Sandy Malcolm Email & Phone Number

Indianapolis

Management of early phase ( I-IIa) clinical development projects in partnership with global CROs

Chorus Resonance* Accountable for delivery of clinical project milestones on time, on budget * Selection of external network of vendors for implementation of clinical activities* Manage external network of vendors to ensure on time and on budget project delivery * Create and manage implementation timeline and clinical trial activities via Chorus custom.

Indianapolis

Partnered with internal and external experts and thought leaders to develop and manage neuroscience clinical trial protocols. Responsible for safety reviews and all aspects of GCP compliance.

Atomoxetine: USMDAuthored/ provided clinical support for key adult ADHD protocol- LYCU(Positive study). Partnered with external disease state and cognition experts to deliver quality study. Developed and managed extensive training for study including cognition battery. Study enrolled at 2x expected rate. Authored/provided clinical support for key adult.

James MartinezMedical lead for development of Pathophysiolgy of Pain Series I and II.Protocol lead for HMDY(DPNP) (study terminated), HMEZ(DPNP) (Positive Study), HMFR (CNP-MS), HMGO (Neurobiology of Depression) and OO10 (Development of Remission from Depression Questionnaire).Provision of MDD/GAD/Fibromyalgia/DPNP medical support for marketing and.

Scientific Knowledge resource for ADHD/atomoxetine Protocol, informed consent, clinical study report author Marketing and clinical trial support; Prepared clinical trial training materials for CRAs and site personnel, delivered training at startups and via CD-ROMs, authored the following atomoxetine protocols and accompanying ICDs; adult BID vs QD).

LYAA, A Phase III Randomized, Double Blind Comparison of Placebo and Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder and B4Z-MC-LYAR, Long-term, Open-Label Safety Study of Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder. Study responsibilities include all.

Core responsibilities: Consistent Regulatory Compliance Communication/Information Management Effective CT process and study management Continuous process improvement

Comparison of Olanzapine versus Risperidone in the Treatment of Negative Symptoms in the Older Adult with Schizophrenia. Study responsibilities include: protocol development, case report form development, coordination of consultant meetings, contract development, development of cognition battery, training (25 sites), management of ASAS-Cog and DAFS.

HGFW, Strategies for Switching from Conventional Antipsychotics to Olanzapine. Responsibilities included protocol development, training of site personnel, case report form development, data management, co-monitoring, site manager for17 sites (209 patients) in multi-center clinical trial. Team SAE resource, chaired CIA job description task force. Meetings.

Evaluation of enviroxime and other analogues for in vitro activity versus Rhinovirus/other Picorna virusesPurification and characterization of Rhinovirus 3AB polyproteinPurification and screen development for Rhinovirus RNA polymeraseInvestigated mechanism of toxicity of FIAU for task forceDeveloped and ran high-throughput screens for inhibitors of HIV.

Key Projects: Developed method for high-frequency transformation of plant protoplasts Genetic and phenotypic analyses of plants regenerated from protoplasts Isolated and purified cysteine protease inhibitors: cystatin and potato crystal protein Developed in vivo assays to test effect of protease inhibitors on corn root worm

Key Projects: Purification and immunological characterization of RNA polymerases from crop plants Developed isolation and purification method for cauliflower mosaic virus

B. S, Microbiology

level courses in immunology, plant physiology, genetics, public and environmental health.

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