LIFE SCIENCES PULSE

Regulatory Insights: Key to Success in the Global Clinical Landscape

 
November 21, 2018

The advent of adaptive trial designs, rolling submissions for indications, as well as the impact of changes in existing and new regulatory policies in global regulated markets, have affected the existing and time-tested process of securing approvals and compliance. ‘Policy 0070 in EMA (European Medicines Agency) on the publication of clinical data for medicinal products for human use’ and the Identification of Medicinal Products (IDMP) are some such disruptions. This has triggered the need to assess new technologies that would ensure harmonized functioning of the pharmaceutical companies.

Effects of a new product in market

With the launch of a new product, the following string of events is set into motion:

Response- The regulatory authorities necessitate a safety and regulatory profile change due to fresh inputs of data collected for the product.

Effect- Due to the disruption, the vicious circle of corresponding changes affecting the product’s composition, packaging, labeling, etc., sets off. This has a domino effect on the entire ecosystem, throughout the targeted markets across the globe.

Risk- However simple or complex these changes are, they tend to multiply challenges. This, in turn, increases manual interventions across the manufacturing lifecycle, which increases the likelihood of an error, thereby affecting business efficiencies.

Damage- This error can result in delay in license renewals, rejections, and billions of dollars in losses. Worse, it has an impact on the company’s reputation, as there is a delay in time-to-market and in addressing latent demand leading to loss of market share.

The Bottlenecks in the flow

The data flow generated due to a product launch might get held up due to the following scenarios:

Disconnected system and data- Most organizations have a fragmented landscape of technology even for related tasks. The lack of interaction between these systems results in a void of information.

Content disconnected from data- As the systems are disconnected, the digital thread connecting the content to the data is missing. This makes it difficult to search, interpret, and make a decision.

Local affiliate differences- Due to the lack of a central repository, in which all the local bodies are aligned, companies are unable to take an informed decision. This hinders the development and marketing phase of the product.

Barrier to information access- Communication problems, translation issues, and the use of local languages make it difficult to sort and assimilate the shared information, which hinders productivity.

Need to have better regulatory insights

There has been a conscious effort to address these challenges through various programs like employing harmonized systems rather than tools in isolation, building warehouses, and conducting business process reviews and consolidation. One such effort has been to re-imagine the management and usage of regulatory information.

The pharmaceutical companies look forward to combining regulatory business applications and their associated processes into a centralized and secured environment while managing regulatory compliance. Technology assists in shaping these changes by leveraging data transformation and workflows. Centralization helps in faster and seamless access to error free data via cloud. It employs artificial intelligence and robotics for enabling reading and collection of information from various sources such as structured documents, handwritten documents, databases, and even internet sources.

The consolidation and harmonization of processes enables users to make better decisions in creating high-quality regulatory submission packages while maintaining integrated business processes. For example, a fast growing biopharmaceutical company based out of USA, believes that such a centralized framework helps to make decisions in a timely manner while being compliant with their internal financial policies and the FDA submission requirements.

This is why global technology leaders are making headway in the medical space using artificial intelligence and electronic records to create an effective dashboard to archive, review, and manage large volumes of data with minimum effort.

Where is the industry headed?

The pharmaceutical industry has entered a period, which requires disruptive transformation in the way regulatory processes are being handled, and new technologies are being adapted in a global environment. According to one of the prime British pharmaceutical companies, with a revenue in billions, the needs of professionals are changing, and they want more access to information quickly which also needs to be fair, balanced, and objective.

With the fast-changing regulatory needs, it is not only a requirement but also a mandate to make necessary changes with agility so that the pharmaceutical companies stay competitive, cost effective, and compliant. This means implementation of a solution in the Global Clinical and Regulatory Landscape that will guarantee the right information to right stakeholders at the right time, through the right platform.

 

Mohit Gupta has a life sciences industry experience of 12+ years and is a part of the Life Sciences Platform team for past 5 years with expertise in regulatory platforms. He has an IT experience of 21 years  and  a Bachelor’s degree in Engineering from NIT Silchar.

Vijaya Kumar is a Post Graduate in pharmacy and a Registered Pharmacist with 16+ years of regulatory experience. He is a Regulatory Domain Consultant with vast experience in USA, Canada, EU regulations and possesses global brand liaison management experience for matured products for Branded NDA applications. Currently, he is responsible for strategic development of CMC projects, new business/scope expansion for existing accounts, and other regulatory initiatives. He did his masters in pharmacy from Annamali University.