State of Safety & Pharmacovigilance : Top 5 Challenges

Safety & Pharmacovigilance, as stated in many of my previous blog posts, is a critical function for any Life Sciences organization. This function deals with the most important stakeholder in the industry i.e. patient. Safety, along with Efficacy, is one of the most important aspect of any medicinal product. In a series of posts, I want to take stock of the state of Safety & Pharmacovigilance market. I will start with some of the challenges industry is facing and look at platform vendor landscape. I will also share what a Next Generation Safety & PV Platform of the future looks like, in my opinion.

This post identifies 5 top Business and IT challenges, based on my experience consulting with clients across the globe:

1. Increasing Case Volumes and Diversified Data Sources: Adverse Events (AEs) keep increasing every year. This is evident in case volumes being reported to the regulators like FDA (FAERS public dashboard). There is also an ever-increasing number of data sources that organizations have to scour for AEs. While some of them have proven to be not so effective (i.e. social media) but others have been found to be invaluable (i.e. EHR/EMR). These two trends mean increasing costs of safety surveillance year over year. This puts organizations in a tough spot with pressure on budgets.
2. Process Standardization and simplification: Despite substantial efforts, across many organizations, simplified and harmonized business processes are yet to be accomplished. For example, a global business process is still a holy grail in many organizations. Some companies have two (2) different safety databases (one for Global and one for Japan) because they could not agree to a simplified, global process. This problem is also exacerbated by lack of capability in technology platforms.
3. Legacy Systems & Tools: Many of the companies have legacy version of safety platforms. Biggest reason for this is prohibitively high cost associated with upgrades. Typical frequency of upgrades is 3 – 5 years, whereas the platform vendors put out a new version almost every year. So, it is always a catch-up game on the currency of platforms
4. End-to-End Platform: There is a dire need for a platform that meets end-to-end (Intake to risk management) capability with cross functional integration to Clinical, Regulatory and other processes. The limited options available to the industry have a lot of functional/feature debt. This forces companies to build customizations that are costly and complex to maintain. It has also resulted in manual processes for workarounds.
5. Innovation: While life sciences industry in general is embracing Digital Transformation, Safety & PV is still lagging. Life sciences R&D is typically conservative, and rightfully so, in adopting innovations like AI, ML & NLP due to regulatory & compliance needs. With the increase of Digital Health/ Medicine and diversified sources of safety data there is a definite need for investment in innovation across the board. This includes innovation by safety platform vendors as well as other stakeholders in the value chain.  

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.

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.