Challenge

A change in the corporate strategy required the R&D organisation of a MidPharma to evolve and structure its activities from a Life Cycle Management and Product Maintenance focus to a mixed model incorporating NME innovation

The R&D head and R&D Leadership team were not clear or aligned on what the new strategic focus, structure, governance, and roles and responsibilities should be for the R&D organisation

Solution

Deeply investigated and diagnosed the organisation’s current focus, structures, practices and processes for R&D activities

Interviewed a broad range of executives from our proprietary network of R&D leaders to explore the processes and models that they applied to managing R&D projects in both product maintenance and innovation, and the nature of outsourcing they applied to each

Explored options and designed an evolved operating model for the new R&D organisation

Result
  • A clearly articulated and comprehensive operating model comprising R&D focus, organisational structure, practices, and processes
  • Alignment and commitment of the R&D leadership team to implement the new model
Challenge

Market changes were causing increased access and pricing pressure, requiring more leadership from the Global Market Access (GMA) team of the diagnostic unit of a Big Pharma

The GMA was not engaging proactively with development and commercial teams to set access and pricing strategy and evolve the company’s development and commercial strategies

Solution

Engaged leaders across the organisation to understand their perspectives on the current and future challenges and the role and value of GMA in addressing those challenges

Facilitated a workshop with the GMA team to drive a detailed and structured discussion of GMA’s future priorities and value proposition for supporting the company

Developed a concise proposal on the GMA team’s strategic focus that was aligned with the leadership team for implementation

Result
  • A clear and consistent value proposition and priorities for the Global Market Access team that was agreed with leadership and became the basis of its operating model
  • Improved product and commercial strategies that respond better to access and pricing dynamics
Challenge

Inconsistent development and delivery of publication strategies across the Medical Affairs’ Scientific Communications Leaders (SCLs) responsible for a Big Pharma’s top therapeutic area

Many SCLs were not viewed as business partners by development and commercial teams, significantly hindering their ability to deliver effective publication strategies for the portfolio

Solution

Structured discussions with 16 development, medical and commercial leaders to gain insight into their expectations and experiences of working with SCLs and of publications

Clearly identified gaps in business partnership, strategy development and publication expertise

Worked closely with SCLs to establish an improved way of operating that included sharing best practice examples and establishing a network of business partnering relationships

Result
  • Enhanced capabilities with new forums for sharing outputs, insights and methodologies, and for sharing experiences in successfully building business partnerships
  • Consistent delivery of effective publication strategies through genuine partnerships between medical affairs and other functions
Challenge

Following a new corporate strategy, a MidPharma had re-oriented its R&D strategy to improve external innovation sourcing and broaden its technology focus

Though the new strategy was clear, the details of the capabilities required to execute it, both existing and new, were less clear, and there was no step-wise plan to rebalance capabilities

Solution

Thoroughly assessed and challenged functional resourcing plans based on context-relevant experience and relevant benchmarks

Interviewed a selection of senior executives in companies that had been on similar journeys to build the required new capabilities

Created and aligned R&D leadership on a resourcing and capability roadmap, ratified this with relevant governance committees and secured commitment to implement

Result
  • Top management alignment on a clear and sequenced plan to add new capabilities in both recombinant proteins and translational medicine, and to increase outsourcing flexibility
  • New hires for key capabilities and a leaner outsourcing model for non-core activities that together enabled the more effective progression of a much more innovative pipeline
Challenge

The digital function of a leading Big Pharma was not creating maximum value for the company because of often poor integration with business teams across the value chain

The digital function was seen as a service provider, not a business partner, and needed to drive a digital agenda in the organization through a partnership mentality with key stakeholders

Solution

Framed the issues and developed hypotheses on solutions with the digital leadership team

Interviewed 21 senior leaders across multiple functions to understand, clarify and elucidate their views on the value of digital and the requirements for greater engagement

Aligned the digital leadership team on the findings, implications and next steps, which enabled a subsequent discussion on the enablers for progress with pharma leadership

Result
  • A more effective digital leadership team with a clear insight into senior leaders’ expectations of the value digital should deliver and the opportunity for greater partnership with them
  • Increased digital impact and engagement across the organisation that is creating a meaningful impact on the business
Challenge

Market Analytics leaders in a global Big Pharma’s European affiliates were concerned that their preparing of a high number of forecast scenarios was not helping decision making

To address this they wanted to assess probabilistic forecasting as an approach to improve decision-making efficiency

Solution

Created and ran a one-day workshop with Analytics teams from five affiliates to explain probabilistic forecasting and to introduce a model for developing their forecasts

Followed up with intensive one-day sessions with each affiliate to build capabilities and train Analytics teams to integrate the approach into their decision-making processes

Gained perspectives, prepared relevant materials, and built adoption and commitment from senior leaders

Result
  • Integrated and embedded probabilistic forecasting into the affiliates’ analytical and decision-making processes
  • More efficient decision-making and more informed discussions on company and product strategies
Challenge

A biotech with a specific therapeutic expertise had developed two lead assets that had potential in several non-core indications and sought partnerships to progress its assets

Business Development activities had stalled and had not yielded sufficient contact with the senior R&D executives who would be open to creative partnership approaches for the various indications

Solution

Thoroughly analysed the lead assets in terms of what would be attractive to what type of company, and crafted succinct value propositions to take to potential partners

Screened the global universe of potential partners for the value propositions, and selected a short list of promising candidates

Anonymously interviewed senior executives in relevant potential partners to explore deal possibilities and understand opportunities and barriers to deals

Result
  • A set of high-quality well-qualified introductions to several promising potential partners and insight into how attractive the assets were, why, and what could be done about it
  • A significant acceleration of Business Development insight that led to important decisions on two assets
Challenge

A Big Pharma Medical Affairs team for a leading immunotherapy portfolio was not delivering as effectively as it could across the multiple indications it was covering

The organisational structure and operating model did not support the complexity of multi-indication medical information requirements

Solution

Interviewed all Medical Affairs and related stakeholders to understand the constraints and expectations of their specific franchises and their ability to deliver the required value

Synthesised the insights from the diagnosis to get to the essence of the issues

Aligned management on a new future structure and set of responsibilities as well as an improved way of operating to optimise the value of the team

Result
  • A clear fit-for-purpose and aligned role for the Medical Affairs team that was able to meet the expectations of its internal stakeholders with a new and optimal team structure and ways of working to deliver the required support
  • Improved medical affairs support for a key product franchise with multiple indications
Challenge

An early stage biotech sought competitive insight and a business development narrative to support fund-raising and the consideration of suitable partnership deals to enable expansion

The biotech’s technology was highly innovative with a corresponding recent rapid growth in the number of companies and pipeline products that were either precedents or competitors

Solution

We carried out a thorough competitor analysis based on the mechanism of action of the technology and the phase of development of companies that were active in the target therapeutic area as well as the specific indication for the company’s lead asset

We analysed comparable deals and companies in terms of upfronts, funding rounds, initial public offerings and pipeline progress

We developed clear and succinct board and investor materials for the CEO to use in ongoing discussions

Result
  • Confirmation and a depth of evidence behind the CEO’s initial instinct regarding positioning the biotech optimally for fund-raising
  • Confidence and tangible evidence to drive further fund-raising for the company
Challenge

An early-stage biotech with a highly innovative new technology that had multiple therapeutic area and indication possibilities sought a focus for its further product and technology developments

The management team and board did not have an evidence-based view on which opportunities were the best ones to pursue for further corporate growth

Solution

Analysed and clarified the corporate ambition and risk appetite, previous growth ideas that had been considered, and the key technology advantages, issues, priorities and challenges

Qualitatively triaged and evaluated the wealth of growth options, with illustrative financial and risk projections driven by market opportunities and comparable partnership and M&A deals

Created an implementation roadmap to convert the strategic choices to a tangible reality including critical path activities, resource requirements and risks to manage

Result
  • An evidence backed strategic roadmap and compelling value propositions to take to potential partners that could further advance the technology and create novel products
  • Engaged in a highly valuable partnership with a major pharma based on the board’s and management team’s clarity in strategic focus and confidence to transact
Challenge

A multi-product biotech with a newly established commercial footprint in the US was not getting the speed of uptake that was expected prior to launch

The specialty product was not straightforward to commercialise as it required a procedure, an associated device and a relationship approach with key centres spread across the US

Solution

Analysed the situation through primary and secondary research to identify drivers and barriers to product adoption, usage and leakage points after the initial positive uptake

Identified two opportunities for improved commercialisation, through accounts that did not modify logistics to accommodate the product and high rates of equipment failure during procedures

Developed an account start-up process to systematically support accounts with pathway logistics, and created a ‘Surgical Executive’ role to provide on-site support

Result
  • Clarity of action for the US commercial team that was aligned with headquarters and addressed the most important growth constraints
  • Product growth accelerated to >100% and remained in excess of 40% year on year after two years
Challenge

The available resource, budget and value data was more suited to clinical projects, and the leadership team did not have a synthetic and succinct dashboard to track discovery activities

Solution

Established the principles, goals and scope of information that the discovery leaders needed to make better decisions

Clarified the sources of relevant information, the areas where qualitative judgement were required, and the processes for creating decision-relevant information

Created a pilot dashboard for use at the discovery leadership team meetings, and initiated the population of the dashboard with relevant data

Result
  • The discovery leadership team used the dashboard routinely to evaluate and track its portfolio and resources across therapeutic areas, modalities, and capabilities

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  • Ongoing focused and high quality decision making on priorities and resourcing in order to increase the value of the entire discovery portfolio
Challenge

A biotech with on-market assets and a novel technology platform needed partners across different regions as it could not fully self-fund global development and commercialisation

The biotech did not have a rich understanding and network into one of its key target regions for partnerships, and needed to accelerate its senior-level access in the right companies

Solution

Developed a strong rationale for partnering and created tailored documentation to support discussions with potential partners that would be attractive in each partner’s eyes

Screened and prioritised a long-list of companies, and identified partner candidates with suitable scale, strategic fit, and capabilities

Contacted partner candidates using our network of senior decision-makers to receive rapid feedback on the partnering value proposition

Result
  • A significantly accelerated business development timeline with direct introductions to senior executives in well qualified and interested companies
  • Multiple new advanced stage partnering negotiations with insight into how to close them
Challenge

Following a period of profitability constraints, a MidPharma was poised for adding external partnerships and bolt-on acquisitions and needed a prioritised set of candidates to approach with a strong rationale for each

The management team had differing views on the relative attractiveness of different candidates and how they would fit the corporate strategy

Solution

Aligned management on future goals and preferred growth options based on management team insights and preferences and the agreed corporate vision and direction

Searched thoroughly for possible expansion candidates based on agreed profiles, and assessed the feasibility and attractiveness of those that best fit the corporate goals

Synthesised and aligned on a clear and actionable growth plan including the rationale for specific moves and interdependencies between the various options to pursue

Result
  • A sequenced and actionable roadmap including candidates for immediate follow up to focus corporate development activities across therapeutic areas, regions, and types of company
  • A richer and more coherent pipeline of partnership and M&A candidates that fit the corporate direction
Challenge

Ambitious targets for pipeline growth in a MidPharma led to a request for R&D to establish how it could do more external innovation in order to support achievement of the new goals

The external innovation team was under-resourced and traditionally focused on earlier technology collaborations rather than the pipeline enrichment that was newly required
 

Solution

Developed a powerful external innovation strategy that supported the delivery of the desired R&D strategy, and designed new activities and processes for the various elements of the organisation involved in external innovation

Benchmarked a subset of peer companies to inform key choices around resourcing, capabilities, targets and necessary investment

Created a business plan that included resourcing, return on investment and impact on the existing organisation and designed the “reconfigured” R&D/BD capabilities

Result
  • The external innovation business plan was approved, implemented, and embedded into the existing R&D and BD processes
  • The company applied the plan to accelerate pipeline enrichment through signing more high quality and focused external innovation deals
Challenge

A new corporate strategy that focused on accessing increased innovation in a MidPharma’s core therapeutic area required extra global reach and capabilities to access external innovation

External innovation activities were split between R&D and BD and not located in a way that would ensure both access to the right innovation and integration with the internal organisation
 

Solution

Defined a clear external innovation focus in terms of pipeline stages, technology modalities, types of collaboration, asset risks, deal archetypes, and geography

Designed a lean external innovation sourcing model inspired by the approaches of other companies and analysis of where the desired technologies and assets were concentrated

Created a business plan and implementation roadmap to successfully embed the new model and characterise the resources and investment requirements for success

Result
  • Executive committee approval for a new resourcing model and processes for external innovation with increased investments into strategic locations
  • A more focused and effective external innovation machine to enrich the innovation pipeline
Challenge

A mature biotech company could not fund the further development and commercialisation of all of its products, so needed good partners for its asset portfolio across different regions

Not many global and regional partners were suitable for the company’s unique products that combined device and drug elements in clinical procedures

Solution

Crafted a strong strategy and rationale for partnering and developed marketing documents in the form of pitch-books and executive summaries

Developed and prioritised a long-list of potential partners for each of the assets using criteria and bespoke profiling of potential partners

Contacted the potential partners using our high-level network, allowing us to reach senior decision-makers and receive rapid feedback on the relevant propositions

Result
  • Three signed deals with different companies for different products in the portfolio including a licensing deal, a divestment and a collaboration
  • A focused and restructured portfolio with the partners and funding to further develop the company’s assets
Challenge

A MidPharma was suffering from the complexity of a highly diverse portfolio of projects, multiple domains of functional expertise, and resource allocation pressures, resulting in project delays with insufficient pipeline progression and launch of valuable products

The decision-making, roles and responsibilities and governance of R&D lacked a focus and sense of urgency for project progression
 

Solution

Interviewed a broad range of executives from within the company’s R&D organisation and related stakeholders to understand the roots of the performance issue

Externally researched into other organisation’s structures, practices and processes for R&D activities that were relevant to and could inspire solutions to the company’s specific challenges

Designed a new operating model for R&D including a strengthening of project teams, revitalised governance, improved project leadership and management
 

Result
  • A new and implemented operating model design including new matrix emphasis, teams, governance and behaviours
  • A significantly refocused R&D portfolio and an acceleration of the progression of the company’s most promising projects
Challenge

Shareholders were pressurising the board of a MidPharma to prioritise its investments either regionally or therapeutically to drive short-term growth

The board were split between doubling down on a successful product franchise and investing in new paths to grow, and incremental NPV analyses on each new opportunity were not helping

Solution

Clarified and focused the feasible strategic alternatives for the company, evaluated each from a strategic and financial perspective, and established the full value and risk implications of creative paths to grow

Facilitated evidence-based discussions with the executive team to narrow down the alternatives to a dominant strategic framework that clearly prioritised where and what to buy, build or disinvest

Result
  • A strategic framework that required a refreshed therapeutic and geographic focus and a ruling out of other options
  • Fast-tracking and investment in the launch of a complementary product with the knowledge that it fitted well with the strategic framework that the company had aligned on
Challenge

Corporate management changes and profitability pressures in a MidPharma led to a new focus on the value that R&D was creating, and how productivity could be significantly improved

The company had a multi-site fully integrated R&D organisation that had not delivered any new products to market for decades

Solution

Thoroughly and critically analysed the R&D portfolio and organisation from discovery through to registration across small molecules and biologics and several therapeutic areas

Developed a pipeline evolution model to explore what kind of output could be expected from the existing portfolio supplemented by business development

Comprehensively benchmarked the R&D organisations and performance of relevant peers, in order to highlight areas for improvement in strategy, structure and outsourcing

Result
  • A new and more focused strategy with new goals and a significant change to the focus, size and footprint of the R&D organisation
  • A more productive basis for enriching the pipeline and increasing the ROI of R&D

Challenge

A large MidPharma with an attractive late-stage pipeline sought to strengthen its commercial footprint in an important region for one of its therapeutic areas

Key stakeholders were not aligned on whether to self-build, acquire or partner in order to best create value, as there was insufficient insight into how feasible each option was
 

Solution

Assessed the corporate ambition and the current portfolio and capabilities from a potential partner’s perspective through structured interviews and analysis

Thoroughly screened and anonymously approached selected CEOs and key stakeholders of potential partners or M&A candidates to explore the nature of feasible deals with the company

Narrowed down the options for commercial footprint expansion with key stakeholders using a decision-making framework and facilitated workshops
 

Result
  • Clear alignment that partnering was not the right approach for the company and identification of the most promising M&A candidates to support self-build
  • A focus for internal resources to be deployed effectively for commercial expansion in a core region and therapeutic area for the company

Strategic collaborations and partnering are a fantastic way to access new markets. 42 of the top 100 pharma companies are headquartered in Europe and this only scratches the surface.

The European pharma sector is much more diverse than the common perception of dominant Big Pharmas. Europe has a fascinating collection of Mid-sized pharma companies with unique therapeutic area focus, deep geographical expertise and a need to collaborate. These European MidPharmas provide non-EU companies with an excellent route into the European market but why are they such good partners?

75% of the European MidPharmas are privately held and therefore do not have the access to capital that some of the larger companies have. This makes it challenging for them to pursue game changing innovation and as such they manage and grow their portfolios inorganically, which is becoming harder as the cost of mergers and acquisitions rises.

The benefit of their need to grow inorganically through collaborations is your assets are of tangible benefit to the them, so are nurtured with an attention that can be absent in larger companies. This is amplified by their therapeutic focus, geographic expertise and deep understanding of customer needs, which make them excellent partners to support non-EU companies in Europe.

Through our experience in the European pharma sector we have helped many companies access strategic collaborations in Europe by understanding their assets and needs, assessing partner profiles to ensure optimum fit and leveraging our unique network to facilitate meaningful business conversations.

Contact us to understand how we could help you find the ideal partner in Europe: info@novasecta.com

Partnering in Europe – Please complete the form below to discover how our clients have found strategic collaborations in Europe

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    Establishing a commercial footprint in Europe is a great approach for companies with global ambition. The European market presents unique challenges, which non-EU companies may not have experienced, so is often seen as a complex environment to enter.

    Although there are challenges to enter the market the rewards are there for companies who understand their markets and utilise European expertise to navigate them, such as Gilead which is now one of the world’s biggest pharma companies.

    Many US and Asian companies enlist local European support to traverse the landscape which combines centralised EU bodies and individual countries, who have their own unique processes for regulation, market access and pricing, to produce a diverse market with individual needs.

    There are many steps to self-commercialisation and they require deep expertise in the European market to execute:

    • Opportunity assessment

    • Go-To-Market model

    • Assess and design launch planning

    • Affiliate establishment

    • Ongoing regional support

    Contact us to understand how we could help you establish your presence in Europe: info@novasecta.com

    Launching in Europe – Please complete the form below to discover how our clients have found their value in Europe

      To view all of our content please complete the form below and submit