Integrated Projects: The way of doing business in the future

Published: September 11, 2017

In today’s pharmaceutical industry, innovation and speed-to-market are more critical than ever. Vivek Sharma, CPhI expert and CEO, Pharma Solutions at Piramal Enterprises, talks about the need for integrated pharmaceutical outsourcing and the benefits/risks of integrated partnerships. This article forms part of the CPhI 2017 Annual Report *, which will be released during the CPhI Worldwide event in Frankfurt (October 24-26, 2017).

The Need for Integrated Pharmaceutical Outsourcing

The life sciences industry is moving towards more complex molecules, niche therapy areas, targeted delivery – all of which require a wide range of expertise, capabilities, and scale, in both development and manufacturing, many of which may not be present in-house. In parallel, there has been an increase in virtual biotech firms with a willingness to externalize clinical development and manufacturing to focus on their competencies and to reduce costs.

Additional drivers for externalization include the impact of drug approvals. In 2016, 13 New Chemical Entities (NCE) were approved compared to 32 in 2015 (Figure 1). That has led to large pharmaceutical firms redefining their core internal activities. Consolidation and cost rationalization in the industry mean reduced capabilities and capacities, and fewer internal people to manage programs. The gap between the internal need and internal demand for resources is further exacerbated by the need to drive more programs (Figure 2) to alleviate the impact of clinical attrition and reduced approvals.

These drivers have all led to the interest from pharmaceutical firms, both big and small, for strategic, integrated partners, who can seamlessly deliver on multiple verticals – such as both drug substance and drug product. By forming strategic alliances with Contract Development and Manufacturing Organizations (CDMOs), both innovators and biotech firms can focus on their core competencies, access specialized expertise, reduce costs, and significantly accelerate timelines towards successful commercialization of their molecules.

Who is an Integrated CDMO?

A CDMO that is ‘integrated’ provides a seamlessly interconnected supply chain, across more than one part of the discovery and development continuum. For example, they could begin with assisting in discovery of NCE, through supporting the clinical development of the active and the formulated product, and culminating in the commercial manufacturing of the Active Pharmaceutical Ingredient (API) and the final drug product. The spectrum of services that the contract partner provides may include a combination of Discovery Services, Drug Substance and Drug Product (Formulation) development and manufacturing, and Clinical Trial Supplies and Packaging. These CDMOs are also often referred to as ‘one-stop shops’ or as ‘end-to-end solutions providers’.

Key Criteria for selecting an Integrated Partner

The right CDMO with an integrated offering can provide a smooth transition from the laboratory to commercial manufacturing, by reducing complexity, streamlining processes and may also create new intellectual property. There are several factors to consider when choosing an integrated partner.

  • Domain expertise and presence across the value chain: Consider whether the CDMO has significant experience and expertise in the specific drug class of the molecule. Outsourcing an oncology product to an experienced CDMO with integrated High Potency Drug Substance and Product capabilities creates value for the innovator in terms of both timelines and costs.
  • Capability and Capacity: To match current and future requirements, it is important to assess CDMO size, equipment and product handling experience to ensure that the CDMO can meet your potential requirements as the candidate molecule moves from development to commercial manufacture.
  • Regulatory Accreditations and Certifications: Owing to constant changes in the regulatory environment, the CDMO must have a proven regulatory track record and compliance with global regulatory agencies such as the US FDA and UK MHRA. This is a requisite to easily facilitate global drug launch.
  • Control on costs and supply chain: The CDMO must be able to adhere to budgets, control supply chain costs and be flexible to modify development/manufacturing processes to address any potential issues that may occur during the project.
  • Service & Delivery Track Record: Select a CDMO with a proven history of success for safely and effectively managing projects and delivering timely results. This includes the number of innovator products the CDMO has helped launch, the existing pipeline, and its experience in carrying out integrated programs.

Integrated partnerships

Benefits to customers

The right integrated development and manufacturing partner can accelerate clinical development and drive value by standing out in the following areas:

  • Improved time to market: Aligning internal capabilities and capacity, to transfer between Drug Substance (DS) and Drug Product (DP) accelerates product delivery to the market. Integrated service providers ensure seamless tech transfer, thus safely and efficiently transferring development/manufacturing information internally.
  • Access to Differentiated Technology: Companies can gain a competitive advantage and access to specialized technical and operational expertise by forming strategic partnerships with CDMOs experienced in areas such as Antibody Drug Conjugation or High potency development and manufacture. This ensures that firms do not have to build expertise from ground up, while tapping into existing state-of-the infrastructure that exists at partners to move programs forward to meet patient needs and investor expectations.
  • Optimization of time and costs: Working with an integrated CDMO with a global network of sites, at scale, provides significant cost and time benefits. An ideal ‘integrated’ CDMO partner, for example, will adjust its drug product capacity availability to any delays in drug substance manufacturing, ensuring that the clinical development program is not delayed.
  • Efficient program management: When running an integrated program, the CDMO typically assigns a Single Point Of Contact (SPOC) to liaise with the customer. This SPOC coordinates all activities at the CDMO thereby minimizing the management time required by the customer. In biotech firms that run a lean organization, this is viewed as a significant value addition.
  • Availability of documentation through a single source: The Regulatory Affairs team of an integrated CDMO can provide expert clinical & regulatory support across all phases of drug development. This includes regulatory support for both API and Finished dosage formulations, including New Chemical Entity (NCE) development, Clinical Trials and Marketed products. A single entity for regulatory filing enables the submission of a robust dossier with data consistency.

Benefits to the CDMO

For a CDMO with a ‘One-Stop-Shop’ offering, an integrated value chain can serve as a differentiation strategy from competitors. CDMO’s with integrated approaches improve ‘customer stickiness’, as customers doing multiple parts of the program at one partner are less liable to leave. In addition, CDMO’s also maximize ‘Customer Lifetime Value’, as customers tend to work with such providers from clinical development through commercialization.

Risks to the Customer and the CDMO

Conversely, Pharmaceutical companies must be wary, as over exposure to a single partner could potentially put the full clinical program at risk. The customer must ensure that the chosen CDMO is world-class in multiple business verticals. The customer must convince themselves that the CDMO of choice has contingency plans ready for adverse events such as operational issues, geo political challenges, among others.

The CDMO’s on the other hand, must carefully analyse the segments they expand into to create integrated value chains, as inaccurate capacity estimation can lead to over-capacity and resource under-utilization. CDMO’s may also consider the risk of having really large customers, the loss of who will lead to significant revenue gaps on exit. Some CDMO’s also may be wary of the pricing pressure that may come with large integrated accounts, leading to potentially less optimal return on the assets.

Piramal’s Integrated Offering

Piramal Pharma Solutions has created a global network of 11 development and manufacturing facilities located in North America (3), Europe (2) and Asia (6) that offer a multitude of services spanning the entire drug life cycle. These range from Drug Discovery & Development, manufacturing and packaging of Clinical Trial Supplies to Commercial Manufacturing of Active Pharmaceutical Ingredients and Finished Dosage Forms. Piramal offers a fully-integrated global supply chain, with access to scientific expertise, state-of-the-art technology, and modern manufacturing capabilities, along with the experience of working with various global regulatory authorities.

Piramal has a long and successful history, and has launched 34 products to support innovator clients, including blockbusters such as Velcade and Ninlaro. With 10 additional launches scheduled for this year, and a robust Phase III and Phase II pipeline of 49 and 27 programs respectively, Piramal is ideally positioned for continued growth. In the area of cancer, for example, where Piramal has established global leadership as a preferred integrated partner, the firm can provide end-to-end solutions by doing the ADC conjugation and the fill finish between its facilities in Europe and North America. Through the recent acquisition of the Ash Stevens high potency drug substance development and manufacturing facility in Michigan, Piramal expects to also supply the active ingredient for the ADC conjugation, thereby completing the integrated supply chain.

Piramal’s leading capabilities in both drug substance and drug product development and manufacturing, focus on customer centricity, a stellar record in quality and compliance, and a seamless blend of diverse geographic offerings has resulted in over 30 successful integrated projects between discovery, drug substance, drug product and clinical packaging. Piramal is now a ‘partner-of-choice’, for firms from large pharmaceuticals to virtual biotechs, in North America, Europe, and Japan.

* This article forms part of the CPhI 2017 Annual Report, which will be released during the CPhI Worldwide event in Frankfurt (October 24-26, 2017). Emphasizing that CPhI Worldwide is also a key opportunity to learn about new trends, business insights and prospects, the revered CPhI Annual Report launches its 5th edition during this year’s CPhI Worldwide. This eagerly anticipated collection of essays will include contributions by Ajaz Hussain, Emil Ciurczak, and Alan Sheppard amongst others, and a contract services overview from Gil Roth of the PBOA. It can be downloaded from www.cphi.com/europe/cphi-annual-report.



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