Rekha Garg, Md, Ms Email & Phone Number

San Diego, California, United States

San Diego, California, United States

Clinical development, regulatory and safety consulting.

La Jolla, CA

• Responsible for development and implementation of global regulatory and safety strategy, including leadership over regulatory strategy, submissions, regulatory compliance, and product registrations across the product.
• Responsible for development of appropriate clinical trial safety, pharmacovigilance, and risk management strategies and an operating model with processes and compliance procedures to support the stage-appropriate.
• Responsible for development of appropriate clinical trial safety, pharmacovigilance, and risk management strategies and an operating model with processes and compliance procedures to support the stage-appropriate.

Cambridge, MA

• Accountable for global safety strategy, operating model and governance model, as well as provided leadership to execute the strategy with excellence, ensuring compliance with global regulations and quality standards.
• Managed strategic global plans and policies to ensure appropriate medical risk management activities while ensuring that these activities are in full compliance with internal company policies as well as with all… Show.
• Managed strategic global plans and policies to ensure appropriate medical risk management activities while ensuring that these activities are in full compliance with internal company policies as well as with all.
• Managed internal governance processes and cross-functional activities related to safety and external contractual relationships covering PV and medical risk management.
• Accountable for identification, assessment and communication of potential safety signals; oversee the generation and analysis of safety data, including clinical trial support through ongoing signal management and.
• Ensured the preparation of required periodic regulatory safety reports, investigator communications, product labeling/package inserts, and other reports as required.

Providing advice to biopharmaceutical companies on topics related to regulatory, safety and risk management including REMS for all stages of development and marketing.

Thousand Oaks, CA

• Developed global regulatory strategy to facilitate and optimize product development, regulatory interactions, global registration, approval, product label, and commercialization for cardiovascular portfolio
• Accountable for lipid lowering marketing application of the first combination product at Amgen to global health authorities based on a marked accelerated timeline to be first to market in the competitive cardiovascular.
• Led the regulatory in-licensing of… Show more
• Led the regulatory in-licensing of ivabradine from Servier and accountable for seeking approval for chronic heart failure with the FDA. Submitted large, complex NDA, based on foreign data, for ivabradine for chronic.
• Utilized regulatory expertise, regulations, and regulatory guidance to optimize global regulatory strategy for product development (e.g., Orphan Drug, Fast Track, Breakthrough Therapy, and global pediatric planning)
• Global RA Lead for multiple global key regulatory interactions at multiple levels of development with global health authorities including the FDA, MEB, EMA, TGA, CFDA, PMDA, MPA, MHRA. Show less

Thousand Oaks, CA

• Led a new centralized function to develop strategies for development, negotiation, governance, infrastructure, execution, assessment reports, vendor management, budget, compliance and life cycle management of product.
• Developed and implemented ESA REMS, a complex REMS of Epogen/Procrit and Aranesp, (two products marketed for over 10 years. primarily clinic/hospital based-prescription and with partner), and multiple indications with.
• Developed and implemented ESA REMS, a complex REMS of Epogen/Procrit and Aranesp, (two products marketed for over 10 years. primarily clinic/hospital based-prescription and with partner), and multiple indications with.
• Developed and negotiation the removal the ETASU from Nplate REMS and Enbrel REMS.
• Led strategies along with contingency plans for product approval or new safety risk for marketed products by evaluating benefit:risk profile of the product along with the global regulatory environment.
• Established Amgen as industry leader in proactive risk management and communication by leading interactions with the FDA regarding REMS policy and guidance document, representative on PhRMA and BIO REMS, on BIO CMI.

Thousand Oaks, CA

• Led team of safety physicians responsible for the global safety strategy and benefit:risk management of marketed and development products for treatment of anemia for nephrology and oncology indications.
• Provided leadership to safety leads on safety strategy along with design and implementation of risk management plans, post-approval commitments, periodic safety reports, Core Safety Information, investigators brochure.
• Collaborated… Show more
• Collaborated with other key stakeholders to ensure efficient methodology and process for safety surveillance activities to detect safety signals and implement appropriate actions, as necessary
• Key safety lead for several FDA advisory committee meetings on anemia products (2007 and 2008 Oncology Division Advisory Committee, 2007 and 2010 Cardio-Renal Advisory Committee)
• Ensured cross collaboration and timely communication of safety risks with development and regulatory colleagues throughout the product lifecycle. Show less

Indianapolis, Indiana

• Led a group of physicians, case managers, surveillance scientist responsible for global safety strategy, signal detection, pro-active surveillance, periodic and annual safety reports, risk management, post-approval.
• Actively involved in transfer from Clintrace safety database to Argus
• Identified and… Show more
• Identified and evaluated safety signals through assessment of individual case safety reports, aggregate trend analysis and review of relevant literature for a given product
• Participated in negotiations with business partners relating to global pharmacovigilance agreements
• Led a team of case managers, safety surveillance scientists, and physicians within the Endocrine/Cardiovascular Therapeutic Area Managed case managers to ensure review, approval and submission of all adverse events to.

Indianapolis, Indiana

• Responsible for optimizing product development across various therapeutic areas (cardiovascular, oncology and critical care) based on scientific knowledge, clinical trials methodology, clinical development, marketing.
• Led the development, design and implementation of phase 2-4 clinical trials for registration, commercialization, observational studies, registries and compassionate use studies including site… Show more
• Led the development, design and implementation of phase 2-4 clinical trials for registration, commercialization, observational studies, registries and compassionate use studies including site and investigator.
• Reviewed and approved investigator initiated proposals
• Collaborated on the statistical analyses plan
• Reviewed, evaluated and interpreted clinical data for clinical study reports

Montvale, NJ

• Developed outcomes strategy and disease management plans for cardiovascular disease in particular, congestive heart failure
• Designed prospective and retrospective studies to support the strategies
• Provided medical expertise in development of health related quality of life questionnaires
• Collaborated on analysis plan, performed data analysis and generated reports

Bethesda, MD

• Accountable for the design and conduct of the Digitalis Investigation Group Study (DIG), the first large simple trial conducted by NHLBI and the Arterial Disease Multiple Intervention Trial (ADMIT) and responsible for.
• Developed request for proposals, reviewed and selected investigators and data coordinating centers, pharmacy coordinating centers
• Numerous… Show more
• Numerous presentations and publications on the results of DIG and ADMIT along with clinical trial methodology including large simple trials Show less

Doctor Of Medicine (M.D.)

Bachelor'S Degree, Biology

Master Of Science (Ms), Epidemiology