Dr. Sophie Olivier appointed as chief medical officer of Genticel team
Genticel, a biopharmaceutical company developing innovative therapeutic vaccines for patients infected with human papillomavirus (HPV), today announces that it has started a phase II study with its lead product ProCervix, a therapeutic vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18. The high-risk human papillomavirus HPV16 and/or HPV18 types are responsible for 70 per cent of cervical cancers worldwide.
ProCervix is targeted at women already infected by the HPV16 and/or HPV18 viruses before high-grade lesions or cancer occur. It is the first therapeutic vaccine to address the medical need of this high-risk population, because the preventive HPV vaccines are only effective in people who are not yet infected.
The Phase I study was conducted at the Vaccine and Infectious Disease Institute of the University of Antwerp, Belgium under the direction of Professor Pierre Van Damme. The results indicated that ProCervix has a satisfactory safety, local tolerance and immunogenicity profile. This study revealed the dose and vaccination regime required for further development. The clearance of HPV virus and maintenance of virus-free status was also markedly higher in the patients treated with ProCervix versus those in the placebo group.
Based on these promising results with ProCervix, endorsed by an international group of experts, Genticel has initiated a randomized, placebo-controlled efficacy Phase II trial. This multi-centric trial has received favorable scientific advice from the European Medical Agency (EMA) and runs across several European countries.
Dr. Sophie Olivier appointed as chief medical officer
Genticel has recruited Dr. Sophie Olivier as chief medical officer to lead the clinical development of its pipeline, in particular the ProCervix phase II trial. Dr. Olivier has over 20 years of experience in gynecology, women’s health and regulatory affairs.
Dr. Sophie Olivier was scientific administrator at the European Medicines Agency (EMA) in London, UK. She was responsible for assessing Pediatric Investigational Plans, in particular vaccines. Prior to EMA, Dr. Olivier also worked for 15 years with Wyeth. As a senior director, Women’s Health and Bone Repair, she was responsible for designing and implementing international clinical development programs in women’s health, leading to FDA and European submissions.
Dr. Olivier is an MD from Aix-Marseille University. She also holds a Master’s degree in Reproductive Biology and a Science and Statistics Masters from Pierre and Marie Curie University – Paris VI.
“We are very pleased to welcome Dr. Olivier. Her expertise in drug development, especially in vaccines and gynecology, and her experience at the EMA are considerable assets for Genticel, in particular for the ProCervix Phase II trial,” said Benedikt Timmerman, CEO of Genticel. “ProCervix is a first-in-class therapeutic HPV vaccine aimed at treating HPV infected women for whom no therapeutic options currently exist and with only ‘watchful waiting’ as an alternative.”
“I am thrilled to join the team at Genticel and to work on the development of these promising therapeutic vaccines,” said Dr. Olivier. “The phase I for the therapeutic candidate vaccine was successful and I look forward to pursuing its development in Europe and abroad.”
About the Human Papillomavirus (HPV)
Recent estimates by the World Health Organization suggest that worldwide approximately 300 million women are carriers of HPV. Of these, about 93 million are infected with HPV16 and/or HPV18 types. Of this population approximately 350,000 patients are diagnosed with cervical cancer each year.
About Genticel SA
Genticel is a leading biopharmaceutical company developing therapeutic vaccines against cancer. The company specializes in therapeutic vaccines aimed at eliminating HPV at early stage. HPV is responsible for the development of cervical cancer. A second vaccine-candidate is in pre-clinical development to target the six most relevant types of HPV. Genticel is based in Paris and Toulouse, France.
For more information: http://www.genticel.com
COVID-19 "causing mass trauma among world’s nurses"
Healthcare providers are facing ongoing nursing shortages, and hospitals are reporting high rates of staff turnover and burnout as a result of the COVID-19 pandemic. In June a report found that levels of burnout among staff in England had reached "emergency" levels.
Registered nurses Molly Rindt and Erika Haywood are nurse mentors on US recruitment platform Incredible Health. In this joint Q&A they tell Healthcare Global about their own experiences of burnout and what can be done to tackle it.
What does it mean to be suffering from burnout?
Some of the most common reasons for nurse burnout include long work hours, sleep deprivation, a high-stress work environment, lack of support, and emotional strain from patient care.
While every profession has its stressors, the nursing industry has some of the highest burnout rates. The massive influence on patients’ lives, the long hours, and many other factors put nurses at risk of severe burnout. And with the rise of COVID-19, many healthcare professionals feel the strain more than ever.
Burnout in nurses affects everyone — individual nurses suffer, patients are impacted, and employers struggle with enormous turnover. This is why it’s crucial for healthcare systems and management to watch for signs of nurse burnout and take steps to provide a healthier workplace. Employers should be careful to watch for burnout symptoms in their healthcare staff — and not ignore them.
Symptoms include constant tiredness, constant anxiety related to work, emotional detachment and unexplained sickness.
How widespread is this problem?
Unfortunately, burnout affects approximately 38% of nurses per year and even the WHO recently labelled burnout as an official medical diagnosis. To put this statistic into perspective, nearly 4 out of 10 nurses will drive to work dreading their shift. Burnout is a reason nurses leave their positions.
Other top reasons for leaving included a stressful work environment, lack of good management or leadership, inadequate staffing, and finding better pay or benefits elsewhere.
Even before the pandemic, demanding workloads and aspects of the work environment such as poor staffing ratios, lack of communication between physicians and nurses, and lack of organisational leadership were known to be associated with burnout in nurses.
Have either of you experienced burnout?
Rindt: I have experienced burnout as an RN. I was constantly fatigued, never felt like I was off work, and would frequently dream I was still at work taking care of patients. In my particular situation, I needed to take a step back and restructure my work schedule to allow for more time off. After doing this, I was able to reduce burnout by deciding to work two shifts back-to-back and then have 2-3 days off.
Haywood: I definitely experienced constant anxiety related to work - so much so it would impact the days I wasn’t at work. At one point, I was even on medication to help combat the anxiety and stress I was facing on the job.
I had heart palpitations, chest pain, and wouldn’t be able to sleep before working the next day, which slowly started to impact other aspects of my life. I knew I couldn’t continue to live this way, it wasn’t sustainable. Because of this, I began to focus on my needs and prioritising self-care, especially during the beginning of the pandemic. Putting my needs first and not feeling guilty were necessary for me to overcome burnout.
What impact is COVID-19 having on nurses' wellbeing?
Some nurses have suffered devastating health consequences. Many nurses have dealt with excessive on-the-job stress, fears of becoming infected, and grief over seeing patients succumb to COVID-19 while isolated from their families.
New evidence gathered by the International Council of Nurses (ICN) suggests COVID-19 is causing mass trauma among the world’s nurses. The number of confirmed nurse deaths now exceeds 2,200, and with high levels of infections in the nursing workforce continuing, overstretched staff are experiencing increasing psychological distress in the face of ever-increasing workloads, continued abuse and protests by anti-vaccinators.
However, other small silver linings that came from the pandemic include increased professional autonomy, leadership opportunities and career growth potential.
How much of the cause of burnout is due to the hospitals or healthcare providers, and what can they do to address it?
Nurse fatigue poses serious problems for healthcare organisations, and a recent survey from Kronos found 63% of nurses say their job has caused burnout. The survey also found that more than 4 out of 5 nurses think hospitals today are losing good staff because other employers offer a better work/life balance.
Nurse burnout not only contributes to staff turnover, but it can impact the facility’s quality of care, patient satisfaction, and even medical outcomes.
Strategies to address burnout include training improving nurse-to-patient ratios, include nurses in policy discussions, and prioritise fostering a healthy work culture in hospitals.
What does your role mentoring nurses on the Incredible Health platform involve?
Rindt: My role can vary based on the needs of the nurses. The nurses love knowing they have someone in their corner who can give interview preparation advice or provide suggestions on how to improve their resume. Knowing that there is someone who is well-versed in the job process and can help set expectations on what to anticipate, really helps to remove a layer of uncertainty.
Haywood: When screening nurses, it is customised to what their individual RN or nurse practitioner needs, and at a time that is most convenient for them. Nurses are busy and often aren’t thought of first. Being able to provide support from the very beginning of their career advancement journey helps tremendously. We also provide resources such as resume templates and tips that can help nurses be successful and feel supported.