Brexit: leveraging the mutual recognition agreement to mitigate risk with commercial drug product release testing (updated 08-20)

The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit.

Fixing the patient recruitment “leaky funnel”: blending data with a patient and site-centric approach to address the challenge

Most people in our industry are familiar with the “Leaky Funnel” analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture. The loss of patients through planning, screening and execution of the study is not only costly, but it can also significantly delay or even prevent the successful execution of an otherwise valid study.

How to renew plant protection products – US regulations

Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.

Minimizing placebo effect in inflammatory bowel disease clinical studies

With 93 Crohn’s Disease (CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned and open to enrollment, there is a significant focus on research into new therapies for inflammatory bowel disease (IBD)1.

Can sponsors ease the challenges faced by patients in Cystic Fibrosis studies?

People living with cystic fibrosis face numerous health challenges, but have continued hope for an improved quality of life through ongoing research to target the root cause of this rare disease and ameliorate life-threatening symptoms. Many approved treatments and standard of care guidelines have proven to boost the median life expectancy, which has grown to nearly 40 years as compared to only 10 years in the 1960s.

Closing the knowledge gap with Real-World Evidence (RWE) studies: the importance of starting early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.

The 7 secrets to success in field trials for crop residue analysis

Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).

How to renew plant protection products – EU regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing and sales of PPPs, a renewal of authorization of the ASs must be sought. This renewal procedure is covered by Commission implementing Regulation (EU) No. 844/2012 and is a European-level process.

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

New REACH nanomaterial requirements: what you need to do

On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.