Company suspends enrolment to trials as coronavirus travel restrictions bite.
The Indian contract development and manufacturing organization (CDMO) Piramal Pharma Solutions (PPS) expects to grow its pool of “preferred partnerships” that includes a mix of both biotechs and large pharma. In an interview with Scrip, CEO Vivek Sharma outlined the value of such “symbiotic” relationships and how PPS is focused on quality as a culture rather than purely limiting it to inspection clearance and product approvals.
Contract development and manufacturing organization, Piramal Pharma Solutions (PPS), prides itself on having collaborated in the launch of 34 products for innovator firms, including few blockbusters, and a blemish-free compliance record, at least so far.
PPS CEO, Vivek Sharma, told Scrip that having facilities both in Asia and the West helps provide a blend of cost effective solutions and local services to clients.
He also stressed the strong quality framework and “well-defined escalation process” at PPS, including where the global head of quality has direct access to the CEO’s office to discuss concerns. PPS is part of the $1.3bn-plus diversified Piramal group of India.
By forming strategic relationships with CDMOs, both innovators and biotech firms can focus on their core competencies, access specialized expertise, control costs and significantly accelerate the successful commercialization of their molecules. And by developing long-term relations, CDMOs are also expanding their services and providing companies with full term services that range from discovery to commercial launch. Additionally, pharmaceutical companies are also focusing on personalized medicines, targeting niche diseases and novel delivery systems, thereby providing CDMOs with a large gap to fill, and expand their capabilities to service these needs.
PPS has witnessed significant growth in revenue over the past three years. We have expanded our global customer base by adding new customers and have also increased wallet share among current customers. Piramal offers a fully-integrated solution, from discovery through commercialization, with access to world-class science, state-of-the-art technology, and modern manufacturing capabilities, along with the experience and track record of working with all key global regulatory agencies.
For example, to supply a complex API to a customer in North America, we can manufacture the RSMs [registered starting material] from our GMP facility in India which will be converted to the final APIs at our FDA approved facility in Toronto. Similarly, for the supply of finished dosages (tablets) in Europe, formulation development is carried out at our site in Ahmedabad, India and the clinical supplies are manufactured at our facility in Morpeth, UK. Our development centers and manufacturing sites have accreditations from regulatory bodies in the US, Europe and Japan. We are committed to R&D programs with a pool of over 700 scientists; including over 150 Ph.Ds. across the globe. This helps us tap into the best talent, irrespective of location.
In order to address and evolve with the dynamic role of regulatory bodies, PPS has introduced several robust initiatives to maintain preparedness towards inspections. Over the past six years, the company has cleared more than 100 regulatory inspections and over 600 customer inspections. Through this steady, yet strong focus on quality compliance, PPS has achieved, and more importantly, maintained an excellent regulatory track record.
We at Piramal are now focused on ‘quality as a culture’, as opposed to ‘quality for compliance’. With a strong quality framework in place, Piramal seeks to be competitive by building a brand that stands out with quality as our identity.
At Piramal we have a well-defined escalation process. Quality team reports to the executive director (Piramal board) and is independent of operations. Site quality heads are empowered to discuss and escalate quality issues to head of global quality, who based on criticality escalates to executive director. Global Head of Quality also has direct access to CEO’s office to escalate and discuss all applicable concerns as needed.
QUEST is a quality mindset initiative rolled out at Piramal sites. It is a continuous improvement drive that rests on four transformational pillars - technology, people, process and system. It is a drive to move beyond compliance. It measures objectively, the quality, health and site audit readiness state by using proprietary tools.
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