- Mailing Address:
- School of Pharmacy
- University of Wisconsin
- 777 Highland Avenue
- Madison, WI 53705-2222
- 7109 Rennebohm Hall
- Phone: 608-890-1198
- Fax: 608-262-5345
- Pharmaceutical Experiment Station
- Pharmaceutical Sciences Division
- ICTR IND/IDE Consultation Service
- MS in Biotechnology Program, SMPH
- UW Experts Guide
- UW Foundation
- UW Institute for Clinical and Translational Research (ICTR)
- UW-Madison, Office of Business Engagement (OBE)
- United States Pharmacopeia (USP)
- Waisman Biomanufacturing
- The Wisconsin Idea
- Wisconsin Alumni Research Foundation (WARF)
Edmund J Elder, PhD, RPh
Director, Zeeh Pharmaceutical Experiment Station
Dr. Elder worked in the pharmaceutical development and drug delivery industry for sixteen (16) years prior to joining the UW School of Pharmacy in 2006. As Director of the Zeeh Pharmaceutical Experiment Station, he is responsible for providing pharmaceutical and biopharmaceutical R&D support and educational programs for researchers, both on and off campus. Ed describes his position as "an industrial role in an academic setting".
Expertise attained by Dr. Elder includes:
- Pharmaceutics (the science of dosage form design, development and manufacturing)
- Physical/chemical characterization (pre-formulation)
- oral and injectable delivery systems
- modified-release (delayed, sustained, extended...)
- enhanced solubilization
- hydrophobic drug delivery (lipid-based systems)
- liquid-filled capsules (softgels and hard capsules)
- Dosage form manufacturing process development and optimization
- Quality by Design (QbD)
- Design for Six Sigma (DFSS)
- Process scale-up
- Technology transfer
- Chemistry, Manufacturing and Controls (CMC)
- GMP / GLP
- Project Management
- Pharmacy Compounding
- Drug Patent Litigation
- Biopharmaceuticals / Biosimilars
- Food and Drug Administration (FDA)
- United States Pharmacopeia (USP)
As a registered pharmacist and experienced pharmaceutical scientist, Dr. Elder holds a key leadership position for the Zeeh Pharmaceutical Experiment Station, providing laboratory services to enable and support pharmaceutical and biotechnology product development across the UW System campuses and for off-campus clients. The Station is also influential in providing educational programs covering the process and science of drug development, in conjunction with the Division of Pharmacy Professional Development.
Dr. Elder is the Chemistry Manufacturing and Contols (CMC) Regulatory Consultant for the UW Institute for Clinical and Translational Research (ICTR) Investigational New Drug - Investigational Device Exemption (IND-IDE) Consultation Service (I3CS) team, providing support to campus researchers pursuing regulatory filings related to their clinical research. He is also a scientific advisor to the UW FDA Regulated Research Oversight Program administered through ICTR.
Dr. Edmund (Ed) Elder acquired substantial experience in the pharmaceutical and drug delivery industry where he worked for sixteen (16) years prior to his tenure at UW. He joined the UW School of Pharmacy in April 2006 and assumed his current role as Director of the Zeeh Pharmaceutical Experiment Station in July 2007. Dr. Elder was granted Affiliate status with the Pharmaceutical Sciences Division in 2014 after previously serving as a Guest Lecturer for seven (7) years.
From August 2000 to April 2006 Ed served as pharmaceutics director and global technical leader in the pharmaceutical growth group at the Dow Chemical Company and transitioned that role into the global product development director for the BioAqueous* Solubilization Services offering from the DowPharma* business unit [*Service Mark of The Dow Chemical Company]. In this capacity he was responsible for managing the technical elements of a drug delivery business based on corporate particle engineering (nanotechnology) capabilities, leading a university collaboration related to the business, and providing pharmaceutics expertise for assessment of emerging business and technology development opportunities in the pharmaceutical and biotechnology sector.
From September 1989 through August 2000 Dr. Elder held various positions of increasing responsibility in scale-up and technology transfer, project management, new technology development, formulation development, process development and optimization for dosage form design, and pharmaceutical development management at Glaxo and Glaxo Wellcome (now GlaxoSmithKline). His responsibilities included leading a formulation and process development group, serving as the chemistry, manufacturing and controls (CMC) team leader for several new product development programs, and also participating as a key member of international development strategy and manufacturing strategy teams affiliated with various new chemical entities.
Dr. Elder is currently serving on the 2020-2025 United States Pharmacopeia (USP) Compounding Expert Committee and was also a member of this USP Expert Committee for the 2010-15 & 2015-20 cycles. He has made scientific presentations at several national and international pharmaceutical industry meetings. He is a member of the Editorial Board for Drug Development and Industrial Pharmacy as well as a reviewer for various prominent journals in the field of pharmaceutical sciences. Throughout his career in industry, Dr. Elder was active in the AAPS Visiting Scientist Program for Schools of Pharmacy, having visited fourteen (14) colleges and universities from 1994-2006 (including UW-Madison in 2005). Furthermore, he has served as a guest lecturer on various occasions at four additional universities. Dr. Elder is a member of the American Association of Pharmaceutical Scientists (AAPS), Sigma Xi (The Scientific Research Honor Society) and a Life Member of the National Eagle Scout Association (NESA).
Ed serves on the advisory boards for Waisman BioManufacturing and the UW Carbone Cancer Center Drug Development Core. He served on the UW Academic Staff Mentoring Committee from 2015-2019 including as co-chair from 2017-2019.
- BS Pharmacy 1985 - Medical University of South Carolina
- PhD Pharm.Sci. 1989 - Medical University of South Carolina
- Principles of Pharmaceutical Sciences (PHM 780)
- Course Introduction / Overview of Pharmaceutical Development
- Formulation Lectures
- Applied Drug Development Curriculum - Division of Pharmacy Professional Development
- An Introduction to the Drug Development Process: Chemistry, Manufacturing and Controls
- Drug Candidate Selection: Physicochemical Characterization, Solubilization, and Solid Form Screening
- Developing Oral Drug Formulations: Practical Strategies for Preclinical and Phase 1
- CMC Project Team Management – The Science, Principles and Practices for Successful Teams
- Biologics Drug Development Curriculum - Division of Pharmacy Professional Development
- Biologics - The Biologics Lifecycle
- Biotechnology Operations (CRB 820) - MS in Biotechnology Program, School of Medicine and Public Health
- Course Director
- Lectures on various aspects of biotech R&D including: overview of biotechnology drug development, introduction to CMC for biologic therapeutics, non-clinical development, IND & BLA filings, and clinical development.
- The Drug Development Process (PHM 750) - MS in Applied Drug Development
- Medical Devices
- Market Image, Packaging & Stability
- Quality by Design & Validation
RPh Licensure: SC, WI
- G Lor, B Lu, B Gidal, E Elder, Compounding Virucidal Hand Sanitizer: The Science behind the Skill, The Journal of the Pharmacy Society of Wisconsin, 23(4-July/August): 22-26, 2020.
- M Berg, TE Welty, BE Gidal, FJ Diaz, R Krebill, JP Szaflarski, BA Dworetzky, JR Pollard, EJ Elder, Jr, W Jiang, X Jiang, RD Switzer, MD Privitera, (2017) Bioquivalence Between Generic and Branded Lamotrigine in People with Epilepsy: The EQUIGEN Randomized Clinical Trial, JAMA Neurology, 74(8):919-926, 2017. doi:10.1001/jamaneurol.2017.0497
- MJ Sacchetti, R Teerakapibal, K Kim, EJ Elder Jr, Role of Water Sorption in Tablet Crushing Strength, Disintegration, and Dissolution, AAPS PharmSciTech, 18, 2214-2226, 2017. doi:10.1208/s12249-016-0699-4
- MD Privitera, TE Welty, BE Gidal, FJ Diaz, R Krebill, JP Szaflarski, BA Dworetzky, JR Pollard, AL Paige, EJ Elder Jr, W Jiang, X Jiang, M Berg, Generic-to-Generic Lamotrigine Switches in People with Epilepsy: The Randomised Controlled EQUIGEN Trial, The Lancet Neurology, 2016, 15(4): 365-372. doi: 10.1016/S1474-4422(16)00014-4
- WR Schwan, JM Kolesar, M Shahjahan Kabir, EJ Elder, JB Williams, R Minerath, JM Cook, CM Witzigmann, A Monte, T Flaherty, Pharmacokinetic/Toxicity properties of the New Anti-Staphylococcal Lead Compound SK-03-92, Antibiotics 2015, 4, 617-626. (doi:10.3390/antibiotics4040617)
- LT Schulz, EJ Elder, KJ Jones, A Vijayan, BD Johnson, JE Meadow, L Vermeulen, Stability of Sodium Nitroprusside and Sodium Thiosulfate 1:10 Intravenous Admixture, Hospital Pharmacy, 2010, 45(10): 1-6. (doi: 10.1310/hpj4510-779)
- ME Matteucci, BK Brettmann, TL Rogers, EJ Elder, RO Williams III, and KP Johnston, Design of Potent Amorphous Drug Nanoparticles for Rapid Generation of Highly Supersaturated Media, Molecular Pharmaceutics, 2007, 4(5): 782-793. (doi: 10.1021/mp0700211)
- EJ Elder, JC Evans, BD Scherzer, JE Hitt, GB Kupperblatt, SA Saghir and DA Markham, Preparation, Characterization, and Scale-up of Ketoconazole with Enhanced Dissolution and Bioavailability, Drug Development and Industrial Pharmacy, 2007, 33:7,755 - 765.
- TL Rogers, IB Gillespie, JE Hitt, KL Fransen, CA Crowl, CJ Tucker, GB Kupperblatt, JN Becker, DL Wilson, C Todd, CF Broomhall, JC Evans and EJ Elder, Development and Characterization of a Scalable Controlled Precipitation Process to Enhance the Dissolution of Poorly Water-Soluble Drugs, Pharmaceutical Research, 2004, 21(11): 2048-2057.
- RD Connors and EJ Elder, Using a Portfolio of Particle Growth Technologies to Enable Delivery of Drugs with Poor Water Solubility, Drug Delivery Technology, 2004, 4(8): 78-83.
- DA Schwinn and L Miles Jackson, Editors; Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams (EJ Elder, contributing member); Board on Health Sciences Policy; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. https://doi.org/10.17226/25689
- EJ Elder, JE Hitt, TL Rogers, CJ Tucker, SA Saghir, S Svenson and JC Evans, Particle Engineering of Poorly Water Soluble Drugs by Controlled Precipitation, Chapter 19 in Polymeric Drug Delivery Volume II - Polymeric Matrices and Drug Particle Engineering, Svenson, S., (Ed.), ACS Symposium Series, Vol. 924, 2006, American Chemical Society, Washington, DC.
- JC Evans, BD Scherzer, CD Tocco, GB Kupperblatt, JN Becker, DL Wilson, SA Saghir and EJ Elder, Preparation of Nanostructured Particles of Poorly Water Soluble Drugs via a Novel Ultra-Rapid Freezing Technology, Chapter 21 in Polymeric Drug Delivery Volume II - Polymeric Matrices and Drug Particle Engineering, Svenson, S., (Ed.), ACS Symposium Series, Vol. 924, 2006, American Chemical Society, Washington, DC.
- EJ Elder (contributor), Dosage Forms (Clinical Supplies and Commercial Product): APIs, Excipients and Raw Materials, Chapter 5.3 in Technology Transfer (ISPE Good Practice Guide), 2003, ISPE, Tampa, FL.
- US 10,729,674, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, August 4, 2020.
- CA 2,852,410, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, June 30, 2020.
- IL 226,377, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, December 27, 2019.
- US 10,039,739, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, August 7, 2018.
- US 9,724,325, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, August 8, 2017.
- US 9,636,322, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, May 2, 2017.
- JP6181733, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, July 28, 2017.
- US 9,308,167, EJ Elder Jr.; MJ Sacchetti; RJ Tlachac; JL Zenk, Nanoparticle isoflavone compositions methods of making and using the same, April 12, 2016.
- US 8,900,635, EJ Elder, MJ Sacchetti, RJ Tlachac and JL Zenk, Nanoparticle Isoflavone Compositions and Methods of Making and Using the Same, December 2, 2014.
- US 8,551,530, EJ Elder, MJ Sacchetti, RJ Tlachac and JL Zenk, Nanoparticle Isoflavone Compositions and Methods of Making and Using the Same, October 8, 2013.
- WO 2012068140 A1, Nanoparticle isoflavone compositions methods of making and using the same, EJ Elder; MJ Sacchetti; RJ Tlachac; JL Zenk, PCT Int. Appl. (PCT/US2011/060829) filed 15 November 2011, published 24 May 2012.
United States Pharmacopeia (USP)
- Compounding Expert Committee, 2010-2015, 2015-2020, 2020-2025
National Academies of Science, Engineering and Medicine
- Board on Health Sciences Policy Committee for Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams, 2019-2020