1. Healthcare

NÉSTOR A. MOLFINO, MD, MSC, FCCP
P ULMONARY /C RITICAL C ARE /I MMUNOGENETICS
435 China Basin, Unit 636
San Francisco, California 94158
PHONE 240-5350737;
WEBSITE: DRNESTORMOLFINO.COM
nestor.molfino@ gmail.com
PROFESSIONAL EXPERIENCE
Drug Development Consultant in Pulmonary/Critical Care Medicine and Immunogenetics
“I work with biopharmaceutical companies, CROs, investors and patient organizations with their drug
development strategies and respective execution either locally or globally.”
INDUSTRY
KALOBIOS PHARMACEUTICALS
SOUTH SAN FRANCISCO, CA, USA
05/2012 to 01/15
Chief Medical Officer
• Responsible for all medical functions including Clinical Development, Safety, Biometrics as well
as establishing strategies for growth and execution of anti-GMCSF, anti –TTSS and anti EphA3
antibodies for pulmonary and oncology indications.
• Participated in a successful IPO and refinancing road shows in 2013
• Hired/mentored personnel in the Medical organization
• Represents Kalobios in all scientific/medical and Business Development discussions
M EDIMMUNE , I NC (A STRA Z ENECA B IOLOGICS )
G AITHERSBURG , MD, USA
20 07 - 2012
Vice 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 RESE ARCH INSTITUTE ,
Rockville, Maryland USA
2003 – 2007
Senior 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)
Résumé Dr. Néstor A. Molfino
Confidential
B AXTER B IOSCIENCE , Columbia, Maryland USA
2000 to 2003
Director, 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.
• Successfully presented in 2 pre-IND meetings and filed respective INDs, and provided clinical
development and medical presentations in three market launches of vaccines.
T HERATECHNOLOGIES I NC . , Montreal, Quebec Canada
Vice President R&D and Scientific Affairs,
(start-up biotechnology: Oncology and Metabolic Diseases – see Table 4)
1997 to 2000
A BBOTT L ABORATORIES , Montreal, Quebec Canada.
Director, Clinical Research
(Pharmaceutical, Hospital and Nutritional Products - see Table 5)
B OEHRINGER I NGELHEIM L TD , Burlington, Ontario Canada
Director, Respiratory and Immunology-see Table 6
1996 to 1997
1994 to 1996
FDA meetings/ submissions
§ Asthma Type C meeting 2013
§ 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)
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Résumé Dr. Néstor A. Molfino
Confidential
C LINICAL PULMONOLOGY PRACTICE
H OSPITAL “F ERMIN S ALABERRY ”, Victoria, Argentina
1994 to present
Pulmonary and Allergy Consultant
• Semi-annual consultation in a non-profit public community hospital. Ad Honorem activity
M OUNT S INAI AND T HE T ORONTO H OSPITALS , Toronto, Ontario Canada
Clinical Research Fellow in Respiratory Medicine/Weekly clinic in Asthma Centre
H OSPITAL M. F ERRER , Buenos Aires, Argentina
Staff, Respiratory Medicine Specialist,
1989 to 1994
1988 to 1989
EDUCATION & TRAINING
• L EADERSHIP AND S TRATEGY IN P HARMACEUTICAL AND B IOTECH 2009
Harvard Business School
Certificate
• M OLECULAR AND C ELL B IOLOGY 1991 - 1994
University of Toronto/Mount Sinai Research Institute, Toronto, Canada
Master of Science degree
Thesis: Vγ region gene usage in bronchoalveolar lavage and peripheral blood lymphocytes of atopic
asthmatics and healthy subjects.
• PULMONARY PHYSIOLOGY 1989-1991
University 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.
• R ESPIRATORY & C RITICAL C ARE M EDICINE R ESIDENCY 1986 - 1988 (C HIEF R ESIDENT
88 - 89)
Hospital Muñiz 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 β2-agonist dry powder
formulation in life-threatening asthma.
• INTERNAL M EDICINE R ESIDENCY 1984-1986
Hospital Fernandez, Buenos Aires Argentina.
• R OTATING INTERNSHIP 1982-1983
Hospital G. Baigorria, Rosario, Argentina.
• M . D. DEGREE 1982
Universidad Nacional de Rosario, Argentina.
3
Résumé Dr. Néstor A. Molfino
Confidential
P UBLICATIONS
In PubMed (54):
The impact of exacerbation frequency on mortality following acute exacerbations of
COPD: a registry-based cohort study.
Schmidt SA, Johansen MB, Olsen M, Xu X, Parker JM, Molfino NA, Lash TL, Sørensen
HT, Christiansen CF.
BMJ Open. 2014 Dec 19;4(12):
A randomized trial of benralizumab, an antiinterleukin 5 receptor α monoclonal antibody,
after acute asthma.
Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F, Fiening JP, Kim
K, Molfino NA.
Am J Emerg Med. 2014 Oct 5.
Benralizumab, an anti-interleukin 5 receptor α monoclonal antibody, versus placebo for
uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study.
Castro M, Wenzel SE, Bleecker ER, Pizzichini E, Kuna P, Busse WW, Gossage DL,
Ward CK, Wu Y, Wang B, Khatry DB, van der Merwe R, Kolbeck R, Molfino NA, Raible
DG.
Lancet Respir Med. 2014 Nov;2(11):879-90.
A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal
antibody in adults with uncontrolled asthma. Oh CK, Leigh R, McLaurin KK, Kim K,
Hultquist M, Molfino NA. Respir Res. 2013 Sep 19;14(1):93
Recent therapeutic breakthroughs in respiratory medicine. Molfino NA. Expert Rev Respir
Med. 2013 Aug;7(4):331-3.
Effects of benralizumab on airway eosinophils in asthmatic patients with sputum
eosinophilia. Laviolette M, Gossage DL, Gauvreau G, Leigh R, Olivenstein R, Katial R,
Busse WW, Wenzel S, Wu Y, Datta V, Kolbeck R, Molfino NA. J Allergy Clin Immunol. 2013
Jul 15.
Hospitalization with acute exacerbation of chronic obstructive pulmonary disease and
associated health resource utilization: a population-based Danish cohort study.
Johannesdottir SA, Christiansen CF, Johansen MB, Olsen M, Xu X, Parker JM, Molfino
NA, Lash TL, Fryzek JP. J Med Econ. 2013 Jul;16(7):897-906.
Challenge models to assess new therapies in chronic obstructive pulmonary disease.
van der Merwe R, Molfino NA. Int J Chron Obstruct Pulmon Dis. 2012;7:597-605.
A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma.
Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba
GP, Molfino NA. Eur Respir J. 2013 Feb;41(2):330-8.
Targeting of eosinophils in asthma. Molfino NA. Expert Opin Biol Ther. 2012 Jul;12(7):807-9.
Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor.
Molfino NA, Gossage D, Kolbeck R, Parker JM, Geba GP. Clin Exp Allergy. 2012
May;42(5):712-37
4
Résumé Dr. Néstor A. Molfino
Confidential
Smoking and idiopathic pulmonary fibrosis. Oh CK, Murray LA, Molfino NA. Pulm Med.
2012;2012:808260
Biology of the interleukin-9 pathway and its therapeutic potential for the treatment of
asthma. Oh CK, Raible D, Geba GP, Molfino NA. Inflamm Allergy Drug Targets. 2011
Jun;10(3):180-6.
Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a
humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies
in subjects with asthma. Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C,
Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group.
BMC Pulm Med. 2011 Feb 28;11:14.
Brain magnetic resonance imaging in adults with asthma. Parker J, Wolansky LJ, Khatry
D, Geba GP, Molfino NA. Contemp Clin Trials. 2011 Jan;32(1):86-9.
MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibodydependent cell-mediated cytotoxicity function. Kolbeck R, Kozhich A, Koike M, Peng L,
Andersson CK, Damschroder MM, Reed JL, Woods R, Dall'acqua WW, Stephens GL,
Erjefalt JS, Bjermer L, Humbles AA, Gossage D, Wu H, Kiener PA, Spitalny GL, Mackay
CR, Molfino NA, Coyle AJ. J Allergy Clin Immunol. 2010 Jun;125(6):1344-1353
Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor
alpha antibody, in a phase I study of subjects with mild asthma. Busse WW, Katial R,
Gossage D, Sari S, Wang B, Kolbeck R, Coyle AJ, Koike M, Spitalny GL, Kiener PA,
Geba GP, Molfino NA. J Allergy Clin Immunol. 2010 Jun;125(6):1237-1244
An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after
subcutaneous and intravenous administration in healthy males. Oh CK, Faggioni R, Jin
F, Roskos LK, Wang B, Birrell C, Wilson R, Molfino NA. Br J Clin Pharmacol. 2010
Jun;69(6):645-55
Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of
asthma. Oh CK, Geba GP, Molfino NA. Eur Respir Rev. 2010 Mar;19(115):46-54
A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing
with a human IL-13 antibody (CAT-354) in subjects with asthma. Singh D, Kane B,
Molfino NA, Faggioni R, Roskos L, Woodcock A. BMC Pulm Med. 2010 Jan 8;10:3
Increased vagal airway tone in fatal asthma. Molfino NA. Med Hypotheses. 2010
Mar;74(3):521-3
Gene-environment interactions in chronic obstructive pulmonary disease. Molfino NA,
Coyle AJ. Int J Chron Obstruct Pulmon Dis. 2008;3(3):491-7.
Genetic predisposition to accelerated decline of lung function in COPD. Molfino NA.
Int J Chron Obstruct Pulmon Dis. 2007;2(2):117-9.
Current thinking on genetics of chronic obstructive pulmonary disease. Molfino NA.
Curr Opin Pulm Med. 2007 Mar;13(2):107-13
5
Résumé Dr. Néstor A. Molfino
Confidential
Chronic obstructive pulmonary disease: histopathology, inflammation and potential
therapies. Molfino NA, Jeffery PK. Pulm Pharmacol Ther. 2007;20(5):462-72
A meta-analysis on the efficacy of oral theophylline in patients with stable COPD.
Molfino NA, Zhang P. Int J Chron Obstruct Pulmon Dis. 2006;1(3):261-6.
Drugs in clinical development for chronic obstructive pulmonary disease. Molfino NA.
Respiration. 2005 Jan-Feb;72(1):105-12.
Trends in pharmacotherapy for chronic airflow limitation in Argentina: 1992-2002.
Molfino NA. Medicina (B Aires). 2004;64(5):407-12.
Treatment of patients with chronic obstructive pulmonary disease (COPD) by primary
care physicians. Molfino NA. Medicina (B Aires). 2004;64(5):445-54.
Lung function evolution and respiratory symptoms. Molfino NA. Arch Bronconeumol. 2004
Oct;40(10):429-30.
Genetics of COPD. Molfino NA. Chest. 2004 May;125(5):1929-40.
Use of intravenous pulsed cyclophosphamide in severe, generalized myasthenia gravis.
De Feo LG, Schottlender J, Martelli NA, Molfino NA. Muscle Nerve. 2002 Jul;26(1):31-6
Eradication of multiple myeloma and breast cancer cells by TH9402-mediated
photodynamic therapy: implication for clinical ex vivo purging of autologous stem cell
transplants. Brasseur N, Ménard I, Forget A, el Jastimi R, Hamel R, Molfino NA, van
Lier JE. Photochem Photobiol. 2000 Dec;72(6):780-7
Risk factors versus mechanisms of death in subjects with asthma. Molfino NA. Am J
Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1355-6.
Effect of inhaled furosemide in acute asthma. Pendino JC, Nannini LJ, Chapman KR,
Slutsky A, Molfino NA. J Asthma. 1998;35(1):89-93.
Treatment of acute severe asthma with inhaled albuterol delivered via jet nebulizer,
metered dose inhaler with spacer, or dry powder. Raimondi AC, Schottlender J,
Lombardi D, Molfino NA. Chest. 1997 Jul;112(1):24-8
Analysis of the T cell receptor Vgamma region gene repertoire in bronchoalveolar lavage
(BAL) and peripheral blood of atopic asthmatics and healthy subjects. Molfino NA,
Doherty PJ, Suurmann IL, Yang SX, Kesten S, Chapman KR, Slutsky AS. Clin Exp
Immunol. 1996 Apr;104(1):144-53.
Cardiovascular safety of high doses of inhaled fenoterol and albuterol in acute severe
asthma. Newhouse MT, Chapman KR, McCallum AL, Abboud RT, Bowie DM, Hodder
RV, Paré PD, Mesic-Fuchs H, Molfino NA. Chest. 1996 Sep;110(3):595-603
Tracheobronchial constriction in asthmatics induced by isocapnic hyperventilation with
dry cold air. Julià-Serdà G, Molfino NA, Califaretti N, Hoffstein V, Zamel N. Chest. 1996
Aug;110(2):404-10.
6
Résumé Dr. Néstor A. Molfino
Confidential
The effect of pre-exposure to 0.12 ppm of ozone on exercise-induced asthma.
Fernandes AL, Molfino NA, McClean PA, Silverman F, Tarlo S, Raizenne M, Slutsky
AS, Zamel N. Chest. 1994 Oct;106(4):1077-82.
Near-fatal asthma. Molfino NA, Slutsky AS. Eur Respir J. 1994 May;7(5):981-90
Trends in pharmacotherapy for chronic airflow limitation in Argentina: 1983-1990.
Molfino NA, Nannini LJ Jr, Chapman KR, Slutsky AS. Medicina (B Aires). 1994;54(2):103-9.
Assessment of airway tone in asthma. Comparison between double lung transplant
patients and healthy subjects. Molfino NA, Slutsky AS, Julià-Serdà G, Hoffstein V,
Szalai JP, Chapman KR, Rebuck AS, Zamel N. Am Rev Respir Dis. 1993 Nov;148(5):1238-43
Molfino NA and Slutsky AS. Proceedings of the Conference on Asthma Deaths: Near-Fatal Asthma.
Clinical and Experimental Allergy 1993; 23: 156-159.
Tracheobronchial dilation during isocapnic hypoxia in conscious humans. Julià-Serdà G,
Molfino NA, Furlott HG, McClean PA, Rebuck AS, Hoffstein V, Slutsky AS, Zamel N,
Chapman KR. J Appl Physiol. 1993 Oct;75(4):1728-33.
Heterogeneous airway tone in asthmatic subjects. Julia-Serda G, Molfino NA, Chapman
KR, McClean PA, Zamel N, Slutsky AS, Hoffstein V. J Appl Physiol. 1992 Dec;73(6):2328-32
Echogram of the upper airway. Julià-Serdà G, Molfino NA, Zamel N. Med Clin (Barc). 1992
Oct 10;99(11):425-9
Changes in cross-sectional airway areas induced by methacholine, histamine, and LTC4
in asthmatic subjects. Molfino NA, Slutsky AS, Hoffstein V, McClean PA, Rebuck AS,
Drazen JM, Zamel N. Am Rev Respir Dis. 1992 Sep;146(3):577-80
The effects of air pollution on allergic bronchial responsiveness. Molfino NA, Slutsky
AS, Zamel N. Clin Exp Allergy. 1992 Jul;22(7):667-72.
The fatality-prone asthmatic patient. Follow-up study after near-fatal attacks. Molfino
NA, Nannini LJ, Rebuck AS, Slutsky AS. Chest. 1992 Mar;101(3):621-3
The effects of air pollution on atopic asthma. Molfino NA. Medicina (B Aires). 1992;52(4):363-7
Effect of low concentrations of ozone on inhaled allergen responses in asthmatic
subjects. Molfino NA, Wright SC, Katz I, Tarlo S, Silverman F, McClean PA, Szalai JP,
Raizenne M, Slutsky AS, Zamel N. Lancet. 1991 Jul 27;338(8761):199-203
Respiratory arrest in near-fatal asthma. Molfino NA, Nannini LJ, Martelli AN, Slutsky
AS. N Engl J Med. 1991 Jan 31;324(5):285-8.
Artifacts in measuring airway areas by acoustic reflections. Molfino N, Zamel N,
Hoffstein V, Fredberg J. Am Rev Respir Dis. 1990 Dec;142(6 Pt 1):1465-6
Other publications (10):
Oh CK and Molfino NA, Hereditary Pulmonary Emphysema in Emery and Rimoin’s Principles and
Practice of Medical Genetics, 6th Edition, 2011 (book chapter)
7
Résumé Dr. Néstor A. Molfino
Confidential
Oh CK, and Molfino NA, Genetics of COPD in Emphysema: Causes, Symptoms and Prevention (book
chapter) 2011
Busse WW, Molfino NA, Kolbeck R. IL-5 Receptor directed strategies. (book chapter) 2011.
Humbles A, Molfino NA et al. Monoclonal antibody therapy directed against interleukin-9: MEDI 528.
Chapter in New Drugs and Targets for Asthma and COPD (2010); vol 39: 137-140.
Molfino NA. New anti-inflammatory therapies for the treatment of COPD. Drug Discovery Today:
Therapeutic Strategies 2008; 5 (2): 93-96
Molfino NA. Asma casi fatal; chapter in Medicina Intensiva; edited by C. Lovesio; 2001 El Ateneo,
Buenos Aires: p. 66-77.
Molfino NA. Near-Fatal Asthma; chapter in Acute Asthma; edited by J. Hall, T. Coldbridge; C. Rodrigo
and G. Rodrigo; 2000 McGraw-Hill, Chicago
Molfino, NA. The role of T-cells in asthma. Practical Allergy & Immunology 1994; 9 (4): 157-163.
Molfino NA. Averting the fatal asthma attack. Emergency Medicine 1991; 23(15): 45-50.
Molfino NA and Zamel N. Clinical Interpretation of bronchial hyperresponsiveness. Respirology 1990;
1(4): 15.
BOARD & A CADEMIC A PPOINTMENTS
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)
SELECTED PRESENTATIONS
2011
2010
2010
2010
2010
2003
2003
1998
Proof-of-concept trials in Asthma and COPD. SMI Conference on Asthma and COPD. London, UK.
New Diagnostics and treatments in severe asthma. Annual Congress of Respiratory Medicine, Buenos Aires, Argentina.
New molecular targets in asthma and COPD. Annual Congress of Respiratory Medicine, Buenos Aires, Argentina.
New Biologics in Asthma. Grand Rounds Lecture. Washington Hospital Center. Washington DC, USA.
Differences between small molecules and biologics. Lecture at Symposium: Advancing Biologics from the lab to the clinic.
Brussels, Belgium
“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
“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
“Targeting Cytokines in Asthma” GTCBio 6th Annual Conference on Cytokines and Inflammation. Orlando, Fa., USA
“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
“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
“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”
“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”
Viral Respiratory Infections and Their Consequences. College of Physicians of Victoria, Argentina
Cellular and Molecular Mechanisms in COPD. Maryland Research Laboratories. Rockville, MD, USA.
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.
2008
2008
2008
2008
2007
2006
2006
8
Résumé Dr. Néstor A. Molfino
Confidential
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
1996
Genetics of asthma. Critical Care Society Scientific meeting. Montevideo, Uruguay.
New perspectives in asthma education and research. Fourth Annual Spring Workshop. Saskatchewan Thoracic Society.
Saskatoon, Canada.
Asthma: Clinical presentation and Epidemiology. Combined R&D-Clinical Symposium on Genetics of Asthma.
1996
1994
1994:
1994:
1993:
1992:
1991:
1991:
1991:
1991:
Wiesbaden, Germany.
Asma potencialmente fatal. Identificación y tratamiento. III IberoAmerican Congress of Respiratory Medicine. Viña del
Mar, Chile.
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.
Workshop on development of Guidelines for the treatment of COPD in Argentina. Argentinean Medical Association,
Buenos Aires, Argentina.
γδ TcR repertoire in atopic asthmatics. The Toronto Hospital Asthma Centre, Department of Medicine, University of
Toronto, Toronto, Canada.
Mechanisms of Cough. Laboratory tests. Respiratory Inter-city Grand Rounds. Saint Michael’s Hospital, Department of
Medicine, University of Toronto, Toronto, Ontario, Canada.
Near-Fatal Asthma. Conference on Asthma Deaths. The Royal College of Physicians, London, England.
Effect of ozone on the allergic response in asthmatic subjects. Congreso Argentino de Neumonologia, Buenos Aires,
Argentina.
Effect of ozone on allergic asthma. Respiratory Division Seminars, Department of Medicine, University of Toronto,
Canada.
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 of diagnosis and treatment (US 2012/0328608)
JOURNAL R EVIEWER
•
•
•
•
Chest
Expert Opinion on Investigational Drugs
Respiration
American Journal of Respiratory and Critical Care Medicine
SUMMARY OF SMALL MOLECULES /BIOLOGICS/DEVICE
DEVELOPMENT EXPERTISE
Table 1. MedImmune (AstraZeneca Biologics)
Project
Clinical
Phase
Indication
No. of
subjects
No. of
Sites
Location
Purpose of Trial
Dr. Molfino’s
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
9
Résumé Dr. Néstor A. Molfino
Confidential
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
Targets
All
COPD
TBD
TBD
TBD
Safety/efficacy
TA Headdesigned
strategy
10
Résumé Dr. Néstor A. Molfino
Confidential
Table 2. Otsuka Maryland Research Institute
Project
Clinical
Phase
Indication
No. of
subjects
No. of
Sites
Location
Purpose of Trial
Dr. Molfino’s
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
Table 3. Baxter Healthcare, Bioscience Division
Project
Clinical
Phase
Indication
No. of
subjects
No. of
Sites
Location
Purpose of
Trial
Dr. Molfino’s
involvement
Alpha-1
antitrypsin
I
30
1
UK
Safety
Meningococcal
vaccines
Influenza
vaccines
Tick-born
encephalitis
vaccines
Pertussis vaccine
Hib vaccine
Anti-bioterrorism
vaccines
Immunoallergy
vaccines
Sepsis NTI
I-IV
Hereditary
Emphysema,
COPD
Prevention
> 7000
>30
Safety/Effic
III
Prevention
9000
70
EU/America
s
USA
III
Prevention
2000
1
US army
Safety/Effic
Project team
member-reviewed
IND
Wrote protocol
Medical Director
Wrote protocol
Medical Director
Medical Director
III-IV
II
NA
>3000
300
NA
3
3
NA
USA
USA
USA
Safety/Effic
Safety/Effic
NA
NA
Prevention
Prevention
Smallpox and
anthrax
Asthma
NA
NA
NA
NA
NA
Prevention
NA
NA
NA
NA
Safety/Effic
Completed trials
Completed trial
Project team
Medical support
Business Dev
support
Business Dev
support
11
Résumé Dr. Néstor A. Molfino
Confidential
Table 4. Theratechnologies, Inc.
Drug
Clinical
Phase
Indication
No. of
Patient
s
No. of
Sites
Location
Purpose of Trial
Dr. Molfino’s
involvement
GRF analogs
(2 trials)
I
Muscle
wasting
50
1
Europe/Canada
Safety and Doseranging
GRF analogs
(3 trials)
II
COPD, frail
elderly,
sleep
300
5-6
Canada/USA/
EU
Pivotal
Photodynam.
Therapy
(device)
Photodynam.
Therapy
(device)
I/II
CML
20
1
Canada
Pivotal
Design develop
strategy, selected
CRO, wrote
protoc.
Design develop
strategy, selected
CRO, wrote
protoc
Plan, design,
conduct
I/II
NHL
30
4
Canada/USA
Pivotal
Plan, design
Table 5. Abbott Laboratories
Drug
Clinical
Phase
Indication
No. of
Patients
No. of
Sites
Location
Purpose of Trial
Dr. Molfino’s
involvement
Sertindole
III
Schizophrenia
60
4
Canada
Pivotal
Conduct
Tiagabine
III
Epilepsy
40
3
Pivotal
Conduct
Marketing support
Design, plan,
conduct
Pivotal
Conduct
Pivotal
Conduct
Marketing support
Conduct
Pivotal
Conduct
Expand Indication
Conduct
Clarithromycin
III/IV
Otitis
100 +
4
Dex
II/III
Anesthesia
20
1
Ritonavir
III/IV
HIV/AIDS
20
2
Lanzoprazole
III/IV
G.I.
100 +
20
Propofol
III
CABG
40
2
Lupron
III/IV
Prostate cancer
100 +
20
Canada
Canada
Canada
Canada
Canada
Canada
Canada
12
Résumé Dr. Néstor A. Molfino
Confidential
Table 6. Boehringer Ingelheim
Drug
Ipratropium
MDI
Ipratropium
MDI
Clinical
Phase
III/IV
Indication
II/III
Asthma
No. of
Patients
300 +
No. of
Sites
15
Location
Purpose of Trial
Canada
New Indication
Dr. Molfino’s
Involvement
Plan, conduct, report
200
1
Canada
Mechanism of action
Plan, conduct
30
1
Canada
Plan, study design,
conduct, report
200
10
Canada
Pivotal- HPB
requirement for
approval
Marketing support
Ipratropium
MDI
II/III
Ipratropium
Solution
Nevirapine
III/IV
COPD
(acoustic
reflection)
COPD
(Inspiratory
flow)
COPD
III
HIV/AIDS
50
NA
Canada
EDR
Fenoterol
MDI
III/IV
Acute
Asthma
350
12
Canada
Pharmacovigilance
Combivent
MDI
NA
III
Acute
Asthma
Asthma
300
10
Canada
Pivotal
Wrote protocol,
Conduct
Plan, get NDA
approval, conduct
Plan, study design
and protocol,
conduct, report
Conduct
2000
NA
Canada,
Australia,
Brazil
Genetics of Asthma
Program with
Sequana Therapeutics
and Mount Sinai
Hospital - Toronto
Represent
Boehringer
Ingelheim in Joint
Research Committee
as Clinical expert
Preclinical
Citizenships: USA, Canada, Argentina (country of origin)
Languages: Spanish (mother tongue), English (fluent), French, Portuguese, Italian
(working knowledge)
References available upon request
13