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 database and MS Project tools* Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues(internal and external), lead risk assessments and contingency planning, and effective communication across and upward * Provide clinical regulatory direction to team using Chorus clinical SOPs and ICH guidelines * Document key team information and decisions in Chorus custom tracking and communication database* Participate in review of database utilization; provide metric reports to track and manage process and justify database design changes. * Managing writing of study specific protocols, informed consent documents, clinical investigator brochures, and final study reports. * Manage clinical change control process * Identify and monitor critical path activities

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 ADHD and social anxiety protocol- LYDQ(Positive study). Prior to study initiation, drove revision of advertising materials to ensure success from the start. Authored/managed Strattera Annual Report 2003/2004LYAV CSRMentored visiting scientistTrained new TA to take over LYCU/LYDQ studiesCoauthored LYBG and S009 publications/posters.Led development of new training materials for psychiatric assessments-PARS(pediatric), Adult ADHD diagnostic and severity of illness interviews (ASRS, AISRS),products used both for US affiliate and global studies. Goal for use of new ADHD tools in studies was to minimize patient/rater burden- ie streamline data collection.

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 physicians: review/retrieval of data and scientific information for use in promotional pieces, creation of slides for speaker training, advisory board presentations, medical letter reviews, medical booth coverage. Responsible for creation of ISE slides based on voice of the customer -mood and pain, fibromylagia, GAD disease state and GAD safety and efficacy. General Clinical trial support- assessment of e-pro vendors (HMFR) protocol writing, ICDs, startup training/OPPS, CTR, poster and manuscript development. Cross Brand Project: O007, NDIS: evaluation of differential diagnostic assessment (Adult ADHD/GAD/mania/MDE) tool for use in PCP setting. Partnered with internal and external experts/AAFP representatives. Developed innovative protocol and championed use of new e- data collection vendor (Maaguzi). Disease state and product training as needed- eg sales representatives, CRAs/

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) (Negative study), LYBP (Positive study) (ADHD + anxiety), S009 (Strattera observational study), liaison to CRO (PAREXEL), provided medical information support at scientific meetings, supported brand team activities including medical review of training/promotional material, ad hoc requests for data, data mining for publications, team member Medical Marketing Interface Core Team-provided input on manuscript ideas, strategies, member Strattera IIT Strategy and Scientific committees, editing of LYBG CSR, wrote OPPS (LYBG), reviewed LYBG manuscript,(contributing author) , managed LYAU (fMRI study-Strattera vs methylphenidate), authored abbreviated report (Zyprexa- HGHG), coached new Strattera TA. Board member Indianapolis CHADD, liaison for adult ADD group. Team award received for LYBG: President's Award (2002

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 aspects of clinical trial and site management, liaison between product team and affiliate. Managed all pre-trial work for LYAO until June 2000. Trained new CRA to run B4Z-C-LYAO

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 certification and monitoring, rater reliability assessments, vendor contracts (3), consultant contracts (15), monitor for 1 clinical trial site, site communication and management, liaison for RRMs and CRMs. Trained new CRA in all aspects of clinical trials. Meetings attended: Mt. Sinai Conference on Cognition, NCDEU. Presented HGFW data at GMC

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 attended: AAGP.

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 III- Tat protein (luciferase)Investigated mechanism of increased sensitivity of tat-directed transactivation to alpha-amanitin

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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