AAIR Research Center is located in Rochester, NY, an area that has a tradition for supporting medical research. It is a division of Allergy Asthma Immunology of Rochester, P.C. a multi- specialty group practice, specializing in allergy, asthma, pulmonary, pain, and the rheumatic diseases. The practice was started in 1985 and has grown to include eight doctors, one nurse practitioner, one physician's assistant, and 4 locations. The practice is closely affiliated with a major teaching hospital. The Research Center has seven doctors and a physician's assistant who are all experienced in clinical trials. The center is headed by Dr. John J. Condemi who has been actively involved in research for 40 years. He has performed Phase 2, 3 and 4 pharmaceutical clinical trials and non-sponsored pharmaceutical research studies since 1969. Dr. Mariola Kubicka is the principal investigator in pediatric studies. Dr. Donald Pulver is the principal investigator for sinusitis studies. Drs. Peter Deane and Emmanuel Quaidoo have been principal investigators in both allergic and rheumatic disease studies. Dr. Albert Hartel is a sub-investigator in allergy and pulmonary studies .Dr. Anatole Kleiner is a sub-investigator in allergy, pulmonary, and rheumatic disease studies. All investigators are certified in the Human Subjects Protection Program at the University of Rochester Medical Center. Curricula vitae are available on request. The center employs an administrator to expedite regulatory applications, a regulatory assistant and four study coordinators three of which are certified by the Association of Clinical Research Professionals.
The Center has 2,400 sq. ft. of dedicated space, including four exam rooms. We can perform on site 8-12 hour studies, including studies requiring intravenous infusions. The center has the flexibility of being able to use a central IRB. Phlebotomy is done at the center and there is a laboratory on site. The Center has a centrifuge, -20° freezer, adequate locked refrigeration space for refrigerated study medication, and climate controlled locked drug storage. We make our own dry ice for frozen lab specimen shipment. Our center has a KoKo spirometer, Burdick EKG machine, and stadiometer. We have a fiberoptic rhinolaryngoscopy for sinusitis studies requiring antral punctures and sinus cultures. We are an AAAAI approved aeroallergen pollen and mold center. The medical center we are in is near an ambulatory care center where endoscopic and special procedures are performed. The center has a large database that draws on the private practice and volunteers from previous studies.
The Center has comfortable, spacious monitor accommodations. We
are conveniently located to the airport and area hotels.
John J. Condemi, M.D.
Medical Director of Research Center and Primary Principal
Investigator
Board Certified in Internal Medicine and Allergy and Immunology
Board Eligible in Rheumatology
Dr. Condemi has extensive experience in conducting clinical
trials. He has been actively conducting clinical trials since 1969.
He has been the principal or sub-investigator on approximately 350
trials. He has performed Phase II, III, and IV pharmaceutical
clinical trials and non-sponsored pharmaceutical research studies.
Dr. Condemi is one of the founding partners of Allergy Asthma
Immunology of Rochester, PC. He is a Fellow in the American Academy
of Allergy Asthma and Immunology (AAAAI), the American College of
Allergy Asthma and Immunology (ACAAI), American College of
Physicians (ACP), American College of Rheumatology (ACR) and is a
member of the New York Academy of Science. He has been and
currently is on the Boards of numerous organizations, has received
many awards for outstanding service. He has been elected by his
peers as one of the best doctors in America every year since 1976.
He has been recognized as one of America's well-known
specialists. He has served on several editorial boards and has
published many papers, abstracts, and chapters. Dr. Condemi's
therapeutic and research interests lie "wherever the immune
system goes".
Donald W. Pulver, M.D.
Principal Investigator for Sinusitis Studies and
Sub-Investigator in other therapeutic areas
Board Certified in Internal Medicine and Allergy and
Immunology
Dr. Pulver has conducted Phase II, III, and IV clinical trials
at AAIR since 1985. He became the principal investigator on
sinusitis trials in 1991 and continues as such. Dr. Pulver is one
of the founding partners of Allergy Asthma Immunology of Rochester,
PC. He is a fellow in the American Academy of Allergy and
Immunology (AAAAI), American College of Allergy and Immunology
(ACAAI), and the Joint Council of Allergy and Immunology. He has
been Chairman of the Aerobiology Committee for the American Academy
of Allergy Asthma and Immunology (AAAAI) and instructs workshops on
fiberoptic rhinolaryngoscopy at the AAAAI annual meetings. He was
the Chairman of the National Allergy Bureau of Aerobiology for
three years. Dr. Pulver is responsible for collecting, counting ,
and reporting the pollen counts in our area. His therapeutic and
research interests lie in acute and chronic sinusitis, rhinitis, allergy, and asthma.
Peter M.G. Deane, M.D.
Principal Investigator / Sub-Investigator
Board Certified in Internal Medicine, Allergy and Immunology, and Rheumatology
Dr. Deane is a graduate of the University of Rochester School of
Medicine and completed National Board of Medical Examiners
certification in 1990. He is board-certified in Allergy and
Immunology (by ABAI) and Rheumatology (by ABIM). He is also
certified in Clinical Densitometry (by ISCD).
Dr. Deane has conducted Phase II, III, and IV clinical trials at
AAIR since he joined in 1998. He is a fellow in the American
Academy of Allergy Asthma and Immunology (FAAAAI) and the American
College of Rheumatology (FACR). Dr. Deane is currently a peer
reviewer for the Journal of Allergy and Clinical Immunology and
Pediatrics. He has published several abstracts, articles, chapters
and co-authored a book Dr. Deane’s therapeutic and research
interest’s lie in allergy, asthma, clinical immunology and
rheumatic diseases.
Emmanuel A. Quaidoo, M.D.
Principal Investigator / Sub-Investigator
Board Certified in Internal Medicine, Allergy and Immunology, and
Rheumatology
Dr. Quaidoo has been conducting Phase II, III, and IV clinical
trials at AAIR since he joined the practice in 1998. He is a fellow
in the American Academy of Allergy Asthma and Immunology (AAAAI),
and a member of the Allergy Sub-Committee of the Rochester
Individual Practice Association. He has published a book chapter
and several abstracts and articles. Dr. Quaidoo's therapeutic
and research interests lie in allergy, asthma and rheumatic
diseases.
Mariola B. Kubicka, M.D.
Principal Investigator / Sub-Investigator
Board Certified in Pediatrics and Allergy and Immunology
Dr. Kubicka became involved in research in 1977 and has been
conducting Phase II, III, and IV clinical trials at AAIR since she
joined the practice in 2002. She is a fellow in the American
Academy of Allergy Asthma and Immunology (AAAAI) and American
Academy of Pediatrics. She has published several articles and is a
speaker for AAFA. Dr. Kubicka's therapeutic and research
interests lie in allergy and asthma.
Albert S. Hartel, M.D.
Principal/Sub-Investigator
Board Certified in Internal Medicine and Allergy and Immunology
Dr. Hartel has been involved in research since 2000 and has been
conducting Phase II, III, and IV clinical trials at AAIR since he
joined the practice in 2006. He is a fellow in the American Academy
of Allergy Asthma and Immunology (AAAAI) and the American College
of Allergy, Asthma and Immunology (ACAAI). He is a member of the
Finger Lakes Allergy Society. He received the first ever Resident
Excellence in Teaching Award. Dr. Hartel has published several
articles and has two research publications pending. Dr.
Hartel's therapeutic and research interests lie in allergy and
asthma.
Anatole K. Kleiner, M.D.
Principal/Sub-Investigator
Board Certified in Internal Medicine and Allergy and Immunology
Board Eligible in Rheumatology
Dr. Kleiner has been involved in research since 1995. He has been a sub-investigator for Phase II, III, and IV clinical trials since joining AAIR in 2008. He is a fellow in the American Academy of Allergy Asthma and Immunology (AAAAI), the American College of Rheumatology (ACR), and the American Medical Association (AMA). Dr. Kleiner has published several articles and abstracts. His therapeutic and research interests lie in allergy, asthma, and the rheumatic diseases.
Terry F. Arnold, PA-C
Sub-Investigator
Mr. Arnold has been conducting Phase II, III, and IV clinical
trials at AAIR since he joined the practice in 2007. He volunteers
at an area outreach center providing care to patients without
health insurance. He is a fellow of the National Committee on
Certification of Physician Assistants, American Academy of
Physician Assistants, New York State Physician Assistant Academy,
and the Rochester Region Physician Assistant Academy. Mr.
Arnold's research interests lie in allergy, pulmonary, and
rheumatic diseases.
Becky Ricotta, MS, CCRC
Research Administrator
Co-Chair ACRP Western New York Chapter
16 years of clinical research experience
Karen Blodgett, RN., CCRC
Study Coordinator
4 years of clinical research experience
Joyce Greenwood, LPN, CCRC
Study Coordinator
Co-Chair ACRP Western New York Chapter
10 years of clinical research experience
Rebecca Hazen, RN., CCRC
Study Coordinator
6 years of clinical research experience
Amy Wielgosz, RN, CRC
Study Coordinator
1 year of clinical research experience
Tina Champaigne, RA
Research Assistant
12 years clinical research experience
All staff excel in subject recruitment and provide
individualized attention to each of our subjects. Our staff is IATA
and ACRP certified. All staff is experienced in remote data entry
and electronic diaries. We have a regulatory specialist to expedite
regulatory applications and contract negotiations.
AAIR Research Center is located in Rochester, NY. The Rochester
area has a population of 1.2 million people. Rochester is the home
of the University of Rochester Medical Center, Rochester General
Hospital who has an affiliation with the Cleveland Clinic, Kodak,
Bausch & Lomb and Xerox. All these companies are continuously
conducting research. The Rochester population supports this
research and is very interested in its progress. Rochesterians are
educated in the importance of ongoing research and are excited to
participate as volunteers.
AAIR Research Center's database includes not only patients
who have participated in previous clinical trials, but also
patients from the AAIR practice. The practice has over 10,000
patients. There are 3,719 patient visits per month. On the average,
2,789 patients per month are treated with allergic and immunologic
problems and 930 patients are treated with rheumatic disease.
The characteristics of our patient population are as
follows:
- 40% male and 60% female
- 93% white and 7% minorities
- Of the pediatric population 50% is between the ages of 0-12 and
50% is between the ages of 13-18
- Of the adult population 50% is between the ages of 19-50, 40%
is between the ages of 51-75 and 10% is over 75 years of
age
