"Piramal Pharma Solutions has all the tools to become a global leader"

Vivek Sharma,
Chief Executive Officer, Piramal Pharma Solutions
A subsidiary of Piramal Group, Piramal Pharma Solutions is a leading Contract Dev e lopment and Manufacturing Organization (CDMO) devoted to Quality, Reliability, Innovation and Customer centricity. Using a collaborative partnership model, Pharma Solutions offers a multitude of services covering the entire drug life cycle. Vivek Sharma, Chief Executive Officer, Piramal Pharma Solutions, in an interview with Mahesh Kallayil, discusses evolving role of CDMOs in Indian Pharma Industry and much more...

How has Piramal Pharma Solutions (PPS) journey been thus far? How will be the road ahead?

Piramal Pharma Solutions began its operations as an Indian centric organization 2 decades ago. Today, it has transformed into a global organization with 12 R & D and manufacturing facilities- 3 in North America, 2 in Europe, and 7 in India. The breath of services that PPS provides has significantly expanded and now includesdiscovery support, drug substance and drug product development, commercial manufacturing, and clinical trial supplies. Further, its generic portfolio has also grown significantly, with PPS filing 40 DMF's to support current and prospective clients with cost effective manufacturing of key medicines.

With external partnerships now becoming an integral part of how pharmaceutical firms and biotechs do business, the future looks bright for leading Contract Development and Manufacturing Organizations (CDMO's), as they are at an inflexion point in their growth curve. Piramal Pharma Solutions has all the tools to become a global leader- a customer centric culture, a strong focus on innovation, a robust balance sheet, a commitment towards investment, and finally, a talent pool that combines speed, with quality and delivery. As our clients seek dependable partners that can offer seamless, integrated solutions, from Discovery through Commercialization, from Drug Substance to Drug Product, we expect PPS to deliver on these needs, and build long term, sustainable and strategic partnerships.

As a leader in Contract Development and Manufacturing Organisations (CDMOs), what are the services and solutions Piramal offer for the entire pharmaceutical industry?

Piramal Pharma Solution's core competency revolves around providing end-to-end solutions to clients, aiding and supporting clients in advancing their assets from discovery into clinical development, and through commercialization. For example- To an aspiring biotech with rapid and cost effective advancement, Piramal Pharma Solutions will assist in identifying the right molecule by synthesizing several molecules to screen for biological activity. Once the right molecule is identified, PPS will then develop a process to 'scale-up' the molecule(s) for toxicology studies and then work closely with the client to develop a formulation to deliver the molecule into humans. Finally, PPS completes the early development process by manufacturing the Active Pharmaceutical Ingredients (API), and the formulated drug product to enable the filing of an Investigational New Drug (IND).

Further, as the drug advances through clinical trials, PPS continues to work closely with the biotech to assist them at every stage of drug development, providing the biotech with the Active Pharmaceutical Ingredient (API), drug product, and Clinical Trial Packaging and Supplies, as needed.

Several clients prefer working with us for both API and drug product, as PPS helps reduce tech transfer time, which in turn speeds up the clinical trial process. Further, we manage all elements of the partnership internally, with a single point of contact, making it easier for clients.

What are the factors to be considered while choosing an outsourcing partner

Several factors must be considered- Alignment of values and culture, transparency and honesty in communication, especially as one works through potential challenges in sciences. Quality, commitment towards safety, and a customer centricity culture, are also key ingredients in a successful CDMO. The CDMO's track record, versatility in its capabilities, its geographical footprint (example: a client may want to launch a drug in North America or Europe, while still deriving the costs benefits from Asia), and the flexibility in meeting timelines, are areas to evaluate in a potential partner. Finally, clients need to make sure that the project will get the time and attention it deserves: Clients should be wary of working with CDMO's that assign substandard teams towards programs that are not their largest revenue generators.

What are the main differences between CDMO, CRO and Functional Service Provider (FSP)?
  • CRO's : Contract Research Organizations; They work principally from Discovery through Early Development (Discovery, Phase I)
  • CDMO's: Contract Development and Manufacturing Organizations; They principally work from Phase I through commercialization
  • FSP, Functional Service Providers: Have deep knowledge across particular verticals (ADME, Computational Chemistry, Protein Cloning and Expression etc.
Please brief us on off shoring in pharmaceuticals?

Certain clients prefer to have their own locations in cost effective geographies, instead of outsourcing it to third parties. For example, a large pharmaceutical company may decide to have their own employees to conduct discovery research in India or China to have 'control' on the process, while still deriving cost benefits.

Currently what are the major challenges for contract manufacturing?

Good CDMO's have a challenge in obtaining capacity to meet growing client needs. In areas such as injectable manufacturing, it is difficult for clients to obtain capacity available for periods up to 12 months. On the flip side, there have been some challenges in Asia, with quality issues at certain firms being highlighted as a cause of concern. In a regulated industry, Quality concerns lead to significant client erosion.

How is the company positioned in the Indian and global market in the field of contract manufacturing?

We are well positioned with multiple locations in the West and in Asia. This allows us to be close to the clients that are interested in local launches while still integrating the supply chain by leveraging our locations in Asia. With excellent manufacturing and development locations, and a clean track record on quality, clients trust us with some of their most valuable assets. We have launched 35 products for clients (including multi-billion dollar drugs such as Ninlaro, and Velcade), and expect to launch 10 more this year, and have a pipeline of around 90 products in Phase II/III.

How does the company keep abreast with the ever-changing trends in pharmaceutical industry?

We constantly encourage our clients to identify their future needs and monitor macro market trends in order to solidify our future investment strategies. We have grown both through organic investments at our sites and through inorganic investments. In the last two years, we have undertaken several acquisitions, including Coldstream Laboratories for injectable capabilities and Ash Stevens for high potency API capabilities. Further, we constantly work on growing our capabilities and look to invest in technologies that speed up drug development and reduce costs. Another key factor influencing the increase in CDMO services is sponsor companies that want to focus on core competencies internally while outsourcing non-core areas. We support such firms in their non-core areas, with an objective to optimize their resources and channelize them in the right direction.

What is the competitiveness of Indian pharmaceutical outsourcing market against the markets of other countries?

The Pharmaceutical industry is currently facing several challenges involving a decline in R & D productivity, reduced rate of approvals, absence of blockbuster medicines, policy driven changes in healthcare spending- all of which have led to an increased focus on cost, and identification of core areas to focus on. This has been instrumental in companies outsourcing various activities across the drug lifecycle. India is one of the world's best-known cost efficient manufacturing centers, with the highest number of U.S. Food and Drug Administration (USFDA) approved manufacturing plants outside the US. The Indian CMO/CRO industry has been rapidly moving up the value chain with key players investing in innovation, talent, and capacity.

Along with the above, India also offers access to a workforce characterized by historically strong process chemistry skills, a vibrant entrepreneurial ecosystem, robust infrastructure, good communication, and access to individuals trained in leadership across the globe.

Growth is also facilitated by attractive terms for investment, a business friendly domestic manufacturing policy that includes 100% Foreign Direct investment. Patented drugs worth approximately US$85 billion in potential annual sales in US are expected to come off patent during 2014-2020, which will place high emphasis on price competitiveness. This will also provide an impetus to the highly cost efficient contract manufacturing set up in India.

How will Piramal continue focusing on delivering Quality and Innovation, with a Customer centric approach?

With a pool of 700+ scientists, including around 100 PhDs across the globe, we are committed to providing innovative R & D solutions to our clients. Key areas of focus include, Biocatalysis (as chiral molecules continue gain traction), Advanced Flow Reactor systems (flow reactors allow for cost effective and safe manufacture of actives), Route Scouting (our highly successful initiative to develop synthetic schemes that reduce costs and provide freedom to operate), and Complex/Novel Formulations (increases bioavailability, extends patent life). We expect our investments in these and other areas, to grow, as we firmly believe in the ability of technology to create long-term value.

At Piramal 'Quality as a Culture' is the key focus as opposed to 'Quality as a Compliance Tool'. While our buyer who pays for the goods is the pharmaceutical client, we believe that our end obligation is to the patients, who trust our products as lifesaving drugs and to improve their quality of life. Piramal has its own Quality Governance model- QuEST (Quality Empowering Strategic Transformation) that drives the quality strategy to advance our sites beyond compliance. At Piramal, we address the evolving regulatory requirements by establishing even higher internal standards that ensure perpetual inspection readiness. For example, over the past 6 years, Piramal has successfully completed 113 regulatory inspections and 631 client inspections. We have an excellent track record with 100% success rate for inspections at all our facilities. This is a result of audit preparedness, focus on data integrity and a highly skilled team that tracks the latest updates on quality guidelines.

Please appraise us about your recent acquisition deal with Ash Stevens Inc

Located in North America, Ash Stevens Inc. is a full service pharmaceutical Contract Development and Manufacturing Organization (CDMO) that has over 50 years of extensive experience in handling highly potent compounds. With the increased demands for its offerings, Ash Stevens now offers comprehensive smallmolecule drug substance development and cGMP manufacturing services. Its FDA licensed cGMP facility located in Riverview, USA specializes in cancer APIs. Further, Ash Stevens is also a long-time provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI), and has participated in the development of many important drugs through these government agencies. To date, Ash Stevens has received 14 FDA manufacturing approvals for innovative APIs. As one of the leaders in HPAPI manufacture, Ash Stevens has an impeccable safety record of working with high potency anti-cancer agents and other highly potent therapeutics. The facility has approvals from US, EU, Australia, Japan, Korea, Mexico regulatory agencies. The acquisition of Ash Stevens fits well with our strategy to build an asset platform that allows us to become the Partner of Choice for oncology, globally.

Currently, around 25% of the molecules in clinical development are potent. Our clients are looking for reliable partners that can assist them in advancing these programs forward. We can now fulfill client requirements as a single source of supply for both high potent APIs and drug products. This acquisition is synergistic with our Antibody Drug Conjugates (ADCs) and injectable business.