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Drug Development Computer modeling and simulation help researchers to better visualize pulmonary functions for faster, less expensive clinical testing of innovative respiratory drugs.
By Jan De Backer, CEO, FluidDA nv, Kontich, BelgiumThierry Marchal, Healthcare Industry Director, ANSYS, Inc.
The cost of developing a new inhalation therapy drug for cut years from the development process and reduce costs respiratory diseases such as asthma, emphysema and by hundreds of millions of dollars.
cystic fibrosis is estimated at more than $1 billion — the The current gold standard for testing airway diseases highest in the pharmaceutical industry. This figure is is FEV1, the volume of air exhaled during the first second considerably more than for developing medications to of a forced expiratory maneuver started from the level of treat cancer or neurological disorders.[1] total lung capacity. Another approach in widespread use The main cause of this extremely high cost is that for assessing patients with pulmonary disorders is the current testing methods of evaluating respiratory drug Saint George Respiratory Questionnaire (SGRQ), a set of effectiveness are only coarse measures of patient long- questions aimed at comparative measurements of patient term outcome. Even so, such methods are extremely health.
time-consuming and expensive, as many patients must These methods were developed primarily to measure be tested over a long period of time. Researchers are long-term survival, but they lack the sensitivity to correlate addressing these issues with the emerging field of in silico with subtle differences in breathing that are more difficult modeling, which uses computer simulation to speed up to identify and quantify. Because of the uncertainty of medical studies and to provide greater detail than is these parameters and discrepancies between them, otherwise practical with extensive lab work and wide- researchers must spend considerable time and expense scale clinical trials. In particular, many in silico respiratory gathering data on drug effectiveness and averaging results studies are based on fluid dynamics simulation to generate accurate images of pulmonary functions, such Phase III
as airway volume and resistance for Animal Studies, Modeling .
20–300 Patients 300–5000 Patients Post–Registration individual patients. The technique already has been used in studying the Cost [million €] respiratory structures of animals and 1200 — because the same functional Patient-Specific Imaging and Simulation parameters can be measured in humans — enables researchers to Existing Test Averaging Results From Large Study Groups proceed more efficiently from pre- clinical to clinical trials. By accurately quantifying these relatively small changes in pulmonary functions, the approach can demonstrate respiratory Patent Expires at drug effectiveness more quickly using fewer patients. This has the potential to Potential cost and time reduction in respiratory drug development through patient-specific functional imaging and computer simulation Based on [1] ANSYS Advantage • 2010 Ansys, Inc.
across large groups of participants over extended periods of time.
The time frame for respiratory drug development is staggering. Preclinical animal studies typically take two to four years, then additional time is needed to transition from animal studies to human clinical trials due to the lack of correlation and common denominators between the different species. Subsequent clinical trials last five to seven years and can involve thousands of patients. Regulatory agencies take up to three years to interpret and verify the clinical trial findings. The total time adds up to nine to 14 years before registration of the drug occurs and the medicine is available by prescription from healthcare professionals.
This leaves pharmaceutical companies with only a few years to recoup development costs before the 15-year patent limit expires. Lengthy development drives up the retail price of respiratory drugs, severely delaying their availability to patients. The process often discourages pharmaceutical companies from risking considerable amounts of resources for an uncertain ROI (return on investment).
By quantifying a new class of functional parameters linked more closely to pulmonary changes, computer modeling and simulation have the potential to significantly lower the time and cost of respiratory drug development. Resulting patient-specific functional-imaging data is an important component of this emerging field, called translational medicine. Researchers in this discipline continually search for parameters that can facilitate the transition of drugs from preclinical to clinical stages. Such Assessment of changes in airway volume and resistance through methods already have been used to represent animal functional imaging using computational fluid dynamics[2] The Medical Value of in Silico Analyses
With the rapidly increasing computational power of
to the technology for future work. Likewise, the standard PCs and the refinement of biomaterial Grid-Enabled Medical Simulation System (GEMSS) models, clinicians are showing a growing interest in project aims to make biomedical vertical applications the routine use of simulation. Clinicians do not have available from the web with encouraging successes the luxury of learning advanced user interfaces, in applications such as stent interfaces.
however, so they need seamless interfaces between Ongoing projects such as the Virtual Physiological medical imaging and engineering simulation software. Human Osteoporosis Project (VPHOP), RT3S and Furthermore, a fully integrated workflow must be ANGIOVISION multiply the opportunities to assist developed for large-scale deployment of this the medical world in lengthening life expectancy technology in local hospitals.
and increasing quality of life through more effective Several successful attempts to make numerical orthopedic, stent and endovascular treatments, modeling accessible and useful to the clinical respectively. The upcoming decade will undoubtedly world involve ANSYS tools. The @neuFuSE toolchain see the development of computer-assisted surgery (www.aneurIST.org) allows physicians to access more (CAS) and the rapid penetration of in silico tech- information about the risk of cerebral aneurysm nology throughout the medical world, including in rupture, for example. During one recent @neurIST facilities close to home.
workshop, 90 percent of attending neurosurgeons confirmed the clear added value brought by this Healthcare Industry Director solution and indicated high interest in gaining access ANSYS Advantage • Volume IV, Issue 2, 2010 Tracheobronchial Tree Segmentation of Sprague Dawley rat respiratory system[4] illustrates modeling of the airway structures and corresponding lobar volumes derived from CT scans.
respiratory structures in studying inhalation profiles and inhaler selection and modeling has the potential to shorten deposition patterns for different respiratory devices. In the development time from patent filing to registration these studies, the common parameters of airway volume by years and to save hundreds of millions of dollars if and resistance determined through functional imaging the approach is used throughout the entire process of provide for a more efficient transition from preclinical to bringing a single drug to market.
clinical trials.
The impact of such savings could be stunning. When By changing the slope of the cost curve in a graph of costs for the development of new compounds are development cost versus time, this translational approach reduced, the prices of these products could be lowered could alter the cost slope from preclinical to clinical trials without affecting profit margins, thus allowing for and significantly reduce expenses over the entire cycle. continuous research and development of innovative Furthermore, the approach could compress development new compounds in the pharmaceutical industry. time, moving registration forward much sooner and thus ultimately, the process could facilitate more sustainable increasing the time for the pharmaceutical company healthcare systems.
to market products under patent protection. Indeed, Such savings are entirely possible in the foreseeable patient-specific imaging and simulation coupled with future, given the tremendous strides made in previous Phase III
Animal Studies, Particle Deposition Modeling, 300–5000 Patients 20–300 Patients Post-Registration Safety & Efficacy Computer-based functional imaging facilitates the translational approach in respiratory drug development through the use of common parameters in moving from preclinical studies to clinical trials.
ANSYS Advantage • 2010 Ansys, Inc.
studies and ongoing work in computer-based modeling and inhalation devices. Successes in this body of work and simulation. Promising work already is pushing the demonstrate the value of functional imaging in both envelope of functional imaging technology. Recent preclinical and clinical development stages as well as the developments in the field of computational fluid dynamics tremendous potential of the approach in revolutionizing and structural simulations have made it possible to the development of new inhalation compounds for simulate pulmonary airflow behavior in the pulmonary combating respiratory disease and improving the quality airways as well as to characterize surrounding tissue. The of life for patients worldwide. nresearch is based on geometries extracted directly from high-resolution computed tomography (HRCT) scans.
Based on this work, computer-based technologies [1] Adams, C.P.; Brantner, V.V. Estimating the Cost of New Drug have the potential for researchers to perform modeling Development: Is It Really 802 Million Dollars? Health Affairs, 2006,
Mar–Apr, 25(2), pp. 420–428.
and simulations to derive functional parameters such as [2] De Backer, J.W.; Vos, W.G.; Devolder, A.; Verhulst, S.I.; Germonpré, airway resistance as a biomarker on individual patients. A P.; Wuyts, F.L.; Parizel, P.M.; De Backer, W. Computational Fluid number of published trials — including FluidDA's studies Dynamics Can Detect Changes in Airway Resistance in Asthmatics — make use of these patient-specific HRCT-based After Acute Bronchodilation. Journal of Biomechanics, 2008, 41(1),
models that were able to describe the distinct flow pp. 106–113.
patterns in the respiratory system. Certain of these [3] Burge, P.S.; Calverley, P.M.; Jones, P.W.; Spencer, S.; Anderson, J.A.; Maslen, T.K. Randomised, Double-Blind, Placebo-Controlled Study studies focused on the effect of inhalation medication and of Fluticasone Propionate in Patients with Moderate to Severe assessment of subsequent changes in airway volume Chronic Obstructive Pulmonary Disease: the ISOLDE Trial. BMJ, and resistance through functional imaging using ANSYS 2000 (May 13), 320(7245), pp. 1297–1303.
FLuENT fluid dynamics software.[2] [4] De Backer, J.W.; Vos, W.G.; Burnell, P.; Verhulst, S.L.; Salmon, P.; De Correlation studies indicate good agreement with Clerck, N.; De Backer, W. Study of the Variability in Upper and Lower Airway Morphology in Sprague-Dawley Rats Using Modern Micro-CT clinical parameters. Similar methods can be used to Scan-Based Segmentation Techniques. The Anatomical Record, 2009,
assess animal respiratory structures in preclinical research May, 292(5), pp. 720–727.
ANSYS Advantage • Volume IV, Issue 2, 2010

Source: https://www.ansys.kr/staticassets/ANSYS/staticassets/resourcelibrary/article/AA-V4-I2-Taming-Cost-of-Respiratory-Drug-Development.pdf

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Tilladelse til gmp - viminco

Tilladelse til fremstilling og indførsel af lægemidler og mellemprodukter til human brug Manufacturer's / Importer's Authorisation regarding Human Medicinal Products Lægemiddelstyrelsen godkender hermed, at The Danish Medicines Agency hereby authorises 1. Autorisationsnummer Authorisation No. 22843 Virksomhed/fremstiller Name of manufacturer