Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KOIOS PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FUER KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
`
`Case No. IPR2016-01370
`Patent Number 8,664,231
`____________
`
`Before JACQUELINE WRIGHT BONILLA, TONI R. SCHEINER,
`and ERICA A. FRANKLIN, Administrative Patent Judges
`
`EXPERT DECLARATION OF JOHN S. CLARK, PHARM.D.
`
`June 9, 2017
`
`
`
`
`
`
`
`
`
`Medac Exhibit 2093
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`

`

`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`I, Dr. John Clark, have been retained as an expert by counsel for medac
`
`Gesellschaft Für Klinische Spezialpräparate Mbh, Inc. (“Medac”) in the above-
`
`captioned Inter Partes Review (“IPR”).
`
`I.
`
`QUALIFICATIONS
`1.
`
`I am a clinical pharmacist and Director of Pharmacy Services at the
`
`University of Michigan Hospitals and Health Centers. I am also a clinical
`
`Associate Professor, where my responsibilities include teaching, practicing, and
`
`performing research in pharmacy practice management and leadership. I have over
`
`20 years of pharmacy management experience. My experience includes preparing
`
`methotrexate treatments for dozens of pediatric patients.
`
`2.
`
`I received a Pharm.D. from the University of Toledo College of
`
`Pharmacy
`
`in 2000, and a Master’s degree
`
`in Health-System Pharmacy
`
`Administration from the University of Wisconsin in 2002. I am a Board Certified
`
`Pharmacotherapy Specialist.
`
`3. My hospital practice
`
`includes positions at
`
`the University of
`
`Wisconsin, Johns Hopkins Hospital, and the University of Michigan. My
`
`academic experience includes appointments at the University of Toledo, University
`
`of Wisconsin, the University of Maryland School of Pharmacy, and the University
`
`of Michigan.
`
`2
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`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`4. My educational background, work experience and a list of my
`
`publications are set forth in my curriculum vitae, which is attached as Tab A to this
`
`report. A list of the cases in which I have testified as an expert at trial or by
`
`deposition over the previous 4 years is attached at Tab B.
`
`II.
`
`SCOPE OF ASSIGNMENT AND SUMMARY OF MY OPINIONS
`5.
`
`I am informed and understand that Koios Pharmaceuticals LLC
`
`(“Koios”) has petitioned for an IPR of Medac’s U.S. Patent No. 8,664,231 (Ex.
`
`1001, “the ‘231 patent”) and has requested the cancellation of claims 1-22 of the
`
`‘231 patent. I am informed and understand that in the IPR, Koios has relied upon
`
`(among other documents) a Wyeth product label “Methotrexate Sodium for
`
`Injection” (Ex. 1021, “Wyeth”) .
`
`6.
`
`I am informed and understand that the claims of the ‘231 patent have
`
`a priority date of July 21, 2006. I have been asked to assess the knowledge of the
`
`person of ordinary skill in the art (POSITA) at that July 21, 2006 date, how
`
`pharmacists prepared methotrexate to treat cancer and other diseases at that time,
`
`and what the POSITA would have understood from Wyeth at that time.
`
`7.
`
`In forming my opinions, I have relied upon my education, experience,
`
`and various written materials. A list of the written materials that I considered in
`
`rendering my opinions is attached to this declaration as Tab C. Aside from the
`
`papers submitted by the parties for this case (such as the Petition), each of the
`
`3
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`listed materials is a type of document that experts in my field would reasonably
`
`rely upon when forming their opinions.
`
`8.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under 18 U.S.C. § 1001. If called to testify as to the truth
`
`of the matters stated herein, I could and would testify competently.
`
`III. LEVEL OF SKILL IN THE ART
`9.
`I have been instructed for, the purposes of this Declaration, to opine
`
`on the knowledge and understanding of a POSITA as of July 21, 2006.
`
`10.
`
`I understand that the factors considered in determining the ordinary
`
`level of skill in the art include: (i) the levels of education and experience of persons
`
`working in the field; (ii) the types of problems encountered in the field; and (iii)
`
`the sophistication of the technology. I understand that a POSITA is not a real
`
`person, but rather a hypothetical individual with the qualities based on the factors
`
`above.
`
`11.
`
`I understand that Medac contends that a POSITA with respect to the
`
`‘231 patent as of July 21, 2006 would have the understanding of: a) a person with
`
`an M.D. and experience using methotrexate to treat inflammatory autoimmune
`
`4
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`diseases; or b) a person with a Ph.D. or Pharm.D. in pharmacology, pharmaceutics,
`
`or chemistry; or c) a person with a lesser degree but with at least several years of
`
`additional experience in methotrexate preparation (e.g., a pharmacy technician or
`
`nurse) in either an academic or industrial setting.
`
`12. Based on my experience as a pharmacist and manager of pharmacy
`
`services, including preparation of methotrexate for patients, I agree with this
`
`definition of the level of ordinary skill in the art.
`
`13.
`
`I understand that Koios has taken the position that a POSITA would
`
`have either a Pharm.D. or a Ph.D. in pharmacy, pharmacology, or a related
`
`discipline; an M.D. or D.O. with experience in using methotrexate; or a BS in
`
`pharmacy with at least two years of experience formulating active pharmaceutical
`
`ingredients for injection. A POSITA would collaborate with others having
`
`expertise in, for example, methods of treating disease and administering medicines.
`
`While I believe that the person in Koios’s definition should have experience in
`
`formulating methotrexate for injection, my opinions are the same regardless of
`
`which of these levels of skill in the art I apply.
`
`IV. USE OF METHOTREXATE FOR CANCER
`14. Since the 1950s, methotrexate has been used to treat many forms of
`
`cancer. As the ‘231 patent notes, methotrexate was originally used against cancer,
`
`including breast cancer and childhood leukemia. Ex. 1001 at 1:24-27. As noted
`
`5
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`Page 00005
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`above, I have prepared methotrexate for dozens of pediatric patients with cancer,
`
`and have been responsible for managing pharmacy services at different institutions
`
`before and after 2006, so I have familiarity with how pharmacists have used
`
`methotrexate for cancer and other diseases, including inflammatory autoimmune
`
`diseases. From 1996-2000, I also served as a pharmacy intern preparing
`
`methotrexate-containing infusion products for cancer patients at Akron General
`
`Medical Center in Akron, Ohio.
`
`15. Based on my experience, before (and after) the July 21, 2006 priority
`
`date for the ‘231 patent, methotrexate dosing for cancer generally involved much
`
`higher doses than methotrexate dosing for inflammatory autoimmune diseases like
`
`rheumatoid arthritis. The ‘231 patent notes that methotrexate doses for cancer can
`
`be 1000 times higher than the doses for rheumatic diseases. Ex. 1001 at 1:56-60.
`
`This is consistent with my experience. Cancer patients on methotrexate
`
`chemotherapy generally receive intravenous (IV) infusions over several hours or
`
`days, with a total methotrexate dose on the order of several grams.
`
`V. THE WYETH REFERENCE
`16.
`I understand that Wyeth (Ex. 1021) is a copy of a product label for
`
`“Methotrexate Sodium for Injection,” asserted as prior art in this case against the
`
`‘231 patent.
`
`17. Wyeth contains the following statement:
`
`6
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`Methotrexate Sodium for Injection should be reconstituted with an
`appropriate sterile, preservative free medium such as 5% Dextrose
`Solution, USP, or Sodium Chloride Injection, USP. Reconstitute the
`20 mg vial to a concentration no greater than 25 mg/mL. The 1 gram
`vial should be reconstituted with 19.4 mL to a concentration of 50
`mg/mL. When high doses of methotrexate are administered by IV
`infusion, the total dose is diluted in 5% Dextrose Solution.
`
`Ex. 1021 at 79.
`
`18.
`
`In my opinion, this statement from Wyeth is not about the use of
`
`methotrexate at 50 mg/ml for subcutaneous injection for rheumatoid arthritis, but
`
`rather for applications like IV infusion for cancer. The end of the paragraph above
`
`refers to “high doses of methotrexate” that are “administered by IV infusion.” A 1
`
`gram vial and a concentration of 50 mg/ml would make sense only for cancer
`
`treatments, and not for subcutaneous injection for other inflammatory autoimmune
`
`diseases, both before July 2006 and to this day.
`
`19. From my pharmacy work, I have experience using 1 gram vials of
`
`lyophilized methotrexate to prepare patient treatments. To the best of my
`
`recollection, vials of that size were used only for treating cancer, and not for
`
`inflammatory autoimmune diseases.
`
`20. Of the two vial sizes that Wyeth mentions (20 mg and 1 gram), only
`
`the 1 gram vial would be suitable for cancer treatments. As noted above, IV
`
`infusions of methotrexate involve doses much higher than injections for
`
`7
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`Page 00007
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`inflammatory autoimmune diseases. For example, Wyeth teaches that acute
`
`lymphoblastic leukemia patients “were treated with intermediate-dose intravenous
`
`methotrexate (1 gm/m2).” Ex. 1021 at 66, 69. Wyeth also teaches that for
`
`osteosarcoma, “[t]he starting dose for high dose methotrexate treatment is 12
`
`grams/m2 … [and] the dose may be escalated to 15 grams/m2.” Id. at 75. Wyeth
`
`also states that a 12 gram/m2 dose is administered “IV as 4 hour infusion (starting
`
`dose).” Id. at 76. The average adult body surface area is 1.7 m2. See, e.g., Ex.
`
`2005 at 24. Accordingly, these examples show that multiple grams are required for
`
`these treatments. To prepare such doses, a pharmacist would use 1 gram vials, but
`
`not 20 mg vials. A 1 gram dose, for example, would require 50 vials in the 20 mg
`
`size, which would be inefficient.
`
`21. The recommended concentrations and volumes for the two vial sizes
`
`in Wyeth also confirm that the 1 gram vial (reconstituted to 50 mg/ml) would be
`
`used only for cancer treatment and not for subcutaneous injection for inflammatory
`
`autoimmune diseases. Wyeth warns that each vial was for “Single Use Only.” Ex.
`
`1021 at 80. A weekly methotrexate dose for inflammatory autoimmune diseases
`
`would be generally no higher than 25 mg. For example, Wyeth states that weekly
`
`methotrexate doses for psoriasis are generally “10 to 25 mg.” Ex. 1021 at 79.
`
`Accordingly, a 20 mg vial be appropriate for that dose. Wyeth says to use “no
`
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`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
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`U.S. Patent No. 8,664,231
`greater than 25 mg/ml” when reconstituting the 20 mg vial, which would result in a
`
`volume of 0.8 ml. That volume would be appropriate for subcutaneous injection.
`
`22. However, a 1 gram vial dose would be many times greater than any
`
`single dose for inflammatory autoimmune diseases. Also, if reconstituted to 50
`
`mg/ml, the resulting 20 ml volume (using 19.4 ml of diluent) would be far too
`
`large for subcutaneous injection. While a fraction of the 20 ml solution could be
`
`used for a single subcutaneous injection of 25 mg, that would require throwing
`
`away the vast majority of the drug (975 mg, or 97.5% of the vial), as the vials are
`
`for “Single Use Only.” Even if a pharmacist ignored this warning, because the
`
`vials are preservative-free, and not to be reconstituted with any preservatives, it
`
`would not be safe or practical for multiple uses (even over a few hours) for patients
`
`suffering from inflammatory autoimmune diseases. Indeed, Wyeth instructs to
`
`“Reconstitute immediately prior to use.” Id. The 20 ml volume would make sense
`
`only for cancer treatments, which involve much higher doses.
`
`23. Further
`
`in my experience, when administering methotrexate
`
`intravenously, after reconstituting the powdered drug according to the instructions
`
`on the label, the drug is further diluted before being infused into the patient. For
`
`example, the total dose for administration may be injected into a one liter saline
`
`bag, which significantly dilutes the reconstituted drug prior to infusion into the
`
`patient. By reconstituting a powdered drug according to the instructions on the
`
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`Attorney Docket No.
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`IPR2016-01370
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`U.S. Patent No. 8,664,231
`label prior to dilution for infusion to the patient, a POSITA can accurately
`
`determine the volume of the diluted drug being infused into the patient and, thus,
`
`the required infusion time for that administration.
`
`24.
`
`I understand that Petitioner (and its expert Dr. Schiff) have argued that
`
`the “Bigmar” reference (Ex. 1026), which is a label for a generic 1 gram
`
`methotrexate vial similar to Wyeth’s, confirms that “the solution was to be
`
`administered in a 50 mg/ml concentration and not to be further diluted.” Petition at
`
`35. I disagree with this statement. As explained above, IV infusion of a solution
`
`reconstituted from the 1 gram vial would require further dilution before
`
`administration. Like Wyeth, Bigmar says: “When high doses of methotrexate are
`
`administered by IV infusion, the total dose is diluted in 5% Dextrose Solution.”
`
`Ex. 1026 at 6. A POSITA would interpret this statement to reflect the general
`
`practice of diluting the methotrexate for infusion after reconstituting it according to
`
`the Bigmar label. Like Wyeth, Bigmar also says: “For intrathecal injection,
`
`reconstitute to a concentration of 1 mg/mL . . . .” Id. Accordingly, Bigmar also
`
`indicates that the reconstituted 1 gram vial should be further diluted from 50 mg/ml
`
`to 1 mg/ml for intrathecal injection.
`
`25.
`
`I have reviewed the Declaration of Dr. Donald Miller that Koios
`
`submitted in this case (Ex. 1033). I understand that Dr. Miller contends that Wyeth
`
`would have taught a POSITA to use a methotrexate solution of 50 mg/ml for
`
`10
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`Attorney Docket No.
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`IPR2016-01370
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`
`U.S. Patent No. 8,664,231
`subcutaneous injection for inflammatory autoimmune diseases. Ex. 1033 ¶ 63. I
`
`disagree with this conclusion for the reasons stated above. An ordinarily skilled
`
`pharmacist would understand from Wyeth that the 50 mg/ml concentration
`
`corresponds only to the 1 gram vial product, which would be used for cancer
`
`treatments and not inflammatory autoimmune diseases. An ordinarily skilled
`
`pharmacist would also understand that not all routes of administration, diseases,
`
`and concentrations in Wyeth could be combined interchangeably for safe and/or
`
`effective use.
`
`VI. COMPENSATION AND PREVIOUS TESTIMONY
`26. The cases for which I have testified as an expert at trial or by
`
`deposition within the preceding four years are listed in Tab B to this report. As
`
`compensation for my time spent working and testifying in connection with this
`
`IPR, I receive $420.00 per hour all work at my home office, and $520 per hour for
`
`all other work and travel. My compensation is not dependent on the outcome of
`
`this case.
`
`VII. SUPPLEMENTAL OR AMENDED OPINION
`27.
`I reserve the right to supplement or amend my opinions in response to
`
`the opinions expressed by Koios or its experts, or in light of any additional
`
`evidence, testimony, discovery or other information that may be provided to me
`
`after the date of this report.
`
`11
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`Page 00011
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`

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`IPR2016-01370
`US. Patent No. 8,664,231
`
`Attorney Docket No.
`110670-0009-651
`
`I declare under penalty of perjury under the laws of the United States of
`
`America that the foregoing is true and correct to the best of my knowledge.
`
`Dated: June 9, 2017
`
`
`
`S. Clark, PharmD.
`
`12
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`Page 00012
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`Page 00012
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`

`

`TAB A
`TAB A
`
`
`
`
`
`
`
`
`Page 00013
`
`

`

`John S. Clark, Pharm.D., M.S., BCPS, FASHP
`
`
`
`
`OFFICE:
`
`Department of Pharmacy Services
`Administrative Offices
`UH B2D301/5008
`1500 E. Medical Center Drive
`Ann Arbor, Michigan 48109-5008
`(734) 232-4882
`Fax: (734) 936-7027
`johnclar@umich.edu
`
`EDUCATION
`
`Master of Science, Pharmacy (Health-System Pharmacy Administration)
`University of Wisconsin School of Pharmacy
`August 2002
`
`Doctor of Pharmacy
`University of Toledo College of Pharmacy
`May 2000
`
`Bachelor of Science in Pharmaceutical Sciences
`University of Toledo College of Pharmacy
`May 1998
`
`CERTIFICATIONS
`
`Board Certified Pharmacotherapy Specialist
`Board of Pharmacy Specialties
`Expires 2017
`
`Teaching Certificate Program for Pharmacy Residents
`University of Wisconsin
`Madison, WI
`August 2001-June 2002
`
`FELLOWSHIP
`
`Fellow
`American Society of Health-System Pharmacists
`June 2012
`
`ACADEMIC EXPERIENCE
`
`Clinical Associate Professor
`University of Michigan College of Pharmacy
`Ann Arbor, MI
`September 2014-present
`
`Clinical Assistant Professor
`University of Michigan College of Pharmacy
`
`Page 00014
`
`

`

`
`
`
`
` Clark 2
`
`
`
`Ann Arbor, MI
`2007-2014
`
`Clinical Assistant Professor
`University of Maryland School of Pharmacy
`Baltimore, MD
`2002-2007
`
`Clinical Instructor
`University of Wisconsin
`Madison, WI
`2000-2002
`
`Pharmaceutical Care Instructor
`University of Toledo
`Toledo, OH
`May 1998-November 1999
`
`HOSPITAL PRACTICE
`
`Associate Chief Pharmacy Officer
`Michigan Medicine (January 2017-present)
`
`Director of Pharmacy Services
`University of Michigan Hospitals and Health Centers (September 2011-January 2017)
`
`Associate Director of Pharmacy
`University of Michigan Hospitals and Health Centers (April 2007-September 2011)
`
`Director, Pediatric Pharmacy Division
`Johns Hopkins Hospital, Baltimore, Maryland (March 2006-March 2007)
`
`Assistant Director of Pharmacy, Pediatrics
`Johns Hopkins Hospital, Baltimore, Maryland (July 2002-March 2006)
`
`Pharmacy Administrative Resident (Specialized Resident in Pharmacy Practice Management)
`University of Wisconsin Hospital and Clinics, Madison, Wisconsin (July 2000-June 2002),
`Program Director: Thomas Thielke, RPh, M.S.
` Advisor: Jim Klauck, RPh, M.S.
`
`Decentral Staff Pharmacist - Pediatrics, Critical Care, Cardiology, Hematology/Oncology
`University of Wisconsin Hospital and Clinics, Madison, Wisconsin (July 2000-June 2002)\
`
`Pharmacy Intern/Senior Intern
`Akron General Medical Center, Akron, Ohio (May 1996-June 1999)
`
`TEACHING EXPERIENCE
`
`Clinical Associate Professor and Clinical Assistant Professor
`University of Michigan College of Pharmacy
`2007-present
`
` 
`
` Precept P4 students on Pharmacy Practice Management (Non-traditional) APPE Rotation – 2014-
`present
` Precept P4 students on Pharmacy Practice Management (Non-traditional) APPE Rotation with Dr. Jim
`Stevenson - 2007-2014
`
`Page 00015
`
`

`

`
`
`
`
` Clark 3
`
`
`
` Pharm 420 – Introduction to Health Care Systems and Pharmacy Law - Course Coordinator –
`Winter 2010 (21 contact hours); Quality Assurance Lecture - 2007-08, 2008-2009 and Hospital
`Pharmacy Practice Lecture - 2008-2009
` Pharm 616 (422) – Health-System Pharmacy Practice and Leadership - Course Coordinator –
`Winter 2012 (46 student contact hours), Winter 2013 (54 contact hours), Winter 2014 (29 contact
`hours), Winter 2015 (19 contact hours)
` Pharm 426 – Immunization Advocacy and Administration - Justifying Pharmacy Clinical Services
`Lecture 2008-2009, 2009-2010, 2010-2011, 2010-2011, 2011-2012, 2012-2013
`
` Pharm 550 – Opportunities in Pharmacy - Communication and Professionalism 2009, 2010, 2011,
`2012; Change Management and Leadership – 2010, 2011, 2012; Preparing for ASHP Midyear Clinical
`Meeting 2012
` Pharm 680 – Pharmacy Student Seminar - Precept seminar students 2007-2008 -2 students, 2008-
`2009 – 3 students, 2009-2010 – 2 students, 2010-2011 – 2 students
` UC 151 – Contemporary Issues in Medication Use and Pharmacy - Course Coordinator Winter
`2008 (18 contact hours) and Winter 2009 (18 contact hours)
` Pharm.D. Investigations – Kate Veltman 2012-2014 – Use of Fentanyl Patches in an Academic
`Medical Center
`
`
`Clinical Assistant Professor
`University of Maryland School of Pharmacy
`Baltimore, MD
`2002-2007
` Precept P4 students on Pharmacy Practice Management Rotation
` Precept P4 students on Institutional Pharmacy Practice Rotation
`
`Clinical Instructor
`University of Wisconsin
`Madison, WI
`2000-2002
` Oriented students to hospital setting
` Secondary preceptor of students on clinical clerkships
`
`Pharmaceutical Care Instructor
`University of Toledo
`Toledo, OH
`May 1999-November 1999
` Evaluated and reviewed materials to determine feasibility of on-line clinical rotation evaluation
`
`Pharmaceutical Care Instructor
`University of Toledo
`Toledo, OH
`August 1998-May 1999
` Bachelor of Science in Pharmacy Externship Assistant Coordinator
` Peer Mentor for Early Practice Development (Entry-level Pharm.D. introductory course).
`
`RESEARCH EXPERIENCE
`
`Wright K, Dekarske B, Clark JS, Chaffee BW. Parenteral Product Error Detection Before and After
`Implementation of Intravenous (IV) Workflow Management Technology.
` Co-Investigator
` 2014
`
`Engels M, Chaffee BW, Clark JS. Comparison and Alignment of an Academic Medical Center’s Strategic
`Goals with Pharmacy Practice Model (PPM) Recommendations
` Co-Investigator
` 2014
`
`Page 00016
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`

`

`
`
`
`
` Clark 4
`
`
`
`
`Veltman K, Clark JS. Use of fentanyl patches in an academic medical center
` Co-Investigator
` 2012
`
`DelMonte MT, Clark JS. Pharmacy resident attitudes toward participation in cardiopulmonary
`resuscitation events
` Co-Investigator
` 2009
`
`Pollard SR, Clark JS. Survey of health-system pharmacy pathways.
` Co-Investigator
` 2007
`
`Fetterly E, Clark JS, Clark AM. National Survey of Resident On-call Programs: Scope of Responsibility
`and Structure
` Co-Investigator
` 2005
`
`Miller K, Davies K, Clark JS. Medication Induced Delirium in Hospitalized Patients.
` Co-Investigator
` 2003
`
`Clark JS, Klauck JA. Recording Pharmacists’ Clinical Interventions: The Utility of a Personal Digital
`Assistant.
` Principal Investigator
` 2001
`
`Klauck JA, Clark JS. A Comparative Study of Point of Care Monitoring of INRs and a Laboratory
`Standard.
` Co-Investigator
` 2001
`
`PEER REVIEWED PUBLICATIONS
`
`Philip W. Brummond, David F. Chen, William W. Churchill, John S. Clark, Kevin R. Dillon, Doina
`Dumitru, Lynn Eschenbauer, Toni Fera, Christopher R. Fortier, Kristine K. Gullickson, Kristen Jurakovich,
`Stan Kent, Jennifer Keonavong, Christine Marchese, Tricia Meyer, Lee B. Murdaugh, Richard K. Ogden,
`Brian C. O’Neal, Steve Rough, Rafael Saenz, Jacob S. Smith. ASHP Guidelines on the Preventing
`Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017;74:e10-33.
`
`Melanie J. Engels^, Bruce W. Chaffee, John S. Clark. Comparison and alignment of an academic medical
`center’s strategic goals with ASHP initiatives. Am J Health-System Pharm. 2015:72:2065-2078.
`
`John S. Clark. A vision for the future of pharmacy residency training. Am J Health-Syst Pharm.
`2014;71:1196-1198.
`
`Jennifer Hlubocky^, Philip Brummond, John S. Clark. Pharmacy practice model change: Lean thinking
`provides a place to start. Am J Health-Syst Pharm 2013;70:845-847.
`Design, Writing, Critical Review
`
`
`Marcy DelMonte^, John S. Clark. Pharmacy residents' experiences and attitudes toward participation in
`cardiopulmonary resuscitation (CPR) events at academic medical centers. Hospital Pharmacy 2011;46:864-
`875.
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`Conceptualization, Analysis, Critical Review
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`Paul C. Walker, Kathy S. Kinsey, Michael D. Kraft, Nancy A. Mason, John S. Clark. Improving student
`education and patient care through an innovative introductory practice experience. Am J Health-Syst
`Pharm. 2011:68;655-660.
`Conceptualization, Critical Review
`
`
`
`John S. Clark, Nabil Khalidi, Kristen C. Klein, Darcie D. Streetman, Michael E. McGregory, John P.
`Johnston. Using a novel approach to collect, disseminate, and assess residency application materials. Am J
`Health-Syst Pharm 2010:67;741-5.
`Conceptualization, Analysis, Writing, Critical Review, Corresponding Author
`
`
`Sacha R. Pollard^, John S. Clark. Survey of health-system pharmacy leadership pathways. Am J Health-
`Syst Pharm 2009;66:947-52.
`Conceptualization, Analysis, Critical Review
`
`
`
`Marlene R. Miller, Michael Rinke*, John S. Clark, Mudd S, Moon MR. Prescribing Errors in a Pediatric
`Emergency Department. Pediatr Emerg Care 2008; 24:1-8.
`Conceptualization, Implementation of Service, Analysis, Critical Review
`
`
`John S. Clark. Developing the future of pharmacy through health-system pharmacy internship programs.
`Am J Health-Syst Pharm 2007; 64:952-4.
`Conceptualization, Implementation of Service, Writing, Analysis, Critical Review, Corresponding
`Author
`
`
`Marlene R. Miller, John S. Clark, Christoph U. Lehmann. Computer-based medication error reporting:
`insights and implications. Qual Saf Health Care 2006;15 208-213.
`Conceptualization, Analysis, Critical Review
`
`
`George Kim*, Michael A. Veltri, John S. Clark, Christoph U. Lehmann. Decreasing Errors in Pediatric
`Continuous Intravenous Infusions. Pediatr Crit Care Med 2006;7:225-230.
`Conceptualization, Implementation of Service, Data Collection, Analysis, Critical Review
`
`
`Kara A. Bazzie^, David Witmer, Brian Pinto, Colleen Bush, John S. Clark, Joseph Deffenbaugh. A
`National Survey of Dietary Supplement Policies in Acute Care Facilities. Am J Health-Syst Pharm
`2006;63:65-70.
`Analysis, Critical Review
`
`
`John S. Clark, James A. Klauck. Recording Pharmacists’ Clinical Interventions with a Personal Digital
`Assistant. Am J Health-Syst Pharm 2003;60: 1772-1774.
`Development and Implementation of Technology, Data Collection, Analysis, Critical Review,
`Corresponding Author
`
`
`Name^ are pharmacy residents, and name* are professional students with which I have worked.
`
`BOOK CHAPTERS
`
`Mark SM, Saenz R, Clark JS, Stevenson JG. Leadership essentials for pharmacists. In Chisholm-Burns MA,
`Vaillancourt AM, Shepherd M. Pharmacy Management, Leadership, Marketing, and Finance. 2nd edition
`2014.
`
`Goldstone LW, Kennedy AK, Clark JS, Phan H. Developing and Evaluating Clinical Pharmacy Services.
`In Chisholm-Burns MA, Vaillancourt AM, Shepherd M. Pharmacy Management, Leadership, Marketing,
`and Finance. 2nd edition 2014.
`
`Clark JS, Pleva M. What’s in it for me? Benefits of postgraduate training. In Bookstaver PB. Cauder CR,
`Smith KM, Quidley AM. Roadmap to postgraduate training in pharmacy. 2013.
`
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`Dalrymple PW, Cohen BA, Clark JS. Managing pediatric knowledge resources in practice. In Lehmann CU,
`Kim GR, Johnson KB. Pediatric Informatics 2009.
`
`NON-REFEREED PUBLICATIONS
`
`Clark JS. Findings of Pharmacy Practice Model Initiative Survey. UHC White Paper. May 2013.
`https://www.uhc.edu/docs/55019630_PPMI_Survey-AMC_Responses_Summary.pdf
`
`Abramowitz P, Ashby DM, Bush PW, Guharoy R, Jorgenson J, Knoer S, Rough SS, Stevenson JG, Wiest
`M, Clark JS, Nesbit TW. Pharmacy Practice Model for Academic Medical Centers. UHC White Paper.
`May 2010. https://www.uhc.edu/docs/003741703_PharmPracticeModel.pdf
`
`Clark JS, Landini KM, Shoemaker DS. Implementing a high volume unit dose packaging machine.
`Pharmacy Purchasing and Products 2009;10;14-17.
`
`Veltri MA, Ascenzi J, Clark JS, Lehmann CU. Standardizing Medication Ordering, Dispensing, and
`Administration Systems to Eliminate the “Rule of Six.” Pharmacy Purchasing and Products 2006;3:30-32.
`
`Clark JS, Koneru MB, Weibel KJ. Improving Quality through Accreditation. J Pharm Soc of Wis
`2001;July/August:18-20.
`
`Clark JS, Vermeulen LC. Hospital Pharmacy in the United States. International Pharmacy Journal
`2002;16:18-19.
`
`FUNDED GRANTS
`
`Mueller BA, Shaw A, Clark JS. Baxter - Time Motion Study of CRRT Solutions. Co-Investigator. $92,574
`– 5% salary support
`October 2015
` Evaluation of Time-Motion of bag preparation
`
`Wright K, Chaffee BW, Clark JS. Baxter - Co-Investigator. $52,822 – 2.5% salary support
`July 2014
` Evaluation of Error Detection of Parenteral Product Preparation in Infusion Pharmacies Before and
`After Implementation of IV Workflow Management Technology.
` Grant to evaluate error detection and use of technology to prevent errors
`
`Clark JS. American Society of Health-System Pharmacists Foundation - $40,000
`April 2012
` Grant to provide residency funding to University of Michigan for one additional PGY-1
`
`Clark JS. Fostering Innovations Grant – University of Michigan Hospitals and Health Centers - $2,960
`March 2010
` Grant to reduce controlled substance disposal in the water supply by using kitty litter as a method of
`disposal
` University of Michigan Health System fully implemented across facilities – 2013
`
`Clark JS. Amgen Pharmacy Residency Grant Program - $40,000
`March 2010
` Grant to provide residency funding to University of Michigan for one additional PGY-2 Oncology
`resident
`
`
`Clark JS. Amgen Pharmacy Residency Grant Program - $40,000
`February 2009
` Grant to provide residency funding to University of Michigan for one additional PGY-1
`
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`Clark JS. Amgen Pharmacy Residency Grant Program - $40,000
`February 2008
` Grant to provide residency funding to University of Michigan for one additional PGY-1
`
`Clark JS, Miller MR. Johns Hopkins Hospital Telethon Grant - $10,000
`April 2004
` Grant to study provision of a pharmacist clinical service in the pediatric emergency department
`
`
`
`GRANTS NOT FUNDED
`
`Engels M, Kelley LR, Clark JS. Cross-walk Analysis Comparing an Academic Medical Center with
`Pharmacy Practice Model Initiative Goals. ASHP Foundation. Co-investigator. $5,000
`October 2013
`
`POSTER PRESENTATIONS
`
`Wright K, Dekarske B, Clark JS, Chaffee BW. Parenteral Product Error Detection Before and After
`Implementation of Intravenous (IV) Workflow Management Technology. Presented at the American
`Society of Health-System Pharmacists (ASHP) Summer Meeting. June 2015.
`
`Engels M, Chaffee BW, Clark JS. Comparison and Alignment of an Academic Medical Center’s Strategic
`Goals with Pharmacy Practice Model (PPM) Recommendations. Presented at the American Society of
`Health-System Pharmacy (ASHP) Midyear Clinical Meeting. December 2013.
`
`Veltman K., Clark JS. Precision of First-Dose Transdermal Fentanyl Prescribing. Presented at the
`American Society of Health-System Pharmacy (ASHP) Midyear Clinical Meeting. December 2013.
`
`Wesolowicz L, Repotski S, Clark JS. Collaboration Between Health Plan and University to Develop PGY-
`1 Managed Care Residency Program. Presented at the American Society of Health-System Pharmacy
`(ASHP) National Pharmacy