22 November 2011| Article by Maiken Hedegaard
Article by Maiken Hedegaard, Life Science Consultant, NNIT
The heart of pharmaceutical R&D is driven by the information flow from four organs, Marketing Authorisation Holder (MAH), Competent Authorities (CA), Clinical Development/Contract Research Organizations (CROs) and the pharmaceutical market. Just ten years ago, most R&D information was distributed as piles of paper, gradually several document management systems and standardised IT formats absorbed the A4s, and recently R&D has been immersed by a tidal wave of smartphones, tablets and medical devices. This very sea of gadgets has opened up new life science opportunities, but also new IT challenges, especially in terms of data security and infrastructure complexity. Nevertheless, mobility is the new black in life science. This article will map current as well as future aspects of mobility in life sciences.
Mapping Mobility in Life Science
Drug Discovery and Development
Mobility is already well-established in drug discovery and development laboratories, and the success is easy to understand when looking into this field. In drug discovery, groups of chemical or biological substances are screened to identify potential drug candidates. Once the potential drug candidates are found they are tested in vitro and in vivo. The most promising compounds are patented and formulated for further investigation in clinical trials. In this Pre-Clinical Phase a huge amount of data is accumulated, and thus, leaves a high demand for sample management. Mobility has facilitated drug discovery and development by means of faster electronic data exchange that allows direct access to raw data from integrated instrument applications; this has also improved sample management and QA/QC routines in GLP/GMP environments. The most widespread mobile drug discovery and development laboratory solutions are Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN).(1,2)
Clinical Trials
Clinical trials are, without comparison, the most critical and most expensive part of the drug development chain. Pharmacovigilance plays a central part in clinical trials since the Investigational New Drug (IND) must be screened from adverse events throughout all clinical trial phases, Phase 0-IIIb. Drug development laboratories and product supply chain are also involved in clinical trials as they deliver IND to trial sites. Today, trial outcomes are reported in paper form or directly via IT systems and smartphone solutions. Most of the IT systems used in clinical trials can be integrated with mobile solutions. This includes the electronic Patient Reported Protocols (ePRO), the Clinician Reported Outcomes (ClinRO) and Electronic Data Capture (EDC) solutions, enabling faster data collection and reviewing; even the analysis can be conducted with the mobile Randomization and Trial Supply Management (RTSM) application. (1,3)
Drug Application and Post-Marketing Procedures
All the accumulated data from Pre-Clinical to Phase 0-IIIb is collected into a dossier. Depending on the type of drug and company strategy, the dossier is sent to the CAs of relevance for approval. If the IND is approved, the company has approximately five years to make profit before the drug patent expires. Therefore, sales reps are under a lot of pressure. Tablet based Customer Relationship Management (CRM) systems have been a good solution for sales reps, as it has brought them a faster workflow and higher flexibility when interacting with customers and R&D. Moreover, pharmaceutical companies have started to request further R&D information from sales reps to approach market trends and patient outcomes in a real-time manner. It is thus likely that patient-centred mobile applications will be the next big trend in life science, which is in line with the increasing tendency of telemedicine, welfare and healthcare technology.(4)
Preparing Life Science for Mobility
Increased Complexity
While mobility brings new and exciting business opportunities in the life science industry, it also brings new IT challenges in quality, traceability and security. Are pharmaceutical companies prepared for the increased infrastructure complexity that mobility causes? FDA recently saved $US 10 million on IT costs by introducing an Enterprise Architecture (EA) Framework.(5) EA is commonly used for aligning IT with business - and business with IT – thus EA can be a great solution when it comes to decreasing infrastructure complexity.
Data Security in a Globalised World
The question is not whether R&D goes mobile, but whether pharmaceutical companies are ready for another dimension of security in terms of data distribution? Clinical trial data is extremely sensitive information as it includes patient data legislations and highly sensitive market information that can affect stock speculations and the generic drug market. In addition, most pharmaceutical companies have expanded their business to Asia, South America and Eastern Europe, which is challenging alone, but companies also need to consider how data security can be ensured, when data is more easily shared globally via smartphones.
Life Science Mobility at Its Best
Last year, mobility in life science was used at its best in the battle against counterfeit (falsified) drugs. The counterfeit drug market turnover is estimated to be worth $US 75 billion, which is very critical, as counterfeit drugs can be poisoning and often lacks the therapeutic effect, sometimes both. Therefore, the introduction of the anti-counterfeit drug app for smartphones was ground-breaking news. It all started in Ghana, where counterfeit drugs take up a quarter of the market. A drug advocacy group joined forces with Hewlett-Packard and several pharmaceutical companies; together they linked a texting-service to the drug production database via a sealed drug package code system. After purchase the seal must be scratched off to disclose the code, which is then texted to the production database that directly verifies or declines the code in a text message to the patient.(7)
In this real-life example, several conflicts were addressed in one inexpensive solution, and that is an example of mobility in action. In many ways, mobility is a new IT paradigm - technology is adjusted to life, not the other way around - an important aspect when it comes to life science technology. Seen from NNIT’s perspective, there is no doubt that the life science industry can benefit immensely from introducing mobility solutions. However, the industry needs to engage more in mobility infrastructure issues, rather than the device alone, to realize the vision of mobility. Once in control, mobility in life science can help make good practices even better.
References:
1 Lefebure, S. Case Examples Show Mobility Putting Life Sciences in Motion. Gartner Industry Research. 2011 Sep.
2 Technology Networks: www.technologynetworks.com/lims/ . Sitet: November 2011.
3 ICH Guideline E6 (R1): Guideline for Good Clinical Practice.
4 Tolve, A. Get ready for CRM 2.0. Eye for Pharma. 2011 Oct. http://social.eyeforpharma.com/marketing/get-ready-crm-20
5 Architecture and Governance Magazine. FDA Consolidates using an Enterprise Architecture Platform : A Case Study. 2008 Sep. http://www.architectureandgovernance.com/content/fda-consolidates-using-enterprise-architecture-platform-case-study
6 http://www.pharmacytimes.com/web-exclusives/Pfizer-Warns-of-Fake-Drugs-Sold-Online
7 http://www.economist.com/node/18008202