Intellectual Property Considerations Research Articles

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process —the historically dominant path to market for most medical devices— and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device “predicates” upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.

Fiber Technology in Drug Delivery and Pharmaceuticals.

The field of fiber technology is a dynamic and innovative domain that offers novel solutions for controlled and targeted therapeutic interventions. This abstract provides an overview of key aspects within this field, encompassing a range of techniques, applications, commercial developments, intellectual property, and regulatory considerations. The foundational introduction establishes the significance of fiber-based drug delivery systems. Electrospinning, a pivotal technique, has been explored in this paper, along with its various methods and applications. Monoaxial, coaxial, triaxial, and side-by-side electrospinning techniques each offer distinct advantages and applications. Centrifugal spinning, solution and melt blowing spinning, and pressurized gyration further contribute to the field's diversity. The review also delves into commercial advancements, highlighting marketed products that have successfully harnessed fiber technology. The role of intellectual property is acknowledged, with patents reflecting the innovative strides in fiber-based drug delivery. The regulatory perspective, essential for ensuring safety and efficacy, is discussed in the context of global regulatory agencies' evaluations. This review encapsulates the multidimensional nature of fiber technology in drug delivery and pharmaceuticals, showcasing its potential to revolutionize medical treatments and underscores the importance of continued collaboration between researchers, industry, and regulators for its advancement.

P048 Identification of IL36RN missense mutations in Crohn’s disease patients as a potentially new drug target for treating rare patients with over-activation of the IL36 signaling cascade

Abstract Background The interleukin 36 (IL-36) family includes the agonists IL-36α, IL-36β, IL-36γ, which activate the NF-κB pathway and the natural antagonist IL-36RA, which inhibits IL-36 signaling. While missense mutations in the gene encoding IL-36RA (IL36RN) are associated with severe skin inflammation, their role in Crohn’s disease (CD) is currently unknown. Therefore, we here investigated if IL36RN mutations contribute to inflammation in CD and whether IL-36 signaling might represent a potential drug target for personalized therapy. Methods Mutations in IL36RN were identified by whole exome sequencing (WES) followed by targeted Sanger sequencing. Peripheral blood mononuclear cells (PBMCs) of affected patients were analyzed by mass cytometry and serum cytokines were measured by ELISA. Identified IL36RN mutations were characterized by overexpression experiments and functional assays. Clinical and molecular responses of one IL-36RN mutant patient to combined treatment with spesolimab and certolizumab pegol was assessed by fecal calprotectin, endoscopy, RNA sequencing and mass cytometry at week 0 and 12 of treatment. Results In a cohort of 47 ulcerative colitis patients, 177 CD patients and 34 healthy controls, we identified 3 CD patients with heterozygous missense mutations in IL36RN (IL-36RA S113L, IL-36RA P76L and IL-36RA L133I). In the patient carrying the IL-36RA S113L variant, we detected elevated serum levels of IL-18 and IL-23, as well as an increased frequency of TH17 cells in PBMCs, suggesting an overactivation of the IL-36 pathway. Overexpression experiments showed that IL-36RA S113L causes decreased expression of IL-36RA, resulting in increased IL-36 signaling. The patient was therefore treated with 1200 mg of the IL-36R blocking antibody spesolimab every 4 weeks and 200 mg of certolizumab pegol biweekly on the basis of an Out Of Scope request. This approach resulted in reduced intestinal inflammation and a reduction in the frequency of pro-inflammatory myeloid cells in PBMCs. Conclusion In this study, we show that pathogenic IL36RN mutations are present in a subset of CD patients and that blocking IL-36 signaling may represent a personalized therapeutic approach for this rare subset of patients in whom conventional biologic therapies have failed. Disclaimer Boehringer Ingelheim was given the opportunity to review the abstract for medical and scientific accuracy as well as intellectual property considerations in relation to the potential mention of BI substances. Boehringer Ingelheim had no role in the design, analysis or interpretation of the results in this study. Spesolimab was made available on the basis of an out of scope request. Boehringer Ingelheim was given the opportunity to review this abstract as a courtesy.

Laboratory based correlative cryo-soft X-ray tomography and cryo-fluorescence microscopy.

Cryo-soft X-ray tomography is the unique technology that can image whole intact cells in 3D under normal and pathological conditions without labelling or fixation, at high throughput and spatial resolution. The sample preparation is relatively straightforward; requiring just fast freezing of the specimen before transfer to the microscope for imaging. It is also possible to image chemically fixed samples where necessary. The technique can be correlated with cryo fluorescence microscopy to localize fluorescent proteins to organelles within the whole cell volume. Cryo-correlated light and soft X-ray tomography is particularly useful for the study of gross morphological changes brought about by disease or drugs. For example, viral fluorescent tags can be co-localized to sites of viral replication in the soft X-ray volume. In general this approach is extremely useful in the study of complex 3D organelle structure, nanoparticle uptake or in the detection of rare events in the context of whole cell structure. The main challenge of soft X-ray tomography is that the soft X-ray illumination required for imaging has heretofore only been available at a small number of synchrotron labs worldwide. Recently, a compact device with a footprint small enough to fit in a standard laboratory setting has been deployed ("the SXT-100") and is routinely imaging cryo prepared samples addressing a variety of disease and drug research applications. The SXT-100 facilitates greater access to this powerful technique and greatly increases the scope and throughput of potential research projects. Furthermore, the availability of cryo-soft X-ray tomography in the laboratory will accelerate the development of novel correlative and multimodal workflows by integration with light and electron microscope based approaches. It also allows for co-location of this powerful imaging modality at BSL3 labs or other facilities where safety or intellectual property considerations are paramount. Here we describe the compact SXT-100 microscope along with its novel integrated cryo-fluorescence imaging capability.

Knowledge Management Perspective of Generative Artificial Intelligence

In this editorial, revisiting Alavi and Leidner (2001) as a conceptual lens, we consider the organizational implications of Generative Artificial Intelligence (GenAI) from a knowledge management (KM) perspective. We examine how GenAI impact the processes of knowledge creation, storage, transfer, and application, highlighting both the opportunities and challenges this technology presents. In knowledge creation, GenAI enhances information? processing and cognitive functions, fostering individual and organizational learning. However, it also introduces risks like AI bias and reduced human socialization, potentially marginalizing junior knowledge workers. For knowledge storage and retrieval, GenAI’s ability to quickly access vast knowledge bases significantly changes employee interactions with KM systems. This raises questions about balancing human-derived tacit knowledge with AI-generated explicit knowledge. The paper also explores GenAI’s role in knowledge transfer, particularly in training and cultivating a learning culture. Challenges include an over-reliance on AI and risks in disseminating sensitive information. In terms of knowledge application, GenAI is seen as a tool to boost productivity and innovation, but issues like knowledge misapplication, intellectual property, and ethical considerations are critical. Conclusively, the paper argues for a balanced approach to integrating GenAI into KM processes. It advocates for harmonizing GenAI’s capabilities with human insights to effectively manage knowledge in contemporary organizations, ensuring both technological advances and ethical responsibility.

Controllable Privacy-Preserving Online Diagnosis with Outsourced SVM over Encrypted Medical Data

With the widespread application of online diagnosis systems, users can upload their physical characteristics anytime and from anywhere to receive clinical diagnoses. However, for privacy and intellectual property considerations, users' physical characteristics, diagnosis results, and the medical diagnosis model should be protected. To achieve an efficient and secure online diagnosis, secure outsourcing and low burden become research objectives. However, few of the existing privacy-preserving schemes focus on the secure outsourcing of the training process, and few consider the supervision of the hospital for the online diagnosis process. By introducing a four-party architecture with two non-colluding servers, a hospital and users, in this paper, we propose a controllable privacy-preserving online diagnosis scheme (CPPOD) with outsourced SVM over encrypted medical data. Concretely, an integer vector homomorphic encryption is employed to protect medical data and user requests. In the encrypted domain, a series of collaborative protocols including data collection, sequence minimum optimization solver, SVM model building, and online diagnosis are constructed and take place between different participants, while no significant increase in computation on either the hospital or user side. CPPOD enables the hospital to delegate online diagnosis services to a cloud server while ensuring that its regulatory capabilities cannot be bypassed unauthorized. Security analysis and performance evaluation suggest that CPPOD performs well regarding security and efficiency.

Ultrasound-assisted continuous crystallization of metastable polymorphic pharmaceutical in a slug-flow tubular crystallizer

Metastable polymorphic pharmaceuticals have garnered significant attention in recent years due to their enhanced physicochemical properties, including solubility, bioavailability, and intellectual property considerations. However, the manufacturing of metastable form pharmaceuticals remains a formidable challenge. The stable preparation of metastable carvedilol (CVD) form Ⅱ crystals during CVD production is elusive, leading to substantial inconsistencies in product quality and regulatory compliance. In this study, we successfully prepared metastable CVD Form Ⅱ crystals using a continuous tubular crystallizer. Our findings demonstrate that the tubular crystallizer exhibits high efficiency and robustness for generating metastable crystal Form Ⅱ. We optimized the crystallization process by incorporating air bubble segments and employing ultrasonic irradiation strategies to overcome blockages and wall sticking issues encountered during operation. Ultimately, we developed an ultrasound-assisted continuous slug-flow tubular crystallization method and evaluated its performance. The results indicate that the CVD crystals produced through this process are resilient, sustainable, and uninterrupted products with promising potential for producing metastable polymorphic pharmaceuticals while effectively addressing encrustation problems associated with continuous tubular crystallization.

An online survey among US patients with immune-mediated conditions: Attitudes about biosimilars.

BACKGROUND: Few surveys about biosimilars have been conducted among US patients. OBJECTIVE: To evaluate attitudes about biosimilars among patients with rheumatoid arthritis (RA), psoriasis and/or psoriatic arthritis (PsO/A), and/or inflammatory bowel disease (IBD). METHODS: WebMD, LLC fielded a 16-item online survey to members of the US Dynata consumer panel meeting these criteria: aged 18 years or older; self-reported specialist diagnosis of RA, PsO/A, or IBD of at least 1 year; and not currently receiving an infliximab biosimilar. A quota of 500 was set, stratified by region and condition. The survey was exempt by the institutional review board, exploratory, and not registered. RESULTS: Overall, 44% (n = 221) of patients were on a biologic; 56% (n = 279) were not on a biologic (40% [n = 199] were biologic naive and 16% [n = 80] used biologics in the past). Among all patients, 66% were unaware of biosimilars and 24% were aware (10% unsure). After being shown the US Food and Drug Administration definition of a biosimilar, main concerns were side effects (59%), long-term safety (50%), and not knowing a lot (46%). Among current users, 43% would switch to a biosimilar and 26% would not (32% unsure). Of those unwilling to switch, 51% were concerned about side effects, 42% about financial support, and 40% about efficacy. When those not on a biologic were asked if their doctor prescribed an original anti-tumor necrosis factor α but their insurance required its biosimilar, 49% would switch and 8% would not (43% unsure). 51% of patients surveyed thought pharmacist-level substitution of an interchangeable biosimilar was acceptable with notification. Survey findings were consistent among the RA, PsO/A, and IBD subgroups. CONCLUSIONS: Although two-thirds of patients surveyed were unaware of biosimilars, the majority were potentially receptive to biosimilar treatment after being provided with the definition of a biosimilar. Patients expressed a desire to know more about biosimilars in general, how they compare with original biologics, their benefits, and cost. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals Inc. (BIPI). WebMD, LLC, fielded the survey. BIPI was given the opportunity to review the article for medical and scientific accuracy and intellectual property considerations. Dr Gibofsky is a consultant/advisor for AbbVie Inc., Biosplice Therapeutics, Lilly, Novartis Pharmaceuticals Corporation, and Pfizer Inc., and he is on the speakers' bureau for AbbVie Inc., Amgen, Lilly, and Pfizer Inc., and has stock ownership in AbbVie Inc., Amgen, Bristol-Myers Squibb Company, Horizon Pharma plc, and Pfizer Inc. Dr Peyrin-Biroulet reports that he has received personal consulting fees from Merck Sharp & Dohme, AbbVie, Janssen, Takeda, Celltrion, Pfizer, Bristol-Myers Squibb Company, Pharmacosmos, Shire, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, UCB-Pharma, Hospira, BIPI, and Lilly. Dr McCabe is an employee of BIPI. Dr McGrath was an employee of BIPI at the time the survey was conducted. Mr Jacobson, Mr Franklin, and Ms O'Hara-Levi report no disclosures.

Digital Research Environment(DRE)-enabled Artificial Intelligence (AI) to facilitate early stage drug development.

Early-stage drug discovery is highly dependent upon drug target evaluation, understanding of disease progression and identification of patient characteristics linked to disease progression overlaid upon chemical libraries of potential drug candidates. Artificial intelligence (AI) has become a credible approach towards dealing with the diversity and volume of data in the modern drug development phase. There are a growing number of services and solutions available to pharmaceutical sponsors though most prefer to constrain their own data to closed solutions given the intellectual property considerations. Newer platforms offer an alternative, outsourced solution leveraging sponsors data with other, external open-source data to anchor predictions (often proprietary algorithms) which are refined given data indexed upon the sponsor's own chemical libraries. Digital research environments (DREs) provide a mechanism to ingest, curate, integrate and otherwise manage the diverse data types relevant for drug discovery activities and also provide workspace services from which target sharing and collaboration can occur providing yet another alternative with sponsors being in control of the platform, data and predictive algorithms. Regulatory engagement will be essential in the operationalizing of the various solutions and alternatives; current treatment of drug discovery data may not be adequate with respect to both quality and useability in the future. More sophisticated AI/ML algorithms are likely based on current performance metrics and diverse data types (e.g., imaging and genomic data) will certainly be a more consistent part of the myriad of data types that fuel future AI-based algorithms. This favors a dynamic DRE-enabled environment to support drug discovery.

Small and Medium Scale Enterprises: An Appraisal of the Role of Taxation and Intellectual Property on Their Growth in Nigeria

This research critically analyzes the concept of small and medium-sized enterprises (SMEs) and looks at the tax and intellectual property implications and considerations. The aim is to expose how Intellectual Property law can help sustain Small and Medium Sized Enterprises (SMEs) in the marketplace and improve the growth and development of the Nigerian economy through taxation. To achieve these, the research examined the essential roles of Intellectual Property in the growth and development of Small and Medium Sized Enterprises. The rights and remedies to which the owners of Small and Medium Sized Enterprises (SMEs) are entitled, as well as the challenges of Intellectual Property Laws and their corresponding tax liabilities under the relevant pieces of legislation in Nigeria, are considered. This research evaluates the factors contributing to the non-compliance of SMEs with tax obligations. These include complex filing procedures, multiple taxations of SMEs, and a lack of proper enlightenment. The finding reveals that SMEs have performed below expectations due to specific reasons ranging from societal constraints to issues of lack of awareness, instability, and change in the economy. Tax compliance among SMEs in Nigeria is poor. To enhance the growth of Nigerian SMEs, there is a need to explore enlightenment and awareness through the use of intellectual property and taxation.

Cross-silo heterogeneous model federated multitask learning

Federated learning (FL) is a machine learning technique that enables participants to collaboratively train high-quality models without exchanging their private data. Participants utilizing cross-silo FL (CS-FL) settings are independent organizations with different task needs, and they are concerned not only with data privacy but also with independently training their unique models due to intellectual property considerations. Most existing FL methods are incapable of satisfying the above scenarios. In this study, we present a novel FL method CoFED based on unlabeled data pseudolabeling via a process known as cotraining, which meets the needs of heterogeneous models, tasks and training processes in CS-FL. Experimental results suggest that the proposed method outperforms competing methods. This is especially true for non-independent and identically distributed (non-IID) settings and heterogeneous models, where the proposed method achieves a 35% performance improvement.

Intellectual Property Considerations and Challenges in the Metaverse

Intellectual Property Considerations and Challenges in the Metaverse

Mentoring for INnovative Design Solutions (MINDS): Key Design Considerations and Collaborative Teamwork across Universities for Clinical Translation

The main purpose of this paper is to share the Mentoring for INnovative Design Solutions (MINDS) Scholars Program developed by Alpha Eta Mu Beta, the International Biomedical Engineering Honor Society. The program’s goals are to (1) introduce biomedical engineering students to an open-ended design experience as part of interuniversity teams with industry and faculty mentors, and (2) develop the ability to create designs considering clinical translatability on teams with different backgrounds and areas of expertise. MINDS uses an experiential learning approach to (1) enrich student curricular experiences through inter-institutional collaboration, (2) build engineering design skills, including three key design considerations for clinical/commercial success: intellectual property protection, regulatory strategy, and market identification; and (3) emphasize the importance of end-user considerations. From 2015 to 2022, MINDS has involved 131 students from 50 universities and 22 faculty and industry mentors. Pre- and post-program surveys show statistically significant improvements in understanding of the design process, regulatory strategy, intellectual property protection, market definition, and key product requirements and features. Students also improved communication and teamwork skills. Many students indicated that MINDS participation made them more likely to choose careers that involve product development and/or entrepreneurship. Students attained a working ability to integrate market needs, regulatory strategy, and intellectual property considerations into the design process. They also further developed soft skills, such as conflict resolution, time management, and effective communication through the challenges of inter-institutional collaboration. Additionally, the program heightened their awareness of how biomedical devices and technologies can benefit society.

Epoetin Alfa: a Creative Way to Treat Anemia

The use of epoetin alfa has been one of the most relevant trends in the past years, therefore, it is important to understand how epoetin alfa differs from other biopharmaceuticals and to summarise the innovative nature of epoetin alfa. This paper aims at why the biopharmaceutical represents innovation in terms of lead-discovery, drug development and fulfilling a previously unmet treatment need. As far as we know, studies on the creativity of epoetin alfa are lacking in the main literature. This paper reveals that the purpose of epoetin alfa’s therapy and current treatment modalities, general principles of the drug discovery process, the creativity in medicinal chemistry & pharmacology of epoetin alfa, choosing the target and sources of compound supply, intellectual property considerations in drug discovery & development, the drawbacks of epoetin alfa and the creativity of epoetin alfa. The contribution of the present research involves that summarising the innovation of epoetin alfa.

Ethics and the co-production of knowledge.

There is an increasing focus on co-production in public health research. By their very nature, such research endeavours involve a different set of relationships, goals, and values than traditional research. To date, ethical issues that arise during the co-production process are dealt with on an ad hoc and case-by-case basis. There is a need to make the ethical considerations of co-production explicit. This article outlines several ethical values that could be considered in co-production using two different ethical frameworks. It also draws upon practical co-production research that highlights some of the ethical issues that arise. It argues that all stakeholders in the co-production process have a responsibility to ensure that the knowledge they co-produce is as beneficial as possible. In doing so, they must adhere to a set of ethics surrounding the generation of such knowledge, including health equity, intellectual property considerations, and respect for the rights of individuals and groups.

Designing an Optimal Modular-Based Product Family Under Intellectual Property and Sustainability Considerations

Abstract With the rapid development of new technology and the growing global competition in industry, it is essential for companies to protect their sensitive product designs and technologies. To ensure that their systems are not exploited by potential patent infringers, original equipment manufacturers often apply physical attributes and/or reduce commonality within a product family to prevent easy reusing and recovering. Yet, these design strategies are key barriers to the sustainable recovery and recycling of products. To address these trade-offs, this paper proposes a stepwise methodology to identify the sustainable optimal product family architecture design while protecting intellectual property on sensitive parts or modules. The developed approach notably allows the selection of suitable and sustainable candidates to share among products, taking into account the cost-benefit of commonality within the product family. To demonstrate and test the proposed methodology, a case study is performed with a printer-product family. Environmental savings resulting from the new modular-based architecture obtained for this product family are quantified and discussed.

Effect of compliance with GOLD treatment recommendations on COPD health care resource utilization, cost, and exacerbations among patients with COPD on maintenance therapy.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

55256 ReacStick: From Conception to Commercialization

ABSTRACT IMPACT: ReacStick concussion testing and monitoring can serve as a 'vital sign for the brain', allowing for an immediate, objective assessment on the field or at the bedside. This project examines the entrepreneuship process from invention to commercialization. OBJECTIVES/GOALS: ReacStick is the first objective, portable, measure of concussion likelihood and severity and uses simple and complex reaction time testing. We detail the entrepreneurship process from product invention through its current mid-stage (patented, 20+ publications, etc.) to future commercialization for diverse applications. METHODS/STUDY POPULATION: ReacStick was invented in 2010 and underwent extensive testing and validation of the underlying innovations. The regulatory landscape of the product was examined, and 510(k) was found to be the best pathway. Competitive analysis was done examining alternative products and comparing against the current gold standards. A customer discovery process was undertaken, and stakeholders were interviewed for feedback and iteration. Testing and validation were completed with athletes, older adults, and people taking medications. An overview of the necessary commercialization concepts is: market opportunity/monetization, intellectual property considerations, regulatory processes, commercialization plan. RESULTS/ANTICIPATED RESULTS: ReacStick accurately predicts concussion and time to recovery and was patented through UM Tech Transfer in 2010, with 10 years currently remaining on the patent. Through customer discovery processes, athletics was determined to be the most viable first market to enter. Next steps include seeking additional patent protection, capital investors, delivery of minimum viable product followed by iteration and improvement for military, emergency medicine and acute care use. The current remaining timeline involves 12-18 months to commercialization and includes regulatory approval, additional patent protection, collaboration with regulatory consultants, capital fundraising and product production. DISCUSSION/SIGNIFICANCE OF FINDINGS: The research team has gone through a lengthy process toward commercialization of ReacStick. Proof of concept and extensive validation of the underlying technology have been completed and the regulatory process has been mapped. Our experience can serve as a model of many of the steps and challenges that lie on the path from lab to sale to end users.

Fall 2020 Proceedings of the Cannabis Chemistry Subdivision

The cannabis industry is unique in many facets, most of them products of history. Cannabis has been prevalent in society for millennia, but for the period between 1937 and 1997 prohibition was imposed in the United States stifling research and creating an unregulated market. From 1997 to present, starting with California, there has been a wave of state-by-state legalizations. Each of these states has individual regulations that operators must comply with. For those working with hemp (cannabis containing less than 0.3% THC by dry weight), there is an entirely different framework of federal regulations. As an unfortunate consequence of this history, the science of cannabis along with the safety culture are relatively unevolved compared with other modern industries. In 2015, the Cannabis Chemistry Subdivision (CANN) of the division of Chemical Health and Safety (CHAS) was recognized by the America Chemical Society (ACS). Since its inception, CANN symposia at ACS National Meetings have served as the premiere venue for cannabis chemists and scientists to share their research, much of it related to improving the health and safety culture in the industry. This proceedings publication highlights 16 presentations that were given at CANN symposia during the Fall 2020 ACS National Meeting. Topics covered include analytical testing methods, consumer education and protection, formulation science, intellectual property considerations, best practices for pharmacokinetics and dosing studies, assessment of smoke exposure, and more.

Incidence and prevalence of systemic sclerosis and systemic sclerosis with interstitial lung disease in the United States.

Although systemic sclerosis (SSc) with interstitial lung disease (SSc-ILD) is a serious condition and incurs a substantial clinical burden, the epidemiology has not been well characterized. To estimate the incidence and prevalence of SSc and SSc-ILD among commercially insured adults in the United States. Adults with medical claims between 2011 and 2016 for SSc or SSc-ILD with and without high-resolution computed tomography scans were identified from the Optum Clinformatics Data Mart. Incidence and prevalence were calculated as rates per 100,000 person-years and 100,000 people, respectively. The crude and age- and sex-adjusted prevalence and incidence of SSc and SSc-ILD were estimated and stratified by year and geography. Sensitivity analyses were conducted based on different cohort identification algorithms. Overall, the crude incidence rates of SSc and SSc-ILD were 16.4 and 1.2 per 100,000 person-years, respectively, and the crude prevalence was 24.4 and 6.9 per 100,000 people, respectively. Patient characteristics were generally similar between the SSc and SSc-ILD groups. Mean age range was 59.2-59.9 years and 61.8-62.9 years in the SSc and SSc-ILD groups, respectively. SSc had an age- and sex-adjusted incidence rate of 15.1 per 100,000 person-years and an adjusted prevalence of 25.9 per 100,000 people. The adjusted incidence rate of SSc-ILD was 1.1 per 100,000 person-years and the adjusted prevalence was 7.3 per 100,000 people. This study provides current estimates of the national incidence and prevalence of SSc and SSc-ILD, which have not been previously well characterized. Further research in the future may help to support health management strategies and resource allocation for adults with SSc and SSc-ILD in the United States. This work was supported by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), which reviewed the manuscript for medical and scientific accuracy, as well as intellectual property considerations. All authors are employed by BIPI and did not receive direct compensation related to the development of the manuscript.