Strategic Pharmaceutical Development Project Leader


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John J. Brennan, Ph.D.
21221 Chattahoochee Avenue
Venice, Florida 34293 www.linkedin.com/in/john-j-brennan-b2929086

224.287.6596 [email protected]

STRATEGIC PHARMACEUTICAL DEVELOPMENT PROJECT LEADER Delivering Broad Therapeutic Expertise for Successful Drug Development and Lifecycle Management
• Accomplished Pharma industry scientist with experience in the global pharmaceutical industry, all stages of drug development and lifecycle management.
• Professional experience centered on early, mid- and late-stage drug development across multiple therapeutic areas.
• Enterprise Leader for multi-function global asset development teams and primary point-of-contact for pipeline governance, therapeutic area executive committees and external alliance partners.
• Project Lead for global regulatory interactions and submissions leading to successful outcomes.
• Partnered with Medical Affairs and Global Commercial Organization to create differentiable Target Product Profiles through competitive analysis, market research, medical advisory boards and effective scientific communications.
• Hands-on understanding of study results and rapid learning of new therapeutic areas.

PROFESSIONAL EXPERIENCE

John Brennan Pharmaceutical Consulting Associates, LLC (Venice, Florida)

January 2018 to Present

Integrating strategic and therapeutic expertise for new drug development organizations and established CROs

• Translational Pharmacology and Preclinical Drug Safety Assessments • Biomarker Evaluation and Point-of-Care Diagnostic Applications • Phase I Clinical Pharmacology Design, Implementation, Execution and Reporting • Phase 2 Proof of Concept and Proof of Principle Evaluations • Phase 3 Global Phase 3 Study Experience and CRO Management • Global Regulatory Interactions, CMC Biologicals and Pediatric Plan Negotiations
• IDMC, Event and Executive Steering Committee Guidance
• Business Development and Alliance Management Interactions

AbbVie (Lake County, IL) Senior Project Leader General Medicine Therapeutic Area

2013 – 2017(retired)

Served as Enterprise Leader for three Global Asset Development Teams. Accountable to Late-Stage Pipeline Governance Committee and Group Vice President for planning and execution of pharmaceutical development strategies leading to successful First-in-Man, Proof-of-Concept, Proof-of- Principle and product registration studies.
● Cystic Fibrosis Asset Development Team. Established early-stage development proof-of-concept outcomes for lead assets in a unique triple combination oral therapy for F508d mutation CF patients. Served as point-of-contact for external alliance partner, internal Alliance Management and New Business Development groups. Provided leadership and direction for Therapeutic Area Strategy and Joint Steering Committees leading to continuation of internal funding and positive investor relations for alliance partner. Co-chair of Joint Development Committee (2017).
● CREON Marketed Product Asset Development Team. Accountable to Senior Management for planning and execution of a critical manufacturing plant qualification activity needed for growth of highly successful marketed product. Asset team point-of-contact for manufacturing technology, clinical operations and regulatory affairs functions. Mentorship for clinical development and medical affairs sub-teams in planning and conducting label enhancement activities for exocrine pancreatic insufficiency (investigator-initiated and Phase 2 studies) through AbbVie Drug Development Center. Development interface for important regulatory interactions.
● Atrasentan Asset Development Team. Leadership of NCE endothelin receptor antagonist late-stage global Phase 3 registration program in diabetic nephropathy. Line management of renal medical directors (2013-2016) responsible for execution of Phase 2 (sperm safety) and Phase 3 (“SONAR”) studies at over 700 sites in 43 countries. Served as primary face of the project for integrating and coordinating therapeutic area, clinical operations, pharmaceutical technology, regulatory liaison, pharmacovigilance, pipeline marketing and project management activities. Provided team support for Independent Data Monitoring Committee and Event Management Committee. Standing member and company representative on Executive Steering Committee comprised of Key Opinion Leaders specializing in diabetic chronic kidney disease. Published manuscripts and multiple congress presentations in 6 years; key contributor to Global Medical Affairs strategy and publication plan for an innovative renal drug product.

John J. Brennan, Ph.D.

[email protected]

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ABBOTT (acquired Solvay Pharmaceuticals, Inc.)

2010 - 2013

Senior Project Director Renal Development (Lake County, IL)
Reported to Vice President, Early Immunology and Renal Development in Global Pharmaceutical Research and Development Division. Served as Global Project Director accountable for Phase 2 execution, reporting and executive governance approval of a highly-specific NCE endothelin receptor antagonist for use in the treatment of diabetic nephropathy. Translated surrogate marker outcomes from Phase 2B to long term outcome endpoint needed for Phase 3 registration program. Accountable for integration and coordination of team functions leading to a strong value proposition and clinical case for Executive Committee approval of proposed registration program. Line management responsibility for three medical directors.
● Analyzed and reported Phase 2B efficacy and safety results from 3 clinical studies in diabetic nephropathy patients. Established proof-of-principle in dose-ranging studies and assessed critical safety marker using bio impedance measurements. Used clinical outcomes to set the dose level for the proposed Phase 3 registration program. Coordinated review and presentation of Phase 2B clinical program results with internal management stakeholders and External Steering Committee.
● Led preparation, presentation of study results and Phase 3 plan at Review Division meetings with US FDA, Health Canada, MHRA and PMDA. Organized and executed presentation and successful approval of a surrogate markerbased Pediatric Development Plan during Scientific Advice proceedings and Pediatric Development Committee review at MHRA.
● Facilitated review of new clinical findings from Phase 2B with USPTO leading to approval of a medical use patent that extended NCE product life to 2028 and beyond.
● Prepared and presented innovative commercial value proposition to Executive Committee resulting in funding approval for Phase 3 registration program for use of NCE in diabetic kidney disease.
● Coordinated, executed External Steering Committee actions resulting in publication of several manuscripts and congress presentations.

Solvay Pharmaceuticals, Inc. Marietta GA
Vice President and Therapeutic Area Head (Cardio-Metabolic), Global Project Management 2008-2010
Based in US Headquarters and reported to Senior VP Global Project Management in Hanover Germany. Led global project teams focused on early and mid-stage development of First-in-Class NCE metalloprotease inhibitors for endothelin converting enzyme and neuroendopeptidase. Drug indication areas included pulmonary arterial hypertension, acute heart failure, hypertension and diabetic nephropathy. ● Collaborated with Global Therapeutic Area leaders in Clinical Development, Regulatory Affairs and Product Strategy
to optimize worldwide development and access for a licensed Omega-3 Fatty Acid oral product. Actions resulted in a 50% increase in 3-year market forecast. ● Provided leadership and direction for Market Access Strategic Team presentation and approval of a novel ECE-NEP inhibitor for pulmonary arterial hypertension; participated in external advisory boards to design First-in-Man and Proof of Concept studies.
ADDITIONAL RELEVANT EXPERIENCE
SOLVAY PHARMACEUTICALS INC., Marietta, GA Group Director, Clinical Development and Medical Affairs 2001 - 2008
Director, Women’s Health Clinical Development Group 1994 - 2001 Director, Drug Metabolism and Pharmacokinetics 1992 – 1994
● Directed activities for life cycle management of Estratest®, Marinol®, Estratab® and AndroGel® in additional indications and new formulations. Served as project lead in meetings with FDA. Chaired review committee for Investigator-Initiated Study proposals.
● Acted as core team member in charge of breakthrough initiative identifying bottlenecks and inventing operational and scientific enhancements that increased development speed through challenge of existing practices.
● Critical drug-drug interaction and pharmacokinetics presentation at FDA Advisory Committee Meeting for LUVOX®. ● Project Lead for development, submission and regulatory approval of ESTROGEL® for treatment of menopausal
symptoms. ● Directed execution, reporting, submission and approval of SNDA for low-dose ESTRATAB® (osteoporosis prevention). ● Direct management responsibility for Bioanalytical Chemistry, Drug Supply Team, US Clinical Pharmacology,
Women’s Health and Men’s Health departments (>20 professionals).

John J. Brennan, Ph.D.

[email protected]

THE SQUIBB INSTITUTE AND BRISTOL MYERS-SQUIBB 1981 - 1992 Assistant and Associate Medical Director, Human Pharmacology Senior Scientist Radiopharmaceutical Product Development
ORTHO PHARMACEUTICAL CORPORATION 1979 – 1981 Senior Scientist, Consumer Products Division

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EDUCATION AND TRAINING
- B.A (Chemistry) Temple University, Philadelphia PA 1974
– Ph.D. (Pharmaceutical Sciences) Philadelphia College of Pharmacy and Science 1980
PROFESSIONAL DEVELOPMENT
– Global Leadership training for Solvay Pharmaceuticals in cooperation with Nijenrode University (NL) – Abbott Global Leadership training – Board of Visitors, Mercer University School of Pharmacy – Mercer University School of Pharmacy Meritorious Service Award – Project Management Professional Certification 2010
AWARDS
Solvay Summit Awards, 2002 and 2009
PROFESSIONAL MEMBERSHIPS
-American Society of Nephrology, Endocrine Society and the American College of Clinical Pharmacology.
PATENTS ISSUED:
Composition and Method for Treating Pediatric Hypogonadism PCT/EP 2008/05 33 72. Unimed Pharmaceuticals, LLC
Methods for Improving Lipid Profiles Using Atrasentan PCT/EP 2017/US Patent 9855245. AbbVie
Methods for Treatment of Menopausal-Associated Symptoms PCT/EP 2006/US Patent 8431557 Solvay Pharmaceuticals, Inc.
BOOKS:
“Drugs and Biological Development-From Molecule to Product and Beyond” Edited by Ronald P. Evan, Springer, New York, 2007. Chapter 12.5, Psychiatry Michael P. Jann, John J. Brennan and Roland Gerritsen vanderHoop.

PUBLICATIONS AND ABSTRACTS
1. Low-dose esterified estrogen therapy: effects on bone, plasma estradiol concentrations, endometrium and lipid levels HK Genant, J Lucas, S Weiss, M Akin, R Emkey, H McNaney-Flint Archives of Internal medicine 157 (22). 2609-2615, 1997
2. The endothelin antagonist atrasentan lowers residual albuminuria in patients with type 2 diabetic nephropathy D De Zeeuw, B Coll, D. Andress, JJ Brennan, H Tang, M Houser Journal of the American Society of Nephrology 25 (5). 1083-1093, 2014
3. Gastrointestinal transit and systemic absorption of captopril from a pulsed-release formulation IR Wilding, SS Davis, M Bakhshaee, HNE Stevens, RA Sparrow Pharmaceutical research 9 (5), 654-657, 1992
4. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men JM Kaufman, MG Miller, JL Garwin, S Fitzpatrick, C McWhirter, JJ Brennan The journal of sexual medicine 8 (7), 2079-2089, 2011
5. Clinical Efficacy of the selective endothelin A receptor antagonist, atrasentan, in patients with diabetes and chronic kidney disease (CKD) DL Andress, B Coll, Y Pritchett, J Brennan, M Molitch, DE Kohan Life sciences 91 (13-14), 739-742, 2012
6. Combined esterified estrogens and methyltestosterone versus esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women JK Warnock, SG Swanson, RW Borel, LM Zipfel, JJ Brennan Menopause 12 (4), 374-384, 2005
7. Rationale and protocol of the Study of Diabetic Nephropathy with Atrasentan (SONAR) trial: A clinical trial design novel to diabetic nephropathy HJ Heerspink, DL Andress, G Bakris, JJ Brennan, R Correa-Rotter Diabetes, Obesity and Metabolism 20 (6), 1369-1376, 2018
8 Chiral separation retention mechanisms in high-performance liquid chromatography using bare silica stationary phase and B-cyclodextrin as a mobile phase additive RH Pullen, JJ Brennan, G Patonay Journal of Chromatography A 691 (1-2), 187-193, 1995
9. A multicenter, open-label, observational study of testosterone gel (1%) in the treatment of adolescent boys with Klinefelter syndrome or anorchia AD Rogol, RS Swerdloff, EO Reiter, JL Ross, TL ZumBrunnen, GA Pratt Journal of adolescent health 54 (1), 20-25, 2014
10. Predictors of atrasentan-associated fluid retention and change in albuminuria in patients with diabetic nephropathy DE Kohan, HJL Heerspink, B Coll, D. Andress, JJ Brennan, DW Kitzman Clinical Journal of the American Society of Nephrology 10 (9), 1568-1574, 2015

11. Pharmacokinetics and relative bioavailability of absorbed testosterone after administration of a 1.62% testosterone gel to different application sites in men and hypogonadism J Miller, M Britto, S. Fitzpatrick, C McWhirter, S. Testino Jr, J Brennan Endocrine Practice 17 (4), 574-583, 2011
12. Prediction of the effect of atrasentan on renal and heart failure outcomes based on short-term changes in multiple risk markers S. Schievink, D. De Zeeuw, PA Smink, D. Andress, JJ Brennan, B Coll European Journal of Preventive Cardiology 23 (7), 758-768. 2016
13. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption J Stahlman, M Britto, S. Fitzpatrick, C. McWhirter, SA Testino Jr, JJ Brennan Current medical research and opinion 28 (2), 291-301, 2012
14. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: Results of a 182-day open-label extension of a 6-month double-blind study JM Kaufman, MG Miller, S Fitzpatrick, C McWhirter, JJ Brennan The journal of sexual medicine 9 (4), 1149-1161, 2012
15. Esterified estrogen therapy in postmenopausal women. Relationships of bone marker changes and plasma estradiol to BMD changes: a two-year study NB Watts, JC Nolan, JJ Brennan, HM Yang Menopause 7 (6), 375-382, 2000
16. Baseline characteristics and enrichment results from the SONAR trial HJL Heerspink, DL Andress, G Bakris, JJ Brennan, R Correa-Rotter Diabetes, Obesity and Metabolism 20 (8), 1829-1835, 2018
17. Effect of the ACE inhibitor ceronapril on cerebral blood flow in hypertensive patients NR Cutler, JJ Sramek, A Luna, I Mena, EP Brass, NM Kurtz, JJ Brennan Annals of Pharmacotherapy 30 (6), 578-582, 1996
18. Effect of application site, clothing barrier, and application site washing on testosterone transfer with a 1.62% testosterone gel J Stahlman, M Britto, S Fitzpatrick, C McWhirter, SA Testino Jr, JJ Brennan Current Medical Research and Opinion 28 (2), 281-290, 2012
19. A radioimmunoassay for SQ 27,519, the active phosphinic acid-carboxylic diacid of the prodrug fosinopril in human serum JI Tu, J Brennan, B Stouffer, WC Eckelman Therapeutic drug monitoring 12 (4), 404-410, 1990
20. Treatment of menopause associated symptoms J Brennan, E Sands, R Horton, Z Bebia US Patent APP. 11/783,889, 2007
21. Serum concentrations of 17B-estradiol and estrone after multiple-dose administration of percutaneous estradiol gel in symptomatic menopausal women JJ Brennan, ZS Lu, M Whitman, P Stafiniak, RG van der Hoop Therapeutic drug monitoring 23 (2), 134-138, 2001

22. The effects of atrasentan on urinary metabolites in patients with type 2 diabetes and nephropathy MJ Pena, D de Zeeuw, D Andress, JJ Brennan, R Correa-Rotter, B Coll Diabetes, Obesity and Metabolism 19 (5), 749-753, 2017
23. Effects of skin washing on systemic absorption of testosterone in hypogonadal males after administration of 1.62% testosterone gel J Stahlman, M Britto, S Fitzpatrick, C McWhirter, SA Testino JR, JJ Brennan Current medical research and opinion 28 (2), 271-279, 2012
24. Fosinopril and hydrochlorothiazide combination versus individual components: lack of a pharmacokinetic interaction HD Uderman, DR Much, J Brennan, CL Delaney, EA Morgenthien Annals of Pharmacotherapy 33 (5), 525-530, 1999
25. Relationship between Atrasentan concentrations and urinary albumin to creatinine ratio in western and Japanese patients with diabetic nephropathy CW Lin, NM Mostafa, DL Andress, JJ Brennan, CE Klein, WM Awni Clinical therapeutics 40 (2), 242-251, 2018
26. Stereospecific determinations of (±)-DU-124884 and its metabolites (±)-KC-9048 in human plasma by liquid chromatography W Naidong, RH Pullen, RF Arrendale, JJ Brennan, JD Hulse, JW Lee Journal of pharmaceutical and biomedical analysis 14 (3), 325-337, 1996
27. Anti-hypertensive effects of intravenous compared with oral captopril JJ Sramek, JJ Brennan, DR Much, D Duchin, A Luna, NR Cutler Journal of human hypertension 9 (11, 875, 1995
28. The comparative bioavailability of captopril after colonic infusion and oral-administration in healthy-volunteers J Brennan, D Odonnell, M Zinny, N Jain, E Ivashkiv, N Arnold Clinical Pharmacology & Therapeutics 49 (2), 131-131, 1991
29. The effect of washing and the absence of interindividual transfer of estradiol gel TL ZumBrunnen, I Meuwsen, M de Vies, JJ Brennan American Journal of Drug Delivery 4 (2), 89-95, 2006
30. The multiple dose pharmacokinetics and cilansetron in subjects with normal and impaired hepatic function RL Pardue, L Zipfel, H Fritsch, J Brennan Clinical Pharmacology and Therapeutics 73 (2), P78-P78, 2003
31. Direct Determination and Substituted Azepinoindole Enantiomers in Rat Plasma using Silica Stationary Phase and beta-Cyclodextrin as a Mobile Phase Additive RH Pullen, JJ Brennan, R Lammers, G Patonay Analytical chemistry 67 (11), 1903-1906, 1995

32 Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial DJ Webb, B Coll, HJL Heerspink, D Andress, Y Pritchett, JJ Brennan Drugs in R&D 17 (3), 441-448, 2017
33. Esterified estrogens and methyltestosterone: effects on sexual interest and hormone profiles CL Goldsmith, J Maly, S Swanson, JJ Brennan, BA Block, HM Yang Obstetrics and Gynecology 103 (4), 63S-63S, 2004
34. The pharmacokinetics and pharmacodynamics of 17-d-norgestimate and ethinyl estradiol alone and in the presence of cilansetron 2 mg TID, in healthy females TL ZumBrunnen, P Boon, J Chang, M DeVries, JJ Brennan Clinical Pharmacology & Therapeutics 77 (2), P56-P56, 2005
35. The multiple-dose pharmacokinetics of fluvoxamine in children and adolescents T ZumBrunnen, Z Lu, J Chang, J Chang, J Nezamus, M Eller, M Labellarte Clinical Pharmacology and Therapeutics 69 (2)
36. Steady state pharmacokinetics of fluvoxamine in young and elderly volunteers J Brennan, J Hui, R Pullen, H Yang, M Baars, D Tolbert Clinical Pharmacology & Therapeutics 63 (2), 1998
37. Comparison of exposure response relationship of atrasentan between North American and Asian populations HJL Heerspink, H Makino, D Andress, JJ Brennan, R Correa-Rotter Diabetes, Obesity and Metabolism 19 (4), 545-552, 2017
38. Combined esterified estrogens and methyltestosterone versus esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women JK Wamock, SG Swanson, RW Borel, LM Zipfel, JJ Brennan Menopause 12 (4), 374-384, 2005
39. Pharmacokinetics and Inhaled (Nebulized) Dronabinol: 104 J Miller, T ZumBrunnen, J Brennan Journal of Clinical Pharmacology 43 (9), 2003
40. Pharmacokinetic Analysis: A Practical Approach PID Lee, GL Amidon, JJ Brennan Journal of Medicinal Chemistry 40 (6), 1046-1046, 1997
41. Radioimmunoassay for ceronapril, a new angiotensin-converting enzyme inhibitor, and its application to a pharmacokinetic study in healthy male volunteers JI Tu, J Brennan, B Stouffer, S Mantha, N Turabi, HM Tsay Therapeutic drug monitoring 14 (3), 209-219, 1992
42. Treatment of Multidrug-Resistant Nephrotic Syndrome (MDR-NS) in Children JJ Brennan, F Schaefer, ME Wigderson US Patent APP 15/211, 781, 2017

43. Comparison of Exposure Response Relationship of Atrasentan between North American and Asian Populations V Perkovic, D Andress, JJ Brennan, B Coll, R Correa-Rotter, J Davis Wiley-Blackwell Publishing Ltd, 2017
44. Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial V Perkovic, D Andress, JJ Brennan, B Coll, R Correa-Rotter Adis International, 2017
45. One-Year Efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: secondary efficacy results JM Kaufman, MG Miller, S Fitzpatrick, C McWhirter, JJ Brennan Journal of Andrology 53-53, 2011
46. Single and multiple dose pharmacokinetics of testosterone in hypogonadal males after application of 1.62% testosterone gel: poster# 2 J Miller, M Britto, S. Fitzpatrick, C McWhirter, S Testino, J Brennan The Journal of Sexual Medicine 8, 2011
47. The effect of concomitant application of moisturizer lotion or sunscreen on the bioavailability of 1.62% testosterone gel in hypogonadal males: Poster # NM2 J Miller, M Britto, S Fitzpatrick, C McWhirter, S Testino, J Brennan The Journal of Sexual Medicine 8, 2011
48. Evaluation of the effects of application site washing on systemic testosterone exposure after application of 1.62% testosterone gel in hypogonadal males: Poster# NM1 J Miller, M Britto, S Fitzpatrick, C McWhirter, S Testino, J Brennan The Journal of Sexual Medicine 8, 2011
49. The Efficacy and safety of a 1.62% testosterone gel for the treatment of hypogonadal men: Primary efficacy results from a phase III study: Poster# 4 J Kaufman, J Brennan, J Garwin, M Miller, S Fitzpatrick, C McWhirter The Journal of Sexual Medicine 8, 2011
50. Pharmacokinetics and efficacy of a 1.62% testosterone gel for the treatment of hypogonadal men: secondary efficacy results from a phase III study: poster# NM5 J Kaufman, J Brennan, J Garwin, M Miller, S Fitzpatrick, C McWhirter The Journal of Sexual Medicine 8, 2011
51. One-Year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: primary efficacy results: Poster# 5 J Kaufman, M Miller, S Fitzpatrick, C McWhirter, J Brennan The Journal of Sexual Medicine 8, 2011

52. The effect of varying the application site on the bioavailability of 1.62% testosterone gel in hypogonadal males: Poster# 3 J Miller, M Britto, S Fitzpatrick, C McWhirter, S Testino, J Brennan The Journal of Sexual Medicine 8, 2011
53. The Efficacy and Safety of a 1.62% testosterone gel for the treatment of hypogonadal men: efficacy results from a phase III study JM Kauffman, JJ Brennan, JL Garwin, MG Miller, S Fitzpatrick, C McWhirter Endocrine Reviews 31 (3), 2010
54. Efficacy and tolerability of the low dose transdermal estradiol gel 0.03% in the improvement of frequency and severity of menopausal ho flashes Z Bebia, L Zipfel, A Allgood, B Parker, J Brennan, E Sands Menopause The Journal of the North American Menopause Society 13 (6), 995-995, 2006
55. Steady state plasma concentrations of estradiol and unconjugated estrone after percutaneous application of a 0.03% estradiol gel to menopausal subjects in a clinical trial M Vo, Z Bebia, T Testino, T ZumBrunnen, L Zipfel, A Allgood, B Parker Menopause the Journal of the North American Menopause Society 13 (6), 1016-1016, 2006
56. Effects on concomitant applications of moisturizer lotion or sunscreen and estradiol gel 0.06%: 86 M Vo, T ZumBrunnen, T Testino, C Lane, B Parke, J Schettler, S Yeung Journal of clinical Pharmacology 46 (9), 2006
57. Micronized progesterone or MPA? Effects on quality of life in combination with esterified estrogens DF Archer, CP Roberts, BA Block, JJ Brennan, HM Yang Obstetrics and Gynecology 103 (4), 62S-62S, 2004
58. The Combination of Testosterone-Gel 1% (Androgel) and Sildenafil for treatment of Erectile Dysfunction: Safety Assessment in Hypogonadal Non-Responders to Sildenafil Monotherapy Z Bebia, B Block, C Lane, J Brennan, L Zipfel, S Schwartz Endocrine Practice 10, 2004
59. The absence of intersubject transfer of 17B-estradiol gel between dosed and non-dosed postmenopausal women after direct skin-to-skin contact TL ZumBrunnen, I Meuwsen, MH de Vries, JJ Brennan Clinical Pharmacology & Therapeutics 75 (2), P57-P57, 2004
60. Combined esterified estrogens and methyltestosterone compared to esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women JK Wamock, RW Borel, LM Zipfel, JJ Brennan Menopause-The Journal of the North American Menopause Society 10 (6), 579-579, 2003
61. Pharmacokinetics of Fosinopril and Hydrochlorothiazide in Healthy Elderly and Young Men DR Much, HD Uderman, B Ameer, J Brennan, BC Stouffer, D Whigan Clinical drug investigation 17 (3), 225-231, 1999
62. Pharmacokinetics-Fosinopril and Hydrochlorothiazide Kinetics HD Uderman, DR Much, J Brennan Annals of Pharmacotherapy 33 (5), 525-530, 1999

63. Low-Dose Esterified Estrogen Therapy: Effects on Bone, Plasma Estradiol Concentrations, Endometrium and Lipid Levels HK Genant, J Lucas, S Weiss, M Akin, R Emkey, H McNaney-Flint Obstetrical & Gynecological Survey 53 (6), 363-364, 1998
64. Pharmacokinetics of single dose fluvoxamine (F) in extensive (EM) vs. poor metabolizers (PM) of dextromethorphan (DM) J Hui, J Brennan, M Hare, R Arrendale, B Zaborny, F Wong Clinical Pharmacology & Therapeutics 63 (2), 1998
65. Estrogen/Androgen balance in postmenopausal women receiving esterified estrogens (ESE), methyltestosterone (MT) and placebo J Brennan, D Ackerman, B Wiita, H Yang, J Simon Clinical Pharmacology & Therapeutics 63 (2), 1998
66. The relationship of plasma estradiol levels to bmd changes in a clinical study of esterified estrogens (Estratab ®) in postmenopausal women N Watts, R Reber, H Genant, J Brennan, S Silfen, HM Yang, J Nolan Journal of Bone and Mineral Research 12, F504-F504, 1997
67. Pharmacokinetic Analysis: A practical approach by Peter ID Lee and Gordon L. Amidon. Thecnomic Publishing, Lancaster, PA 1996 xiii+ 548 pp 15.5 x 23.5 cm. ISBN 1-56676-425-4 JJ Brennan Journal of Medicinal Chemistry 40(6), 1046-1046, 1997
68. Lowest Effective Plasma Concentration (Cp) Ranges of Estrogens that Prevent Bone Mineral Density (BMD) Loss in postmenopausal women receiving esterified estrogens (ESE): PII-11 J Brennan, J Nolan, J Hui, R Arrendale, D Pederson, M Hare, N Banav, Clinical Pharmacology & Therapeutics 61 (2), 1997
69. Plasma Concentrations (Cp) of Estrogens are Correlated with Bone Mineral Density (BMD) Changes in Postmenopausal Women Receiving Esterified Estrogens (ESE) in an Osteoporosis J Brennan, J Nolan, J Hui, R Arrendale, D Pederson, M Hare, N Banav Clinical Pharmacology & Therapeutics 61 (2), 1997
70. Bone Mineral Density Response of Unopposed Esterified Estrogens; Group BMD Changes vs Individual Responses J Mortola, R Emkey, S Silfen, JC Nolan, J Brennan Fertility and Sterility 1001 (1997), S 228, 1997
71. P-282 Bone Mineral Density Response to Unopposed Esterified Estrogens; Group BMD changes vs Individual Responses J Mortola, R Emkey, S Silfen, JC Nolan, J Brennan Fertility and Sterility 68, S228, 1997
72. Multiple-Dose Pharmacokinetics of Fosinopril-Hydrochlorodothiazide in Healthy Elderly and Young volunteers: 37 D Much, H Uderman, D VanHarken, B Stouffer, D Whigan, J Brennan The Journal of Clinical Pharmacology 36 (9), 1996

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Strategic Pharmaceutical Development Project Leader