Susan Caldwell

Background in regulatory medical writing (MW) and drug product development, with a strong publication record—an unusual combination of MW expertise, analytical skills, management experience, medical knowledge. Experienced in all phases of drug, biologic, and medical device products:

• ICH-compliant regulatory submissions (INDs, NDAs, sNDAs, BLAs, sBLAs, 6 eCTDs, and 2 combination drug/device submissions), clinical study protocols, amendments, clinical study reports (CSRs), serious adverse event (SAE) narratives, investigator brochures (IBs), process development/CMC documents, manuscripts, brochures, SOPs
• Clinical writing: oncology; neurology; infectious diseases; immunology, allergy, and inflammation; cardiology; ophthalmology; Read more

Background in regulatory medical writing (MW) and drug product development, with a strong publication record—an unusual combination of MW expertise, analytical skills, management experience, medical knowledge. Experienced in all phases of drug, biologic, and medical device products:

• ICH-compliant regulatory submissions (INDs, NDAs, sNDAs, BLAs, sBLAs, 6 eCTDs, and 2 combination drug/device submissions), clinical study protocols, amendments, clinical study reports (CSRs), serious adverse event (SAE) narratives, investigator brochures (IBs), process development/CMC documents, manuscripts, brochures, SOPs
• Clinical writing: oncology; neurology; infectious diseases; immunology, allergy, and inflammation; cardiology; ophthalmology; drug, biologic, and medical device manufacturing (CMC); and more. Examples: age-related macular degeneration (AMD), analgesia, anemia, atherosclerosis, chronic granulomatous disease (CGD), chronic kidney disease (CKD), congestive heart failure (CHF), coronary artery disease (CAD), Crohn’s disease, glioblastoma multiforme (GBM), graft-versus-host disease (GVHD), hepatitis B and C virus, HIV, infant epilepsy, influenza virus, multiple sclerosis (MS), multiple myeloma, non-small-cell lung cancer (NSCLC), pancreatic cancer, phenylketonuria (PKU), renal failure, squamous cell carcinoma (SCC)
• Headed MW groups at 5 companies; staffed, trained, mentored, managed writers. Implemented QC; MW project management
• Drug, biologic, medical device product development (discovery and preclinical to clinical research, postmarketing, process development, manufacturing)
• CMC/process development MW and lab experience

Accomplishments: (1) Led MW team in developing an NDA/eCTD submission for Kyprolis (carfilzomib), approved in July 2012; (2) Major MW on Betaseron sBLA team (FDA approved).

Academic: PhD: medical microbiology & immunology; postdoctoral research: infectious diseases, 10 years of hands-on laboratory research experience.

Publications: Medical articles, book chapters, newsletters, web content.

Typical consulting project includes supervision of writers and/or generating documents for submissions to regulatory agencies (eg, FDA). Documents include, but are not limited to, INDs, NDAs, sNDAs, and sBLAs (all in eCTD format); CSRs, IBs; clinical study protocols and amendments; briefing packages; EOP meeting preparation; pharmacology and toxicology reports; CMC documentation; PowerPoint slide preparation; biomedical manuscripts, posters, abstracts, and oral presentations.

Partial list of clients includes:

• Pfizer, Inc.
• Puma Biotechology
• Juno Therapeutics, Inc.
• Gilead Sciences
• Seattle Genetics, Inc.
• Palo Alto Medical Foundation
• Sutter Health
• Fibrogen, Inc.
• Exelexis, Inc.
• Onyx Pharmaceuticals, Inc.
• Medtronic, Inc.
• Light Sciences Oncology, Inc.
• Sciclone Pharmaceuticals
• Biomarin Pharmaceuticals
• Raland Technologies, Inc.
• Regimmune Corporation
• Medivation, Inc.

Partial list of clients includes:

• Pfizer, Inc.
• Puma Biotechology
• Juno Therapeutics, Inc.
• Gilead Sciences
• Seattle Genetics, Inc.
• Palo Alto Medical Foundation
• Sutter Health
• Fibrogen, Inc.
• Exelexis, Inc.
• Onyx Pharmaceuticals, Inc.
• Medtronic, Inc.
• Light Sciences Oncology, Inc.
• Sciclone Pharmaceuticals
• Biomarin Pharmaceuticals
• Raland Technologies, Inc.
• Regimmune Corporation
• Medivation, Inc.