How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
How identifying the genetic and non-genetic factors influence drug performance
Why is it crucial to take into account genetic and non-genetic factors when talking about risk mitigation and side effects?
Patients respond in a different way to drugs. Unluckily some patients can experience adverse reactions while in others a drug will not be efficacious. Identifying the genetic and non-genetic factors that influence the pharmacokinetics and pharmacodynamics of drugs helps to understand which patient subcategories are more likely to benefit from the drug and which are more likely to experience adverse reactions. This is shifting the paradigm that a drug can be used for anyone with a certain pathology to a more personalized approach where the choice of the drug and its dose is influenced by the characteristics of the individual patient.
How do you see pharmacogenomics influencing the future of CT and Risk Minimisation Measures?
Before answering the question, we need to take a step back and see which are the areas in which genetic differences are of most relevance to drugs. These can be grouped into four main categories: genes that are relevant to drug’s pharmacokinetics, genes that code for intended or unintended drug targets and other pathways related to drug’s pharmacological effect, genes not directly related to drug’s pharmacology that can predispose to toxicities such as immune reactions and genes that influence disease susceptibility or progression. Therefore, in clinical trials, pharmacogenomics can inform which patients are more likely to respond to a drug and therefore will be enrolled in a clinical trial. From a safety perspective, a clinical trial can be used to explore the hypothesis that patients with a certain genetic variant should take a different drug dose (as compared to patients without the variant) or are at increased risk of experiencing an adverse reaction.
If the results from a study show that a certain genetic variant is associated with an increased risk of experiencing adverse reactions or requires a dose adjustment to reduce the possibility of experiencing an important risk, risk minimization measures can be tailored to these patients’ subpopulations. A genetic test might be required to identify at-risk patients.
What is the biggest challenge in modifying current safety strategies to meet new government standards?
Probably the greatest challenge is the ever-increasing number of pharmacovigilance requirements, that can be different on a country-by-country basis. These requirements are not always aligned with ICH guidelines and therefore demand adaptations of the pharmacovigilance system to maintain efficiency and effectiveness.
Caveat: the above answers only represent the views of the interviewee, not those of his employer or of any other organization.
Giovanni FURLAN is a Safety Risk Lead, Director at Pfizer. He has more than 20 years’ experience in the drug safety arena and a degree in Chemistry and Pharmaceutical Technology, a qualified pharmacist. Giovanni started with processing individual case safety reports in a major pharma company. Since then, he set up, developed and managed drug safety units, integrated the safety operations of two pharmacovigilance departments. Qualified Person Responsible for Pharmacovigilance (EU QPPV) and Local Responsible Person for Pharmacovigilance for many years, led a team of physicians in charge of analyzing the company’s products evolving safety profiles. Worked at local, European, and global levels in medium and big pharma and in a CRO. Giovanni holds a unique blend of strategic, operational, and scientific skills. Expert in all aspects of pharmacovigilance systems, preparation of aggregate reports, signal detection and evaluation, risk management plans, interaction with regulatory authorities. Successfully undergone several audits and inspections, with significant experience in preparing and implementing corrective and preventive action plans. Giovanni delivered presentations in major congresses and has published many articles on various pharmacovigilance topics. Fellow of the International Society of Pharmacovigilance.