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The founders of AllerQuest are authorities in the field of penicillin
drug allergy testing. We have published numerous scientific papers on
this topic and have been active in the research and development of
these reagents.
We are scientists, physicians, and pharmaceutical
manufacturing experts in the field of penicillin drug allergy testing.
Biographical Sketches of AllerQuest Management
Professional Advisors for AllerQuest, LLC:
Louis M. Mendelson, M.D. lmendelson@allerquest.com
President and CEO
Dr. Louis Mendelson attended Vanderbilt University and received his
M.D. from the Medical College of Virginia. He served his pediatric
internship and residency at the Bronx Municipal Hospital Center at
Albert Einstein School of Medicine in New York. Dr. Mendelson then
served two years in the U.S. Air Force. Upon completion of his
fellowship in allergy and immunology at the University of California
at San Diego, Dr. Mendelson moved to Hartford, Connecticut in 1972.
He is the senior partner in a private practice of allergy and
immunology consisting of seven allergists. He is Clinical Professor
of Pediatrics at the University of Connecticut School of Medicine and
Chief of Allergy and Immunology at the Connecticut Children's Medical
Center.
Dr. Mendelson has chaired and served on many committees of the
American Academy of Allergy, Asthma and Immunology (AAAAI), including
the committee on adverse drug reactions. Among his numerous honors,
in 2001 Dr. Mendelson was elected to the Board of Directors of the
AAAAI for a three-year term. Dr. Mendelson received the AAAAI
Distinguished Clinician Award for 2000, his work on penicillin allergy
being cited as one of the reasons for this prestigious honor.
Dr. Mendelson served as president of the Connecticut and New England
Allergy Society and was one of the organizers of the Regional, State,
and Local Allergy and Immunology Societies for the AAAAI. He has been
selected to Best Doctors in America from 1986 to 2004.
In 1984 Dr. Mendelson co-authored a study in which children and
adolescents with a history of penicillin allergy were electively skin
tested with PRE-PEN® and a new, analyzed, and stabilized MDM
preparation synthesized by Dr. Charlotte Ressler; the subjects were
subsequently challenged with oral penicillin and re-skin tested.3 This
pioneering approach underscored the fact that, when patients are well
and not in immediate need of penicillin, skin testing with a
combination of penicillin reagents is safe and non-sensitizing and
confirmed that it is a highly predictive diagnostic procedure in
individuals labeled as allergic to penicillin. In a soon-to-be
published study in which 5,000 patients with a history of penicillin
allergy were electively skin tested with PRE-PEN® and the Ressler
MDM preparation, more than 90% of the patients were found to be skin
test negative and able to tolerate oral penicillin without risk of a
severe allergic reaction.
In 2001 the FDA was prepared to take PRE-PEN® off the market. At
that time, at the request of the American Academy of Allergy, Asthma
and Immunology, American College of Allergy, Asthma and Immunology,
and Joint Council of Allergy, Asthma and Immunology, Dr. Mendelson and
Dr. Mark Dykewicz met with representatives of the FDA in a series of
meetings to convince them of the clinical importance of PRE-PEN®
and the clinical need for PRE-PEN® to remain on the market. The
FDA subsequently granted Hollister Stier a three-year extension to
continue to produce PRE-PEN® and to find a new manufacturer.
Among others, Dr. Mendelson has had a long-standing interest in
providing clinicians with a minor determinant mixture (MDM) skin test
preparation to evaluate patients with suspected penicillin allergy and
to prevent the erroneous labeling of patients as allergic to
penicillin.1-8 He has served as one of the consultants to the FDA, to
Kremers Urban, and, in the mid-1990's, to Schwarz Pharma in attempts
to bring MDM to the clinical arena. After PRE-PEN® had been
removed from the market in early 2004, Drs. Mendelson, Adkinson,
Ressler, and associates founded AllerQuest with the goal of
synthesizing and manufacturing PRE-PEN® and MDM and bringing these
penicillin skin test diagnostics to market. Dr. Mendelson and the
other founding members of AllerQuest are committed to the training of
future allergists and have agreed to give a percentage of the
company's profits to the Educational Research Trust of the AAAAI.
At AllerQuest Dr. Mendelson articulates the strategy of the company,
organizes a high caliber and effective management team, sets
milestones and enforces accountability for milestone achievement. He
is also responsible for overseeing the financial affairs of the
company.
Charlotte Ressler, PhD cressler@allerquest.com
Senior Vice-President, Research and Development
Dr. Ressler is Professor Emerita of Pharmacology at the University of
Connecticut School of Medicine. Dr Ressler received a B.A. magna cum
laude in chemistry at New York University and a Ph.D. in synthetic
organic chemistry at Columbia University. As a Research Associate and
then Assistant Professor in the Department of Biochemistry at Cornell
University Medical School she participated in the first elucidation of
the structure and synthesis of a polypeptide hormone, oxytocin. She
remained there as Established Investigator of the American Heart
Association, after which she moved to the new Institute of Muscle
Disease where she was Division Head of Protein Chemistry.
Dr. Ressler has been the recipient of four awards in chemistry and is
a member of Phi Beta Kappa. Dr. Ressler has served on various USPHS
and international study section review panels in medicinal chemistry,
and on the AAAAI committee for Adverse Drug Reactions and
Biologicals. She has also served as consultant to the FDA, the USDA,
and several drug companies, and has been an expert witness and
consultant on food toxins.
Dr. Ressler's long-range interests have been in the biochemistry of
sulfur, including transmethylation, a naturally occurring
transulfuration inhibitor in food, cystine-containing posterior
pituitary hormones, and penicillin transformation products. Her
synthetic experience includes the synthesis of peptides,
polylysine-drug conjugates, 9,10 amino acid surrogates, penicillin
minor determinants (MDM) and other chemicals of biological interest.
She is author or coauthor of 93 scientific publications, 32 on
synthesis, 17 on structure elucidation and purification of natural
products, 24 on metabolism and pharmacology, and 9 on penicillin 2-5
and sulfonamide 9,10 drug allergy.
As Professor of Pharmacology at the University of Connecticut School
of Medicine (UConn), in response to the clinical need for MDM brought
to her attention by Dr. Mendelson in 1975, she published in 1985 the
stabilization of the penicillin MDM skin test preparation. This study
demonstrated the instability of MDM components in solution and
described a stable, reproducible, and analyzed MDM, thereby avoiding
false negatives and increasing the safety of the penicillin skin
test. Based on this work, in 1989 she received an award and honorary
membership in the Ontario Allergy Society.
Dr. Ressler has 25 years of experience in the synthesis of
MDM. Initially, her MDM preparation was tested clinically by
Dr. Mendelson and his associates under UConn IRB in the early 1980's.
Ressler MDM has now been administered to close to 6000 patients in
Connecticut and Canada with excellent results.
In 1987-1989 Dr. Ressler was enlisted as consultant for the
development of Kremers- Urban MDM and provided the HPLC Certificate Of
Analysis for Schwarz Pharma-Kremers- Urban MDM. The patent
"Lyophilized MDM Composition and Method of Making It" issued to
Schwarz Pharma-Kremers-Urban in 1994 is a slight variation of her
method published in 1985. When production of PRE-PEN® had been
halted by the FDA in 2001, she advised Hollister-Stier on concerns
about the site producing PRE-PEN®.
Dr. Ressler has also been involved in studies of sulfa allergy. Her
laboratory developed a reagent to assess cross-reactivity among
sulfonamides and to probe sensitivity to sulfa-methoxoazole in vitro.
At AllerQuest Dr. Ressler has responsibility of training research and
development personnel in the synthesis and analysis of PRE-PEN® as
well as leading the development for manufacture of MDM and
subsequently other skin test reagents. She will also prepare the IND
document for MDM and assist with the NDA for MDM.
N. Franklin Adkinson, Jr., MD fadkinson@allerquest.com
Vice-President, Chief Medical Officer
Dr. Adkinson is considered one of the foremost authorities in drug
allergy. He was a Morehead Scholar and Honors graduate of the
University of North Carolina at Chapel Hill, after which he went to
Johns Hopkins for medical school and an Osler Residency in Internal
Medicine. After post-doctoral training in allergy and immunology at
the NIH, Dr. Adkinson returned to the Johns Hopkins Medical School
faculty where he has pursued an academic career with continuous NIH
funding since 1973. He has been Co-Director of the Division of
Allergy and Immunology, and is currently Training Program Director for
Allergy-Immunology and Professor of Medicine at the Johns Hopkins
Asthma & Allergy Center. He also initiated and now directs the
Graduate Training Program in Clinical Investigation which has trained
more than 50 academic physicians undertaking careers in clinical
research. He has held numerous positions in the American Academy of
Allergy, Asthma and Immunology (AAAAI), including a term on the Board
of Directors, as well as Chair of the Committee on Allergic Drug
Reactions. Dr. Adkinson is currently Managing Editor of the
authoritative two-volume text, Allergy: Principles and Practice, now
in its 6th edition, and is the current author of its chapter "Drug
Allergy."
Dr. Adkinson has co-authored more than 300 papers in the scientific
and medical literature, including 71 on drug hypersensitivity and 29
specifically dealing with allergy to beta lactam antibiotics (see
References 11-40). One of his first papers, written as an Intern on
the Osler Medical Service and published in the New England Journal of
Medicine in 1971, detailed the routine application of skin testing
with penicilloyl-polylysine (Pre-Pen®) and a penicillin minor
determinant mixture (MDM) on a general medical service.11 This seminal
study did much to establish the value of penicillin skin testing.
Throughout his career Dr. Adkinson has been a strong advocate of
penicillin skin testing, and he, along with others, has worked
continuously to encourage licensure of an MDM reagent. He was a
consultant to Kremers-Urban, the originators of Pre-Pen®, in the
1980's and early 90's and used their MDM preparation under a
physician-sponsored IND in more than 5000 patients in multiple
clinical trials.
At AllerQuest Dr. Adkinson is responsible for clinical trial design
and oversight in the development of MDM and potentially other drug
allergy diagnostics. He will lead the company's team interacting with
the FDA and other medical regulatory bodies, review and respond to any
reported adverse reactions, and interface with physician/prescriber
queries and comments. Dr. Adkinson will also assemble and coordinate
the company's application for SBIR funding for MDM product
development.
James D. Wolfe, MD jwolfe@allerquest.com
Vice-President, Scientific Affairs
Dr. Wolfe is Clinical Professor of Medicine, Stanford University
School of Medicine, Founder/President of Allergy
and Asthma Associates of Santa Clara Valley Research Center,
and until recently Chairman of the Division of Allergy-Immunology,
Santa Clara Valley Medical Center.
Dr. Wolfe earned his M.D. degree from U.C.S.F. Medical School in 1972
followed by pulmonary and allergy/immunology fellowships at
U.C.L.A. and Johns Hopkins. Dr. Wolfe is certified by the American
Board of Internal Medicine and by Boards in the sub-specialties of
Pulmonary Diseases and Allergy and Immunology. He is a fellow of the
American Academy of Allergy, Asthma and Immunology and the American
College of Chest Physicians, and is a member of Phi Beta Kappa and
Alpha Omega Alpha Honor Medical Society. Dr. Wolfe has published
extensively on new drug therapies for asthma and allergic diseases and
is a lead author of articles appearing in the New England Journal of
Medicine, Annals of Internal Medicine, JAMA, Chest and the Journal of
Allergy, Asthma and Clinical Immunology.
Dr. Wolfe is a senior partner in an allergy specialty medical practice
in the San Francisco Bay Area in which there are seven allergists, 75
employees and six offices. Dr. Wolfe has been selected Best Doctors
in America from 1996 to 2009.
Dr. Wolfe oversees a clinical research center in which over 250 phase
II-IV clinical drug trials have been conducted for numerous
pharmaceutical companies including Altana Pharma, AstraZeneca,
Aventis, Genentech, GlaxoSmithKline, Immunex, Merck, Novartis, Pfizer,
and Protein Design Labs. Dr. Wolfe has been a consultant to many of
the above companies in the clinical development of their products.
Clinical studies performed in Dr. Wolfe's research center have
contributed to the eventual FDA approval of many drugs currently
available for the treatment of allergies and asthma including Allegra,
Claritin, Advair, Alvesco and Xolair. Dr. Wolfe has expertise testing
patients for penicillin allergy with PrePen® and MDM dating back
to the 1970s when he first participated with Dr. N. Franklin Adkinson
in the clinical evaluation of patients with penicillin drug allergy.
At AllerQuest Dr. Wolfe is responsible for external relationships and
developmental partnerships, acquisitions and protection of
intellectual property, identifying and concluding agreements with
distributors in major markets, and assessment of the market potential
of future products.
Henry Elstein, ESQ.
Elstein & Elstein
Attorneys at Law
1087 Broad Street
Bridgeport, CT 06604
Attorney Elstein received his BA in 1956 and LLB degree in 1959 from
Yale University. He was admitted to the Connecticut Bar in 1959 and
the New York Bar in 1985. He is a member of the Connecticut, New
York, and American Bar Associations.
Attorney Elstein's areas of concentration are business organization,
contracts, and leasing and financing. Representative clients include
Autozone, Inc., Northeast Builders & Home Supply Centers, LLC, and
Scott Swimming Pools, Inc. Attorney Elstein has been counsel to
clients holding licenses on patents issued to Yale, Cornell, and
Tulane Universities.
Michael J. Caruso, CPA
Barron, Yanaros & Caruso
Certified Public Accounts
1160 Silas Deane Highway
Wethersfield, CT 06109
Michael J. Caruso, CPA, brings 25 years of experience to the
organization as an outside consultant. Mr. Caruso is a 1980 graduate
of the University of Hartford with a B.S. in Business Administration.
As a principal in the firm of Barron, Yanaros & Caruso, Mr. Caruso has
specialized in providing managerial, tax and accounting advice to
medical practice groups and business startups, with a focus on entity
organization and budgeting. Mr. Caruso is currently involved with the
American Academy of Allergy, Asthma and Immunology as a speaker in
their annual practice management workshops, speaking on "Understanding
the Financial Health of Your Practice," at their Chicago workshop in
2004, and as a planned speaker at their St. Louis workshop in 2005.
He is a member of the American Institute of Certified Public
Accountants and the Connecticut Society of Certified Public
Accountants.
Sudhakar S. Wagle, Ph.D.
10724 N. Essex Court
Mequon, WI 53092
Sudhakar S. Wagle, PhD, former Sr. Vice President for Research and
Development at Schwarz Pharma, is one of the original developers of
PRE-PEN® at Kremers-Urban. Dr. Wagle will serve as scientific
consultant for AllerQuest's manufacture of PRE-PEN®.
Michael J. Pikal, Ph.D. michael.pikal@uconn.edu
School of Pharmacy
University of Connecticut
372 Fairfield Rd
Storrs, CT 06269-2092
Dr. Pikal is Professor of Pharmaceutics, Pfizer Distinguished Chair in
Pharmaceutical Technology, and Director of University of Connecticut's
Center for Pharmaceutical Processing Research at the University of
Connecticut Storrs campus. He has been the recipient of many awards in
pharmaceutical science and is a recognized authority in freeze-drying
technology. Dr. Pikal will serve as scientific consultant for
AllerQuest's manufacture of penicillin MDM and other lyophilized
products.
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