Kx Advisors Spotlight: Jenna Riffell

Kx Advisors Spotlight: Jenna Riffell

The Journey from Patient to Healthcare Thought Leader

Some people find their interest in healthcare and science by reading books or watching documentaries. Dr. Jenna Riffell, Kx Vice President, had a hands-on experience that sparked her passion. At fourteen, doctors discovered that she had a detached retina—a medical condition that is rare in young people and can lead to blindness. She was immediately attracted to the complexities of healthcare and the impact it can have on patients’ lives.

She studied Chemistry and Biochemistry at the University of British Columbia, graduating with combined honors. Jenna continued on to earn a PhD in Biochemistry and Molecular Biology, with a focus on cancer drug development. In Jenna’s postdoctoral fellowship, she partnered with a pharma company at the Institute of Cancer Research and the Royal Marsden Hospital. There, Jenna developed an interest in translating research innovation into patient care.

Transitioning to Healthcare Growth Strategy with Kx

As a natural problem-solver with a knack for strategy, consulting was a strong fit for Jenna. When asked why she joined Kx, Jenna says, “working at a boutique consulting firm allows me to see the impact I make, both for my clients and internally. Contributing to my clients’ successes is what makes me most excited to come to work each day.” Additionally, Kx utilizes her project management skills and scientific background, especially her expertise in experimental data and drug development. Jenna brings her expertise to both client work and thought leadership, including Kx’s annual Hot Indications paper focused on pharma R&D trends. Jenna’s creativity, analytical rigor, and communication skills make her an enormously valued employee and partner for our clients.

As a leader of the transatlantic team, Jenna emphasizes the impact of Kx’s culture, both in London and virtually. She mentions that one of the best things about Kx is that “working with such a close-knit team that challenges me and encourages me to deliver my best.” She currently enjoys seeing more of her international colleagues’ faces on video in 2020 and spending more of her downtime practicing classical piano.

Interested In Healthcare Consulting?

Jenna encourages fellow academics interested in consulting to be prepared for a learning curve. As she transitioned into the field, Kx’s value on individual contributions empowered Jenna to share her innovative ideas. Jenna enjoys the entrepreneurial spirit fostered by Kx and the ability to make a difference in our clients’ healthcare projects. Have questions about our work? Get in touch with us at info@kxadvisors.com.

 

Kx Advisors Spotlight: Dr. Sam Eaton

Kx Advisors Spotlight: Dr. Sam Eaton

Finding Answers To Big Questions  

Dr. Sam Eaton, Kx Senior Consultant, is a problem solver by nature. His drive to find answers drew him to academia and to earn a PhD in Cardiovascular Pharmacology at the University of North Carolina During his doctoral studies Sam immersed himself in understanding orphan drugs and the business supporting them. In the process, he uncovered his passion for combining his scientific expertise with business strategy. Sam joined Kx Advisors after graduation to continue finding answers to tough problems.  

Transitioning From Academia To Consulting   

When asked, “Why Kx?” Sam answered: “I knew working at Kx would allow me to utilize my scientific background while growing as a business leader.” Sam immediately found that he enjoyed the range of challenging and interesting projects, as well as Kx’s willingness to leverage his clinical background. He felt Kx’s culture was a critical factor in transitioning from academics, crediting Kx’s small project teams for the collaborative environment that empowers employees to make a positive impact for clients. Sam has established himself as a top performer with Kx leadership by delivering first-class client service and acting as a mentor to junior staff.   

Being a Senior Consultant isn’t the only way Sam creates a positive impact. During grad school, he volunteered at a zoo where he worked with giraffes and rhinos, and fostered dogs for a Labrador rescue. He now enjoys playing tennis, playing fetch with his own rescue dog, and spending time with loved ones during his downtime.

Interested In Healthcare Consulting? 

While the shift from academics to business can be challenging, Sam encourages doctoral candidates to look for employers that offer strong mentorship. As a pillar of the team, Sam‘s most substantial contributions are his strong scientific expertise and leadership skills. Have questions about our work? Get in touch with us at info@kxadvisors.com.

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

Elective Procedures After COVID-19: How To Support Rebounding Demand

Elective Procedures After COVID-19: How To Support Rebounding Demand

Due to COVID-19, pharmaceutical and medical device organizations face unprecedented obstacles, impacting product forecasting, pipelines, and overall corporate strategy. One major business challenge created by this pandemic is the policy-driven limitation on elective procedures, resulting in restricted healthcare provider (HCP) accessibility for patients.  Approximately 27% of patients experienced an elective procedure delay or cancelation due to COVID-19, according to an April 13th poll of over 2,500 US adults.  

Defining Elective and Essential Procedures  

There is no single definition of elective procedure, and the meaning of the term varies across the globe and from person to person, given how HCPs and patients view the urgency of medical situations. Generally, an elective procedure is recognized as a non-urgent procedure that can be scheduled in advance. The term elective procedure may be associated with non-immediately life-saving procedures; however, examples of necessary elective procedures include cancer surgeries, kidney stone removal, mental health services, and joint replacements.  

The Impact of Pandemic Restrictions   

The impact on individual hospitals and the procedures they perform is dependent on their location, the severity of the pandemic there, and how different regions are managing the epidemic. While some hospitals are fully operational, others have been prioritizing COVID-19 patients and chose, or were legislated, to scale back on elective procedures.  

We are beginning to see a rebound in hospital visits and elective procedures performed in COVID-impacted areas. There is evidence that hospital visit declines in the US may have bottomed out, with a 4% increase in outpatient hospital visits in the second week of April marking the first increase in visit volume since early March. As lockdown measures are relaxed, the re-introduction of elective procedures may take some time. The pandemic has increased anxiety about seeking treatment, keeping patients from going to hospitals. Emergency room visits are down by about 50% across New York City Health and Hospital locations. This fear could take time to subside and impact patient behavior for longer than policy measures restrict procedures.  

The evolution of elective procedures will be region-dependent, as strategies to lift lockdown measures and priorities are decided at a national or regional level. As the pandemic continues and cases decrease, nations are facing the challenging decision of whether to prioritize certain elective procedures, and if so, which elective procedures to bring back first. In the United Kingdom, mental health and cancer surgeries are being prioritized amongst elective procedures. However, as we see demand rise again for specific products or procedures, this resurgence will likely result in a backlog of procedures. This backlog will have a direct impact on other procedures. For example, we may see a surge of cancer surgeries that were delayed by pandemic mitigation measures, resulting in less available operating room space and limited opportunities for other operations.  

Preparing For Procedures Now And Post-COVID-19   

With the rollback of lockdown measures and changes on the horizon for elective procedures, healthcare organizations can support HCPs and patients in new ways. There are several factors procedure-focused companies must consider as they face the pandemic’s challenges now and throughout the global recovery:  

  • Map demand and prepare for the backlog: Companies must monitor changes in government regulations, medical association guidance, and access to personal protective equipment (PPE), as well as analyze the continuing evolution of COVID-19 to determine which products can meet demand in identified places at the correct time. Part of this calculation must include a backlog in regions that begin to allow elective procedures. With this expected backlog of elective procedures, companies must ensure they are ready to support HCPs and patients to ensure a smooth ramp up.  
  • Explore new ways to aid HCPs performing procedures: Crafting specialized product protocols, creating guidance for performing specific procedures more safely, and providing PPE where appropriate can support HCPs as they adapt. HCP accessibility and increased demand could also have implications for field team deployment. While it may now be more appropriate for field teams to actively reach out to HCPs, COVID-19 safety concerns may intensify scrutiny on sales rep involvement in surgeries. Understanding the changing landscape will be key for healthcare companies during this rebound phase. 
  • Devise additional ways to help patients: With the looming fear of exposure to COVID-19 while in care settings for procedures, pharmaceutical and medical device companies can support HCPs’ new protocols to keep patients safe during procedures. From reinforcing safety of minimally invasive procedures in outpatient clinics rather than hospitals, to crafting additional guidelines for keeping medical devices uncontaminated, companies can provide value in new ways.  

How Kx Advisors 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 demand during and after COVID-19 and adapt your  corporate strategy to position you for long-term success.   

 

Contact Our Team Today

Should You Do Market Research During COVID-19?

Should You Do Market Research During COVID-19?

Uncertainty Sparked By COVID-19

As COVID-19 upends daily life and wreaks havoc on the global economy, companies throughout the healthcare industry are adjusting their strategic plans and putting various activities on hold. Healthcare strategy, marketing, and business development leaders are wondering – is now a good time to do market research given the crisis? Should we move forward with market research studies when customers and other stakeholders are preoccupied with their circumstances? With the environment around the world changing so rapidly, will the findings of today be valuable tomorrow?

In most cases, the answer is yes; now is a good time to do market research. Actionable insights backed by research are more critical now than ever before. However, some barriers present challenges and may make certain types of research unfeasible or less attractive. To better understand how COVID-19 may impact your market research efforts, we recommend evaluating three research dimensions:

  • Who: Target Stakeholders
  • What: Insights
  • How: Methodologies

COVID-19’s Impact on Market Research

Who: Target Stakeholders

While many healthcare providers are on the frontlines of COVID-19, some specialists are experiencing procedure cancellations, office closures, or a shift to only treating essential patients. An overall decline in patient volume for many healthcare providers (HCP), especially in outpatient settings, solves a significant challenge that organizations typically face when conducting research – the accessibility of experts. Finding and recruiting quality stakeholders with relevant expertise can be challenging and time-consuming. For HCP studies, those specialists focused on outpatient treatment or inpatient specialists less involved in COVID-19 treatment like surgeons, are ideal candidates for market research due to potential increased availability with declining patient volume. Other stakeholders, including patients, payers, and industry experts, remain ideal stakeholders for upcoming studies as a result of increased availability with stay-at-home mandates. Inpatient providers and administrators treating the virus likely have limited availability to partake in market research, making studies focused on those stakeholders not ideal.

  Target Stakeholders For COVID-19 Market Research

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What: Insights

The goal of your market research is crucial in determining whether it will be successful during this pandemic. Any research focused on understanding and adapting to the epidemic can support your organization in acclimating to the evolving environment and outperforming competitors. Upstream research for products still in development can continue without significant impact, as can research to understand the general market or competitive dynamics. However, insights gleaned from research that is especially sensitive to the pandemic, like financial benchmarking or willingness to pay analysis, may not be applicable beyond this short-term timeframe and should be delayed until the global healthcare landscape settles.  

 COVID-19 Market Research Insights

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How: Methodologies

With stay-at-home orders and other social distancing mandates in place across the globe, organizations should avoid face-to-face methodologies in most instances. Due to these restrictions, virtual-friendly methods are ideal for any market research during this crisis. This could include phone interviews, online surveys, and online focus groups, which specialists are still eager to participate in. These methods tap into the rise of online engagement we are seeing during the pandemic, making recruitment easier for interviews and surveys.

COVID-19 Market Research Methods

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Moving Forward With Market Research

Although COVID-19 has derailed many aspects of our society, your organization can continue with a critical activity: market research. Modifying your strategies to the conditions of the pandemic can allow you to move forward and even collect qualitative and quantitative information more easily.

Kx Advisors, Your Partner in Strategy

Our healthcare experts can guide you through adjusting your strategy with insights gathered from market research. As data-driven decision-makers, we’re experts at designing research to inform quantitative models, developing forecasts in emerging and innovative markets, and quantifying what is challenging to quantify. We can support your organization with market research and turn the results into actionable insights.

 

Contact Our Team Today