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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.



Four(4) Themes for Innovation in Regulatory Affairs

Innovation is something that all organizations strive for with the belief that it will drive value creation and market sustenance. Life Sciences industry is built on innovation, in a way, in terms of their constant search for new drugs, devices and cures. Technology has become ubiquitous in driving not only scientific innovation in terms of discovering and marketing new treatments, but also in building, integrating and managing platforms that support the scientific innovation.

Regulatory Affairs, to me, is one function that does not get as much credit and focus as some of the more popular ones like Discovery, Clinical, Safety, Sales & Marketing. Yet, that is the function that could make or break the launch of a successful product and even more to ensure that product stays in the market to realize its full potential. Many activities performed in regulatory are operational in nature and deals quite a bit with managing content i.e. documents. With the advent of regulations like IDMP, EU MDR etc. many companies are realizing the need for mastering and harmonization of data across the functions to be able to reign in the silos built over decades. This is where I feel leveraging some of the technology innovations will make Regulatory Affairs more efficient, reduce the risk of non-compliance and truly deliver the returns expected from the investment.

Key to building and managing a successful Regulatory Affairs organization, in my opinion, is to deliver on the following objectives:

  1. Continued Regulatory Compliance: Meet ever changing regulatory needs
  2. Technology Currency: Ensure the systems and platforms are always current in terms of technology used
  3. Operational Excellence: Always look for improvement in operations to ensure successful delivery despite dwindling budgets and increasing demands and
  4. Faster time to Market: Drive faster regulatory approvals and life cycle maintenance activities to maximize the product potential in the marketplace

From an innovation standpoint, four (4) themes that can help achieve these objectives are:

  1. Digitization of Content: Ability to create, manage and obtain insights from content leveraging digital tools & technologies
  2. Business Process Efficiencies: Achieving efficiencies through optimized orchestration of end-to-end business processes across functions
  3. Cross-Functional System Integration: Integration of systems across functions like Manufacturing, Regulatory Affairs, Safety & Pharmacovigilance, Commercial etc. to better leverage data and content
  4. Technology Innovation: Leverage technological advances like RPA, AI, ML, Blockchain etc. to innovate Regulatory Affairs

While these themes/levers are good to use on “what” can be done, it is critical that we also identify “where” these can be leveraged. What would be even more useful is to identify these use cases within a given function of Regulatory Affairs, like Labeling Management. My next post will address this aspect.

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