‘PaxPharma access to users anywhere in world, in a secure fashion’

Tell us about Persistent Systems’ expertise in various business arenas and how successfully it has grown over the period?

Ram Pazhayannur

Persistent Systems is a global company established in 1990, specialising in software product and technology services. For more than two decades, Persistent has been an innovation partner for the world’s largest technology brands, enterprises and pioneering start-ups. With a global team of more than 6,000 employees, Persistent has 300 customers spread across North America, Europe, and Asia. Today, Persistent focuses on developing best- in-class solutions in four key next-generation technology areas: cloud computing, mobility, analytics and collaboration, for telecommunications, life sciences, consumer packaged goods, banking and financial services and healthcare verticals. Thanks to our extensive technology product expertise, today our customers also turn to us for technology strategy and consulting services. Persistent’s customers benefit from our deep knowledge of next-generation cloud, BI and Analytics, collaboration as well as mobility-based computing platforms. By leveraging our strategic technology partnerships, IP-based accelerators, and agile development processes companies can successfully navigate increasing time-to-market pressures and deliver the highest quality solutions, faster and more cost effectively.

Recently, Persistent has introduced PaxPharma in the US market. Could you tell us about the product and its importance in the pharma industry?

PaxPharma is a solution that helps pharma companies automate their entire product lifecycle – from new product introduction, to financial planning, bills of materials management, artwork and labelling management and label change management from Pharmacovigilance. This is important to the pharma companies in many ways, the first being the ability to manage compliances. FDA and other regulatory authorities mandate what to say on labels, how to say it, and where to say it. These rules are very complex and pharma companies rely heavily on the expertise of specific individuals to ensure compliances to these rules. By using PaxPharma, the enforcement and inspection of these rules could be automated, thereby reducing errors and bringing efficiencies across the organisation. Data shows that packaging recall due to errors account to as much as three per cent of revenues, which is a huge saving, if done correctly the first time around. The other advantage is the improved speed to market. Pharma companies today are feeling the same kind of pressures consumer packaged goods (CPG) companies felt few years ago in releasing products to market, faster, at lower costs and in multiple variants. This coupled with compliances that are an order of magnitude higher than CPG industries, results in lengthened review cycles, across multiple departments, thus making the whole product development cycle just that much longer and difficult to manage without automation. One of our customers mentioned that they could triple their product releases with zero increase in headcount across departments just by implementing Paxpro – as they now have better control of their entire process, automation to replace manual review and inspection tasks, greater collaboration through online tools, and one “system of records” through integration with other systems of theirs. Reduced costs are another mentionable advantage. Our solutions are built on some of the best technologies in the industry and are complaint with the pharma security requirements.

What role did Paxpro play in designing and launching the product in the market?

PaxPharma has been built with significant inputs from our customers and partners. Inputs for PaxPharma have also come in from our internal innovation and product teams, however, they were additionally validated by the customers and key advisors.

Tell us why did Persistent System introduced PaxPharma first in the US market? Which other countries are you planning to launch the product and by when? Also when are going to launch it in the Indian market and how beneficial will it be for Indian pharma companies?

We announced PaxPharma in the US first. For the global markets, PaxPharma being delivered as a SaaS solution, geography isn’t an issue. Our sales teams globally are actively marketing PaxPharma. In addition, several of our customers have global operations and use the solution across their offices worldwide. That is one of the key value propositions of PaxPharma – access to users anywhere in world, in a secure fashion. In India, we are currently in discussions with a few companies.

What unique features does PaxPharma have?

PaxPharma delivers an enhanced user experience through a fully integrated solution with secure data transfer across modules that significantly helps reduce human error, ensure regulatory compliance, and improve time to market. PaxPharma includes a unique FDA rules database module that manages the rules and regulations set by the FDA for each product type, from OTC drug to cosmetics. This module automatically selects several of the FDA rules based on product attributes specified by the labelling specialist – greatly reducing errors and providing significant time savings. Near print-ready drug fact templates (DFT’s) and labelling documents can be produced using this module allowing marketing managers to have better control of their artwork and labelling assets while reducing dependency on graphic artists and post production iterations.

PaxPharma modules include: NPI/NPD; BOM/SKU; FDA rules database for accurate and compliance-based product labelling; Artwork lifecycle management; Document Lifecycle management for pharmacovigilance; Real time reports; Project Management.

PaxPharma is a complete solution as it is compliance-based, Design to Print (D2P) automation solution, what all qualities it addresses to the regulatory?

PaxPharma is compliant with CFR 21 Part 11 guidelines and comes with all the necessary features such as audit trails, eSignatures, document control, user access control, label rules database, to name a few.

Does this product have a trace and track feature as well?

No, PaxPharma doesn’t currently have track and trace capabilities. PaxPharma, however, integrates with 3rd party Track and Trace systems and manages all the artwork related attributes (SR#, artwork changes, etc.) resulting from Track and Trace implementations.

What is the USP of PaxPharma?

Our main USP is offering one solution to manage your entire product lifecycle in a compliant manner; a solution that is simple to use, easy to onboard and that can scale to thousands of users in a controlled and secure manner.

Do you think PaxPharma is a cost effective solution for the pharma industry? What special features it has in comparison to other competitors?

The typical ROI for most companies from using PaxPharma is less than one year, this is purely from labour savings, not to mention recalls due to packaging errors, which could run into several millions of dollars. The FDA label rules module is the first of its kind in the industry and is unique to PaxPharma. Our automated proofing and inspection tools are also one of the best in the industry and comes loaded with a host of features for the pharma industry.

PaxPharma includes a unique FDA rule database module which is in line with the FDA rules and regulations set by the FDA for each product type, from OTC drug to cosmetics. What all regulation has been followed by before launching the product in the market?

There are several guidelines that the product must meet before it can be declared safe for release to the market – drug safety guidelines as mandated by the clinical trials requirements, drug safety declarations as mandated by the label rules, manufacturing processes as outlined by GMP processes, adverse effects management as governed by the pharmacovigilance guidelines, etc.

Whom do you consider as a competitor and why?

Incumbents in this market (not pharma in particular, but D2P in general), are providers such as Esko Webcenter, Shawk Blue and Kodal D2L. New entrants are PLM provides such as Dassault Enovia, Oracle Agile, Siemens TeamCenter.

With the help of PaxPharma how much business do you plan to generate for the US market and in India?

This would not be the right time for us to disclose the financial of PaxPharma, however, we are confident of the product and the benefits it provides the users, so we definitely see a good growth trajectory.

Presently, how many people are associated with the Persistent System?

We are over 6000 employees globally at Persistent Systems at present.

What are your corporate plans for the Indian market?

As I mentioned earlier, with PaxPharma, we see it as a global product that can be used by anyone anywhere. In the Indian market, we are already in talks with companies and now have to wait and watch how it takes off.

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