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Criteria to Assess Potential Delayed Risks of Gene Therapy. We generally will not require long- term follow- up observations following exposure to gene transfer technology when the risk of delayed adverse events is low. To assess the risk related to your product, we recommend that you use available preclinical and clinical evidence. To assess the risks of delayed adverse events, you may use current information about your product and similar products based on studies that you and others have performed. As more data accumulates, it is important to reassess the risk to your subjects and, if appropriate, revise your protocol as it relates to long- term follow- up observations. We consider the assessment of risks to be a continuous process. New information may support the need for long- term follow- up observations or the revision of an existing study. For example, if recently reported evidence suggests a newly identified risk associated with your product or similar products, long- term follow- up observations may be necessary to mitigate long- term risks to subjects receiving these vectors. Similarly, if sufficient data accumulate to suggest that your product is not associated with delayed risks, it may be appropriate to reduce or eliminate provisions for long- term follow- up observations. Pertinent previous preclinical and clinical experience with your product or similar products is highly relevant in the assessment of delayed adverse events. JOURNAL OF PERSONALlTY ASSESSMENT. 1994.63(3), 534-553 Copyright O 1994. Lawrence Erlbaum Associates, Inc. Form C of the MHLC Scales: A Condition-Specific Measure of Locus of Control Kenneth A. ASSESSING SOCIAL SUPPORT 129 of satisfaction with the available support. These two factors in social support may vary in their relation to one another, depending on the individual's personality. Some people may think that only. Self-control, an aspect of inhibitory control, is the ability to control one's emotions and behavior in the face of temptations and impulses. As an executive function, self-control is a cognitive process that is necessary for.Experience with products in the same vector class, administered by a similar route, and given for the same clinical indication may contribute helpful information. We recommend you refer to the series of questions in Figure 1, “Framework to Assess the Risk of Gene Therapy- Related Delayed Adverse Events” to help you assess the level of risk. When the risk of delayed adverse events is low based on your answers to these questions, a plan for long- term follow- up observations may not be necessary to mitigate risks to subjects. Evidence from preclinical studies will help you answer questions 1 – 3. Rotter's Locus of Control Scale For each question select the statement that you agree with the most 1. Children get into trouble because their patents punish them too much. The trouble with most children nowadays is that. Rotter's Locus of Control Scale This is a questionnaire to find out the way in which certain important events in our society affect different people. Each item consists of a pair of alternatives lettered a or b. Multivariate logistic regression analysis was used to test the three hypotheses as to the effect of culture on the likelihood of (1) an internal locus of control orientation, (2) an innovative orientation, or (3) a combined. Include all of the primary data relevant to the assessment of the risk of delayed events when you submit your IND to FDA (see 2. CFR 3. 12. 2. 3(a)(8), (1. We suggest you use the framework in Figure 1 by answering the questions in sequence as follows: Question 1: “Is your gene therapy product used only for ex vivo modification of cells?”If the answer is “no,” go to Question 2. If the answer is “yes,” go to Questions 3 and 4. Question 2: “Do preclinical study results show persistence of vector sequences?”If the answer is “no,” the risk of gene therapy- related delayed adverse events is low, and long- term follow- up observations may not be needed. If the answer is “yes,” go to questions 3 and 4. If it is unknown whether your vector persists, for the purpose of assessing risk, we recommend that you either assume that it does persist, or perform a preclinical study to assay for vector persistence in a relevant animal species. Please refer to Section IV. B, “Considerations for Preclinical Study Design to Assess Vector Biodistribution and Persistence,” for help with preclinical trial design and details on the use and expected sensitivity of polymerase chain reaction (PCR) assay for biodistribution studies. In assays performed after the final administration of vector, persistence is indicated by detectable levels of vector sequences above the threshold level in the PCR assay and absence of an apparent downward trend over several time points. In contrast, persistence is unlikely if you cannot detect vector sequences with a sensitive PCR assay or if the assay for vector sequences demonstrates a downward trend over time. We encourage you to consult with OCTGT, CBER for specific advice about determination of persistence and biodistribution in your test system. Question 3: “Are vector sequences integrated?”. If the answer is “no,” go to question 4. If the answer is “yes,” we would require that clinical protocols with the product include clinical long- term follow- up observations. Question 4: “Does the vector have potential for latency and reactivation?”. If the answer is “no,” the risk is low that exposure to your gene transfer technology will be followed by gene therapy- related delayed adverse events. Long- term follow- up observations may not be needed. If the answer is “yes,” we would require that all your clinical protocols with the product include clinical long- term follow- up observations. Laboratory and preclinical evidence of the low risk of delayed adverse events following exposure to a similar product may show that long- term follow- up observations are not needed. If you provide data from a similar product, we can assess the relevance to your product if you provide a clear explanation. We provide the following two examples: Your product is a plasmid and the similar product is also a plasmid, but has different coding sequences for the proposed therapeutic gene product. The similar product has been used in preclinical and clinical studies, administered by an identical route and in an identical final formulation to that proposed in the prospective studies. Reference to a published study demonstrating lack of persistence of the vector for the similar product may adequately address concerns regarding the persistence of the proposed vector. Your proposed product and the similar product differ only with respect to route of administration. The similar product was administered into tumors (intratumorally). The proposed product is to be given intravenously. There is a published study demonstrating the lack of persistence of the vector when administered intratumorally. The data from the studies with the similar product are not sufficiently relevant, since there was no intended systemic exposure to the product. Thus, there is insufficient similarity to conclude that long- term follow- up observations are not necessary to mitigate long- term risks to subjects. In the absence of relevant data from a study involving a similar product, we recommend that you assess the risk of vector persistence in a preclinical study with the proposed product administered by the intravenous route. If you believe you have evidence from studies on a similar product that is adequate to support conclusions that the vector is unlikely to persist in human hosts and that the vector’s DNA does not integrate into the human genome, you may decide to submit a clinical protocol that does not provide for long- term follow- up observations. We will review such submissions and, if we disagree based upon our review of your submission or other additional information, we may conclude that long- term follow- up observations for delayed adverse events are necessary to mitigate long- term risks, and that without long- term follow- up observations, the study presents an unreasonable and significant risk to study subjects (2. CFR 3. 12. 4. 2(b)(1)(i) and (b)(2)(i)). We provide the following examples of evidence that might cause us to require you to perform long- term follow- up observations for delayed adverse events: A preclinical toxicology study indicates that expression of the transgene is associated with delayed toxicity. The transgene provides functional replacement of a host gene; the transgene product is potentially immunogenic. Data collected in your short- term clinical study indicate vector persistence, even though data from your preclinical studies suggested that the vector did not persist. Figure 1. Framework to Assess the Risk of Gene Therapy- Related Delayed Adverse Events. If you have evidence that suggests that the vector may integrate or if the vector was intentionally designed to facilitate integration (please refer to Table 1, Section IV. C), the answer is “yes.” If you have no evidence regarding integration, we recommend that you include preclinical study in your development plan to address this question. If you or others identify an increased risk of delayed adverse events from persistent gene expression or from exposure to your product based on additional information reported after your protocol is accepted, you should plan to perform long- term follow- up observations even if the answer to these questions is “No”. See Section IV. A of the text for examples. See Section V of the text for recommendations on how to perform clinical long- term follow- up observations. Return to Table of Contents. Considerations for Preclinical Study Design to Assess Vector Biodistribution and Persistence. As discussed in Section IV. A, vector persistence heightens the risk of delayed adverse events following exposure to gene transfer technology. Indeed, the longer the vector persists, the greater the duration and degree of risk of delayed adverse events. We recommend that you perform preclinical biodistribution studies using methods that are shown to be sensitive and quantitative to detect vector sequences. Such studies would be designed to determine the distribution of your vector in nontarget tissues and the persistence of the vector in both nontarget and target tissues following direct in vivo administration of the vector product. If possible and applicable, we recommend that the studies employ an animal species that permits vector transduction and/or vector replication and that the animal species be biologically responsive to the specific transgene of interest (Ref. The duration of the preclinical studies will vary, depending on the animal model employed. Projections of delayed adverse reactions in human subjects may be derived from assessment of data from appropriate long- term observational studies in animals, when possible. A biodistribution study in animals can be performed either as a separate study or as a component of a toxicology study. Consider the following points in your animal study design to permit evaluation of vector localization and persistence (Ref. Animal Study Design. The best free accounting software 2. Free accounting for home businesses. Whether you're a freelancer or a flautist, a graphic designer or a greengrocer, if you're running any kind of business you really need some kind of accounting software to stay on top of things - as we discovered, the age- old system of chucking everything into a drawer and panicking at tax return time isn't the best. But that doesn't mean you need to invest huge sums or learn something hopelessly complicated. The best free accounting software is easy to use and enables you to see how well you're doing and who owes you money. New Book: GnuCash 2.4 Small Business Accounting. 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This is the original arrangement and tempo of the March of the Belgian Paratroopers by Pierre Leemans. March Of The Belgian Paratroopers ScoreLGOP = Little Groups of Paratroopers). After the demise of the best Airborne plan, a most terrifying effect occurs on the battlefield. This effect is known as the rule of the LGOPs. This is, in its purest form, small groups of pissed- off 1. American Paratroopers. They are well- trained, armed- to- the- teeth and lack serious adult supervision. They collectively remember the Commander's intent as . I can't sleep at night; they pop up from nowhere and we never know when or how they will strike next. Seems like the black- hearted devils are everywhere..! Gavin (played by Ryan O'Neil in the film A Bridge Too Far about the epic battle for Arnhem's bridge to enter Germany and end the war, called . Wedded to obsolete traditions? Who says we have to use silly, useless D & C to instill fighting discipline in Soldiers? 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The men who fought in Vietnam need to know that their sacrifices did count- just ask the people of Thailand. But if we are to learn from our war there, we must not make excuses that the politicians . Crete was a costly victory for the Germans because of the . It was still a victory and proof deep Airborne operations can work in spite of no amphibious forces around to help. If you click on the hypelink above or here on Crete, you'll see the Royal Navy sank the amphibious forces that the Allied Commander defending the island thought were necessary to win. Years later, on Grenada the same thing happened, the enemy expected sea attack from marines, but instead, the Rangers and 8. Airborne came from long away and caught them by surprise. The invasion of Panama was a . Dien Bien Phu was a poorly selected firebase in the low ground, many other poorly defended positions have been over- ran that were established by ground and sea transport, also. In the Second Indo- China war, the U. The following is a list, albeit incomplete, of paratrooper forces from around the world.
S. Deep airdrops of combat power can work, its what you do afterwards on the ground that is the key. If you sit still, the enemy is likely to gain the initiative whether you walked, flew or motored there. After the Paratrooper lands he must be MORE MOBILE than any enemy and that can be done by speed- marching, solving the Soldier's load, human powered vehicles and airdropped armor. Army Air Service was doing . By the end of the war, we were combining arms as we would have to do again in WWII. Overhead, our planes gave close air support and bombed and strafed supply installations and troop columns in the rear of the German lines. French tanks manned by Americans supported the infantry assaults. The United States Army's first modern battle had begun. Putnam & Sons, NY. Thanks for showing me. Please keep me in mind for future areas of similar style. Although why anyone would want to jump out of a functional aircraft is still a mystery to me- . It is believed that Chinese acrobats used parachute- like devices as long ago as 1. The principle was recognized by several writers, and Leonardo da Vinci proposed the basic idea for parachutes in 1. Leonardo da Vinci sketched a man- sized parachute with a man in mind to be lowered by it, even though no one had ever flown. He visualized it as a tool to escape from tall buildings and structures in event of fire. The dimensions he calculated as necessary to safely land a person 3. A few years later other French aeronauts jumped from balloons. He made a number of exhibition jumps, including one of about 8,0. England in 1. 80. Cocking developed a parachute like an upside umbrella, he felt being upside down it would control oscillations ( to bad he didn't know about an apex hole) He demonstrated in 1. England suspended from a balloon named Nassau, and piloted by Charles Green, who cut him loose. It worked fine at first, but the stiffening tubes started to give way , then a hole developed in the canopy, then it collapsed (it was the first parachute fatality). Thomas Baldwin the younger brother got elected for the task, the brothers took the balloon to 5,0. The first successful descent from an airplane was made by Capt. Albert Berry of the United States Army in 1. In World War I, parachutes were used by observers to escape from captive balloons but were considered impractical for airplanes. Only in the last stage of the war were they finally used in aircraft. She had been jumping since she was fifteen years old. After that jump she was never seen again. The Generals report to the Army was great, but they ignored it, and later American pilots flew into combat without parachutes because the Generals thought they would abandon their planes at the very slightest chance of trouble, hence no parachutes. When it came time to depart the aircraft, they lifted the container from under the seat, stood on the seat and tossed the container over the side, then followed it, a little crude but it worked and all the other pilots envied them, especially since they had to ride theirs down in flames. Young. 1. 91. 8: Isolated French raids in WW I during which two- man demolition teams parachuted behind German lines to destroy communications. But Colonel Mitchell thought of others ways to use parachutes. To him goes the distinction of suggesting the first Airborne parachute assault forces. Army Air Corps during WWI even before they had chutes for American flyers! We could equip each man with a parachute, so when we desired to make a rear attack on the enemy, we could carry these men over the lines and drop them off at a prearranged strong point, fortify it, and we could supply them by aircraft with food and ammunition. Our low flying attack aviation would then cover every road in the vicinity, both day and night, so as to prevent the Germans falling on them before they could thoroughly organize the position. Then we could attack the Germans from the rear, aided by an attack from our Army from the front, and support the maneuver with our great Air Force. The idea came from the mind of a visionary who wouldn't live to see his ideas come into being. But he was proven right. The first use of Paratroops goes back to WWI when Italian officers landed behind Austrian lines for reconnaissance. Army Air Corps flew a field artillery battery complete with equipment to Panama as a demonstration of . Then, in maneuvers near Fort Du. Pont, Delaware, AAC Capt. Gliders had been towed 1,1. All pilots involved were women. The board was headed by Maj. Huffman, who sent letters to known jumpers in the country to demonstrate equipment and techniques that might be purchased by the government. He presented the first free- fall parachute, a concept that required the jumper to manually release the canopy with a rip cord instead of a static line. The Irvin model used a harness instead of a coat. The canopy was thirty two feet in diameter, with twenty four suspension lines. Instead of being extracted by a static line, the canopy was deployed by a pilot chute that sprang from the container when the jumper pulled the rip cord. Irvan proved them wrong by making a delayed- opening jump from 1,5. By 1. 92. 2 a parachute was a required part of the uniform of the military and airmail pilots, and the design remained unchanged for the next fifty years. The Initial collective drop was made at Cinisello Balsamo, near Milan, on 6 November 1. CA- 7. 3 troop carriers of the Regfa Aerornautica. The Italians used the Salvator static- line parachute and used no reserve, a policy decision that must have seemed mistaken to the unit's General Gutdoni as he fell to his death a year later, his Salvator streaming above htm m the dreaded . The Russians even had bombers and gliders to deliver tanks and . The French also started in 1. French were defeated before they could use them. They designed what was then called the T- 4 and was the first chute to have four risers so it could be steered. They also developed the reserve parachute, something only the U. S. No other nation, at that time, used reserves. |
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December 2016
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