PRINCIPAL

 M. Gedde, MD, PhD,
President,
American Biotechnology Associates™

Dr. Gedde is a pharmaceutical development specialist whose qualifications, background and experience are so unique, that she's possibly  the premier consultant in the industry (see qualifications and experience below).

Dr. Gedde has extremely high professional standards, along with extremely high standards of ethics and moral integrity. This is one reason she has started her pharmaceutical industry job seeker and headhunting services. She cares about you, and the industry at large. Because of her own standards, she also requires the same of those who wish to use her pharmaceutical job and consultancy job searching sites.

Dr. Gedde is both a philanthropist and a capitalist. For instance, she donates the maximum IRS limit of her income to non-profit organizations, yet wants to make a comfortable living and must pay the high costs of operating her service oriented websites.

The extremely high professional, ethical and moral standards she holds herself to, combined with her philanthropic approach, are the basis of why she started both her pharmaceutical jobs site (for those looking for pharmaceutical jobs or independent contracting consultant work), and her pharmaceutical industry headhunting site, (designed for companies in the industry, and those with human resource departments needing personnel or contractors). Her own standards help assure both parties of finding the "perfect fit", because she cares about both individuals and the industry overall. 

Dr. Gedde is a broadly trained scientist and physician, but is foremost an experienced, multi-faceted pharmaceutical development professional.  

During four years as a director in the pharmaceutical development field and as a consultant to other directors, she has worked closely with professionals in all areas of the pharmaceutical development process, including:

• R&D  - designing in vitro research programs in support of clinical development and regulatory applications, including managing and supervising development labs, designing studies and tactics and ensuring the quality and completeness of the work.

• Chemistry - both medicinal (providing structure-activity feedback data) and analytical (coordinating activity and concentration assays).

• Regulatory - writing various regulatory submissions, including NDAs and INDs.

• Manufacturing - contributing to release testing and quality control.

• Discovery - contributing to discovery planning, and coordinating transition of projects from the discovery phase into preclinical and clinical development.

• Preclinical research - managing and interpreting animal and in vitro studies supportive of clinical development.

• Formulations development - providing key functional data distinguishing formulations.

• Clinical science and operations - designing clinical studies, ensuring their scientific soundness, and developing procedures to effectively implement the protocols and ensure their quality.

• Marketing - preparation of key messages and providing scientific support for marketing campaigns.

• Total project management - leading teams to make decisions in the team environment.

• Business development - making presentations and assisting with negotiations.

DR. GEDDE'S UNIQUE EDUCATION, TRAINING AND QUALIFICATIONS:

Dr. Gedde is an MD physician (licensed in two states) and holds a PhD in biophysical chemistry (both from Stanford University). Dr. Gedde also holds a BA in biochemistry from Columbia University and is a board certified clinical pathologist. She has also trained at a string of other world class institutions, including: Columbia University, Rockefeller University, the University of Pennsylvania, the University of California at Berkeley and Memorial Sloan-Kettering Cancer Institute. 

Dr. Gedde was also awarded a Howard Hughes Medical Institute Physician Postdoctoral Fellowship. 

She has also spent a dozen years conducting in-depth laboratory research in areas of microbiology, molecular biology, biophysics, biochemistry, protein chemistry, and models of disease in depth. Dr. Gedde is both devoted to and highly enjoys her work, and is thus willing and capable of performing excellent development work, even up to providing top-level performance working 18 hours, 7 days per week, if necessary, including holidays.

With such an extensive combination of skill sets and experience, Dr. Gedde is not only capable of being a great asset to any pharmaceutical company, but is also perfect for bringing together client companies with those seeking jobs or consulting work with them.

FULL BIO

Degrees and Licenses

• 1981 - B.A. Barnard College, Columbia University (Biochemistry) Cum Laude
• 1993 - M.D. Stanford University School of Medicine
• 1993 - Ph.D. Stanford University Department of Chemistry (Biophysical Chemistry)

Licensed to practice medicine in Arizona, Colorado, Hawaii, and Pennsylvania

Clinical Experience

1993 to 1997
University of Pennsylvania Medical Center, Philadelphia, PA
Resident and Clinical Instructor,
Division of Laboratory Medicine,
Department of Pathology and Laboratory Medicine

1994 to 1995
Chief Resident, Division of Laboratory Medicine

1997
Board Certification, Clinical Pathology

· Trained in all areas of the clinical laboratory (including molecular diagnostics, hematology, immunology, coagulation, transfusion medicine, microbiology and chemistry), with emphasis of diagnosis and therapy of leukemias and lymphomas.

· Worked with virtually all clinical services and therapeutic areas in the hospital through consultations, nightly call, and clinical rounds. Duties included administering transfusion therapies on the oncology and bone marrow transplant services.

· As Chief Resident, I led morning resident rounds, organized didactic and journal club series, and was liaison to the administration, facilitating two-way communication between faculty and residents. I addressed resident complaints and practiced conflict resolution. Organizational duties included planning resident schedules and budgeting program expenses.

· To improve the quality of the clinical pathology resident service, I spearheaded an initiative to completely revise the Clinical Pathology Resident On Call Manual, and negotiated the purchase of new computers.

· As Clinical Instructor, I taught General Pathology as well as advanced topics to medical students for three years, was invited to design and give a course on laboratory testing for nurses, and published two continuing education articles.

· In recognition of my research accomplishments, I was asked to speak as part of a departmental presentation to the new Chairman of the Board of Trustees of the University of Pennsylvania.

· Memorably, my Chief Resident counterpart in Anatomic Pathology and I recruited the help of the residency director and department chair to address tensions that had arisen between residents of different national backgrounds. Though some people we talked to thought we should stay away from the issue entirely, we believed that the best use of our roles was to address it openly. Our efforts culminated in a specially-called meeting of residents and faculty, where the tensions were resolved. I am proud that this resulted in a healthier working environment for all residents.

2003 – 2004
Solo General Practice, Maui, Hawaii

· Provided basic medical care in a small general practice, consulting with specialists and coordinating treatment as needed. Advocated for patient interests within established medical structures such as HMOs.

· Special interest in protocols for cleansing/detoxification and for neurotransmitter rebalancing, for patients experiencing chronic illness.

2004
Silky Skin Laser Spa, Maui, Hawaii
Medical Director

· Provided laser hair removal and other aesthetic treatments to client-patients in a relaxing and beautiful medical spa environment (see www.silkyskin.org).

· Worked hand-in-hand with owners to address medical-legal questions while developing a viable business model in the demanding Maui market.

· Developed and implemented a successful marketing program that included phone contacts, promotions, print and radio ads, door-to-door contact, and a web presence. Competitive edge was based on an innovative concept, a high degree of professionalism, and close attention to client needs.

· Clients showed high levels of loyalty; for example, after the owners chose to relocate the business in Colorado, one client elected to receive a follow up treatment at the new location, though it meant she had to travel from Maui to Colorado, and though numerous other practices offering the treatment were available to her.

Pharmaceutical Industry Experience

1999 to 2002
IntraBiotics Pharmaceuticals, Inc., Mountain View, CA
Department of Microbiology

9/99 to 9/00 Senior Scientist
10/00 to 6/01 Assistant Director
6/01 to 4/02 Director

· Responsible for the microbiology portions of anti-infective programs in clinical development. Devised integrated microbiology and clinical development plans and implemented them in a challenging team matrix environment.

· Initially, was responsible for two programs; after one year, all six clinical development programs were placed under my direction. Ultimately, I was promoted to Director of Microbiology and reported to the President.

· Programs encompassed two novel compounds (iseganan and ramoplanin) and six indications (Phase III: oral mucositis, prevention of VR-enterococcal bloodstream infections; Phase II: clearance of nasal staphylococcal colonization, prevention of ventilator-associated pneumonia; Phase I: treatment of cystic fibrosis pulmonary infections; Pre-IND: treatment of autism).

· Lead programs focused on treatment of side effects of cancer therapy, and included extensive efforts on three pivotal Phase 3 trials in bone marrow transplant patients at cancer centers across the US and in Europe.

· Worked with clinical colleagues to set protocols for sample and data collection that were scientifically valid yet practical and acceptable to patients and study staff. Developed customized data analysis plans for each indication.

· Developed relationships with investigators/coordinators through Investigator Meetings, site visits and regular phone contact. Worked directly with study sites and clinical investigators/coordinators to track and fine tune data collection protocols. Established metrics for analyzing site performance, and developed site-specific plans to improve study quality and timeliness.

· Directed large external contract laboratories to accomplish in vitro portions of clinical trial testing on time and within budget.

· Identified gaps in microbiology development programs and conveyed the importance of addressing them to management. Worked with internal decision makers to get budgeting, and recruited internal and external scientists to complete the work. Used program management tools such as integrated timelines to communicate with program teams about critical upcoming tasks.

· Achieved team consensus on complex, cross-disciplinary program issues. For example: effectively explained regulatory and commercialization risks associated with different anti-infective testing methods, despite misconceptions of some team members in this area, and got team and corporate support for work needed to address the issue.

· Synergized cross-functionally (with clinical science, clinical operations, regulatory, analytical chemistry, marketing) on numerous tasks needed to address FDA concerns and move programs forward.

· Wrote microbiology sections of clinical protocols and clinical study reports for current studies. Reworked past clinical study reports and investigator brochures for clarity, accuracy and appropriate levels of detail. Worked with regulatory and marketing to develop draft package inserts.

· Worked with leading academic collaborators to accomplish studies on mechanism of action, efficacy in animals, and bacterial ecology in humans. Communicated significance of findings to program teams. Developed relationships with industry thought leaders and obtained their opinions on key points of in vitro and in vivo development programs.

· Mentored five junior microbiologists while allocating and reallocating their efforts to support evolving program and corporate goals. Promoted three employees, one of them twice; one promotion was unprecedented in the company (promotion to Scientist rank of an employee who had talent and skill but no advanced degree). Documented the underperformance of one employee, and achieved her firing without incident.

· Upon a major company-wide restructuring, was asked to stay to head my department. Despite a 95% layoff of our division, retained a key employee based on the strength of our relationship, ensuring our ability to do future work.

· Made scientific and business presentations to external clients on two discovery-stage programs, leading to the programs being sold.

· Spearheaded a biowarfare grant application for use of inhaled iseganan against anthrax, and filed a provisional patent. Other program work resulted in authorship of one original research article and four poster presentations.

2002 to present
Pharmaceutical Development Consultants, LLC
President

· Pharmaceutical Development Consultants (PDC) provides pharmaceutical consulting services for drugs in all therapeutic areas and at all stages of development, with a specialty in the pre-clinical and clinical development of anti-infectives.

· Since its inception, PDC has designed and implemented clinical and non-clinical portions of development programs by working with sponsors within their team matrix environments and by managing third-party collaborators and contractors.

· Contracts are obtained through pre-existing strong working relationships and by developing new sponsor relationships. In all cases PDC works as champion for the pharmaceutical company in synergizing efforts of all players to achieve drug approval and marketing.

· Major programs have included oritavancin (a novel glycopeptide) and omiganan (a fast track anti-microbial peptide) both in Phase 3 clinical development for serious gram-positive infections.

· A key role has been as contact person for outside thought leaders. Developed new in vivo, in vitro and human study ideas with key external researchers to address FDA concerns and promote commercialization.

· Used creative experimental design to get needed information while remaining within budget and timeline; for example, worked with in vivo pharmacodynamics experts to efficiently determine antibiotic efficacy against resistant organisms. Conveyed pros and cons of proposed external studies to the sponsor, and managed relationships with external investigators when their goals and the sponsor’s did not coincide.

· Accomplished both specialized and routine testing needed to complete clinical trials by supervising and coordinating the sponsor’s multimillion dollar contracts with contract research organizations. Built on relationships previously established (Omnicare, Covance) and developed new ones with uniquely positioned contractors (Cognigen, Blaine Healthcare Associates).

· Assisted regulatory, marketing, clinical affairs and chemistry with multiple tasks, including determining FDA requirements, providing source publications, providing extensive data analysis, and writing documents for submission to the FDA.

· Spearheaded the NDA writing process for a sponsor that was experiencing high executive turnover. Led external contractors through steps of evaluating and organizing the material, writing the text, and reviewing and editing the section for our area of expertise.

· Detected a critical issue regarding antibiotic testing that had the potential to seriously damage a major program. After showing the sponsor the importance of the issue, gathered a group of 6 contractors to brainstorm the problem and develop data-based solutions. This led to the sponsor’s addressing the problem before irreversible damage was done.

Medical and Basic Science

1995 to 1997
University of Pennsylvania School of Medicine, Philadelphia, PA
Postdoctoral Fellow, Department of Microbiology

1997 to 1999
University of California at Berkeley, Berkeley, CA
Postdoctoral Fellow, Department of Molecular and Cell Biology
Advisor: Daniel A. Portnoy

1996 to 1999
Howard Hughes Medical Institute Physician Postdoctoral Fellow

· Demonstrated that the pH-dependence of listeriolysin O (a pore-forming toxin made by the intracellular pathogen Listeria monocytogenes) compartmentalizes the activity of this toxin and prevents premature destruction of the host cell. To accomplish this, purified and mutagenized listeriolysin O, exchanged mutant alleles into L. monocytogenes, and investigated effects of mutant and native protein expression in tissue culture and animal models. Collaborated synergistically with 3 other laboratory members on this work.

· The work resulted in 3 original research articles (2 as first author or equivalent), an oral platform presentation at a national meeting, 3 poster presentations at national and international meetings, and numerous other oral presentation venues including NIH Training Grant and School of Public Health seminar series, the UC Berkeley Molecular and Cell Biology departmental retreat, and the HHMI Annual Meeting of Fellows.

· In response to my competitive grant application titled “Structural Basis of the pH Dependence of the Bacterial Pore-Forming Toxin Listeriolysin O,” was awarded a Howard Hughes Medical Institute Physician Postdoctoral Fellowship (3 years of support). Was also supported by an NIH Infectious Diseases and Virology Training Grant.

· Spearheaded the laboratory safety program and personally trained each laboratory member with regard to biological, chemical, electrical, and radiation hazards. Trained, supervised and mentored an undergraduate student who subsequently went on to work in a biotech startup, and helped train 7 other graduate students, technicians, and postdocs.

· This postdoctoral work complemented my rigorous chemistry, biochemistry and biophysics training with hands-on experience in molecular biology and molecular genetics, equipping me to engage researchers from a huge range of disciplines in productive discussions and collaborations.

1986 to 1993
Stanford University, Stanford, CA
Graduate Student, Department of Chemistry
Thesis Advisor: Wray H. Huestis
Thesis: “Cell pH-Mediated Shape Change in the Human Erythrocyte”

· Solved the paradox of pH-associated red cell shape change by developing assays and mathematical models for red cell physiological relationships, performing nonlinear multivariate statistical analysis on a 500-entry dataset, and assessing red cell protein-membrane interactions using a hydrophobic, radioiodinated, photoactivatable membrane probe. Also, demonstrated the amphipathic nature of chlorpromazine binding to plasma membrane components.

· Collaborated synergistically with 2 other graduate students on this work.

· Supervised and mentored an undergraduate student on the red cell shape project, who subsequently went on to medical school. Made numerous research and journal articles presentations to laboratory and departmental groups. Was supported by a Jameson Research Foundation Fellowship.

· Relevant to psychopharmacology (action of neuroleptics and general anesthetics) and biophysical problems in general. Resulted in 4 poster presentations at national meetings and 5 original research articles, 4 as first author.

· My advisor thanked me for being a voice of calm and moderation in a group that included several nationalities and some difficult personalities.

1985 to 1986
Stanford University School of Medicine, Stanford, CA
Medical Student Research Assistant, Department of Neurology

· Developed a chromium-51 assay of damage to cultured neurons and used it to assess glutamate neurotoxicity. Was supported by a Kevin Walton Summer Fellowship. Relevant to stroke, epilepsy and trauma. Resulted in 2 original research articles, 1 as first author.

1984 to 1985
The Rockefeller University, New York, NY
Research Assistant, Laboratory of Metabolism/Pharmacology

· Performed clinical assays of hemoglobin synthesis pathway enzymes and intermediates using biochemical and organic chemical separations and assays. Relevant to in-born errors of metabolism and hepatic metabolic disorders.

1983 to 1984
Memorial Sloan-Kettering Cancer Center, New York, NY
Research Assistant, Laboratory of Developmental Genetics

· Studied the molecular basis of a murine developmental defect using tissue culture and protein chemistry approaches. Relevant to congenital disorders and to cancer.

Other Projects

· ABA Pharmaceutical Jobs (www.abapharmaceuticaljobs.com) and ABA Pharmaceutical Industry Headhunters (www.abapharmaceuticalindustryheadhunters.com), linked websites that comprise a web-based pharmaceutical referral service.

· HGH MD (www.hgh-md.com), an anti-aging / human growth hormone educational website.

· Development of an effective, competitive nutraceutical supplement for the anti-aging market, to reach the market by the end of 2004.

· SusPro (www.suspro.org), an educational non-profit organization dedicated to developing methods for sustainable housing, energy, and agriculture. I serve as donor and spokesperson for this inspiring and worthy organization. Activities include networking at local and regional functions, and contacting high-priority potential donors.

Honors and Awards

1985
Kevin Walton Summer Fellowship

1990 to 1992
Jameson Research Foundation Fellowship

1995 to 1996
Infectious Diseases and Virology Training Grant (NIH)

1996 to 1999
Howard Hughes Medical Institute Physician Postdoctoral Research Fellowship

Publications

Thesis
Gedde MM. 1993. Cell pH-mediated shape change in the human erythrocyte. Department of Chemistry, Stanford University.

Original Research Articles

1. Maulucci-Gedde M, Choi DW. 1987. Cortical neurons exposed to glutamate rapidly leak preloaded 51-chromium. Experimental Neurology 96:420-429.

2. Choi DW, Maulucci-Gedde M, Kriegstein AR. 1987. Glutamate toxicity in cortical cell culture. Journal of Neuroscience 7:357-368.

3. Gedde MM, Yang E, Huestis WH. 1995. Response of human erythrocyte shape to altered cell pH. Blood 86:1595-1599.

4. Mazzaccaro RJ, Gedde MM, Jensen ER, van Santen HM, Ploegh HL, Rock KL, Bloom BR. 1996. Major histocompatibility class 1 presentation of soluble antigen facilitated by Mycobacterium tuberculosis infection. Proceedings of the National Academy of Science, USA 93:11786-11791.

5. Gedde MM, Huestis WH. 1997. Membrane potential and human erythrocyte shape. Biophysical Journal 72:1220-1233.

6. Gedde MM, Davis DK, Huestis WH. 1997. Cytoplasmic pH and human erythrocyte shape. Biophysical Journal 72:1234-1246.

7. Gedde MM, Yang E, Huestis WH. 1999. Resolution of the paradox of red cell changes in low and high pH. Biochimica et Biophysica Acta 1417:246-253.

8. Gedde MM, Higgins DE, Tilney LG, Portnoy DA. 2000. Role of listeriolysin O in cell-to-cell spread of Listeria monocytogenes. Infection and Immunity 68:999-1003.

9. Glomski IJ,* Gedde MM,* Tsang AW, Swanson JA, Portnoy DA. 2002. The Listeria monocytogenes hemolysin has an acidic pH optimum to compartmentalize activity and prevent damage to infected host cells. Journal of Cell Biology 156:1 12.
*These authors contributed equally.

10. Baden LR, Critchley IA, Sahm DF, So W, Gedde M, Porter S, Moellering RC Jr, Eliopoulos G. 2002. Molecular characterization of vancomycin-resistant enterococci repopulating the gastrointestinal tract following treatment with a novel glycolipodepsipeptide, ramoplanin. Journal of Clinical Microbiology 40:1160 3.

11. Chen JY, Brunauer LS, Chu FC, Helsel CM, Gedde MM, Huestis WH. 2003. Selective amphipathic nature of chlorpromazine binding to plasma membrane bilayers. Biochimica Biophysica Acta (Biomembranes) 1616(1):95-105.

Continuing Education Articles

1. Gedde MM, Kricka LJ. 1994. Serum ferritin measurement: a case study approach to quality improvement. Endocrinology and Metabolism In-Service Training and Continuing Education 12(7): 179-183.

2. Gedde MM, Kricka LJ. 1994. Rhabdomyolysis. Endocrinology and Metabolism In-Service Training and Continuing Education 12(9): 241-246.

Abstracts

Dec 1989
American Society for Cell Biology, Houston, TX
Gedde MM, Huestis WH. “Roles of internal pH, cell volume, and membrane potential in human erythrocyte pH-induced shape change.” Journal of Cell Biology 109:175a.

Feb 1991
Biophysical Society, San Francisco, CA
Gedde MM, Huestis WH. “Human erythrocyte shape change induced by changes in buffer pH is most dependent on changes in cytoplasmic pH.” Biophysical Journal 59:639a.

Dec 1993
American Society for Cell Biology, New Orleans, LA
Gedde MM, Yang E, Huestis WH. “Hydrophobic protein-lipid associations in human erythrocyte cell pH-mediated shape change.” Molecular Biology of the Cell 4:85a.

Dec 1997
American Society for Cell Biology, Washington, D.C
Gedde MM, Higgins DE, Tilney LG, Portnoy DA. “Role of the pore-forming protein, listeriolysin O, in the cell-to-cell spread of Listeria monocytogenes.” Molecular Biology of the Cell 8:237a.

Dec 1998
American Society for Cell Biology, San Francisco, CA
Chen JY, Chu FC, Gedde MM, Huestis WH. "Selective electrostatic interactions of chlorpromazine with plasma membrane components." Molecular Biology of the Cell 9:80a.

Feb 1999
Biophysical Society, Baltimore, MD
Gedde MM, Portnoy DA. “Structural basis of the pH-dependence of the pore-forming protein listeriolysin O.” Biophysical Journal 76:22a.

Feb 2000
1st International ASM Conference on Enterococci, Banff, Alberta, Canada
So W, White DJ, Gedde MM. “Comparison of selective media for isolation of vancomycin-resistant enterococci.” February 27 to March 2, 2000.

Feb 2000
1st International ASM Conference on Enterococci, Banff, Alberta, Canada
Baden L, Critchley I, Sahm D, So W, Gedde MM, Porter S, Moellering RC Jr, Eliopoulos G. “Pulsed-field gel electrophoresis of VRE DNA isolated during a phase II clinical study of the novel glycolipodepsipeptide ramoplanin.” February 27 to March 2, 2000.

May 2000
American Society for Microbiology, Los Angeles, CA
Gedde MM, Glomski IJ, Portnoy DA. “The role of the acidic pH optimum of listeriolysin O in Listeria monocytogenes pathogenesis.” 100th General Meeting. Abstract D-59, p 239.

Sep 2000
Symposium on Pore-Forming Toxins, Trento, Italy
Glomski IJ, Gedde MM, Portnoy DA. “Increasing the hemolytic activity of listeriolysin O at neutral pH decreases the virulence of Listeria monocytogenes.” September 14-17, 2000.

Dec 2000
1st Intl Symposium on Resistant Gram-Positive Infections, San Antonio, TX
White DJ, Visweswaran V, So W, Hurst MA, Gedde MM. “Resistance profile of ramoplanin, a novel glycolipodepsipeptide with selective gram-positive activity.” December 3-5, 2000.

Oct 2001
North American Cystic Fibrosis Conference, Orlando, FL
Loury DL, Gedde MM, Woods DE. "Aerosolized protegrin analog iseganan (IB-367) reduces microbial density in a rat model of lung infection with Pseudomonas aeruginosa." October 25 28, 2001.

Patents

1. Gedde MM, Fujii CA. 2001. Use of cationic antimicrobial agents for the treatment and prevention of anthrax. Filed December 21, 2001.