Microbiology and Molecular Biology

Dr. Winker's specialty is medical writing for regulatory submissions and scientific publications. She provides a comprehensive range of medical writing and reviewing services to biotech/pharmaceutical companies and university clients. Her broad experience with clinical development for pharmaceutical market application of biologics (BLA) and small molecule therapeutics (NDA) includes a thorough knowledge of regulatory guidelines (FDA, ICH/GCP), patient safety requirements, and a proven track record of delivering high-quality clear and concise documents on or before schedule.

Her experience also includes writing and/or reviewing clinical study reports (CSR) and integrated summaries of efficacy and safety (SCE/ISE and SCS/ISS), clinical overview/expert reports, white papers, preclinical/non-clinical reports, and summaries for regulatory documentation and submission to FDA (US) and/or EMEA (Europe).

Dr. Winker, a modern biology scientist with PhD and post-docs, is familiar with current concepts and techniques in biotechnology, molecular biology, immunology, medical microbiology, medical parasitology, clinical and non-clinical research, regulatory guidelines and a wide range of biomedical topics: cardiology and chronic heart failure, diabetes, postmenopausal osteoporosis, metastatic bone disease, oncology, virology, immunodeficiency diseases (HIV and others), and a wide range of infectious diseases (malaria, small pox, anthrax, plague, tularemia, and botulism).

After 10+ years in basic research (PhD and postdocs), Salome received her practical clinical research training 1995-1999 as a clinical trial monitor (clinical research associate [CRA]) in pharmaceutical companies and a contract research organization (CRO). Since 1999 her career as a medical writer has taken her into clinical and/or regulatory affairs departments of several biotech companies and CROs of any size, form, and technological status with respect to available software, document templates, reference manager database, documentum as document management system, and paper and/or electronic submission being performed.

Writing and reviewing clear, concise, and comprehensive clinical and non-clinical documents for:

• pre-IND and IND submissions: Investigator Brochures (IB), Protocols, Informed Consent documents, various other IND Sections, and briefing books for pre-IND meetings
• CTD/eCTD submissions of NDA/BLA: Clinical Study Reports (CSRs) for Module 5, Module 2 Summaries of Clinical Efficacy (SCE) and Safety (SCS), Integrated Summary of Safety (ISS), Clinical Overview, US and EU labeling documents, and briefing books for various FDA/EMEA meetings

Experience with the clinical development of:

• small molecule drug therapy for indications such as cardiology and chronic heart failure, diabetes, osteoporosis and other bone diseases
• biologics for the treatment of diabetes, oncology, virology, and immunodeficiency diseases
• vaccines and adjuvants for protection against small pox, anthrax, plague, tularemia, Venezuelan equine encephalitis, botulism, malaria

Publications of Salome D. Winker-La Roche, PhD

1.       La Roche SD, Leisinger Th. 1990.  Sequence Analysis and Expression of the Bacterial Dichloromethane Dehalogenase Structural Gene, a Member of the Glutathion S-Transferase Supergene Family. J Bacteriol 172:164-171.

2.       La Roche SD, Leisinger Th. 1991.  Identification of dcmR, the Regulatory Gene Governing Expression of Dichloromethane Dehalogenase in Methylobacterium sp. Strain DM4.  J Bacteriol 173:6714-6721.

3.       La Roche SD, Leisinger Th. 1991.  Genetics of Dichloromethane Degradation in Methylobacterium sp. Strain DM4, Ph.D. Thesis at the Swiss Federal Institute of Technology, Zurich, Switzerland.

4.       La Roche SD, Shafer BK, Strathern JN. 1995.  A ste12 Allele Having a Differential Effect an a- Versus  a-Cells.  Mol Gen Genet 246:80-90.

5.       Rousso P, Buclin T, Nussberger J, Decosterd LA, La Roche SD, Brunner-Ferber F, Biollaz J. 1999.  Effects of a dual inhibitor of angiotensin converting enzyme and neutral endopeptidase, MDL 100,240, on endocrine and renal functions in healthy volunteers.  J Hypertens 17:427-437.

6.      Hopkins RJ, Kramer WG, Blackwelder WC, Ashtekar M, Hague L, Winker-La Roche SD, Berezuk G, Smith D, Leese PT.  2004.  Safety and Pharmacokinetic Evaluation of Intravenous Vaccinia Immune Globulin in Healthy Volunteers.  Clin Infect Dis 39:759-66.