Medical Manager

Gustavo Andrés Fischbein, MD.

+54-911-****-**** • ab9m9t@r.postjobfree.com

Outcome-focused trilingual executive with more than 20 years of expert team leadership, planning and strategic

vision of the complex Pharma World; endorsed by professional broad experience as Medical Doctor within

Clinical Research, Product Development and Medical Affairs fields, with specialization in Neurology &

Pharmaceutical Medicine.

Clinical Research • Clinical Development Plans • ANDAs & NDAs programs • Protocol design and writing (phase I-

II-III & IV) • Bioequivalence (PK/PD) • ICH-GCP • Clinical Operations • Medical Affairs • KOL Advisory Boards •

Scientific marketing support • Promotional material preparation • New drug product launches • Sales force training •

Presentations to Regulatory Authorities • Main Therapeutic Areas: CNS (Parkinson Disease and Movement Disorders,

Multiple Sclerosis, Epilepsy, Headaches, Dementia and Stroke), Ophthalmology, Anesthesia, Cardiovascular,

Respiratory, Gastrointestinal, Hematology, Infectious Diseases and Oncology.

PROFESSIONAL EXPERIENCE:

• Favaloro Fundation, Neurosciences Institute (March 2013 – present)

Visiting mentor and clinical coach to neurology residents. Also assisting with diagnosis and treatment of ambulatory cases.

• Consulting Practice (August 2012 – present)

Independent adviser to pharmaceutical companies in their clinical research projects.

• Osmotica Pharmaceutical

Medical Director (July 2006 – July 2012)

Medical affairs director to the company providing scientific expertise, standard of care, protocol designs, statistical analysis

options, product design considerations, PK-PD proof of concept study designs, bioequivalence trials and timeline assessments

for mainly neurologically based new products and general clinical development for all therapeutic areas in the company.

Personally directed and managed multiple multi-center phase II trials and contributed to multiple FDA meetings on US IND’s,

presentations to KOLs to gain the latest insights into optimal product development and vetting bids from CRO’s on pivotal

clinical trial programs. Responsible for project evaluation and development of clinical research strategic programs (phase I-IV)

to support registration and marketing.

• AstraZeneca

Clinical Operations Manager (September 2001 – April 2006)

Responsible for the evaluation, implementation and development of Phase II, IIIa/b and IV international and multicenter

clinical trials in multiple therapeutic areas (CNS, cardiovascular, respiratory, gastrointestinal, Infection, Hematology and

Oncology); accountable for Clinical Research Associates staff, Clinical Study Administrators and Data Management

Department; organizing and coordinating all research project related activities, administering resources and guaranteeing the

marked objectives and quality of clinical trials conducted under GCP and ICH guidelines.

• AstraZeneca

Clinical Process Manager (January 1999 – December 2000)

Responsible for the development, coordination and local implementation of Guidelines, Policies, SOPs and Processes across the

Clinical Function. Responsible in providing training advice on the development, and design and evaluation of training courses;

participating in the Global Group for support and production in the design and development of global training material.

• AstraZeneca

Medical Advisor and Clinical Research Associate (June 1998 – August 2001)

Medical Management, participating in the development, conducting and monitoring of clinical research protocols, both

multicentre and international, and in the drawing up of scientific papers, as well as in the scientific assistance to the Marketing

Department and the training of representatives from sales forces.

• French Hospital - Alfredo Thomson Department of Neurology

Resident Physician (June 1992 – May 1997)

Chairman of Neurology Residents (June 1997 – May 1998)

Provide competent, compassionate patient care; working effectively as a member of the health care team. Academic training,

teach and mentor junior residents, interns and medical students, conflict management and emergency room overnight calls.

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EDUCATIONAL QUALIFICATIONS:

• Pharmaceutical Industry Business Management Degree – Universidad Abierta Interamericana & Argentinean Society of

Pharmaceutical Marketing (SAMF); 2009.

• Executive Program of Negotiation – Universidad de Palermo, Graduate School of Business; 2006.

• Senior Management & Leadership Program, from the Leaders Program of the Thinking Community – Universidad Abierta

Interamericana; 2005.

• Biannual Course on Pharmaceutical Medicine – Medical Advisors Association of the Argentine Pharmaceutical Industry,

(AMAIFA); 1999 – 2000.

• Residency in Clinical Neurology – French Hospital, Alfredo Thomson Department of Neurology; 1992 – 1998.

• Medicine; Medical Doctor (M.N: 85.149) – Faculty of Medicine, University of Buenos Aires (UBA); 1987 – 1991.

• Baccalaureate in Biology Sciences – Buenos Aires National School (CNBA), UBA; 1981 – 1986.

PROFESSIONAL PROFILE:

• Member of the MDS – Movement Disorders Society; from 2010 to date.

• Member of the AAN – American Academy of Neurology; from 2008 to date.

• Member of the DIA – Drug Information Association; from September 2002 to date.

• Member of Pharmaceutical Medicine Argentinean Society (SAMEFA) – M emb er o f I nter natio nal Federatio n o f

P har maceutical P hysicians ; from December 1998 to date.

• Associate Member of the Argentine Society of Neurology; appointed in November 1998 to date.

• Councilor of the Argentine Headache Association; from November 1999 to 2004.

• Permanent Member of the Argentine Headache Association; from October 1998 to date.

• Medical Investigator at the ZEUS I Protocol (Zomig European Study); 1996 – 1998.

• Medical Investigator at the TAPIRSS multicentre Protocol; 1995 – 1998.

• Member of the International Stroke Trial Collaborative Group and Collaborator of the multicentre International Stroke

Trial (IST); 1995 – 1996.

• Intern Advisor at the Colegiales Nursing Home and at the Lacroze Clinic; 1994 – 1995

• Member of the Medical Staff of the López Clinic; 1992 – 1995.

• Resident Physician and Chairman of Residents in the Alfredo Thomson Department of Neurology of the French Hospital;

June 1992 – May 1998.

• Full-time rotation at the Intensive Care Unit in the Methodist Hospital of Texas Medical Centre, Houston, USA (Fellowship

granted) within the Baylor College of Medicine; January – February 1992.

ACADEMIC ACTIVITIES:

• President of the Scientific Committee; III Argentinean Congress of Pharmaceutical Medicine, 2012.

• Lecturer at Advanced Clinical Pharmacological Research Course; from the Metabolic Research Foundation - University of

El Salvador. Theme: Clinical Trials Organization and Management, Monitoring (basic and advanced) and Informed Consent;

2004 – 2010.

• Lecturer at Advanced Monitoring and Clinical and Pharmacological Research Course; from the Medical College of the

University of Buenos Aires and the Rheumatology Department of the Hospital Ramos Mejía; 2004 – 2005.

• Lecturer at the post-graduate Master in Clinical Research, Universidad Abierta Interamericana. Theme: Clinical Trials

Organization and Management; 2004 – 2005.

• Lecturer at the SAMEFA Annual Theoretical-Practical Course for Monitors and Clinical Study Coordinators Training;

2003 – 2004.

• Head of Assignments at the Pharmacology II Parallel Teaching Chair of the French Hospital; 1994.

• Assistant at the Pharmacology Teaching Chair of the Medical School, University of Buenos Aires; July 1992 – June 1994.

PAPERS & PATENTS:

• 14 scientific papers presented at different symposiums and congresses and also published in well recognized scientific medical

journals.

• Co-inventor and author of 2 USPTO Patent Applications for pharmaceutical devices: Rupturing controlled release device

comprising a sub-coat (200********) and Triple combination release multi-layered tablet (200********).

CONFERENCES AND SYMPOSIA:

Attendance and speaker at more than 100 congresses, seminars, symposia, courses and conferences, both from the medical

scientific environment and the pharmaceutical industry, related to marketing and clinical research.

SKILLS:

• Spanish; mother tongue – English; fluent – French; thorough command of the language.

• Information technology knowledge (Windows environment & Microsoft Office Suite).

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