Day 1 :
Grupo Ferrer Internacional, Spain
Keynote: Impact of the polypill approach in the efficacy and safety of trinomia®: Post-marketing pharmacovigilance data after three-years
Time : 10:00-10:45
Jorge I Gonzalez Borroto is a Toxicologist, working for more than 15 years in the field of Nonclinical Toxicology and Safety Assessment. He has experiences in Pharma Company and Contract Research Organization. He is a Senior Toxicologist involved in Pharmacovigilance to support the efficacy, safety and well-use of medicines of our company. He has experience as Medical Adviser in Dermatological area.
Statement of the Problem: Fixed dose combination therapy including acetylsalicylic acid, beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors, and statins have been advocated by the World Health Organization (WHO) for Cardiovascular Disease (CVD) secondary prevention since 2001 due to better efficacy, adherence, scalability, and cost-effectiveness. Trinomia is a fixed dose combination therapy for CVD secondary prevention with demonstrated similar bioequivalence with respect to the reference drugs. The expected patient´s efficacy of this cardiovascular-polypill show similar/greater reduction in risk factors as well as a greater increase in adherence compared with usual treatments in CVD secondary prevention. The 2012 European Society of Cardiology Guidelines on cardiovascular disease prevention in clinical practice states that reducing dosage demands is the most effective single approach toward enhancing adherence. Trinomia will cover the requirements to reduce dosage demands in adult patients.
Methodology: Polypill project (trinomia) is the European new fixed-drug combination developed as a therapy for secondary CVD prevention through a public-private strategic partnership between the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Spain and Ferrer Internacional S.A., Spain to help overcome the unmet clinical need in CVD prevention.
Findings: Trinomia is currently an approved new fixed dose combination and constitute a galenic-innovation combining several active ingredients that concomitantly reduce risk factors or pathological mechanisms of CVD in a single capsule. Multi-treatments schedules are frequent after cardiovascular events and represent health issues, such as adverse drug-drug interactions, medication errors and treatment non-adherence.
Conclusion & Significance: The CNIC-Ferrer polypill strategy has recently progressed in the CVD field, reducing complex-medication regimen, helping to solve additional risks associated with poly-medicated patients. Trinomia’s pharmacovigilance post-marketing data after three-years demonstrate as expected, that is a well-tolerated drug with good safety profile representing a valuable alternative for secondary prevention of CVD.
Keyrus Biopharma, Belgium
Time : 11:15-12:00
Essam Ghanem is an experienced Physician and qualified person for pharmacovigilance with almost 25 years of experience in Clinical Research and Drug Development at academic institutes, pharmaceutical industry and clinical research organizations. He has eight years of working experience as EUQPPV and as Consultant Safety Physician in the pharmaceutical industry. He is the Founder of the pharmacovigilance consultation company Vigi-Care BVBA. Currently, he is Head of Drug Safety and Pharmacovigilance at Keyrus Biopharma
The health authorities’ activities are targeting public health protection from the harm of used medicines, emphasizing their role in medicines risk assessment. Such achievement requires optimization of their collaboration with industry, addressing criticalities. The interactions with the involved stakeholders have a pivotal role where transparency during assessment of medicines’ benefit–risk profile throughout its life cycle should be ensured. Structured benefit/risk assessment framework earlier in drug development is challenging for medicinal products approval that necessitate positive benefit-risk balance parameters. At the end, the key question is “Do the health authorities’ interactions with patients and healthcare professionals have a beneficial impact on the taken decision”?
- Drug Safety | Pharmacovigilance and Risk Management | Biopharmaceutical Sciences | Adverse Drug Reaction | Good Pharmacovigilance Practice | Clinical Trials on Various Disorders
Location: Forum 15
Jorge I Gonzalez Borroto
Grupo Ferrer Internacional, Spain
Keyrus Biopharma, Belgium
Otsuka Novel Products GmbH, Germany
In 2010, Anna completed her Doctor of Veterinary Medicine in equine internal medicine and cardiology from the Ludwig Maximilian University in Munich, Germany. With over five years of professional experience as a Safety Physician and Drug Safety Manager, Anna currently delivers high quality pharmacovigilance and risk management expertise to Otsuka Novel Products GmbH for multi-drug resistance tuberculosis (MDR-TB). Effective, timely, and benefit risk balanced treatment of MDR-TB poses unique challenges because this disease area involves drug mobilization primarily through compassionate use and expanded access programs. In particular, Anna has contributed significantly to the global medical safety strategy for MDR-TB by setting up, improving and implementing various safety management processes. Besides safety management, her main area of interest has always been medical review, including process and content wise efficient and accurate implementation on global level. Her interests include travelling, golfing, skiing and riding.
Case quality is founded on accurate medical review and this quality ultimately translates into all subsequent activities, i.e. aggregate reports, signal management and all other product safety activities.
Accurate medical review starts with source data verification, triage – preliminary medical review, and data entry (relevant laboratory data, medical history etc. to be medically justified and entered, correct AE coding).
Ultimately these activities translate into a justified medical review statement which is disclosing the rationale why the adverse event is assessed as related or not related.
Drug Consult Pharmacy, Nigeria
Temitope Oyeneye completed her Graduation at Olabisi Onabanjo University and internship at Lagos University Teaching Hospital in Lagos, Nigeria. Presently, she is working as Pharmacist at Drug Consult Pharmacy, Nigeria. She has years of experience in interpreting a prescription and administration of pharmaceutical drugs at both government hospital and private corporate pharmacy stores.
The future of achievable pharmacovigilance depends solemnly on spontaneous adverse drug reaction (ADR). ADR reporting with yellow cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). ADR reporting among health care workers in Nigerian tertiary institutions is at a very low practice. A total of 180 questionnaires were distributed to different healthcare practitioners (HCPs) in three tertiary hospitals: The Federal Neuro-Psychiatric Hospital, Yaba; Lagos University Teaching Hospital, Idi-Araba and; National Orthopaedic Hospital, Igbobi all in Lagos Nigeria. The questionnaire sought the demographics of the HCPs, their knowledge and education on pharmacovigilance, practice and attitude to pharmacovigilance, the factors that they perceived may influence pharmacovigilance practice and suggestions on the possible ways to improve ADR reporting. The result gave 95.6% response rate. A majority of the respondents showed an appreciable knowledge of PV. Education and training was the most recognized means of improving ADR reporting. In conclusion, pharmacovigilance practice among the Nigerian health care professional proves to be inefficient and lack a proper data base documentation. Though, there has been a slight improvement when compared to previous studies, social workers and all sectors of the health care system needs to be involved. Government needs to include private hospitals, retails dispensaries, providers and traditional medicine. More awareness should be created on the yellow card reporting scheme. Social workers and continuous education, training and integration of ADR reporting into hospital activities would likely improve reporting and PV practice in general.
University of Bologna, Italy
Fiorenza Stagni is a Postdoctoral Fellow at the Department of Biomedical and Neuromotor Sciences of the University of Bologna (Italy). In 2014 she obtained her PhD in Biomedical Sciences. In the framework of her doctoral work, she examined the effects of perinatal therapies on the neurodevelopmental alterations that characterize Down syndrome (DS), exploiting a mouse model of this pathology. She is currently involved in an international project aimed at identifying a panel of drugs that may be safely used during pregnancy or in infants in order to counteract the neurodevelopmental defects linked to DS. In 2016 she was awarded by the
Trisomy 21 Research Society for the best dissertation in the field of DS (defended in 2014-2015). During the last years, she has received several Travel Awards for her the participation to international congresses and she was author of 13 publication in the field of preclinical studies for DS.
Statement of the Problem: No therapies currently exist for intellectual disability in Down syndrome (DS), a genetic disorder caused by triplication of chromosome 21. Intellectual disability is attributable to a severe reduction of neurogenesis that can be traced back to prenatal life stages. Accumulating evidence suggests that the triplicated gene APP (amyloid precursor protein) may be a particularly crucial determinant of neurogenesis alterations, because the AICD fragment of APP inhibits the mitogenic SHH pathway by increasing the expression levels of PTCH1, the inhibitory receptor of the SHH pathway. Since AICD derives from the cleavage operated by APP gamma-secretase, it may be envisaged that inhibitors of gamma-secretase may reduce excessive AICD levels with consequent restoration of the SHH pathway and, thus, neurogenesis.
Methodology & Theoretical Orientation: We used the Ts65Dn mouse model of DS in order to establish whether neonatal treatment with an inhibitor of gamma secretase (ELND006) reduces AICD levels and restores neurogenesis in the hippocampus, a region that largely develops postnatally in rodents and plays a crucial role in learning and memory.
Findings: We found that inhibition of gamma-secretase normalized the levels of AICD and PTCH1. This effect was accompanied by full restoration of hippocampal neurogenesis and total granule cell number. Treatment additionally restored neurite and synapse development and hippocampal functional connectivity.
Conclusion & Significance: Results show that the APP/AICD system may be a key target for the improvement of neurodevelopmental alterations in DS. The inhibitor of gamma secretase used in our study, however, was not free of side effects. A challenging issue is now the creation of new molecules that, while selectively inhibiting APP gamma-secretase, are truly devoid of side effects. This achievement may have an important translational impact for DS and other APP-linked brain disorders.
Parminder Kaur is a regulatory affairs and PV expert with 19 years of recognized global expertise in a broad range of therapy areas. She has played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies. She has provided strategic input for regulatory matters regarding product development aimed for EU launch, ranging from innovative product development incl. gene therapies, biologicals and biosimilars, vaccine and generic product approval as well as orphan designations and early access to unapproved medicines. She has also been highly involved in the pharmacovigilance set-up at various companies. She has played a major role in setting the QA systems in compliance with the European legislation at various companies; assisted various companies during inspections and audits conducted by EU Regulatory Authorities. She is acting as EU-QPPV and deputy QPPV for some companies. Currently, she is running her own consulting firm - RegPak BioPharma Consulting, Netherlands.
Effective pharmacovigilance requires a set of rules, operating procedures, and practices that must be followed to ensure the quality and integrity of marketed product. Good Pharmacovigilance Practice (GVP) is a quality standard for monitoring the safety of medicines and if necessary, taking action to reduce the risks and increase the benefits of medicines. It ensures the detection, collection, assessment, understanding, and prevention of adverse effects with medicinal products. As per GVP, every Marketing Authorization Holder (MAH) must ensure that they have an adequate and effective quality system for monitoring the medicines they have license for. It is expected that MAH: maintains a pharmacovigilance system; document all actions they take concerning safety reporting and signal detection and; have enough competent, appropriately qualified and trained staff to work the system. In order to gain a greater understanding of GVP requirements, this session will cover GVP modules I to XVI covering major pharmacovigilance processes which should be implemented by the pharma companies doing business in EU.