Over the past twenty years I've had the great pleasure of working with exceptional teams to spearhead the research and development of many innovative therapies. My scientific interest and expertise spans multiple therapeutic approaches and clinical areas. I value the drug development experience I garnered from both the biotech sponsor and CRO provider side. My company, Alters Bioscience Consulting, provides services in preclinical/translational drug development, strategic planning/project assessment, and scientific/medical/corporate writing. I take pride in being an efficient and cost-effective source of expertise for my clients. Alters Bioscience Consulting has advanced therapeutic agents from basic research through lead selection, optimization, preclinical development, IND-enabling studies, and Phase I clinical trials. Preclinical drug development services include: • Development of preclinical development strategy • Implementation of preclinical study plan • Analysis and reporting of results Alters Bioscience Consulting has worked with clients to select and optimize their product portfolio for internal development, perform due-diligence on available agents for in-licensing or partnership, and create and present information for potential spinouts or investors. Strategic planning/project assessment services include: • Determine competitive landscape • Evaluate product in-licensing opportunities • Create Target Product Profile (TPP) • Perform due-diligence on new corporate ventures • Create executive summaries and corporate brochures Alters Bioscience Consulting has assisted clients with scientific/medical/corporate writing and communication. Scientific/medical/corporate writing services include: • Study reports • INDs and Investigator Brochures • Grants • Manuscripts, abstracts, and presentations Specialties:CLINICAL DISEASE AREAS • Oncology • Endocrinology • Autoimmunity • Infectious Disease • Asthma/Allergy • Pain • Inflammation • Transplantation THERAPEUTIC APPROACHES • Peptides • Proteins • Small molecules • Nanoparticles • Immunotherapy • Cell and gene therapy • Vaccines • Drug delivery STUDY TYPES • In vitro activity • Mechanism of action • In vivo proof of concept • Selection of predictive model • Efficacy and dose optimization • Pharmacokinetics • Pharmacodynamics • ADME and Toxicology