Cell and Gene Therapy: The Next Frontier in Healthcare

Cell and Gene Therapy: The Next Frontier in Healthcare 

Executive Summary

  • Cell and gene therapies (CGTs) have become one of the most promising technology categories in biopharma with the global market expected to grow from ~$7B in 2021 to ~$58B in 2026
  • CGT treatments are broad and can be categorized into three technology approaches: 1) Cell & gene-modified cell therapies, 2) Gene therapy & genome editing, and 3) DNA & RNA therapeutics
  • The main drivers of anticipated growth of the sector are CAR-T and cell therapies in oncology as well as gene therapies targeting rare diseases
  • CGT development has accelerated with M&A and licensing deals, which have been strong over the last 5 years, in particular after FDA approvals of Luxturna and Kymriah in 2017
  • Despite significant optimism, CGT has faced a number of commercial, clinical, and regulatory hurdles that have dampened expectations in the last year

Introduction

Cell and Gene Therapy (CGT) is one of the most promising new frontiers in advanced therapies with the potential for transformational disease-modifying outcomes. As an example, Luxturna, approved by the FDA in 2017, can restore vision in children and young adults with a rare disease that would otherwise lead to blindness. The promise of CGT is potentially very broad, holding hope for treating or even reversing many currently uncurable and more common genetic diseases like hemophilia A or Parkinson’s.

Current State of Cell & Gene Therapy

Although the space is constantly expanding in breadth and application, CGTs can be grouped into three broad types of technologies: cell and gene-modified cell therapies, gene therapy and genome editing, and DNA and RNA therapeutics.

The first CGT was approved by the FDA in 2017 (Kymriah ‒ developed by Novartis and indicated for acute lymphoblastic leukemia and diffuse large B-cell lymphoma). Since then, only 17 CGTs have launched in the US through 2021.

 

Despite a relatively low market size of $7B in 2021, CGT is forecast to grow to a market size of $58B by 2026 at a 52% CAGR, compared to only 5% for small molecules and 1% for non-CGT biologics (incl. vaccines) markets. This forecast is underpinned by a growing interest in CGT with total financing in regenerative medicine doubling from ~$10 billion in 2019 to ~$20 billion in 2020, according to the Alliance for Regenerative Medicine.[i] Interest stems from Big Pharma as well as from private equity and venture capital. In 2020, 16 out of 20 largest biopharma manufacturers had CGT products in their portfolio, although CGT account for more than 20% of pipeline assets for 2 of the 16 manufacturers.[ii] Out of all private investment made in life sciences, roughly a third is directed toward CGT ($68 billion in 2021).[iii]

Approximately 46% of the cumulative worldwide sales in CGT ($70.5 billion) is expected to come from assets currently in clinical trials. Significant growth in this segment is expected to be driven by gene therapies, which account for half of the top 10 assets with the highest projected sales. These include Valoctocogene Roxaparvovec (valrox) by BioMarin and Etranacogene Dezaparvovec by uniQure, targeting Hemophilia A and B, respectively.

Overall, CGTs have accounted for just over 14% of the 63 biologics approved and marketed in the US in 2020 and 2021. In 2021, out of 130 conventional drugs and biologics approved by the FDA, only 6 were CGTs. However, the clinical-stage pipeline is very strong with 1,183 assets across all three clinical phases. Cell therapies and gene-modified cell therapies (incl. CAR-T) account for almost two thirds of the pipeline.

In evaluating CGT assets in the pipeline, there are clear patterns that emerge with respect to therapeutic areas with more substantial investment within each technology category. Cell and gene-modified cell therapy assets predominantly focus on oncology (62% of all clinical stage programs), while assets from gene therapy and genome editing, in addition to oncology, concentrate on central nervous system (CNS) and ophthalmology applications. Over a quarter of DNA and RNA therapeutics in the pipeline focus on oncology and ~10% each target CNS and GI indications.

Rare diseases make up a significant portion of clinical stage programs, in particular for gene therapy and genome editing. Almost half of gene therapy and genome editing assets in the pipeline are targeting rare diseases, while cell and gene-modified therapies focus on non-rare diseases, many of which are in oncology.

Pipeline Category Spotlight: Gene Therapy & Genome Editing

Within CGT, gene therapy and genome editing is highly diverse, as biopharma companies are pursuing a range of therapeutic area applications. The goal of gene therapy is to treat a disease by either replacing, inactivating or including new genes into cells, either inside (in vivo) or outside patient’s body (ex vivo). This process is conducted using vectors, of which viruses are the most popular form (e.g., adenovirus, adeno-associated virus, lentivirus and retrovirus). Currently, there are only two FDA-approved gene therapies (Zolgensma and Luxturna). These two gene therapies target rare diseases, but as popularity of the technology grows, it is expected that gene therapy will be used to address more common conditions such as hemophilia A or stubbornly high LDL cholesterol.

Recent Challenges

Despite significant optimism and investment, CGTs have faced substantial hurdles to approval and access, in particular for treatments with long-term or potentially lifetime efficacy. While the effects of RNA interference are transient, gene therapy treatments and gene editing therapies like CRISPR-Cas9 are intended be permanent solutions. This raises the bar for long-term data – both for regulators seeking extended safety data for approvals and payers seeking validation of long-term efficacy to justify $1-2M+ single treatment pricing.

Bluebird bio received EMA approval for two gene therapies—Zynteglo (severe beta thalassemia) and Skysona (cerebral adrenoleukodystrophy)—but subsequently exited EU operations in 2021 due to difficulties gaining payer reimbursement. Bluebird has also encountered several clinical holds and extended FDA reviews. With these hurdles, bluebird’s future is in doubt as it faces the possibility of running out of cash with its stock trading 98% below its March 2018 peak despite the potential for three gene therapy approvals in the next two years, signaling a more challenging environment than anticipated for the sector moving forward.

Cell and Gene Therapy Deals Landscape

Only a small portion of launched CGTs originated or were owned by large biopharma companies. Licensing agreements are understandably more common than acquisitions. However, the promise of CGT has led to significant large consolidator interest and investment in pipeline assets.

 

When looking at deals >$1B in value in the last two years, licensing agreements are about as frequent as M&A.

The deals landscape around CGT has been very active in the last five years as large biopharma companies look to expand capabilities in rare diseases, hematology, immunology, and oncology. Notable deals post-pandemic include Bayer acquisition of Asklepios Biopharmaceuticals (Askbio) in December 2020 for $4B ($2B upfront) to strengthen its emerging gene therapy business through its adeno-associated virus (AAV)-based technology platform and Eli Lilly adding its first gene therapy to its portfolio through the purchase of Prevail Therapeutics in January 2021 for $1B.

When looking for partners, large biopharma often evaluates particular cell and gene therapy technology potential and strategic fit of a target. Companies are often either looking to expand existing CGT capabilities (e.g., Sanofi-Translate Bio deal to strengthen Sanofi’s mRNA center of excellence), to build up a CGT portfolio (e.g., Astellas buying Audentes to develop expertise in AAV), or to access a specific technology platform (e.g. Sumitomo acquisition of Spirovant). Large biopharma is also spreading its bets and investing in early-stage biopharma companies that are looking for ways to make cell and gene therapies address a wider range of diseases, to reduce potential side effects, or to streamline the manufacturing process. One example is Takeda’s collaboration with Code Bio to develop liver-directed gene therapy using lipid nanoparticles (LNP). LNPs are an alternative to virus-based vectors that should not trigger immune response and can carry a larger load than AAV, thus enabling gene therapy to tackle disorders where a larger gene is affected.[1]

Conclusion

These are exciting times for cell and gene therapies. “These concepts are no longer the stuff of science fiction,” noted the former FDA Commissioner Scott Gottlieb. The technologies have potential for breakthrough innovations across a wide range of therapeutic areas and conditions. Some companies choose to engage by developing capabilities in-house, while many others have chosen M&A, licensing agreements, or partnership deals with smaller companies and startups. Given the plethora of investment opportunities and multiple directions in which the CGT space is currently growing, it is even more important for the overall commercial success to choose the right deal partner and the right format for collaboration.

How Kx Can Help

Our experts evaluate business opportunities, deliver top-notch expertise, and make data-driven recommendations to our healthcare clients. Kx can support your growth strategy from opportunity assessments for pipeline investment through commercialization. Contact Sean Vander Linde at sean.vanderlinde@kxadvisors.com to learn more. 

Contact Our Team Today

References

[i] Alliance for Regenerative Medicine, Annual Report 2020
[ii] Toby AuWerter, Jeff Smith and Lydia The, “Biopharma portfolio strategy in the era of cell and gene therapy,” McKinsey & Company, April 2020
[iii] Steve Kemler, Adam Lohr, “Cell & Gene Therapy Investment Outlook in 2022 & Beyond,” Feb. 21, 2022, https://www.cellandgene.com/doc/cell-gene-therapies-investment-outlook-in-beyond-0001
[1] Madeleine Armstrong, “Genetic Medicine: The Next Generation,” Evaluate Vantage, April 2022

Strategizing for Your First Drug Launch

Strategizing for Your First Drug Launch

Part 1 of Kx’s 3-part series

Introduction

“We have 12 months to either make it or break it post-launch”. This sentiment has echoed from one pharmaceutical board room to the next for years. And though it may be overused, for pre-revenue pharmaceutical companies planning to directly launch their first product, the idiom couldn’t be truer.

With increasing payer scrutiny, heightened competition in specialty drug markets, and more restrictive in-person access to HCPs due to COVID-19, achieving commercial success out of the gate is crucial for pharmaceuticals. In an analysis of 149 new drug launches, roughly 64% of drugs met or beat expectations in their launch years. Of those, 86% continued to meet or beat analyst expectations in year 2. For the drugs that missed expectations in year 1, 70% went on to miss again in year 2. Only about 30% managed to reverse course by year 3. (Deloitte, 2020). In other words, winning in Year 1 is paramount to a drug’s long-term success and ROI.

Unfortunately, drug research and development costs are on the rise (an estimated 8.5% YoY over general price inflation) (Joseph A DiMasi 1, 2016), and pre-revenue drug companies rarely have the resources and cash flow to mimic the commercial strategies of Big Pharma and legacy incumbents. Further, these “cookie-cutter” commercial strategies applied to the wrong market or product can kill a launch before it even begins. Still, there are unique competitive advantages held by commercial leaders at smaller pharmaceutical companies that cannot be matched by larger peers and incumbents:

  • The full might of your commercial team is able to focus on one product
  • Leaner organization size and operations enable nimbler post-launch commercial tactics

Kx’s blog series on Strategizing for your First Drug Launch is intended to support late-stage, pre-revenue pharmaceutical companies who are planning to directly commercialize their first product capitalize on these competitive advantages. Kx’s 3-step approach draws on concepts from academic experts such as James Collins and Jerry Porras and on our direct, real-world expertise consulting clients through launch planning. It is designed to help your company build a dynamic commercial strategy tailored to your drug:

  1. Cast a launch vision
  2. Build a brand plan and supporting operating plan around your drug
  3. Utilize a dynamic launch P&L model to refine your launch strategy to meet internal constraints

This first post in our 3-part blog series will focus on Step 1: the launch vision.

Cast a holistic launch vision with a guiding ‘north star’ and quantifiable goals before you start commercial planning

In a 1996 publication of the Harvard Business Review, James Collins and Jerry Porras asserted that “a well-conceived vision consists of two major components: core ideology and envisioned future. Core ideology, the yin in our scheme, defines what we stand for and why we exist. Yin is unchanging and complements yang, the envisioned future. The envisioned future is what we aspire to become, to achieve, to create – something that will require significant change and progress to attain” (James C. Collins, 1996). Kx agrees that the exercise of determining the core ideology of a company (i.e., its core values combined with its core purpose) should take place at a company’s inception, well before commercialization. However, because of the outsize impact a first drug launch can have on a pharmaceutical company’s holistic success, we recommend that executives revisit and repurpose three modified components of Collins’ and Porras’ framework to cast a “Launch Vision” specific to your leading asset:

1. Launch Purpose

The launch purpose should be distinct from the core purpose of a company. For instance, Pfizer’s corporate core purpose is to “deliver breakthroughs that change patients’ lives” (Pfizer, 2022). Yet, for their SARS-CoV2 vaccine launch in 2020, Pfizer consistently messaged a more focused launch purpose to “move with the same level of [timely] urgency to safely supply a high-quality vaccine around the world” (Pfizer, 2020). This launch purpose is both more specific, and also directly linked to the unique characteristics and launch environment of the drug itself. Because Pfizer launched a first-to-market vaccine, swift distribution and broad market access were necessary cornerstones of the launch to combat the pandemic.

To align on principles for the launch purpose, executives should consider a number of questions:

  • What did we set out to achieve with this drug during R&D?
  • What makes my drug unique as a product? What is my drug solving that is different?
  • What are the characteristics of the market environment into which our drug is launching?

2. Lofty Launch Goal (LLG)

It is imperative for executives to define what launch success means before fleshing out the commercial strategy. Far too often, leaders across the healthcare industry communicate that their #1 goal in launch is to “maximize revenues” or “maximize profits” when communicating to their commercial organizations and investors. But these goals are fundamentally flawed in that they are not measurable. A commercial team should have the ability to know when it has achieved its goals.

Collins and Porras specifically state that companies should define a “Big, Hairy, Audacious Goal” or BHAG that serves as the 10-year or even 30-year measurable goal for the company. They classify BHAGs into four broad categories: target, common-enemy, role-model, and internal-transformation (James C. Collins, 1996). For drug launch planning, Kx recommends developing a goal or set of goals similar to a BHAG, and typically segments these lofty launch goals (LLGs) into three buckets:

  • Financial:
    • E.g., reach $200M of US revenue by end of Year 2
    • E.g., achieve simple payback before 2025
  • Competitive
    • E.g., become the #2 drug in our indication by Year 3 of launch
    • E.g., knock off Competitor X as the #1 drug company in our target indication
  • Brand
    • E.g., become brand with highest unaided awareness among our target HCPs
    • E.g., become the Apple of our target therapeutic category
    • E.g., introduce the first premium drug to cash-pay market

3. The Vivid Description of Launch Success

The vivid description of launch success should answer the question, “what would the environment around our drug look like if we achieve our goal and fulfill our purpose”? The answer to this question could include anything related to your first drug, but typical elements may include:

  • Market & competitive position
  • Paradigm shifts in provider practices
  • Quality of relationships with prescribers
  • Brand awareness
  • Prescriber reach and conversion
  • Patient quality of life
  • Patient access to your drug

The primary utility of the vivid description is to motivate and inspire the commercial team with something tangible to which they can aspire during the strategic planning phases ahead of launch. Often even more than the LLG, it has the ability to ground the commercial organization in a common, tangible envisioned future of success.

The Launch Purpose (your “north star”) combined with the Lofty Launch Goal and Vivid Description of Success (your “finish line”) together form the holistic Launch Vision to support your commercial and executive teams throughout the pre-launch planning process. With the Launch Vision in place, commercial leadership can pivot to building out the backbone of the first drug launch strategy: the brand plan and ideal operating plan. Read more about our end-to-end launch strategy capabilities in Steps 2 and 3 of this blog series!

How Kx Advisors can support you in building your first drug’s “Launch Vision”

The “Launch Vision” stage of first drug launch planning is typically executed internally by commercial and executive leadership. However, Kx Advisors’ pharmaceutical launch excellence team supports clients during this initial phase by facilitating workshops and discussions with senior leadership, providing relevant in-market and out-of-market insights from decades of launch strategy experience, and much more. To learn more about Kx’s launch planning capabilities, contact Chris at chris.waybill@kxadvisors.com.

Contact Our Team Today

References

Deloitte. (2020, March 26). Key factors to improve drug launches. Retrieved from Deloitte Insights: https://www2.deloitte.com/us/en/insights/industry/life-sciences/successful-drug-launch-strategy.html

James C. Collins, J. I. (1996). INNOVATING TO BRING IMPORTANT NEW THERAPIES TO PATIENTS. Harvard Business Review, 65-77.

Joseph A DiMasi 1, H. G. (2016, March 21). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 1. Retrieved from Policy & Medicine: https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html#:~:text=Developing%20a%20new%20prescription%20medicine,the%20Journal%20of%20Health%20Economics.

Pfizer. (2020, December 02). Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19. Retrieved from Pfizer: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-achieve-first-authorization-world

Pfizer. (2022). INNOVATING TO BRING IMPORTANT NEW THERAPIES TO PATIENTS. Retrieved from Pfizer: https://www.pfizer.com/science/research-development/breakthroughs

Digital Priorities of the C-Suite

Digital Priorities of the C-Suite

How Vertical Solution Providers Can Support Health System Competitiveness  

Since the onset of COVID-19, health system C-Suites’ view of “digital” has rapidly evolved from latest buzzword to cause for concern, then call to action, and ultimately exciting, but existential, imperative. Health system leaders recognize the myriad of new entrants vying to “own” the patient relationship as serious competition. As evaluations continue of the direct-to- consumer, virtual-first options, and omni-channel capabilities offered by big-box stores, leaders are comparing their own internal capabilities and options for next steps. With this emergence of digitally enabled competitive threats, Kx wanted to better understand the prevailing approach(es) of health systems to vendor evaluation and solutioning. We recently conducted in-depth interviews with CIOs, CMIOs, and Digital Strategy executives from some of the nation’s most progressive enterprises. Compilation of our findings revealed a nearly unanimous perception of opportunities and boundaries regarding horizontal vs. vertical options in healthcare digital technology.

Environmental Shifts

Almost overnight, the pandemic shifted consumers’ ideas about digital experience in healthcare. Consumers now expect convenient, personalized, tech enabled care, and providers must adapt their processes, adopt new tools, and transform their mindset to more closely mirror other industries that focus on the consumer. With nearly $30B in U.S. venture capital funding introduced in 20211, upstarts, larger solution providers, and Big Tech (e.g., Microsoft, Google, Amazon, Apple) are all well-capitalized and rapidly mobilizing to introduce consumer-friendly tools and capture market share.   The proliferation of both vertical solutions and horizontal (Big Tech) offerings is prompting health system buyers to commit to a vision of their digital transformation end-state and whom they will partner with along the way. There’s broad acknowledgment of the imperative to pursue digital strategies that progress the quality and efficiency of care and strengthen their connection with the patient beyond and in between each episode of care. Nothing less than convenient, consumer-friendly experiences will suffice in our digitally saturated post-pandemic world. Given these requirements – which match so closely to some of Big Tech’s core competencies – Big Tech seems like the obvious answer. However, despite the variety of foundational capabilities that Big Tech brings to the health system enterprise, we uncovered a tech partnership “line in the sand” in the minds of health system leaders.  

Necessity of Specificity   

Apart from Microsoft (due to the Nuance acquisition), our conversations found that health systems leaders generally preferred vertical vendors over horizontal technology providers for impact areas such as the EHR, clinical workflows and patient engagement. The lack of explicit enterprise strategy from Big Tech in healthcare is a significant detractor, characterized by one health system leader as “[the company] floating around like a rudderless ship, with no commitment, support, or strategy around healthcare.” Other reasons include the overall lack of expertise, the perception of healthcare opportunities as potentially lower-margin than other industries, and likely pushback from EHRs to interact with Big Tech solutions.  Even so, horizonal tech players remain a contender in the areas where they lead across industries. The key drivers of health systems considering a Big Tech purchase or co-development partnership include the following:   

  • Proven and well-regarded cloud infrastructure and data migration capabilities from Amazon and Microsoft that are trusted in regulated industries (Google’s solution in this space is negatively perceived across the provider market) 
  • Stated interest and initial positive results from Amazon, Microsoft, and Google to create the necessary data ecosystems for developing and running analytics, and deriving actionable insights to support the delivery of efficient, high-quality care  
  • Broad success in the consumer wearables market (Apple’s Watch, Google’s FitBit) and the acknowledgement that patient-generated data will become more relevant and useful over time   

Implications for Vertical Players  

This conclusion from health system enterprise decision makers – that vertical solution vendors are better positioned than horizontal tech players to support their digital transformation initiatives – is good news for Digital Health companies but comes with caveats.  An academic medical center CMIO stated “there are plenty of interesting startups that offer more intricate solutions, but they may go out of business and leave us without a solution.”  Despite the risk factors, digital health solutions are instrumental, highly visible components of health systems’ enterprise strategies and are typically considered on a different plane than Big Tech.  To capitalize on the positives and mitigate some of those negative considerations, digital health companies can understand and prepare for expectations that health systems have of them, including:  

  • Configuration Flexibility: Flexibility and willingness to configure the solution to meet unique health system needs  
  • Security Commitment: Readily available security documentation and a willingness to meet enterprise-specific security and compliance requirements 
  • Clear ROI Story: A competitive pricing model and the ability to speak to both near-term and downstream ROI implications of the product (including being able to “sell” this storyline to a variety of health system stakeholders – clinical, IT, Finance, etc.) 
  • Understanding of Competitive Implications: A thoughtful analysis of the health system’s competitive landscape and perceived advantages gained via user adoption of the solution 
  • Credible Implementation Plan: A thorough implementation plan that forecasts a reasonable timeline, strategies for end-user change management support, and EHR integration plans  
  • Team-wide Subject Matter Expertise: Consistent exhibition of deep expertise in the subject matter addressed by the solution – credentialing and reinforcing trust in the solution’s capabilities throughout the sales, implementation, and stabilization cycles 
  • Ability to Measure Impact: A plan to show impact through easily digestible, configurable, self-service reports accessible upon go-live 

Our interviews concluded that as long as vertical vendors continue satisfying the true needs of health systems, health system leaders will continue preferring to partner with vertical solution vendors. Keeping pace with morphing buzzwords and emerging external threats are daily challenges faced by every health system C-Suite. By reliably performing as expected, vertical solution vendors will maintain their preferred status with health systems, simplify aspects of each organization’s digital transformation journey, and support the overall goals of the health system business.  

How Kx Can Help You  

Kx Advisors’ Digital Health and Health IT team partners with digital health solutions companies so they can outshine the competition, delight their customers and end users, and maximize their growth potential. Ready to start winning against your competition and achieving your growth goals? Contact Rachael at rachael.england@kxadvisors.com to learn more. 

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Six Considerations to Evolve Your Capital Equipment Pricing Strategy

Six Considerations to Evolve Your Capital Equipment Pricing Strategy  

Capital Equipment Pricing Models  

As the world of capital equipment changes rapidly, manufacturers must find innovative ways to stay competitive. With new technology and enhancements, such as software upgrades and digital and connectivity solutions, as a crucial part of the value proposition of capital equipment, manufacturers can offer alternative pricing solutions to provide greater customer customization. Flexible pricing is especially pertinent for highervalue equipment on the market, such as AI-assisted imaging equipment, roboticallyassisted surgical equipment, and advanced monitoring equipment. With the shift in procedures from hospitals to smaller office-based labs and ambulatory surgical centers, manufacturers can also capture new business opportunities with these alternative models.  

New Pricing Models for Capital Equipment  

The traditional pricing models offered three options: an upfront purchase with each component sold separately, a consumable upcharge model, or a leasing model. A combination of new technology and more customized pricing improves a manufacturer’s value proposition. With new pricing models, manufacturers can boost revenues, increase penetration, and build long-term relationships with clients by offering greater flexibility.  

These new models include:   

  • Risk-based or outcomes-based model: Risk-sharing pricing strategies factor in a cost savings component from any operational efficiencies gained and clinical outcomes achieved in this model 
  • Recurring revenue stream model: Instead of the traditional transfer of ownership model, manufacturers offer a subscription with a recurring fee. The purchaser or user is granted access to a set number of capital equipment devices for the subscription period. This fee may or may not include unlimited usage in the number of consumables 
  • Patient usage pricing model: Based on patient usage, manufacturers can offer a per-patient fee for the equipment over a period of time with this model 
  • Enterpriselevel model: This model bundles the customers capital equipment needs across entire care units and multiple hospitals within the network. The bundle would normally include both equipment and services components. Payment schedules could be yearly or bi-yearly

Six Considerations for Identifying the Right Pricing Model  

With so many pricing models emerging, it can be challenging to identify the right one for your product offerings. As your organization moves towards a new pricing model, like the ones above, there are six key considerations to keep in mind to identify the most effective model for your team: 

  1. Set clear objectives: With an identified goal, your organization can better evaluate the potential models. Objectives can include increasing revenue, expanding the adoption rate, smoothing revenue, maximizing profit, and expanding account use of a suite of products and services. For example, if a manufacturer’s goal is to increase the use of a full suite of products, the recurring revenue stream model may be a better fit for their goal 
  2. Identify the value drivers of your product:  Drivers, such as clinical efficacy, payment model, ROI, and the strength of existing relationships, impact pricing and the manufacturer’s ability to customize the pricing model  
  3. Determine the decision-maker: Sometimes the end-user who makes the purchase decision is different from the purchaser who chooses the pricing model. Broadly, there are three types of capital equipment buyers: economic, clinical, and operational. The economic buyer’s sole focus is to improve their organization’s profit. In contrast, the clinical buyer is more focused on the clinical value of the product offerings, like patient outcomes or improved patient experienceOperational buyers typically focus on other factors such as department workflow, device integration with key clinical systems, or maintenance and uptime. Knowing the levels of influence and priorities for each buyer type will help determines which pricing model to offerIf the buying decision is more committee-basedthe pricing model will need to consider all stakeholder needs  
  4. Consider the impact on clients’ budgets: Pricing structure might impact where a client categorizes a purchase (i.e., capital expenses or operational expenses). Often capital expenses will fall under the hospital’s capital budget while operational expenses fall under the department’s budget, which may sway some clinicians towards a capital expense model  
  5. Understand clients’ financial health: Innovative recurring pricing models might be a better fit for clients working under capital restraints. This consideration is crucial overseas, especially in countries where COVID-19 has ravaged hospitals, which would seek to reduce the upfront cost of purchasing capital equipment  
  6. Establish benchmarking metrics: This consideration is the most important for risk-based or outcomes-based pricing, as identifying the equipment’s impact on patient outcomes or operational efficiencies dictates price. These metrics could include hospital readmission rates or the number of adverse events related to the equipment. When determining these benchmarks manufacturers must ensure they are measurable and that clients have the right infrastructure system in place to measure them 

How Kx Can Help You  

With our expertise in pricing strategy, Kx Advisors can guide your team through developing an optimized capital equipment business model. Our team of healthcare experts will help you evaluate your base, identify your customer segments, effectively appeal to your ideal customer, and position your organization for long-term success.  

Contact Our Team Today

Using Your Product Launch Forecast as a Strategic Tool

Using Your Product Launch Forecast as a Strategic Tool 

Forecasting as a Decision-Making Tool

Too often, commercial planning teams approach revenue forecasting as a required financial exercise rather than a strategic planning activity. The highest performing teams, however, develop revenue models to drive decision-making and reinforce strategy. The forecasting process – designing the model, understanding the demand funnel, gathering insights, aligning on assumptions, and analyzing results – can drive decisions and deliver more value than the output itself. Elevating a revenue forecast to a powerful decision-making tool requires careful planning and thoughtful design considerations.

Crafting Your Product Launch Forecast to Inform Strategy

While revenue models are commonly designed to inform resource allocation, investor communications, or inventory planning, the most robust and accurate models are also designed to inform commercial strategy.  With the correct design considerations, your commercial planning team can learn more about the patient segments driving forecast value, identify opportunities in the patient journey to drive product adoption, and pinpoint the investments needed to drive share. Further, the most effective models consider multiple scenarios to plan for key unknowns.

Unfortunately, many project teams jump into forecasting with unclear objectives, insufficient data sources, or too many scenarios, and ultimately fail to develop a useful decision-making tool. Your team can avoid common modeling pitfalls by following best practices in three critical planning steps:

  1. Create the decision-making framework  
  2. Find the applicable data for the model   
  3. Define the scenarios    

Create the Decision-making Framework

The first step of any model should be aligning on the end goals (i.e., defining the decisions model will inform).  An end goal could be, for example, determining the focus and magnitude of commercial investments, evaluating strategic options in the face of a new market force, or determining supply need for a quarterly production plan. After identifying the overarching question(s), your team can determine how to approach the model.  

Your team can use the end goal to decide on the type of model. The type of model, from market share model to launch planning to production demand, determines the model’s specificity. Analyzing the structure before gathering data to ensure the model aligns with the end goal will save your team time and effort.  For example, is an annual model sufficient to calculate net revenue, or does the organization need monthly/weekly sales granularity to inform production planning? Is there a need (and reliable data) to support international country-level forecasts, or would a regional forecast be more accurate and equally actionable? Once you understand the key questions the model is answering, the desired output, and the aligned model type, your team will have the clarity to move to the next step: finding the data.     

Find the Applicable Data for the Model    

First, your team should identify and classify relevant data sources about your product and market, such as epidemiology studies, claims data sets, qualitative interviews, quantitative surveys, historical product sales, and competitor sales, among others, for input. Forecasting teams should take a “best source” approach –evaluating every assumption individually for the highest confidence source. Without pinpointing potential knowledge gaps, models can provide incorrect or incomplete information, impacting the outputs of the model, and ultimately, the launch’s success.  

If the data does not exist in the public domain or within research resources, it can often be collected. Kx specializes in designing and executing market research with key stakeholders (e.g., providers, patients, and payers) to inform quantitative forecasts.   When designing primary market research, it is important to start with the model structure and work backward to design the research to fit the model. Designing for the model’s purpose will lead to a more accurate forecast. Finally, research should be designed to enable a “living, breathing” forecast. Research approaches such as choice-based conjoint surveys can allow forecasters to simulate new market conditions as they arise and update key assumptions without conducting additional market research. 

Define the Scenarios  

After outlining the criteria for the data, the next step is to determine which scenarios need to be analyzed. Often teams will initially attempt to investigate and list all possible options, but if the model becomes too complex, it will lose its effectiveness. Instead, the best practice is to define a base case or most likely scenario. A base case typically uses a consensus estimate or confidence-based weighting along key assumptions to drive forecast outputs. Once your team identifies the most likely scenario, define the parameters you want to test. Identifying priorities and areas of uncertainty will help determine which scenarios to test. For example, breadth of market access or coverage, varying price points, the impact of future clinical study outcomes on adoption, and changes to competitor mix are some of the most frequently explored scenarios.  

How Kx Can Help With Your Product Launch Forecast

Over the last four decades, our team has developed proven modeling and forecasting approaches that produce accurate, insightful outputs and drive strategic decision making. Our team acts as strategic partners to help guide you through the entire process, including developing the product launch forecast, gathering the underlying data and insights, aligning internal stakeholders, and ultimately preparing the model for you to run.  

 

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How Understanding Cognitive Bias Can Drive Patient Volumes

How Understanding Cognitive Bias Can Drive Patient Volumes

Understanding Patient and Healthcare Provider Behavior 

We all strive to make rational choices. But as humans, we are prone to bias and misjudgment. In the medical field, cognitive biases can have a profound impact on both patients and healthcare providers. Kx frequently conducts studies to uncover cognitive biases in referral pathways, including specialist referrals for more advanced therapies or interventions.

By pinpointing these biases, our team helps specialty drug and medical device clients focus their marketing and education efforts and increase market penetration within their eligible patient population. 

Common Dilemmas

Often specialists do not refer patients for treatment quickly enough or at all. These delays in or lack of treatment not only allow the patient’s condition to deteriorate, but also prevent the drug and device companies from fully reaching their addressable patient population. In our recent studies, Kx found that cognitive biases exist at each stage of the referral process.

Cognitive bias map of specialist referral pathway
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The Kx Solution

When guiding healthcare organizations by improving their specialist referral pathway, the Kx team runs an in-depth qualitative analysis speaking with specialists to understand critical attitudes, behaviors, and beliefs across the population of relevant doctors. Key differences within demographic segments (e.g., age, specialty, practice type) and behavioral segments (e.g., willingness to refer, referral choice) help identify drivers of attitudes and potential solutions for changing these behaviors. 

Uncovering Cognitive Bias to Reach the Addressable Patient Population  

Kx developed the following key findings to drive the patients through the specialist referral pathway:

  1. Awareness that symptom recognition is often the most significant barrier in the referral process and education to combat the issue. Early in the referral process, during the diagnosis phase, cognitive biases result in the specialist not probing consistently, missing symptoms by not asking the right questions, or simply not asking enough clarifying questions. Incorrectly identifying patients’ health status based on outward appearance or insufficiently probing symptoms can result in critical underdiagnoses or undertreatment.
  2. A clear path to referral, particularly one with a singular point of contact, can help referring physicians feel more at ease. Successful drug and device companies reduce friction in referral pathways by helping referring physicians establish clear points of contact across hospitals, specialists, and surgical teams. Elucidating a single point of contact cuts down on ambiguity and removes an obstacle for referring providers.
  3. Direct relationships between the referring specialists and the treatment teams (surgery team) build comfort and encourage referrals.
  4. When creating tools for doctors, simplicity and ease of use are key factors. Biases exist among doctors to simplify complex thought processes. Though tools, like decision guides for complex cases, can be extremely beneficial, they must be simple and easy to understand and use to overcome biases and help physicians better identify which patients need further treatment.

How Kx Can Help

Our healthcare experts can guide you by adjusting various aspects of our corporate strategy, including your referral pathway, with insights from market research. Cognitive bias is built into our research methodology, enabling your team to overcome any we find and fulfill more referrals. As data-driven decision-makers, we design research using both traditional factors and behavioral science to pinpoint process improvement and qualitative analysis opportunities. 

 

Contact Our Team Today

Kx’s Four-Step Customer Segmentation Process

Kx’s Four-Step Customer Segmentation Process

How To Level Up Your Customer Segmentation Strategy: Behavioral Segmentation  

Kxcustomer segmentation delves deeper than any traditional segmentation by looking at underlying behavioral and attitudinal factors that can replace the standard identifiers. Your team can improve your process by expanding on the factors you include in your segmentation beyond demographics and traditional commercial indicators. Below are some of the behavioral segmentation variables your team can include: 

  • Attitudes: These variables influence customers’ perception of products and their receptiveness to trying out a new product 
  • Roles and  level of influence: Customers’ roles can impact drivers of purchase or use, and prioritizations of these drivers, based on different roles/responsibilities and experiences of the user/purchasers   
  • Experience and situational context: Analyzing these factors can showcase different unmet needs based on the type of user and provide context into what healthcare companies can do to drive increased adoption/purchase

Customer Segmentation Graphic

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Developing Customer Segments With Sales Teams In Mind 

While customer segments are a vital marketing tool, focusing on behavioral segmentation allows your sales team to provide a more personalized experience. Throughout this process, marketing teams must ensure that each segment is:  

  • Specificthe segments are mutually exclusive and collectively exhaustive, and each customer can only fit in one segment  
  • Meaningfulapparent differences exist among segments, and these differences are significant drivers of behavior and preferences  
  • Actionable: markers for different segments support easy identification and targeting for therapy development teams  

Creating digestible segments specifically for the sales funnel empowers the sales team to better secure business. 

KxFourStep Approach For Segment Profiles 

Our experts uniquely leverage these variables to identify accounts that give the biggest share of wallet. Kx conducts the segmentation through three steps: 

  1. Determine segmentation goals: Kx works with organizations on clarifying their goals and mapping their segments to match these goals, including identifying the segments that are most likely to drive profit and have the most significant lifetime value  
  2. Identify the markers for distinct segments : Defining key demographics is critical for the success of the segmentation process as it dictates the approach of any go-to-market strategy. Our experts start with traditional indicators and slowly work through the in-depth behavioral indicators, identifying the deep and nuanced permutations within the target base
  3. Develop and quantify segment profiles or archetypes: When Kx works with organizations on customer segmentation, our team builds out the different segment profiles, or archetypes of customers. Our team performs in-depth qualitative research to understand the drivers of high product affinity within each segment, giving your sales team insights they need to message to their targets effectively. After setting the boundaries, quantifying each segment’s size allows your team to gauge which segments are the highest value for your team, and provide the most significangrowth opportunities. To do so, we conduct quant research and K-clustering to identify combinations of variables that statistically show segments 
  4. Implementation: Perhaps the most challenging aspect of the implementation process is where the tie between marketing and sales matters most. The cardinal implementation rule for marketing teams is that all archetypes rolled out must be unique. With that in mind, the fewer archetypes, the better the sales team’s result as they can customize their approach and connect more effectively with their targetsOur team is skilled at designing tailored strategies for implementation and can support your team through the procedure 

How Kx Can Help 

With product planning and launch strategyexpertise, Kx Advisors can guide your team through customer segmentation and targeting. Our team of healthcare experts will help you evaluate your baseidentify your customer segments, effectively appeal to your ideal customer, and position your organization for long-term success.  

Contact Our Team Today

Why Your Orphan Drug Needs A Global Market Access Strategy

Why Your Orphan Drug Needs A Global Market Access Strategy

Key Takeaways

  • An effective global market access strategy for rare diseases requires a higher degree of regional customization compared to other launch prep activities
  • While regulatory approval in first-tier US and EU markets can often translate on a global scale, as many local regulatory bodies look to FDA or EMA approval as the gold standard, local market access requirements vary significantly
  • This variation includes, among other factors:
    • Price referencing
    • Health technology assessments
    • Public vs. private payer dynamics
    • Rebates and discounts
    • Reimbursement restrictions (e.g., step-through requirements)
    • Real-world-evidence-based payment models
  • Companies must be ready to develop individual market strategies to address these country-specific challenges

Why You Need A Global Market Access Strategy

Each country poses unique challenges in developing a rare disease market access strategy. While some areas face a scattered patient population, others may face challenges such as immature physician and patient advocacy networks. Additionally, the high cost of certain drugs, like gene therapies, are handled differently by different countries. These nuances in market behaviors and structure underlie the importance of looking across the global landscape when developing a market access strategy. For US-based pharma companies, developing a comprehensive market access plan, rather than simply pivoting off a US-focused market access strategy, will ensure the long-term launch plan meets global needs and is positioned for success.

World Map Showing Why Companies Need Global Strategy

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How To Develop A Global Market Strategy

Rare disease companies need to answer complex key questions:

  1. Which markets will be targeted for launch?
  2. How much compromise in pricing is possible to gain access in global markets, particularly given reference pricing?
  3. What evidence is available or will be developed to support global market access?­

The first step in entering a market is to identify which markets offer a path to reimbursement with sufficient pricing potential. The next step is assessing your pricing flexibility, as offering a lower price than in the US or even the EU5 can increase the likelihood of reimbursement in key OUS markets. When making these assessments, identifying patient access schemes, such as named patient supply (NPS), can validate and drive demand. Once an orphan drug gains regulatory approval, companies must be prepared to work with stakeholders, such as patient advocacy groups and KOLs, to demonstrate need for the orphan drug, clinical and cost effectiveness, and drive favorable reimbursement decisions. These stakeholders are pivotal in some markets, ensuring that patients can get treatments at affordable costs throughout the duration of their treatment. As an example, in Brazil, patient advocacy groups work closely with patients to navigate court systems that enable patients to make a legislative case for drug access and coverage before national approval, including for orphan drugs (see more below). 

Rare Disease Brazil Case Study

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External Reference Pricing

External reference pricing adds significant complexity to global market access strategy as the application of referencing varies greatly among countries, including:

  • Product Applicability: categories of products for which referencing is applied, including referencing only for drugs in a specific care setting (e.g., inpatient hospital), innovative medicines for which there is no alternative available on the market, or high-cost medicines
  • Basket Composition: both the total number and specific countries selected to include in the reference basket (typically selected based on comparable GDP per capita)
  • Calculation Method: use of either an average price or selection of the lowest price of basket countries
  • Decision Process: whether used as the main systematic criterion (most common) or as supportive information only when setting a drug price
  • Re-evaluation: pricing must be re-evaluated frequently after initial price is set

In Europe, the vast majority of countries use some form of reference pricing. With reference pricing, there is increased pricing interdependence between countries. Given the high prices of orphan drugs, it is critical for rare disease companies to develop a launch sequencing strategy that factors in price referencing. This could include strategically launching first in high-priced countries without reference pricing, then focusing on lower-priced countries.

Real-World Evidence

RWE is gaining momentum globally as real-world data (RWD) sources become available—specifically electronic health records and claims data that provide a basis for evaluating outcomes. New treatment costs remain high for rare diseases, putting pressure on pharma and biotech companies to demonstrate results for premium pricing with payers. Gene therapies are especially costly due to their complexity, making RWE an ideal tool. A prime example is the AveXis-Novartis approach to payer contracting with Zolgensma, a one-time gene therapy treatment that replaces lifetime chronic therapy for patients with spinal muscular atrophy Type 1, and which launched in the US in June 2019. Gene therapies are breaking pricing norms since manufacturers are only able to generate revenue from “one-shot” treatment for each patient, and Zolgensma made waves with a US price point of $2.1M per patient—the most expensive treatment on the market as of this writing. Novartis worked with payers to establish efficacy-based reimbursement and a 5-year installment payment option to spread payment for treatment over time. With these arrangements, risk is lower for payers, who can pay $425K annually for five years and better justify a patient switch from Biogen’s Spinraza, a chronic treatment estimated to cost $4M+ over a 10-year period. Zolgensma won coverage for 90% of US commercial patients within its first full quarter on the market, with all payers taking advantage of value-based contracting; however, initial uptake of the installment-based payment system was limited.  

Similarly, in May of this year, Zolgensma received conditional approval in Europe with the “Day One” access program, which ensures the cost of patients treated before national pricing and reimbursement agreements are in place aligns with the value-based prices negotiated following clinical and economic assessments. Working within the existing pricing and local reimbursement frameworks, the “Day One” access program for EU governments and reimbursement agencies allows the company to tackle entry into markets faster and with more flexibility. This system sets up a win for each stakeholder: the patient, the health and reimbursement bodies, and AveXis-Novartis. With the Temporary Authorization for Use (ATU) program, it became immediately accessible in France and should be available in Germany shortly. 

Coverage for therapies like Zolgensma remains dependent on demonstrating values, so companies must leverage proof of value when looking to capture new patient markets. RWE and patient-reported outcomes (PROs) provide stakeholders with concrete data to inform formulary addition and clinical trial outcome endpoints.

Case Study USA

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Moving Forward

An effective global market access strategy for orphan drugs must be adaptable to different regions and their unique challenges to be effective. As companies work through the key questions outlined above to create a successful global market access strategy, tools like RWE and external reference pricing can support tackling a large range of location-specific issues.

How Kx Can Help

Our experts evaluate business opportunities, deliver top-notch expertise, and make data-driven recommendations to our healthcare clients. Kx Advisors can guide your organization through the process of developing and implementing a global market access strategy for your rare disease drug.

Contact Our Team Today

Sources

https://www.pacificbridgemedical.com/wp-content/uploads/2014/03/Orphan-Drugs-in-Asia-2017.pdf

http://info.evaluategroup.com/rs/evaluatepharmaltd/images/2014OD.pdf

https://www.europeanpharmaceuticalreview.com/article/62846/orphan-drugs-regulation-eu/

https://ec.europa.eu/health/sites/health/files/files/committee/stamp/2015-05_stamp2/5.pdf

https://www.eurordis.org/training-health-technology-assessment

https://www.rtihs.org/sites/default/files/Rare%20Disease%20Webinar%20Slides_Final%20Feb%2027.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4802694/

https://www.biospace.com/article/releases/avexis-announces-innovative-zolgensma-gene-therapy-access-programs-for-us-payers-and-families/

https://www.fiercepharma.com/pharma/novartis-zolgensma-beats-data-woe-payer-resistance-strong-and-high-interest-ceo

https://www.globenewswire.com/news-release/2020/05/19/2035354/0/en/AveXis-receives-EC-approval-and-activates-Day-One-access-program-for-Zolgensma-the-only-gene-therapy-for-spinal-muscular-atrophy-SMA.html

https://mapbiopharma.com/home/2020/04/landmark-pay-for-performance-contract-agreed-in-germany/

How Medical Practices Can Keep Patients Safe: COVID-19 Best Strategies

How Medical Practices Can Keep Patients Safe: COVID-19 Best Strategies

As medical practices reopen to pent-up demand, they must adjust the patient experience to protect both patients and staff from COVID-19. Kx Advisors surveyed one hundred aesthetic physicians across the US to understand the obstacles they face in each step of the patient experience, analyzing the extent of COVID-19’s impact. Building on guidance from the CDC, our experts compiled best practices from these physicians on how they are addressing these pain points. These COVID-19 best strategies aren’t exclusive to aesthetic practices; many can be applied to other clinics and provider practice settings.

COVID-19 Best Strategies For Medical Practices

Map Showing COVID-19 Best Strategies For Medical Practices Pain Points and Solutions

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Waves of COVID-19 restrictions

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Applying These Prevention Methods  

Our experts compiled these strategies into four main prevention methods that practices can use:

  • Reduced time: Practices can limit the time patients spend in the practice, reducing the risk of COVID-19 spread
  • Reduced carrier density: Practices can space out appointments, space out waiting room chairs, and eliminate physical check-out to reduce density in the practice
  • Transmission prevention equipment: With PPE for both physicians and patients, medical practices can keep staff and patients safe
  • Adapted infrastructure: Using an online scheduling program, installing plexiglass at check-in, asking patients to wait in their cars, and leveraging telemedicine can reduce additional risk

Practices also shared suggestions to industry partners on how companies can support them during this reopening period.  Top items included product pricing adjustments, expired product replacement, marketing support, limited rep office visits, and help with product-specific guidelines for safe administration. Companies that serve medical practices can adjust their strategy to align with the above guidance and better support their clients.

How Kx Can Help

Kx Advisors is continuing to evaluate business models, deliver top-notch expertise, and make profitable recommendations to our healthcare clients. Our team of experts can help your organization assess how you can best support your aesthetic clients and adapt your  corporate strategy to position you for long-term success.

Contact Our Team Today

How Does COVID-19 Change Clinical Pipeline Prioritization?

How Does COVID-19 Change Clinical Pipeline Prioritization?

Gauging The Impact Of COVID-19 For Your Organization

The healthcare industry faces specific hurdles, resulting in reduced physician-patient interactions and lower procedure volume. Pharmaceutical and medical device organizations face several unique barriers as COVID-19 persists, highlighting the potential need to adjust strategic planning for both new and existing products. One of those barriers is the disruption to clinical study timelines, including delayed initiation of new studies and challenges to completing ongoing studies safely and efficiently. Depending on the severity of a delay or obstacles to initiation, certain programs may need to be deprioritized. Corporate leaders, clinical development decision-makers, and new product teams must consider what the new normal may look like and assess their pipelines, adapting their plans accordingly.  

Analyzing COVID-19 Challenges

We see pipeline prioritization as an iterative process that is necessary to maximize growth potential and manage risks for all biopharma and medical device companies. COVID-19 poses several disparate challenges for clinical companies as they adjust estimates for development costs, timing, risk tolerance, and strategic priorities within their pipelines:

  • The changes made in response to COVID-19 may have a long-lasting impact: Healthcare provider closures and a rise in telemedicine may foreshadow future patterns. Oral treatments for severe conditions are seeing strong adherence and higher-quantity refills to minimize person-to-person contact. However, we anticipate a slowdown for recently launched products and potential discontinuations for therapies that require regular physician office or hospital visits for administration or dose titrations
  • External funding hurdles may emerge: External continued pipeline financing advancement exists, but pre-revenue companies will continue to experience an increased pressure to showcase their unique capabilities in a competitive market. Clinical organizations will need to show that their innovative treatments can attain clinical trial results in a socially-distant era
  • Ongoing clinical trial challenges will persist: Both small and large biotech companies are experiencing clinical trial disruptions, as new risks to patient and provider safety have emerged.  These disruptions include trial site closures, increased safety precautions for patients, delayed assessments, and supply shortages. Additionally, Institutional Review Boards may be unable or unwilling to review new protocols or amendments, halting further clinical progress

Pipeline Prioritization During COVID-19

As we continue to monitor the lasting impact of COVID-19, strategy, clinical development, and new product teams must analyze and monitor these hurdles and their effect on business:

  • Analyze the magnitude of impact on your unique organization: How these considerations fit together internally and within the competitive landscape is unique to each organization – for larger organizations, incremental timeline extensions and associated costs will be manageable, while small biotech companies may be at risk of missing milestones to generate data to support follow-on fundraising. This analysis provides a foundation to segment your pipeline
  • Rethink your timeline and identify potential program tradeoffs: Re-examine your path to launch based on newly emergent clinical development hurdles and their impact on your business. Teams should also assess what program tradeoffs can be made regarding project timelines and costs. Additionally, organizations should consider the extent to which current and planned programs are adaptable to this disrupted environment through remote monitoring, data collection, and investigational drug management
  • Revisit Net Present Value (NPV) inputs for development costs and commercial opportunities: The attributes most desirable in a clinical development program under normal circumstances are primarily associated with our lower impact category. Still, changes on the margin may impact overall forecasting of clinical development costs and peak commercial opportunities and must be considered

Kx Advisors Is Here For You

With biopharma expertise and corporate strategy experience, Kx Advisors can guide you through the impacts of the pandemic. Our team of healthcare experts will help you evaluate your pipeline, revise critical timelines, assess tradeoff decisions, and identify new ways to take advantage of new opportunities within the fluid global landscape.

Contact Our Team Today