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”?