Milbhor D’ Silva, Astellas, discusses pharma’s #drugsafety strategies

drug safety,pharmacovigilance,risk management,signal management,epidemiology,medical information,benefit risk 

We spoke to Milbhor D’ Silva, Vice President, Product Safety & Pharmacovigilance, Astellas Pharma Global Development about the current challenges facing the Pharma industry.

What is the biggest change that you are seeing in pharma's drug safety strategies at the moment and what are the key challenges that pharma faces in effective benefit/risk communication?

a) How to manage ever increasing amounts of data with a limited human resource pool. Unfortunately the technology which is currently available doesn't seem to have kept pace with what is being offered to other industries that promote ready access to information streams from a variety of sources.
b) Major regulatory emphasis on correctly prosecuting safety data with objectivity during drug approval process and throughout product life-cycle.
c) Operationally, increasing amounts of outsourcing and off-shoring of case processing to CROs, difficulties in the effective governance of such liaisons, and challenges in building efficiency in PV organization in the context of flattened PV headcounts.
d) Analytically, scientific evaluations and contextual understanding of just not safety data but other external data (epidemiology, toxicology, HEOR, CER) that may inform conclusions about known safety data, and an increasing reliance of the application of methodologies to assist in better safety decision making, are challenging advancements Pharma is making.
e) Lastly, an increasing pressure and shift by Pharma to raise the PV talent to a much higher degree than at any other time in the last 30 years and to place the responsibility and accountability for safety strategy ownership in the PV department's hands, as opposed to in Development's hands.


What is the biggest change that you are seeing in pharma's drug safety strategies at the moment and what are the key challenges that pharma faces in effective benefit/risk communication?

a) The fact that ICH regions are not harmonized on key points that would enhance the effectiveness of a system to inform, educate, and message relevant risk and benefit information in a timely and user-friendly manner
Milbhor D’ Silva
Vice President, Product Safety & Pharmacovigilance
Astellas Pharma Global Development
Panel Session: The existing harmonisation practices are not working, how can we do this better?
Panel session: The future of post authorisation safety- where are we heading?
Overcoming key challenges in drug safety
b) Difficulty in risk characterization particularly with first in class compound and hence uncertainty on what exactly to communicate
c) Lack of incentivization, time, cooperation, and contribution from HCPs and Pharmacists plus other health care auxiliary staff who are closely working with patients and are responsible for both individual and public health
d) Current proposals to communicate R/B information will likely increase the burden on what is already a potentially more complex and challenged healthcare system in the US (hospitals, pharmacies, physicians, pharmacists, nurses, etc.) to allow the goals of the R/B communication to be met.
e) Internal competing interests among various functions/stakeholders within a company that potentially delay or dilute the intended thrust on how, when, and what should be communicated to external stakeholders.
f) In the case of external stakeholders, particularly Health Authorities (HAs), selecting the appropriate/suitable method or vehicle for communicating R/B information to multiple HAs with differential preferences is another daunting task.


Don't miss Milbhor D’ Silva at the World Drug Safety Congress Americas!