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Expert is an independent modeling consultant from Huntsville, Alabama. Until recently, he was a senior principal scientist in CFD Research Corporation (CFDRC), Huntsville, Alabama. He has a strong background in PBBM/PBPK modeling and simulation methods, CFD, scientific computing, mathematical modeling and has combined them to create unique methods to analyze oral and inhalation forms of drug delivery. He is an IITian, Computational Scientist and a CFD Engineer with decades of research experience, software development & deployment, with a passion for solving real life problems. His out of the box thinking and problem solving abilities are demonstrated by peer-reviewed international publications, citations from 31 countries, 200+ times invited reviews for research manuscripts/grants, 20+ times aiding investors (predict drug approval chances using modeling), and multiple research grants from the government/private companies.

Since 2014, he has won grants from the FDA, NIH, DoD, private pharma (Merck, Gentuity) to create spatially resolved schemes for drug delivery. He is the principal inventor/developer of an algorithm that can solve the transport and absorption in cylindrical geometries, nearly 10000 times faster than CFD computations. He has optimized the oral and pulmonary drug delivery using multiscale multiphysics computational drug transport, absorption, ADMET PBPK using his mixture of parallel-CFD, Q3D, compartmental, and particle transport algorithms. FDA has acknowledged his role, in their “Regulatory Science Report.”

Some of his recent works include: (i) Modeling the Pharmacokinetics (PK) of orally-administered drugs in the human Gastrointestinal tract (NIH grant). (ii) Modeling the delivery and bio-equivalence of inhaled corticosteroids and bronchodilators using his Q3D methods (FDA grant) (iii) Modeling the delivery of corticosteroids in children (NIH grant) (iv) Modeling the deposition and the subsequent PK of reference and test (generic) anti-asthmatic drugs (Lupin, Neutec, Amneal: to aid developments of their test drugs against reference drugs like DULERA, ADVAIR, and QVAR (respectively); also, to aid their ANDA applications)

Since 2018, he has helped generic companies to computationally test the bio-equivalence of their TEST drugs. In particular, his multiscale models are anatomically and physiologically consistent (unlike 0D compartmental models like GastroPlus, Simcyp or SimulationsPlus), thereby providing regional metrics. Here is a summary of his capabilities:
1. Inhalation delivery: Predicting the bioequivalence of orally inhaled test drugs, against their REFERENCE counterparts (for e.g., anti-asthmatic TEST drugs to match REFERENCE drugs like ADVAIR, DULERA, QVAR, etc.).
2. Inhalation delivery: Providing (i) visualizable, spatially-resolved deposition and associated metrics (regional depositions, C:P ratios, mouth depositions, exhaled ratios). These are essential to proving bioequivalence of test drugs (in ANDA applications)
3. Inhalation delivery: Possess a variety of complete 24 generations of spatially resolved models: several male, female, pediatric and geriatric models, different diseased models with varying levels of disease progression (asthma, COPD etc.).
4. Inhalation delivery: A full inhalation framework with integrated detailed models of “device to dose to deposition to clearance to pharmacokinetic”. Provide the final PK metrics (and Cmax, AUC, Tmax) for the parent and metabolites.
5. Oral delivery: Have modelled variations from (i) clearance rates in the population, (ii) chewing rates (if chewed), (iii) food-effects (including food-composition), (iv) formulations (IR, CR, solutions, MR).
6. Oral delivery: Have predicted Regional Toxicity (max and average) in the different Gastro Intestinal segments.
7. Provide tailor-made solutions, writing reports as part of FDA submission (he have developed a decade-long relationship with the FDA teams), knows potential original/ANDA submission issues/follow-up-questions and provide proactive guidance through M&S.
8. Reasonable charge rates, and extremely rapid project turn-over time-frame.
9. Continuous guidance to address FDA queries.

He has also helped investors (more than 20 times) to predict the chances of a drug getting agency (FDA) approval using his modelling schemes; thereby helping them make “big financial decisions”.