News

December 2, 2021

On 31 January 2022, Clinical Trials Regulation (Regulation (EU) No 536/2014) will go live, repealing EU Clinical Directive (EC No 2001/20/EC) and changing how Clinical Trials are conducted in the European Union (EU).

November 9, 2021

Although hair disorders are common, their management still represents a major clinical challenge in dermatological practice despite the emergence of new diagnostic tools and new treatment options.

October 29, 2021

Today is World Psoriasis Day. It is a great opportunity to share a review of the literature on this chronic skin pathology.

October 12, 2021

October is Breast Cancer Screening Awareness Month.

More than 355,000 women were newly diagnosed with breast cancer, and nearly 92,000 women died from the disease across the EU-27 in 2020.

September 30, 2021

International Translation Day is a great opportunity to talk about the translation service offered by our medical communication agency.

September 7, 2021

A clinical study may undergo important modifications in response to extenuating circumstances such as the COVID-19 pandemic. The CONSERVE* 2021 Statement offers guidance for writing clinical study reports (CSRs) and clinical study protocols (CSPs) related to studies that undergo modifications that:

June 28, 2021

Neonatal screening, also called newborn screening (NBS), allows the early detection and clinical management of newborns with a range of health conditions.

The date for this international NBS day was chosen in honor of Dr. Robert Guthrie, whose birthday is June 28^th. In the United States in the 1960s, Dr Guthrie developed the first NBS test for phenylketonuria (PKU), using a drop of blood collected on blotting paper. This blotting paper technique is still used today in all NBS programs. The blood sample is usually collected in the first 3 days of life from the newborn’s heel, or sometimes from their hand.

Technological advances now allow the screening of up to 50 disorders from just a few dried blood spots! Most of these are congenital metabolic disorders and endocrine disorders.

France was a pioneer in NBS, with the setting up of a national screening program in 1972. Since then, more than 35 million newborns have been screened, allowing earlier management of more than 23,500 individuals. In France, the cost of NBS is 100% covered by the health insurance system. NBS is not mandatory, but “refusing screening would be highly detrimental for the child” (Haute Autorité de Santé, HAS).

Six rare diseases are currently screened as part of the NBS program in France: phenylketonuria (PKU), congenital hypothyroidism (CH), sickle cell disease (SCD; overseas, and in mainland France if risk factors identified), congenital adrenal hyperplasia (CAH), cystic fibrosis (CF) , and medium-chain acyl-CoA dehydrogenase deficiency. However, this is much fewer than the more than 20 diseases screened in some European countries, such as in Italy where the NBS program includes up to 31 diseases!

The HAS recommends adding 7 inborn errors of metabolism to the French national NBS program: maple syrup urine disease (MSUD), homocystinuria (HCY), type 1 tyrosinemia (TYR-1), type 1 glutaric aciduria (GA-1), isovaleric acidemia (IVA), long chain hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, and carnitine uptake defect (CUD).

NBS is one of the areas of expertise of our medical writers at Santé Active Edition – Synergy Pharm. In particular, we have written a scientific article on NBS for CF in France, based on a day of discussions between clinicians and biologists; translated the guidelines for the clinical management and follow-up of infants with an inconclusive CF diagnosis through NBS; and produced referenced slideshows on this topic. Our scientific writers have also carried out other projects on CF, outside of the context of NBS: https://www.synpharm.com/en/world-rare-disease-day/

Sources:
HAS 2020: https://www.has-sante.fr/jcms/p_3149627/fr/depistage-neonatal-quelles-maladies-depister
ISNS Press Release: https://www.isns-neoscreening.org/wp-content/uploads/2021/06/Press-release-INBS-16-June-announcement.pdf
Loeber et al. Neonatal Screening in Europe Revisited: An ISNS Perspective on the Current State and Developments Since 2010. Int J Neonatal Screen. 2021;7(1):15 (https://www.mdpi.com/2409-515X/7/1/15)

June 24, 2021

June the 27th is World Microbiome Day. This yearly event aims to raise awareness of the diversity of human, animal and environmental microbiomes, and of their effects on health.

Our medical writers at Santé Active Edition – Synergy Pharm have participated in the writing of several scientific articles and reviews on the skin and intestinal microbiomes, highlighting their vital importance for human health, most notably in acne, atopic dermatitis, rosacea, wound healing, and in intestinal disorders. In addition, microbiomes in the environment play a fundamental role in maintaining the balance needed for healthy ecosystems.

Bianchi et al. Effects of a New Emollient-Based Treatment on Skin Microflora Balance and Barrier Function in Children with Mild Atopic Dermatitis. Pediatr Dermatol. 2016;33(2):165-71.

Cutibacterium acnes (P. acnes) and Acne: What We Have Learnt During These Last Years. JEADV 2018; 32(Suppl 2):1-23.

The Jungle on the Skin: Cutaneous Microbiome. Am J Clin Dermatol 2020; 21 (Suppl 1):1-50.

June 9, 2021

Today is MedComms Day! We would like to take this opportunity to tell you about our core business activity: medical and scientific writing.

Our medical communication agency has been serving the pharmaceutical and cosmetics industries, biotech companies, manufacturers of medical devices, healthcare professionals, and the wider scientific research community for more than 30 years. How? Medical communication, and particularly the writing of regulatory and clinical documentation related to the development of drugs and other healthcare products, is an integral part of these sectors.

Many documents are needed during the development and “lifespan” of a drug, from the pre-clinical research phase to marketing and beyond. Regulatory medical writing helps industry meet this demand.

• Setting up a clinical study requires the submission of a Clinical Trial Authorization (CTA) application to the health regulatory authorities. Many documents need to be written for this application: an Investigational Medicine Product Dossier (IMPD), an investigator’s brochure, a synopsis and a clinical trial protocol, an informed consent form (ICF), etc. In addition, a Clinical Study Report (CSR) needs to be written after each trial phase to communicate the results to the regulatory authorities, and a lay summary must also be published in the European database of clinical studies.
• Preparing a drug Marketing Authorization Application (MAA) also requires specific skills, involving the writing of a Common Technical Document (CTD, clinical and nonclinical), and a Pediatric Investigation Plan (PIP), if applicable. After submitting the MAA dossier, national (e.g., the French Agency for the Safety of Medicines and Health Products, ANSM) or international (European Medicines Agency [EMA], Food Drug Administration [FDA]) health agencies usually require detailed responses to answer specific questions about the drug being assessed.
• Pharmacovigilance documents (e.g., Periodic Safety Update Reports [PSURs], Development Safety Update Reports [DSURs] are also essential documents that need to be written at various points during the “lifespan” of a drug.

Publishing the results of experimental, nonclinical, and clinical studies in peer-reviewed journals is essential for enabling researchers to share their findings with the scientific community, and thus move science forward. Scientific article writing is the first step in this process. The scientific paper is then submitted for peer review. As scientific writing is subject to specific rules and the selection criteria of peer-reviewed journals are very strict, many authors also hire a medical writer to proofread or rewrite their scientific paper before submission to increase the chance of their article being accepted for publication in their target journal. In some cases, authors feel uncomfortable writing in English and use our medical article translation or language editing services before submission of their article to an international journal.

Medical communication is also required for conferences and meetings: an abstract of the study must be submitted, and then a poster or a slide show have to be created to present the results. For after the event, some companies or associations ask us to produce a conference report intended for participants who were unable to attend. Conference reports can be produced in several formats, e.g., as conference proceedings, scientific articles, or summary slideshows. Medical writers can also write, create, and produce all these documents!

The general public also have a need for a range of documents intended for them, such as the lay summaries of clinical trials mentioned above, website content dedicated to patients, medical brochures, leaflets, scientific sketchnotes (a of mix short texts and drawings), etc.

Our team is passionate about scientific and medical writing: our profession is diverse and enriching with many various missions on many various themes!

May 31, 2021

Did you know that tobacco is the main risk factor for bladder cancer?

In 75% of cases, bladder cancer is non-invasive but 5-year progression (0.8% – 45%) and recurrence (31% – 78%) rates are high. Patients with this type of cancer must therefore undergo regular examinations to enable early treatment.

Several urinary tests have been developed to overcome the drawbacks of reference examination methods;  in particular the invasive nature of cystoscopy, and the problems of sensitivity and of intra- and inter-observer reproducibility associated with cytology.

The results of a recent study support the use of the Xpert Bladder Cancer Monitor test developed by Cepheid for the monitoring of these patients in clinical practice. We would like to thank Géraldine Cancel-Tassin, Morgan Rouprêt, Ugo Pinar, Cécile Gaffory, Félicien Vanié, Valérie Ondet, Eva Compérat, Olivier Cussenot, Myriam Livrozet, and Laura Fabre for entrusting our medical writing team with writing and English editing of this article!