Alexander Berg

Program Director, Clinical Research / Associate Professor of Practice

Administration

School of Health Systems and Innovation

Alexander Berg

Alexander Berg, PharmD, PhD, FCP, is a clinical pharmacologist and pharmacometrician with extensive experience in clinical development and scientific operations leadership. His work has spanned pharmaceutical companies, nonprofit research organizations, consulting firms, and global health initiatives, with particular expertise in clinical pharmacology and model-informed drug development (MIDD). He has led clinical pharmacology and MIDD initiatives from early-phase studies through regulatory submission and has applied modeling, simulation, and data analytics to inform drug-development decisions. In addition to his scientific work, Dr. Berg has held senior leadership roles overseeing multidisciplinary scientific and operational teams. His current academic interests include the implementation of a new M.S. in Clinical Research at NDSU, designed to prepare students for careers as clinical research professionals.

In addition to his scientific work, Dr. Berg is a musician and recording artist, with over 100 recording credits as a keyboardist, engineer, and/or producer.

Areas of Study & Research

Drug and regimen development for the treatment of tuberculosis, clinical pharmacology, and model-informed drug development (MIDD)

Other Research Interests

Quantitative decision making, translational drug development

Previous Work

Dr. Berg has held scientific and leadership positions across the pharmaceutical, consulting, and nonprofit sectors. His previous roles include Vice President of Clinical Pharmacology Development and Operations at Allucent; Vice President of Operations at Simulations Plus; Scientific Director of the Critical Path to TB Drug Regimens initiative at the Critical Path Institute; and clinical pharmacology and pharmacometrics positions at Upsher-Smith Laboratories. He is also President and Owner of IceBerg Consulting LLC, where he provides consulting services in clinical pharmacology, pharmacometrics, drug development, and related scientific and business areas.

Awards & Honors

Fellow, American College of Clinical Pharmacology
McKeen Cattell Memorial Award, American College of Clinical Pharmacology, 2014

Professional Associations

  • American College of Clinical Pharmacology (ACCP)
  • International Society of Pharmacometrics (ISoP)
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)

Education

  • Postdoctoral Fellowship, Clinical Pharmacology - Mayo Clinic Graduate School, Rochester, Minnesota, 2011
  • Doctor of Pharmacy (PharmD), Pharmacy Practice - North Dakota State University, Fargo, North Dakota, 2010
  • Doctor of Philosophy (PhD), Pharmaceutical Sciences - North Dakota State University, Fargo, North Dakota, 2008
  • Bachelor of Science (BS), Pharmaceutical Sciences - North Dakota State University, Fargo, North Dakota, 2005

Publications

• Clary J, Roberts J, Hanna D, Tagliavini A, Sordello S, Upton A, Hermann D, Berg A*. A Stochastic Simulation-Based Approach to Inform Relapsing Mouse Model (RMM) Study Design for Non-Clinical Assessment of Tuberculosis. Antimicrobial Agents Chemother. 2026 Feb 4;70(2):e0110325 . *Corresponding Author

• Sordello S, Brock L, Tagliavini A, Federico D, Boulenc X, Pergher M, Claustre EH, Metcalf D, Walter N, Robertson G, Clary J, Berg A, Mdluli K, Hermann D, Flood D, Upton A. A modeling-based framework to evaluate forgiveness of tuberculosis treatment in a BALB/c relapsing mouse model. Antimicrobial Agents Chemother. 2026 Feb 4;70(2):e0110325

• Jones A, Saini J, Kriel B, Via LE, Cai Y, Allies D, Hanna D, Hermann D, Loxton AG, Walzl G, Diacon AH, Romero K, Higashiyama R, Liu Y, Berg A*. Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts. BMC Infect Dis. 2022 22, 327 *Corresponding Author

• Berg A, Clary J, Hanna D, Nuermberger E, Lenaerts A, Ammerman N, Ramey M, Hartley D, Hermann D. Model-Based Meta-Analysis of Relapsing Mouse Model Studies from the Critical Path to Tuberculosis Drug Regimens Initiative Database. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0179321.

• Humphries H, Almond l, Berg A, Gardner I, Hatley O, et al. Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs. CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1382-1395.

• Srivastava S, Deshpande D, Magombedze G, van Zyl J, Cirrincione K, Martin K, Bendet P, Berg A, et al. Duration of pretomanid/moxifloxacin/pyrazinamide therapy compared with standard therapy based on time-to-extinction mathematics. J Antimicrob Chemother. 2020 Feb 1;75(2):392-399.

• Conrado DJ, Larkindale J, Berg A, et al. Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy. J Pharmacokinet Pharmacodyn. 2019 Oct; 46(5): 441-455.

• Patel N, Hatley O, Berg A, et al. Towards bridging translational gap in cardiotoxicity prediction: an application of progressive cardiac risk assessment strategy in TdP risk assessment of moxifloxacin. AAPS J. 2018 Mar 14;20(3):47.

• Polak S, Romero K, Berg A, et al. Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development. J Pharmacokin Pharmacodyn. 2018 Jun;45(3):457-467.

• Berg, AK, Myrvik, M, Van Ess, P. Pharmacokinetics, pharmacodynamics, and tolerability of USL261, midazolam nasal spray: Randomized study in healthy geriatric and non-geriatric adults. Epilepsy Behav. 2017 Jun;71(A):51-59

• Berg AK, Wu W, Buckner J, Reid JM, Ames MM. Quantification of the impact of enzyme-inducing antiepileptic drugs on irinotecan pharmacokinetics and SN-38 exposure. J Clin Pharmacol. 2015 Nov;55(11):1303-12.

• Berg AK, Mandrekar SJ, Ziegler KL, et al. Population pharmacokinetic model for cancer chemoprevention with sulindac in healthy subjects. J Clin Pharmacol. 2013 Apr;53(4):403-12.

• Sylvester RK, Steen P, Tate J, Berg AK, et al. Temozolomide-induced severe myelosuppression: analysis of clinically associated polymorphisms in two patients. Anticancer Drugs. 2011 Jan;22(1):104-10.

• Berg AK, Yu Q, Qian S, Haldar M, Srivastava DK. Solvent-assisted slow conversion of a dithiazole derivative produces a competitive inhibitor of peptide deformylase. Biochem Biophys Acta. 2010 Apr;1804(4):704-13.

• Berg AK, Srivastava DK. Delineation of alternative conformational states in E. coli peptide deformylase via thermodynamic studies for the binding of actinonin. Biochemistry. 2009 Feb 24;48(7):1584-94.

• Manokaran S, Berg AK, Zhang X, Chen W, Srivastava DK. Modulation of ligand binding affinity of tumorigenic carbonic anhydrase XII by interaction with cationic CdTe quantum dots. J Biomed Nanotech. 2008; 4(4):491-8.

• Berg AK, Manokaran S, Eiler D, Kooren J, Mallik S, Srivastava DK. Energetic rationale for an unexpected and abrupt reversal of the guanidinium chloride-induced unfolding pathway of peptide deformylase. Protein Sci. 2008 Jan;17(1):11-5.

• Kertz J, Almeida PF, Frazier AA, Berg AK, Hinderliter A. The cooperative response of 2+ synaptotagmin I C2A. A hypothesis for a Ca2+-driven molecular hammer. Biophys J. 2007 Feb 15;92(4):1409-18.

Presentations

• Berg A. AI Tools in Diagnostics & Drug Discovery. Invited panelist: 46th Annual TD Cowen Health Care Conference, Mar 4, 2026; Boston, MA.

• Clary J, Watson S, Mdluli K, Levi M, Flood D, Hermann D, Berg A*. Bayesian analysis of nonclinical studies to guide regimen selection for Tuberculosis. Poster at: American Conference on Pharmacometrics, Oct 20 2025; Denver, CO. *Corresponding Author

• Berg A. Analysis of relapsing mouse model studies using a Bayesian model-based approach. Speaker in the TBScience session at: the Union World Conference on Lung Health, Nov 15, 2023; Paris, France.

• Berg A. A Stochastic Simulation-Based Approach to Inform RMM Study Design. Speaker at: the 2023 Gordon Research Conference on TB Drug Discovery and Development, July 24, 2023; Barcelona, Spain.

• Berg A. Enabling model-informed drug and regimen development through informative data sharing. Speaker at: the TB Data Science Meeting, Oct 15, 2018; The Hague, Netherlands.

• Berg A. Sputum LAM as a ‘real-time’ pharmacodynamic biomarker of pulmonary TB. Speaker at: the InterTB conference. Oct 22, 2018; London, England.

• Berg A. Application of PBPK modeling to inform regimen development for TB. Speaker at: the Grand Challenges meeting. Oct 25, 2018; Berlin, Germany.

• Romero K, Berg A*, Larkindale J, members of the Duchenne Regulatory Science Consortium. Accelerating drug development for Duchenne muscular dystrophy: data sharing and quantitative drug development tools through the duchenne regulatory science consortium. Poster at the 8th American Conference on Pharmacometrics; Oct 17, 2017; Ft. Lauderdale, FL *Presenter

• Berg A. A Cardiac risk algorithm to predict the probability of drug-induced torsades de pointes with novel anti-TB agents. Speaker at: The 10th International Workshop on Pharmacology of TB Drugs; Oct 15, 2017; Atlanta, GA.

• Berg A, Hanna D, Lenaerts A, et al. Model-Based Assessment of the Sterilizing Mouse Model: Data Consolidation and Standardization Enabling Quantitative Analysis Efforts by the CPTR Initiative. Poster at: 10th International Workshop on Pharmacology of Tuberculosis Drugs; Oct 15, 2017; Atlanta, GA.

• Berg A. Accelerating the Search for New Tuberculosis Drug Regimens: Development and Qualification of Drug Development Tools. Speaker at: The 7th Annual Indiana CTSI Symposium on Disease and Therapeutic Response Modeling and Simulation; Oct 11, 2017; Indianapolis, IN.

• Berg AK, Bancke L, Kapelan B, Meng TC, Moe C, Van Ess P. Pharmacokinetics of midazolam nasal spray in pediatric subjects with epilepsy. Poster at: The 70th American Epilepsy Society Annual Meeting; Dec 3, 2016; Houston TX.

• Bancke L, Meng TC, Kapelan B, Moe C, Berg AK, Van Ess P. Tolerability of midazolam nasal spray in pediatric subjects with epilepsy. Poster at: The 70th American Epilepsy Society Annual Meeting; Dec 3, 2016; Houston TX.

• Berg A. Strategic implementation of MID3 in biotech and small pharma. Speaker at: The Land O’ Lakes 19th Annual Drug Metabolism and Applied Pharmacokinetics Conference; Sep 2, 2016; Madison, WI.

• Berg AK, Myrvik M, Van Ess P. Tolerability and pharmacodynamics of midazolam nasal spray (USL261) in healthy geriatric and non-geriatric adults. Poster at: The 69th American Epilepsy Society Annual Meeting; Dec 4, 2015; Philadelphia, PA.

• Van Ess P, Myrvik M, Berg AK. Pharmacokinetics of midazolam nasal spray (USL261) in healthy geriatric and non- geriatric adults. Poster at: The 69th American Epilepsy Society Annual Meeting; Dec 4, 2015; Philadelphia, PA.

• Attwood RJ, Garofoli AC, Baudoin MR, Berg AK, et al. Impact of emergency department clinical pharmacist response to an automated electronic notification system on timing and appropriateness of antimicrobials in severe sepsis or septic shock in the emergency department. Ann Emerg Med. 2012 Oct; 60(4):S118.

• Woloszyn AV, Attwood RJ, Garofoli AC, Berg AK, et al. "Sepsis spider": an electronic notification system to improve compliance with sepsis resuscitation bundles in the emergency department. Crit Care Med. 2011 Dec;39(12):23.