Technical breakthrough in HIV vaccines development

There have been lots of promising research proposals in terms of developing HIV vaccine, however, only several candidates passed through all preclinical stages and were tested in clinical studies. Phil Berman is a scientist who was in ahead of developing the main element of the only vaccine which demonstrated efficacy against HIV in a clinical study. He claims that one of the main reason why very few vaccines were tested in clinical trials is the technical difficulty of producing vaccines using the envelope proteins of the HIV.
It has been reported that a brand-new approach of manufacturing HIV vaccines was developed at The University of California, Santa Cruz by Professor Berman. This method helps to solve the main technical issues which restrained the development of this research area. Berman has told about this new approach at the conference on HIV vaccines “Emerging Technologies in Vaccine Discovery and Development” which was held in Canada from January 28 to February 1.
Professor Berman declared: “Dozens of interesting vaccine candidates have been described, but most have not been tested in humans because it has not previously been possible to manufacture them affordable and in a timely fashion. The technology we developed should break the logjam in HIV vaccine development, because it tremendously shortens the time, improves the yield, and lowers the cost”.
His laboratory uses robotics which helps to make the time needed to get stable cell lines which produce the proteins for a vaccine much shorter. What’s more, the amount of protein produced by cell lines has significantly increased while the cost of the procedure – decreased. Researchers plan to publish their results this year.

Source: Medical.

X7 Research takes part in the Scope Summit

Dear colleagues, X7 Research company participates in the Scope Summit for Clinical Ops Executives, which takes place February 12-15 in Orlando, Florida.

It’s already the 9th Annual SCOPE Summit, during which in-depth discussions will be held in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Resource Management and Capacity Planning, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Artificial Intelligence (AI), Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.

The more detailed information you can find out by clicking on the link to the official website of the event.

X7 Research vacancies in Moscow and St. Petersburg

Dear friends! We are looking for new talents in Moscow and St. Petersburg offices.

You can apply for a position:

  • Data manager
  • CRF Designer
  • Biostatistics specialist
  • Medical writer
  • Project manager
  • CRA I, II, III
  • Business Development Intern

X7 Research is a contract research organization founded by a group of professionals with extensive experience in conducting clinical trials in various therapeutic fields around the world. Our company provides full services for the drug development for pharmaceutical companies. X7 Research performs all types of research, from preclinical to post-marketing research.

You can get acquainted with all the vacancies by clicking on the link.

Any questions about vacancies and your CV should be sent to email: info@x7research.ru.

The problem of developing pediatric medicines in Russia and European Union

According to the Ethical Principles for Medical Research Involving Human Subjects of the Declaration of Helsinki, “Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.”

The Federal Law “On drug circulation” (2010) states that young people (before 18 years) in Russia can participate in clinical studies only on achieving informed consent from parents or adoptive parents. Children can be considered as potential patients for the clinical study only if conducting this study is necessary for the promotion of health or prophylaxis of infectious diseases at an early age or if the purpose of the study is to adjust the dosing regimen for children. In these cases, it is mandatory that clinical studies with adults were conducted first except for the cases when the tested medicine was developed only for young people usage. It is prohibited to include in the study orphaned children or children deprived of parental care.

EMA and European Commission are inviting all stakeholders to take part in a workshop organized together with the European Commission to reveal and discuss possible advances for implementation in the EU regulatory documents for pediatric medicines, so called the Paediatric Regulation. The workshop will take place in London on 20 March 2018.

The Paediatric Regulation was accepted in 2007. Ten years later, in 2017, it was published that there was a significant increase in the number of developed medicines for children in different therapeutic fields since that time, especially in rheumatology and infectious diseases. However, it was also outlined that there was a little progress in developing medicines for treating childhood diseases or diseases which present different courses in children and adults. Based on this statistic, the European Commission, EMA and its Paediatric Committee (PDCO) plan to develop a detailed set of actions which must be taken to boost the development of pediatric medicines in Europe.

Sources: EMA, Cyberleninka, Consultant.

The current situation with falsified medicines in the EU: measures to overcome and penalties

The Falsified Medicines Directive (2011/62/EU) (FMD) says that all EU countries should apply adequate and impactful punishments for those people who are involved in the manufacture and distribution of fake medicines. The penalties for this law infringement highly vary across the EU. For instance, the maximum length of imprisonment in Sweden, Finland and Greece is just one year while in Austria, Slovenia and Slovakia it may rise to 15 years. The maximum fines also range a lot across Europe: from 4300 € in Lithuania to €1 million in Spain and even to ‘unlimited’ in the UK.

Vytenis Andriukaitis, Commissioner for Health and Food Safety, declared: “I urge all EU countries to make sure that criminals falsifying medicines are punished. After all, falsified medicines can kill. The EU Directive includes several other measures to help citizens steer clear of falsified medicines, notably a common EU logo which helps consumers identify legal online pharmacies that sell authentic and safe products. I encourage all online shoppers to stay safe by looking out for the logo and ensuring that an online pharmacy is legitimate before making a purchase”.

What’s more, a pan-EU authentication system for medicines will be launched in February 2019. This system will allow to check the authenticity of prescribed medicines before giving them to patients.

Falsified medicines may be not only ineffective, but they also may harm patient’s health or even lead to death, and that is why fake medicines are considered to be a serious threat to public health. There are lots of falsified medicines in different therapeutic areas including treatments for cancer, erectile dysfunction, and Hepatitis C. Unfortunately, falsified medicines can and do go into the EU supply system. More than 400 cases of identifying falsified medicines were registered between 2013 and 2017 in the EU countries.

Source: EC.

MSMU named after I.M. Sechenov helps the best students become professionals

The First Moscow State Medical University named after Sechenov is a university-organizer of the “Medicine” direction of the Olympiad “I am a professional”.

“I am a professional” is a large-scale educational Olympiad of a new format for students of different specialties: technical, humanitarian and natural-science. The tasks for the participants were made by experts from the leading Russian universities and the largest companies. The Olympiad is held for the first time and includes 27 directions.

At the beginning of the week, January 29 and 30, at the Moscow State Medical University named after I.M. Sechenov and another 8 venues passed the final stage of the Olympiad in the direction “Medicine”. Hundreds of the best students of medical universities in Russia took part in it. The results will be known in the period from February 19 to March 2. Participants who will be among the best will be invited to the awards ceremony.

Right now, about a hundred of the best medical students of the country, the finalists of the Olympiad, are in the sanatorium “Zvenigorod” of the MSMU at the Winter Medical School Sechenov.PRO. During the school, the participants will be congratulated by the rector of the Sechenov University Peter Glybochko and the head of the project “I am a professional” Valery Kasamar. Also, at the opening lecture was given to the Nobel Prize winner in chemistry Avram Hershko.

X7 Research strongly supports this kind of initiatives. Stimulating the best students of the country will have a positive impact on the development of all sectors of the economy, including the development and improvement of technologies in the pharmaceutical industry.

Pharmacovigilance for small-to-medium-sized pharmaceutical companies

It can be challenging not for only for small-to-medium-sized pharmaceutical companies (SMEs) to follow and comply the updated regulatory requirements, but for large enterprises as well. SMEs are under pressure because they have restricted financial resources and they have to get the drug to the market as soon as possible. It is a common practice that small biotechnology companies develop medicines for rare conditions and focus on very specific target populations.

For that reason, SMEs usually involve contract research organizations (CROs) to conduct all steps of clinical trials.  What’s more, SME sometimes outsource several CROs located in different places to conduct clinical studies. This leads to the fact that safety data may be analyzed, submitted and revised separately which can influence the final results and conclusions. All these aspects put SMEs at risk when they submit new drug applications (NDAs) to get the approval.  That’s why it is crucial to review and analyze the combined data first.

This implies that SMEs should outsource end-to-end regulatory and safety and risk management organizations or single CRO service with experienced specialists in this area, otherwise, the companies may not ensure the proper evaluation of safety and efficacy of their products during the post-approval phase.

Employing a reliable pharmacovigilance functional service provider (FSPs) to outsource safety responsibilities during clinical trials and the postmarketing stage is a good solution to assure best-practice operations.

Source: appliedclinicaltrialsonline.

FDA offers a new, risk-based strategy to protect customers from homeopathic drugs with safety concerns

Recently the U.S. Food and Drug Administration (FDA) offered new risk-based enforcement priorities to protect consumers from taking potentially harmful homeopathic drugs. In order to do that the FDA will update the current regulations which cover the situations when serious diseases and/or conditions are stated as indications for taking these drugs. Moreover, the update will better address the situations when homeopathic drugs contain potentially harmful agents which do not meet GMP standards.

According to law, all homeopathic drugs should also be approved, and they have the same requirements regarding adulteration and misbranding issues as all allopathic drugs. Though, prescription and nonprescription homeopathic drugs have been produced and distributed without getting the FDA approval since 1988.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” stated FDA Commissioner Scott Gottlieb, M.D.

The FDA is planning to put efforts into improving the regulations for manufacturing of homeopathic drug products which safety reports are concerning; include potentially harmful ingredients; routes of administration are not oral or topical; are indicated for treating serious or life-threatening illnesses; are indicated for vulnerable populations (for example, children); do not meet the requirements of quality, efficacy or purity.

For example, homeopathic drug products for children which contain potentially dangerous ingredients such as belladonna may be subjected to this enforcement approach.

Source: FDA.

X7 Research takes part in the DIA Pharmacovigilance and Risk Management Strategies Conference

X7 Research Company participates in the three-days DIA conference. The topic of the conference is “Pharmacovigilance and Risk Management Strategies”.

The content of this event was developed by top experts from the biopharmaceutical industry and global regulatory agencies, and DIA will convene the best speakers from around the world to discuss the current challenges and issues that matter most to professionals working in the field.

This year, regulators and industry experts will take an in-depth look at global harmonization of ICH E19, addressing optimization of safety data collection. Insights and forward-thinking approaches to pharmacovigilance and risk management to ensure the safety of existing as well as advanced new therapies as these enter development and the postmarket setting will be discussed.  Projects applying cutting edge technologies like machine learning/artificial intelligence to manage large volumes of potential safety data will be examined.

The conference was launched on January 22 and will last until January 24. The capital of the USA – Washington DC was chosen as the city for this event.

More details on the materials and subtopics of the conference you can find on our website. And also see other events that our company plans to visit in 2018. You can find an event that you are interested in and contact us by email info@x7cpr.com. We will be glad to meet you at this and the following events!

GCP course for professionals

Dear colleagues, the course of the program for specialists “Good Clinical Practice”, developed by the First Moscow State Medical University named after Sechenov together with the X7 Research company, will be held from 13 to 26 April 2018.

You can get acquainted with the course program “International Standard ICH – GCP” on the Introduction page.

Requirements for students and the enrolling procedure are described on the “Course Overview” page.

Registration is open until April 2nd inclusively. We will be glad to see you among the students on our course!

The number of students is limited.