Pfizer Stock Research Articles

Longitudinal Assessment of High- and Low-Contrast Visual Acuity in Normally-Sighted Children (P10-9.009)

<h3>Objective:</h3> To characterize longitudinal visual changes in healthy children. <h3>Background:</h3> Visual acuity (VA) is often used as an outcome measure in clinical and research investigations, although age-related normative contrast data is lacking. We have previously demonstrated in a cross-sectional cohort (ages 5–20 years, grouped by age) that mean monocular and binocular high-contrast visual acuity (HCVA) and monocular low-contrast letter acuity (LCLA) scores increase with age linearly between 5–14 years in normally-sighted youth; however, improvements in acuity scores have not been validated longitudinally in individual children. <h3>Design/Methods:</h3> Children and young adults without neurologic, systemic, or ocular diseases (except refractive error) enrolled in our research program were eligible for longitudinal vision testing. Binocular HCVA and LCLA were assessed at 2 meters using EDTRS and Sloan charts (2.5% and 1.25% contrast). Linear regression with generalized estimating equations to account for repeated observations were used to calculate mean annual visual acuity change. <h3>Results:</h3> Among 101 subjects enrolled in the cross-sectional study, 27 subjects returned for longitudinal testing at a mean of 2.78 years after initial testing. For subjects ≥13 years of age, the mean annual change in binocular scores in letters was −0.67 (p=0.01), −0.82 (p=0.04), and −1.58 (p=0.01) for HCVA, LCLA 2.5%, and LCLA 1.25%, respectively. For subjects &lt;13 years, the mean annual change in binocular scores was 2.31 (p=0.008), 1.71 (p=0.003), and 2.03 (p=0.04) for HCVA, LCLA 2.5%, and LCLA 1.25%, respectively. For all levels of contrast, subjects &lt;7 years of age demonstrated the greatest mean annual changes. <h3>Conclusions:</h3> While HCVA, LCLA 2.5%, and LCLA 1.25% increase annually in children &lt;13 years, scores are expected to remain constant or slightly decrease thereafter. Given variabilities in normal visual acuity changes across the age span, clinicians should use caution when interpreting treatment response or disease progression based on such measures. <b>Disclosure:</b> Mr. Sollee has nothing to disclose. Amy Lavery has nothing to disclose. An immediate family member of Geraldine Liu has received publishing royalties from a publication relating to health care. Dr. Pistilli has nothing to disclose. Gui-Shuang Ying has nothing to disclose. Dr. Waldman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for SwanBio. An immediate family member of Dr. Waldman has stock in Pfizer. The institution of Dr. Waldman has received research support from Ionis Pharmaceuticals. Dr. Waldman has received publishing royalties from a publication relating to health care.

Association Between Self And Caregiver Reported Sleep Problems And Polysomnographic Findings In Post-stroke Patients: A Cross Sectional Study. (S20.007)

<h3>Objective:</h3> To determine post-stroke sleep disturbances (PSSD) by polysomnography (PSG) and compare them with patient and caregiver reported symptoms and sleep questionnaires <h3>Background:</h3> Post stroke sleep disturbances (PSSD) are common with prevalence of 70–80%. The awareness of patients and caregivers about the various sleep problems and its implications on quality of life &amp; outcome has not studied extensively. Identification can aid in optimum management and rehabilitation of post-stroke patients. <h3>Design/Methods:</h3> In a cross-sectional study, we screened post-stroke patients (between one month to one year after stroke onset) &amp; their caregivers about various sleep problems. This was done by a screening questionnaire, followed by specific sleep questionnaires (Pittsburgh sleep quality index (PSQI) and STOP BANG questionnaire). A subset of consenting patients underwent overnight PSG. The association of sleep questionnaires with PSG findings were done. <h3>Results:</h3> In the study period (January 2021 and June 2022), 103 post-stroke patients were enrolled, of which 41(39.8%) underwent PSG. While only 15.5% (16/103) patients and/or caregivers reported any sleep disorders themselves, when specifically asked about insomnia, snoring, excessive daytime sleepiness &amp; abnormal leg movements in sleep, this number increased to 60.2% (60/103). Further, a PSQI&gt;5, signifying poor sleep quality was present in 71.8% (74/103), and high risk of obstructive sleep apnea (OSA) by STOP BANG questionnaire was present in 33% (34/103). PSG showed Apnea Hypopnea Index (AHI)&gt;5 in 65.9% (27/41) patients, 39% (16/41) had periodic leg movements (PLMS) and 34.2% (14/41) had disrupted sleep. Even when patients &amp; caregivers had denied any sleep disturbances, the PSG in 29 such patients showed OSA in 62 % (18/29) and PLMS in 34.5% (10/29). <h3>Conclusions:</h3> The study provided insight into the knowledge gap between patient &amp; caregiver perceived sleep disturbances &amp; sleep questionnaires and polysomnography. Longitudinal studies are warranted in this population to assess the effect of treatment of sleep disturbances on outcomes like quality of life and stroke recurrence. <b>Disclosure:</b> Dr. Tayade has nothing to disclose. Dr. Vibha has nothing to disclose. Dr. Tripathi has nothing to disclose. Rajesh Kumar Singh has nothing to disclose. Dr. Elavarasi has stock in Pfizer. Dr. Elavarasi has stock in PGHL. The institution of Dr. Elavarasi has received research support from All India Institute of Medical Sciences, New Delhi. The institution of Dr. Elavarasi has received research support from Indian Council for Medical Research.

Effects of ALZ-801, an Oral Amyloid Oligomer Inhibitor, on Biomarkers of Alzheimer’s Disease (AD): 12-Month Results of Phase 2 Biomarker Study in Early AD (S26.007)

<h3>Objective:</h3> To evaluate effects of ALZ-801 on plasma and imaging biomarkers of AD pathology. <h3>Background:</h3> ALZ-801 (valiltramiprosate) is an oral small molecule inhibitor of amyloid oligomer formation. Fully enrolled Phase 2 study in APOE4 carriers is evaluating effects on plasma biomarkers, including hyperphosphorylated tau (p-tau₁₈₁) and beta amyloid (Aβ42 and Aβ40). Plasma p-tau₁₈₁ is elevated in AD and reduced by efficacious doses of lecanemab and aducanumab. APOLLOE4 Phase 3 trial is ongoing in Early AD patients with APOE4/4 genotype. <h3>Design/Methods:</h3> Phase 2 study enrolled subjects with MMSE ≥ 22 and CDR-G 0.5/1, and amyloid positive by CSF or PET scans who received ALZ-801 265 mg BID over 2 years (7 European sites). Biomarker analyses were conducted with Lumipulse (CSF) and Simoa (plasma) assays at Dr. Kaj Blennow’s laboratory. Hippocampal volume (HV) atrophy was assessed by Clario. Changes from baseline were analyzed in mITT population on observed data with paired t-tests and 2-sided p-values. <h3>Results:</h3> mITT population included 84 subjects with 75 completing 52 weeks. Mean age was 69 years, 51% female, MMSE 26.0, 70/30% MCI/Mild AD. Significant plasma p-tau₁₈₁ reduction started at 13 weeks and reached −41% at 52 weeks (p=0.016), with significant reduction in plasma Aβ42 and Aβ40 at 52 weeks (−5%, p=0.002 &amp; p=0.005). Hippocampal atrophy was reduced by 25% compared to matched ADNI controls. Composite cognitive Z-score improved significantly at 13 and 26 weeks and remained above baseline at 52 weeks. Common adverse events were mild nausea and COVID infection, with no drug-related serious events or ARIA-E. <h3>Conclusions:</h3> ALZ-801 produced a significant reduction of plasma p-tau₁₈₁, a marker of amyloid-induced neuronal injury in AD, as well as slowing of hippocampal atrophy at 1 year and cognitive stabilization, suggesting a disease modifying effect in AD patients. These biomarker and clinical effects are being confirmed in the Phase 3 trial. <b>Disclosure:</b> Dr. Hey has received personal compensation for serving as an employee of Alzheon. Dr. Hey has stock in Alzheon. Dr. Hey has stock in Alzheon. Dr. Hey has received intellectual property interests from a discovery or technology relating to health care. Dr. Abushakra has received personal compensation for serving as an employee of Alzheon Inc. Dr. Abushakra has stock in Alzheon Inc. The institution of Dr. Abushakra has received research support from NIA. Dr. Abushakra has received intellectual property interests from a discovery or technology relating to health care. Kaj Blennow has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen, Axon, JOMDD, Roche, Siemens. Kaj Blennow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Julius Clinical. Kaj Blennow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MagQu. Dr. Scheltens has nothing to disclose. Dr. Hort has received personal compensation in the range of $0-$499 for serving as a Consultant for Alzheimerchain. Dr. Hort has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Hort has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Schwabe. Dr. Hort has stock in Alzheon. Dr. Sheardova has stock in Alzheon. Niels Prins has nothing to disclose. Mrs. Rutgers has received personal compensation for serving as an employee of Brain Research Center Amsterdam B.V.. Dr. Dautzenberg has nothing to disclose. Dr. Pazdera has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Pazdera has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Patrick Kesslak has nothing to disclose. Rosalind Mandelbaum has nothing to disclose. Dr. Power has received personal compensation for serving as an employee of Alzheon. Dr. Power has stock in Pfizer. Dr. Power has stock in Alzheon. Dr. Tolar has received personal compensation for serving as an employee of Alzheon. Dr. Tolar has received intellectual property interests from a discovery or technology relating to health care.

Prevalence of Elevated Intracranial Pressure in Alexander Disease (S2.005)

<h3>Objective:</h3> To determine the prevalence of elevated intracranial pressure (ICP) in subjects with Alexander disease (AxD). <h3>Background:</h3> AxD is caused by a gain of function mutation in <i>GFAP</i> and formation of Rosenthal fibers. With a predilection for perivascular, subpial, and subependymal astrocytes, Rosenthal fibers are hypothesized to impair CSF circulation, resulting in increased ICP. <h3>Design/Methods:</h3> Subjects with AxD, confirmed by <i>GFAP</i> testing and enrolled in a natural history study, were included. Study procedures included neurologic exam, LP with opening pressure (OP), and brain MRI. OP was conservatively defined as elevated if &gt;28 cm H2O. MRIs were reviewed by a neuroradiologist (masked to clinical data and OP) for imaging signs of elevated ICP (e.g., flattened sclerae, enlarged optic nerve sheaths, empty sella, and sinus venous stenoses). Linear mixed effects regression was used to explore OP as a function of age. Random forest analysis was used to predict OP from imaging variables. <h3>Results:</h3> Sixty-one LPs were performed in 40 subjects; 20 (50%) had elevated OP on at least one LP. Eighteen subjects had longitudinal LPs; 9 demonstrated an increase in OP compared to baseline, while the others were stable (N=2) or decreased (N=5, all asymptomatic and untreated). The remaining 2 subjects received acetazolamide for headache and vomiting with symptom benefit and reduced OP. There was no association between age and OP (p=0.19). Anesthesia (N=35) and procedures were well tolerated without complications. Twenty-one subjects (totaling 28 LPs) had an undilated fundus exam ≤1 day prior to the LP; none had papilledema. MRI features of elevated ICP predicted high OP (R²=0.637). <h3>Conclusions:</h3> Elevated OP and MRI features of elevated ICP occur frequently in AxD, even in the absence of clinical signs. The implications of elevated ICP on patients’ outcomes and whether elevated ICP requires treatment need to be determined in patients with AxD. <b>Disclosure:</b> The institution of Mr. Joung has received research support from Ionis Pharmaceuticals. Mr. Sollee has nothing to disclose. Miss Gallison has nothing to disclose. An immediate family member of Geraldine Liu has received publishing royalties from a publication relating to health care. Ms. Cooper has nothing to disclose. Mr. Faig has nothing to disclose. Dr. McClung has nothing to disclose. The institution of Dr. Drum has received research support from American Society of Anesthesiologists. Dr. Narula has received personal compensation in the range of $0-$499 for serving as a Consultant for Medscape . Dr. Liu has received publishing royalties from a publication relating to health care. Dr. Avery has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid. Dr. Avery has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. The institution of Dr. Avery has received research support from NIH. Dr. Avery has received intellectual property interests from a discovery or technology relating to health care. Dr. Vossough has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Syneos Health. Dr. Vossough has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for DeepSight. Dr. Vossough has received publishing royalties from a publication relating to health care. Dr. Waldman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for SwanBio. An immediate family member of Dr. Waldman has stock in Pfizer. The institution of Dr. Waldman has received research support from Ionis Pharmaceuticals. Dr. Waldman has received publishing royalties from a publication relating to health care.

Impact of Medication Optimization and Recommendations by Clinical Pharmacists Embedded in a Memory Disorder Clinic (P3-7.005)

<h3>Objective:</h3> The purpose of this study is to determine the impact of pharmacist recommendations on reduction of potentially inappropriate medications (PIMs) in an older adult population with dementia or mild cognitive impairment (MCI). <h3>Background:</h3> Older adults with dementia or MCI are particularly vulnerable to adverse effects from PIMs. Many PIMs are anticholinergic medications which have been correlated with development of cognitive impairment in older adults. Previous studies have demonstrated that pharmacist interventions may reduce PIMs in older adults, but the impact of pharmacists embedded in an outpatient memory care clinic has not been adequately studied. <h3>Design/Methods:</h3> This prospective interventional study within an outpatient neurology center included patients at least 65 years old and diagnosed with dementia or MCI. Pharmacists utilized the American Geriatrics Society Beers Criteria, the Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions, and the Anticholinergic Burden Scale (ACB) to identify PIMs and made recommendations to prescribers when appropriate based on clinical judgement. Primary outcomes included frequency and prevalence of PIMs before vs. after pharmacist intervention and rate of acceptance of pharmacy recommendations. Additional outcomes included ACB scores before vs. after intervention. <h3>Results:</h3> A total of 180 patients were included. Pharmacists made recommendations for 49% of patients. Common pharmacist recommendations included laboratory monitoring, medication discontinuations or substitutions. Out of 192 total pharmacist recommendations, 61 (32%) were accepted by providers within the neurology center’s memory clinic. After pharmacist intervention, the frequency and prevalence of PIMs as well as ACB scores were significantly reduced (p &lt; 0.01). <h3>Conclusions:</h3> Pharmacist intervention resulted in a significant reduction in PIMs and ACB scores in patients with dementia or MCI. Future studies should incorporate a prospective design to examine the clinical benefit of pharmacist intervention and explore additional methods to improve multidisciplinary collaboration between pharmacists and prescribers. <b>Disclosure:</b> Dr. Mattle has nothing to disclose. Miss Coli has nothing to disclose. Miss Lee has nothing to disclose. Dr. Aladeen has nothing to disclose. Dr. Ajtai has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Rainka has stock in Abbvie. Dr. Rainka has stock in acadia. Dr. Rainka has stock in alon. Dr. Rainka has stock in biogen. Dr. Rainka has stock in bristol myers squib. Dr. Rainka has stock in eisai. Dr. Rainka has stock in Lilly. Dr. Rainka has stock in novartis. Dr. Rainka has stock in pfizer. Dr. Rainka has stock in roche. Dr. Rainka has stock in Sage. Dr. Rainka has stock in alkermes.

Valproic Acid is an Effective Anti-Emetic Treatment in Alexander Disease (P10-9.010)

<h3>Objective:</h3> To explore safety and effectiveness of anti-emetic strategies in Alexander disease (AxD). <h3>Background:</h3> Emesis is a frequent symptom in AxD and leads to inadequate intake and food avoidance behaviors. As a result, weight loss and failure to thrive are common in AxD. We explored emesis treatment strategies to determine their relative benefits and side effects in clinical practice. <h3>Design/Methods:</h3> Medical records of patients with AxD (&lt;21 years) participating in a natural history cohort study were reviewed for history of emesis, difficulty with weight gain, and medications. Patients were retrospectively evaluated for response to medication, which was defined as a clinically meaningful decrease in emesis. Treatment failure was defined as no improvement, worsened emesis, clinically significant weight loss, or presence of an intolerable side effect. Deceased patients, patients with a Nissen fundoplication, and patients with insufficient longitudinal data were excluded. Fisher’s exact tests were used to compare response rates of valproic acid to those of anti-reflux medications (proton pump inhibitors, H2 antagonists analyzed together) or cyproheptadine. <h3>Results:</h3> Among 59 subjects with vomiting, 34 subjects met inclusion criteria. Emesis was treated with multiple anti-reflux medications (N=24), cyproheptadine (N=19), and valproic acid (VPA, N=22). Overall, 48% of patients responded to multiple anti-reflux medications, 32% responded to cyproheptadine, and 95% responded to VPA. VPA had a higher success rate in reducing emesis compared to multiple reflux medications (p=0.0001) or cyproheptadine (p&lt;0.0001). Adverse effects from VPA included bone fractures (N=1) in a non-ambulatory patient, hyperammonemia (N=2) which resolved with dose lowering, and mild hair loss (N=2). <h3>Conclusions:</h3> Recognizing the limitations of retrospective review, 95% of AxD patients on VPA showed improvements in emesis and weight gain. Response rates to VPA were greater compared to anti-reflux medications or cyproheptadine. VPA is well tolerated overall, although use should be monitored for known adverse effects. <b>Disclosure:</b> Ms. Sergio has nothing to disclose. Miss Gallison has nothing to disclose. Dr. Porcari has nothing to disclose. The institution of Mr. Joung has received research support from Ionis Pharmaceuticals. Mr. Faig has nothing to disclose. An immediate family member of Geraldine Liu has received publishing royalties from a publication relating to health care. Dr. Waldman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for SwanBio. An immediate family member of Dr. Waldman has stock in Pfizer. The institution of Dr. Waldman has received research support from Ionis Pharmaceuticals. Dr. Waldman has received publishing royalties from a publication relating to health care.

Prevalence of Amyloid-Related Imaging Abnormalities in APOE4/4 Homozygotes with Early Alzheimer’s Disease: Baseline Findings from Ongoing Clinical Trials of Oral Anti-Amyloid Agent ALZ-801 (Valiltramiprosate) (P5-6.003)

Prevalence of Amyloid-Related Imaging Abnormalities in APOE4/4 Homozygotes with Early Alzheimer’s Disease: Baseline Findings from Ongoing Clinical Trials of Oral Anti-Amyloid Agent ALZ-801 (Valiltramiprosate) (P5-6.003)

Case of a Pure Arterial Malformation and Review of the Literature. (P12-5.029)

<h3>Objective:</h3> NA <h3>Background:</h3> Pure arterial malformations are dilated, overlapping, and tortuous arteries forming a mass of arterial loops without a venous component. These malformations are rare, with limited cases reported in the literature. Affecting any of the intracranial arteries, they are usually found incidentally and often have a benign course. <h3>Design/Methods:</h3> We present a case of a pure arterial malformation in a young female with hyperprolactinemia. Furthermore, we review the literature and provide an updated summary of these malformations. <h3>Results:</h3> A 28-year-old female with a history of infantile hemangiomas, polycystic ovary syndrome, and hyperprolactinemia presented with acne, mild hirsutism, and galactorrhea. Her neurological exam was normal. Magnetic Resonance Imaging (MRI) of the brain with and without contrast ruled out a prolactinoma but revealed a 3 cm vascular malformation at the margin of the left cavernous sinus extending posteriorly into the anterior left perimesencephalic cistern. Initial differentials included a pial arteriovenous malformation or less likely a dural arteriovenous fistula. A diagnostic cerebral angiogram revealed a pure arterial malformation without arteriovenous shunting. This was composed of dysplasia of the left posterior communicating artery and anterior choroidal arteries. Stenosis of the left internal carotid artery distally with collateral support into the left anterior cerebral artery and middle cerebral artery was also noted. Genetic testing for vascular malformation syndromes, including genes known to be associated with hereditary hemorrhagic telangiectasia, was negative. Repeat MRI/MRA done 8 months from the initial scan revealed no abnormal large arterial venous shunting or definite saccular aneurysm formation. <h3>Conclusions:</h3> Although rare, pure arterial malformations should be considered in the differential diagnosis for patients presenting with a cranial vascular malformation. Management of these lesions is usually conservative given their lack of arteriovenous shunting and low risk of rupture, with only a few cases undergoing surgery or endovascular treatment. <b>Disclosure:</b> Dr. Ahmed has nothing to disclose. Dr. Regenhardt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Rapid Medical. Dr. Regenhardt has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Johnson and Bell Trial Lawyers. The institution of Dr. Regenhardt has received research support from National Institutes of Health. The institution of Dr. Regenhardt has received research support from Society of Vascular and Interventional Neurology. The institution of Dr. Regenhardt has received research support from Heitman Foundation. Dr. Vranic has nothing to disclose. Dr. Dmytriw has nothing to disclose. James D. Rabinov has stock in Pfizer.

Associations Between CDR-Global and Meaningful Outcomes in Patients with Alzheimer’s Disease (P5-6.010)

Associations Between CDR-Global and Meaningful Outcomes in Patients with Alzheimer’s Disease (P5-6.010)

International Capital Flows and Dynamic Changes in Pfizer Stock Prices: A Long-term Perspective

The stock and exchange rate markets play central roles in domestic and international trade. Since volatility of either one of them can bring significant impact to any business. It is essential to find how changes in exchange rate influence the stock market so that policymakers can build appropriate regulations to boost the national stock market, and investors may invest by taking the minimum risk. This paper selects the stock of a well-known multinational firm, Pfizer, and the US dollar index from October 27, 2005, to September 5, 2019. It applies the ADF test to validate the stationarity of the sample data, the VAR model with IRF to investigate whether the increasing exchange rate brings a positive effect on Pfizer's stock return or not, and the ARMA-GARCHX model to study whether the volatility of exchange rate is significant to changes of Pfizer's stock return in the long run. The study's findings indicate that the exchange rate volatility does not have a long-term relationship with Pfizer's stock price.

Evidence of Abnormal Trading on COVID-19 Pfizer Vaccine Development Information

The 2019 COVID-19 pandemic led to an economic slowdown worldwide and shook the investment world. Pharmaceutical investments were influenced by the anticipation of COVID-19 vaccine developments. Our study examines the real-time impact of public announcements concerning COVID-19 vaccine developments on stock returns and volatilities for Pfizer, Moderna, and the S&amp;P 500. Market Return and Information Event methodology were used to analyze stock activities immediately before important public COVID-19 vaccine development announcements related to Pfizer and Moderna vaccines. This methodology was employed for vaccine news announcements between 2 January 2020 and 4 March 2022. Stock returns and volatility were analyzed with time-series regression analysis. Findings demonstrated that increased trade volatilities occurred immediately prior to COVID-19 vaccine development news was made public. Specifically, Pfizer stock returns were significantly higher (above the mean) immediately before positive COVID-19 vaccine development information was made public. Also, increased volume volatility was observed for Pfizer, Moderna, and the S&amp;P 500 index stocks immediately before positive vaccine development information concerning Pfizer and Moderna vaccines were made public. These findings suggest that the vaccine information may have been leaked before being made public. If so, the findings may indicate that investors were taking advantage of insider information while trying to mitigate the appearance that they engaged in insider trading.

Pfizer Stock Price Prediction Based on Extreme Learning Machine

Nowadays, an Extreme learning machine (ELM) is known to be a fast learning algorithm of single-hidden layer feedforward neural network (SLFNs), and overcomes the disadvantages of the classical learning algorithm in neural network methods multiple iterations, huge search space and a large number of calculations, only needs to set the appropriate numbers of hidden layer nodes, assigns the weight of input and deviation of hidden layers without iteration. Research shows that the stock market is a very complex nonlinear system, which requires artificial intelligence theory, statistics theory and economic theory to study the stock price forecast. In this paper, ELM is introduced in predicting the stock price of Pfizer company, and by comparing it with SVM and BP, we analyze its feasibility and advantage in stock price prediction. The experiment results show that ELM is of high accuracy of prediction and apparent advantages in parameter selection and learning speed．

Valuing treatment in oncology: embracing a broader notion of value.

Over the past decade, we have witnessed unprecedented, groundbreaking innovation in pharmaceuticals. This has been particularly true in oncology, where new therapies have increased survival and at times offered clinical cure. However, the impact of these promising treatments has been attenuated by persistent access and cost challenges that may limit their effect. A narrative has emerged that many of these so-called breakthroughs are not priced according to the value they provide. Traditional cost-effectiveness analyses would appear to support these doubts, often suggesting that innovative therapies do not represent value for money. However, there is a case to be made that innovative therapies require equally innovative value assessments. To explore this emerging viewpoint, this article provides a brief introduction to the current value debate and oncology-specific considerations when assessing elements of value. We offer a brief background on the nature and development of quality-adjusted life-years as a part of cost-effectiveness analyses and some of their key limitations; a primer on "novel" elements of value, which capture specific aspects of patient and societal preferences not included in quality-adjusted life-years; and their applicability to oncology including discussion on areas where further thought and research might be needed. We conclude with a potential checklist of novel elements of value that should be considered. DISCLOSURES: This Viewpoints article was funded by Novartis, Inc., which also provided funding to COVIA Health Solutions for manuscript development. The sponsor was involved in developing the manuscript. Kamal-Bahl and Puckett are employees of COVIA Health Solutions, a consulting firm that provides services to biopharmaceutical clients, trade organizations, and foundations. Kamal-Bahl holds stock in Merck and Pfizer. Singh is an employee of Novartis Pharmaceuticals. Willke received personal fees from COVIA Health Solutions for work on the manuscript.

Payer perceptions on the use of patient-reported outcomes in oncology decision making.

BACKGROUND: In oncology, especially with accelerated regulatory approvals and niche populations, US payers appreciate all evidence that can help support formulary decision making, including evidence beyond traditional safety and efficacy data from clinical trials. Research suggests payers incorporate patient-reported outcome (PRO) evidence in their decision making and expect the importance of PRO evidence to grow. Greater understanding on payers' use of PRO information in oncology is needed. OBJECTIVE: To assess US payer perceptions regarding the use of PRO evidence in informing oncology formulary decision making. METHODS: A multidisciplinary steering committee involving a measurement specialist, health economics and outcomes research experts, and payers developed a survey containing single-answer, multiple-answer, and free-response questions. The pilot survey was tested at a mini-advisory board with 5 US payers and revised based on feedback. In February 2020, the survey was distributed to 221 US payers through the AMCP Market Insights program and 10 additional payer panelists who were invited to discuss and contextualize the survey results. Results were presented primarily as frequencies of responses and evaluated by plan size, type of health plan, and geography (regional vs national). Differences in categorical data responses were compared using Pearson chi-square or Fisher exact tests. Two-tailed values are reported and a P value less than or equal to 0.05 was used to indicate statistical significance. RESULTS: Overall, 106 of 231 payers (45.9%) completed the survey; 45.5% represented small plans (< 1 million lives), and 54.5% represented large plans (≥ 1 million lives). Respondents were largely pharmacists (89.9%), with 55.6% of all respondents indicating their job was pharmacy administrator. The majority of payers (60.0% of small health plans and 57.8% of large plans) felt PRO evidence from clinical trials is useful. Similarly, the majority of payers (57.8% of small plans and 51.9% of large plans) felt PRO evidence from real-world studies is useful. Almost half (47.1%) suggested formulary review would be influenced by a lack of PRO evidence from oncology clinical trials either somewhat, much, or a great deal. Most payers (78.2%) thought PRO evidence is useful for providing additional context for safety of oncology therapies. More than one-third of payers (34.3%) valued PRO evidence when comparing 2 similar therapies, and 51.5% felt PRO evidence may help in measuring value for value-based agreements. Panelists indicated PRO evidence can be useful for developing treatment pathways for addressing health-related quality of life, informing provider-patient dialogues, and defining progression-free survival length and quality. CONCLUSIONS: US payers view PRO evidence from both clinical trials and real-world studies as useful for supplementing traditional clinical trial data when making oncology formulary decisions and for refining treatment pathways and care delivery models. Manufacturers of oncology therapies should collect and consider leveraging PRO evidence from both settings when engaging with US payers. DISCLOSURES: Pfizer provided funding for this research, and employees of Pfizer contributed to the development of the survey instrument, were involved in the interpretation of the data, and contributed to the discussion and output as authors. Biskupiak, Oderda, and Brixner are managers of Millcreek Outcomes Group and were paid as consultants on this project. Burgoyne was a consultant for Pfizer on this project. Arondekar, Deal, and Niyazov are employees of Pfizer and own Pfizer stock. Qwek was an employee of Pfizer at the time of this project and owns Pfizer stock.

Greater uptake, an alternative reimbursement methodology needed to realize cost-saving potential of oncology biosimilars in the United States.

BACKGROUND: Biologics are an important treatment option for solid tumors and hematological malignancies but are a primary driver of health care spending growth. The United States has yet to realize the promise of reduced costs via biosimilars because of slow uptake, partially resulting from commercial payer reimbursement models that create economic incentives favoring the prescribing of reference biologics. OBJECTIVE: To examine the economic feasibility of an alternative reimbursement methodology that prospectively shares savings across commercial payers and providers to shift economic incentives in favor of lower-cost oncology biosimilars. METHODS: Using 3 oncology monoclonal antibody drugs (trastuzumab, bevacizumab, and rituximab) as examples, we developed an alternative reimbursement model that would offer an additional per unit payment (or "extra consideration") such that providers' net income per unit for biosimilars and reference biologics become equal. Provider-negotiated rates (or payer-allowable amounts) and average sales prices were obtained from claims data and projected to develop prices/costs from 2021 through 2025. Scenario analyses by varying key model assumptions were performed. RESULTS: The alternative reimbursement model achieved 1-year and 5-year payer savings in the commercial market for all 3 drugs in the sites of service analyzed. The base analysis showed first-year cost savings to payers, net of cost sharing, of up to 9% in physician offices (POs) and up to 1% in non-340B hospital outpatient departments (HOPDs) for patients using the drugs analyzed. Five-year cumulative savings per patient ranged from about $12,600-$16,100 in PO and $2,200-$4,100 in HOPD. Payer savings varied depending on the characteristics of the provider with which the payer was negotiating (eg, lower- vs highermarkup providers, POs vs HOPDs). CONCLUSIONS: Positive payer savings shown in our modeling suggest that an alternative reimbursement arrangement could facilitate an economic compromise wherein commercial payers can save on biosimilars while providers' incomes are preserved. DISCLOSURES: Research funding was provided by Pfizer Inc. Yang and Shelbaya are employees of Pfizer Inc. and own Pfizer stock. Carioto, Pyenson, Smith, Jacobson, and Pittinger are employees of Milliman Inc., which received research funding from Pfizer Inc., for work on this study. Milliman, Inc., provides actuarial and other professional services to organizations throughout the healthcare industry. None of these are contingent, equity or investment relationships.

Treatment utilization patterns of newly initiated oral anticancer agents in a national sample of Medicare beneficiaries.

BACKGROUND: Few studies have examined oral anticancer treatment utilization patterns among Medicare beneficiaries. OBJECTIVE: To assess treatment utilization patterns of newly initiated oral anticancer agents across national samples of Medicare beneficiaries for 5 cancer types: chronic myeloid leukemia (CML), multiple myeloma (MM), metastatic prostate cancer (mPC), metastatic renal cell carcinoma (mRCC), and metastatic breast cancer (mBC). METHODS: This retrospective claims analysis used 100% Medicare Chronic Condition Data Warehouse (CCW) Parts A, B, and D files from 2011 to 2014 (for CML, MM, mPC, and mRCC patients) and a 5% random fee-for-service sample from 2011 to 2013 (for mBC patients). Outcomes of interest were the number of 30-day supply prescriptions, adherence, and discontinuation of newly initiated (ie, index) oral anticancer agents indicated for each of the cancers. Adherence was calculated with both the "traditional" proportion of days covered (PDC) approach, measured over a fixed 1-year period or until hospice/death, and a "modified" PDC approach, measured over the time between the first and last fill of the index oral anticancer agent. Patients with PDC of at least 0.80 were deemed as being adherent. Discontinuation was defined as the presence of a continuous 90-day gap in the availability of days supply of the index oral anticancer agent. RESULTS: Our study included 1,650, 7,461, 6,998, 2,553, and 79 patients for CML, MM, mPC, mRCC, and mBC, respectively. Patients with mRCC had the highest proportion of patients with only 1 fill of their index anticancer agent (28%) followed by mBC (17%), MM (17%), mPC (12%), and CML (12%). Patients with CML had the highest mean (SD) number of 30-day supply equivalent prescriptions (8.3 [4.6]), followed by patients with mPC (6.5 [4.2]), MM (5.7 [4.1]), mBC (4.7 [3.2]), and mRCC (4.5 [3.9]). Using the modified PDC measured between the first and last fills, approximately three-quarters of patients with CML (74%), mRCC (71%), and mBC (70%) were adherent to the index oral anticancer agent. Adherence was highest for patients with mPC (87%) and lowest for patients with MM (58%). The percentage of patients defined as adherent to the index oral anticancer agent decreased for all cancers when using the traditional PDC measure over a fixed 1-year period: CML (54%), MM (35%), mPC (48%), mRCC (37%), and mBC (22%). Rates of discontinuation for patients in our sample were 32% (CML), 38% (mPC), 42% (mRCC), 48% (MM), and 58% (mBC). CONCLUSIONS: Between 13% and 42% of Medicare patients were nonadherent between the first and last fill of their newly initiated oral anticancer therapies across a range of cancers. This study provides a valuable benchmark for stakeholders seeking to measure and improve adherence to oral anticancer agents in Medicare patients. DISCLOSURES: This study was supported by Humana, Inc. (Louisville, KY). The sponsor played a role in the development of the study protocol, interpretation of results, and revisions of the manuscript. The sponsor was not involved in data analysis. Brown is employed by Humana, Inc., and Ward was employed by Humana, Inc., from research inception through initial drafts. Doshi has served as an advisory board member or consultant for Allergan, Ironwood Pharmaceuticals, Janssen, Kite Pharma, Merck, Otsuka, Regeneron, Sarepta, Sage Therapeutics, Sanofi, and Vertex and has received research funding from AbbVie, Biogen, Humana, Janssen, Novartis, PhRMA, Regeneron, Sanofi, and Valeant. Her spouse holds stock in Merck and Pfizer. All other authors have no financial conflicts of interest to report.

Analysis of Pfizer Inc. under COVID-19

Pfizer, a global pharmaceutical company, and the spearhead for a COVID-19 vaccine, is situated to grow in the future, through short-term vaccine rollout and long-term development of oth-er pharmaceutical products and markets with its leading position in the pharmaceutical market. Pfiz-er stock has ample opportunity to grow in the future, both in the short and long term.

Epidemiology and treatment patterns for locally advanced or metastatic urothelial carcinoma: a systematic literature review and gap analysis.

BACKGROUND: Several immuno-oncology (IO) agents targeting programmed death-1 or programmed death-ligand 1 (PD-1/L1) are approved second-line therapy options for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) previously treated with platinum-based chemotherapy or first-line options in patients ineligible for cisplatin whose tumors express PD-L1 or for any platinum-based chemotherapy regardless of PD-L1 expression levels. However, literature on the epidemiology of la/mUC is limited, and real-world treatment patterns are not well established, especially with respect to therapies used following IO. OBJECTIVES: To (a) report the epidemiology of urothelial carcinoma (UC) and la/mUC; (b) identify and summarize the published literature on la/mUC treatment patterns, including IO and post-IO treatment; and (c) identify evidence gaps. METHODS: A systematic literature review was conducted using Cochrane dual-reviewer methodology and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Literature databases and selected congress abstracts (2017-2018) were searched for retrospective studies published January 2013-August 2018 in English reporting epidemiological and treatment data (all lines of therapy) for adult patients with la/mUC. RESULTS: Among 6,584 database references and 1,832 congress abstracts screened, 45 publications (29 manuscripts, 1 poster, 15 abstracts; reporting 37 unique studies) were retained. All studies related to treatment patterns, and the majority were from the United States (n = 17), Japan (n = 8), and the United Kingdom (n = 5). Epidemiological data were not identified among the searches thus online registries were leveraged. Among the identified publications, 21 (20 unique) reported on cisplatin versus non-cisplatin regimens, 14 (8 unique) on IO, and 9 (7 unique) on vinflunine. Cisplatin use varied both within and among countries (ranging from 18.4% in 1 U.S. study to 87.9% in 1 Japanese study). The use of IO was higher in later lines of therapy, ranging from 1.4% to 7.9% as first-line therapy to 57.8% as second-line and 64.4% as third-line therapy. Among studies reporting IO discontinuation rates, 41.4%-71% of patients were reported to discontinue IO across the studies, and the median time to discontinuation ranged from 2.7 to 5.8 months. Only 25%-35.5% of patients received subsequent therapy following IO discontinuation; post-IO treatments varied widely. CONCLUSIONS: Additional published data on the country-specific epidemiology of UC and la/mUC are needed, including rates of progression from early-stage disease to la/mUC. There was large variation in treatment rates, particularly cisplatin use, within and across countries. The few published real-world IO studies reported high levels of discontinuation with only a small percentage of patients receiving subsequent therapy. As IO therapies continue to be granted regulatory approval in countries outside the United States and novel therapies gain approval in the post-IO setting, the treatment paradigm for patients with la/mUC is shifting, and future studies with more recent data will be required. DISCLOSURES: This study was funded by Astellas/Seagen. Hepp is an employee of and owns stock in Seagen. Shah was a contractor for Astellas Pharma at the time of the study and owns stock in Pfizer. Smoyer is an employee and shareholder of Envision Pharma Group, paid consultants to Seagen. Vadagam was an employee of Envision Pharma Group, paid consultants to Seagen, at the time of the study. Parts of these data have been presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2019 Annual Meeting; May 18-22, 2019; New Orleans, LA.

Addiction as a Coping Response: Hyperkatifeia, Deaths of Despair, and COVID-19.

Addiction as a Coping Response: Hyperkatifeia, Deaths of Despair, and COVID-19.

Avelumab Alone or in Combination with Chemotherapy vs Chemotherapy Alone in Platinum-Resistant or Platinum-Refractory Ovarian Cancer (JAVELIN Ovarian 200): A Randomised, Open-Label, Phase 3 Study

Avelumab Alone or in Combination with Chemotherapy vs Chemotherapy Alone in Platinum-Resistant or Platinum-Refractory Ovarian Cancer (JAVELIN Ovarian 200): A Randomised, Open-Label, Phase 3 Study