Posts Tagged Market Access

Storytelling, Giving Back, and Legacy: How AESARA is Doing it Differently

A market access agency.
https://aesara.com

A few months ago, I was sipping my morning coffee and perusing the health economics and outcomes research (HEOR) news feed as I do twice daily for HealthEconomics.Com. I stumbled across a blurb about a market access firm devoting time, talent and treasure to disaster relief from Hurricane Irma and Maria. The company was AESARA. One of my long-time colleagues, Dr. Lynn Okamoto, was in a leadership position there; being intrigued, I delved a bit deeper.

You see, I’m always keen to showcase the extraordinary individuals who make up the HEOR, Market Access (MA) and real-world evidence (RWE) field, and in my own small way attempt to debunk the myth that we are just geeky scientists. Many of you may remember a series that HealthEconomics.Com did a few years ago called HE-Artists: Health Economists and their Artistic Passions. This series revealed the breadth of impact made by our HEOR community, and showcased many phenomenal, multi-faceted, talented individuals who make their corner of the world a better place, while also doing extraordinary work in their careers.

As I read more about AESARA, I found a group of individuals who were indeed following their passion as a digital-forward market access agency. But also, I found a leader who was intent on making change in both HEOR and in needy communities around the globe. Meet Sissi Pham, Pharm D, Chief Executive Officer and Lynn Okamoto, PharmD, Chief Business and Technology Officer of AESARA. Sissi prefers not to showcase her or the staff’s pictures on their website, but rather, to use metaphors and symbolism to highlight their individual and corporate mission.

Sissi’s symbol is the Delta glyph and Lynn’s symbol is Theta. Each staff member has a symbol, and the personal meaning of these symbols is described here. Below is my interview with Dr. Sissi Pham, with additional commentary by Dr. Lynn Okamoto.

[PP] What life experiences or events influenced you as a person and female executive in the HEOR field?

[SP] What influences me as a person, the work I do, and the mission of AESARA are all driven by being an immigrant to this country. I am Vietnamese by origin and I arrived in America with my parents and two other siblings at the end of the Vietnam War in 1975. My parents built a life for their children filled with many opportunities, even though they started here with absolutely nothing. It was very impactful to watch how my parents made change happen. My parents had high expectations from all of us to make a difference and “do good”. 

Another influence was a combination of my age and a significant event with my loved one. I was turning 50 years old and simultaneously, my father was passing away with two types of cancer. These events coalesced with a personal inventory of my purpose, and questions of whether I was doing all I could to make my father proud of the sacrifice he had made for me. 

Thirdly, I wondered about my legacy, my meaning in life. I do not have children but have been fortunate enough to earn a good living.  I saw examples of successful business leaders implementing a culture of philanthropy and social giving. I was inspired by this and made the decision that my next business venture would include this approach.

 [PP] Describe what a digital-forward market access agency is and how AESARA is doing things differently?

[SP] I have always enjoyed packaging and translating HEOR science and information to be used by the sales force and medical science or health outcomes liaisons with their customers. As a discipline, we are very challenged with how to communicate efficiently and effectively to the patients, providers and payers.  There is so much technology available – beyond Excel™ and PowerPoint™ – that we are not using in the health outcomes and market access space.

So, I started AESARA in April 2016 as a health outcomes market access agency similar to the brand or commercial agency that supports the product marketing in pharma. However, we don’t just do the creative work, we are also subject matter strategists; we have the subject matter expertise to turn the data in digestible content that can be used for decision-making and patient access.

[PP] Specifically, what are you doing differently with communication tools?

[SP] If you think about Ogilvy, they deliver glossy brochures, slide decks, and other very visual content that includes simple and actionable marketing language. In the commercial sector, agencies have learned how to distill complex clinical trial information into material that communicates the message for a brand to providers. At AESARA, we are trying to do something similar with HEOR and budget impact model data, or any of the evidence necessary for value-based decisions.

I am a big follower of Nancy Duarte and the Duarte Method. We use this approach to package evidence for our clients. In addition, our Creative team specializes in graphics that are grounded in the language we (HEOR) speak.

Truthfully, the digital forward component is something that pharma has been slower to adopt. We are moving this up in adoption curve and are using interactive pieces to support the communication of all forms of evidence: dossier, infographics, and other tools with the intent of disrupting the value communication space.

[PP] Lynn Okamoto’s focus is technology. Tell us more about what you are trying to accomplish.

[LO] Our HEOR, RWE and Market Access field is document-heavy, often relying upon old systems for collaborating and sharing. We are creating systems to be used internally by clients that allow them to be more productive, more efficient, and more quickly identify where evidence needs to be updated, then share final documents globally in real-time. This allows people to get the information they need for better decision-making. We are focusing on streamlining and strengthening these linkages across people and documents.

[PP] Let’s circle back to what intrigued me initially about AESARA – your Foundation. What is the mission and what have you accomplished so far?

[SP] Our Foundation is in its early days, being just 3 years old. I wanted to build a company that could sustain a Foundation over time. It’s a commitment we’ve made as a company. We haven’t clearly defined exactly what we support. It’s not targeted yet. We aren’t quite there yet. But we do know – and all of our employees support this – that we have an interest in giving back.

As I continue to formulate the Foundation purpose, I keep coming back to our strengths. We have world-class talent on the business side, including skilled health economists, as well as operations, technology, and finance capabilities. How can we leverage this, pro bono, to improve healthcare?

We began to do this in Puerto Rico after Hurricane Maria.  We focused our efforts on Loíza, Puerto Rico with 25 volunteers consisting of AESARA employees and family members.  In addition to hands-on disaster assistance efforts like painting and tiling homes and roof installation, we used our in-house consulting skills to help problem-solve for this community to help prepare for the next disaster. We helped develop a plan to upgrade their current urgent care center, as well as figure out ways to establish emergency shelters and use these effectively in between emergency use.  Moreover, we contribute to a collective funding across multiple agencies to maximize the disaster relief efforts.

[LO] Everyone we hire at AESARA values the Foundation and its focus. Today, many of employees represent a generation that wants to find a way to give back.  Joining a company who values that is very important to them, and these are the kind of individuals we want to hire.

[PP] Let’s close with a look into the future. What do you wish was different in our HEOR field in 10 years?

[SP] I hope the HEOR & Market Access data we generate is on par with the clinical evidence, that the customers understand it, and use it to make decisions.


If you’d like to know more about AESARA, visit https://aesara.com/

If you’d like to have your organization or leadership featured in Profiles from the HEOR C-Suite, contact Dr. Patti Peeples, CEO of HealthEconomics.Com

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Building Trust In Real World Evidence – From Regulators To Patients

Bill Fox
Chief Strategist for Global Healthcare, Life Sciences, and Insurance
MarkLogic

 

 

In a climate of growing consumer distrust for companies that have access to their personal information, organizations that generate real world evidence must join the likes of financial services institutions and the government to ensure that the sensitive data in their charge is well governed, selectively accessible, and highly secure.


 

Real world evidence (RWE) is here to stay. And it brings with it a world of possibility—and vulnerability. As value-based reimbursement slowly displaces fee for service, payers and providers are under mounting pressure to deliver better patient outcomes at less cost. This, in turn, increases the burden on life sciences companies to not only demonstrate the effectiveness and safety of their products to the FDA through the traditional clinical trial process, but to also show evidence of their product’s overall value to patient health and total cost of care when the drug gets out in into the real world. RWE can play a crucial role in fulfilling the requirements of each of these stakeholders, with life sciences companies having additional interest in leveraging RWE to expedite market access for their products.

Historically, available evidence on pharmaceutical and medical device products has come from tightly-controlled clinical trials and is delivered to the FDA by the product’s sponsor. However, with increasing insight into the limitations of clinical trials in predicting a product’s safety and efficacy in wider, unstudied populations, the FDA has come to recognize that an abundance of product data is routinely collected via doctor visits, insurance claims, device registries, wearable technology, and even social media channels. And, though this real world data may not have the same data quality and bias controls as data collected in clinical trials, high-quality real world data (RWD) sources can dramatically enhance understanding of both the benefits and adverse effects of a product over its lifecycle—in everyday use across larger demographics.

 


“We need to close the evidence gap between the information we use to make FDA’s decisions and the evidence increasingly used by the medical community, by payers, and by others charged with making healthcare decisions”1

– Scott Gottlieb, FDA Commissioner


 

Further paving the way for real world evidence initiatives, the 21st Century Cures Act authorized $6.3 billion in funding to expedite the process by which new drugs and devices reach approval. The bill incentivizes life sciences companies to invest in data strategies that supplement traditional clinical, and pragmatic trials, and to potentially support FDA approval of new indications for previously approved drugs.

 

AVOIDING RISKS IN REAL WORLD EVIDENCE DEVELOPMENT

But, for all of its clear advantages and widespread support, the process of turning data from varied sources—with varying degrees of quality and lineage—into real world evidence also opens the door to a multitude of data quality, governance, and security issues that must be addressed in order to protect the integrity of the evidence produced.

 

Click to see a larger image.

 

DATA GOVERNANCE AND LINEAGE

In the wake of the recent data privacy fiasco in which 87 million unsuspecting Facebook users had their data unknowingly collected by a political firm, Cambridge Analytica, my colleague, David Gorbet, authored an article, Don’t Let a Data Debacle Like Facebook’s Happen at Your Company, on Entrepreneur.com outlining key lessons that every organization should learn from the recent debacle that has wrecked consumer confidence in the social media giant.

Data governance challenges should likewise weigh heavily on the minds of RWE generators responsible for safeguarding mass quantities of potentially sensitive data. To start with, repurposing of routine medical data for additional analyses often requires data cleaning and cross-referencing. These techniques can confirm the data’s internal consistency and identify missing values, but they cannot determine its accuracy and authenticity. How do you ensure accountability in your real world data when the data is sourced from many different silos, each with its own notions of data governance? Comparing data from traditional clinical research, or pragmatic trials, to source documents through audits (i.e., external consistency) is an essential additional step in verifying the accuracy and completeness of the data. This type of verification is important for real world data intended for use in regulatory analyses. And speaking of regulations, another significant challenge in working with real world data is posed by regulations regarding patient privacy and confidentiality.

HIPAA requires healthcare entities and their business associates to protect the privacy of patient information. The sharing of healthcare data between departments and organizations is often frustrated by the need to protect this data. To work within these confines, or regulations, data scientists are forced to wrangle the data to meet requirements for de-identification. Attempts to “de-identify” real world data in this manner can obfuscate it to the point that it loses its value. And in certain situations, as in the case of the strict data residency and sovereignty laws of some European countries, researchers are altogether prohibited from moving or sharing any patient data.

In many traditional database systems, data must undergo a number of separate transformation processes before it can be loaded into the database. These processes can lead to data quality disaster when a user sees a value from the database but is not clear where it came from. Was the value part of the original record? Or, was it added in transformation Step 2B? It can quickly become impossible to make heads or tails of the lineage and therefore the reliability of the data.

Tracing data lineage becomes much easier when data is loaded as is, while maintaining all its original metadata and schema, and transformation processes are performed against a canonical version of the data (while maintaining the original data unchanged), instead of having to perform multiple transformation steps before the data is ingested into the database. In this way, data scientists can see both the original data and the transformed data—making the enrichment and harmonization process much more transparent.1

 

MASTER DATA MANAGEMENT

For RWE, a consistent and accurate view of real world data is critical for hypothesis testing and analysis. However, when data is spread across disparate silos, it is difficult and costly to ascertain what the data means, whether it’s correct, how it relates to other data, and whether or not it’s secure. The main objective of master data management (MDM) is to provide a single, unified source of truth that sheds light on all of this ambiguity. This will prevent users from using overlapping, and possibly invalid or inconsistent, versions of data. But, MDM can prove a challenging undertaking. The projects are commonly large, costly and can take years to execute—if they succeed at all (and most don’t).

Without MDM, data silos and duplicate copies of data make it nearly impossible to secure and track the use of your real world data—increasing the possibility of breaches and exposure of sensitive information. Federation and warehousing with relational technology have proven too costly and brittle to solve these master data problems at scale. To protect their data, organizations need a better approach to MDM.

 

ENSURING DATA SECURITY

At this very moment, hackers are tirelessly searching and probing for vulnerabilities in the networks of organizations across the healthcare ecosystem. Their objective is a simple one: to acquire the protected health information (PHI) of patients and consumers, which, according to Becker’s is 10-20 times more valuable than credit card information. Regulated by HIPAA to protect the privacy of individuals, the theft of PHI can jeopardize consumer privacy, reputation, and identity—as well as patient trust in the organization that failed to keep their private data safe. Despite worldwide security spending expected to reach $170 billion by 2020—cyber attacks, data breaches, and the unsanctioned use of consumer data will continue to occur at an alarming rate.

Hospital networks, biotech, pharmaceutical, and medical device manufacturers all are vulnerable:

  • Data generated by clinical and pragmatic trials present risks on the level of patient privacy, and to the competitive objectives of the company
  • Organizational intelligence and trade secrets related to the discovery and production of complex drugs
  • Drug pricing and promotional information. Especially important in the face of budgetary pressures to ensure better patient outcomes while reducing healthcare costs2

As a former Deputy Chief of Economic and Cyber Crime at the Philadelphia District Attorney’s Office, and Special Assistant U.S. Attorney, I’ve been investigating, prosecuting and thinking about data security for 20 years. With the increase in inappropriate data sharing, and cyber attacks growing in sophistication, it’s clear to me that more vigilant methods must be employed to protect and govern the use of real world data assets.

 

PROTECT YOUR DATA AND YOUR REPUTATION

Traditional databases and traditional data security thinking focused on building walls around the network that would protect the data from outsiders, and lacked granular access controls offering too many all-or-none data access. This traditional cyber methodology is no longer sufficient to protect against modern threats to data security. Today’s RWE-generating organizations need the ability to clearly define who can see what data at the most granular level. Exposure of PHI, even to valid application users, may violate privacy regulations and put patient and consumer data at unnecessary risk. Controlling data access and security at the database-level addresses these risks more effectively and helps prevents exploitation of application or network flaws that may disclose sensitive data.

With security features that allow for policy-based management of how data is protected and exported in the database, an Enterprise NoSQL database platform can enable organizations to safeguard patient data with capabilities such as:

  • Advanced encryption that protects data from hackers and insider threats using standards-based cryptography, advanced key management, and granular separation of duties.
  • Redaction features that eliminate exposure of sensitive information by removing specifics to prevent sensitive data leaks.
  • Element-level security. This allows specific information to be hidden from particular users, providing an even more granular level of security enforced in the database.

In an environment of increasing cyber threat and sliding-scale ethics around the use of personal data by some companies entrusted with it—trust is at an all-time premium for organizations engaged in RWE generation. Developing real world evidence on an agile technology platform grounded in enterprise reliability and government-grade security can reduce time to insight while strengthening data governance—and waning consumer confidence.

 

Download this free whitepaper to learn more about The Opportunity of Real Word Data, or contact MarkLogic to learn how other life sciences organization are securely and efficiently accelerating their real world evidence initiatives.





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