Regulatory affairs

AAPS PharmSci 360 preview: ‘Small-conference feel and big-conference breadth’

30-Oct-2018 By Melissa Fassbender

AAPS PharmSci 360 is a new conference this year, created in response to a desire for “fresh science,” specifically with chemical and biomolecular components. So what can you expect?

‘Magic mushroom’ drug receives breakthrough therapy designation

26-Oct-2018 By Maggie Lynch

Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.

Law to provide reimbursement for clinical trial costs, laying ‘a path forward for change’

23-Oct-2018 By Melissa Fassbender

Changes at the state and federal level are paving the way for increased participation in clinical trials by providing patient reimbursement for study-related costs.

CPhI Worldwide

Less is more: Significant CDMO consolidation expected as pharma looks to work with fewer suppliers

22-Oct-2018 By Melissa Fassbender

CPhI panelists agree that there is going to be significant consolidation in the CDMO space – and express the desire to work with fewer suppliers, the top five of which currently account for 15% of the total market.

PCI adds new facility for clinical trial returns

22-Oct-2018 By Maggie Lynch

An additional investment at the PCI clinical services’ site brought forth an expansion to support the return of investigational drug products used in clinical trials.

Adaptive designs and master protocols: ACRO, CROs welcome new FDA guidances

19-Oct-2018 By Melissa Fassbender

New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.

FDA looks to remove innovation barriers in digital health space, finding balance between speed and quality

18-Oct-2018 By Melissa Fassbender

The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.

FDA guidance on clinical trial data disclosure falls short, while noncompliance remains high

08-Oct-2018 By Melissa Fassbender

The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.

US FDA says compounder used non-sterile wipes during sterile drug production

08-Oct-2018 By Flora Southey

The US FDA has issued a warning letter to a compounding pharmacy in California, US, after a facility inspection revealed FDCA violations.

Trials and tribulations: Rare disease research and the shifting care paradigm

26-Sep-2018 By Melissa Fassbender

As aging populations grow and treatment paradigms shift, the industry must prepare for greater challenges in the rare disease clinical trial space, says CRO executive.

OTC test lab or microbrewery? US FDA warns lab for mixing beer tech with media

24-Sep-2018 By Flora Southey

The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.

Report: Deception in clinical trials ‘squanders precious research resources’

21-Sep-2018 By Melissa Fassbender

Deception among clinical research participants is prevalent and a global issue, say researchers, with self-reported adherence found to be largely inaccurate.

Q&A

Digital innovation in trials: ‘We’re all stakeholders,’ says ACD/Labs exec

19-Sep-2018 By Maggie Lynch

Digital innovation in clinical trials aims to make data more accessible through electronic management.

Computing and modeling tech, telemedicine among the most promising enablers of patient centricity

18-Sep-2018 By Melissa Fassbender

Looking to establish patients as partners in the drug development process, the industry has launched several initiatives driven in part by advancements in technology, still, several challenges present.

Foundation awards grant to C-Path consortium to research sickle cell anemia

13-Sep-2018 By Maggie Lynch

Doris Duke Charitable Foundation awarded a grant to C-Path to form a consortium to accelerate research developments in sickle cell anemia.

WDBMD acquires DZS Clinical Services, deal to leverage complementary CRO services, says CEO

10-Sep-2018 By Maggie Lynch

DZS Clinical Services has been acquired by the global CRO WDMD in a deal that will expand its service offerings globally with the addition of coverage in Europe and Japan.

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

07-Sep-2018 By Melissa Fassbender

This month marked the effective start date for Parexel's new executive VP and CFO Greg Rush, who joins August's People on the Move with several other c-suite hires, including a new CEO at Citoxlab and COO at ProSciento.

At the source

Hu-manity.co eyes next-gen human rights: 'Data will be the currency of the future'

05-Sep-2018 By Melissa Fassbender

Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.

Wasdell opening ‘gateway’ into Europe, North America with new Ireland-based facility

04-Sep-2018 By Melissa Fassbender

With plans to “futureproof” its service offerings, Wasdell is investing €30m in a testing and distribution facility in Ireland – a growing market and gateway into Europe and North America, says CEO.

FDA promoting innovative clinical trial designs as part of new pilot program

30-Aug-2018 By Melissa Fassbender

The FDA has launched a new pilot program targeting complex, innovative clinical trials designs as part of its commitment under PDUFA VI.

IIVS teams up with labs to validate a non-animal test for regulatory submissions

29-Aug-2018 By Melissa Fassbender

IIVS is collaborating with global laboratories to validate an improved skin sensitization reactivity method to meet toxicology and regulatory requirements.

Deloitte acquires risk-based platform designed to address GxP requirements

29-Aug-2018 By Maggie Lynch

Deloitte’s acquisition of QSpace expands its IT quality and compliance solutions offering for life sciences firms, including contract research and manufacturing organizations.

Why patient counseling is an essential component of genetic testing

28-Aug-2018 By Melissa Fassbender

Genetic testing could potentially transform the way clinical trials are conducted – but for the patient, the role of the genetic counselor is a key component of this process.

SGS opening new biopharma testing lab in Geneva

28-Aug-2018 By Melissa Fassbender

The analytical and bioanalytical contract solutions provider SGS is expanding its biopharmaceutical testing capabilities in Geneva, Switzerland.

US FDA warns CRO for 'incorrect archiving of study materials'

20-Aug-2018 By Flora Southey

The US FDA has issued a warning letter to North American Science Associates, following an inspection of the CRO’s Brooklyn Park facility in Minnesota.

CROs respond: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’

20-Aug-2018 By Melissa Fassbender

Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.

Syneos acquires consulting firm to boost regulatory, safety, pharmacovigilance capabilities

20-Aug-2018 By Melissa Fassbender

Syneos Health has acquired the UK-based advisory firm Kinapse in a deal that will double its consulting footprint in Europe and further strengthen its commercial offerings – one company's fastest-growing lines of business, says CEO.

UK reaffirms commitment to ‘a competitive service for clinical trial assessment’ post Brexit

15-Aug-2018 By Melissa Fassbender

In an update on the implementation of the new Clinical Trials Regulation, the MHRA expresses increased confidence that the UK will exit the EU with a deal – and reaffirms its commitment to align with parts of the legislation “within the UK’s control.”

Clinical, commercial cross-selling fuels record Q2 at Syneos

14-Aug-2018 By Melissa Fassbender

Collaboration and cross-selling across Syneos Health's clinical and commercial organizations drove a record quarter marked by new strategic relationships as customers look to increase outsourcing in response to pricing pressures.

India poised to become ‘one of the largest clinical trial hubs,’ says CRO

13-Aug-2018 By Melissa Fassbender

Regulatory changes have brought clinical research in India “back on track” – with the market expected to grow at a CAGR of approximately 12%.

Certara outlines the role of quantitative systems pharmacology in FIH trial design, EMA responds

09-Aug-2018 By Melissa Fassbender

Modeling and simulation can provide “meaningful prediction” of a drug’s pharmacodynamic range and maximum dose – the use of which might have prevented the tragic outcome of the BIAL 10-2474 trial in 2016, says Certara VP.

State of the Industry: What readers have to say

08-Aug-2018 By Melissa Fassbender

Outsourcing-Pharma recently conducted a second ‘state of the industry’ survey to gauge views about the current state of the global pharmaceutical outsourcing market and the evolving relationships of those involved.

Global in vitro toxicity testing market to reach $8.8bn by 2023

02-Aug-2018 By Melissa Fassbender

The global market for in vitro toxicity testing is predicted to reach $8.8bn by 2023 – and demand is expected to increase, driven by new technologies and regulations, says Charles River.

FDA guidance encourages EHR use but doesn’t solve interoperability challenges: Industry responds

01-Aug-2018 By Melissa Fassbender

The FDA guidance addresses EHR data use in clinical trials – and while “one of the most prescriptive in recent memory” – does not solve interoperability challenges or address other sources of data, such as wearables.

EMA pulls back on activity, with 30%+ staff losses expected

01-Aug-2018 By Ben Hargreaves

The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.

ACRES: ‘Help is needed at sites to overcome the fractured nature of current processes and procedures’

30-Jul-2018 By Melissa Fassbender

The Alliance for Clinical Research Excellence and Safety (ACRES) has released a global quality standard for clinical research sites aimed at increasing data accuracy and integrity.

How to use mobile tech for data capture and improve clinical trials: CTTI recommendations

30-Jul-2018 By Melissa Fassbender

CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.

Premier Research acquires CA-based firm to develop regulatory services division

30-Jul-2018 By Maggie Lynch

Premier Research has acquired Regulatory Professionals, establishing a new regulatory services division in response to customer demand.

Researchers call for EMA-style transparency regulations in Pan-America

26-Jul-2018 By Maggie Lynch

Pan-American countries should adopt EMA-style regulations to increase clinical trial transparency and streamline research, according to a recent report.

Synexus launches new patient registry to support longitudinal brain aging study

23-Jul-2018 By Melissa Fassbender

Synexus is looking to register 30,000 adults for a five-year study with the goal of identifying potential prevention methods and possible treatments for Alzheimer’s disease and other dementias.

A call for action: IAOCR urges CROs support more high throughput research centres in UK

19-Jul-2018 By Flora Southey

CRO executives are being urged to write letters of support for more high throughput clinical research centres in the UK, which could help attract foreign investment, says IAOCR.

US FDA targets endpoints, preclinical testing and trial design to advance gene therapies

18-Jul-2018 By Flora Southey

The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.

Targeting special patient populations with the help of AI

17-Jul-2018 By Melissa Fassbender

The industry is increasingly engaging in collaborations to gain access to technology, such as AI, which is being touted as a potential solution to some of the most challenging aspects of running clinical trials.

No longer an option: Pediatric considerations in drug development

17-Jul-2018 By Melissa Fassbender

Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.

FDA outlines renewed efforts to include older adults in clinical trials

17-Jul-2018 By Melissa Fassbender

“Arbitrary upper age limits for trial entry are almost never justified,” says FDA, which has renewed its efforts to include older adults in clinical trials and tackle some of the key enrollment challenges.

How to promote new therapies for neonates through education and extended exclusivity

17-Jul-2018 By Melissa Fassbender

It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.