The Outsourcing Issue Feature: Part 1

The journey toward patient centricity can be introspective. Trying to solve for improved patient outcomes and improving the overall patient experience requires a top-down review of an organization’s internal drivers. Although the endgame for the industry as a whole is to keep the patient a priori in all situations, a divided supply chain, coupled with all the elements of bringing a drug to market, can make a streamlined focus on patient centricity challenging. There are numerous organizational obstacles to overcome before the patient experience is placed top of mind throughout the value chain. However, an internally motivated patient-centric mindset adopted by every CRO, CDMO and packaging and supply chain player has the ability to positively impact the industry from start to finish. This is especially true if the heads of all organizations consider what their company could be doing differently — and how they can implement these changes for real-world, value-based results. 

Internal Interruption

Speaking to an audience at the annual eyeforpharma event, Jim Robinson, President and COO at Alkermes, explained that the first step to becoming fully patient centric is to measure the company in relation to the patient, ultimately understanding how the organization is positioned.1 For instance, has a company’s branding overwhelmed the patient, even to the point of creating confusion in treatment instruction? “Is the organization’s attention to branding an issue, and does a fixation on promoting the organization get in the way of prioritizing the patient? How can you elevate the patient experience?” mused Robinson at the conference. “Is your organization disconnected from the patient?” he asked further, urging companies to stop taking things like branding for granted. Ultimately, many organizations are focused on “brand-centricity not patient centricity,” he cautioned.

In order to alter the current industry mindset so the patient ultimately benefits, an upheaval in organizational structure and everyday operations is warranted. At the event, Robinson called for a change in the culture of the industry — such that the entire supply chain is interrupted. “When you’re trying to build a collaborative environment and change the culture — and be able to deliver on this — you can’t do it with just the commercial organization or the medical affairs organization, it has to be research, commercial and the medical affairs all pushing together,” noted Robinson.1 Speaking of an “ah-ha” research moment, which made him realize the organization could do better, he called for patient centricity in all facets of production. “Now target product profiles had an urgency to incorporate a patient focus, ensuring anything a patient touched made sense....Getting their input was also critically important, and we got their input by being able to sit down and talk to patients directly about what’s important to them.”1

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Patient Centric at All Phases

To be truly effective, patient centricity must be incorporated into all phases of development. Patient centricity must be integrated into every area and aspect of the supply chain; it must be an all-encompassing system where patient needs come first, and this begins in drug discovery and research. Perhaps the trend in pharmaceuticals most compatible with the new era in patient centricity is precision medicine.2 The idea of tailored treatment reinforces the idea that a patient has been considered from start to finish — and there is no doubt that outcomes will also be improved as medicines become better targeted to meet the individual’s needs. Precision medicine includes some of the most innovative tech taking over the industry, including genomic sequencing, biomarker research, bioinformatics and big data analysis.3 

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Precision medicine is offering the industry tremendous opportunity for more advanced and accurate outcomes; it will also contribute to cost savings. According to a research study that polled top industry executives, conducted by consumer insight firm PwC Strategy& (PwC), there is an almost unanimous push toward precision medicine throughout the industry.4 Of the global pharma leaders surveyed by PwC, 92% responded that they have identified precision medicine as an opportunity, while 84% have already added tackling precision medicine to their corporate agenda.

Precisely Patient Centric

Part of the motivation for applying precision medicine to the initial phases of drug development is the opportunity to cut spending. Respondents indicated a reduction in time-to-market and making R&D processes more efficient as drivers for furthering a precision medicine agenda within their organization or network. According to PwC’s executive summary results, “even a conservative estimate puts the cost savings in drug development at 17 percent, leading to a potential annual savings of US $26 billion for the industry worldwide.”4

In order to alter the current industry mindset so the patient ultimately benefits, an upheaval in organizational structure and everyday operations is warranted.

Poised for Precision Profit

The research and drug discovery sectors, in particular, stand to benefit from the trend toward precision medicine. Respondents identified areas along the value chain, including the identification of new drug targets (53%), improving effectiveness (42%), improved decision making (22%) and efficiency (18%) as advantages in implementing precision medicine early on.4 According to the survey, respondents pointed to the following areas as mechanisms by which precision medicine could improve drug development overall:

  • More accurate identification of new drug targets
  • Greater clarity regarding the target patient profile
  • More targeted clinical trials requiring smaller statistically valid pools of patients, leading to better trial outcomes and faster time-to-market
  • Greater likelihood of regulatory approval
  • More certain reimbursement and adoption of medicines
  • Longer market exclusivity

Over 75% of respondents felt that incorporating precision medicine into R&D would help reduce the average R&D cycle — which can last approximately 10 years — by roughly eight months, and one out of three respondents felt that a full one-year reduction was plausible. Global spending on R&D is about $150 billion worldwide — again, implementing precision medicine effectively could reduce that figure by $26 billion annually, or by $19 billion for the United States, Switzerland and the five largest countries in the European Union, where spending is the highest. Sales would no doubt also experience an upsurge, which is not factored in here.

Real World Value

Bringing patient centricity and R&D together would increase tangible real-world evidence (RWE). As pharma moves to a value-based medicine system, this would pacify payers, stakeholders and government, who are eager for positive results to confirm investment.3,5 Financial reimbursements are inextricably linked to proven RWE that a drug’s outcome is positive, measured through clinical trials.5 However, an emphasis on RWE has also led to a decline in R&D spending — this is because, unless a treatment is known to be beneficial, it is met with risk aversion. This catch-22 could be solved by a patient-centric R&D model with an emphasis on increased RWE in data, which could, in turn, help spur investment in the strained sector.5 As one respondent to the PwC precision medicine study optimistically stated, “Demographics and innovation will lead to intensified cost containment pressure. Precision medicine is one promising way to fundamentally support the value story.”4

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Collaboration is Crucial

A potential opportunity to leverage RWE in trials is through partnerships with tech companies who have been able to scale-up successfully while focusing on customization.3 Leveraging the ability of tech giants, such as Amazon or Google, to identify patients and track their individual needs fits nicely with the goal of precision medicine. Relying on these data-centric organizations might be what is needed to reshape trials and diagnostic testing. For instance, a standardized blood test may be replaced with a more sophisticated diagnostic option that will screen for many abnormalities at once — as opposed to subjecting a patient to numerous tests.3 As Craig Venter, the scientist behind the Celera human genome sequencing endeavor and head of Human Longevity Inc., explains, this will shape our approach to medicine and data, linking them intricately together. “Medicine has been a clinical science, supported by data. Medicine is about to become a data science, supported by clinicians,” he predicted.3

Challenges to Overcome

In spite of the obvious advantages of a transition to precision medicine starting from the earliest phases, there are quite a few barriers to entry to overcome before the tools needed are adapted. For many organization leaders, the lack of knowledge of data analytics has presented a tremendous issue, and they are looking for external partnerships to remedy this.4 To overcome a perceived lack of internal data capabilities, 87% of respondents have opted for “targeted collaborations beyond pharmaceutical firms” as a solution, with 65% looking to external experts to help break down the data. Other barriers to transition include “the uncertain legal and regulatory framework surrounding precision medicine, a limited ability to integrate data sources due to a lack of widely accepted standards and methods, and continuous regulatory oversight with rules that were written for a previous generation of healthcare and data.”

Connecting in Clinical Trials

Perhaps the area where data most stands out in drug development is in relation to clinical trials. The National Cancer Institute and the Centers for Disease Control and Prevention rely on the following 4Ps model, where precision medicine is defined as “evidence based medicine,” as follows:3

  • Predictive: Identifying disease early through greater use of prognostic tests and screening procedures.
  • Preventative: Intercepting the disease rather than tackling it once it becomes symptomatic – moving away from the “ambulance at the bottom of the cliff” approach to treating patients.
  • Personalized: Developing and choosing medicines that will change the patient experience from one of hope to one of certainty of response.
  • Participatory: Taking a modern view of the diverse stakeholders who play a role in patient care now and democratizing information so everyone can be informed.

The trends most apparent in this breakdown are the importance of data as a tool in precision medicine and of making testing more precise. A patient’s history will also take precedence in a patient-centric approach to treatment. Data, such as a patient’s genetics, health history, diet, lifestyle and even their microbiome, will be incorporated to predict potential outcomes.3

Patient centricity in clinical trials is achieved first and foremost by communicating with the patient, understanding their motivation for undergoing a trial and demonstrating sensitivity to this.3 Clinical research organizations can implement patient centricity by prioritizing patient goals. Companies are looking to reshape their approach to trials by considering all aspects, including patient comfort.6 In trials, patient centricity is distinguished from patient engagement. According to Forte Research, “patient engagement is a participant’s activity during the trial, where patient centricity is really a frame of mind held by site leadership and operations to provide the best possible patient care throughout a protocol.”6 Indeed, patients respond well when they feel they have been provided for throughout — one way this plays out is through transportation to and from trials. Doctor recommendations can also make a tremendous difference. A study by Tufts University found that 72% of patients would be more willing to participate in a trial if a doctor they trusted recommended it to them.6

Looking Ahead in Patient Centricity

The future of patient-centric medicine is bright. It will undoubtedly touch all aspects of patient care and health treatments and outcomes, with data being a major component of diagnostic testing, clinical trials and R&D. With specific patient data informing drug reactions, it will not be long before a one-size-fits-all approach to medicine is effectively replaced. Instead, analysis on what is right for an individual will revolutionize the way patients are treated, with medicine becoming more targeted and efficacious. Organizations will be able to identify therapies based on effectiveness analytics, while clinical trials become more targeted. This will lead to faster drug development and a decrease in unnecessary R&D spending, for overall improved patient outcomes.

Read Part 2: Remember the User – Incorporating Patient Centricity into Drug Design
Read Part 3: The Impact of Patients as Consumers: New Fill/Finish and Packaging Solutions

 

References

  1. “eyeforpharma Philadelphia 2018.” eyeforpharma. n.d. Web.
  2. Harsha, Rajasimha. “Patient centricity in the era of data-driven value-based precision medicine.” Journal of Pharmacogenomics & Pharmacoproteomics. 8: 4(Suppl) (2017).
  3. Precision Medicine Starts Here. Blue Latitude Health. 18 May 2018. Web.
  4. Danner, Stephan, Thomas Solbach, Mark Ludwig. “Capitalizing on precision medicine: How pharmaceutical firms can shape the future of healthcare.” PwC Strategy&. 24 Aug. 2017. Web.
  5. Rönicke, Volker, Michael Ruhl, Thomas Solbach. “Revitalizing pharmaceutical R&D: The value of real world evidence.” PwC Strategy&. 2 Mar. 2015. Web.
  6. Mel Johnson. “5 Takeaways for More Patient-Centric Clinical Trials.” Forte. 21 Jun. 2017. Web.