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Peter B. Bottini is listed as RETIRED Clinical Research & Phamacovigilance Leader | Bioequivalence | Study Design | SOP Development | GCP | Strategic Planning at Bottini Consulting LLC, based in Morgantown, West Virginia, United States. AeroLeads shows a work email signal at comcast.net, phone signal with area code 304, and a matched LinkedIn profile for Peter B. Bottini.
Peter B. Bottini previously worked as Founding President at Bottini Consulting Llc and Vice President, Clinical Services at Alvogen. Peter B. Bottini holds Pharm.D., Clinical Pharmacy from University Of Missouri-Kansas City.
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A Doctor of Pharmacy and accomplished pharmaceutical executive with an entrepreneurial spirit. Extensive hands-on and management experience in Clinical Research, Pharmacovigilance and Strategic Planning. Innovative clinical and regulatory strategist with proven ability for NDA approvals. Effective leader that uses respect and a “lead-by-example” approach to achieve objectives. Key accomplishments include: 9 successful NDAs, including products with Orphan Drug and Fast Tract Approval designations; design and operation of a Phase 1 clinical pharmacology center in Ireland; initiation/supervision of Clinical Research Departments at two companies; cordinator and/or investigator for over 30 clinical trials; key project manager in the integration of US and international pharmacovigilance programs; directed the selection and management of pharmacovigilance database; responsible for FDA pre- and postmarketing reporting of adverse drug reactions at 2 companies. Author of over 20 publications, 30 abstracts and 2 book chapters. Specialties: Pharmacovigilance and REMS, medical writing, clinical protocol development and execution, NDA clinical preparation/review, clinical & safety due diligence inspections, bioequivalence studies, SOP development, GCP.
Listed skills include Clinical Trials, Clinical Development, Pharmaceutical Industry, Pharmacovigilance, and 21 others.
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Morgantown, Wv
Supporting companies to achieve their business objectives in the areas of Clinical Research, Pharamacovigilance/Drug Safety and strategic planning. Innovative clinical and regulatory strategist. • Established medical services for a new product launch • Developed new protocols for dry eye disease and migraine headaches• Developed a cGCP training program
Budgetary and project management responsibilities for clinical trials and pharmacovigilance. Supervisory responsibility for Medical Information. Assist Business Development in the marketing of contract clinical and pharmacovigilance services.
Morgantown, Wv
Headed North American global pharmacovigilance activities (2007-2009), with responsibility for USA and CAN, a multimillion budget and an international staff of 25 (including pharmacists, nurses and physicians). Responsible for Drug Information and Medical Writing.
Research Triangle Park, Nc
Created, staffed and supervised the Medical Affairs department, with oversight and budget responsibility for Medical Scientific Services, including Medical Liaisons, Medical Information, Medical Writing and Product Safety
Morgantown, Wv
Managed clinical research and pre-/postmarketing pharmacovigilance activity. Supervised departmental sections of Preclinical and Clinical Operations, Statistics, Data Management, Medical Information, Medical Writing and Product Safety. Responsibility for Phase 2-3 clinical development and regulatory support for IND/NDA submissions.
Investigator and/or coordinator for over 30 clinical research projects. Supervised the medical therapy of patients with hypertensive cardiovascular disease. Consulted with physicians and medical students regarding appropriate pharmacotherapy. Participated in hypertension clinics.
Established clinical research centers through joint ventures with physician groups and/or multiple specialty practices. Provided clinical projects, regulatory and research infrastructure to clinical sites in the areas of hypertension, lipid lowering therapy, headache and upper respiratory tract infections.
Gainesville, Ga
Responsible for strategic planning and clinical development for Phase 2-3 NDA and IND projects. Oversaw CRO activities for nifedipine and verapamil Phase 2-3 clinical trials. Prepared and presented scientific presentations to current and prospective clients
Vice-chairman of the Scientific Committee. Clinical and regulatory strategic responsibility for Phase 1-3 clinical trials. Budgetary and operational responsibility for the Phase 1 Clinical Pharmacology Center.
Designed, staffed and supervised the Phase 1 Clinical Pharmacology Center. Clinical and regulatory strategic responsibility for Phase 1 clinical trials. Prepared and presented scientific presentations to current and prospective business partners. Collaborated on strategic planning for a corporate public offering.
Project Leader for Diltiazem HCl. Supervised diltiazem clinical research activity, including clinical monitors, study and project budgets. Key participant in diltiazem clinical development. Clinical liaison to the diltiazem marketing team. Clinical support for the NDA submissions for Prinzmetal’s angina, exercise induced angina, essential hypertension. Created diltiazem protocols in for the treatment of Prinzmetal’s angina, exercise induced angina, essential hypertension.
Clinical pharmacology instructor to pharmacy and medical students.
Activities and Societies: Licensed Pharmacist in Missouri Phi Delta Chi Professional Pharmacy Fraternity (alumnus) Beta Beta Beta National.
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Peter B. Bottini works for Bottini Consulting LLC.
Peter B. Bottini is listed as RETIRED Clinical Research & Phamacovigilance Leader | Bioequivalence | Study Design | SOP Development | GCP | Strategic Planning at Bottini Consulting LLC.
AeroLeads has found 1 work email signal at @comcast.net for Peter B. Bottini at Bottini Consulting LLC.
AeroLeads has found 2 phone signal(s) with area code 304 for Peter B. Bottini at Bottini Consulting LLC.
Peter B. Bottini is based in Morgantown, West Virginia, United States while working with Bottini Consulting LLC.
Peter B. Bottini has worked for Bottini Consulting Llc, Alvogen, Mylan Inc., Mylan Bertek Pharmaceuticals, and Mylan.
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Peter B. Bottini holds Pharm.D., Clinical Pharmacy from University Of Missouri-Kansas City.
Peter B. Bottini is listed with skills including Clinical Trials, Clinical Development, Pharmaceutical Industry, Pharmacovigilance, Medical Writing, Clinical Research, Fda, and Protocol.
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