Dr. Claire Madden-Smith, Senior Vice President, Juniper Pharma Services09.08.16
As many of the larger contract development and manufacturing organizations (CDMOs) expand their capabilities and services to offer a one-stop-shop model, others recognize the advantages of forming strategic alliances with complementary contract service providers.
This article discusses the role of supply chain collaborations in the changing outsourcing landscape and the drivers that are fuelling such partnerships to progress drugs through the preclinical, early phase drug development and manufacturing stages.
The current landscape
It is widely recognized that the drug discovery and development landscape has changed significantly during the last ten years. The global restructuring of the pharmaceutical industry has resulted in new ways of working, with a shift from internally focused research and development to an external model, with a growing number of contract research, development and manufacturing organizations delivering the specialist expertise and scale needed to meet the supply needs of pharmaceutical companies.
In the contract services sector, there has been a clear trend towards mergers and acquisitions, often aimed at expanding services and capabilities, as well as increasing geographic presence.
Arguably, this could be seen as an effort to resurrect the one-stop-shop organizational model that existed within big pharma companies prior to the advent of modern drug development outsourcing as it is today. Many believe that this model was dismantled to improve efficiencies and remove the need for heavy footprints, capital expenditure and fixed costs.
Interestingly, while larger CDMOs expand their in-house capabilities, the industry is also witnessing the emergence of more and more strategic alliances between smaller contract service providers that have specialist expertise to bring to the table.
While growing in popularity, this coming together approach dates back to the late 1920s, when a groundbreaking collaboration led to the discovery, development and manufacture of penicillin . In 1928, Sir Alexander Fleming realized that a substance released by mold inhibited the growth of bacteria but was unable to develop a stable form. After distributing the original mold to chemists around the world, a group from the University of Oxford was able to produce stable penicillin in 1938, which then went on to be scaled up and manufactured by groups in the U.S. In total, it took more than 15 years of collaborative research and development to transform the original discovery into a mass produced drug. While timelines for collaboration aim to be shorter today, there is a lot that can be learned from this early example of successful alliances.
Drivers for change
There are a number of factors that are leading to the need for strategic alliances among contract service providers.
For many years, drug developers have been under increasing pressure to speed up time taken to bring new drugs to market, while also reducing costs during drug development and manufacture. In many cases, small-scale providers can offer the operational flexibility needed to move products from the clinical development stages through to commercial scale in a nimble and agile manner. However, if they are to deliver the range of services needed to handle complex and challenging projects, they may need to form strategic alliances with complementary service providers.
The so-called biotech boom is also contributing to the trend towards alliances. Currently, biopharmaceuticals are generating global revenues of $163 billion, making up around 20 percent of the pharmaceutical market. As the fastest growing segment of the industry, with annual growth rates of 8 percent, funding is being pumped into the sector from investors. Strong supply chain integration and partnerships between contracted suppliers is proving to be a compelling offering to small or virtual biotech firms that don’t always want to work with larger players.
In addition, the molecules in development are increasingly providing technical challenges that require specialist skills and a science-led approach to drug development. With reducing in-house R&D teams, niche contract organizations can bring the expertise and flexibility, to push development rapidly towards earlier value inflection points for investors.
Benefits of collaborative working
By their nature, specialist contract service providers are nimble and able to make quicker decisions, which speeds up the research and drug development process. Working in collaboration with trusted partners and applying problem solving along the R&D pipeline can improve their efficiency further.
By working together collectively and combining their expertise into one offering, CDMOs can become more competitive in an increasingly buoyant outsourcing market. When faced with the choice between a one-stop-shop provider or working with multiple partners, pharmaceutical companies may opt for the former to simplify communication and relationship management. However, strategic alliances can provide the best of both worlds—a breadth of services, combined with specialist expertise and in many cases, a single project team.
Pharmaceutical companies can benefit from experts in specialist areas from a team of CROs and CDMOs that all know each other, work together, complement one another and share similar values and approaches.
Our clients have seen this work first hand with several alliances that we have developed and nurtured over the last few years. As with any working relationship, a partnership such as this requires commitment from both parties upfront to get to know each other’s specialism. There is then a need to ensure that both partners are aligned in the delivery of a project as well as evaluating how it can be improved next time. Success only ensues when the needs of the client are put first, providing the template of how the combined offering is delivered.
The collaboration Juniper Pharma Services put in place with XenoGesis back in 2014, for example, was driven collectively by a belief that an integrated biopharmaceutics service would offer a significant advantage to early development activities. The offering has been worked-on and refined by both companies. By working together in an open manner, we have focused on ensuring the alliance is meeting the goal of moving through to an optimal formulation strategy in 8-12 weeks.
The key to the relationship has been to combine respective expertise into a single offering, here specifically our team’s development knowledge with XenoGesis’ expertise in preclinical drug metabolism and pharmacokinetics (DMPK). The result for clients is a robust, rapid and cost effective screen to find a formulation pathway for poorly water-soluble drugs.
As drug developers are increasingly dealing with more complex and challenging molecules, there is a greater focus on early stage work to increase the chances of project success and promote stronger drug candidates. While it can be difficult to predict every eventuality that may occur when bringing a drug candidate to clinic, it is possible to mitigate the risk of a promising molecule failing by adding additional expertise, capabilities and technologies to a project.
Summary
As we look to the future, we can expect an increasing number of strategic alliances and collaborations to form as pharmaceutical companies demand a range of services to help bring more complex and challenging molecules to market. The need for science-led expertise will remain as important as ever. With multiple contract service providers working together towards common goals, the needs of a changing industry can be met effectively and creatively.
Dr. Claire Madden-Smith is senior vice president at Juniper Pharma Services. She has over 17 years of CRO and CMO business and technical experience, and currently strategically leads Juniper’s pharmaceutical development services. Dr. Madden-Smith holds a degree in chemistry and a doctorate in physical chemistry from Loughborough University. Previously she has chaired the marketing committee of the Controlled Release Society and served on the materials science focus group of the Academy of Pharmaceutical Science GB.
This article discusses the role of supply chain collaborations in the changing outsourcing landscape and the drivers that are fuelling such partnerships to progress drugs through the preclinical, early phase drug development and manufacturing stages.
The current landscape
It is widely recognized that the drug discovery and development landscape has changed significantly during the last ten years. The global restructuring of the pharmaceutical industry has resulted in new ways of working, with a shift from internally focused research and development to an external model, with a growing number of contract research, development and manufacturing organizations delivering the specialist expertise and scale needed to meet the supply needs of pharmaceutical companies.
In the contract services sector, there has been a clear trend towards mergers and acquisitions, often aimed at expanding services and capabilities, as well as increasing geographic presence.
Arguably, this could be seen as an effort to resurrect the one-stop-shop organizational model that existed within big pharma companies prior to the advent of modern drug development outsourcing as it is today. Many believe that this model was dismantled to improve efficiencies and remove the need for heavy footprints, capital expenditure and fixed costs.
Interestingly, while larger CDMOs expand their in-house capabilities, the industry is also witnessing the emergence of more and more strategic alliances between smaller contract service providers that have specialist expertise to bring to the table.
While growing in popularity, this coming together approach dates back to the late 1920s, when a groundbreaking collaboration led to the discovery, development and manufacture of penicillin . In 1928, Sir Alexander Fleming realized that a substance released by mold inhibited the growth of bacteria but was unable to develop a stable form. After distributing the original mold to chemists around the world, a group from the University of Oxford was able to produce stable penicillin in 1938, which then went on to be scaled up and manufactured by groups in the U.S. In total, it took more than 15 years of collaborative research and development to transform the original discovery into a mass produced drug. While timelines for collaboration aim to be shorter today, there is a lot that can be learned from this early example of successful alliances.
Drivers for change
There are a number of factors that are leading to the need for strategic alliances among contract service providers.
For many years, drug developers have been under increasing pressure to speed up time taken to bring new drugs to market, while also reducing costs during drug development and manufacture. In many cases, small-scale providers can offer the operational flexibility needed to move products from the clinical development stages through to commercial scale in a nimble and agile manner. However, if they are to deliver the range of services needed to handle complex and challenging projects, they may need to form strategic alliances with complementary service providers.
The so-called biotech boom is also contributing to the trend towards alliances. Currently, biopharmaceuticals are generating global revenues of $163 billion, making up around 20 percent of the pharmaceutical market. As the fastest growing segment of the industry, with annual growth rates of 8 percent, funding is being pumped into the sector from investors. Strong supply chain integration and partnerships between contracted suppliers is proving to be a compelling offering to small or virtual biotech firms that don’t always want to work with larger players.
In addition, the molecules in development are increasingly providing technical challenges that require specialist skills and a science-led approach to drug development. With reducing in-house R&D teams, niche contract organizations can bring the expertise and flexibility, to push development rapidly towards earlier value inflection points for investors.
Benefits of collaborative working
By their nature, specialist contract service providers are nimble and able to make quicker decisions, which speeds up the research and drug development process. Working in collaboration with trusted partners and applying problem solving along the R&D pipeline can improve their efficiency further.
By working together collectively and combining their expertise into one offering, CDMOs can become more competitive in an increasingly buoyant outsourcing market. When faced with the choice between a one-stop-shop provider or working with multiple partners, pharmaceutical companies may opt for the former to simplify communication and relationship management. However, strategic alliances can provide the best of both worlds—a breadth of services, combined with specialist expertise and in many cases, a single project team.
Pharmaceutical companies can benefit from experts in specialist areas from a team of CROs and CDMOs that all know each other, work together, complement one another and share similar values and approaches.
Our clients have seen this work first hand with several alliances that we have developed and nurtured over the last few years. As with any working relationship, a partnership such as this requires commitment from both parties upfront to get to know each other’s specialism. There is then a need to ensure that both partners are aligned in the delivery of a project as well as evaluating how it can be improved next time. Success only ensues when the needs of the client are put first, providing the template of how the combined offering is delivered.
The collaboration Juniper Pharma Services put in place with XenoGesis back in 2014, for example, was driven collectively by a belief that an integrated biopharmaceutics service would offer a significant advantage to early development activities. The offering has been worked-on and refined by both companies. By working together in an open manner, we have focused on ensuring the alliance is meeting the goal of moving through to an optimal formulation strategy in 8-12 weeks.
The key to the relationship has been to combine respective expertise into a single offering, here specifically our team’s development knowledge with XenoGesis’ expertise in preclinical drug metabolism and pharmacokinetics (DMPK). The result for clients is a robust, rapid and cost effective screen to find a formulation pathway for poorly water-soluble drugs.
As drug developers are increasingly dealing with more complex and challenging molecules, there is a greater focus on early stage work to increase the chances of project success and promote stronger drug candidates. While it can be difficult to predict every eventuality that may occur when bringing a drug candidate to clinic, it is possible to mitigate the risk of a promising molecule failing by adding additional expertise, capabilities and technologies to a project.
Summary
As we look to the future, we can expect an increasing number of strategic alliances and collaborations to form as pharmaceutical companies demand a range of services to help bring more complex and challenging molecules to market. The need for science-led expertise will remain as important as ever. With multiple contract service providers working together towards common goals, the needs of a changing industry can be met effectively and creatively.
Dr. Claire Madden-Smith is senior vice president at Juniper Pharma Services. She has over 17 years of CRO and CMO business and technical experience, and currently strategically leads Juniper’s pharmaceutical development services. Dr. Madden-Smith holds a degree in chemistry and a doctorate in physical chemistry from Loughborough University. Previously she has chaired the marketing committee of the Controlled Release Society and served on the materials science focus group of the Academy of Pharmaceutical Science GB.
