At the end of 2016, I attended the CBI 2nd Annual IDMP Update Forum in Philadelphia, a small but highly focused and effective conference with two days of meetings and discussions. There were presentations by industry leaders involved in understanding and addressing the challenges that IDMP compliance presents to the pharmaceutical industry, and also presentations by some of the vendors in this area.

The meeting kicked off with a keynote from John Kiser, Senior Director, Regulatory Policy and Intelligence, AbbVie.  This brought up some of the key challenges for IDMP compliance that were repeated again and again across the conference:

  • We need to think strategically, about master data management (MDM), not just about what is needed for IDMP compliance.
  • Even though the timelines are moving out, it’s really important not to take our eye off the ball. IDMP projects are being driven out of EU, and the US has to get moving to keep up. Don’t wait, start planning and kicking off pilots and proof-of-concepts with vendors now.
  • IDMP compliance planning shouldn’t just involve regulatory affairs and supply chain departments, as IDMP will impact quality, clinical operations, pharmacovigilance and safety, production, IT and more.

How text analytics using I2E can help

One comment that interested me was that while manual curation may provide the data elements for the current understanding of Iteration 1, other strategies will be needed to deal with potential changes in the implementation guidance, and to accommodate the flexibility required for Iteration 2 and beyond.


Uncovering new toxicities from chronic non-rodent studies

Preclinical toxicology studies are an essential part of the drug discovery-development pipeline, to support the safe conduct of clinical trials. And drug safety is, of course, one of the most critical aspects to ensure during drug development.

We were pleased to see the recent publication by Merck on a text-mining approach to assess the value of chronic non-rodent toxicology studies. 

Preclinical safety assessment groups employ a variety of animal models and assays to satisfy regulatory agency requirements to identify and characterize drug toxicities, describe drug exposures, and provide qualitative and quantitative risk assessments for human exposure. These require considerable resource investment, however the results are often “locked away” in internal reports. This means re-use of these valuable data is difficult and costly.

This is a common situation within the pharmaceutical industry – where critical information is locked away in textual reports, such as the informed scientific conclusions of pathologists, histologists, safety experts. Natural language processing can overcome the barriers, extracting structured facts from unstructured documents, and Merck’s paper describes an evaluation of a text mining workflow to access these important data.


Last week I attended the Cambridge Rare Disease Network (CRDN) 2016 SummitCRDN is a newly established charity working to build a community of people in Cambridge to address the unmet needs in rare disease research and treatment. As last year, there was a great set of speakers, from patient groups, academia, pharma/biotech and vendors.

There has been a step-change in awareness within the pharma industry in the last decade, with an increasing interest and investment in tackling rare diseases. I blogged last year about an interview with Patrick Vallance on this same topic.  He gave several reasons why GSK are interested in rare disease, and these three reasons all were echoed by the CRDN speakers.

The topmost of these reasons was given most clearly by speakers from patient groups, such as Daniel Lewi from the Cure & Action for Tay-Sachs (CATS) Foundation, Karen Harrison from ALD Life, and Emily Kramer-Kolingoff, from Emily’s Entourage. They spoke of the huge impact that rare disease has on individuals and families, and the urgent need for research into new or repurposed treatments for the 1 in 17 people affected by a rare disease.


Linguamatics are delighted once more to sponsor the Findacure Student Voice Essay Competition. Findacure is a UK charity that is building the rare disease community to drive research and develop treatments.   

The winning essay will be published in the Orphanet Journal of Rare Diseases, and the essay topics are:

  1. The impact of a rare disease is much more widespread than its direct symptoms. Discuss how, with particular reference to the patient experience.
  2. How can rare diseases lead the way in medical research and clinical innovation?
  3. How can clinicians and researchers, including students, help to deliver the UK Strategy for Rare Diseases?

One of the big challenges for the development of treatments for rare disease is the need for a thorough understanding of the natural history of each of the 7000 currently known rare diseases. It’s critical to have detailed systematic information on both the genotypic aspect (the genes and mutations), and the phenotypic aspect (pathways involved or disrupted, symptom severities, etc.).


How ready are you for IDMP?

IDMP (IDentification of Medicinal Products) is a set of international standards developed by ISO that will become mandatory in Europe in a phased approach, effective from 2018, and will also be adopted by the FDA and globally over the next few years. As with any new regulatory change, it is valuable to hear about others' experiences and ideally understand and learn from industry best practice. 

Joining the IRISS Forum is the best way of keeping track of IDMP. I joined IRISS this year - it is an excellent source for up-to-date IDMP information and also valuable input from industry experts (such as Andrew Marr, Vada Perkins, and others).

The IRISS (Implementation of Regulatory Information Submission Standards) Forum was created to address the need for a single central forum for open and broad stakeholder discussion of evolving standards, user requirements and practical, global implementation issues of these standards for the mutual benefit of both industry, government agencies and ultimately, public health.

IRISS recently (September 2016) surveyed its members, both pharmaceutical and vendor, across the current state of readiness around IDMP compliance. The companies that took part in the industry survey covered a wide range of organizational sizes, from small companies those with less than 100 EU authorizations to larger ones with more than 5000 (or, less than 10 active ingredients to more than 250). Over 80% of those in the survey had a global reach.