Regulatory affairs

Bulgaria-based CRO August Research adds new sites in Georgia and Moldova

21-Jan-2019 By Melissa Fassbender

August Research is adding clinical trial operations in Georgia and Moldova, expanding the CRO’s reach in Central and Eastern Europe – a less developed market with “fewer competitive trials and lower costs,” says CEO.

Lonza, Takeda reach regulatory milestone in oncology tie-up

17-Jan-2019 By Maggie Lynch

Lonza provided development, manufacturing, and clinical packaging services for Takeda’s Alunbrig, which has received EMA marketing authorization.

Completion bonuses in clinical trials are an incentive, not coercion: Researchers make their case

16-Jan-2019 By Melissa Fassbender

Researchers are making the case for clinical trial completion bonuses – the complete rejection of which they argue is unnecessary and problematic.

Calls for diversity: 72% of genetic discoveries have taken place in 3 countries

15-Jan-2019 By Melissa Fassbender

Genetic discoveries have taken place in narrow population groups, say researchers, who for the first time, reveal that such studies are concentrated in a handful of countries – and conducted by a ‘tight-knit group of researchers.’

For clinical trials, ‘convenience’ services to be a standard offering in 2019

11-Jan-2019 By Melissa Fassbender

The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch.

The EMA’s 5 goals: Fostering innovative trial design, exploiting AI, and other recommendations

09-Jan-2019 By Melissa Fassbender

The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives.

Iqvia's new safety platform looks to reduce pharmacovigilance costs, complexity

08-Jan-2019 By Melissa Fassbender

Driven by a more than 20% increase in adverse event volumes, Iqvia has developed a SaaS safety platform designed to reduce the cost and complexity of pharmacovigilance activities – and help companies add value back into their business, says VP.

Upperton’s new R&D facility receives MHRA approval

08-Jan-2019 By Maggie Lynch

Upperton Pharma’s new and expanded facilities received a positive inspection from MHRA, enabling both research and development and clinical manufacturing at the site.

Syneos Health: ‘Heightened influx of information’ drives 2019 trends, challenges

08-Jan-2019 By Melissa Fassbender

Access to an increasing amount of information is catalyzing research, while also lending to higher levels of professional burnout on behalf of health care professionals, says company executive.

How the UK proposes to regulate clinical trials in case of a ‘no-deal’ Brexit: Updated guidance released

07-Jan-2019 By Melissa Fassbender

The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”

Digital tech exploded in 2018: Will 2019 see broad adoption?

04-Jan-2019 By Melissa Fassbender

Awareness around the potential opportunities created by artificial intelligence has never been higher, but pharma’s biggest challenge in 2019 will be adopting and scaling the right technology to improve patient outcomes, says an industry executive.

A year in review: A perspective from the Society for Clinical Research Sites

19-Dec-2018 By Jessica Knott, senior communications manager, Society for Clinical Research Sites

The Society for Clinical Research Sites builds its focus and programming around improving site sustainability. However, a troubling and ever-present factor within the clinical research industry is that, by and large, many of the problems facing the site...

Trials suggest long-acting antipsychotics use should be expanded

19-Dec-2018 By Maggie Lynch

Clinical trials suggest that long-acting injectable antipsychotics should be expanded into a broader range of clinical settings and patient populations, says Premier Research executive.

2018 regulatory round-up: Patient safety, data transparency, innovative trial designs

18-Dec-2018 By Melissa Fassbender

Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.

Through a different lens: From Brexit to digital innovation, clinical research is sparking change that matters

17-Dec-2018 By Doug Peddicord, executive director, Association of Clinical Research Organizations (ACRO)

Clinical research organizations all share a common goal of advancing health innovations. They are investing and learning, iterating and re-inventing.

VeraSci’s eCOA ‘evolution’ to provide data ready for submission

17-Dec-2018 By Maggie Lynch

VeraSci is enhancing its eCOA platform to improve the participant experience, data collection, and consistency.

Infographic: Women in clinical research through the years

11-Dec-2018 By Maggie Lynch

Women have seen deficits and gains in their attempts to be included in clinical research, but as 2019 approaches equality seems forthcoming.

The biggest paradigm shift in decades? ICH E6 R2

11-Dec-2018 By Melissa Fassbender

ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.

2019: The year of women in research?

11-Dec-2018 By Maggie Lynch

It’s been 25 years since the NIH Revitalization Act, yet, the industry is only now approaching parity in clinical research, says researcher.

Parexel and Eli Lilly team up to develop clinical researcher pool in China

10-Dec-2018 By Melissa Fassbender

Parexel and Eli Lilly are launching a clinical research learning and development program in China as recent reforms have “dramatically” increased the need for new sites in the country.

Evotec and LEO Pharma partner for hit identification platform use

06-Dec-2018 By Maggie Lynch

Evotec to use its hit identification platform in LEO Pharma alliance, another drug discovery partnership among the many.

‘Patients will lose’ if airlines refuse to transport lab animals: NABR files complaint

06-Dec-2018 By Melissa Fassbender

A lobby group has filed a complaint alleging illegal discrimination by airlines refusing to transport lab animals – a battle that will be difficult to win, says an industry expert.

How the industry is addressing the ethical concerns of incorporating big data into health care

05-Dec-2018 By Melissa Fassbender

In the era of big data, the industry is working to address the ethical concerns of integrating patient information into the health care landscape – though a key challenge will be reaching a consensus on what constitutes reliable evidence.

Guest column

To access the rewards of big data in health care, potential risks must be managed

05-Dec-2018 By Melanie Brickman Borchard, PhD, MSc, director of life sciences, New York Academy of Sciences

Increased access to real-world data sources opens up new possibilities, but it also raises new ethical questions, which cannot be tackled by one organization, government agency, or company alone.

FDA’s MyStudies release is a ‘major milestone’ with ‘profound’ implications, says Iqvia

04-Dec-2018 By Melissa Fassbender

The FDA recently released open source code and technical documents for its new mobile app – MyStudies – which is designed to collect information about medication use, health system touchpoints, and patient-reported outcomes.

Number of South Korean biotech sites increased by 12% last year: Novotech

03-Dec-2018 By Melissa Fassbender

The Asia-Pacific CRO Novotech has grown its operations in South Korea, a market that has seen greater interest from North American and European companies, says exec.

Janssen: ‘There’s too much at stake to settle for doing things the way we’ve always done them’

28-Nov-2018 By Melissa Fassbender

The industry must be “relentless” in driving the adoption of new advances in technology, says Janssen, which has shifted from doing things for patients and investigators, to doing things with them.

Canada-based CRO Biopharma Services passes WHO inspection

27-Nov-2018 By Maggie Lynch

WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.

World Courier making multi-million dollar tech investment

21-Nov-2018 By Maggie Lynch

World Courier has made a multimillion-dollar investment in its supply chain technology to help meet the expanding needs of the pharmaceutical industry.

PHARMA INTEGRATES

Limiting health care data collection is a bogus, fake conversation, says Health iQ exec

21-Nov-2018 By Flora Southey

Rather than limit health care data collection, the industry should focus on ensuring those data sets are used ‘in the most appropriate way,’ according to Health iQ chief commercial officer.

Once significantly behind, China begins to close the drug development gap

20-Nov-2018 By Melissa Fassbender

Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.

Blockchain could solve many challenges facing the clinical trials process: Analyst

20-Nov-2018 By Melissa Fassbender

Blockchain provides real-time visibility into the entire clinical trial supply chain and has the potential to solve several of the industry’s biggest challenges.

Revised FIH guidelines: AstraZeneca reflects a year later

20-Nov-2018 By Maggie Lynch

Sponsors have had to take steps to follow the new EMA guidelines for first-in-human clinical trials, which can pose risk and operational challenges.

AAPS PharmSci 360

Animal models are less informative than a coin flip, says AAPS speaker

19-Nov-2018 By Melissa Fassbender

The predictive value of animal models is less than 50%, which makes them less informative than a coin flip, says AAPS speaker – who also argues that clinical trial participants are not fully aware of the risks.

AAPS PharmSci 360

Man’s best friend: Using shared diseases in humans and dogs to support drug development

19-Nov-2018 By Melissa Fassbender

More than six million pet dogs are diagnosed with cancer every year – posing researchers with the opportunity to co-develop drugs for humans and animals.

FDA looks to reduce the number of clinical trials in dogs

19-Nov-2018 By Melissa Fassbender

The FDA has proposed a study to create a non-animal based model for drug development as part of its overall commitment to reduce the number of animals used in research.

Guest column

‘No one ever gets fired for hiring a Top 10 CRO.’ Why?

15-Nov-2018 By Matthew Barrows, senior business consultant

It’s a phrase we’ve all heard a thousand times – often from clients explaining why they didn’t go with your business as they’ve opted for the assumed ‘safe bet’ of a global leader.

Metrics completes serialization activities at NC-based site

15-Nov-2018 By Maggie Lynch

Metrics Contract Services’ newly-opened manufacturing site has qualified two commercial bottling lines for serialization with DSCSA requirements set to be enforced this month.

With numerous product handoffs, immuno-oncology trials require a tight-knit supply chain

13-Nov-2018 By Melissa Fassbender

Immuno-oncology clinical trials are fundamentally different from traditional oncology studies as it pertains to logistics, and require close coordination across several stakeholders, says CRO.

Direct-to-patient clinical trials face new logistical challenges

13-Nov-2018 By Melissa Fassbender

Tracking the chain of custody for trial kits and ensuring patient data blinding – in compliance with HIPPA and GDPR – are among the unique logistical challenges to direct-to-patient clinical trials.

How to secure the clinical supply chain in the face of a natural disaster

13-Nov-2018 By Melissa Fassbender

To manage the supply chain challenges faced by natural disasters, experts say to expect the unexpected – ensuring a strong shipping strategy is in place with temperature control and robust management.

ACRP developing competence standards for PIs: 'A major step forward to advance excellence in clinical research'

05-Nov-2018 By Melissa Fassbender

The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles.

People on the Move: Outsourcing-Pharma roundup October '18

02-Nov-2018 By Melissa Fassbender

CROs this month have made significant new hires with WCG adding eight to its scientific leadership team, PPD hiring four, and BioIVT filling its new-created role of CCO.

Also, making the move from Bioclinica, David Kiger has been named...

Parexel launches advisory service dedicated to Chinese market

01-Nov-2018 By Melissa Fassbender

Parexel is launching a new advisory service to help clients navigate the market opportunities in China.

Watchdog files lawsuit against FDA to revamp informed consent, citing 150 deaths

01-Nov-2018 By Melissa Fassbender

The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.

Sponsors should consider the potential advantages, challenges of master protocols: CRO

31-Oct-2018 By Melissa Fassbender

Sponsors are encouraged to use a master protocol approach to accelerate clinical development programs, though experts say the advantages and challenges should be carefully weighed.

Sponsors ‘still have further to go’ as 50% of trials go unreported: Report

31-Oct-2018 By Melissa Fassbender

Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.

Infographic: FDA gains authority to prescribe less, but opioid prescriptions decreasing

30-Oct-2018 By Maggie Lynch

President Donald Trump signed the SUPPORT Act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn't the only crisis.

The top 3 challenges to next-gen processing and how the industry is racing forward

30-Oct-2018 By Melissa Fassbender

Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.

FDA gains authority after SUPPORT Act, but is authority enough?

30-Oct-2018 By Maggie Lynch

President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.