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M.
Gedde, MD, PhD, bio summary.

Dr.
M. Gedde MD, PhD is an award winning, broadly trained scientist and
traditional / holistic physician. Her background and experience are
totally unique, and includes being one of the top pharmaceutical
development specialists in the U.S.

  • Licensed
    to practice in 4 states including Maui Hawaii, Pennsylvania, Arizona & Colorado. 

  • MD
    and PhD from Stanford University. 


  • Licensed by the Drug Enforcement Administration for access to
    prescribing all classifications of FDA approved drugs.

  • Biophysical
    chemist PhD.

  • BA
    from Columbia University.

  • Board
    certified clinical pathologist.


  • Postdoctoral Fellowship, University of California, Berkeley.

  • Residency,
    Pathology & Laboratory Medicine, University of Pennsylvania.

  • Awarded
    a Howard Hughes Medical Institute Physician Postdoctoral
    Fellow. 


  • Pharmaceutical and Nutraceutical development director and
    consultant.

  • A
    dozen years total experience in molecular biology, microbiology,
    protein chemistry, biochemistry and biophysics.

  • Pioneer in


    brainwave entrainment via sound, light (including binaural
    "left/right" alternation and the Ganzfeld effect) & Electrical
    Current Stimulation while being monitored by a professional,
    including coupling and triggering the stimuli with biofeedback.

  • Hypnotherapy.
    Developer of the first copyrighted recordings by a medical
    professional, utilizing positive affirmations for self-help
    self-improvement. Created first recordings to utilize entrainment
    sounds, including binaural beats, Therasounds
    ™.
    Cds, tapes, and Mp3 downloads in public and professional therapist
    use versions. See
    www.hypnosis-tapes.org
    .


  • Additional research at a string of other world class institutions, including:

    • Rockefeller
      University

    • University
      of Pennsylvania

    • Sloan-Kettering
      Cancer Institute

  • Psychiatry
    training. Training in the influence, impact and effects of the mind
    (psychological factors) on the body. Psycho-physiology, the mind-body
    connection, etc.

  • Board
    certified clinical pathologist.

  • 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.

Both
a philanthropist and a capitalist, Dr. Gedde donates the maximum allowed
limit of her income to non-profit organizations (only ones who are
dedicated to helping people and in which ALL contributions go to their
projects, not management). One example is Suspro (Sustainability Project
http://www.suspro.org). They develop
and teach how to help yourself and the world through alternative energy,
sustainable shelter & agriculture / food growing – anywhere. 

She
also supports nonprofits that deal with personal growth / self-improvement /
non-denominational spirituality / education / adult & child abuse victims and
substance abuse organizations. This website is an example of non profit
medical education. She cannot financially contribute to any more at
this time, but is willing to give endorsements to good causes (no hgh
companies please). 


Her
doctoral and postdoctoral research work included in depth experience in
biochemistry, biophysics, protein chemistry, molecular biology, molecular
genetics, microbiology, and animal and cell culture models of disease.

As
a pharmaceutical director, Dr. Gedde worked closely with professionals in
all areas of the development process, including chemistry and
manufacturing, discovery, preclinical research, formulations development,
clinical science, clinical operations, regulatory affairs, quality
control, marketing, project management, and business development.

Dr.
Gedde also presently has sites for independent
pharmaceutical headhunting contract and employment (www.abapharmaceuticaljobs.com),

www.natural-hormone-balance.net
is available for pharma
development consultation via telecommuting, and is writing 3 books, one on
flu pandemic, one on easy positive and successful child raising, and
"Benjamin Franklin’s Secrets to Success". They will first be made
available via eBook. If you wish to be notified when they’re released or
free chapters are online, please sign up for the newsletter at
www.thegoldenrule.net.



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.

 

 

 

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©2002 HGH MD. All rights reserved.
Dr. M. Gedde, MD, PhD, President

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