UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ETON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`Patent Owner
`
`Case PGR2020-00086
`Patent No. 10,653,719
`
`DECLARATION OF DR. ROBERT J. KUHN
`
`1
`
`EXELA 2001
`Eton Pharmaceuticals v. Exela Pharma Sciences
`PGR2020-00086
`
`

`

`
`I, Dr. Robert J. Kuhn, declare as follows:
`
`1. My name is Dr. Robert J. Kuhn. I am over the age of twenty-one (21)
`
`years, and I am competent to testify to the matters stated herein.
`
`2.
`
`I have been asked by Fish & Richardson P.C. on behalf of Exela
`
`Pharma Sciences, LLC (“Exela”) to provide this declaration in the matter of the
`
`Post Grant Review of U.S. Patent No. 10,653,719 (the “’719 patent”).
`
`3.
`
`I am being compensated for my work in connection with this IPR
`
`proceeding at a rate of $400/hour for preparation of my declaration. My
`
`compensation is not in any way contingent on the substance of my opinions or the
`
`outcome of these proceedings.
`
`I.
`
`4.
`
`ASSIGNMENT
`
`I have been asked to review the Sandoz Label (Ex. 1005) and
`
`calculate the daily aluminum exposure that would result from use of a product
`
`associated with the Sandoz Label, and according to the Dosage and Administration
`
`instructions in the Sandoz Label, for patients receiving total parenteral nutrition
`
`(TPN) containing that product. I have also been asked to comment on whether it
`
`would have been possible to prepare a TPN solution for a patient that provides a
`
`maximum daily aluminum exposure of no greater than 5 mcg/kg/day if that TPN
`
`solution used as a component a product associated with the Sandoz Label. I have
`
`further been asked to comment whether an L-cysteine hydrochloride composition
`
`
`
`2
`
`

`

`with no more than 250 mcg/L1 aluminum could be used in a TPN composition to
`
`provide a maximum daily aluminum exposure of no greater than 5 mcg/kg/day.
`
`II. EXPERIENCE AND QUALIFICATIONS
`
`5.
`
`I received a Bachelor of Science degree in Pharmacy from the Ohio
`
`State University in 1980. I received my Doctorate in Pharmacy from the
`
`University of Texas at Austin and University of Texas Health Science Center in
`
`1984. In 1985, I completed an ASHP Pediatric Pharmacotherapy Fellowship at
`
`Children’s Hospital in Columbus, Ohio. I have worked as a practicing pharmacist
`
`since 1981.
`
`6.
`
`I am currently the Kentucky Hospital Association Endowed Professor
`
`in the Department of Pharmacy Practice and Science at the College of Pharmacy at
`
`the University of Kentucky. I am also a professor in the Division of Pediatric
`
`Pulmonology in the Department of Pediatrics at the University of Kentucky. In
`
`2017, I became a fellow of both the American Society of Health Systems
`
`Pharmacists and the American Association of Clinical Pharmacy.
`
`7.
`
`I am also currently a practicing Pediatric Clinical Pharmacist at the
`
`Kentucky Children’s Hospital at the University of Kentucky, where I also served
`
`as the Associate Director of Pharmacy Services from 2008 to 2012. My current
`
`duties as Pediatric Clinical Pharmacist include compounding parenteral nutrition
`
`
`1 The unit mcg/L is equivalent to the unit ppp or “parts per billion.”
`
`
`
`3
`
`

`

`(PN) solutions for pediatric and infant patients. I have over 38 years of experience
`
`in compounding PN solutions, including for neonatal, pediatric, and adult patients.
`
`In my capacity as a Pediatric Clinical Pharmacist, I work directly with the
`
`pediatricians responsible for the care of patients in need of PN solutions. In our
`
`hospital, pharmacists start the form orders for PN solutions and, in some cases,
`
`write the order for the PN solution under the pediatrician’s authority. Ultimately,
`
`pharmacists are responsible for making sure the components added to the PN
`
`solutions are compatible, calculating the risk of toxicity from the components of
`
`the PN solution, and ensuring the sterility of the PN solution. I thus have
`
`substantial experience and knowledge in the standard PN solutions given to infants
`
`in need of PN solutions, including the components used to create a standard PN
`
`solution and the historical high levels of aluminum in many of those components,
`
`as well as the aluminum content in compounded PN solutions.
`
`8.
`
`In addition to my teaching and clinical responsibilities, I have also
`
`engaged in pharmacy research relating to aluminum contamination in PN solutions
`
`and methods for removing aluminum from such solutions.
`
`9.
`
`A more complete recitation of my professional background and
`
`expertise is provided in my curriculum vitae, attached here as Exhibit A.
`
`
`
`4
`
`

`

`III. OVERVIEW OF PN COMPOSITIONS AND THEIR USE
`
`10. Parenteral nutrition (PN) refers to the intravenous administration of
`
`nutrients including amino acids, electrolytes, carbohydrates, and optionally lipids.
`
`If a patient receives all of their nutrients intravenously, this is referred to as total
`
`parenteral nutrition (TPN). TPN solutions are administered intravenously over a
`
`24 hour period.
`
`11. TPN solutions are compounded daily from multiple components. The
`
`process for compounding a TPN solution starts with a prescription for the various
`
`nutrients that the infant patient requires. A pediatric pharmacist like myself will
`
`then take that prescription, and with the assistance of a computer program,
`
`calculate the concentration of the various components needed to provide the
`
`prescribed dosages.
`
`12. There are standard components that are included in the majority of
`
`TPN solutions for infants. Those standard components include a mixture of amino
`
`acids (not including L-cysteine), dextrose, sodium chloride, sodium phosphate,
`
`potassium chloride, potassium phosphate, calcium gluconate, magnesium sulfate,
`
`zinc chloride, trace elements solution, selenium, pediatric vitamins solution,
`
`heparin, levocarnitine, and L-cysteine. Infant patients may also receive lipids as
`
`part of a TPN regimen, but those are separated from the other components prior to
`
`administration because of a risk of fungal contamination.
`
`
`
`5
`
`

`

`13. A mixture of amino acids are included in TPN solution for protein
`
`synthesis. Ideally, an infant patient would receive 4g of amino acids per kg of
`
`infant weight per day. Because infant patients may not be able to tolerate 4g/kg
`
`initially, we often start them with a lower dose of amino acids and then increase to
`
`as close to 4g/kg as possible. This ramp-up period to 4g/kg of amino acids
`
`generally takes a matter of two to three days, and the faster the better.
`
`14. L-cysteine is another essential amino acid that is separately included
`
`in TPN solutions for infant patients, provided as a solution of L-cysteine
`
`hydrochloride.
`
`15. One concern associated with TPN treatment for infants is aluminum
`
`contamination of many of the components used to compound the TPN solutions.
`
`Infants are at an increased risk of aluminum toxicity because of anatomic,
`
`physiologic, and nutrition-related factors not present in other populations. In 2004,
`
`the Food and Drug Administration recommended restricting daily aluminum
`
`administration to 5 mcg/kg/day and issued a rule requiring that additives used to
`
`compound TPN have the maximum aluminum content at expiration listed on the
`
`product label. Although the pharmacist can work to decrease the risk of aluminum
`
`toxicity in this population by selecting components with the lowest labeled
`
`aluminum concentrations, for years it remained difficult if not impossible to stay
`
`under this ceiling. For example, prior to 2019, the only L-cysteine hydrochloride
`
`
`
`6
`
`

`

`product available for use in compounding TPN solutions was an unapproved 50
`
`mg/mL solution of L-cysteine hydrochloride distributed by Sandoz that was
`
`labeled to contain up to 5,000 mcg/L of aluminum. I was concerned by the
`
`maximum aluminum level for this product, but there were no alternative sources of
`
`L-cysteine hydrochloride with a lower aluminum level. Recently, Exela’s L-
`
`cysteine hydrochloride product, ELCYS®, which is labeled as having a much
`
`lower maximum aluminum concentration (120 mcg/L), was introduced to the
`
`market. This was an extremely important advance in the availability of low-
`
`aluminum TPN components, which has enabled pharmacists to compound TPN
`
`solutions for infants with significantly lower daily aluminum levels.
`
`IV. THE SANDOZ LABEL (EX. 1005)
`
`16.
`
`I have reviewed Ex. 1005 (the “Sandoz Label”), which comprises the
`
`package insert and container labeling for an L-Cysteine Hydrochloride Injection,
`
`USP 50 mg/mL product (the “Cysteine HCl Product”).
`
`17. The package insert’s Indications and Usage section states: “L-
`
`Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an
`
`additive to Crystalline Amino Acid Injections to meet the intravenous amino acid
`
`nutritional requirements of infants receiving total parenteral nutrition.” (Ex. 1005
`
`at 2.)
`
`
`
`7
`
`

`

`18. The package insert’s Dosage and Administration section states in
`
`relevant part: “L-Cysteine Hydrochloride Injection USP is intended for use only
`
`after dilution in Crystalline Amino Acid Injection. Each 0.5 gram of L-Cysteine
`
`Hydrochloride Monohydrate should be combined aseptically with 12.5 grams of
`
`Crystalline Amino Acid Injection, such as that present in 250 mL of 5%
`
`Crystalline Amino Acid Injection.” (Ex. 1005 at 3.)
`
`19. The package insert also includes the following Warning: “This
`
`product contains aluminum that may be toxic. Aluminum may reach toxic levels
`
`with prolonged parenteral administration if kidney function is impaired. Premature
`
`neonates are particularly at risk because their kidneys are immature, and they
`
`require large amounts of calcium and phosphate solutions, which contain
`
`aluminum. Research indicates that patients with impaired kidney function,
`
`including premature neonates, who receive parenteral levels of aluminum at greater
`
`than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central
`
`nervous system and bone toxicity. Tissue loading may occur at even lower rates of
`
`administration.” (Ex. 1005 at 2.)
`
`20. The package labeling states: “Contains no more than 5,000 mcg/L of
`
`aluminum.” (Ex. 1005 at 5.) “5,000 mcg/L” corresponds to 5,000 ppb.
`
`21. A pharmacist, like myself, calculating the potential aluminum
`
`exposure for a patient receiving TPN solution that uses the Cysteine HCl Product
`
`
`
`8
`
`

`

`would use the 5,000 mcg/L aluminum concentration to do so. The package label
`
`expressly teaches the product could contain up to 5,000 mcg/L of aluminum, and
`
`any prudent pharmacist would use that maximum aluminum level to calculate
`
`potential aluminum exposure so as to not underestimate the content of the potential
`
`for aluminum toxicity.
`
`22. As a pharmacist, I understand from the literature on PN components
`
`and my own research and experience that for L-cysteine hydrochloride solutions
`
`packaged in glass the aluminum content will increase over time, including through
`
`the product’s expiration, which is typically 24 months after manufacture. Ideally,
`
`L-cysteine hydrochloride solutions with a longer remaining shelf life would be
`
`used for neonatal patients because their aluminum levels might be lower than
`
`products with a shorter remaining shelf life (i.e., closer to their expiration date).
`
`However, in the past when L-cysteine hydrochloride solutions had been in
`
`shortage, pharmacists had to use what was available, including solutions that were
`
`near expiration.
`
`23. Given this phenomenon of increasing aluminum content over time, for
`
`the sake of patient exposure and safety, pharmacists like myself have to assume the
`
`aluminum concentration of an L-cysteine hydrochloride product is the maximum
`
`aluminum content as stated on the container label. That means that for the
`
`Cysteine HCl Product, we must consider the aluminum content to be 5,000 mcg/L,
`
`
`
`9
`
`

`

`as stated on the Sandoz Label. To do otherwise would not be safe, particularly
`
`when considering that neonates receiving TPN solutions are at a high risk for
`
`aluminum toxicity.
`
`24. Based on this, and as I demonstrate below, the Cysteine HCl Product
`
`would be understood by clinicians like myself to deliver up to 14 mcg/kg/day to
`
`an infant receiving TPN, because of the maximum aluminum content stated on the
`
`container labeling. In other words, clinicians would understand that the Cysteine
`
`HCl Product alone (i.e., setting aside the aluminum contribution of the other TPN
`
`components) may deliver levels of aluminum that vastly exceed FDA’s
`
`recommended 5 mcg/kg/day aluminum exposure limit for these fragile patients
`
`with impaired kidney function. .
`
`V. CALCULATION OF DAILY ALUMINUM EXPOSURE BASED
`ON THE DOSING AND ADMINISTRATION INSTRUCTIONS
`IN THE SANDOZ LABEL
`
`25. According to the Dosage and Administration section of the Sandoz
`
`Label’s package insert (Ex. 1005 at 3), “[e]ach 0.5 gram of L-Cysteine
`
`Hydrochloride Monohydrate should be combined aseptically with 12.5 grams of
`
`Crystalline Amino Acid Injection such as that present in 250 mL of 5% Crystalline
`
`Amino Acid Injection.” This teaches a ratio of 0.5 g L-cysteine hydrochloride
`
`(“Cys HCl”) to 12.5 g of Amino Acids (“AA”), or 0.04 grams Cys HCl /1 gram
`
`AA:
`
`
`
`10
`
`

`

`0.5 g Cys HCl
`12.5 g AA
`
` =
`
`0.04 g Cys HCl
`1 g AA
`
`
`
`26. Next, one must convert this ratio to milligrams of L-cysteine
`
`hydrochloride per gram of AA:
`
`0.04 mg Cys HCl
`12.5 g AA
`
` x (
`
`1000 mg
`g
`
`) =
`
`40 mg Cys HCl
`1 g AA
`
`
`
`27.
`
`In the next step, one must determine the volume of the 50 mg/mL
`
`Cysteine HCl Product that corresponds to 40 mg of L-cysteine hydrochloride,
`
`which is accomplished by simple division to give 0.8 mL of solution.
`
`40 mg Cys HCl ∗
`
`1 ml
`50 mg Cys HCl
`
`= 0.8 mL Cysteine HCl Product
`
`
`
`28. Plugging this into the above Cys HCl:AA ratio shows that 0.8 mL of
`
`the 50 mg/mL Cysteine HCl Product should be administered with every gram of
`
`Amino Acid:
`
`0.8 mL Cysteine HCl Product
`1 g AA
`
`
`
`29. As described above, it is standard TPN prescribing procedure for an
`
`infant to ramp up quickly to a dose of between 3.5 and 4 g AA/kg/day, with 3-3.5
`
`g/kg/day being the typical prescription. Multiplying the 3.5 g AA/kg/day by 0.8
`
`mL/g AA gives a daily dosage volume of the Cysteine HCl Product of 2.8
`
`mL/kg/day:
`
`
`
`11
`
`

`

`3.5 g AA kg⁄
`
`day⁄
`
`∗
`
`0.8 mL Cysteine HCl Product
`1 g AA
`
`= 2.8 mL Cysteine HCl Product/kg/day
`
`
`
`30. The Sandoz Label discloses that the Cysteine HCl Product contains no
`
`more than 5,000 mcg/L of aluminum (Ex. 1005 at 5). Converting the aluminum
`
`concentration to mcg/mL and multiplying that concentration by the 2.8 mL/kg/day
`
`gives a daily aluminum exposure of 14 mcg/kg/day attributable solely to the
`
`Cysteine HCl Product.
`
`5,000 mcg Al
`1 L
`
`∗
`
`1L
`1000 mL
`
`∗ 2.8 mL Cys HCl Product kg⁄
`
`day⁄
`
`= 𝟏𝟒 𝐦𝐜𝐠 𝐀𝐥/𝐤𝐠/𝐝𝐚𝐲
`
`
`
`VI.
`
`IT IS NOT FEASIBLE TO PREPARE TPN SOLUTIONS FOR
`INFANTS THAT CONTAIN NO MORE THAN 5
`MCG/KG/DAY OF ALUMINUM USING THE CYSTEINE HCL
`PRODUCT
`
`31. A daily aluminum exposure of 14 mcg/kg/day significantly exceeds
`
`the Sandoz Label’s warning not to exceed parenteral levels of aluminum greater
`
`than 4 to 5 mcg/kg/day in patients with impaired kidney function. This is
`
`worsened by the fact that L-cysteine hydrochloride is only one of many
`
`components of a TPN solution, the majority of which further contribute to the daily
`
`aluminum exposure of the patient. Based on the Sandoz Label, it would not be
`
`possible for a pharmacist to compound a TPN solution for an infant patient
`
`containing the Cysteine HCl Product that complies with the Sandoz Label’s
`
`
`
`12
`
`

`

`warning.2 It is therefore quite obvious to me and my peers that the maximum
`
`aluminum levels in L-cysteine hydrochloride solutions would need to be very
`
`drastically reduced in order to prepare aluminum-compliant TPN solutions.
`
`32. Unfortunately, for years pharmacists had no choice but to compound
`
`TPN solutions with aluminum content that exceeded the 5 mcg/kg/day upper limit,
`
`in part due to the fact that the only L-cysteine hydrochloride solution available
`
`contained up to 5,000 mcg/L aluminum. The risk of withholding L-cysteine from
`
`neonatal and infant patients who received TPN exceeded the risk of exposing them
`
`to the aluminum levels described in the Sandoz Label. As a result, neonatal and
`
`infant patients received TPN solutions with very high aluminum content when the
`
`high-aluminum Cysteine HCl Product was the only option available.
`
`VII. AN L-CYSTEINE HCL PRODUCT WITH NO MORE THAN
`250 PPB OF ALUMINUM WOULD ALLOW A PHARMACIST
`TO PREPARE TPN SOLUTIONS FOR INFANTS THAT
`CONTAIN NO MORE THAN 5 MCG/KG/DAY OF
`ALUMINUM
`
`33. The same process used above can be used to calculate the daily
`
`aluminum exposure from a theoretical L-cysteine hydrochloride solution with a
`
`lower maximum aluminum concentration to determine if it could be used to
`
`compound a TPN solution that could comply with the 5 mcg/kg/day upper limit for
`
`
`2 Ex. 2012 Poole, RL, Schiff L, Hintz SR, Wong A, Mackenzi N, Kerner JA Jr.
`Aluminum exposure from pediatric parenteral nutrition: meeting the new FDA
`regulation. JPEN J Parenter Enteral Nutr 2008;32:242-6.
`
`
`
`13
`
`

`

`aluminum. Assuming the same parameters above for daily dose and concentration
`
`of L-cysteine hydrochloride, one can calculate the daily aluminum exposure from a
`
`theoretical L-cysteine hydrochloride product that contains 250 mcg/L of aluminum
`
`would be 0.7 mcg/kg/day:
`
`250 mcg Al
`1 L
`
`∗
`
`1L
`1000 mL
`
`∗ 2.8 mL Cys HCl sol′n/kg/day = 0.7 mcg/kg/day Al
`
`34. Based on this calculation and my professional experience, it would be
`
`possible for a pharmacist to compound a TPN solution for an infant patient that
`
`does not exceed 5 mcg/kg/day of aluminum using a theoretical L-cysteine
`
`hydrochloride product with no more than 250 ppb of aluminum.
`
`35.
`
`In my decades of experience in the field of clinical pharmacy, the first
`
`and only L-cysteine hydrochloride solution that has made this feasible is ELCYS®,
`
`which is labeled to contain no more than 120 mcg/L of aluminum. (ELCYS Label
`
`§ 11.)
`
`
`
`
`
`
`
`
`
`14
`
`

`

`36.
`
`I hereby declare that all statements made are of my own knowledge
`
`and are trne. I further declare that these statements were made with the laiowledge
`
`that willful false statements are punishable by tine or imprisonment, or both, under
`
`Section 1001 of the Title 18 of the United States Code and that sueh willful false
`
`statements may jeopardize the validity of this proceeding.
`
`Date: リ5 岛2(
`
`Respectfully submitted.
`与#*c .一.
`RoberMjKuhn, PharmD
`
`15
`
`

`

` 
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` 
` 
` 
` 
` 
` 
`
`EXHIBIT A 
`
`EXHIBIT A
`
`16
`
`16
`
`

`

`Robert Joseph Kuhn
`Curriculum Vitae
`
`August 2019
`
`Pharmacy Practice & Science
`College of Pharmacy
`University of Kentucky
`789 S Limestone Street BPC 233
`Lexington KY 40536-0569
`Telephone: 859-323-6970
`Fax: 859-323-0069
`
`October 10, 1954
`
`KY: 9215
`OH: 03-21-4012
`
`
`
`
`GENERAL INFORMATION:
`Home Address:
`116 Foaling Ridge Lane
`
`
`
`Lexington KY 40356-8855
`
`
`
`Telephone: 859-219-8470
`
`
`
`Email: rjkuhn1@email.uky.edu
`
`Office Address:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Birthdate:
`
`License Number:
`
`
`
`
`Marital Status:
`
`Children:
`
`
`
`
`
`EDUCATION AND TRAINING:
`1976 University of Steubenville, Steubenville, OH
`
`Bachelor of Art in Philosophy
`
`1980 Ohio State University, Columbus, OH
`
`Bachelor of Science in Pharmacy
`
`1984 University of Texas at Austin and University of Texas
`
`Health Science Center at San Antonio, Austin, TX
`
`Doctor of Pharmacy
`
`1985 Children’s Hospital, Columbus, Ohio
`
`ASHP Pediatric Pharmacotherapy Fellowship
`
`
`
`
`
`
`Married to Janet Goshe Kuhn
`
`Matthew Joseph
`Nicholas Robert
`
`Birthdate: September 16, 1985
`Birthdate: June 9, 1989
`
`
`
`1
`
`17
`
`

`

`ACADEMIC APPOINTMENTS:
`
`2013-
`
`
`
`Kentucky Hospital Association Endowed Professor
`Department of Pharmacy Practice and Science
`College of Pharmacy
`
`1998 – Present
`
`1998 – Present
`
`1995 – 2003
`
`1994 – Present
`
`1991 – 1998
`
`1991 – 1998
`
`1988 – 1991
`
`1985 – 1991
`
`Division of Pediatric Pulmonology
`Department of Pediatrics
`University of Kentucky
`Lexington, KY
`
`Pharmacy Practice & Science
`College of Pharmacy
`University of Kentucky
`Lexington, KY
`
`Ambulatory Care
`Pharmacy Practice & Science
`College of Pharmacy
`University of Kentucky
`Lexington, KY
`
`Graduate School
`University of Kentucky
`Lexington, KY
`
`Department of Pediatrics
`College of Medicine
`University of Kentucky
`Lexington, KY
`
`Pharmacy Practice & Science
`College of Pharmacy
`University of Kentucky
`Lexington, KY
`
`Department of Pediatrics
`College of Medicine
`University of Kentucky
`Lexington, KY
`
`Pharmacy Practice & Science
`College of Pharmacy
`University of Kentucky
`
`2
`
`Professor
`
`Professor
`
`Vice Chair
`
`Faculty
`
`Associate Professor
`
`Associate Professor
`
`Assistant Professor
`
`Assistant Professor
`
`18
`
`

`

`
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`
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Lexington, KY
`
`
`Pediatrics Infectious Disease
`Rotation Doctor of Pharmacy Program
`Ohio State University
`Columbus, OH
`
`Part-time Co-Preceptor
`
`Clinical Instructor
`
`Graduate Teaching Assistant
`
`Associate Director/Pharmacy
` Services
`
`Pediatric Clinical Pharmacist
`
`
`Part-time Pharmacist
`
`Part-time Pharmacist
`
`Part-time Pharmacist
`
`Part-time Pharmacist
`
`Part-time Pharmacist
`
`Staff Pharmacist
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1984 – 1985
`
`
`
`
`
`
`
`1984 – 1985
`
`
`
`
`
`1983 – 1984
`
`
`
`
`ADMINISTRATIVE/PROFESSIONAL APPOINTMENTS
`
`2008 – 2012
`
`
`
`1985 – Present
`
`
`
`January – June 1984
`
`
`
`
`October 1983 – June 1984
`
`
`
`
`
`September 1983 – June 1984
`
`
`
`
`
`November 1982 – August 1983 Audie Murphy VA Hospital
`
`
`
`
`San Antonio, TX
`
`July 1982 – July 1983
`
`
`
`
`February 1981 – June 1982
`
`Doctor of Pharmacy Program
`Ohio State University
`Columbus, OH
`
`University of Texas at Austin
`Austin, TX
`
`Kentucky Children’s Hospital
`University of Kentucky
`
`Lexington, KY
`
`Kentucky Children’s Hospital
`University of Kentucky
`
`Lexington, KY
`
`Round Rock Community Hospital
`Round Rock, TX
`
`Shoal Creek Hospital
`Austin, TX
`
`
`
`Lockhart General Hospital
`Lockhart, TX
`
`Medical Center Hospital
`San Antonio, TX
`
`Toledo Hospital
`Toledo, OH
`
`
`
`PROFESSIONAL EXPERIENCE:
`
`2013--2016
`2009 – 2010
`2007--2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`Board of Pharmaceutical Specialty Committee for Pediatrics, Member
`Pediatric Pharmacy Advocacy Group, Vice President of Finance
`Member of the North American Cystic Fibrosis Planning Committee
`Cystic Fibrosis Foundation, Bethesda, MD
`
`
`
`3
`
`19
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2004—2006
`2001 – 2007
`1999
`
`1995 – 2005
`1995 – 1996
`
`1995 – 1997
`
`1995 – 1996
`
`1995
`
`1995--1997
`1994 – 2006
`1994 – 1996
`1994 – 1995
`1995—1996
`1995 – 1996
`1993
`1993 – 1994
`1993 – 1995
`
`1990 – 1992
`1989 – 2001
`1988 – Present
`1986 – Present
`1985 – 2001
`1985 – Present
`1984 – 1999
`1980 – Present
`
`HONORS:
`2017
`
`2017
`
`2017
`
`2017
`
`2017
`
`
`
`2013
`
`2010
`
`
`
`2009
`
`2008
`2007
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pediatric Pharmacy Advocacy Group- President
`Pediatric Pharmacy Advocacy Group, Board of Directors
`New Practitioners Program for Pediatric Pharmacists. 8th Annual
`Pediatric Pharmacy Advocacy Group Meeting, Vancouver Canada,
`Symposium Coordinator
`Kentucky Health Policy, Department of Health Service, Board Member
`Kentucky Cabinet for Human Resources, Drug Formulary Committee,
`Chair
`Kentucky Pharmacists Association, Ad Hoc Committee, Revision of
`Pharmacy Practice Act
`American Society of Health System Pharmacists, Committee on
`Academia, Chair
`Kentucky Health Policy Board, Practice Parameters, Otitis Media-
`Committee, Member
`Pediatric Pharmacy Advocacy Group, Board of Directors
`Southern Society for Pediatric Research
`Kentucky Society of Health System Pharmacists, Board of Directors
`Kentucky Society of Health System Pharmacists, President-elect
`Kentucky Society of Health System Pharmacists, President
`American Society of Hospital Pharmacists SPG on Pediatrics, Chair
`Great Lakes Residency Conference Planning Committee
`American Society of Hospital Pharmacists SPG on Pediatrics, Vice-Chair
`Kentucky Cabinet for Human Resources, Drug Formulary Advisory
`Committee, Vice-Chair
`American Association of Colleges of Pharmacy, Membership Committee
`American Pharmaceutical Association
`American College of Clinical Pharmacy
`Bluegrass Pharmaceutical Association
`Kentucky Pharmaceutical Association
`Kentucky Society of Health System Pharmacists
`ASHP Pediatric Special Practice Group
`American Society of Health System Pharmacists
`
`
`The Paul Parker Award- The University of Kentucky
`Fellow, American Society of Health System Pharmacists
`ACCP Pediatric PRN Outstanding Achievement Award
`Fellow, American Association of Clinical Pharmacy
`Asby Lectureship, University of Oklahoma College of Pharmacy
`
`
`
`
`
`
`Endowed Professor – Kentucky Hospital Association- UK COP
`Richard Helms Award Excellence in Pediatric Pharmacy Practice Award
`Pediatric Pharmacy Advocacy Group, St. Charles, MO, Oct. 9, 2010
`Miles Faculty Award for Outstanding Public Service, UK College of
`Pharmacy
`Pharmacist of the Year, Kentucky Society of Health Systems Pharmacists
`President Citation Award for Outstanding Service – Pediatric Pharmacy
`Advocacy Group – Norfolk, VA September 2007
`
`
`
`4
`
`20
`
`

`

`2001
`2006
`2006
`
`2001
`1999
`1998
`1997 – 1998
`1996
`1995 – 1996
`1991, 1997, 1989, 2005
`1989
`
`1988
`1984
`
`1981
`1981
`1980
`1976
`1976
`
`
`TEACHING ACTIVITY:
`2018-Present
`
`2015-2016
`
`2012-2018
`
`2008- 2017
`
`2009- 2017
`
`2005 – 2010
`
`2004 – 2010
`
`2000 – 2007
`
`1999 – 2004
`
`1998 – Present
`1997 – 2002
`
`1996 – 1997
`
`
`
`1996 – 1997
`
`
`
`
`1992 – 1994
`
`
`
`
`1991 – 1992
`
`
`
`
`1998 – 2003
`1986 – Present
`1986 – 1994
`
`1986 – 1989
`
`1986 – 1996
`
`
`
`
`Fellow Status, Kentucky Society of Health System Pharmacists
`Fellow of the National Academy of Practice, Washington, DC
`President Award – Pediatric Pharmacy Advocacy Group – San Francisco,
`CA
`Outstanding Alumni, The Ohio State University College of Pharmacy
`Clinical Science Award, Kentucky Society of Health System Pharmacists
`Visiting Professor, Kitasato University, Tokyo, Japan
`Preceptor of the Year, University of Kentucky Pharmacy Residents
`Pharmacist of the Year, Kentucky Pharmaceutical Association
`Pharmacist of the Year, Bluegrass Pharmacist Association
`Visiting Professor, Kitasato University, Tokyo, Japan
`Nursing Service Award, Outstanding Clinical Service,
`Division of Pediatric Nursing
`Service Award, Kentucky Cystic Fibrosis Services
`American Society of Hospital Pharmacist Pediatric Pharmacotherapy
`Fellowship
`SAPHA Outstanding Member Award, The Ohio State University
`Upjohn Award, The Ohio State University
`Rho Chi Society
`Baconian Society, College of Steubenville
`Summa Cum Laude Graduate, College of Steubenville
`
`
`
`Lecturer
`
`Course Coordinator
`PHR 948 Pulmonary (Integrated Disease and Drug)
`Course Coordinator
`PPS 896—02 Medical Spanish for Pharmacist
`
`Course Coordinator
`PPS 967-Advanced Therapeutics
`
`
`Lecturer
`PPS 923 Health Promotion and Disease Prevention
`Lecturer
`PPS 947 Advance Pharmacotherapeutics
`
`Lecturer
`Non-Prescription Medications
`
`
`
`Coordinator/Lecturer
`Pulmonary Section PHR 959
`
`
`
`Special Topics PHR 895 Medical Spanish for Pharmacists Lecturer
`Non-Prescription Medications PHR 929
`
`Coordinator/Lecturer
`Pediatrics Elective PPS 973
`
`
`
` Coordinator/Lecturer
`Integrated Therapeutics PHR 959 & 969
`
`Lecturer
`Contemporary Aspects of Pharmacy Practice
`
`Small Group Facilitator
`CAPPS PHR 919, 929
`
`Pharmacy Practice Clerkship, Pediatric/Neonatology
`Lecturer
`PHP 884
`Attention Deficit Disorder Treatment Issue
`Social Science 510
`AACP Pathophysiology Course
`Purdue University
`
`Pediatric Advanced Life Support
`Pediatric Code Training for New Residents
`Pharmacotherapeutics PHR 854
`
`Pathology II PHR 867
`
`
`
`Pharmacy Practice Clerkship:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Lecturer
`
`Instructor
`Lecturer
`Lecturer
`Lecturer
`Lecturer
`
`5
`
`21
`
`

`

`
`
`
`
`
`Pediatrics – Neonatology
`
`
`Applied Therapeutics I PHR 866, 868
`Clinical Orientation Clerkship, Pediatrics PHR 870
`Institutional Practice PHR 880
`
`
`
`
`Lecturer
`Lecturer
`Lecturer
`
`
`
`1985 – 1997
`1985 – 1997
`1985 – 1990
`
`
`
`
`
`
`
`PUBLICATIONS:
`
`Nolt, V, Pijut K Autry EB, Williams W, Burgess D, Burgess D Arora V, Kuhn RJ Amikacin target
`achievement in adult cystic fibrosis patients utilizing Monte Carlo simulation. Pediatric Pulm in press Dec
`2018.
`
`Kuhn RJ Managing the Complexity of Drug Therapy in Individuals with Cystic Fibrosis on line interactive
`book chapter Projects in Knowledge Inc. Livingston NJ 2017
`
`Autry EB, Rybak JM, Leung NR, Gardner BM, Burgess DR, Anstead MI, Kuhn RJ. Pharmacokinetic and
`Pharmacodynamic Analyses of Ceftaroline in Adults with Cystic Fibrosis. Pharmacotherapy: 2016: 36:13-
`18.
`
`Damhoff H, Kuhn R, Stadler L, Severe Malaria Complicated by G6PD Deficiency in a Pediatric Tanzanian
`Immigrant. J Pediatr Pharmacol Ther: 2014:19:324-334.
`
`Damhoff H. Kuhn R, Baker-Justice S. Medication Preparation in Pediatric Emergencies: Comparison of a
`Web-Based, Standard-Dose, Bar Code–Enabled System and a Traditional Approach J Pediatr Pharmacol
`Ther 2014:19 (3) 174-181
`
`
`Yokel R, Harris R, Spilling, Abramov, V, Lone, J, Kuhn R. A Filtration System That Greatly Reduces
`Aluminum in Calcium Gluconate Injection, USP Used to Prepare Parenteral Nutrition Solutions J Pediatr
`Pharmacol Ther 2014:19 (3) 189-195
`
`
`Cory TJ, Birket SE, Murphy BS, Hayes D Jr, Anstead MI, Kuhn RJ, Bush HM, Feola DJ. Impact of
`azithromycin treatment on macrophage gene expression in subjects with cystic fibrosis.J Cyst Fib 2013
`Sep. 7: S1569-1993(13)00140-9
`
`Wu X, Hayes D,Zwicshenberger JB, Kuhn RJ, Mansour HM. Design and Physicochemical characterization
`of advanced spray-dried tacrolimus multifunctional particles for inhalation. Drug Design, Development
`and Therapy 2013:7, 59-72.
`
`Phan, H, Kuhn RJ Cystic Fibrosis in Pediatric Pharmacotherapy 1st Edition, American College of Clinical
`Pharmacy, 2013,223-244.
`
`
`
`
`6
`
`22
`
`

`

`Wier HA, Kuhn RJ. Pancreatic enzyme supplementation. Current Opinion in Pediatrics, 2011;23:541-544.
`
`Warrington SE, Kuhn RJ. Use of intranasal medications in pediatric patients. Orthopedics, 2011; 34(6).
`
`Oschman A, McCabe T, Kuhn RJ. Dexmedetomidine for opioid and benzodiazepine withdrawal in
`pediatric patients. Am J Health-Syst Pharm, 2011;68:1233-38.
`
`Wertz DA, Chang CL, Stephenson JJ, Zhang J, Kuhn RJ. Economic impact of tobramycin in patients with
`cystic fibrosis in a managed care population. Journal of Medical Economics, 2011.
`
`Wetze DA, Stephenson JJ, Hsieh H, Chang C, Zhang J, Kuhn RJ. Impact of initiation of tobramycin
`solution for inhalation (tis) on quality of life among patients with cystic fibrosis (CF). Pediatric
`Pulmonology, 2011;34:341.
`
`Walsh KA, Davis GA, Hayes Jr D, Kuhn RJ, Weant KA, Flynn JD. Tobramycin pharmacokinetics in patients
`with cystic fibrosis before and after bilateral lung transplantation. Transplant Infectious Disease, 2011.
`
`Warrington SE, Kuhn RJ, Anstead M, Gokun Y. Long-term safety and effectiveness of Linezolid in
`Patients with Cystic Fibrosis. Pediatric Pulmonology. 2011; 34:341.
`
`Hayes D Jr, Anstead MI, Warren RT, Kuhn RJ, Ballard HO. Inhaled morphine for palliation of dyspnea in
`end-stage cystic fibrosis. Am J Health Syst Pharm. 2010; 1(9):737-40.
`
`Oschman A, Kuhn RJ. Venous thromboembolism in the pediatric population. Orthopedics, 2010;33:180-
`4.
`
`Hayes D Jr, Kanga JF, Anstead MI, Kuhn RJ. Novel approach to the eradication of Pseudomonas
`aeruginosa in an infant with CF after outpatient treatment failure. Pediatric Pulmonology 2008
`May;43:511-3.
`
`Novak KJ, Douglas WI, Kuhn RJ. Hypotension Following Cardiac Surgery Associated with Paroxetine and
`Mirtazapine Withdrawal. J Pediatr Pharmacol Ther 2008;13:25-28
`
`Rapp RP, Kuhn RJ Clinical pharmaceutics and calcium ceftriaxone. (Letter)
` Ann Pharmacotherapy 2007:41:
`
`Kuhn R, Eyting S, Henninges, F and Potthoff A. In Vitro Comparison of Physical Parameters, Enzyme
`Activity, Acid Resistance, and pH Dissolution Characteristics of Enteric-Coated Pancreatic Enzyme
`Preparations: Implications for Clinical Variability and Pharmacy Substitution The