SDE Recap: Hyderabad SDE 2019

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Hyderabad, the “City of Technology” (High Tech City) led the platform for the discussion of Use of Biometric Technologies in Clinical Development at the PHUSE Single Day Event held on 18th May 2019.

The day comprised nine presentations by different speakers, with the theme of New Era of Biometrics in Clinical Development. We welcomed 240 participants from 23 different companies and 3 institutes.

Sarvesh Singh, PHUSE APAC Director, inaugurated the session, welcoming the speakers and participants, and gave an overview of biometrics and its use in clinical trials.

Mahesh Iyer, from Sineflex Solutions, the first speaker of the day, started the morning sessions by throwing various questions to the other speakers and attendees. He asked how you know whether a drug has an average effect on an individual and how clinical development will move from the concept of overall population aspect to personalised medicine. Mahesh gave several scenarios where the healthcare industry still needs to be developed. He then spoke about genomics, Big Data, AI/ML and other advanced analytics that will help not only to predict but also to prescribe. Mahesh’s presentation focussed on The Challenges in the New Era of Clinical Development.

Deepu Joseph, from Quanticate, took to the floor with his presentation on The Evolution of Biometrics and Pathway to the Future. He explained the need for biometrics, which supports the faster approach of research, patient centricity, and areas of focus such as real-world evidence and health economics and outcomes research, as well as how efficient digitalisation can be, and how data quality and standards can be maintained.

Deepu’s session was followed by Srinivas Vithala, from Novartis, talking about SAS, R and Changing Trends in Regulatory Landscape. This focussed mainly on programming technologies such as R for statistical analysis – an alternative to SAS – which aids deep learning about patient conditions by providing algorithms, and thus is being used by the FDA in review of clinical data.

Deven Babre, from Cognizant, then explored Escaping Digital Chaos in Biometrics. Deven spoke about data sources in the past, present and future and raised concern about to what extent virtual trials will be both successful and helpful with digitalisation, because trials are still conventional. He then concluded his session by saying that digitalisation can be a boon, but only when used in a required way with minimum, or no, chaos.

Shobhit Shrotriya, from Accenture, ended the morning sessions by presenting Internet of Clinical Things – Future of Clinical Development. He mentioned that the Internet of Clinical Things has the potential to change the clinical trial execution process, and that digital devices help in improving patient care. Giving interesting examples, he highlighted how digital disruption had its impact on patients’ lives, explaining the difference between a robotic/digitalised doctor and a human doctor.

The afternoon sessions started with Ravi Adla, from Ephicacy, talking about mHealth Technology in Clinical Trials. Ravi clearly explained the dependency of humans on mobiles, which has led to the increased use of digital devices in healthcare. This seems to be promising for aligning and delivering patient data in a contextual and timely manner, thereby decreasing the burden on study participants.

Suresh Chenji, from Syneos Health, on the topic Recent Innovative Approaches and Requirements for New Product Development, explained about the various types of master protocols, giving the Real Data and Lung-MAP case study as an example, which includes recent drug development approaches and the role of biometrics within that.

Sugam Salvi, from PPD, led the following presentation on Biometrics Monitoring Devices – A Digital Revolution, discussing the trends and opportunities of digital health such as more personalised care and real-time responsiveness. However, since there is a lack of knowledge of how to use BMDs appropriately, we need to take into account considerations such as concept of interest, context of use, GCP, and data standards.

The final session concluded with Vamsikrishna Vadlamani, from Cognizant, presenting his research paper Increasing Use of Health Services in Remote Areas Using Mobile Technology – SMART Approach. This study explains the quantitative aspects of evolution, examining the statistical analysis and the use of  mobile technologies as an electronic decision support system, that helped primary healthcare workers in improving the quality of life of patients (QOL).

The Panel Discussion, headed by Sarvesh Singh, provided good scope for attendee participation. Dinesh Pillaipakkamnatt, from Sineflex Solutions, Srinivas Vithala, Deven Babre and Shobhit Shrotriya formed the panel.

One clinician among the participants raised concerns/questions to the panel and presenters, in relation to real-time scenarios such as: How far can digitalisation be really helpful for patients? Will there be a place for considering human emotions in the whole treatment process with digital doctors? Can patient data that is digitalised be safe and how can we ensure its correct usage? This made for a very interesting session.

The conclusion of the Single Day Event was that despite having evolved into the healthcare industry and their use in drug development and research, biometrics and advanced technologies, though appearing to be a boon, still have their limitations in terms of data privacy and security. However, with better understanding of these technologies and when used appropriately, as required, digitalisation/biometrics do seem to have a promising future in certain aspects of clinical development.

The take-home note for everyone, as stated by Sarvesh Singh and the panel, was:

Participants attended the session thinking “I don’t know what I don’t know.

Then after the first half of the day, they thought “Now I know what I don’t know.

The session created an awareness and curiosity that led everyone to be inspired, which in turn also gave place to perspiration. I am reminded of the famous Thomas Edison quote:

Success comes with 1% inspiration and 99% perspiration.”

With the awareness, curiosity and inspiration created, we need to start learning/gaining knowledge, which comes through “literature search”. Next, consider your problem (context of use, and whether this can actually be applied) and try to solve itdesign thinking and marketing your idea/storytelling will help you to solve the issue.

Sunitha Yarram, from Sumptuous Solutions, and Hanumantha Rao, from Cognizant, chairing the Single Day Event.

Sarvesh Singh thanking all the sponsors – Cognizant, Ephicacy, GCE Solutions, PAREXEL, PPD, Sumptuous Solutions and Syneos Health – and giving mementoes to the presenters. Sarvesh also expressed thanks to all the attendees, volunteers and everyone behind the scenes for making the event such a success.

A special thank you to Jayapandian Nagamalaiyan, from Bayer, [Chair of Indian PHUSE SDE] very well-known to the PHUSE attendees. Jayapandian, India SDE Lead was the key person behind the success of the event, having put all his efforts into taking care of every aspect from start to finish.

Interesting presentations by the speakers, the Q&A sessions, the Panel Discussion and quizzes by the host to the audience, along with the breaks, all helped the attendees to interact with one another.

The venue, AVASA Hotels, certainly added to the day’s success. Attendees enjoyed the hotel’s excellent hospitality, delicious lunch and refreshments, their extraordinary audiovisual effects, and the comfortable space available for networking.

by

Dr Poojitha Mandava, PharmD

Junior Statistical Programmer, Bayer

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