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Blockchain for Labeling Management and Regulatory Submissions

I write this post as I sit at DIA2018. After the first day of conversations with many clients, academics and partners I feel vindicated in my belief that it is not outrageous to make the idea if leveraging Blockchain for Labeling Management. In fact, extending it to the entire Regulatory Submissions is very much in the realm of possibility. The biggest hurdle, in my opinion, is the change in mindset across the board with all the stakeholders.

As we have experienced in the industry with the site visits and Source Document Validation (SDV), we err on the side of being over cautious. Understandably so due to the high stakes on the table. However, it took the regulators to come out with the guidance until everyone started thinking about Risk Based Monitoring. Hence I believe this idea will go through the same iterations of being thought as outlandish or impossible and then wait for the news of success from the few brave and innovative organizations to get a breakthrough and then will catch fire. A couple of years ago putting Clinical, Regulatory and Safety information on the cloud was an uphill task. Now every sponsor has a “Cloud First” strategy.

Coming to the idea of leveraging Blockchain, the key tenets of Trust, Immutability, Finality and Provenance driving creation of a ‘Shared Ledger’ of transactions with ability to execute ‘SmartContracts’ with each transaction are benefits that we cannot ignore.

Imagine a distributed system that records all transactions related to the changes to labels all the way from initial change to the CCDS to all transactions related to the submission activities, eventual submission to regulators/HAs as well as follow on activities related to change in labels, artwork etc. being recorded as and when it happens. Ability to collaborate with not just internal stakeholders at HQ, Affiliates or Regulatory Hubs but also with external stakeholders like CROs and FSPs.

Blockchain Labeling Management

Even better, extending such a Blockchain to regulators who would not only get to see the review ready submission, but also all the transactions that happened in putting the submission together. All of this with utmost security using Cryptography so the Regulators/HAs can access the information they are expected to review but also trust that the information has not been tampered with. This will even enable fewer regulatory inspections and site visits while ensuring the process is fool proof in ensuring Safe and Efficacious drugs are delivered to the patients.

I would be working on socializing this idea further with my clients, partners and other key stakeholders in the Life Sciences industry and working towards a “Zero Submission” product approval very soon in the future.



Automation in Regulatory Affairs : 5 essential criteria for process selection

In the last month at least 3 clients (top 10 Pharma) that I spoke to brought up Automation in the context of Regulatory Affairs. While it is very common for everyone to get excited about some of the popular technology trends and jump on the bandwagon to adopt these within a business context, many such initiatives fail to find traction and success unless they are carefully managed with a strategy and plan.

Regulatory Affairs function is not immune to this temptation. However, the excitement is typically tampered by the implications of things not working out resulting in regulatory compliance issues and product approvals. However, many activities within Regulatory Operations are repetitive in nature and are very conducive to being considered for automation. In my opinion, the criteria that should be considered while assessing a business process for automation are:

  1. Process Type: Nature of the Business Process in terms of Strategic vs. Tactical
  2. Frequency: How frequently is the process invoked to deliver business value
  3. Manual Tasks: How many tasks within a process are manual in nature and are leading to process inefficiencies and errors
  4. Benefit: How much hard/soft benefit can be delivered by automating the tasks
  5. Performance: Can the steps be measured easily to assess the performance

Assessment & Prioritization:

To create a strategic plan for automation, each process in Regulatory Affairs ranging from Regulatory Strategy to Life Cycle Maintenance can be assessed based on these criteria. RA-Automation-Criteria

Prioritization of the processes and/or tasks within a process can be done by arriving at a balanced scorecard for automation. The weightages provided in the chart can be used as reference but can always be tailored based on any given organizations’ needs and inputs. The criteria can also be leveraged at the enterprise level to assess other functional areas like Clinical and Safety, in order to prioritize at the department level to assign and approve budgets. The key is a structured way of identifying opportunities, assessing them for automation ability and prioritizing based on balanced scorecard. RA-Balanced-Scorecard

The above score card does not cover all the processes of the Regulatory Affairs processes. However, it is used to illustrate how to create a balanced score card to prioritize the processes for automation.

While organizations are considering moving to a Regulatory Information Management platform of the future, they can still consider automation as a way to compliment process improvements achieved. In fact, I strongly recommend creating an ‘Automation’ workstream as part of the RIM initiative so that all the work done to harmonize the processes and transform the processes in preparation for new platform adoption can be harnessed to assess and prioritize the processes for automation with minimal impact to ongoing work.

In a subsequent post, I will look at the processes within Regulatory Affairs that can be prioritized over others, based on my experience. I will also look at potential use cases within each process.

Top 5 platform choices for End-to-End Regulatory Information Management

Regulatory Affairs

Over the last 6 months I have spent a lot of time talking to various clients about transforming their Regulatory Affairs organization in terms of Processes, Data and Systems. Many organizations are looking for a holistic approach to transformation, across all the three aspects and additionally assure better user experience. The following are the themes that are emerging, with regards to challenges faced by Regulatory Affairs organizations:

  • Functional, Geographical and Departmental silos creating hurdles for x-functional collaboration
  • Fragmented systems and tools, a situation that is a result of efforts to build best-of-the-breed platforms combined with legacy systems that leave the burden of end-to-end integration to the pharma companies
  • Need for continuous upgrade / enhancements of various tools to keep up with regulatory and technology changes which create a need for projects all the time disrupting business and IT teams
  • Inefficient business processes and data governance that is either a result of trying to make up for lack of features in the chosen systems & tools or due to #1 above
  • Finally, lack of human centered design of systems leading to lower of adoption, process inefficiencies, compliance issues etc.

In order to overcome these challenges, many organizations have prioritized programs to find a platform that can become their Regulatory Affairs Management platform of the future. Having spent time working with various pharma companies, tool vendors and industry experts in Regulatory Affairs, I have come to the conclusion that the following five platforms are leading the pack in terms of becoming the platform of choice for end-to-end Regulatory Information Management. Also, I know of at least one Top 20 Pharma, Biotech, Med Devices customer that has selected one of these platforms to invest in and make it their platform of the future.

  1. AMPLEXOR LS Suite
  2. ArisGlobal LifeSphere Regulatory
  3. OpenText Documentum D2 LS Suite
  4. PAREXEL Regulatory Cloud and
  5. Veeva Vault RIM

Some of the other notable names that are either being considered by smaller pharma, generics companies etc.:

  1. DXC Regulatory Suite
  2. Lorenz
  3. CuneSoft
  4. I4I
  5. Extedo
  6. Samarind
  7. Mission 3
  8. Freyr
  9. Educe

If the challenges I have listed in this post resonate with you then I strongly recommend considering one of the top 5 platforms listed above as a means to address these challenges. While platform is not a silver bullet that can solve all the challenges listed, it is definitely a good starting point. Along with the platform, “Business Process Transformation” and “Innovation” should be high on the agenda to make a difference to your Regulatory Affairs staff and help them improve their cycle times and in turn faster approvals to your products. In a subsequent post, I will look at the criteria to be used in evaluating the right platform for your needs as well as elaborate on the need for Business Process Transformation and opportunities for innovation in Regulatory Affairs.

Hello Regulatory Intelligence, meet Artificial Intelligence

One of the cool things about being part of technology industry is living through certain hype cycles. I have experienced, in past 20 years of my professional life, ups and downs that tend to get everybody riled up about ‘this is going to end the world’ dooms day scenarios like Y2K to ‘this can do everything’ conversations about things like Artificial Intelligence, Virtual Reality etc. I still remember back in the day when my friends in the Computer Science branch in college had subjects like Virtual Reality, Neural Networks and Artificial Intelligence. I am talking about 1994 – 1998, which is almost 2 decades+ to the day. Not many of them pursued their careers in those areas, but it is amazing to think that it took as long as it did to get to current developments in this space that is revolutionizing the consumer and enterprise software industry.

There have been many developments along the way that got us here from Internet to client / server technologies to cloud to big data to NLP, to name a few.  Today we can genuinely claim there are things that machines can do, faster and cheaper and more than anything else, SMARTER than humans with very little to no intervention from us. As BigData hype reaches a plateau, Deep Learning is picking up steam and more and more companies are investing in this area to genuinely unleash the power of data through smarter analysis with help from neural networks, NLP, Deep Learning and the likes.

Having spent considerable amount of time dealing with Life Sciences industry for the past 14 years, I can speak to the utmost conservative approach these companies take when it comes to technology adoption. It is a heavily regulated industry and rightfully so since it deals with human lives. Life Sciences companies can release life saving ‘Elixirs’ but can also unleash ‘Drug from the Devil’. In my experience Life Sciences companies typically are 2 to 3 years behind in terms of technology adoption. This may change depending on the department within the value chain but this tends to be the average duration before they use the latest version of Windows or IE or Office.

I hope to highlight some of the use cases where newer technology developments can be leveraged in Drug/Device/Vaccine development, specifically in the areas of Regulatory and Safety in a series of posts starting with this one. I will try to prioritize areas where there is a lot of manual intervention (Compliance) as well as areas that could leverage technology to deliver faster ROI (increase Revenue) and improve Operational Excellence (Reduce Cost).

One of the first areas that I thought could benefit from these technological advances is Regulatory Intelligence. The EU Regulatory Intelligence Network Group (RING Europe) defines it as “Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.”  RI is a key part of Life Sciences industry primarily for three reasons:

  1. It is a heavily regulated industry
  2. If companies operate globally they ought to comply with ever changing regulations and
  3. Influence policy and advocacy of future development

Please refer to this presentation from Carol Hynes of GSK for more details on “Regulatory Intelligence: Implications for product development“.

Many organizations have built Regulatory Intelligence Repositories by collating information from various sources. The diagram below represents various sources of RI data (courtesy : Regulatory Intelligence 101 By Meredith Brown-Tuttle).


These repositories cannot be built overnight. They have to be collated piece-by-piece over a period of time. The sources could go beyond the ones identified in the above diagram. Also, the repository may contain structured as well as unstructured content and data. Extracting information from such repositories is typically not a straight forward process. It definitely will not be as easy as asking a colleague who would then manually conduct the research needed and collate the information that can then be circulated to one or more individuals in the Reg Affairs organization for consumption and decision making . Therefore leveraging Automation, Machine Learning and Natural Language Processing in order to glean into the information in such repositories will make the life of Regulatory Intelligence colleagues lot easier. They can easily query the repository in their language of preference (for regular users with NLP capabilities) or write No-SQL and Semantic queries (experienced/super users) to extract the relevant information.

Information thus obtained can be leveraged to put together documents, newsletters and other communication vehicles which in turn could be stored back in the repository thus continually enriching and expanding the wealth of information available. This idea can be extended to create a federation of such repositories (internal, external, partners, vendors etc.) that can be scoured for the necessary information. Also leveraging even more advanced technology advances like Deep Learning might enhance the effectiveness and Return on Investment even more.

As always, your feedback and comments are most welcome. Thank you.






Why did FDA issue the DRAFT guidance to submit REMS using SPL?

I was looking at the FDA report from Sep 2014 titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)” to better understand the need for the new DRAFT guidance to submitting REMS using SPL, as outlined in the guidance document issued in Sep 2017 titled “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling”. I felt it would be easier for people to understand the need for the guidance if they understand the backstory leading up to the new guidance. Please refer to the original report and subsequent guidance for more details.

Feedback to FDA, through various stakeholder engagement sessions participated by vendors, healthcare community and other impacted groups:

  • Stakeholders are not uniformly impacted by REMS requirements
  • Communication about REMS requirements should be improved
  • There should be flexibility to implement a REMS program based on the nature and variety of health care settings.
  • REMS are vital tools that will be increasingly necessary, and content delivery must be streamlined without compromising the content itself
  • FDA should standardize REMS across platforms, media, and delivery technologies and work to fully integrate them into health care systems—which will increase access by both health care providers and patients, and enable improved assessments to further advance standardization.
  • FDA should use human factor evaluation approaches like Failure Mode and Effects Analysis (FMEA) to support and standardize REMS program design.
  • FDA can improve REMS assessments with a variety of tools and techniques
  • FDA should structure and standardize REMS information.

Based on engagement with industry stakeholders and the feedback received, FDA prioritized 4 projects in four different areas:

  1. Patient Benefit/Risk Information under REMS
    • Providing Patient Benefit/Risk Information by Improving Tools for Prescriber-to-Patient Counseling
  2. Prescriber Education under REMS:
    • Prescriber Education—REMS and Continuing Education (CE) for Health Care Providers
  3. Pharmacy Systems under REMS:
    • Standardizing REMS Information for Inclusion into Pharmacy Systems Using Structured Product Labeling (SPL)
  4. Practice Settings under REMS:
    • Providing a Central Source of REMS Information for Practice Settings

Of these projects, the project titles “Pharmacy Systems under REMS” led to issuing the guidance that is issued in September 2017 and distributed for public comments. The objectives of this project were:

  • Make structured REMS information available to health care providers, patients, and FDA.
  • Provide a single conduit of comprehensive information about REMS programs.
  • Facilitate the integration of REMS into pharmacy systems and health information technology, including systems for electronic prescribing.
  • Improve the efficiency of FDA’s review of proposed REMS by allowing the Agency to receive REMS submissions in a consistent format.
  • Support FDA’s ongoing REMS standardization efforts by enabling the cataloging of similarities and differences between REMS programs.

The project’s final deliverable was set to be a revised SPL Implementation Guide that describes how sponsors, health care information system developers, and other stakeholders can share REMS information leveraging the existing SPL standard.

To help address the concerns expressed by various stakeholders, FDA wants to take steps to streamline the access to REMS information

  • FDA intends to require applicants of NDAs, ANDAs, and BLAs to submit the content of their REMS documents in Structured Product Labeling (SPL) format
  • SPL can be used to capture and present REMS information in a format that is:
    • Easily shared with stakeholders and
    • Readily incorporated into health information technology
  • Twenty-four months after the final version of the guidance is published in the Federal Register, applicants must submit REMS documents in electronic format consistent with the requirements set forth below:
    • Types of submissions : NDAs, ANDAs and certain BLAs
    • Also applies to all subsequent submissions including amendments, supplements, and reports, to the submission types identified above
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