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Within the global community, the only constant is change. In Spring 2020, as COVID-19 became a global pandemic, countries closed their borders and closed schools, businesses, and governments. Universities that already had significant online presences and available courses/programs could be reassured that at least some of their programming would continue with minimal interruption. Effective university leaders were able to identify paths forward for their institutions that encompassed their education and were much more able to support faculty, staff, and students with the abrupt change. The authors look at professors as learning leaders, the leadership in higher education institutions, as well as leadership in the private sector. They examine how andragogical leadership can be utilized to shift current educational practices and consider how we might shape learning environments in order to foster more robust learning environments. But essentially, they explain how education leaders develop and organize institutional learning as technology continues to play an essential role.

Background Heregulin is a ligand for the protooncogene product ErbB/HER that acts as a key mitogenic factor for human Schwann cells (hSCs). Heregulin is required for sustained hSC growth in vitro but must be thoroughly removed before cell collection for transplantation due to potential safety concerns. The goal of this study was to develop simple cell-based assays to assess the effectiveness of heregulin addition to and removal from aliquots of hSC culture medium. These bioassays were based on the capacity of a β1-heregulin peptide to elicit ErbB/HER receptor signaling in adherent ErbB2+/ErbB3+ cells. Results Western blotting was used to measure the activity of three different β1-heregulin/ErbB-activated kinases (ErbB3/HER3, ERK/MAPK and Akt/PKB) using phospho-specific antibodies against key activating residues. The duration, dose-dependency and specificity of β1-heregulin-initiated kinase phosphorylation were investigated, and controls were implemented for assay optimization and reproducibility to detect β1-heregulin activity in the nanomolar range. Results from these assays showed that the culture medium from transplantable hSCs elicited no detectable activation of the aforementioned kinases in independent rounds of testing, indicating that the implemented measures can ensure that the final hSC product is devoid of bioactive β1-heregulin molecules prior to transplantation. Conclusions These assays may be valuable to detect impurities such as undefined soluble factors or factors for which other biochemical or biological assays are not yet available. Our workflow can be modified as necessary to determine the presence of ErbB/HER, ERK, and Akt activators other than β1-heregulin using native samples, such as fresh isolates from cell- or tissue extracts in addition to culture medium.

The declining trend of international student enrollment in the United States has been investigated from the standpoint of social discrimination, and more recently, by accounting for the compounding effects of COVID-19-based campus closures and remote learning operations. The purpose of this study was to explore whether experiences of campus alienation are related to difficulties international students faced while accessing campus services remotely. A survey was developed and validated for the study. It was completed by 417 international students attending US postsecondary institutions. A canonical correlation was conducted to evaluate the multivariate shared relationships between campus exclusion, COVID-19 racism, and country of origin as one set of variables, and difficulties accessing campus services remotely (DASCR) and international travel difficulties as the other set. Results revealed one significant canonical function; this model explained 27% of variance shared between the two variable sets. Indicators of shared variance provided evidence for significant relationships between experiences characterizing campus alienation and DASCR. Implications are drawn in light of policy and program development, and practical examples are provided for postsecondary educators on how to offer pertinent outreach to their international students and advocate for inclusive campus policies in managing international student engagement remotely during campus closure.

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatment options, many patients seek access to cell-based therapies for the possibility of treatment responses demonstrated in clinical trials. Here, we describe the use of the FDA’s expanded access to investigational new drug (IND) to address rare and emergency conditions that include stiff-person syndrome, spinal cord injury, traumatic brain stem injury, complex congenital heart disease, ischemic stroke, and peripheral nerve injury. We have administered both allogeneic bone marrow-derived mesenchymal stem cell (MSC) and autologous Schwann cell (SC) therapy to patients upon emergency request using Single Patient Expanded Access (SPEA) INDs approved by the FDA. In this report, we present our experience with 10 completed SPEA protocols.

Purpose Leber hereditary optic neuropathy (LHON) is a disorder characterized by severe and rapidly progressive visual loss when caused by a mutation in the mitochondrial gene encoding NADH:ubiquinone oxidoreductase subunit 4 (ND4). We have initiated a gene therapy trial to determine the safety and tolerability of escalated doses of an adeno-associated virus vector (AAV) expressing a normal ND4 complementary DNA in patients with a G to A mutation at nucleotide 11778 of the mitochondrial genome. Design In this prospective open-label trial (NCT02161380), the study drug (self-complementary AAV [scAAV]2(Y444,500,730F)- P1ND4v2 ) was intravitreally injected unilaterally into the eyes of 5 blind participants with G11778A LHON. Four participants with visual loss for more than 12 months were treated. The fifth participant had visual loss for less than 12 months. The first 3 participants were treated at the low dose of vector (5 × 10 9 vg), and the fourth participant was treated at the medium dose (2.46 × 10 10 vg). The fifth participant with visual loss for less than 12 months received the low dose. Treated participants were followed for 90 to 180 days and underwent ocular and systemic safety assessments along with visual structure and function examinations. Participants Five legally blind patients with G11778A LHON. Main Outcome Measures Loss of visual acuity. Results Visual acuity as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart remained unchanged from baseline to 3 months in the first 3 participants. For 2 participants with 90-day follow-up, acuity increased from hand movements to 7 letters in 1 and by 15 letters in 1, representing an improvement equivalent to 3 lines. No one lost vision, and no serious adverse events were observed. Minor adverse events included a transient increase of intraocular pressure (IOP), exposure keratitis, subconjunctival hemorrhage, a sore throat, and a transient increase in neutralizing antibodies (NAbs) against AAV2 in 1 participant. All blood samples were negative for vector DNA. Conclusions No serious safety problems were observed in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitochondrial disorder. Additional study follow-up of these and additional participants planned for the next 4 years is needed to confirm these preliminary observations.

Common barriers to broad-based adoption of Computer Science in secondary schools include 1) insufficient numbers of trained teachers who are capable of teaching CS courses in K-12 schools, and 2) a narrow base of students interested in taking CS courses which does not include a large number of females or students from traditionally underrepresented racial groups. In an effort to overcome these obstacles, we developed and employed a teacher professional development program to develop both content and pedagogical strategies to teach Computer Science Principles while also broadening and expanding participation in CS. Teachers were selected for this program in an effort to understand the impact of the intervention with teachers of diverse backgrounds, who teach in a variety of types of schools and with diverse student populations, and with a range of previous Computer Science content knowledge and teaching experience. Teacher content mastery, confidence and attitudes, as well as student content mastery and confidence were assessed at multiple times. Key goals of the program were to develop ability and confidence in programming skills among teachers and students, and to train and encourage teachers to use peer instruction, allowing for a great deal of interaction among students and engagement with the content facilitating the development of expertise among students. Significant findings showed that teachers improved in both knowledge and confidence after taking the workshop, and the gains were evident for their students as well. Their students also demonstrated improvement in both skills and confidence after taking CS Principles, regardless of gender, race, or ethnicity.

The transplantation of rodent Schwann cells (SCs) provides anatomical and functional restitution in a variety of spinal cord injury (SCI) models, supporting the recent translation of SCs to phase 1 clinical trials for human SCI. Whereas human (Hu)SCs have been examined experimentally in a complete SCI transection paradigm, to date the reported behavior of SCs when transplanted after a clinically relevant contusive SCI has been restricted to the use of rodent SCs. Here, in a xenotransplant, contusive SCI paradigm, the survival, biodistribution, proliferation and tumorgenicity as well as host responses to HuSCs, cultured according to a protocol analogous to that developed for clinical application, were investigated. HuSCs persisted within the contused nude rat spinal cord through 6 months after transplantation (longest time examined), exhibited low cell proliferation, displayed no evidence of tumorigenicity and showed a restricted biodistribution to the lesion. Neuropathological examination of the CNS revealed no adverse effects of HuSCs. Animals exhibiting higher numbers of surviving HuSCs within the lesion showed greater volumes of preserved white matter and host rat SC and astrocyte ingress as well as axon ingrowth and myelination. These results demonstrate the safety of HuSCs when employed in a clinically relevant experimental SCI paradigm. Further, signs of a potentially positive influence of HuSC transplants on host tissue pathology were observed. These findings show that HuSCs exhibit a favorable toxicity profile for up to 6 months after transplantation into the contused rat spinal cord, an important outcome for FDA consideration of their use in human clinical trials.

Leber hereditary optic neuropathy (LHON) is a disorder characterized by severe and rapidly progressive visual loss when caused by a mutation in the mitochondrial gene encoding NADH:ubiquinone oxidoreductase subunit 4 (ND4). We have initiated a gene therapy trial to determine the safety and tolerability of escalated doses of an adeno-associated virus vector (AAV) expressing a normal ND4 complementary DNA in patients with a G to A mutation at nucleotide 11778 of the mitochondrial genome.In this prospective open-label trial (NCT02161380), the study drug (self-complementary AAV [scAAV]2(Y444,500,730F)-P1ND4v2) was intravitreally injected unilaterally into the eyes of 5 blind participants with G11778A LHON. Four participants with visual loss for more than 12 months were treated. The fifth participant had visual loss for less than 12 months. The first 3 participants were treated at the low dose of vector (5 × 10(9) vg), and the fourth participant was treated at the medium dose (2.46 × 10(10) vg). The fifth participant with visual loss for less than 12 months received the low dose. Treated participants were followed for 90 to 180 days and underwent ocular and systemic safety assessments along with visual structure and function examinations.Five legally blind patients with G11778A LHON.Loss of visual acuity.Visual acuity as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart remained unchanged from baseline to 3 months in the first 3 participants. For 2 participants with 90-day follow-up, acuity increased from hand movements to 7 letters in 1 and by 15 letters in 1, representing an improvement equivalent to 3 lines. No one lost vision, and no serious adverse events were observed. Minor adverse events included a transient increase of intraocular pressure (IOP), exposure keratitis, subconjunctival hemorrhage, a sore throat, and a transient increase in neutralizing antibodies (NAbs) against AAV2 in 1 participant. All blood samples were negative for vector DNA.No serious safety problems were observed in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitochondrial disorder. Additional study follow-up of these and additional participants planned for the next 4 years is needed to confirm these preliminary observations.

Deccan basalts of west-central India are hydrogeologically inhomogeneous rocks. A proper understanding of the physical framework of the basalts within which groundwater resides and moves is a key to the hydrogeology of these rocks. Two types of basalt, the vesicular amygdaloidal basalt and the compact basalt, occur as alternate layers in the volcanic pile. Although the rocks are generally inhomogeneous, structures in the basalt, such as sheet joints and vertical joints, serve as zones of groundwater flow. In the shallow subsurface, two groundwater systems are operative. Groundwater system A consists of a vesicular amygdaloidal basalt underlain by a compact basalt, whereas groundwater system B consists of a vesicular amygdaloidal basalt overlain by a compact basalt. Groundwater system A has a better developed network of openings and, as a consequence, this system has a higher transmissivity and storage coefficient than groundwater system B. Wells tapping groundwater system A have higher yields on average and irrigate more hectares of cropland than do wells tapping groundwater system B. This simple systems concept offers a practical methodology for understanding the geometry of the physical framework that contains groundwater in the Deccan basalts. The efficacy of the concept is in its widespread utility for the region. The concept may also be extrapolated to help understand the hydrogeology of deeper Deccan basalt groundwater systems.

In India, groundwater resources from the hard-rock regions in general and from the Deccan Volcanic Province in particular are being obtained from 115-mm, 152-mm and 165-mm diameter bore holes (commonly known as bore wells). With no definite criteria for pump selection, these bore wells are either overdeveloped or underutilized, and the groundwater resources are thereby being mismanaged. PUMPS is a computer program that helps select a proper pumping system on a bore well in the Deccan basalt, taking into account the productivity of the bore well and considering a stabilized drawdown above the main aquifer tapped by the bore well. This method of pump selection has yielded encouraging results and all the bore wells with pumping systems installed using PUMPS have proven to be effective in providing the required yields without overstressing the aquifers.

DUGREC is a computer program to estimate hydraulic conductivities for the Deccan basalts of India. Large-diameter dugwells are still a very common source of water supply in the Deccan basaltic region of west-central India. It is easier to conduct accurate recovery tests rather than conventional pumping tests on large-diameter dugwells in the Deccan basalts of India. DUGREC is a program written in BASICA for IBM PC microcomputers and compatibles to calculate hydraulic conductivity values for the shallow unconfined Deccan basaltic aquifers using dugwell recovery data.

The recent series of ad interim orders issued by the Bombay High Court under ordinary original civil jurisdiction following public interest litigation (PIL) on the provision of free clotting factor concentrates for persons living with haemophilia, especially those below the poverty line and emergency cases, highlights the need to think about the ethicality of various aspects of access to medicine and the rights of patients suffering from rare diseases from the public health perspective. The PIL (number 82/2012) [Vinay Vijay Nair and Ors vs. Department of Health, State of Maharashtra and Ors), which calls for free treatment for all haemophiliacs who go to the designated hospitals, was followed by the issuance of five ad interim orders (July 19, 2012, October 22, 2012, November 6, 2012, January 24, 2013, and March 19, 2013).