Wednesday, 25 April 2018

Social media analytics ‘The WEB RADR trials’



Web RADR (Recognising Adverse Drug Reactions) is platform which provides technological solutions for robust pharmacovigilance. Web RADR has its key contributions in Governance and policy, Social media and Analytics.

Web RADR is led by the European Medical Agency to provide its recommendation on developing mobile based application and use of social media for monitoring adverse drug reactions. Web- RADR goes in consultation with bodies like Eudravigilance- Expert Working Group (EV- EWG), Patient’s and Consumer Working Party (PCWP).

Key stakeholders in this project include Novartis Pharma, Janssen Pharmaceutica, Sanofi-Aventis, UCB and Amgen
Web RADR along with Epidemico (An organization with the capability to analyse and visualize data, comprising of public health leaders, software experts and data scientist) is now working its way to provide access to social media content by visualization using technology by Epidemico in detecting signals. Analysis of social media content through Big Data Analytics would be applied in forecasting problems with marketed medicinal products, it would enable the regulators to understand nature of safety signals and all of the content screening would be done on data which would be publically available, without violating data protection act adding further to this where social networking users would also have the provision to opt out of data collection.

Through a recent it was determined that in 2016, Facebook has highest number of threads with 2.2 Billion post, Twitter following with around 318 millions tweets and You tube with 1.5 billion videos.
Alongside with screening digital content from social media, Web RADR in collaboration with World Health Organization’s, Uppsala Monitoring Centre would be developing analytical tool, which would help in extraction of relevant and quality data from social media for  screening and would also focus on case triaging and linkage of duplicate reports.
Another initiative led by Web-RADR is designing android/ IOS based apps with key functions to report ADR and provide alerts. The apps would be linked with various regulatory agencies and would provide tailored alerts to the users about safety issues and warnings. The app would also facilitate anonymous ADR submissions using customized reporting forms. Web-RADR would be making the app soon available in different languages and additional products would be added in the product list for easy recognition of suspect.

In UK almost 4000+ users have used Yellow Card app with 400+ safety reports being sent to MHRA


Web- RADR , together with University Medical Centre Groningen and University College London would analysing barriers for patient and healthcare professionals to use mobile application for reporting ADR, studies through conjoint analysis where different versions of app are tested on different levels of health, literacy and usability on focussed population groups of patients adolescents, orphan disease populations and elderly patients have been undertaken by the University.
Web-RADR would also be conducting Scientific Impact Evaluation, together with University of Liverpool to determine whether mobile based application and social media content screening would be a value addition to Pharmacovigilance as output of these activities would impact policy recommendations.

Reference:
·         WEB-RADR, Work Packages (url: https://web-radr.eu/work-packages/wp5/ )
·         EPIDEMICO (url: https://www.epidemico.com/ )

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Cliniminds offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.

Monday, 2 April 2018

MHRA’s Black Triangle Report




In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.

One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle () on their package insert, to ensure that these drugs are intensively monitored.

The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction.

You may find the black triangle drugs at the Electronic Medicines Compendium, British National Formulary, Nurse Prescribers’ Formulary etc.… A black triangle symbol may be assigned to any new active drug / vaccine or even a Biosimilar (Biosimilar are similar biological therapeutic products). Black triangle is not restricted to only drugs, it may also include new route of administration, new drug delivery systems or even new patient population.

Black triangle drugs are reviewed every 2 years by the MHRA and monitoring black triangles reports helps in identifying benefit risk profile of drug and unrecognized adverse effects.

Reference:

·         List of medicines under additional monitoring, European Medical Agency (url: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852 )
·         EMC (https://www.medicines.org.uk/emc/ )

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Thursday, 29 March 2018

European Medical Agency to increase fees upto 1.7 %



There would be an increase in fees upto 1.7 % from April 1st 2018 as mentioned in the notification of Commission Regulation (EU) No 2018/471 (amending Council Regulation (EC) No 297/95), the fees however would be implemented for all activities carried out by the agency except pharmacovigilance. Apart from Pharmacovigilance the agency has also exempted fees ofMicro Small or Medium Sized Enterprise, Orphan Medicinal Products, Medicinal Products for Paediatric Use, Advanced Therapy Medicinal Productsetc… Detailed information on has been provided on an explanatory note.

The agency every year revises its fees as per the statistical data from EUROSTAT (European Union’s statistical office), the current revision is made in accordance with the inflation rate for 2017.
Reference:

1.       Explanatory note on general fees payable to the European Medicines Agency
2.       COMMISSION REGULATION (EU) 2018/471 of 21 March 2018
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Cliniminds (www.cliniminds.com),leader in Pharmacovigilance & Clinical research training and consulting 

Clinimindsoffers ‘Hands On training case processing on ORACLE Argus Safety and other safety databases. Our students are entitled for free DIA membership.


Friday, 9 March 2018

Artificial Intelligence Seeing through the lens of Pharmacovigilance

Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug.
The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies.


With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance.
Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence.

What is Artificial Intelligence ?       
Artificial intelligence may be called as an ability of a computer system to perform task that require human intelligence such as cognition through visual acuity, voice recognition, language translation leading to decision execution of a certain function.
Machine learning is based on reinforced data, where in which when an algorithm is executed to accomplish a specific task.

If it accomplishes the algorithm ends and the entire procedure in auto stored in the program, which means next time one does not need to manually execute the program, it would be auto executed in order to accomplish the task, if presented with the exact same variables as that of the earlier scenario.
In the second case if the task is not accomplished then too the procedure would be stored in the program and next time when the program is auto executed it would not take the same path thus minimizing error.

This process self-learning through experience is called machine learning For example imagine a scenario where in which you have you have received an email from a patient who has experienced nausea, followed by headache and bleeding from nose on Lisinopril, the patient also mentions that he has a history renal impairment and also that he was a chain smoker for which he took Varenicline to quit smoking.

An algorithm created on the principle of machine learning would have the capability to auto recognises and identify the suspect drug from concomitant therapy, adverse event from medical history and not only this through robotic process automation it may integrate the email with safety database, which means not only it identifies the suspect drug and the adverse event, it now also does the auto data entry, prepares auto case narrative and auto sends letters to the patient or physician for further follow up  from the safety database.

This is ‘Artificial Intelligence’, a capability attained through self-learning to process thousands of data within seconds.With automation employees engaged in manual data entry would be upskilled in the execution of AI process.

Cliniminds (www.cliniminds.com ) offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.


Thursday, 8 March 2018

PvPI to include vector borne disease as part Pharmacovigilance for Public health


Pharmacovigilance programme of India (PvPI), soon to include diseases caused in tropical climate, vector borne diseases like malaria and dengue, tuberculosis and HIV- AIDS as part the Pharmacovigilance for public health. The programme would be soon incorporated by all South East Asian Regulatory Network (SEARN) member countries.


When carrying out pharmacovigilance activities for the above targeted diseases, a common questionnaire has been developed by the  WHO for SEARN countries.

The PvPI would now have an added responsibility of updating adverse drug reaction database on Vigiflow based on the reports received from other SEARN centres.
This indeed shows a remarkable progress of our country- INDIA in translating pharmacovigilance for better patient safety.

Cliniminds offers corporate training programs exclusively designed for working professionals who want to get upskilled in pharmacovigilance, upon the completion of which each participant would awarded with Advanced Post Graduate Diploma in Pharmacovigilance accredited from ACCRE, USA

For more information visit: www.cliniminds.com or email us at info@cliniminds.com

Tuesday, 20 February 2018

Increasing Role of Business Analytics in the Pharmaceutical Companies

A pharmaceutical company wanted to in-license a phase I molecule and wanted to estimate its future value and take decision, whether to in-license the molecule at current offered price or not.                                                                   Approach: A detail study of molecule and its therapy area of development was undertaken to understand disease landscape and current market players. In-order to identify futuristic events an in-depth research related to upcoming molecules, epidemiological changes, pricing and treatment patterns was conducted. These inputs were further validated through primary research with KOLs, physicians and regulatory bodies, primarily to understand expected quantitative impact of future events. Once all required information was available, a robust macro enabled excel based forecast model was developed, with future trends in epidemiology, pricing, patient numbers and upcoming molecules as inputs. These quantitative inputs were derived using benchmarking studies and analogue analysis and were applied at appropriate step within the forecast model. Based on trial and clinical data analysis of the molecule of interest, primary research and analogue analysis studies, potential market share was estimated in next 10 years. These all when entered into the forecast provided potential revenue of the molecule that was being evaluated for in-licensing.
Outcome:The results of the model showed that asking price for the molecule was too high as compared to its expected revenue in next 10 year, thus pharmaceutical company did not pursue buying that molecule. When finally the molecule got launched, its revenues were quite in line as predicted by our model, thus saving the pharmaceutical company from a loss making deal.                                                                                                                                                                  About Cliniminds: Cliniminds offers professional job linked programs in pharma business analytics, clinical trials, pharmacovigilance and other health science domains. Programs are designed in line with industry requirements. For more information, visit our website – www.cliniminds.com or call at +91 9810068241

Monday, 15 January 2018

How pharma data / business analytics are helping pharmaceutical companies?

Case Study:
A top pharmaceutical company was interested to develop a medicine for diabetes, and for which it wanted to asses and identify attractive patient segments.


Approach
Secondary research was undertaken to understand current diabetes treatment guidelines and therapy landscape, to identify patient segments. Following this trial analysis was undertaken to identify upcoming trends and molecules in different patient segments of diabetes. The molecules and trends were further analyzed to ascertain their expected relevance on the diabetes landscape through clinical data and benchmark analysis. Key trends analyzed during the study were related to epidemiology, pricing, regulatory activities, and market access regulations across geographies. These findings were further validated through an intense primary research involving key opinion leaders, payers, physicians and regulatory bodies. The all inputs from primary and secondary research with collated together and analytical tools, such as PESTLE, SWOT, ANSOFF and 5 WHY’s were used to generate insights out of the information. Final report clearly laid out “WHERE TO PLAY” and “HOW TO PLAY” strategic options within diabetes.

Outcome
Project helped client to clearly understand the development opportunities within diabetes and design development plan for molecule as per plan.

About Cliniminds

Cliniminds is India’s leading Health Sciences Education, Training & Consulting organization offering specialised program in pharmaceutical data / business analytics, and other health sciences programs. All Cliniminds programs are linked with job placements. Cliniminds has trained and placed over 6,500 professionals in the health sciences domain.


For more information, please call 9810068241 or mail at info@cliniminds.com; www.cliniminds.com