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2. Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

Author

Stephenson, D., Alexander, R., Aggarwal, V., Badawy, R., Bain, L., Bhatnagar, R., Bloem, B.R., Boroojerdi, B., Burton, J., Cedarbaum, J.M., Cosman, J., Dexter, D.T., Dockendorf, M., Dorsey, E.R., Dowling, A.V., Evers, L.J.W., Fisher, K., Frasier, M., Garcia-Gancedo, L., Goldsack, J.C., Hill, D., Hitchcock, J., Hu, M.T., Lawton, M.P., Lee, S.J. van der, Lindemann, M, Marek, K., Mehrotra, N., Meinders, M.J., Minchik, M., Oliva, L., Romero, K., Roussos, G., Rubens, R., Sadar, S., Scheeren, J., Sengoku, E., Simuni, T., Stebbins, G., Taylor, K.I., Yang, B., Zach, N., Stephenson, D., Alexander, R., Aggarwal, V., Badawy, R., Bain, L., Bhatnagar, R., Bloem, B.R., Boroojerdi, B., Burton, J., Cedarbaum, J.M., Cosman, J., Dexter, D.T., Dockendorf, M., Dorsey, E.R., Dowling, A.V., Evers, L.J.W., Fisher, K., Frasier, M., Garcia-Gancedo, L., Goldsack, J.C., Hill, D., Hitchcock, J., Hu, M.T., Lawton, M.P., Lee, S.J. van der, Lindemann, M, Marek, K., Mehrotra, N., Meinders, M.J., Minchik, M., Oliva, L., Romero, K., Roussos, G., Rubens, R., Sadar, S., Scheeren, J., Sengoku, E., Simuni, T., Stebbins, G., Taylor, K.I., Yang, B., and Zach, N.

Abstract

Contains fulltext : 229477.pdf (publisher's version ) (Open Access), Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved b

Published
2020

9. Zichtbaar maken van gemeentelijke beleidsvrijheid

Author

Brandsen, T., de Graaf, L.J., Hendriks, F., van den Munckhof, E.D., Hanemaayer, D., Kalders, P., Scheeren, J., and Legitimiteit, vitaliteit en meervoudigheid: staat, stad en maatschappelijk bestuur in een netwerksamenleving

Published
2006

11. Bevorderen van deelname en deelnamekansen aan een leven lang leren

Author

Baert, Herman, Van Damme, D, Douterlungne, Mia, Baert, T, De Meester, K, Kusters, Walter, Scheeren, J, Van Wiele, Isabel, and Wouters, Martine

Abstract

Afdeling Sociale pedagogiek en gezinspedagogiek. Centrum voor Sociale en beroepspedagogiek. Centrum voor Permanente vorming in beroepen en organisaties (CPVBO) Hoger instituut voor de Arbeid (HIVA) Departement Pedagogische wetenschappen. ispartof: Werkt de arbeidsmarkt? Beleidsgericht arbeidsmarktonderzoek in Vlaanderen / Stuurgroep Strategisch Arbeidsmarktonderzoek (Eds.). - Antwerpen: Standaard Uitgeverij pages:207-220 ispartof: pages:207-220 status: published

Published
2002

32. Synthesis of ( S )-(-)-Propranolol by Using Cs 2.5 H 0.5 PW 12 O 40 Nanocatalyst as Green, Eco-Friendly, Reusable, and Recyclable Catalyst.

Author

Gharib, Ali, Jahangir, Manouchehr, Roshani, Mina, Pesyan, Nader Noroozi, Scheeren, J. (Hans) W., Mohadesazadeh, Sara, and Lagzian, Shirin

Subjects
CHEMICAL synthesis, PROPRANOLOL, CATALYSTS recycling, METAL catalysts, NANOSTRUCTURED materials
Abstract

The Cs2.5H0.5PW12O40nanoparticle catalyst appear to be a new and efficient solid acid catalyst for an economical, environmentally benign synthesis of (S)-(-)-propranolol. Cs2.5H0.5PW12O40nanocatalyst are used as a new, recyclable and reusable. Synthesis of (S)-(-)-propranolol is carried out in two steps with usual reagents: heteropolyacid, (+)-tartaric acid catalyzed enantioselective synthesis of (S)-(-)-propranolol via kinetic resolution of key intermediate α-naphthyl glycidyl ether with high optical and chemical yield. With this synthesis, we have two products in the first reaction and it is not necessary to purify the crude oil. This by-product is removed in the second step by extraction and yield is satisfactory. The nanocatalyst of Cs2.5H0.5PW12O40catalyzed the synthesis of propranolol in high yields and good selectivity. [ABSTRACT FROM PUBLISHER]

Published
2015
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42. Acetylation of p-Aminophenol by Preyssler's anion [NaP5W30O110]14-, [NaP5W29MoO110]14-with green condition at room temperature

Author

Gharib, Ali, Scheeren, J., Bamoharram, Fatemeh, Roshani, Mina, and Jahangir, Manouchehr

Abstract

Acetylation of p-Aminophenol by Preyssler's anion [NaP5W30O110]14-, [NaP5W29MoO110]14-with green condition at room temperatureSynthesis of acetaminophen at green condition and room temperature in the presence of the Preyssler type heteropolyacids has been investigated in order to contribute toward clean technology, which is the most important need of the society. All of the catalysts are recyclable and reusable.

Published
2009
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48. Crystal and molecular structure of dihydro-8b,8c-diphenyl-1H,3H,4H,5H,7H,8H,-2,6-dioxa-3a,4a,7a,8a-tetraazacyclopenta[def]fluorene-4,8-dithione

Author

Gieling, G. T. W., Nolte, R. J. M., Scheeren, J. W., Smits, J. M. M., Beurskens, Paul T., and Beurskens, Gezina

Abstract

The title compound C20H18N4O2S2 crystallizes in the monoclinic space group P21/n witha=8.4930(1) Å,b=11.4880(1) Å,c=20.0709(2) Å, ß=94.933(1)°,V=1951.01(3) Å3,Z=4. The crystal structure has been solved by vector search methods and refined by fullmatrix least-squares toR=0.04 for 2888 reflections and 116 restraints. The title compound has a suitable geometry for synthesizing receptor molecules with a cleft for selective complexation.

Published
1995
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49. Changes in the Renin-Angiotensin-Aldosterone System and in Sodium and Potassium Balance during Development of Renal Hypertension in Rats

Author

Leenen, F. H. H., Scheeren, J. W., Omylanowski, D., Elema, J. D., Van Der Wal, B., and De Jong, W.

Abstract

1. The relationships between the renin-angiotensin-aldosterone system, sodium and potassium balance and systolic blood pressure were studied during development of moderate (160–180 mmHg; clip i.d. 0.25 mm) and severe (200–230 mmHg; clip i.d. 0.20 mm) renal hypertension in rats with an undisturbed contralateral kidney. 2. In severely hypertensive rats renin activity in the peripheral plasma increased from day 9, by which time the systolic blood pressure was elevated to 160–180 mmHg. The rate of total corticosteroid and aldosterone production in vitro increased from day 14 and plasma renin substrate concentration increased from day 24. In moderately hypertensive rats, none of these changes occurred. 3. During the first 10 days after the application of 0.25 and 0.20 mm clips, sodium and potassium retention/g gain in body weight were higher than in sham-operated controls. During the next 10 days, the positive balance stabilized in animals with a 0.25 mm clip whereas, in animals with a 0.20 mm clip, sodium and potassium balance returned to the level of the sham-operated controls through increased renal losses. Despite these changes the systolic pressure rose further in animals with a 0.20 mm clip. 4. The initial sodium retention could be a factor in the early rise of blood pressure and could account for the delay in the rise of peripheral plasma renin activity. The subsequent loss of the retained sodium and potassium during the development of severe hypertension could have facilitated the rise in peripheral plasma renin activity, but did not initiate this rise.

Published
1975
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