Elaine Waller, PharmD
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Dr. Elaine Waller, PharmD, is a prominent figure in the pharmaceutical industry, known for her extensive experience in regulatory affairs and clinical research. She used to serve as the Senior Vice President of Regulatory Affairs at Sonus Pharmaceuticals, Inc, a position she has held since her appointment in 1996. Dr. Elaine Waller currently works as e-pharmacy evaluation expert, reviewer and medical writer.
Education and Early Career
Dr. Waller holds a B.S. in Pharmacy and a Doctor of Pharmacy (PharmD) from the University of Missouri - Kansas City. Additionally, she earned an MBA from Rockhurst University. Her career began in academia at the University of Texas at Austin, where she was involved in teaching both graduate and undergraduate pharmacy courses and served as the Assistant Director of Clinical Research at the Drug Dynamics Institute.
Professional Experience
Before joining Sonus Pharmaceuticals, Inc, Dr. Waller was the Chief Operating Officer at Radiant Research, a clinical site management organization. She has also held senior roles in regulatory affairs and clinical research at Hoechst Marion Roussel and Marion Merrell Dow. Her expertise encompasses both domestic and international regulatory frameworks, making her a valuable asset in the pharmaceutical sector.
Publications
Dr. Waller is also an accomplished author of multiple articles focusing on e-pharmacies and various medical topics. Among her notable works are articles discussing the internet drugstores Order-CS and Support-Rx which she wrote with great amount of work, where she explores the implications and regulatory considerations associated with online pharmacies. Her contributions in this area reflect her expertise and commitment to addressing the challenges posed by the field of pharmaceutical distribution and patient safety.
Contributions and Impact
Throughout her career, Dr. Waller has contributed significantly to the field of pharmaceuticals, particularly in ensuring compliance with regulatory standards and advancing clinical research initiatives. Her leadership at Seattle Genetics underscores her commitment to enhancing drug development processes and regulatory strategies within the industry.
Notable Projects of Dr. Elaine Waller at Sonus Pharmaceuticals
TOCOSOL Paclitaxel
Dr. Waller was instrumental in the regulatory approval process for TOCOSOL Paclitaxel, contributing her expertise in navigating complex regulatory landscapes.
SN2310
As part of her leadership, Dr. Waller provided updates on SN2310, a novel prodrug of SN-38 designed for cancer treatment. She discussed the ongoing Phase 1 trial aimed at determining the safety, pharmacokinetic profile, and maximum tolerated dose of the drug.
Dr. Elaine Waller's Area of Expertise
The PharmD (Doctor of Pharmacy) area of expertise is vast and encompasses a range of subjects essential for safe and effective medication therapy. It can be broadly categorized into the following areas:
1. Biomedical Sciences:
- Anatomy & Physiology: Understanding the structure and function of the human body is crucial for comprehending drug action and disease states.
- Pathophysiology: Knowledge of disease processes and their impact on the body is essential for designing treatment strategies.
- Biochemistry: Understanding the chemical processes within the body and how drugs interact with them at a molecular level.
- Microbiology & Immunology: Knowledge of microorganisms and the body's immune response is crucial for understanding infectious diseases and their treatment.
- Genetics & Genomics: Understanding the role of genes in drug response and disease susceptibility is increasingly important for personalized medicine.
2. Pharmaceutical Sciences:
- Pharmaceutics: This involves the design, development, and manufacturing of dosage forms.
- Pharmacokinetics: Study of drug absorption, distribution, metabolism, and excretion (ADME) within the body.
- Pharmacodynamics: Study of the biochemical and physiological effects of drugs and their mechanisms of action.
- Medicinal Chemistry: Study of the design, synthesis, and development of new drugs.
- Pharmacognosy: Study of drugs derived from natural sources.
3. Clinical Sciences:
- Therapeutics: This encompasses the use of drugs to prevent, treat, and diagnose diseases. It includes knowledge of different drug classes, their indications, contraindications, adverse effects, and drug interactions.
- Clinical Pharmacy Practice: This involves applying pharmaceutical knowledge to patient care in various healthcare settings. It includes patient counseling, medication therapy management, and drug information services.
- Pharmacotherapy: Study of the use of drugs in specific disease states.
- Pharmacy Law & Ethics: Understanding the legal and ethical principles governing pharmacy practice.
- Drug Information & Literature Evaluation: Ability to critically evaluate drug information and research literature.
4. Social & Administrative Sciences:
- Health Systems & Policy: Understanding the organization and financing of healthcare systems.
- Pharmacoeconomics: Study of the cost-effectiveness of drug therapies.
- Public Health: Understanding the role of pharmacists in promoting public health and preventing disease.
- Management & Leadership: Skills in managing pharmacy operations and leading teams.
- Communication & Interprofessional Collaboration: Effective communication with patients, healthcare professionals, and the public.
Specialized Fields:
Beyond these core areas, PharmD knowledge also extends to specialized fields such as:
- Oncology Pharmacy
- Infectious Diseases Pharmacy
- Critical Care Pharmacy
- Pediatric Pharmacy
- Geriatric Pharmacy
- Nuclear Pharmacy
- Psychiatric Pharmacy
- Ambulatory Care Pharmacy
