Resume

Project Medical

Location:

Potomac, MD

Posted:

October 12, 2012

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Resume:

NESTORA . M OLFINO, MD, M S C, F CCP

PULMONARY/CRITICAL CARE/IMMUNOGENETICS

**** ***** **** **. - *******, MD 20854

HOME 301-***-**** aboz3z@r.postjobfree.com

PROFESSIONAL EXPERIENCE

INDUSTRYINDUSTRY

KALOBIOS

SOUTH SANFRANCISCO, CA, USA 2012-PRESENT

SOUTH SANFRANCISCO, CA, USA 2012-PRESENTChief Medical Officer

x Responsible for all medical functions including clinical development, safety and

biometrics

including establising strategies and executin of programs

MEDIMMUNE, INC (ASTRAZENECA BIOLOGICS)

GAITHERSBURG, MD, USA 2007-2012

GAITHERSBURG, MD, USA 2007-2012Vice President, Clinical Development, Respiratory Therapeutic Area Head - see Table 1

? Responsible for all phases of global clinical development of mAbs in respiratory

conditions

? Responsible for the development of strategies and implementation of tactics to

accelerate the

development of mAbs in Respiratory and Inflammation in the US and Europe

? Responsible for driving the integration of the MedImmune strategy with respiratory

indications in

the US and European markets pursued by AstraZeneca.

? Manage cross-functional development teams in the US (Gaithersburg) and European

(Cambridge,

UK) offices- ~ 10 direct reports

? Chaired international Advisory Boards in Asthma and COPD and created the Washington

Airways

Workshop as a forum to get advice on the strategic directions in clinical development in

Respiratory Medicine

For all Therapeutic Areas at MedImmune:

? Selected to chair the Protocol Review Committee

? Selected to of the Respiratory, Inflammation and Autoimmunity Therapeutic Area Team

prior to

IMED implementation

? Member of the Safety Monitoring Committee

OTSUKA MARYLAND RESEARCH INSTITUTE, Rockville, Maryland USA 20032007OTSUKA MARYLAND RESEARCH INSTITUTESenior Director,

Clinical Development -see Table 2

Project Leader in the pulmonary development program:

Responsible for clinical strategy in pulmonary compounds and Phase I, II and III;

Organized and

chaired Scientific Advisory Boards: US and EU

? Member of the Pharmacogenomics Group

? In 2005-06 acting Project Leader for dry eye Phase III= NDA preparation/filing

? In 2006-06 acting Project Leader for Polycystic Kidney Disease = IND Global (US, EU,

Japan)

BAXTER BIOSCIENCE, Columbia, Maryland USA 2000 to 2003

BAXTER BIOSCIENCEDirector, Medical Affairs - see Table 3

? Responsible for all aspects of global medical support of licensed vaccines as well as

those under

clinical development.

? Responsible for supporting global customer needs, marketing goals, clinical operations

as well as the

ongoing pharmacovigilance activities related to the safety and efficacy of vaccines.

? Additional duties include participation in divisional strategic teams including the

identification of new

indications for existing licensed products or new opportunities for development in the

pulmonary area,

immunoallergy and sepsis.

Resume Dr. Nestor A. Molfino

Confidential

? Successfully presented in 2 pre-IND meetings and filed respective INDs, and provided

clinical

development and medical presentations in three market launches of vaccines.

Resume Dr. Nestor A. Molfino

Confidential

THERATECHNOLOGIES INC., Montreal, Quebec Canada 1997 to 2000THERATECHNOLOGIES INC.

Vice President R&D and Scientific Affairs,

(start-up biotechnology: Oncology and Metabolic Diseases see Table 4)

? Responsible for the pre-clinical and clinical phases of drug development.

? Streamlined R& D output while maintaining innovation in drug discovery and accelerating

Clinical

Development to produce worldwide registration dossiers.

? Established the structure, processes and systems of the R&D and Scientific Affairs

Department and

established International Scientific Advisory Boards for lead products.

ABBOTT LABORATORIES, Montreal, Quebec Canada. 1996 to 1997ABBOTT LABORATORIESDirector, Clinical Research

(Pharmaceutical, Hospital and Nutritional Products - see Table 5)

? Responsible for planning, conducting and reporting phase III-IV clinical research

trials in the

Pharmaceutical (anti-infectives, gastrointestinal, respiratory, CNS products), Hospital

(anesthetics,

hormonal and dialysis products) and Nutritional (adult and pediatric) Divisions required

as part of

international and/or national drug development plans or for competitive marketing.

BOEHRINGER INGELHEIM LTD, Burlington, Ontario Canada 1994 to 1996BOEHRINGER INGELHEIM LTDDirector, Respiratory and Immunology-see Table 6

? Developed protocols to support inhaled powder and HFA-based MDI worldwide dossiers for

the

COPD and asthma indications.

? Developed strategy and reported study supporting the safety of inhaled fenoterol in the

acute setting.

Participated in the team who established the collaboration with Sequana Therapeutics, La

Jolla, USA

for the clinical development of new anti-asthma compounds aimed at new molecular targets

identified

by positional cloning.

? Developed strategies to study gene expression in the asthmatic airway and set out an

international team

to develop transgenic and knockout animal models of asthma.

? Provided medical and scientific support to Regulatory Affairs, Sales and Marketing,

Drug Safety

Officers, Medical Information and Continuing Medical Education in Canada and South-

America.

FDA meetings/ submissions

? Asthma Type C meeting, 2009

? COPD type C meeting, 2006

? PKD type A meeting, 2005

? COPD End of Phase II meeting, 2005

? Influenza vaccine pre-IND meeting, 2002

? Antimeningococcal vaccine pre-IND meeting, 2002

? CML purging system (orphan drug application), 2000

? Combivent pre-NDA meeting, 1996

? Nevirapine pre-NDA meeting, 1995

International submissions

? Antimeningococcal vaccine (Australia) 2002

? Antimeningococcal vaccine (Canada) 2002

? Antimeningococcal vaccine (European Union: mutual recognition procedure) 2000

? Propofol (Canada 1996)

? Nevirapine (Canada 1995)

? Combivent (Argentina 1995)

Resume Dr. Nestor A. Molfino

Confidential

CLINICAL PULMONOLOGY PRACTICE

HOSPITAL lFERMIN SALABERRY', Victoria, Argentina 1994 to present

HOSPITAL FERMIN SALABERRY,

Pulmonary and Allergy Consultant

? Semi-annual consultation in a non-profit public community hospital. Ad Honorem activity

MOUNT SINAI AND THE TORONTO HOSPITALS, Toronto, Ontario Canada 1989 to 1994

MOUNT SINAI AND THE TORONTO HOSPITALS

Clinical Research Fellow in Respiratory Medicine/Weekly clinic in Asthma Centre

HOSPITAL M. FERRER, Buenos Aires, Argentina 1988 to 1989

HOSPITAL M. FERRER

Staff, Respiratory Medicine Specialist,

EDUCATION & TRAINING

x LEADERSHIP AND STRATEGY IN PHARMACEUTICAL AND BIOTECH 2009

? LEADERSHIP AND STRATEGY IN PHARMACEUTICAL AND BIOTECH 2009

Harvard Business School

Certificate

x MOLECULAR AND CELL BIOLOGY 1991-1994

? MOLECULAR AND CELL BIOLOGY 1991-1994

University of Toronto/Mount Sinai Research Institute, Toronto, Canada

Master of Science degree

Thesis: V? region gene usage in bronchoalveolar lavage and peripheral blood lymphocytes

of atopic

asthmatics and healthy subjects.

x PULMONARY PHYSIOLOGY1989-1991

PULMONARY PHYSIOLOGY1989-1991University of Toronto/Tri-Hospital Pulmonary Service, Toronto, Canada

Fellow of the Medical Research Council of Canada

First report in the literature on the environmental ozone-allergen interaction in

asthmatics. First report in

the literature on the development of bronchoconstriction during apnea in emphysema

subjects and

asthmatics.

x RESPIRATORY & CRITICAL CARE MEDICINE RESIDENCY1986-1988

(

CHIEF RESIDENT88-89

)

? RESPIRATORY & CRITICAL CARE MEDICINE RESIDENCY

1986-1988 (CHIEF RESIDENT88-89)

Hospital Muniz and Hospital M. Ferrer, Buenos Aires Argentina

Certifications: Respiratory Medicine and Phthisiology

Reported for the first time in the literature on the development of respiratory arrest

without cardiac

arrhythmias in near-fatal asthma. First report in the literature on the efficacy of a ?-

agonist dry powder

formulation in life-threatening asthma.

x INTERNAL MEDICINE RESIDENCY1984-1986

INTERNAL MEDICINE RESIDENCY1984-1986

Hospital Fernandez, Buenos Aires Argentina.

x ROTATING INTERNSHIP1982-1983

ROTATING INTERNSHIP1982-1983

Hospital G. Baigorria

Rosario, Argentina.

xM.D. DEGREE 1982

? M. D. DEGREE 1982

Universidad Nacional de Rosario, Argentina.

Resume Dr. Nestor A. Molfino

Confidential

SELECTED PUBLICATIONS

BOARD & ACADEMIC APPOINTMENTS

1999-2002: Member of the Natural Sciences and Engineering Research Council (NSERC)

Strategic Projects Selection Panel in Biotechnology (Canada)

1998: Appointed Fellow of the American College of Chest Physicians

1996-2000: Adjunct Professor, Department of Medicine McGill University, Montreal, Canada

1994-1996: Assistant Professor, Department of Medicine, University of Toronto, Canada

1989-Present: Certified Specialist in Pulmonary Medicine & phthysiology (Argentina)

Resume Dr. Nestor A. Molfino

Confidential

SELECTED PRESENTATIONS

2011 Proof-of-concept trials in Asthma and COPD. SMI Conference on Asthma and COPD.

London, UK.

2010 New Diagnostics and treatments in severe asthma. Annual Congress of Respiratory

Medicine, Buenos Aires, Argentina.

2010 New molecular targets in asthma and COPD. Annual Congress of Respiratory Medicine,

Buenos Aires, Argentina.

2010 New Biologics in Asthma. Grand Rounds Lecture. Washington Hospital Center.

Washington DC, USA.

2010 Differences between small molecules and biologics. Lecture at Symposium: Advancing

Biologics from the lab to the clinic.

Brussels, Belgium

2008 A Phase I Single Escalating Intravenous Dose of MEDI-563, an Anti-IL5Ra Humanized

Monoclonal Antibody, in

Atopic Asthma Oral presentation at ERS 2008, Berlin, Germany

2008 Safety Profile, Pharmacokinetics and Biologic Activity of a Single IV Dose of the

Anti-IL5 Receptor Alpha Antibody

MEDI-563 in Patients with Mild Asthma Poster presentation/Discussion at ATS 2008,

Toronto, Canada

2008 Targeting Cytokines in Asthma GTCBio 6 Annual Conference on Cytokines and

Inflammation. Orlando, Fa., USA

2008 Clinical Development of Vaccines, Small Molecules and Biologics for Respiratory

Diseases Innovative Medicines

Initiative Summit in COPD and Asthma sponsored by ERS and European Federation of

Pharmaceutical Industry Associations

(EFPIA). Leuven, Belgium

2007 COPD: what is genes and what is environment? 41 Annual Meeting of the European

Society for Clinical Investigation.

http://www.esci.eu.com/2007/120307abstract4.doc. Eur J Clin Inv 2007; 37:37

2006 Clinical evaluation of a new inhibitor of neutrophilic inflammation, tetomilast

(OPC-6535),in chronic obstructive

pulmonary disease (COPD) at the ERS Munich 2006 Congress in the session Recent advances

in the treatment of

COPD

2006 Efficacy and tolerability of tetomilast, a new inhibitor of neutrophilic

inflammation, in chronic obstructive

pulmonary disease at the ERS Munich 2006 Congress in the session Recent advances in the

treatment of COPD

2003 Viral Respiratory Infections and Their Consequences. College of Physicians of

Victoria, Argentina

2003 Cellular and Molecular Mechanisms in COPD. Maryland Research Laboratories.

Rockville, MD, USA.

1998 Accelerating Drug Development. The Cross-roads of Biotechnology. Biotechnology

Research Institute. Montreal, Canada

1997 Safety and dose finding studies for different classes of drugs. Canadian Association

of Pharmaceutical Regulatory Affairs.

Toronto, Canada

1997 Genetics of Asthma. Immunoscience Venture, Abbott Park, Chicago, USA

1996 Fatal Asthma. Critical Care Society Scientific meeting. Montevideo, Uruguay.

1996 Use of steroids in asthma. Critical Care Society Scientific meeting. Montevideo,

Uruguay.

1996 Genetics of asthma. Critical Care Society Scientific meeting. Montevideo, Uruguay.

1996 New perspectives in asthma education and research. Fourth Annual Spring Workshop.

Saskatchewan Thoracic Society.

Saskatoon, Canada.

1996 Asthma: Clinical presentation and Epidemiology. Combined R&D-Clinical Symposium on

Genetics of Asthma.

Wiesbaden, Germany.

1994 Asma potencialmente fatal. Identificacion y tratamiento. III IberoAmerican Congress

of Respiratory Medicine. Vina del

Mar, Chile.

1994: How generalizable are the studies on Near-Fatal Asthma to Fatal Asthma? Centres of

Excellence (McGill University).

First Canadian Workshop in Near-Fatal Asthma. Montreal, Canada.

1994: Workshop on development of Guidelines for the treatment of COPD in Argentina.

Argentinean Medical Association,

Buenos Aires, Argentina.

1993: TcR repertoire in atopic asthmatics. The Toronto Hospital Asthma Centre,

Department of Medicine, University of

Toronto, Toronto, Canada.

1992: Mechanisms of Cough. Laboratory tests. Respiratory Inter-city Grand Rounds. Saint

Michael s Hospital, Department of

Medicine, University of Toronto, Toronto, Ontario, Canada.

1991: Near-Fatal Asthma. Conference on Asthma Deaths. The Royal College of Physicians,

London, England.

1991: Effect of ozone on the allergic response in asthmatic subjects. Congreso Argentino

de Neumonologia, Buenos Aires,

Argentina.

1991: Effect of ozone on allergic asthma. Respiratory Division Seminars, Department of

Medicine, University of Toronto,

Canada.

1991: Respiratory Arrest in Near-Fatal Asthma. Respiratory Division Seminars, Department

of Medicine, McMaster University,

Hamilton, Ontario, Canada.

PATENTS

? Rhodamine derivatives for photodynamic prevention and treatment of immunoreactive

disorders US 60/157,790

PCT/CA00/01142

? Methods of using a thiazole derivative (US provisional application No. 60/814,545)

? Methods of treatment (US provisional 61/334,729)

? Methods For Reducing The Frequency And Severity Of Acute Exacerbations Of Asthma

(U.S.Provisional61/562,544)

JOURNAL REVIEWER

? Chest

? Expert Opinion on Investigational Drugs

Resume Dr. Nestor A. Molfino

Confidential

? Respiration

? American Journal of Respiratory and Critical Care Medicine

SUMMARY OF SMALL MOLECULES /BIOLOGICS/DEVICE DEVELOPMENT EXPERTISE

Table 1. MedImmune (AstraZeneca Biologics)

Project Clinical Indication No. of No. of Location Purpose of Trial Dr. Molfino s

Phase subjects Sites involvement

Anti-IL5r I Asthma 45 3 US Safety TA Head

Anti-IL5r II Asthma 26 5 US/Can Dose-ranging TA Head

Airway biopsy

Anti-IL5r II Asthma 40 8 US MAD TA Head

Anti-IL9 II Asthma 38 5 US MAD TA Head

Anti-IL9 II Asthma 30 4 Canada LAR TA Head

Anti-IL9 II Asthma 20 3 US BAL neutralization TA Head

Anti-IL9 II Asthma 18 4 US/Can EIB blockade TA Head

Anti-IL9 IIb Asthma 320 60 Global Asthma control TA Head

Anti-IL13 I Asthma 30 1 US PK/PD TA Head

Anti-IL13 II Asthma 240 30 EU Asthma control TA Head

Other All COPD TBD TBD TBD Safety/efficacy TA Head-

Targets designed

strategy

Table 2. Otsuka Maryland Research Institute

Project Clinical Indication No. of No. of Location Purpose of Trial Dr. Molfino s

Phase subjects Sites involvement

Tetomilast I COPD 16 1 USA Bioequiv Project Leader

Tetomilast II COPD 240 40 USA Dose-range Project Leader

Tetomilast II COPD 40 2 USA Cumul DR Project Leader

Tolvaptan III HypoNa+ 240 50 USA Pivotal Project Leader

Rebapamide III Dry eye 1500 > 100 USA Pivotal Project Leader

Tolvaptan III PKD 1200 > 100 Global Pivotal Project Leader

Resume Dr. Nestor A. Molfino

Confidential

Table 3. Baxter Healthcare, Bioscience Division

Project Clinical Indication No. of No. of Location Purpose of Dr. Molfino s

Phase subjects Sites Trial involvement

Alpha-1 I Hereditary 30 1 UK Safety Project team

antitrypsin Emphysema, member-reviewed

COPD IND

Meningococcal I-IV Prevention > 7000 >30 EU/America Safety/Effic Wrote protocol

vaccines s Medical Director

Influenza III Prevention 9000 70 USA Safety/Effic Wrote protocol

vaccines Medical Director

Tick-born III Prevention 2000 1 US army Safety/Effic Medical Director

encephalitis

vaccines

Pertussis vaccine III-IV Prevention >3000 3 USA Safety/Effic Completed trials

Hib vaccine II Prevention 300 3 USA Safety/Effic Completed trial

Anti-bioterrorism NA Smallpox and NA NA USA NA Project team

vaccines anthrax Medical support

Immunoallergy NA Asthma NA NA NA NA Business Dev

vaccines support

Sepsis NTI NA Prevention NA NA NA NA Business Dev

support

Table 4. Theratechnologies, Inc.

Drug Clinical Indication No. of No. of Location Purpose of Trial Dr. Molfino s

Phase Patient Sites involvement

GRF analogs I Muscle 50 1 Europe/Canada Safety and Dose- Design develop

(2 trials) wasting ranging strategy, selected

CRO, wrote

protoc.

GRF analogs II COPD, frail 300 5-6 Canada/USA/ Pivotal Design develop

(3 trials) elderly, EU strategy, selected

sleep CRO, wrote

protoc

Photodynam. I/II CML 20 1 Canada Pivotal Plan, design,

Therapy conduct

(device)

Photodynam. I/II NHL 30 4 Canada/USA Pivotal Plan, design

Therapy

(device)

Resume Dr. Nestor A. Molfino

Confidential

Table 5. Abbott Laboratories

Drug Clinical Indication No. of No. of Location Purpose of Trial Dr. Molfino s

Phase Patients Sites involvement

Sertindole III Schizophrenia 60 4 Canada Pivotal Conduct

Canada

Tiagabine III Epilepsy 40 3 Pivotal Conduct

Canada

Clarithromycin III/IV Otitis 100 + 4 Marketing support Design, plan,

conduct

Canada

Dex II/III Anesthesia 20 1 Pivotal Conduct

Canada

Ritonavir III/IV HIV/AIDS 20 2 Pivotal Conduct

Canada

Lanzoprazole III/IV G.I. 100 + 20 Marketing support Conduct

Canada

Propofol III CABG 40 2 Pivotal Conduct

Canada

Lupron III/IV Prostate cancer 100 + 20 Expand Indication Conduct

Table 6. Boehringer Ingelheim

Drug Clinical Indication No. of No. of Location Purpose of Trial Dr. Molfino s

Phase Patients Sites Involvement

Ipratropium III/IV Asthma 300 + 15 Canada New Indication Plan, conduct, report

MDI

Ipratropium II/III COPD 200 1 Canada Mechanism of action Plan, conduct

MDI (acoustic

reflection)

Ipratropium II/III COPD 30 1 Canada Pivotal- HPB Plan, study design,

MDI (Inspiratory requirement for conduct, report

flow) approval

Ipratropium III/IV COPD 200 10 Canada Marketing support Wrote protocol,

Solution Conduct

Nevirapine III HIV/AIDS 50 NA Canada EDR Plan, get NDA

approval, conduct

Fenoterol III/IV Acute 350 12 Canada Pharmacovigilance Plan, study design

MDI Asthma and protocol,

conduct, report

Combivent III Acute 300 10 Canada Pivotal Conduct

MDI Asthma

NA Preclinical Asthma 2000 NA Canada, Genetics of Asthma Represent

Australia, Program with Boehringer

Brazil Sequana Therapeutics Ingelheim in Joint

and Mount Sinai Research Committee

Hospital - Toronto as Clinical expert

Citizenships: USA, Canada, Argentina (country of origin)

Languages: Spanish (mother tongue), English (fluent), French, Portuguese, Italian

(working

knowledge)References available upon request

Contact this candidate