News

September 23, 2022

In our news update a few months ago we told you about cystic fibrosis, a rare disease that is one of the areas of expertise of our experienced medical and scientific writing team. In particular, we have already helped our clients with a range of projects on this topic, including:

• Congress reports of the international North American cystic fibrosis research (NACFC) held in the US
• Writing a scientific article from a day of exchanges between clinicians and biologists
• Translation of management and follow-up recommendations
• Creation of referenced slideshows.

The “Virades de l’espoir”, walks of hope to help in the fight against cystic fibrosis organized by the association Vaincre la Mucoviscidose in France, provide a timely opportunity to focus on this disease. Similar events take place in many countries around the world, including the Great Strides™ walking challenges organized by the Cystic Fibrosis Trust in the UK and the Cystic Fibrosis Foundation in the US.

2002-2022: 20 years of major progress

The year 2022 marks 20 years of major advances in the diagnosis and management of cystic fibrosis in France and around the world:

• The introduction of widespread systematic neonatal screening for cystic fibrosis, in which France led the way with the design and use of a single nationwide decision making algorithm as early as 2002.
• The creation of cystic fibrosis reference and competence centers (CRCM) to coordinate patient care.

These measures have made it possible to improve the prognosis of this disease, allowing early diagnosis and multidisciplinary management organized within the CRCMs from the first weeks of life thanks to neonatal screening. The benefits for patients have been observed at all levels of care, with a favorable cost-benefit ratio:

• improved respiratory and nutritional prognoses
• increased survival
• reduction in the burden of treatments.

More recently, as we mentioned in our news update, innovative medicines, such as the triple therapy elexacaftor-tezacaftor-ivacaftor (Kaftrio®), have also led to a rapid improvement in the health status and quality of life of eligible patients. This treatment was first administered to a very small number of patients in France, thanks to an “autorisation temporaire d’utilisation nominative”, ATUn* [nominative temporary authorization for use]. However, marketing authorization (MA), extension of the indication, and inclusion of Kaftrio® in the compassionate prescription framework of the French National Agency for the Safety of Medicines and Health Products (ANSM), has gradually led to a larger number of patients being able to benefit from this treatment.

Further progress is needed

Despite these important advances, many patients are still missing out on innovative treatments. In addition, there are currently no curative treatments for patients with cystic fibrosis. Thus, further efforts are needed to continue to combat this disease.

“Virades de l’espoir”: Walks of Hope to raise awareness and funds

The “Virades de l’espoir”, created in 1985, help raise awareness of the fight against cystic fibrosis and raise funds to improve the lives of patients with the disease, most notably by funding research into the development of new treatments.

On or around Sunday, September 25 2022 people all over France will participate in the “Virades de l’espoir” and/or take on online challenges to support this fight. Find the complete program here: https://virades.vaincrelamuco.org/

*Name prior to the reform of derogation-based access to medicine schemes which came into force on July 1, 2021 in France.

September 21, 2022

Alzheimer’s disease is a major global healthcare challenge. The number of people living with Alzheimer’s disease or other forms of dementia is currently estimated at over 55 million worldwide, and this number is expected to reach 78 million by 2030. The prevalence of dementia is estimated at around 10 million across all European countries, and is expected to almost double by 2050. In France, 2.2 million people may be affected by the disease by 2050.

Associations and foundations around the world, including Alzheimer’s disease international, the UK Alzheimer’s society, and the French Fondation Vaincre Alzheimer and the France Alzheimer association, organize events every year to raise awareness about the disease, and fight prejudice against those living with Alzheimer’s by highlighting the preserved abilities of those affected by the disease and encouraging the general public to see the disease in a new light.

This year, World Alzheimer’s Day is on September 21, 2022. As part of the theme, “Know dementia, Know Alzheimer’s”, we invite you to take another look at the impact of this neurodegenerative disease on the different types of memory: not all types of memory are affected in the same way by the disease, and some memories are relatively well preserved.

Impact of Alzheimer’s disease on the different types of memory

• The most notable first signs of memory problems in Alzheimer’s disease concern episodic memory, which is involved in the recall of personal events. People with this type of memory deficit often struggle to remember what they did the day before, or recent significant events.

• Deficits in semantic memory, which result in problems remembering general information, are perhaps less noticeable than other types of memory loss but probably appear at the same time, or even before other memory problems. This type of memory deficit can result in individuals finding it increasing difficult to find words, and recall the names of people, objects and places.

• Alzheimer’s disease also leads to working memory disorders, which makes it difficult to retain short-term information, such as telephone numbers.

• On the other hand, procedural memory, which is involved in the performance of gestures and skills that do not require direct conscious awareness, such as knowing how to play the piano or ride a bike, remains preserved for a relatively long time during the disease course.

• Finally, sensory memory is the form of memory that best resists Alzheimer’s disease and can be used in sensory stimulation workshops.

More information on the types of memory can be found in this sketchnote made for the French social action organization “Observatoire des mémoires du Groupe B2V”.

The expertise of Santé Active Edition – Synergy Pharm

Neurology is one of the areas of expertise of our medical writing team.

You may also be interested in other projects we have carried out on this theme for the “Observatoire des mémoires du Groupe B2V”:

• An interview with Dr Maï Panchal on the prospects for the treatment of Alzheimer’s disease: https://www.observatoireb2vdesmemoires.fr/publications/maladie-dalzheimer-quelles-perspectives-de-traitement
• A sketchnote on the need to take care of the cerebral and cognitive reserve in order to delay the appearance of the first symptoms of neurodegenerative diseases: https://www.observatoireb2vdesmemoires.fr/comprendre/la-reserve-cerebrale-et-cognitive

To learn more:

Further information about the types of memory affected in Alzheimer’s disease can be found at:

• https://www.francealzheimer.org/memoire-long-terme-court-terme/
• https://www.alzheimers.org.uk/get-support/staying-independent/understanding-types-memory

For information on the disease, its impact on daily life, and the latest World Alzheimer Report, you can download the open-access resources available from websites of Alzheimer’s Disease International and the Vaincre Alzheimer Foundation:

• https://www.alzint.org/
• https://www.vaincrealzheimer.org/la-fondation/brochures/

Information about ongoing research projects and recent research advances can be found on the websites of Alzheimer Europe and the Fondation Recherche Alzheimer:

• https://www.alzheimer-europe.org/research
• https://alzheimer-recherche.org/savoir-plus-avancees-de-recherche/

Resources related to diseases related to Alzheimer’s (Lewy body disease, frontotemporal dementia etc.) can be found at https://entretiensalzheimer.org/index.php/digitalz/ and https://www.alzheimers.org.uk/about-dementia/types-dementia

September 13, 2022

Synergy Pharm keeps you informed about medication safety, the theme chosen by the World Health Organization (WHO) for the 2022 edition of World Patient Safety Day.

Regulatory documents for drug safety:

Several regulatory documents are required to ensure the safety of a drug before it is made available on the market.

• One of the first key steps is the drug benefit/risk assessment included in the CTD (Common Technical Document) submitted to the health authorities.
• Additional specific documents may be requested at the time of submission, such as the “120-day safety update” and the DALA (Drug Abuse Liability Assessment) for the Food and Drug Administration (FDA) in the United States.
• Once the product is available on the market, various pharmacovigilance systems are set up to allow the safety of the product to be monitored during its use by patients. Several safety reports are thus issued during the drug development phase (DSURs) and are periodically updated (PSURs/PBRERs).

Specialized in medical writing, our experienced team can assist you in the drafting of these regulatory documents. Synergy Pharm is member of France Biotech and holds the accreditation for French research tax credit (CIR) as a service company involved in research and development (R&D) projects.

Raising patient awareness on medication safety:

Ensuring the safe use of medication is essential for reducing patient harm. Especially since the COVID-19 pandemic has significantly exacerbated the risk of medication errors and associated medication-related harm. There are several interventions that can help to limit the frequency and impact of medication errors.

On 17 September 2022, the WHO is organizing a global campaign on the theme of “Medication Safety” with “Medication Without Harm” as the slogan to raise awareness among the public and health professionals about safety issues related to the use of medication. This program aims to reduce severe avoidable medication-related harm by 50%, globally, in the next 5 years. To help achieve this goal, the WHO has developed a patient engagement tool called “5 Moments for Medication Safety” to facilitate and empower patients to be more involved in their own care. This tool includes a list of questions that can be asked at different levels of care and in different settings and circumstances:

• Starting a medication
• Taking a medication
• Adding a medication
• Reviewing medication
• Stopping medication

More information on this campaign and on the series of medication safety webinars organized by the WHO can be found at: https://www.who.int/campaigns/world-patient-safety-day/2022

July 21, 2022

Synergy Pharm USA can support you from A to Z with the publication of your peer-reviewed journal supplement. We can produce your supplement from conference presentations or your study results. At our health communication agency, several scientific or medical articles can be written in parallel by our medical writers, which allows the rapid publication of the supplement after the event. Our editorial assistance and medical writing team can help to coordinate your project, reducing the delays associated with author proofreading, article review, submission and publication.

May 19, 2022

On 26 May 2022, Regulation (EU) 2017/746 will come into force for in vitro diagnostic medical devices (IVDMDs). Full details of this new regulation (IVDR) are available at: https://eur-lex.europa.eu/eli/reg/2017/746/oj

Help is on hand to guide companies through the transition

• The French National Agency for the Safety of Medicines and Health Products (ANSM) recently hosted a webinar presenting the new classification rules, the timetable for the implementation of this new European regulation, and plans for the transition. Replays of the webinar are available here: https://www.youtube.com/watch?v=1yjnlBNNQHo

• Elsewhere, the European Society of Human Genetics hosted a dedicated, day-long, IVDR webinar, providing generation information about the new regulation, its impact on diagnostic laboratories, and practical approaches to obtain compliance. Replays of the sections of the webinar are available here: https://www.eshg.org/index.php?id=ivdrday

The expertise of Santé Active Edition – Synergy Pharm

Specialists in medical writing, our experienced team has the skills needed to accompany you in the drafting of your regulatory documentation: clinical evaluation reports (CERs) including state of the art and literature reviews, as well as all the documentation related to your clinical investigations (CIs), such as investigator brochures (IBs), clinical study reports (CSRs), and more.

We can also support you in writing the scientific article relating to your clinical investigation.  

Recent examples of articles about IVDMDs written by our team include:

• Cancel-Tassin et al. World J Urol. 2021
• Ehret et al. J Clin Virol. 2022

Do not hesitate to contact us to discuss your projects!

April 18, 2022

April 18 is European Patients’ Rights Day (EPRD).

The European Charter of Patients’ Rights proclaims 14 rights that aim to guarantee “a high level of protection of human health” and to ensure the provision of high quality of health services in European countries, in particular during the Covid pandemic.

More specifically, this charter proclaims:

• The right to information (“access to all that scientific research and technological innovation makes available”),
• The right to consent for any procedure or treatment, but also for participation in clinical trials,
• The right to innovation (“right of access to innovative procedures, including diagnostic procedures”), which implies the right of access to treatments or medical devices assessed in clinical trials.

The European Clinical Trials Regulation (Regulation (EU) No 536/2014) also aims to guarantee the rights of patients, and all of the medical writers at Synergy Pharm/Santé Active Edition are committed to ensuring that information relating to compliance with ethical standards and good clinical practice is clearly stated in publications reporting the results of clinical trials.

Our regulatory medical writing team also provides other medical writing services for clinical projects, including the information notes and Informed Consent Forms (ICFs) that should be provided to patients before their inclusion in a clinical study, as well as other study-related documents: Clinical Study Protocols (CSPs), Investigator’s Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs) for Clinical Trial Authorizations (CTAs), Clinical Study Reports (CSRs), etc.

March 14, 2022

On the occasion of the national “Week Against Cancer” campaign in France, it is important to highlight research efforts aimed at reducing the side effects associated with cancer treatments.

Indeed, while the range of treatments available – used alone or in combination – are effective against cancer, they can have many side effects, particularly on the skin. Xerosis is one of the most frequent side effects of cancer therapy and requires appropriate management to help maintain patient quality of life and prevent potential interruptions to cancer treatment.

A recent multicenter, real-world, phase IV study demonstrated the benefits of using an emollient containing a postbiotic in the management of 319 patients with xerosis associated with a range of cancer treatments (chemotherapy, targeted therapy, radiotherapy, hormonotherapy and immunotherapy).

A previous multicentre, real-world, phase IV study had already demonstrated the effectiveness of this emollient for the management of xerosis in 5,910 patients with a range of skin conditions (atopic dermatitis, senile xerosis, ichthyosis, psoriasis, prurigo nodularis of Hyde etc.) and underlying systemic conditions (diabetes mellitus, thyroid disease, renal insufficiency, etc.).

These two articles, published in Dermatology and Therapy and written by our medical writing team, can be found here:

• https://link.springer.com/article/10.1007/s13555-022-00685-2
• https://link.springer.com/article/10.1007/s13555-020-00415-6

March 9, 2022

Next week (14^th – 20^th of March) is the 24^th Brain Awareness Week (BAW), “a global campaign to foster public enthusiasm and support for brain science” (https://www.brainawareness.org/about/).

There are many events taking place across the world, and several activities are also being proposed to help you get involved in the campaign.

In France, the “Société des Neurosciences” is hosting an extensive program, with replays of a range of conferences also being made available.

Many of the topics covered are related to themes* that our medical writing team has addressed in the form of articles and/or sketchnotes for the general public in collaboration with the “Observatoire B2V des Mémoires” (B2V Memory Observatory): https://www.synpharm.com/en/sketchnote/

*Learning, Brain and Artificial Intelligence, Brain and New Technologies, Brain and Society, Brain and Sport, Sleep, The 5 senses, Emotions, Memory, The Sick Brain.

February 28, 2022

By definition, a rare disease has a prevalence of 1/2,000. But rare diseases are numerous and would affect more than 3 million people in France, more than 300 million in the world!

Most of these diseases have no treatment. Nevertheless, many actors are mobilized in the fight against rare diseases to improve the diagnosis, care and follow-up of the patients concerned; research in this area also allows significant medical advances.

In 2021, we again had the opportunity to put our medical writing skills at the service of several rare diseases, including craniofacial microsomia, cystic fibrosis, and inherited epidermolysis bullosa.

January 25, 2022

Synergy Pharm feels particularly concerned about Neglected Tropical Diseases (NTDs) and keeps you informed about the activities of the WHO.

On Sunday 30 January 2022, the WHO will celebrate the World Neglected Tropical Diseases Day (WNTDD). The WHO activities aim to mobilize the world to defeat NTD (https://www.who.int/campaigns/world-ntd-day/world-ntd-day-2022).