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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Caldwell, Susan, BA, PhD
Business Name Biotech Ink, LLC
Certifications
Education
  • PhD, Medical Microbiology and Immunology, Wake Forest University School of Medicine
  • Postdoctoral Research, Human Infectious Diseases, Wake Forest University School of Medicine
Business Address 969-G Edgewater Blvd.
No. 303
Foster City, CA 94404
USA
Contact information
Telephone:
Fax:
Mobile Number:
Email address:
Website URL:
650-286-9300
650-286-9301
650-346-7761
caldwell@biotechink.com
http://www.biotechink.com
Specialties
  • Write, edit, and review medical manuscripts, clinical study protocols and amendments, clinical study reports (CSRs), serious adverse event (SAE) narratives, investigator brochures (IBs), process development reports, manufacturing (CMC) documentation, medical conference minutes, full regulatory submissions (INDs, NDAs, BLAs, sBLAs, 5 eCTDs, and 2 combination drug/device submissions since 2005), slide sets, white papers, internal reports, web sites, and many other document types.
  • NDA, BLA, sBLA, and IND submissions in eCTD format; eCTD clinical and preclinical content, scope, organization, and format to ensure submission readiness.
  • Drug and medical device development experience from discovery and preclinical through clinical research and postmarketing, process development, and manufacturing.
  • Orphan drug document preparation
Experience

Medical Writer Consultant and President
Biotech Ink, LLC; Foster City, CA
Jan 2005-present

Advise clients on appropriate content, scope, organization, and format of materials for eCTD submissions and individual research reports and protocols. At all stages of document development, recommend strategies for optimal data presentation in regulatory submissions. Work with client to develop best strategy for document development, including the appropriate use of abbreviated clinical study reports, manuscript submissions, and other approaches. Fine-tune tables and figures to optimize for clear, concise content presentation to complement data analyses. Advise clients on document preparation decisions that enhance publication readiness. Provide comprehensive document review services to ensure high-quality document work products.

Medical writing: Provide clients with medical writing, reviewing, and editing services. Write manuscripts for peer-reviewed journals, abstracts, posters, white papers, brochures, newsletters, and slide sets. Regulatory documents include regulatory submissions (eCTDs as INDs, NDAs, and BLAs); clinical study protocols, amendments, reports (CSRs), and IBs; clinical data evaluations; drug safety documents, including serious adverse event (SAE) narratives; CMC, PK, and toxicology reports; GXP audit reports; literature reviews; and informed consent forms. Prepare documents for publication with Acrobat and ISIToolbox. Use EDMS software, including SharePoint and Open Text Document Management.

Medical writing infrastructure: As needed, form and supervise writers for companies that need writing support. Develop infrastructure documents (eg, SOPs, style guides, work practice documents, preflight checklists, and Word and PowerPoint templates). Develop eCTD submission templates that are fully ICH compliant.

Technical and other writing: Write technical documents for CMC and process sciences, including experimental design, data presentation, and data analysis. Draft and edit web site content.

Management: Provide project management services for eCTD submissions and other large projects. Form medical or scientific writing teams (including medical writers, medical copy editors, and proofreaders), and direct writers’ work to ensure on-time and on-budget project completion. Publishing: Write for and publish the Biotech Ink Insider, a free weekly newsletter for medical writers, editors, copywriters, and publishers.

Senior Associate, Medical Writing (Consultant)
Raland Technologies, Inc., Life Science Services & Solutions; Rochester, NY
Dec 2008-May 2009

Advised client on strategies for developing preclinical eCTD modules. Analyzed data and developed preclinical documents in support of NDA and MAA eCTD submissions for an oncology indication. Worked to ensure that (1) timelines for document development were met, (2) the scope of submission content was well defined, and (3) the publishing group was kept informed of writing issues. Collaborated with the preclinical department to ensure accurate identification of all legacy documents. Developed complete library of ICH-compliant preclinical templates for Module 2 in the eCTD and regulatory style guide for use with eCTD document development.

Medical Writer Consultant
Scios, Inc. (a Johnson & Johnson Company); Fremont, CA
Apr 2005-Jul 2005

Recommended use of clinical research data and other content to develop clear, concisely worded clinical study reports. Wrote, reviewed, and edited clinical documents pertaining to congestive heart failure (CHF). Provided medical writing services to support development of drug products, and revised clinical study documentation (protocol amendments, IBs, SAE and AE narratives, and CSRs).  

Senior Director, Writing and Publishing
ICON Clinical Research, PLC; Redwood City, CA
Feb 2004-Jan 2005

Expanded medical writing and publishing services for a large clinical research organization. Directed activities of writers and an epublisher. Supported clients with manuscripts and documents for phase 1-4 clinical studies. Clinical disciplines included cardiovascular disease, oncology, infectious diseases, inflammatory diseases, and analgesia. Nonclinical areas included toxicology, PK, pharmacology, and CMC.

Medical writing: Wrote and reviewed regulatory documents for drugs, biologics, and medical devices, including clinical study protocols, amendments, and CSRs; IBs; SAE and AE narratives; informed consent forms; and two CTDs, two as drug-device combinations. Performed QC and reported on clinical, basic research, process sciences, and CMC documents. Wrote and edited abstracts, slides, posters, and manuscripts.

Technical and other writing: Developed process development and CMC documentation for two CTD submissions. Developed, reviewed, and edited web site content. Prepared and edited press releases.

Infrastructure: Developed processes and templates, style guide, and other materials to support medical writing; hired medical writers and epublishing manager; prepared budgets; mentored writers; acquired ISIToolbox and CoreDossier software for in-house publishing, and Documentum for document management.

Administration: Served as project manager for all medical writing work. Developed budgets, assigned project resources, and met timelines; interfaced with other departments to ensure input for medical writing projects; created slide kits and marketed medical writing services; advised senior management on status of projects, staffing changes, and other issues. Served on numerous management and project teams.

Publishing:  Used ISIToolbox to publish parts of an eCTD and prepared CSRs for esubmissions (for example, hyperlinking, cross-referencing, and pagination across volumes); planned writing strategy for future esubmissions; worked with electronic publishing manager to publish a CTD and an eCTD.

Management: Directed 7 medical writers, 1 editor, 2 medical writing consultants, and 1 publisher.

Technical Writer Consultant
Touchstone Technologies, Inc.; Fremont, CA
Jun 2003-Sep 2003

Provided writing services to support development of computer validation plans for a large biotechnology company.

Director, Medical Writing
Abgenix, Inc.; Fremont, CA (Abgenix was sold to Amgen, Inc., in 2006)
Jun 2002-Jan 2004

Clinical disciplines included oncology (renal cell, NSCLC, colorectal, breast, pancreatic, and prostate), inflammatory diseases (GVHD, psoriasis, and COPD), and fully human monoclonal antibody technology.

Medical writing: Wrote and reviewed manuscripts, slide kits, CSRs, protocols, IBs, SAE and AE narratives, style guide, and summaries. Provided writing support for preclinical and clinical research, process development, and CMC. Developed abstracts, posters, and slides for FDA advisory board and other meetings.

Technical and other writing: Developed web content; drafted, reviewed, and edited press releases.

Infrastructure: Developed infrastructure documents (eg, SOPs, templates, and checklists) to support medical writing; helped implement Documentum (EDMS); member, Biosafety Committee.

Administration: In addition to managing writers and writing/editing documents, served as medical writing project manager. Shepherded documents through review and approval; planned project schedules and ensured on-time and on-budget project completion; performed budget and resource planning.

Publishing:  Published CSRs for esubmissions (eg, hyperlinking, cross-referencing, paginating, and processing scanned documents for esubmissions) with Adobe Acrobat (full version) and ISIToolbox.

Management: Directed 4 medical writer consultants, 1 technical editor, and 1 word processor.

Director, Technical Writing; Associate Director, Medical Editing
Pharmacyclics, Inc; Sunnyvale, CA
Jan 1999-May 2002

Wrote documents for drug and medical device products. Clinical disciplines included oncology (brain metastases, squamous cell carcinoma, and GBM), cardiovascular disease (PAD and CAD), and ophthalmology (AMD).

Medical writing: Drafted and reviewed regulatory documents, including study protocols, amendments, SAE narratives, CSRs, IBs, PIs, PK reports, a mock NDA, and clinical development plans. Drafted manuscripts, slide kits, abstracts, and posters. Generated reports for toxicology, PK, process development, and manufacturing projects.

Technical and other writing: Wrote and edited SOPs, working guidelines, MSDSs, and stability reports. Wrote, reviewed, and edited press releases. Developed intranet web site content.

Infrastructure: Formed medical writing group and hired medical writing consultants; informed management of medical writing project status; developed processes to facilitate document production; helped implement Documentum (EDMS) and CoreDossier (electronic publishing software) systems; supervised Reference Manager database development and developed intranet web content.

Administration: Served as project manager for all medical writing work. Guided documents through review and approval; planned project schedules and ensured timely document completion; did budget and intradepartmental project planning.

Publishing:  Collaborated to publish esubmission documents; authored and implemented writing strategy for publishing CSRs and esubmissions; ensured documents met publishing requirements.

Management: Directed 6 staff medical writers and 12 medical writer consultants.

Associate Director, Medical Writing
Berlex Laboratories; Richmond, CA (later merged with Bayer Healthcare)
Sep 1995-Jan 1999

Clinical areas of writing experience included multiple sclerosis, oncology (leukemia), and MRI contrast agents.

Medical writing: Drafted and reviewed manuscripts; Summary Basis for Approval, Integrated Safety Summary, Integrated Efficacy Summary, package insert, SAE narratives, IB, and supplemental BLA for Betaseron; wrote CSRs; developed abstracts and slides; generated CSRs for Phase 4 studies.

Technical and other writing: Developed CMC and process development documentation and stability study reports. Reviewed and edited press releases.

Infrastructure: Wrote, edited, reviewed, and approved SOPs for clinical research and working procedures for process development; ensured staff received continuing education; participated in implementation and configuration of Documentum (EDMS) and CoreDossier (epublishing software).

Administration: Served as project manager for all medical writing work. Planned project schedules and ensured timely document completion; participated in budget preparation; assigned timelines and directed medical writing project management activities.

Publishing:  Published partly electronic BLA for Betaseron using manual methods combined with the use of CoreDossier, Adobe Acrobat, and Documentum.

Management: Directed 4 staff medical writers, 5 medical writer consultants, and 2 clinical administrators.

Partner
BioInformation Resources; Miami, FL
1993-1995

Owned and operated BioInformation Resources. Specialized in biomedical information research from online databases. Analyzed information and wrote reports. Performed competitive intelligence and market analysis; projected industry trends. Obtained patent and product liability data for lawsuits.

Senior Scientist
Baxter Diagnostics (a subsidiary of Baxter Healthcare, Inc.); Miami, FL
1991-1993

Wrote regulatory documents, including PMAs, for diagnostic devices. Wrote study protocols and final reports. Managed clinical studies; generated and analyzed data. Chaired meetings to manage clinical trials. Developed diagnostic assay for acute hepatitis A virus infection. Co-chaired Biosafety Committee; served on Management Safety Committee. Brought BL-3 containment laboratory into cGMP compliance, and supervised its operations. Wrote clinical, CMC, and SOP documents to support assay manufacture; directed assay manufacture. Supervised 2 technicians.

Scientist II; Scientist I
Genelabs Incorporated; Redwood City, CA (merged with GlaxoSmithKline in January 2009)
1987-1990

Directed phase 1 clinical trial support for GLQ223. Generated data in an IND for GLQ223, a drug with antiviral activity against HIV. Screened substances for antiviral activity. Wrote portions of patents, INDs, manuscripts for publication, SOPs, and procedures. Coordinated phase 1 trial support between Medical Affairs, Pharmaceutical Development, QA and QC, and Regulatory Affairs. Presented data at meetings. Supervised 5 technicians and operations of a BL-3 containment laboratory. Served as Biosafety Officer.

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