Work with thought leaders and academic experts in drug discovery

Companies can benefit from working with academic researchers in Drug Discovery in several ways. These experts can provide valuable insights and expertise in developing new drugs, conducting preclinical and clinical trials, and optimizing drug discovery processes. They can also offer access to cutting-edge technologies and research facilities, as well as collaborations with other academic institutions and industry partners. Additionally, academic researchers can help companies stay updated with the latest advancements in the field and provide guidance on regulatory requirements and intellectual property issues. By collaborating with academic researchers in Drug Discovery, companies can accelerate their drug development efforts, enhance their scientific credibility, and gain a competitive edge in the market.

Experts on NotedSource with backgrounds in drug discovery include Regan Hamel, Aimee Eggler, Giuliana Noratto, Nora S Vyas, Ph.D., Samiul Amin, Katelyn Katelyn Masiuk, Enrico Capobianco, Barry Setlow, Nitin Pandey, Daniel Greenfield, Matheus Ferraz, Patrick G. Grant, Ph.D., and Ruiyan Tan.

Aimee Eggler

Villanova, Pennsylvania, United States of America
Professor of Chemistry and Biochemistry at Villanova University
Most Relevant Research Interests
Drug Discovery
Other Research Interests (26)
Biochemistry
Biochemistry education
Cell culture
Oxidative stress
Natural products
And 21 more
About
Dr. Eggler has 20 years of experience in the field of redox biology, with a focus on the Nrf2 transcription factor, a master regulator of antioxidant, detoxification and anti-inflammatory genes. She is also an award-winning educator and the recipient of the Villanova University Junior Faculty Excellence in Teaching award. Her interests in education include innovation in teaching metabolism from a logic-based perspective.
Most Relevant Publications (3+)

25 total publications

Discovery of N-(benzo[1,2,3]triazol-1-yl)-N-(benzyl)acetamido)phenyl) carboxamides as severe acute respiratory syndrome coronavirus (SARS-CoV) 3CLpro inhibitors: Identification of ML300 and noncovalent nanomolar inhibitors with an induced-fit binding

Bioorganic & Medicinal Chemistry Letters / Nov 01, 2013

Turlington, M., Chun, A., Tomar, S., Eggler, A., Grum-Tokars, V., Jacobs, J., Daniels, J. S., Dawson, E., Saldanha, A., Chase, P., Baez-Santos, Y. M., Lindsley, C. W., Hodder, P., Mesecar, A. D., & Stauffer, S. R. (2013). Discovery of N-(benzo[1,2,3]triazol-1-yl)-N-(benzyl)acetamido)phenyl) carboxamides as severe acute respiratory syndrome coronavirus (SARS-CoV) 3CLpro inhibitors: Identification of ML300 and noncovalent nanomolar inhibitors with an induced-fit binding. Bioorganic & Medicinal Chemistry Letters, 23(22), 6172–6177. https://doi.org/10.1016/j.bmcl.2013.08.112

Discovery, Synthesis, And Structure-Based Optimization of a Series of N-(tert-Butyl)-2-(N-arylamido)-2-(pyridin-3-yl) Acetamides (ML188) as Potent Noncovalent Small Molecule Inhibitors of the Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) 3CL Protease

Journal of Medicinal Chemistry / Jan 03, 2013

Jacobs, J., Grum-Tokars, V., Zhou, Y., Turlington, M., Saldanha, S. A., Chase, P., Eggler, A., Dawson, E. S., Baez-Santos, Y. M., Tomar, S., Mielech, A. M., Baker, S. C., Lindsley, C. W., Hodder, P., Mesecar, A., & Stauffer, S. R. (2013). Discovery, Synthesis, And Structure-Based Optimization of a Series of N-(tert-Butyl)-2-(N-arylamido)-2-(pyridin-3-yl) Acetamides (ML188) as Potent Noncovalent Small Molecule Inhibitors of the Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) 3CL Protease. Journal of Medicinal Chemistry, 56(2), 534–546. https://doi.org/10.1021/jm301580n

Insecticidal Activity of Cyanohydrin and Monoterpenoid Compounds

Molecules / Apr 03, 2000

Peterson, C., Tsao, R., Eggler, A., & Coats, J. (2000). Insecticidal Activity of Cyanohydrin and Monoterpenoid Compounds. Molecules, 5(12), 648–654. https://doi.org/10.3390/50400648

Giuliana Noratto

Food Scientist PhD and Registered Dietician - Texas A&M University
Most Relevant Research Interests
Drug Discovery
Other Research Interests (40)
Food Science
human nutrition
disease prevention and treatment
Nutrition
Human Health
And 35 more
About
Dr. Giuliana Noratto is a senior associate research scientist at Texas A&M AgriLife. She received her Ph.D. in food science and technology from Texas A&M University System, and her M.Sc. in food science and technology from Universidad Nacional Agraria La Molina. She also holds a B.S. in food science and technology from Universidad Nacional Agraria La Molina. Dr. Noratto’s research interests include food safety and quality, sensory science, and food processing.
Most Relevant Publications (3+)

91 total publications

Dark Sweet Cherry (Prunus avium) Anthocyanins Suppressed ERK1/2-Akt/mTOR Cell Signaling and Oxidative Stress: Implications for TNBC Growth and Invasion

Molecules / Oct 25, 2022

Silveira Rabelo, A. C., Mertens-Talcott, S. U., Chew, B. P., & Noratto, G. (2022). Dark Sweet Cherry (Prunus avium) Anthocyanins Suppressed ERK1/2-Akt/mTOR Cell Signaling and Oxidative Stress: Implications for TNBC Growth and Invasion. Molecules, 27(21), 7245. https://doi.org/10.3390/molecules27217245

Phytocomplexes from liquorice (Glycyrrhiza glabra L.) leaves — Chemical characterization and evaluation of their antioxidant, anti-genotoxic and anti-inflammatory activity

Fitoterapia / Jun 01, 2011

Siracusa, L., Saija, A., Cristani, M., Cimino, F., D’Arrigo, M., Trombetta, D., Rao, F., & Ruberto, G. (2011). Phytocomplexes from liquorice (Glycyrrhiza glabra L.) leaves — Chemical characterization and evaluation of their antioxidant, anti-genotoxic and anti-inflammatory activity. Fitoterapia, 82(4), 546–556. https://doi.org/10.1016/j.fitote.2011.01.009

Flavonol-rich fractions of yaupon holly leaves (Ilex vomitoria, Aquifoliaceae) induce microRNA-146a and have anti-inflammatory and chemopreventive effects in intestinal myofribroblast CCD-18Co cells

Fitoterapia / Jun 01, 2011

Noratto, G. D., Kim, Y., Talcott, S. T., & Mertens-Talcott, S. U. (2011). Flavonol-rich fractions of yaupon holly leaves (Ilex vomitoria, Aquifoliaceae) induce microRNA-146a and have anti-inflammatory and chemopreventive effects in intestinal myofribroblast CCD-18Co cells. Fitoterapia, 82(4), 557–569. https://doi.org/10.1016/j.fitote.2011.01.013

Nora S Vyas, Ph.D.

Associate Professor of Mental Health, with interest in civic engagement and partnerships
Most Relevant Research Interests
Drug Discovery
Other Research Interests (26)
Psychosis
neuroimaging
neuropsychology
mindfulness
neurodevelopmental disorders
And 21 more
About
Dr Nora S Vyas is an Associate Professor in Psychology at the Department of Psychology, Kingston University. She joined Kingston University in 2012, and previously held a Senior Lecturer position at Middlesex University. Dr Vyas completed her PhD in psychiatry at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), University of London in 2008. Following her PhD, she worked at the Child Psychiatry Branch, National Institutes of Health (Washington DC, USA) as a Lindemann Trust Fellow (English-Speaking Union), preceded by a Fulbright Distinguished Fellowship in 2010. Dr Vyas teaches at undergraduate and postgraduate level in child/adolescent and adult mental health, health psychology, and clinical/cognitive neuroscience. Her research focuses on using clinical, cognitive, and imaging techniques to study individuals with serious mental health problems such as bipolar disorder and schizophrenia. She applies these skills in other fields such as oncology and mindfulness. Her research specialism is early-onset psychosis, and she has published her work widely.
Most Relevant Publications (1+)

30 total publications

Recent Developments in Neurochemical Imaging in Schizophrenia: An Update

Current Medicinal Chemistry / Jan 01, 2013

S. Vyas, N., H. Patel, N., Herscovitch, P., K. Puri, B., & Lanzenberger, R. (2013). Recent Developments in Neurochemical Imaging in Schizophrenia: An Update. Current Medicinal Chemistry, 20(3), 351–356. https://doi.org/10.2174/092986713804870765

Samiul Amin

Professor of Practice at University of Miami Professor of Practice and Director ECAP at University of Miami with expertise in Formulation Design, Rheology, Biosurfactants, Biopolymers and Materials Science.
Most Relevant Research Interests
Drug Discovery
Other Research Interests (50)
Complex Fluids
Rheology
Microrheology
Protein Aggregation
Colloid and Surface Chemistry
And 45 more
About
With over 22 years of industry and academic experience in SoftMatter, colloids, and complex fluids, I am a Professor of Practice and Director of the Engineering Corporate Affiliate Program (ECAP) at the University of Miami. My mission is to bridge the gap between engineering education/research and industry needs, and to foster a culture of creativity, innovation, and entrepreneurship among students and faculty. I am also co-founder of FastFormulator a Formulation Design Lab developing novel sustainable formulations for a wide range of industries utilizing an integrated approach of High THroughput FOrmulation Automation/Advanced CHaracterization/AI-ML and based on deep colloid science/complex fluids insights. <br> As a leading researcher and consultant in formulation design and performance optimization of consumer, cosmetic, biopharmaceutical, and homecare products, I collaborate with multiple global companies and organizations to develop novel and sustainable solutions based on high throughput formulation, AI/ML, advanced characterization and novel sustainable materials. I also teach courses in polymers, surfactants, emulsions, rheology, tribology, and innovation management, and chair international conferences in my field of expertise. I am passionate about advancing the science and engineering of complex fluids and cosmetics, and sharing my knowledge and insights with the next generation of engineers and innovators.
Most Relevant Publications (14+)

68 total publications

Combined Dynamic Light Scattering and Raman Spectroscopy Approach for Characterizing the Aggregation of Therapeutic Proteins

Molecules / Dec 12, 2014

Lewis, E., Qi, W., Kidder, L., Amin, S., Kenyon, S., & Blake, S. (2014). Combined Dynamic Light Scattering and Raman Spectroscopy Approach for Characterizing the Aggregation of Therapeutic Proteins. Molecules, 19(12), 20888–20905. https://doi.org/10.3390/molecules191220888

Sustainable thermoresponsive whey protein‐ and chitosan‐based oil‐in‐water emulsions for cosmetic applications

International Journal of Cosmetic Science / Dec 05, 2021

Speer, S., & Amin, S. (2021). Sustainable thermoresponsive whey protein‐ and chitosan‐based oil‐in‐water emulsions for cosmetic applications. International Journal of Cosmetic Science, 44(1), 30–41. Portico. https://doi.org/10.1111/ics.12752

High‐performance sulphate‐free cleansers: Surface activity, foaming and rheology

International Journal of Cosmetic Science / Nov 14, 2021

Yorke, K., Potanin, A., Jogun, S., Morgan, A., Shen, H., & Amin, S. (2021). High‐performance sulphate‐free cleansers: Surface activity, foaming and rheology. International Journal of Cosmetic Science, 43(6), 636–652. Portico. https://doi.org/10.1111/ics.12740

Rheological stability of carbomer in hydroalcoholic gels: Influence of alcohol type

International Journal of Cosmetic Science / Dec 01, 2021

Kolman, M., Smith, C., Chakrabarty, D., & Amin, S. (2021). Rheological stability of carbomer in hydroalcoholic gels: Influence of alcohol type. International Journal of Cosmetic Science, 43(6), 748–763. Portico. https://doi.org/10.1111/ics.12750

Flow and performance effects of talc alternatives on powder cosmetic formulations

International Journal of Cosmetic Science / Sep 01, 2021

Ajayi, O. M., & Amin, S. (2021). Flow and performance effects of talc alternatives on powder cosmetic formulations. International Journal of Cosmetic Science, 43(5), 588–600. Portico. https://doi.org/10.1111/ics.12733

Challenges and effective routes for formulating and delivery of epidermal growth factors in skin care

International Journal of Cosmetic Science / Jan 15, 2021

Eskens, O., & Amin, S. (2021). Challenges and effective routes for formulating and delivery of epidermal growth factors in skin care. International Journal of Cosmetic Science, 43(2), 123–130. Portico. https://doi.org/10.1111/ics.12685

Impact of polyelectrolyte‐surfactant interactions on the rheology and wet lubrication performance of conditioning shampoo

International Journal of Cosmetic Science / Mar 18, 2021

Benhur, A. M., Diaz, J., & Amin, S. (2021). Impact of polyelectrolyte‐surfactant interactions on the rheology and wet lubrication performance of conditioning shampoo. International Journal of Cosmetic Science, 43(2), 246–253. Portico. https://doi.org/10.1111/ics.12689

Optimizing interactions between soluble silk fibroin and capryl glucoside for design of a natural and high‐performance co‐surfactant system

International Journal of Cosmetic Science / Dec 30, 2020

Maxwell, R., Costache, M. C., Giarrosso, A., Bosques, C., & Amin, S. (2020). Optimizing interactions between soluble silk fibroin and capryl glucoside for design of a natural and high‐performance co‐surfactant system. International Journal of Cosmetic Science, 43(1), 68–77. Portico. https://doi.org/10.1111/ics.12676

Design of high‐performance curling mascara through utilization of smart thermoresponsive polymer

International Journal of Cosmetic Science / Aug 19, 2020

Chen, S., & Amin, S. (2020). Design of high‐performance curling mascara through utilization of smart thermoresponsive polymer. International Journal of Cosmetic Science, 42(6), 557–563. Portico. https://doi.org/10.1111/ics.12639

Design of sustainable lip gloss formulation with biosurfactants and silica particles

International Journal of Cosmetic Science / Aug 20, 2020

Drakontis, C. E., & Amin, S. (2020). Design of sustainable lip gloss formulation with biosurfactants and silica particles. International Journal of Cosmetic Science, 42(6), 573–580. Portico. https://doi.org/10.1111/ics.12642

Engineering rheological response in chitosan–sophorolipid systems through controlled interactions

International Journal of Cosmetic Science / Jul 20, 2020

Pingali, S., Benhur, A. M., & Amin, S. (2020). Engineering rheological response in chitosan–sophorolipid systems through controlled interactions. International Journal of Cosmetic Science, 42(4), 407–414. Portico. https://doi.org/10.1111/ics.12640

Microstructure design of CTAC:FA and BTAC:FA lamellar gels for optimized rheological performance utilizing automated formulation platform

International Journal of Cosmetic Science / Apr 24, 2020

Davies, A. R., & Amin, S. (2020). Microstructure design of CTAC:FA and BTAC:FA lamellar gels for optimized rheological performance utilizing automated formulation platform. International Journal of Cosmetic Science, 42(3), 259–269. Portico. https://doi.org/10.1111/ics.12609

Designing high‐performance colour cosmetics through optimization of powder flow characteristics

International Journal of Cosmetic Science / Mar 11, 2020

Liu, X., Drakontis, C., & Amin, S. (2020). Designing high‐performance colour cosmetics through optimization of powder flow characteristics. International Journal of Cosmetic Science, 42(2), 208–216. Portico. https://doi.org/10.1111/ics.12608

Microrheological study of ternary surfactant‐biosurfactant mixtures

International Journal of Cosmetic Science / Jun 28, 2019

Xu, L., & Amin, S. (2019). Microrheological study of ternary surfactant‐biosurfactant mixtures. International Journal of Cosmetic Science, 41(4), 364–370. Portico. https://doi.org/10.1111/ics.12541

Katelyn Katelyn Masiuk

Co-Founder and CSO at Immunovec
Most Relevant Research Interests
Drug Discovery
Other Research Interests (13)
Cell Biology
Genetics
Molecular Medicine
Molecular Biology
Pharmacology
And 8 more
About
Katelyn Masiuk is the co-founder and Chief Scientific Officer of ImmunoVec. She is also a medical student in the MSTP program at UCLA. Her research interests include immunology and virology.
Most Relevant Publications (2+)

13 total publications

Editing the Sickle Cell Disease Mutation in Human Hematopoietic Stem Cells: Comparison of Endonucleases and Homologous Donor Templates

Molecular Therapy / Aug 01, 2019

Romero, Z., Lomova, A., Said, S., Miggelbrink, A., Kuo, C. Y., Campo-Fernandez, B., Hoban, M. D., Masiuk, K. E., Clark, D. N., Long, J., Sanchez, J. M., Velez, M., Miyahira, E., Zhang, R., Brown, D., Wang, X., Kurmangaliyev, Y. Z., Hollis, R. P., & Kohn, D. B. (2019). Editing the Sickle Cell Disease Mutation in Human Hematopoietic Stem Cells: Comparison of Endonucleases and Homologous Donor Templates. Molecular Therapy, 27(8), 1389–1406. https://doi.org/10.1016/j.ymthe.2019.05.014

Improving Gene Therapy Efficiency through the Enrichment of Human Hematopoietic Stem Cells

Molecular Therapy / Sep 01, 2017

Masiuk, K. E., Brown, D., Laborada, J., Hollis, R. P., Urbinati, F., & Kohn, D. B. (2017). Improving Gene Therapy Efficiency through the Enrichment of Human Hematopoietic Stem Cells. Molecular Therapy, 25(9), 2163–2175. https://doi.org/10.1016/j.ymthe.2017.05.023

Barry Setlow

Dept. of Psychiatry; Center for Addiction Research and Education, University of Florida
Most Relevant Research Interests
Drug Discovery
Other Research Interests (36)
Neuroscience
General Neuroscience
Cellular and Molecular Neuroscience
Cognitive Neuroscience
Neuropsychology and Physiological Psychology
And 31 more
Most Relevant Publications (1+)

111 total publications

Simultaneous quantification of cannabinoids tetrahydrocannabinol, cannabidiol and CB1 receptor antagonist in rat plasma: An application to characterize pharmacokinetics after passive cannabis smoke inhalation and co-administration of rimonabant

Journal of Pharmaceutical and Biomedical Analysis / Oct 01, 2018

Ravula, A., Chandasana, H., Setlow, B., Febo, M., Bruijnzeel, A. W., & Derendorf, H. (2018). Simultaneous quantification of cannabinoids tetrahydrocannabinol, cannabidiol and CB1 receptor antagonist in rat plasma: An application to characterize pharmacokinetics after passive cannabis smoke inhalation and co-administration of rimonabant. Journal of Pharmaceutical and Biomedical Analysis, 160, 119–125. https://doi.org/10.1016/j.jpba.2018.07.004

Daniel Greenfield

Ph.D. candidate (anticipated Mar 2023) in Biophysics with a focus on quantitative techniques in biomedicine
Most Relevant Research Interests
Drug Discovery
Other Research Interests (13)
Machine Learning
Medical Devices
Edge Computing
Biomedical Optics
Organic Chemistry
And 8 more
Most Relevant Publications (1+)

10 total publications

Virtual Screening for Ligand Discovery at the σ1 Receptor

ACS Medicinal Chemistry Letters / Jul 27, 2020

Greenfield, D. A., Schmidt, H. R., Skiba, M. A., Mandler, M. D., Anderson, J. R., Sliz, P., & Kruse, A. C. (2020). Virtual Screening for Ligand Discovery at the σ1 Receptor. ACS Medicinal Chemistry Letters, 11(8), 1555–1561. https://doi.org/10.1021/acsmedchemlett.9b00314

Matheus Ferraz

PhD in computational chemistry, bioinformatician with experience in industry
Most Relevant Research Interests
Drug Discovery
Other Research Interests (31)
Computational Chemistry
Protein Design
Machine Learning
Virology
Microbiology
And 26 more
Most Relevant Publications (1+)

17 total publications

Inhibition of 3-Hydroxykynurenine Transaminase from Aedes aegypti and Anopheles gambiae: A Mosquito-Specific Target to Combat the Transmission of Arboviruses

ACS Bio &amp; Med Chem Au / Feb 16, 2023

Maciel, L. G., Ferraz, M. V. F., Oliveira, A. A., Lins, R. D., dos Anjos, J. V., Guido, R. V. C., & Soares, T. A. (2023). Inhibition of 3-Hydroxykynurenine Transaminase from Aedes aegypti and Anopheles gambiae: A Mosquito-Specific Target to Combat the Transmission of Arboviruses. ACS Bio &amp; Med Chem Au, 3(2), 211–222. https://doi.org/10.1021/acsbiomedchemau.2c00080

Patrick G. Grant, Ph.D.

California
Multi Discipline Experience with Multiple Open Inovation Solutions
Most Relevant Research Interests
Drug Discovery
Other Research Interests (42)
Multidisciplinary
General Agricultural and Biological Sciences
General Chemistry
Toxicology
Mechanical Engineering
And 37 more
Most Relevant Publications (1+)

41 total publications

A quantitative minimally invasive assay for the detection of metals in the stratum corneum

Journal of Pharmaceutical and Biomedical Analysis / Mar 01, 2000

Cullander, C., Jeske, S., Imbert, D., Grant, P. G., & Bench, G. (2000). A quantitative minimally invasive assay for the detection of metals in the stratum corneum. Journal of Pharmaceutical and Biomedical Analysis, 22(2), 265–279. https://doi.org/10.1016/s0731-7085(99)00248-4

Ruiyan Tan

Toronto
Most Relevant Research Interests
Drug Discovery
Other Research Interests (6)
Pharmaceutical Science
Cardiology
Neuroscience
Anatomy & Physiology
Fetal development
And 1 more
Most Relevant Publications (2+)

4 total publications

68Ga-Labeled [Thz14]Bombesin(7–14) Analogs: Promising GRPR-Targeting Agonist PET Tracers with Low Pancreas Uptake

Molecules / Feb 20, 2023

Wang, L., Bratanovic, I. J., Zhang, Z., Kuo, H.-T., Merkens, H., Zeisler, J., Zhang, C., Tan, R., Bénard, F., & Lin, K.-S. (2023). 68Ga-Labeled [Thz14]Bombesin(7–14) Analogs: Promising GRPR-Targeting Agonist PET Tracers with Low Pancreas Uptake. Molecules, 28(4), 1977. https://doi.org/10.3390/molecules28041977

68Ga-Labeled [Leu13ψThz14]Bombesin(7–14) Derivatives: Promising GRPR-Targeting PET Tracers with Low Pancreas Uptake

Molecules / Jun 11, 2022

Wang, L., Zhang, Z., Merkens, H., Zeisler, J., Zhang, C., Roxin, A., Tan, R., Bénard, F., & Lin, K.-S. (2022). 68Ga-Labeled [Leu13ψThz14]Bombesin(7–14) Derivatives: Promising GRPR-Targeting PET Tracers with Low Pancreas Uptake. Molecules, 27(12), 3777. https://doi.org/10.3390/molecules27123777

Example drug discovery projects

How can companies collaborate more effectively with researchers, experts, and thought leaders to make progress on drug discovery?

Development of Novel Drug Candidates

An academic researcher in Drug Discovery can collaborate with a company to develop novel drug candidates. By leveraging their expertise in molecular biology, pharmacology, and medicinal chemistry, the researcher can identify potential drug targets, design and synthesize new compounds, and evaluate their efficacy and safety. This collaboration can help the company expand its drug pipeline and bring innovative therapies to the market.

Optimization of Drug Discovery Processes

Companies can collaborate with academic researchers to optimize their drug discovery processes. The researcher can provide insights into the latest techniques and technologies for high-throughput screening, virtual screening, and computational modeling. They can also help in streamlining the hit-to-lead and lead optimization stages, improving the efficiency and success rate of drug discovery projects.

Preclinical and Clinical Trials

Academic researchers with expertise in Drug Discovery can assist companies in conducting preclinical and clinical trials. They can design and execute studies to evaluate the safety, efficacy, and pharmacokinetics of potential drug candidates. Their knowledge of regulatory requirements and ethical guidelines ensures that the trials are conducted in compliance with industry standards.

Collaborations with Other Academic Institutions

By collaborating with academic researchers, companies can tap into a network of other experts and institutions in the field of Drug Discovery. These collaborations can lead to joint research projects, knowledge sharing, and access to specialized resources and facilities. Such partnerships can foster innovation and accelerate the development of new drugs.

Intellectual Property and Regulatory Guidance

Academic researchers can provide guidance on intellectual property (IP) and regulatory matters related to drug discovery. They can help companies navigate the complex landscape of patents, copyrights, and licensing agreements. Additionally, they can offer insights into regulatory requirements and assist in preparing documentation for regulatory submissions, ensuring compliance with relevant laws and regulations.