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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.

 

 

Virtual drug firms, increased outsourced needs of innovator companies, improved drug approval timelines and increasing API consumption augur well for the contract manufacturing segment. How have the initial months of 2017 been in terms of growth for industry in general and PPS in particular?

 

In response to certain macro trends, the CDMO industry has undergone significant consolidation in the past few years to obtain proximity to clients and their end markets through a network of global sites.

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.

 

 

 

Some experts claim the demand for Western CMOs is on the up, shifting away from traditional cost-effective strongholds like India and China. What’s your assessment of the situation and is Piramal’s acquisition strategy, in part, driven by the need to stay close to customers in Europe/the US?

 

 

PPS has created a global network of 11 development and manufacturing facilities - three located in North America, two in Europe and six in Asia - that offer a multitude of services spanning the entire drug life cycle. These range from drug discovery and development, manufacturing and packaging of clinical trial supplies, to commercial manufacturing of active pharmaceutical ingredients (APIs) and finished dosage forms. The advantage of having access to facilities both in Asia and the West is that it enables us to provide cost effective solutions and at the same time serve clients locally.

 

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.

 

 

 

How do PPS’ injectable and high potency APIs (HPAPI) acquisitions enable it to cross sell its capabilities of discovery, antibody drug conjugates and development and commercial scale manufacturing of formulations and APIs?

 

 

Our acquisitions in the past two years help us serve our customers with three local facilities in North America, including the injectable facility in Kentucky for fill finish needs, the Toronto facility for complex high value APIs, and now, Ash Stevens in Riverview for high potency APIs. These are synergistic with our global capabilities and can help fulfil client requirements as an integrated CDMO for oncology drugs. As an example, a collaborator working in an oncology injectable formulation can get all their needs served at Piramal. We would make the early intermediates out of India, manufacture the active [HPAPI] out of Riverview, and finally, complete the injectable drug product out of its Kentucky facility.

 

 

 

Some multinationals tend to have preferred partnerships with full-service CROs/CDMOs, which could perhaps be a double-edged sword at one level, shrinking the client pool. Or do such alliances help de-risk the business?

 

 

Piramal continues to grow its preferred partner pool, and has a mixture of both biotechs and large pharma firms as part of such an alliance. Having preferred partnerships leads to co-investments and a symbiotic relationship where both partners are committed towards a common goal. In one such partnership, our large pharma partner has recently co-invested with us in building a new plant in Europe, at a Piramal location, to help launch a key drug. We expect the launch to happen next year, providing benefits to both partners, and more importantly, to the end patient. Such preferred partnerships build trust, and also help CDMOs identify future needs of their clients very early, ensuring that they are ready to assist in their partner’s future successes. While there is some risk with customer concentration, there are significant benefits from such preferred relationships. Some of our 30-plus integrated projects are with preferred partners.

 

 

 

There have in the past been some concerns around compliance issues/data integrity at Indian contract research/manufacturing sites, though PPS has had a clean record. Are clients still wary, in general, of outsourcing critical projects to Indian firms?

 

 

Compliance issues are no longer associated with a particular region, as firms across geographies have been cited by regulators for non-compliance. The increased regulatory scrutiny has played a significant role in challenging and changing the quality compliance/regulatory processes followed within several organizations.

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.

 

 

 

 

Does compliance and quality have a hotline to the PPS CEO’s office? And has Piramal’s quality empowering strategic transformation (QUEST) contributed in ensuring that the compliance system stays effective at various levels?

 

 

At PPS, quality is not purely limited to inspection clearance and product approvals, but is a part of the company’s identity, and emphasizes on patient safety as a key driver.

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.

 

 

 

The global biologics medicines market is estimated to exceed $390bn by 2020, by which time biologics are expected to account for up to 28% by value of the global market for pharmaceuticals. How is PPS shaping its play in this area? Are viral testing, other services already provided by PPS?

 

 

 

Biologics is a growing segment in the pharmaceutical sector and we are actively following the developments therein. As appropriate assets become available, we may decide to invest as appropriate. However, small molecules still form the majority of the market and we anticipate continued growth in the small molecule outsourcing market. Currently we are focused on serving our small molecule customers through our unique platform of integrated offerings.

 

 

 

What about the newer areas such as genomics and microbiomics? Is PPS geared towards such areas in terms of service, given their immense potential and complexity?

 

 

We are constantly monitoring market trends, and the CDMO landscape, to identify services that fit our unique integrated offering. However, presently we have no plans to enter these areas.

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