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Pharmacy Medical

Boston, Massachusetts, United States
August 09, 2018

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Shikha Patel Resume Page 1-401-***-**** Boston, MA 02215 SHIKHA PATEL

Bridges gaps in drug development and application by applying drug safety requirements and health authority regulations. Regulatory Affairs Compliance w Medical Information/ Communications w Clinical Trials Pharmacy w Drug Safety Expertise 401-***-**** Boston, MA 02215 Exposed to a global overview of pharmaceutical industry pathways in major departments including medical and regulatory affairs, health economics and outcomes research, clinical development, and pharmacovigilance. Observe various departments in the industry involved in different phases of drug development in the U.S. Facilitate efficient review processes for key documents including clinical protocols, clinical study reports, and integrated safety and efficacy summaries. Quality Oversight & ICSR

Pharmaceutical Product Development

Evidence-Based Medicine Evaluation

Cross-Functional Collaboration

Clinical Documentation

Community Outreach

Early Drug Development

Clinical Protocols Development

Prescription Drug Planning


Doctor of Pharmacy, Bouvé College of Health Sciences – Northeastern University May 2018 BS in Pharmacy Studies, Bouvé College of Health Sciences – Northeastern University Dean’s List (2012 – 2016) 2017 Undertook clinical rotations in three key areas:

#1. Pharmaceutical Industry

Intern – Pharmacy Regulatory Sciences, Biogen 09/2017 – 10/2017 Worked with medical affairs, drug safety and risk management, regulatory advertisement and promotion, and commercial teams. Gained exposure to regulatory information and operations, early drug development, and U.S. regulations.

• Participated in meetings held by the global medical writing, study management, and scientific research teams for a study focused on neurodegenerative therapeutics; observed clinical trial regulations and assisted with writing protocols.

• Trained on Risk Evaluation & Mitigation Strategy (REMS) documentation for Biogen’s multiple sclerosis products in collaboration with safety, pharmacovigilance, and drug evaluation teams. Worked with the FDA to ensure regulatory compliance.

• Aided in ensuring legal and FDA compliance by helping with reviews for the Regulatory Advertisement-Promotional Department.

• Participated in MCPHS fellowship conference series to develop an understanding of emerging markets and precision medicines. Intern – Pharmacy in Regulatory Sciences and Commercial Department, South African Druggist Malawi 08/2017 – 09/2017 Collaborated with pharmacists and pharmacy manager to create registration dossier for the generic products in the pipeline.

• Reviewed regulatory guidance documents for marketed drugs in Malawi verified by the Pharmacy, Medicines, & Poison Board of Malawi (PMPB) and Medicines Committee (MedCom).

• Conducted quality control inspection visits in collaboration with the PMPB team at the manufacturing plant site.

• Shadowed commercial/marketing strategies for marketed OTC drugs including SADAMOL® and SADASPRIN®. Intern – Clinical Trials Pharmacy, Massachusetts General Hospital 06/2017 – 07/2017 Worked with various study types including emergency use and expanded access clinical study approvals with controlled medications.

• Reviewed ~2 new protocols/week for the clinical trials pharmacy. Contributed to meetings on clinical investigational drug trials within the pharmacy, Institutional Review Board meetings at Partners HealthCare, and site initiation and site qualification visits.

• Leveraged electronic drug accountability system Velos to prepare and dispense medications for patients enrolled in various clinical trials.

#2. Inpatient Clinical Health Systems (leveraged EPIC as the electronic drug system) Intern – Oncology Pharmacy, Dana-Farber Cancer Institute 03/2018 – 04/2018 Shikha Patel Resume Page 2 401-***-**** Boston, MA 02215

• Carried out interdisciplinary medical rounds reviewing oncology drug therapy regimens including pharmacology, toxicology, pharmacokinetics, and drug interactions. Helped monitor and transition the care for discharged patients.

• Delivered in-service presentations on the treatment options for non-small cell lung cancer, SVC syndrome, and acute myeloid leukemia to the medical team while conducting rounds in liquid oncology and solid tumor oncology departments.

• Assisted the preceptor in therapeutic integration sessions and class activities for students. Intern – Internal Medical Pharmacy, Brigham & Women’s Hospital 11/2017 – 12/2017

• Participated in daily general medical rounds to assess health and progress of patients suffering from various ailments.

• Authored weekly blogs on new shingles vaccine, diabetes, pericarditis management, and other general medicine topics.

• Developed mock-EPIC templates suggesting treatments for cases for the general medicine elective at Northeastern University.

#3. Outpatient Services

Intern – Ambulatory Care Pharmacy, Cambridge Health Alliance (CHA) 01/2018 – 02/2018

• Conducted patient visits, counseling, post-discharge follow-up, and monitoring; focused on chronic disease state management for cases like Hepatitis C, hypertension, diabetes, and anticoagulation. Developed medication therapy management plans.

• Initiated a retrospective project on vitamin B-12 deficiency with the prolonged use of metformin within the CHA community patients; prepared the proposal and developed key hypotheses. Research in progress. Intern – Pharmacy, Walgreens Specialty AIDS Action Committee 05/2017 – 06/2017

• Improved prescription adherence in HIV patients with high-pill burdens by providing blister packaging and performing medication therapy management on antiretroviral medication, nutrition, maintenance medication, and pre-exposure prophylaxis.

• Collaborated with primary healthcare providers to suggest alternative regimens due to interactions, side effects, and cost barriers for patients’ antiretroviral therapies.

• Increased Otezla prescriptions and expedited insurance approval by ~23% by drafting a business proposal. Contributed to special medication meetings with drug representatives from various companies to discuss barriers and needs.

• Participated in drug information sessions organized by pharmaceutical companies for the continuity of education on particular regimens and the pipeline for HIV/AIDS.


Intern – Rehabilitation Hospital Pharmacy, Spaulding Rehabilitation Hospital 08/2015 – 12/2015

• Received IV training on sterile and non-sterile compounding like oral suspensions, syrups, and solutions as well as repackaging medications for pediatric dosages. Restocked Omni cells and updated crash-carts for a 150-bed hospital.

• Reduced medication errors during transitions of care by ~30% by proactively monitoring and cross-verifying patient information with outpatient hospital.

Intern – Pharmacy, CVS Community Pharmacy 01/2015 – 05/2015

• Managed business metrics and created weekly action plans while operating in a high-volume store with 4000 prescriptions/week.

• Reduced medication errors significantly by pitching the introduction of color-coded prescription labeling.

• Monitored patient compliance. Participated in outreach; counseled on smoking cessation and diabetes management. Intern – Pharmacy, Partners in Hope Hospital 04/2014 – 09/2014

• Improved adherence to antiretroviral and antimalarial medications in an emerging healthcare system with high-risk patients.

• Recommended the incorporation of electronic record systems for the hospital after comparing Malawian and U.S. healthcare.

• Carried out inventory and cost-effective stock ordering with government contractors using non-electronic systems. Intern – Pharmacy, African Bible Clinic Hospital 04/2014 – 09/2014

• Administered immunizations to pediatrics at the “Under Five Clinic” weekly for MMR, poliovirus, Tdap, and pneumococcal.

• Prepared sterile surgical instruments and equipment needed for patients undergoing orofacial cleft surgeries.

• Organized and implemented monthly outpatient nutrition clinics for low-income village residents. Shikha Patel Resume Page 3 401-***-**** Boston, MA 02215 R ESEARCH

• Evidence-based Medicine: Co-authored to update a systematic review of the Cochrane database; “Does pre-exposure prophylaxis

(PrEP) with tenofovir/emtricitabine prevent HIV infection better than placebo in uninfected, high risk individuals who exhibit high adherence rates while on varying dosing regimens?”

• Research Methodology & Biostatistics: Utilized research design for experimental and observational studies, hypotheses testing, and introducing basic statistics to research papers. Completed the NIH Human Subjects Certificate Program.

• Specialty Service Expansion Plan in Neurology: Developed and executed a business proposal for Tufts Neurology department to generate funds through evaluations in operations, market and computer analysis, financial cash-flow projections, and HR.

• Increasing Adherence to Antiretroviral Therapies: Authored an article on economic, literacy, and cultural barriers to adherence and counseling of HIV/AIDS patients living in Sub-Saharan Africa. P RESENTATIONS

• Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism 03/2018

• Non-Small Cell Lung Cancer and SVC Syndrome Complication 02/2018

• Acute Myeloid Leukemia and Treatments 02/2018

• Long-Term Effects of Metformin leading to Vitamin B-12 Deficiency 01/2018

• Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects with End-Stage Renal Disease on Hemodialysis 11/2017

• Expanded Access and Guidance for Industry on Charging for Expanded Access Drug Use under an IND 10/2017

• Drug Regulatory Bodies and Processes in the U.S., European Union, and African Union 09/2017

• Spinal Muscular Atrophy and Biogen’s SPINRAZAÒ Approval 09/2017

• Drug Development Process and Expedited Approval Pathways in U.S. 07/2017

• Get Informed on Parasitic Loiasis 07/2017

• Studying Safety of Cannabidiol (GWP42003-P) in Children and Adults with Inadequately Controlled Dravet Syndrome 06/2017

• Post-Exposure Prophylaxis (PrEP) for Women 06/2017

• Business Proposal on OTEZLA and Expediting Insurance Approval for Patients Efficiently 06/2017

• Reducing Hospitalizations in Patients with Heart Failure: The Pharmacist’s Role 05/2017

• Ticker Pharmaceuticals: SABTREO 04/2017

• SGLT-2 Inhibitors should be considered Preferred Agents for Diabetes Treatment 03/2017

• Does Pre-Exposure Prophylaxis with Tenofovir/Emtricitabine Prevent HIV better than Placebo? 11/2016

• Opioid Overdose Awareness Public Health Intervention for Worcester County 11/2016

• Effects of Tolvaptan, a Vasopressin Antagonist in Patients Hospitalized with Worsening Heart Failure 05/2016

• Public Service Announcement: Opioid Crisis and Naloxone Administration 03/2016 C OMMUNITY & A FFILIATIONS

African PaintNite at Fenway Community Center: Founder and mentor of an African art class. 05/2016 – Present Re-Think Your Drink, Boston: Helping campus community choose healthier beverages. 09/2016 – Present Susan Bailis Assisted Living Facility: Educate seniors on chronic disease states. 01/2015 – 06/2016 Lilongwe Educational Assistance Program: Founded this distance-education program. Led fundraisers. 08/2010 – 05/2015 Affiliations: Industry Pharmacists Organization, American Pharmacists Association-Academy of Student Pharmacists, Northeastern University Student Health Plan, American Society of Health-System Pharmacists, Massachusetts Society of Health-System Pharmacists

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