloud solution for pharmacovigilance

27-Jan-2020 By Staff Reporter

The CRO will utilize the platform to provide clinical and post-marketing drug safety services to clients.

White males overrepresented in clinical trials for first-time cancer treatment

24-Jan-2020 By Ben Hargreaves

The levels of patients enrolling for a clinical trial as a first form of treatment for cancer is 0.1%, whilst also being predominantly made up of white males with private insurance.

EMA welcomes Court of Justice transparency finding

23-Jan-2020 By Ben Hargreaves

EMA wins court’s decision in favor of citizens being able to access clinical study and toxicology reports submitted to the agency.

WCG continues acquisitive streak with biostatistical consultancy buyout

23-Jan-2020 By Ben Hargreaves

WCG adds to its portfolio of solutions for clinical trial sponsors by acquiring Statistics Collaborative.

FDA places Innate cancer trial on partial clinical hold over CMO issue

14-Jan-2020 By Nick Taylor

The US FDA puts Innate Pharma trial on partial clinical hold after learning of CMO problems.

Tools for doctors key to increasing clinical trial diversity, say experts

06-Jan-2020 By Nick Taylor

Sponsors should ‘continually’ think about providing tools to help healthcare professionals discuss clinical trials with women and older people.

Pharma companies slow to adopt AI will be ‘left behind’

11-Dec-2019 By Ben Hargreaves

Though pharma companies now accept the value of AI and machine learning, extra effort is required by the industry to realize the potential business and patient benefits, says Iqvia exec.

Growth in risk-based approaches the ‘main challenge’ to address in 2020

11-Dec-2019 By Vassia Barba

This year brought the ‘biggest momentum shift’ in the adoption of risk-based approach to trial management in the clinical research industry, says CluePoints executive.

BASi completes PCRS takeover, continuing deal-driven expansion

10-Dec-2019 By Nick Taylor

BASi buys PCRS, adding surgical and medical device contract services to growing portfolio.

Zosano readies contract manufacturers for pre-approval inspections

25-Nov-2019 By Nick Taylor

Zosano Pharma prepares contract manufacturers to host pre-approval inspections to support filing for approval of migraine drug.

Sosei Heptares pulls dementia trial to minimize CRO expenditure

18-Nov-2019 By Nick Taylor

Sosei Heptares withdraws Phase II dementia with Lewy bodies trial to reduce spending on contract research while clinical activity is suspended.

The next act: ACRO, R&D Caucus moving forward with second Cures bill

07-Nov-2019 By Melissa Fassbender

ACRO is collaborating with the Congressional Research and Development Caucus and others to bring forth a new Cures bill focused, in part, on patient engagement, data, and digital health – with draft legislation anticipated early next year.

People on the Move: Outsourcing-Pharma roundup October ‘19

01-Nov-2019 By Melissa Fassbender

This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.

Sponsors need to understand and prepare for CCPA: Greenphire

30-Oct-2019 By Melissa Fassbender

California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.

Letter to the Editor

Counterpoint: 3 reasons Right to Try is less flexible than expanded access

29-Oct-2019 By Richard Klein, director of expanded access programs and policy, GE2P2 Global Foundation

In a letter to the editor, Richard Klein, director of expanded access programs and policy for the GE2P2 Global Foundation, outlines three reasons why Right to Try is less flexible than expanded access.

FDA guidance ‘a step in the right direction’

11-Oct-2019 By Melissa Fassbender

The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.

Right to Try programs to ‘significantly accelerate' drug development: Beacon of Hope CRO

09-Oct-2019 By Melissa Fassbender

Beacon of Hope CRO is working with sponsors and other service providers to design Right to Try treatment programs, which the company’s founder says have ‘unmatched’ flexibility, an ability to treat screen fails and create ‘interim clinical milestones,’...

Elligo advancing RWD project under FDA grant

03-Oct-2019 By Melissa Fassbender

The FDA has awarded a grant to Elligo Health Research to continue work exploring the ability to extract clinical evidence from real-world data.

Rho: 'The hurdles are high when you have a drug that the world doesn’t need'

01-Oct-2019 By Melissa Fassbender

Rho experts speak to the challenges facing drug development, meeting unmet needs, quality by design, and advances in technology, among other topics, during a sit-down at the CRO’s headquarters.

Pilot project to answer where and how RWE can be used

27-Sep-2019 By Melissa Fassbender

The Friends of Cancer Research, in collaboration with Iqvia and other health care research organizations, are working to determine where and when real-world data can be trusted.

Elsevier developing risk calculator for DDIs ‘aligned with pharma’s needs and challenges’

24-Sep-2019 By Melissa Fassbender

To improve patient safety and reduce risk, Elsevier is developing an improved drug-drug interaction risk calculator in collaboration with several pharma partners, including Boehringer Ingelheim, Eli Lilly, and Servier.

AI in drug development: ACRO, DIA, and Owkin to talk use cases and what comes next

18-Sep-2019 By Melissa Fassbender

There has been a lot of discussion surrounding the use of artificial intelligence in drug development – with several deals, alliances, and partnerships made so far this year. Here, Outsourcing-Pharma takes a look back at some of these announcements, as...

Gottlieb on board to advance Aetion’s RWE work, guide platform development

17-Sep-2019 By Melissa Fassbender

Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.

South Korea's 5-year plan to advance clinical trials a boon for US biotech

13-Sep-2019 By Melissa Fassbender

South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.

Pharma consultancy Boyds enhances clinical, medical affairs services

12-Sep-2019 By Melissa Fassbender

The pharmaceutical and biotech product development consultancy Boyds acquires Blue Duck Consulting to boost its clinical and medical affairs services offering.

FDA and CluePoints to further explore risk-based site inspection approaches

12-Sep-2019 By Melissa Fassbender

The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.

‘Everything to do with patient centricity’: Wearables to redefine research approaches

11-Sep-2019 By Melissa Fassbender

After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.

What’s next for M&A? Precision medicine, diagnostics, new customers to disrupt pharma services market

06-Sep-2019 By Melissa Fassbender

Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.

Advarra to acquire CTMS provider Forte, build research 'ecosystem' for streamlined operations

05-Sep-2019 By Melissa Fassbender

Advarra is set to acquire Forte in a bid to expand its offerings to include an integrated suite of standards-based trial management products and services – a platform for ‘an interconnected clinical research ecosystem,’ says CEO.

People on the Move: Outsourcing-Pharma roundup August ‘19

04-Sep-2019 By Melissa Fassbender

The last month of summer saw several hires, including a lead for Worldwide Clinical Trials’ Japan operations, CEO appointments at CordenPharma and LabConnect, and Altasciences’ new CSO, who joins the company from Syneos.

FDA encourages male participation in breast cancer clinical trials

28-Aug-2019 By Melissa Fassbender

The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.

Iqvia launches patient portal that provides trial participants with study updates, outcomes

15-Aug-2019 By Melissa Fassbender

Iqvia today launches its new patient portal, designed to support clinical trial participants throughout the process with a “direct connection to the clinical research environment,” says company executive.

Traceability is key in the growing global cold chain market

14-Aug-2019 By Maggie Lynch

As the pharmaceutical industry grows globally, the market for cold chain technology, solutions, and innovations is working to keep pace.

On the industrialization of cell and gene therapy manufacturing: No scale without a seamless supply chain

14-Aug-2019 By Maggie Lynch

The cell and gene therapy industry cannot grow without a ‘standardized, systematized, industrialized foundation,’ according to experts from Lonza and Vineti, which have teamed up to advance a ‘vein-to-vein’ delivery network.

‘A tsunami of change coming to clinical development’: AbbVie talks digital disruption

07-Aug-2019 By Maggie Lynch

At a time when innovation is rapid, clinical development is evolving at the same pace, and new technologies are bringing disruptive opportunities to research, says AbbVie executive.

‘The future is challenging us to innovate our delivery methods’: PRA

06-Aug-2019 By Melissa Fassbender

Biopharmaceutical companies are increasingly relying on CROs in Japan, says an executive with PRA, which recently established a new subsidiary in the country.

People on the Move: Outsourcing-Pharma roundup July ‘19

02-Aug-2019 By Melissa Fassbender

CordenPharma has a new CEO, Arbour Group advances plans to expand in RTP, Ashfield brings on a former Iqvia VP, and Recursion adds to its c-suite after raising $121m this month.

Iqvia sees ‘a lot of runway ahead’ despite growth in Q2

30-Jul-2019 By Maggie Lynch

Iqvia is looking to the future and opportunities in AI, after reporting $2.74bn in revenue for Q2 FY19.

Veristat opens office in Taiwan to support ‘fast-growing' clinical development market

29-Jul-2019 By Maggie Lynch

Veristat launches clinical trial, biostatistics, and programming operations in Taipei, Taiwan in response to increasing client demand for regulatory submission support for both local and North American-based sponsors.

Global infectious disease drug development partnership aims to ‘stimulate pharma’

29-Jul-2019 By Maggie Lynch

Penta and Cromsource partner in an aim to improve pediatric drug development for infectious disease therapies worldwide.

Universal flexible partnering agreement to ease drug discovery partnerships: Insilico

25-Jul-2019 By Maggie Lynch

Insilico Medicine develops a semi-automated contracting system to ease the collaboration process between AI companies and industry partners in the discovery space.

The Living Heart: FDA renews contract with Dassault to evaluate 3D simulation, virtual patients

24-Jul-2019 By Melissa Fassbender

Dassault Systèmes’ Living Heart Project is moving forward with an in silico clinical trial underway and plans to evaluate the use of virtual patients – as the French software company hopes to reduce costs, timelines, and improve quality across the industry,...

Parexel opens consulting subsidiary in Hong Kong

23-Jul-2019 By Melissa Fassbender

Parexel’s consulting subsidiary Health Advances opens in Hong Kong to provide business strategy as well as scientific and clinical expertise to customers in the region.