Advances in translational science require innovative solutions, and engagement of productive transdisciplinary teams play a critical role. While various forms of scientific meetings have long provided venues for sharing scientific findings and generating new collaborations, many conferences lack opportunities for active discussions. We describe the use of an Un-Meeting to foster innovative translational science teams through engaged discussions across multidisciplinary groups addressing a shared theme. The Un-Meeting was delivered by the University of Rochester Center for Leading Innovation and Collaboration, the national coordinating center for the National Institutes of Health Clinical and Translational Science Awards (CTSA) program. This pilot CTSA program Un-Meeting focused on engaging translational scientists, policy-makers, community members, advocates, and public health professionals to address the opioid crisis. The participant-driven format leveraged lightning talks, attendee-led idea generation, and extensive breakout discussions to foster multidisciplinary networking. Results indicated participation by a broad set of attendees and a high level of networking during the meeting. These results, coupled with the growth of the Un-Meeting across the CTSA Consortium, provide practices and models to potentially advance team and translational science. While future work will further assess the impact of Un-Meetings, this format presents a promising approach to enhance translational science.

Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.

Rapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the technology and the guidelines that govern its application. Subsequently, there are challenges in determining appropriate regulatory pathways for evolving products at the initial research and developmental stages. Myriad factors necessitate several rounds of iterative review and the involvement of multiple divisions within the FDA. To better understand the regulatory science issues roiling around the area of additive manufacturing of medical products, a group of experts, led by a Clinical and Translational Science Award working group, convened the Regulatory Science to Advance Precision Medicine at the Fall Forum to discuss some of the current regulatory science roadblocks.

OBJECTIVES/SPECIFIC AIMS: To develop a regulatory science case study as an educational resource to inform the regulatory science considerations in medical product development for a range of scientific priority areas and emerging technologies. METHODS/STUDY POPULATION: Precision medicine represents one of the major regulatory science priority areas and the use of biomarkers holds promise for predicting the response to individual treatment strategies. Although progress has been made toward developing biomarkers, the development and validation of clinically useful biomarkers has presented significant regulatory science challenges, including the utilization of biomarkers in predicting responses to different cancer therapies. This case study reviews the technical, regulatory, and policy issues related to the development and use of lung cancer drugs Opdivo® and Keytruda® and an understanding of the codevelopment and utilization of their associated biomarkers. RESULTS/ANTICIPATED RESULTS: A detailed instructor guide with extensive resources such as diagrams and timelines will accompany the case study and will be used to highlight the development and approval process of 2 competing drugs and their associated biomarkers. The resources will provide a better understanding of their progression through the FDA regulatory process and opportunities and challenges for their use. DISCUSSION/SIGNIFICANCE OF IMPACT: Building on the case study framework we have developed, the detailed timelines and a collection of available resources, an extensive and modular case study will be finalized and made available to academic institutions, industry, regulatory agencies, and the public. The full case study and links to a series of resources will be disseminated as a standalone resource for integration into courses or programs interested in learning about specific regulatory science needs and opportunities to enhance medical product development and approval.

The discovery of the first electromagnetic counterpart to a gravitational wave signal has generated follow-up observations by over 50 facilities world-wide, ushering in the new era of multi-messenger astronomy. In this paper, we present follow-up observations of the gravitational wave event GW170817 and its electromagnetic counterpart SSS17a/DLT17ck (IAU label AT2017gfo) by 14 Australian telescopes and partner observatories as part of Australian-based and Australian-led research programs. We report early- to late-time multi-wavelength observations, including optical imaging and spectroscopy, mid-infrared imaging, radio imaging, and searches for fast radio bursts. Our optical spectra reveal that the transient source emission cooled from approximately 6 400 K to 2 100 K over a 7-d period and produced no significant optical emission lines. The spectral profiles, cooling rate, and photometric light curves are consistent with the expected outburst and subsequent processes of a binary neutron star merger. Star formation in the host galaxy probably ceased at least a Gyr ago, although there is evidence for a galaxy merger. Binary pulsars with short (100 Myr) decay times are therefore unlikely progenitors, but pulsars like PSR B1534+12 with its 2.7 Gyr coalescence time could produce such a merger. The displacement (~2.2 kpc) of the binary star system from the centre of the main galaxy is not unusual for stars in the host galaxy or stars originating in the merging galaxy, and therefore any constraints on the kick velocity imparted to the progenitor are poor.

A prevalence study of personnel on a Royal Naval Air Station revealed that 23·0% of 2479 personnel were carrying a meningococcus. Selected groups of personnel were subsequently swabbed monthly for a year. We have shown that it is only by repeated swabbing and the use of optimal methods including enrichment media that one can have a hope of identifying the ‘true’ carriage rate. A presumed virulent strain of Neisseria meningitidis B 15 P1·16 was repeatedly isolated from three personnel who remained well, as did their colleagues both at their work place and socially. The study served to emphasize our lack of knowledge of the virulence factors associated with N. meningitidis.

New types of transparent conductive oxides with low indices of refraction have been developed for use in optical stacks for the amorphous silicon (a-Si) solar cell and other thin film applications. The alloys are ZnO based with Si and MgF added to reduce the index of the materials through the creation of SiO2 or MgF2, with n=1.3-1.4, or the addition of voids in the materials. Alloys with 12-14% Si or Mg have indices of refraction at λ=800nm between 1.6 and 1.7. These materials are presently being used in optical stacks to enhance light scattering by Al/multi-layer/ZnO back reflectors in a-Si based solar cells to increase light absorption in the semiconductor layers and increase open circuit currents and boost device efficiencies. In contrast to Ag/ZnO back reflectors which have long term stability issues due to electromigration of Ag, these Al based back reflectors should be stable and usable in manufactured PV products. In this manuscript, structural properties for the materials will be reported as well as the performance of solar cell devices made using these new types of materials.

A new back reflector comprised of an Al/(multi-layered stack)/ZnO structure is being developed to replace Al/ZnO used in manufacturing and boost conversion efficiencies with improved back reflector performance. Use of the multi-layered stack should lead to improved reflectivity which will in turn improve solar cell currents and efficiencies. The results from studies of different transparent conductive oxides (TCOs) which comprise the multi-layered stack are reported with emphasis on ZnO alloys. Alloying with Si or MgF2 and using moderately high substrate temperatures, TCOs with low indices of refraction between 1.6 and 1.7 have been fabricated. The Si, Mg and F contents for these alloys were near 14, 12 and 33 at.%. Structural analysis demonstrates that alloys with MgF2 have smother surfaces and finer morphologies than those for ZnO. The expected high values for multi-layered structures with these alloys have yet to be achieved but this is likely due to properties of layers in the structure other than the ZnO alloys which have yet to be fully optimized.