Functional Studies Sample Clauses

Functional Studies. To determine the function of novel proteins, both in vivo and in vitro models are utilized. In both cases the research involves two major approaches; firstly, administration of purified protein at varying doses and times of treatment, secondly, administration of an antisense oligonucleotide directed at the novel gene sequence to block expression of the protein product. Subsequently, a variety of metabolic parameters are measured and gene expression of key enzyme pathways determined. The availability of real-time PCR technology in our laboratories allows us to quickly and confidently quantitate changes in expression in tissue samples following protein treatment. Each phase of the research program is currently underway and running simultaneously; different genes identified are at various stages of development throughout the program. At the end of the research and development program, we will have identified a number of new genes involved in obesity development; we will have produced their protein products and further developed this research by determining the basic function of the novel protein in tissue culture systems and in whale animal studies. The result will be key lead compounds for further development by Lipha in Stage We currently have identified eight novel genes and these genes will proceed through various stages of the above research plan during 1999/2000. The development and progress achieved with each of these previously identified novel genes and new genes uncovered will be reported to the Autogen Scientific Advisory Board under the following Milestones-,
Sample 1
AutoNDA by SimpleDocs
Functional Studies. The H24 peptide is currently being chemically synthesised and should arrive early July. It will be used to ICV treat Psammomys obesus animals to examine if it has an effect on food intake, body weight or glucose or insulin levels. 8 A, 8 B and 8 C animals will be treated with 30 ug/day for 7 days and if an effect is seen 15 ug and 3 ug doses will be administered into further animals to establish a dose response. Polyclonal antibodies will be raised to H24. H24 conjugated to KLH will be made and injected into rabbits. After 4 months (including 2-3 boosters), the antibodies will be isolated and purified, including Westerns to confirm the specificity of the antibody for H24. [*] Research Plan Hypothesis Altered expression/activity of [*] contributes to type 2 diabetes. Background Several methods of gene discovery simultaneously identified the various components of this system as being differentially expressed in obese, type 2 diabetic Psammomys obesus. Differential display PCR in muscle of Psammomys obesus was used to identify [*] and microarray analysis showed differential expression of calpastatin in diabetic animals. Subsequent analyses demonstrated that [*] was overexpressed in the muscle of diabetic animals and the expression of this proteolytic enzyme was associated with blood glucose concentration independent of body weight and plasma insulin levels. Both fasting and 2-week dietary energy restriction significantly reduced the expression of CAPN3. In addition, calpastatin (CAST; endogenous inhibitor of [*]) gene expression was significantly reduced by fasting and dietary energy restriction in muscle. CAST was also overexpressed in the liver of diabetic and obese animals. Together these results suggest that dysregulation within the [*] system may be involved in the pathophysiology of obesity and/or type 2 diabetes in Psammomys obesus. Research Plan
Sample 1

Related to Functional Studies

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Development Plan As defined in Section 3.2(a).

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Time is Money Join Law Insider Premium to draft better contracts faster.