Dr. Elaine S. Waller, PharmD, MBA

Dr. Elaine S. Waller, PharmD, MBA

Founder & Lead Pharmacist at Order-CS

e-Pharmacy Evaluation Expert · Clinical Research Leader

Dallas, Oregon
Licensed Pharmacist (RPh)

Professional Bio

Dr. Elaine S. Waller, PharmD, MBA, is the founder and lead pharmacist of Order-CS, established in 2010 to provide accessible, high-quality medications worldwide. As the lead pharmacist, she oversees all clinical and regulatory operations at Order-CS, ensuring compliance with FDA, MHRA, and international pharmacy standards.

Dr. Waller is also a highly experienced pharmaceutical executive whose career spans regulatory affairs, clinical research, quality assurance, and health-services research. She helped bring landmark oncology drugs such as brentuximab vedotin (Adcetris) to FDA approval through her leadership at Sonus Pharmaceuticals and Seagen (formerly Seattle Genetics).

In addition to her industry leadership, Dr. Waller began her career in academia at the University of Texas at Austin, where she held teaching positions in graduate and undergraduate pharmacy education and served as Assistant Director of Clinical Research at the Drug Dynamics Institute.

Scientific Publications

1988

Comparative Bioavailability of Furosemide from Solution and 40 mg Tablets with Different Dissolution Characteristics Following Oral Administration in Normal Men

E.S. Waller, M.L. Crismon, M.T. Bauza, J.T. Doluisio, R.V. Smith. Biopharmaceutics & Drug Disposition, 9(2), 211-218. DOI

1988

Systolic Blood Pressure Response in Three Subgroups of Hypertensives Treated with Sustained-Release Diltiazem

E.S. Waller. Journal of Cardiovascular Pharmacology, 1988. DOI

1986

Pharmacokinetics of Orally Administered Pentoxifylline in Humans

E.S. Waller. Journal of Pharmaceutical Sciences, 1986. DOI

1985

Central Nervous System Toxicity Associated with Concurrent Use of Triazolam and Cimetidine

M.L. Britton, E.S. Waller. Drug Intelligence and Clinical Pharmacy (now Annals of Pharmacotherapy), 19(9), 666-668.

1985

Pharmacokinetics of Furosemide After Three Different Single Oral Doses

E.S. Waller, et al. Biopharmaceutics & Drug Disposition, 6(2), 109-117. DOI

1985

Tolmetin in Breast Milk

E.S. Waller. Drug Intelligence and Clinical Pharmacy, 1985. DOI

1984

Auranofin: More than Just Oral Gold

E.S. Waller. Clinical Pharmacy, 1984.

1984

Safety of Indos

E.S. Waller. Pharmacotherapy, 1984. DOI

1984

The Pharmacokinetics of Intramuscular Gold Sodium Thiomalate in Normal Volunteers

E.S. Waller. Biopharmaceutics & Drug Disposition, 1984. DOI

1983

Evaluation of New Indomethacin Dosage Forms

E.S. Waller. Pharmacotherapy, 3(6), 324-333. DOI / PubMed

1982

Disposition and Absolute Bioavailability of Furosemide in Healthy Males

E.S. Waller. Journal of Pharmaceutical Sciences, 1982. DOI

1982

Pharmacokinetics of Furosemide (Lasix) After Three Different, Single, Oral Doses to Healthy Men

E.S. Waller. Drug Intelligence and Clinical Pharmacy, 1982.

1982

Pharmacokinetics of Gold Sodium Thiomalate

E.S. Waller. Research Communications in Chemical Pathology and Pharmacology, 1982.

1982

The Effect of Probenecid on Nafcillin Disposition

E.S. Waller. Journal of Clinical Pharmacology, 1982. DOI

1982

The Production of Free Fatty Acids in Post-Heparin Plasma During Equilibrium Dialysis

E.S. Waller. Research Communications in Chemical Pathology and Pharmacology, 1982.

1981

Influence of Food on the Bioavailability of Trental® (Pentoxifylline) in Man

E.S. Waller. Drug Development and Industrial Pharmacy, 1981. DOI

1981

Pharmacokinetic Principles of Lidocaine Dosing in Relation to Disease State

E.S. Waller. Journal of Clinical Pharmacology, 1981. DOI

1981

Appropriate Lidocaine Doses — Science Added to the Art

E.S. Waller. Texas Medicine, 77(1), 60-64.

1980

Dapsone-Induced Hemolytic Anemia in a Patient with Relapsing Polychondritis

E.S. Waller. Drug Intelligence and Clinical Pharmacy, 1980. DOI

Areas of Expertise

Global Regulatory Affairs

Strategy and submissions (NDA, BLA, sBLA) for oncology and biologics. Longstanding engagement with FDA as a key signatory.

Clinical Research & Development

Leadership of clinical operations for oncology and biologics. Management of multi-center clinical programs and site networks.

Quality Assurance & Compliance

Senior responsibility for GxP quality systems. Expertise in CAPA, deviation investigations, and compounding pharmacy quality.

E-Pharmacy Evaluation

Evaluation of online pharmacies for safety and legality. Author of public-facing guides on e-pharmacy operations.

Academic & Health-Services Research

Pharmacokinetics, bioavailability, and drug interaction research conducted at the Drug Dynamics Institute, UT Austin.

Medical & Regulatory Writing

FDA correspondence, corporate regulatory documentation, peer-reviewed manuscripts, and consumer-education content.

Professional Experience

2010 – Present

Founder & Lead Pharmacist

Order-CS

Founded and leads the international pharmacy service, ensuring regulatory compliance and quality patient care.

2008 – 2018

Executive Vice President, Regulatory Affairs

Seagen / Seattle Genetics, Inc.

Led regulatory strategy for multiple antibody-drug conjugate (ADC) programs, including the landmark approval of Adcetris.

2012 – 2015

Quality Manager & Pharmacist-in-Charge

Medistat RX, LLC

Oversaw production quality, documentation, and environmental monitoring for a compounding pharmacy.

2003 – 2008

SVP Regulatory Affairs & Quality Assurance

Sonus Pharmaceuticals, Inc.

Provided leadership for domestic and international regulatory strategies and quality systems. Also served as General Counsel.

Prior Leadership

Chief Operating Officer

Radiant Research (Clinical Site Management Network)

VP, North American Regulatory Affairs

Hoechst Marion Roussel / Marion Merrell Dow

Expert Commentary & Perspectives

Challenges in Global e-Pharmacy Quality Control: A 20-Year Regulatory Perspective

Having spent over two decades navigating FDA regulatory pathways for complex biologics and now overseeing clinical operations at Order-CS, I have witnessed firsthand the widening quality gap between regulated pharmaceutical supply chains and the largely unverified world of online pharmacy sourcing. The core challenge lies not in a lack of standards — FDA cGMP, MHRA compliance frameworks, and USP <797>/<795> compounding guidelines all exist — but in the difficulty of enforcing them across jurisdictional boundaries. An e-pharmacy operating out of one country may claim compliance with another country's regulations without any mechanism for audit or verification. My recommended approach combines three pillars: mandatory third-party certification of dispensing facilities against international GxP standards, public registries of licensed e-pharmacy operators linked to national pharmacy boards, and patient-facing education tools that empower consumers to verify a pharmacy's credentials before purchase. Without these structural safeguards, the convenience of global online pharmacy access will continue to be undermined by quality and safety risks.

Evaluating the GxP Supply Chain for Biological Therapeutics

During my tenure as Executive Vice President of Regulatory Affairs at Seagen, ensuring GxP compliance across the supply chain for antibody-drug conjugates like brentuximab vedotin (Adcetris) was central to every regulatory submission we filed. ADC manufacturing is uniquely challenging because it requires quality oversight spanning monoclonal antibody production, small-molecule cytotoxic drug synthesis, and the chemical conjugation process that links them — each operating under different regulatory frameworks. One of the most critical lessons I carried from biologics into pharmacy operations is that supply chain quality cannot be delegated. Whether the product is a temperature-sensitive biologic or a dispensed prescription medication, the chain of custody must include documented cold-chain integrity, lot traceability, and expiry verification at every transfer point. The same principles that governed our BLA 125388 submission — documented evidence, audit readiness, and patient-centric quality systems — apply equally to ensuring that patients receiving medications through international pharmacy services get products that meet the same standards as those dispensed at their local pharmacy.

References & Sources

[1] SEC Schedule 14A Biography
[2] SonusPharma – Dr. Elaine Waller Profile
[3] FDA Supplement Approval Letter (BLA 125388/S-094)
[4] Top Women in Biotech 2014
[5] MarketScreener – Elaine Waller Positions
[6] Order-cs.com Pharmacy Article (Author Bio)
[7] Seattle Genetics Annual Report / Management Listing
[8] Waller ES, Kercher NL. Regulatory Authorities and the Laws. In: Evens RP, ed. Drug and Biological Development: From Molecule to Product and Beyond. Springer; 2007. ISBN 978-0-387-32978-9.
[9] Britton ML, Waller ES. Central Nervous System Toxicity Associated with Concurrent Use of Triazolam and Cimetidine. Drug Intell Clin Pharm. 1985;19:666-668.
[10] Waller ES. Appropriate Lidocaine Doses — Science Added to the Art. Texas Medicine. 1981;77(1):60-64.
[11] Waller ES, et al. Pharmacokinetics of Furosemide After Three Different Single Oral Doses. Biopharm Drug Dispos. 1985;6(2):109-117. DOI
[12] Waller ES, Crismon ML. Comparative Bioavailability of Furosemide from Solution and 40 mg Tablets with Different Dissolution Characteristics. Biopharm Drug Dispos. 1988;9(2):211-218. DOI
[13] Waller ES. Evaluation of New Indomethacin Dosage Forms. Pharmacotherapy. 1983;3(6):324-333. DOI / PubMed
[14] Waller ES, Raebel MA. Relapsing Polychondritis in a Latin American Man. Am J Hosp Pharm. 1979;36(6):806-810.

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