Exhibit 1009
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`DECLARATION OF MATTHEW W. DAVIS M.D. RPH.
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`Page 1 of 26
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`CELGENE EXHIBIT 2046
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Inter Partes Review :
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`PETITION FOR INTER PARTES REVIEW OF
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`Case No.
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`Petitioner
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`Filed
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`Attorney Docket No.
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`Customer No.
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`U.S. PATENT NO. 6,315,720 UNDER 35 USC §§
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`311-319 AND 37 CFR §42.100 ET SEQ.
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`To be Assigned
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`To be Named
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`27571
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`Appeal Related Matters
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`Patent Trial and Appeal Board
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`US Patent and Trademark Office
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`PO Box 1450
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`Alexandria, Virginia 22313-1450
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`Sir:
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`DECLARATION OF MATTHEW W. DAVIS M.D. R.Ph.
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`I, the undersigned, hereby declare the following, based on my own
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`knowledge, information, and belief:
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`Page 2 of 26
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`1.
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`I am presently Senior Vice President of Clinical Operations and
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`Development at Sun Pharmaceuticals.
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`2.
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`I received an M.D. degree from the Medical College of Pennsylvania
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`in 1994 and a B.S. in Pharmacy from Temple University School of Pharmacy. I
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`did an internship in surgery, followed by a residency in urology. I am a registered
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`pharmacist, R.Ph, as well as a licensed physician.
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`3.
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`Since 1998, I have directed clinical development and medical affairs
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`at a number of different companies. These companies include, Endo
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`Pharmaceuticals, Dermik Laboratories, Dr. Reddy’s Laboratories, Eisai Global
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`Research and most recently, URL Pharma, now Sun Pharmaceuticals.
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`4.
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`I have co-authored 20 articles in peer reviewed scientific and medical
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`journals. I am the sole inventor of 17 U.S. patents, named inventor on numerous
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`other patents and patent applications. A copy of my resume is attached.
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`5.
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`I have reviewed U.S. Patent No. 6,315,720, its file history as well as
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`the prior art cited in the Petition: (i) Powell et al. (Postgrad. Med. J. 70:901 (1994),
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`(“Powell”), Exhibit 1002); (ii) Dishman et al. (Am. J. Hosp. Pharm 51: 899 (1994),
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`(“Dishman”), Exhibit 1003); (iii) Bastani et al. (Psychopharmacology 99:S122
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`(1989), (Bastani”), Exhibit 1004); (iv) Mitchell et al. (New England J. Med.
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`333(2):101 (1995), (“Mitchell”), Exhibit 1007); (v) Honigfeld (Psychiatric
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`Services 47:52 (1996), (“Honigfeld”), Exhibit 1008); (vi) the 47th Meeting of the
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`Dermatologic and Ophthalmic Advisory Board (September 4-5, 1997, (the “FDA
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`Meeting”), Exhibit 1005 (a) and (b)); and (ix) CDC Meeting (Centers for Disease
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`Control, Preventing Birth Defects, March 26, 1997, (the “CDC Meeting”), Exhibit
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`1006).
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`6.
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`The medical community was acutely aware of the need to put in-place
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`a program for tightly controlling the distribution of drugs causing adverse side
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`effects. In fact, there were numerous drug dispensing and restriction programs in
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`place in the mid to late 1990’s, including: (i) restricted distribution (Fentanyl,
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`Oralet); (ii) limited quantity (Clozaril); (iii) consent (Accutane, Felbatol); (iv)
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`laboratory testing (Clozaril/ requiring a white blood count); (v) registry (AZT,
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`Acyclovir); and, (vi) patient/provider education (Accutane). Exhibit 1006 at 8. I
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`found the following statements from FDA and CDC meetings held in 1997
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`especially informative.
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`Page 4 of 26
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`7.
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`Dr. Bergfeld recommended the system (STEPS) “What I would like to
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`recommend is that registry for the physician include that they have signed off on
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`an informed consent that they have been informed about the information, they have
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`read it, and they agree to participate in that manner. ” Dr. Williams then
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`responded, “[t]hat is reasonable.” (Exhibit 1005(a) at 121).
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`8.
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`Dr. Woodcock from the FDA stated “the need to impose a mandatory
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`restriction, under regulation, depends on our judgment of whether that is necessary
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`to ensure the safety of the product. So, it really depends on how safe we feel the
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`safety would be under a voluntary system or whatever safety is available compared
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`to the need for additional safety that would merit, that would require for approval a
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`restricted distribution.” (Exhibit 1005(a) at 220).
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`9.
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`Finally, Dr. Williams stated that, “[t]he other thing is that the way the
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`system is being developed, it would be designed to utilize some of the systems that
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`are currently in place within pharmacy practice where there are central computer
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`databases that pharmacists log in and out on when they are filling prescriptions. A
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`portion of one of those databases will be carved out to actually have the pharmacist
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`tracking and recording information on this patient so that we’d be in a position to
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`monitor that the pharmacist was in fact complying with the program.” (Exhibit
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`1005(b) at 159).
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`10. Dishman describes a clozapine prescription program instituted by the
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`Department of Veterans Affairs (VA). (Dishman) Exhibit 1003, Abstract.
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`Clozapine is an antipsychotic drug. A National Clozapine Coordinating Center
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`(NCCC) was established in 1994 that required each hospital dispensing clozapine
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`to have a computerized clozapine prescription lockout system, which ties the
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`hospital’s laboratory database to the outpatient pharmacy dispensing software. Id.
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`at 900. The program only allows clozapine prescriptions to be processed when the
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`white blood cell counts are within defined limits, i.e., when certain pre-defined
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`clinical criteria are met. Id. The NCCC guidelines require extensive patient
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`evaluation and documentation. In order to receive clozapine, the patients have to
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`undergo a complete physical examination, including laboratory tests. Id. Patients
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`are screened by the pharmacist to determine eligibility for treatment with
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`clozapine. Id. The pharmacist then sends the information to the NCCC and after
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`approval, the patient is then enrolled in the hospital’s clozapine tracking system
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`and therapy is begun. Id.
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`11. A similar clozapine monitoring system has been instituted at
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`numerous other hospitals throughout the U.S., for example, see the Clozaril Patient
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`Management System (CPMS) as described by Bastani, Exhibit 1004. The CPMS
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`program provides for extensive counseling of patients, including meetings with
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`physicians, psychiatric research technicians and supportive group therapy. Id. at
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`S123. Honigfeld also discusses the Clozapine national registry, which was
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`operating throughout the 1990s, maintaining all patient, physician, pharmacy data
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`in an integrated, computerized database. Exhibit 1008, at 53. Dishman, Bastani
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`and Honigfeld disclose the requirement that patient data is maintained in a
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`computerized storage medium, and prescriptions are distributed only by registered
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`pharmacies when patients’ white blood cell counts (taken weekly) are within an
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`acceptable range. Exhibit 1003, at 900; Exhibit 1004 at S123; Exhibit 1008, at 53.
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` 12.
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`In my opinion, the Clozaril management systems which was in use in
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`both the VA and in numerous hospitals throughout the U.S. well before August
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`1998, is very similar to the method for delivering a drug to a patient while avoiding
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`the occurrence of an adverse side effect in which prescriptions are filled only after
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`a computer database has been consulted, as set forth in claims 1 and 28.
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`13. Similarly, Powell sets forth methods for delivering thalidomide, a
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`drug causing severe adverse side effects and birth defects to patients in need of the
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`drug while avoiding the side effects known or suspected to be associated with the
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`drug. Exhibit 1002.
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`14. Powell discloses the need for testing, i.e. pregnancy testing, of
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`patients prior to the clinical use and dispensing of thalidomide. Exhibit 1002. It
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`also discloses the importance of fully informed consent prior to delivering
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`thalidomide to patients, and continued monitoring throughout treatment, including
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`recordation of adverse events. Id. Powell provides specific guidelines for
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`counseling patients before, during and after treatment, concerning the risks
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`attendant to fetal exposure to said drug and states that before treatment the patient
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`must have a negative pregnancy test. Exhibit 1002 at 901. Dishman and
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`Honigfeld also disclose extensive screening, interviewing and evaluation of
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`patients prior to clearance for clozapine therapy. Exhibit 1003, at 900; Exhibit
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`1006 at 53. The CDC looked to, and recognized key aspects of programs such as
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`the clozapine registry when discussing steps that needed to be taken to protect
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`against the severe adverse events associated with thalidomide administration.
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`Exhibit 1006 at 8.
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`Page 8 of 26
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`15. Mitchell describes another program for the restricted use of
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`isotretinoin, or “Accutane”, which is used for the treatment of severe recalcitrant
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`cystic acne, but was found to be teratogenic in humans. The program was instituted
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`in 1988. Exhibit 1007, at 101. Similar to the programs set in place for thalidomide
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`and clozapine, the program established for isotretinoin clearly describes “a method
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`for delivering a drug to a patient in need of the drug while avoiding the occurrence
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`of an adverse side effect known or suspected of being caused by said drug”.
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`Mitchell describes patient qualification checklists and brochures, contraceptive
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`information and a contraception referral program, a consent form, and the need for
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`pregnancy testing of patients that may be administered the drug. Id. The program
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`was reinforced by periodic communications directed at prescribers and
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`pharmacists. Id.
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`16. Physicians, pharmacies, and pharmaceutical companies have a
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`fundamental obligation to protect patients that stretches back to the time of
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`Hippocrates, “Do no harm.” It is very clear that by the time the patent application
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`was filed in October 2000, the means to protect patients from harm using a
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`computer registration system for pharmacies, patients and physicians was readily
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`available.
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`Page 9 of 26
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`17.
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`It would have been obvious to me to combine the teachings of Powell
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`with Dishman, Bastani, in view of the FDA and CDC Meetings, because each
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`describes methods directed to protecting patients from side effects of dangerous
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`drugs, and the government’s overwhelming and compelling understanding that risk
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`mitigation systems were necessary to protect the public from dangers associated
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`with approved drugs. Anyone in the pharmaceutical industry that worked closely
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`with the FDA at that time, which I did, knew that establishing risk mitigation
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`programs for dangerous drugs required extesnive communication with the FDA,
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`evaluating the pros and cons of what had been done in the past for similar drug
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`products (e.g. drug products used for the same indications or with similar adverse
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`event profiles) and what could be done better going forward to protect patients. It
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`is not a question of whether the combination of teachings was predictable, it was
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`clearly predictable; it is a question of which drug risk mitigation programs to look
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`to for guidance on establishing the method of the ‘720 patent. There were many
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`programs in place, all the steps were there Thus, it was merely a matter of picking
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`and choosing the elements that were readily available to the medical community
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`and then combining them in an entirely predictable manner.
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`18.
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`I come to the same conclusion with respect to combining the
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`teachings of Mitchell, Honigfeld, and the FDA and CDC Meetings. As discussed
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`above, all of the “steps” of the claims in the ‘720 patent are plainly outlined in the
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`references. The motivation to put the steps together are clear from the
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`overwhelming need to protect the public from the clear and present dangers
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`associated with drugs having adverse event profiles. Moreover, the roadmap
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`forward was laid-out from programs set in-place for clozapine and isotretinoin.
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`19. With regards to the diagnostic testing set forth in claims 7 through 10,
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`as a physician and pharmacist, I frequently ordered blood tests, and/or consulted
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`patient records, prior to prescribing a drug. For example, in patients on diuretics, it
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`is the standard of care to check potassium levels prior to prescribing digoxin to
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`avoid arrhythmias. In pharmacy school in 1987, it was taught that prior to
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`dispensing phenytoin to the elderly or infirm, a check of the serum albumin level
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`must be ordered. Phenytoin is a narrow therapeutic index drug that is highly
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`protein bound. This means that the Michaelis-Menten equation for saturable
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`pharmacokinetics (which requires albumin levels) is needed in order to safely dose
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`patients with low albumin levels. In fact, I programed my Radio Shack® computer
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`to calculate corrected phenytoin dosing in light of hypoalbuminemia using the
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`Michaelis-Menten equation in the late 1980’s. Thus, it is of the utmost importance
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`to understand a patient’s health and drug history for proper drug administration, to
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`avoid known or suspected adverse events. It has long been common practice to
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`request or consult diagnostic tests, including pregnancy testing and genetic testing,
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`prior to determining a patient’s risk associated with a potential drug, and deciding
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`whether or not the drug is safe to prescribe. In the case of Accutane, for example,
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`doctors would frequently advise that monthly pregnancy tests should be taken
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`when patients are on drugs that could potentially harm the fetus. In general, drugs
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`do not distribute uniformily in the body - a one compartment pharmacokinetic
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`model. If a drug evenly disturbed throughout the body, blood levels would be
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`entirely predictive of tissue levels, which is no the case. In fact, many drugs are
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`preferentially absorbed by certain body tissues. In these multi-compartment
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`models, blood levels are not predictive of tissue distribution. As such, it is also
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`important to perform diagnostic testing that would be predictive of drug levels in
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`various tissues of interest.
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`20. Similarly, with respect to claims 15 through 19, follow up diagnostic
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`testing, patient interviews and, importantly for women of childbearing age,
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`pregnancy testing on a regular basis, is a matter of routine practice, and obvious, in
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`the course of prescribing drugs to a patient.
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`21. With respect to claim 20, it is very common practice in the medical
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`field to provide drug and medical device samples to patients, when available. As a
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`surgical resident in 1994 and a Urological resident in 1996, I commonly gave drug
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`samples to our clinical patients.
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`22. With respect to claim 27, it would have been obvious to one of
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`ordinary skill in the art to limit prescriptions to 28 days for teratogenic drugs, as
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`this was, and is, standard practice in the industry. Physicians prescribe in units of
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`30 days and 28 days guarantees follow up will not occur on weekends.
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`23. Adverse side effects occurring as a result of concomitant drug use,
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`also termed “drug-drug interactions” are unfortunately common, and frequently
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`lethal. In fact, the Federal Food and Drug Administration requires that “Drug
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`Interactions” be reported on all drug product package inserts, and that warnings be
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`included as to the nature and extent of drug interactions. As stated above, it is
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`necessary to consult a patient’s medical history, conduct patient interviews, and to
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`request or consult diagnostic tests prior to determining a patient’s risk associated
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`with a potential drug, deciding whether or not the drug is safe to prescribe,
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`particularly when the patient takes multiple drugs, and to check drug levels on a
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`regular basis for the purpose of determining whether any dosage adjustments are
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`required. In fact, the FDA’s published guidance on labeling for human
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`prescription drugs requires dosing and administration instructions for concomitant
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`therapy. See U.S. Department of Health and Human Services, Food and Drug
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`Administration, Guidance for Industry – Labeling for Human Prescription Drug
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`and Biological Products – Implementing the PLR Content and Format
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`Requirements (February 2013). I was writing drug package inserts with
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`concomitant therapy warnings in the 1990s, as this FDA requirement has been in
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`place for a long time.
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`24. Regarding the use of facsimile for transmitting data to a computerized
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`database maintaining patient records, the use of optical character recognition
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`software to interpret faxed data records, and calling patients on the telephone, for
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`follow-up or to collect additional patient data, as claimed in claims 6 and 17 of the
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`‘720 patent, were practiced long before October 23, 2000. We used OCR fax
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`technology and patient callback systems at Endo Pharmaceuticals (Algos) prior to
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`2000 in our clinical trials to collect patient data. These were standard practices in
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`the pharmaceutical development industry at that time.
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`25. Thus, all of this information was readily available to the medical
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`community in the 1990s. The overwhelming clinical importance for putting
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`together a computerized registry to control distribution of drugs capable of adverse
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`side effects, particularly those with the potential for birth defects and fatalities, was
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`clearly articulated by the FDA, the CDC and the medical literature. The need for
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`development of a method of delivering a drug that enhances patient safety using a
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`computerized registry, like those done for clozapine, isotretinoin, and even the
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`recommendations for restricted use of thalidomide evidenced in Powell was clear
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`long before 2000. The means to build such a computerized registry were readily
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`available in the 1990s, as evidenced by the clozapine national registry. A
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`computerized registry, counseling, the identification of various at-risk
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`subpopulations, and diagnostic testing to avoid adverse events and side effects was
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`already in place for more than one dangerous drug and as discussed above, it
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`would have been obvious to one of ordinary skill in the art based on other available
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`programs, and required by the FDA, that available methodologies for risk
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`mitigation be researched and if necessary implemented, prior to drug approval.
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`26.
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`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
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`believed to be true; and further that these statements are made with the knowledge
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`that willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under section 1001 of Title 18 of the United States Code,
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`and that such willful false statements may jeopardize the validity of the application
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`or any patent issuing thereon.
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`Page 15 of 26
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`Signed this day of , 2013.
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`________________________
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`Matthew W. Davis M.D. R.Ph.
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`Page 16 of 26
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`Exhibit
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`RESUME OF MATTHEW W. DAVIS M.D. RHP.
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`Page 17 of 26
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`Matthew W Davis, MD, RPh
`2 Erwinna Valley Way • Erwinna • PA 18920
`Cell (267) 261-5882 • Fax (610) 294-5087 • md@davisinfo.com
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`
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`Curriculum Vitae
`
`SUMMARY
`
`Ø “C” level experience, vision & execution
`o Corporate
`§ A key member of executive team (CEO, CFO, etc) that conducted
`the successful sale of URL Pharma for $800,000,000 (not including
`future performance-based payments).
`§ A key member of executive team (CEO, CFO, etc) that conducted
`the successful recap of URL Pharma.
`§ Multiple successful Wall Street interactions.
`o Departmental
`§ Created and then ran multiple departments
`• Medical Affairs (Endo, Reddy Pharmaceuticals & URL
`Pharma)
`• Clinical Development (Reddy Pharmaceuticals & URL
`Pharma)
`• Pharmacovigilance (Endo, Reddy Pharmaceuticals & URL
`Pharma)
`• Materialvigilance (Dermik Laboratories)
`§ Broad FDA experience
`• Division of Anesthesia, Analgesia & Rheumatology Products
`• Division of Special Pathogens and Immunologic Drug
`Products
`• Division of Nonprescription Clinical Evaluation
`• Division of Cardiorenal Drug Products
`• Division of Gastrointestinal and Coagulation Drug Products
`• Division of Dermatologic and Dental Drug Products
`• Division of Anesthetic, Critical Care and Addiction Drug
`Products
`• Division of Anti-Infective Drug Products
`• Office of Hematology and Oncology Products
`• Division of Drug Marketing, Advertising and Communications
`• Office of Compliance
`§
`Intellectual technology – 19 patents in last 5 years
`o Teams
`§
`Integral member of Commercial & Business Development teams.
`§ Proven track record of leading international & corporate teams.
`Ø Proven track record in new drug approvals– 4 NDAs approved in last 5 years.
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`Page 18 of 26
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`EMPLOYMENT HISTORY
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`Chief Medical Officer, Senior Vice President
`URL Pharma / Takeda / Sun Pharma
`Corporate Officer / Reported to CEO
`
`
`October 2005 – Present
`Philadelphia, PA
`
`Key Achievement: By obtaining FDA approval and solely inventing all
`intellectual property for Colcrys®, created vast wealth for the owners of
`URL upon Takeda’s purchase of URL Pharma.
`
`Corporate Strategy: At the time of hiring, there were over 2,000
`unapproved drugs marketed in the US. URL identified colchicine as a
`drug it desired to obtain approval, but had no NDA experience.
`
` Ø
`
` Major contributor to the success of Colcrys®, which led to the sale of
`URL Pharma ($800,000,000 upfront payment by Takeda).
`o Was single member of Clinical / Medical / Pharmacovigilance
`department until the end of Phase III.
`o Responsible for preclinical and clinical program.
`o Led all FDA meetings.
`o Sole inventor of all 17 Orange Book patents.
`o
`Integral member of Colcrys® launch team.
`Ø A key member of team responsible for sale of URL Pharma.
`Ø A key member of team responsible for investor Recap.
`Ø Started up and responsible for Pre-Clinical, Clinical Development,
`Medical Affairs & Pharmacovigilance departments.
`Ø Responsible for robust pipeline of NCEs (non-organic & organic).
`Ø Integral member of multiple teams.
`o Business Development
`o Sales & Commerical Operations
`o Health Care Compliance
`o Production Selection (Portfolio Management)
`
`US Patents Issued: 7601758, 7619004, 7820681, 7906519, 7915269, 7935731,
`7964647, 7964648, 7981938, 8067042, 8093296, 8093297, 8093298, 8097655,
`8231915, 8415395, 8415396, 8440721 & 8440722
`
`
`
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`Page 19 of 26
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`Director, Oncology Clinical Development
`Eisai Global Clinical Research
`
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`May 2005 – September 2005
`Ridgefield Park, NJ
`
`Ø Responsible for development of multiple oncology compounds.
`
`
`
`
`
`Vice President, Clinical Development and Medical Affairs April 2003 – October 2004
`Reddy Pharmaceuticals / Dr. Reddy’s Laboratories
`Bridgewater, NJ
`
`
`Key Achievement: Obtained approval for Amvaz®.
`Corporate Strategy: At the time of my hire, DRL had the innovative idea of
`taking advantage of the time period between the patent expiration of a
`compound and the patent term extension of the compound. The case
`law stated that a DIFFERENT salt of a compound would NOT be protected
`during this time period. Was hired to gain amlodipine maleate (Amvaz®)
`approval prior to Norvasc® (amlodipine besylate) patent term extension
`expiration.
`
` Ø
`
` Started up Clinical Development, Medical Affairs & Pharmacovigilance
`departments.
`Ø Helped gained Amvaz® FDA approval.
`Ø Integral member of Amvaz® launch team.
`Ø Had stable of 12 Amvaz® like opportunities.
`
`
`
`Director, Clinical Development and Medical Affairs
`Dermik Laboratories / Aventis (now Sanofi – Aventis)
`
`
`December 2000 – March 2003
`Berwyn, PA
`
`Key Achievement: Integral member of BenzaClin®, Carac®, Dermatop®,
`Benzamycin® Pak launch teams.
`Corporate Strategy: To be the leading US dermatology company.
`
`Ø Created & ran Medical Affairs
`Ø Headed Clinical Development
`Ø Integral member of BenzaClin®, Carac®, Dermatop®, Benzamycin® Pak
`launch teams
`
`
`
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`Page 20 of 26
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`Manager, Medical Affairs (Head of Medical Affairs)
`Endo Pharmaceuticals
`
`
`July 1998 – November 2000
`Chads Ford, PA
`
`Key Achievement: On team that discovered, helped to gain approval
`and launched Lidoderm®.
`Corporate Strategy: To be the leading US pain company.
`
`Ø Created & ran Medical Affairs & Pharmacovigilance.
`Ø Conducted Lidoderm® phase IV study that was the cornerstone for
`successful launch.
`o Current sales of $1,200,000,000 per year (current IMS MAT)
`
`
`
`
`
`Adjunct Assistant Professor of Pharmacy
`Temple University School of Pharmacy
`
`
`September 1998 – December 2007
`Philadelphia, PA
`
`Ø Lectured on drug development (Pre-clinical to Phase IV).
`Ø Lectured on pharmacovigilance, pharmacoepidemiology, and the role of
`the pharmacist in the pharmaceutical industry.
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`Page 21 of 26
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`
`EDUCATION
`
`Urology Resident (Post Graduate Year 3 and Year 4)
`Washington Hospital Center
`
`Surgery Resident (Post Graduate Year 1 and Year 2)
`Brown University
`
`Doctor of Medicine - Degree
`Medical College of Pennsylvania
`
`Bachelor of Science in Pharmacy – Degree, Cum Laude
`Temple University School of Pharmacy
`
`Undergraduate Pre-pharmacy requirements
`University of Pennsylvania
`
`July 1996 – June 1998
`Washington, DC
`
`July 1994 – June 1996
`Providence, RI
`
`August 1989 – May 1994
`Philadelphia, PA
`
`August 1985 – May 1989
`Philadelphia, PA
`
`August 1983 – May 1985
`Philadelphia, PA
`
`STATE LICENSE
`Ø Registered Pharmacist in Pennsylvania (inactive): RP-036578L
`Ø New York Medical License: 237105
`
`PAST AND PRESENT PROFESSIONAL AFFILIATIONS
`Ø American College of Rheumatology
`Ø American Urological Association
`Ø American Society of Clinical Oncologists
`Ø American Academy of Dermatology
`Ø American Diabetic Association
`Ø American Geriatric Association
`Ø American Medical Association
`Ø American Pain Society
`Ø Drug Information Association
`Ø European Academy of Dermatology and Venereology
`Ø International Academy of Cosmetic Dermatology
`
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`EDITORIAL BOARDS
`Ø Editorial Advisory Board - Journal of Pharmacy Finance Economics and
`Policy (Closed 2008)
`
`
`
`PROFESSIONAL PRESENTATIONS
`
`Conference Chair
`Ø Pharmaceutical Education Associates – Aligning Medical Affairs with
`Marketing: Optimal Drug Promotion Through Innovation and
`Collaboration, Princeton, NJ, April 2004
`Ø Pharmaceutical Education Associates - OIG’s New Compliance Program
`Guidance For Pharmaceutical Manufacturers: What you Need to Know,
`Philadelphia, PA, July 2003
`Ø Pharmaceutical Education Associates - Medical Affairs and Marketing:
`Aligning for Success, Philadelphia, PA, April 2003
`Ø Barnett International - Phase IV & Peri-Approval Clinical Research
`Programs, Philadelphia, PA, February 2003
`
`
`Presentations
`Ø “The Race for Market Share: Capitalizing on Pharmaceutical Growth”,
`Financial Research Associates, LLC – Investing in India: A Road Map to the
`Heart of a Dynamic Emerging Market, New York City, NY, April 2005 (Panel
`Chairman & Presenter)
`Ø “Successful Partnerships Between Medical Affairs and Marketing”,
`Pharmaceutical Education Associates – Aligning Medical Affairs with
`Marketing: Optimal Drug Promotion Through Innovation and
`Collaboration, Princeton, NJ, April 2004
`Ø “Phase IV: The Role of Open-Label Studies in Publications”,
`Pharmaceutical Education Associates - Medical Affairs and Marketing:
`Aligning for Success, Philadelphia, PA, April 2003
`Ø “Phase IV: Is There a Place for Open Label, Community-Based Trials?”,
`Pharmaceutical Education Associates - The New Business of Clinical Trials:
`Cost, Quality and Time, Philadelphia, PA, March 2003
`Ø “Open Label Studies: Publication Challenges and Solutions”, Barnett
`International - Phase IV & Peri-Approval Clinical Research Programs,
`Philadelphia, PA, February 2003
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`Ø “Conducting Phase IV Physician Awareness Trials- How to maximize your
`product's exposure while staying in regulatory compliance”, Barnett
`International - Phase IV Clinical Research Programs, Philadelphia, PA,
`February 2002
`Ø “Conducting Phase IV Non-Inferiority Trials to Address Competition Issues”,
`Barnett International - Phase IV Clinical Research Programs, Philadelphia,
`PA, February 2002
`Ø “Strategies for Cost Management in Physician Awareness Trials”, Barnett
`International - Cost Management in Clinical Trials, Philadelphia, PA, March
`2002
`
`
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`Page 24 of 26
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`

`
`PUBLICATIONS
`Ø Davis MW, Wason S, Digiacinto JL. Colchicine-antimicrobial drug interactions:
`What pharmacists need to know in treating gout. Consult Pharm. 2013
`Mar;28(3):176-83.
`Ø Wason S, Digiacinto JL, Davis MW. Effect of cyclosporine on the
`pharmacokinetics of colchicine in healthy subjects. Postgrad Med. 2012
`Jul;124(4):189-96.
`Ø Wason S, DiGiacinto JL, Davis MW. Effects of grapefruit and Seville orange
`juices on the pharmacokinetic properties of colchicine in healthy subjects.
`Clin Ther. 2012 (Article in Press, Corrected Proof) August 30.
`Ø Wason S, Faulkner RD, Davis MW. Are dosing adjustments required for
`colchicine in the elderly compared with younger patients? Adv Ther. 2012
`Jun 29;29(6):551-6.
`Ø Nasr A, Lauterio TJ, Davis MW. Unapproved drugs in the United States and the
`food and drug administration. Adv Ther. 2011 Oct;28(10):842-56.
`Ø Terkeltaub RA, Furst DE, Digiacinto JL, Kook KA, Davis MW. Novel evidence-
`based colchicine dose-reduction algorithm to predict and prevent
`colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein
`inhibitors. Arthritis Rheum. 2011 Aug;63(8):2226-37.
`Ø Terkeltaub RA, Furst DE, DiGiacinto JL, Kook KA, Davis MW. Erratum: Novel
`evidence-based colchicine dose-reduction algorithm to predict and prevent
`colchicine toxicity in the presence of cytochrome P450 3A4. Arthritis Rheum.
`2011;63(11):3521.
`Ø Wertheimer AI, Davis MW, Lauterio TJ. A new perspective on the
`pharmacoeconomics of colchicine. Curr Med Res Opin. 2011 May;27(5):931-
`7.
`Ø Davis MW. Colchicine ignites controversy. Rheumatol News. 2010
`March;9(3):13.
`Ø Godfrey, A.R., J. Digiacinto, and M.W. Davis, Single-Dose Bioequivalence of
`105-mg Fenofibric Acid Tablets Versus 145-mg Fenofibrate Tablets Under
`Fasting and Fed Conditions: A Report of Two Phase I, Open-Label, Single-
`Dose, Randomized, Crossover Clinical Trials. Clin Ther, 2011. 33(6): p. 766-75.
`Ø Terkeltaub, R., D. Furst, et al. (2010). "High Versus Low Dosing of Oral
`Colchicine for Early Acute Gout Flare: Twenty-Four-Hour Outcome of the First
`Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
`Dose-Comparison Colchicine Study." Arthritis Rheum 62(4): 1060-1068.
`Ø Weiss JW, Shavin J, Davis MW. Improving Patient Satisfaction and Acne
`Severity in Patients with Mild to Moderate Acne: The BEST Study. Cutis 2003; 71
`(suppl 2):3-4.
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`Page 25 of 26
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`Ø Rist T, Davis MW. Study Design and Selection Criteria in the BEST Study. Cutis
`2003; 71 (suppl 2):5-9.
`Ø Weiss JW, Shavin J, Davis MW. Overall Results of the BEST Study Following
`Treatment of Patients with Mild to Moderate Acne. Cutis 2003; 71 (suppl 2):10-
`17.
`Ø Fernandez-Obregon A, Davis MW. The BEST Study: Evaluating Efficacy by
`Selected Demographic Subsets. Cutis 2003; 71 (suppl 2):18-26.
`Ø Rodriguez D, Davis MW. The BEST Study: Results According to Prior Treatment.
`Cutis 2003; 71 (suppl 2):27-34.
`Ø Gammaitoni AR, Davis MW. Pharmacokinetics and Tolerability of Lidocaine
`Patch 5% with Extended Dosing. Annals of Pharmacotherapy 2002; 36:236-40.
`Ø Weiss JW, Shavin J, Davis MW. Preliminary Results of a Nonrandomized,
`Multicenter, Open-Label Study of Patient Satisfaction after Treatment with
`Combination Benzoyl Peroxide/Clindamycin Topical Gel for Mild to Moderate
`Acne. Clinical Therapeutics 2002; 24:1706-17.
`Ø Gammaitoni AR, Davis MW. Comparison of the Pharmacokinetics of
`Oxycodone Administered in Three Percocet Formulations. Journal of Clinical
`Pharmacology 2002; 42:192-7.
`Ø Katz NP, Gammaitoni AR, Davis MW, Dworkin RH. Lidocaine Patch 5%
`Reduces Pain Intensity and Interference with Quality of Life in Patients with
`Postherpetic Neuralgia: An Effectiveness Trial. Pain Medicine 2002; 3:324-32.
`
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