Advance of magnetoencephalography (MEG) in epilepsy diagnosis
Objectives/Methodology
Magnetoencephalography (MEG) is one of several neurophysiological tests (PET, SPECT, EEG, and the Wada test) used to localize brain function. Unlike MRI—which measures static structures—neurophysiological tests such as MEG technology measure various aspects of brain metabolism or function with millisecond resolution and greater sensitivity than PET and SPECT. This point is key since it is well recognised that rapid changes in brain activity occur during the propagation of a epileptic seizure. There was a realisation of the potential use of this sophisticated imaging system in the pre-surgical planning of patients with intractable epilepsy.
Our engagement with this client began when we assisted them in understanding the size of the market opportunity for magnetoencephalography systems in the USA.
Through a combination of secondary and primary research methodologies we were able to provide the client with a clear understanding of the competitive dynamics of the market – who were the key players in the market, which systems were commercially available within the US market and what was the scale of the market opportunity.
In a follow-on assignment we travelled with the client and conducted face-to-face interviews with key-opinion leading neurologists in major Level 4 epilepsy centers in Boston, Houston and San Francisco to explore a number of investigative themes, including,
Is the main player in the market, as suggested from our preliminary analysis, overcharging for its machines and providing poor post-purchase care to its clients? If so, this would allow our client to potentially gain a competitive advantage by addressing this issue on commercialization.
What are the functional requirements and anticipated costs that a MEG purchaser looks for in a novel system's costs?
What are the main areas of dissatisfaction with current systems?
What factors might prompt switching to alternative systems?
What might be the level of acceptance of machines with superior functionality offered by a new market entrant?
Might the MEG technology be used for applications beyond diagnosis of intractable epilepsy, perhaps for dementia and Alzheimer’s patients and other neurological conditions?
The client then engaged Veracity Health in a third follow-on assignment that aimed to allow an understanding of the reimbursement for use of MEG in epilepsy diagnosis. The company needed to understand what the current costs health insurers believed were associated with the use of MEG and how did these costs finally impact on their decision to reimburse for the MEG procedure. It was then important to understand what is the level of payment for conducting a MEG procedure.
Furthermore, it was vital to understand how these reimbursement levels might change to reflect the true cost of conducting the procedure. Through a combination of secondary and primary research methodologies we were able to advise the client on matters relating to reimbursement.
Analysis of the opportunity for magnetoencephalography (MEG) systems in the USA
Outcomes
The client was able to use the results and recommendations from our studies to assist in commercialisation of their MEG technology in the USA.
The client's MEG Measurement System gained US FDA 510(k) approval in 2017 and the client technology is now commercially available in the USA. It represented the first product to be made available by the client in its strategy to enter the healthcare sector.
Mycoplasma detection technology - a "needs analysis"
Objectives/Methodology
Mycoplasmas have gained great attention in the context of cell cultures. As they naturally reside in plant and animal tissues, every cell culture medium containing plant- or animal-derived supplements is prone to contamination by mycoplasmas.
Due to their small size of only 0.1–0.8 μm on average, and their variable shape resulting from the missing cell wall, mycoplasmas can pass through standard sterilizing filters and enter cell cultures with culture media or raw material-derived additives.
Especially in the biopharmaceutical and cell therapy industry, the effects of mycoplasma contamination are devastating, as entire production batches must be discarded leading to the disruption or cessation of production in manufacturing plants. There is a clear and present and expanding demand for mycoplasma testing solutions.
Our client has developed an innovative PCR-based rapid microbial testing system. In order to guide the continued development of the company’s product it requested the assistance of a consultancy to clarify some key points of interest related to functionality and potential unmet needs within the market. In order to tackle these issues, the client considered that it would be necessary to gather the viewpoints of individuals working within the Contract Development and Manufacturing Organisations (CDMOs) and companies developing products within the cell and gene therapy and biologics sectors of the biopharmaceutical industry.
For this assignment we were requested to contact and conduct interviews with representatives within Contract Development and Manufacturing Organisations and companies (end users) active within the cell and gene therapy space. The focus of interviews was to understand use of mycoplasma testing services, specifically PCR-based analytics for detection of mycoplasma contamination in products developed for the cell and gene therapy markets.
Sample themes explored in primary research (telephone interviews) were:
Status of current mycoplasma detection testing/products used
Review of factors which might drive adoption/use of a new mycoplasma PCR detection test
Review of test sensitivity and sample volume (current tests used, unmet needs)
Test systems used/test pricing
Competitive landscape – key companies and products
Factors affecting adoption of new technologies (product switching)/barriers to entry
Mycoplasma detection technology
Outcomes
This assignment was completed satisfactorily and the client is currently continuing the development of its product and pursuing commercialisation.
INAAT Diagnostic Testing
INAAT Diagnostic Testing - Market Entry, Africa
Objectives/Methodology
The continuous emergence in recent years of new highly infectious pathogens such as Zika virus, Ebola virus, SARS, and SARS CoV-2 has meant that there is an imminent and urgent need for the development of novel diagnostic tests which will allow the rapid and accurate identification of the causative pathogenic microorganisms to drive timely and effective treatment.
Presently, testing-related competencies appear to be restricted in many parts of Africa. Testing is hampered by a limited number of test kits which can prevent scaling up of testing beyond a few public health laboratories. Furthermore, African countries have been hampered in their testing efforts by the lack of access to supplies of key enzyme reagents and other reagents that are key to the RT-PCR testing that is gold standard currently for Covid-19 testing within public health laboratories.
Novel Covid-19 diagnostics based on lateral flow rapid diagnostic tests and nucleic acid amplification technology have been developed. A promising nucleic acid amplification technology is Loop-mediated isothermal amplification (LAMP), which enables simple and rapid nucleic acid amplification. LAMP demonstrates extremely high amplification efficiency at temperatures between 60°C and 70°C. Furthermore, compatibility with fluorescence, electrochemical, chemiluminescence, colorimetric, and turbidimetric detection mechanisms opens up a wide variety of LAMP applications.
The flexibility, accessibility, and robustness of isothermal nucleic acid amplification testing, INAAT through use of the LAMP technology drives potential application in low, middle-income countries. These are locations where resources are limited in terms of laboratory capacity and trained personnel and where remoteness of testing sites can be problematic for use of more traditional RT-PCR.
A client made an approach with a request for research aimed at identifying opportunities for Isothermal Nucleic Acid Amplification testing in Africa. Ultimately the client needed to better understand how to enter the market for LAMP-based diagnostics in Africa, with key questions focused on,
1. What LAMP products are available in Africa?
2. Provide details of sales/distribution channels (are there any subsidies offered by governments or NGOs at any point?)
3. How approval for sale is regulated (is it through the WHO? Or through National Regulatory Agencies, NRAs, other mechanisms?)
4. What is the approval process/path to market entry
5. What are current procurement processes/mechanisms that might be relevant for NAT/INAAT in Africa
6. Are there any independent country programmes that target infectious disease testing using LAMP technology
7. Data on LAMP system tests and pricing
Acute Kidney Injury
Acute Kidney Injury - A voice of customer opportunity analysis
Acute kidney injury (AKI) is an unpredictable and potentially deadly condition. It is precisely so because AKI can progress without symptoms and therefore without detection for hours or days leading ultimately to irreversible kidney damage. When AKI is severe enough to require dialysis, mortality rates soar to 50 to 90%. In the absence of a drug for treatment of kidney damage it is vitally important that accurate and timely detection of AKI, particularly in high risk critically ill patients, is made. Patients undergoing cardiac surgery are recognised to be a clear high risk group for AKI. It is estimated that up to one-third of patients undergoing cardiac surgery, such as coronary artery bypass or transcatheter aortic valve replacement (TAVR), are expected to develop some form of AKI, This clearly has an effect of increasing the burden and costs on ICU, or critical care beds within nephrology departments and on dialysis units.
Renal dysfunction following cardiac surgery is particularly due to complications of ischaemic origin affecting the renal medulla, which is particularly susceptible to injury because of the lower partial oxygen tension there, compared to the renal cortex. In early response to ischaemic challenge to the renal medulla a compensatory mechanism of reduced glomerular filtration rate and transport of solutes to the thick ascending limb (TAL) of the medulla is noted. However, this protective reperfusion mechanism is undermined by production of reactive oxygen species (toxic free radicals) that have the effect of reverting reperfusion and again decreasing medullary blood flow. TAL activity also increases and overall, from a clinical perspective this series of events translates to sustained injury during the reperfusion phase. The oxygen balance is tilted toward consumption because of increased demand for tubular solute transport and a deleterious hypoxic atmosphere is created.
At the tissue level an initial ischaemic episode in cardiac surgery patients can rapidly move to a cascade of events which ultimately leads to irreversible kidney damage and renal failure. This path leads to limited treatment options other than renal replacement therapy. Ischemia and subsequent reperfusion elicit AKI through endothelial dysfunction, a robust period of leukocyte-mediated inflammation and decreased blood flow at the microvascular or capillary level. In ischaemic/reperfusion injury (I/R), upregulation of proteins related to kidney development occurs in a specific spatial and temporal sequence.
Initial insult is associated with,
increased expression of injury and/or apoptosis markers, followed by a regeneration phase with upregulation of kidney mesenchymal proteins followed by upregulation of tubular markers, with endothelial marker expression occurring throughout early and mid regeneration.
These insights into the cascade mechanism in renal tissue suggest specific therapeutic targets that may be effective, but only so during a narrow window around the initial ischemic insult.
A valued client, for whom we had completed a number of assignments, expressed an interest in understanding the potential opportunity for AKI treatment devices for patients at high risk in cardiac surgery procedures. A prototype had shown promise in preventing ischaemia and hypoxia in relevant experimental models and suggested potential prophylactic use to prevent AKI in cardiac surgery patients.
In-depth face-to-face interviews were conducted with key opinion leaders (KOLs) attending the American Society of Nephrology meeting in New Orleans in the final quarter of 2017. Interviews, conducted in the presence of a team from the client headquarters, involved a discussion around current treatment options and the challenges faced when treating high risk cardiac surgery patients with I/R injury leading to AKI. The treatment concept was presented to KOLs and their feedback was sought on the merits of the overall concept and its potential for use in treatment of I/R injury and prevention of progression to cardiac surgery associated AKI (CSA-AKI).
Outcomes
Secondary and primary research provided the client with the data requested and they welcomed the findings, conclusions and recommendations from this assignment. They determined that given a clearer picture of the challenges and opportunities for their product in the African market they were able to define focus and generate a roadmap to commercialisation.
Outcomes
The clear and present opportunity for an innovative product and indication of widespread use by nephrologists due to a clear unmet need was confirmed at interview.
KOLs were enthusiastic about the product concept and welcomed its further development.
Multiple testing points for mycoplasma contamination in manufacture of advanced therapy medicinal products and biologics, including
- raw material testing
- testing of working cell culture
- seed culture, fermentation and cultivation (in-process controls)
- harvest (to adhere to regulatory authority demands)
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