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, Business Development

Dr. Wolfe is Clinical Professor of Medicine, Stanford University School of Medicine, Chairman of the Division of Allergy-Immunology, Santa Clara Valley Medical Center, and Founder/President of Allergy and Asthma Associates of Santa Clara Valley Research 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, 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 2007.

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, 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.

Richard Bauer, PhD, MBA   rbauer@allerquest.com
Associate Vice-President, Director of Regulatory Affairs and Chief Operating Officer

Dr. Bauer received his degree in analytical chemistry from the University of New Hampshire. He has 15 years of international experience in the pharmaceutical industry. His expertise is in Quality Control, Quality Assurance, Stability, Clinical Supplies Manufacturing and Analytical Development for both APIs (Active Pharmaceutical Ingredients) and Finished Products. Dr. Bauer has contributed to the CMC (Chemistry, Manufacturing, and Controls) section of numerous CTAs (Clinical Trial Authorizations), IMPDs (Investigational Medicinal Product Dossier), INDs (Investigational New Drugs) and NDAs (New Drug Applications). As Director of Quality for Bayer Pharmaceuticals he implemented Quality Systems, Annual Product Reviews, and Technical Complaints programs and had the responsibility for releasing all products for the US market.

Dr. Bauer interacted frequently with regulatory agencies for Pre-Approval Inspections, FDA Annual Inspections, and European Audits. He established Quality Agreements and Contract Manufacturing Agreements with partners that include Johnson and Johnson, Pfizer, Pharmacia-Upjohn, Alza, Baxter, Abbott, and Cardinal Health.

At AllerQuest Dr. Bauer's experience in Quality Assurance will be used to ensure the quality of all released product. He maintains all production records, stability documents, and other GMP documentation. He prepares the NDA document and updates it and the IND as required by the FDA. Dr. Bauer is also responsible for the daily operations of the company, including payroll, taxes, purchasing, billing, invoicing, and handling and monitoring technical complaints.

Brendan Murphy, BS, MS, MBA   bmurphy@allerquest.com
Assistant Vice-President, Contract Manufacturing

Mr. Murphy received his BS in Mechanical Engineering and MBA from the University of Massachusetts and an MS in Finance from Fairfield University. Mr. Murphy has 13 years of experience in the pharmaceutical industry and has worked in both a large pharmaceutical setting, at Bayer AG, as well as in contract manufacturing, at Armstrong Pharmaceuticals.

Armstrong Pharmaceuticals is a contract manufacturer for aerosols specializing in meter dose inhalers for respiratory therapy. Clients included Astra (Astra-Zeneca), Barre-National (Alpharma), Boehringer-Ingelheim, Dupont, Merck, Rhone Poulenc Rohrer (Aventis) as well as many other pharmaceutical companies. During his nine-year tenure there he held various positions of increasing responsibility including compounding chemist, maintenance supervisor, and department manager for both compounding and maintenance, as well as engineering manager. He was also a member of the Executive Steering Committee at Armstrong Pharmaceuticals. Since joining Bayer's pharmaceutical division in 2000, Mr. Murphy has been the plant engineer for Bayer's oral solid dosage facility. He served as the project engineer for a $2.8 million, high speed bottle packaging line. Mr. Murphy provided the engineering support for three product launches. He also supported the day-to-day operation of both bottle packaging and blister packaging operations. After Bayer AG announced its corporate restructuring, he worked on teams to support the successful transfer of the packaging operations to other Bayer facilities and contract manufacturers. He recently was selected to join Bayer's Specialty Pharmaceutical Group, whose primary focus will be oncological and cardiovascular products, to support the research facilities in West Haven, CT.

At AllerQuest Mr. Murphy interfaces with the contract manufacturers. He is responsible for overseeing the manufacture of the penicillin skin test products. His functions include selecting equipment and writing manufacturing batch records and protocols for equipment and process validation.

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.