Exhibit 1007
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`DECLARATION OF MATTHEW W. DAVIS M.D. RPH.
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`Page 1 of 27
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`CELGENE EXHIBIT 2036
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
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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. 6,045,501 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 27
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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, a B.S. in Pharmacy from Temple University School of Pharmacy. I did an
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`internship in surgery, followed by a residency in urology. I am a pharmacist, R.Ph,
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`as well as a licensed physician.
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`3.
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`Since 1998, I have directed clinical development, medical affairs and
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`pharmacovigilance at a number of different companies. These companies include,
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`Endo Pharmaceuticals, Dermik Laboratories, Dr. Reddy’s Laboratories, Eisai
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`Global 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. 6,045,501, its file history as well as
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`the prior art cited in the Petition: (i) Dishman et al. (Am. J. Hosp. Pharm 51: 899
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`(1994), (“Dishman”), Exhibit 1004); (ii) Bastani et al. (Psychopharmacology
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`99:S122 (1989), (Bastani”), Exhibit 1005); (iii) Powell et al. (Postgrad. Med. J.
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`70:901 (1994), (“Powell”), Exhibit 1006); (iv) Mitchell et al. (New England J.
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`Med. 333(2):101 (1995), (“Mitchell”), Exhibit 1008); (v) Honigfeld (Psychiatric
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`Services 47:52 (1996), (“Honigfeld”) (Exhibit 1009); (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 1010 (a) and (b); and (vii) CDC Meeting (Centers for Disease
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`Control, Preventing Birth Defects, March 26, 1997, (Exhibit 1011) (the “CDC
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`Meeting”)).
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`6.
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`Dishman discloses a program instituted by the Department of
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`Veterans Affairs (VA) for controlling the dispensing of an antipsychotic drug,
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`clozapine. Exhibit 1004, Abstract. Because clozapine treatment is associated with
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`a number of serious and potentially fatal serious side effects, its use needs to be
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`tightly controlled. Exhibit 1005 at S122. In 1994, the VA developed a clozapine
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`monitoring program. Exhibit 1004 at 900. A National Clozapine Coordinating
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`Center (NCCC) was established. Id. The NCCC required that each hospital have a
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`computerized clozapine prescription lockout system, which ties the hospital’s
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`laboratory database to the outpatient pharmacy dispensing software. Id. The
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`program only allows clozapine prescriptions to be processed when the white blood
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`cell counts are within defined limits, i.e., when certain pre-defined clinical criteria
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`are met. Id. The NCCC guidelines require extensive patient evaluation and
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`documentation. In order to receive clozapine, the patients have to undergo a
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`complete physical examination, including laboratory tests. Id. Patients are
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`screened by the pharmacist to determine eligibility for treatment with clozapine.
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`Id. The pharmacist then sends the information to the NCCC and after approval,
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`the patient is then enrolled in the hospital’s clozapine tracking system and therapy
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`is begun. Id. In other words, the clozapine monitoring system in the VA, provides
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`for (i) “registration into one or more computer readable storage media of the
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`prescriber, pharmacy and patient”; (ii) “a means to monitor and authorize
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`distribution of contraindicated drugs, including teratogenic drugs”; and (iii) denial
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`of “dispension or prescriptions of contraindicated drugs, including teratogenic
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`drugs, to patients, pharmacies or prescribers who fail to abide by the methods of
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`the present invention”. Exhibit 1001 at 10:13-20. A similar clozapine monitoring
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`system has been instituted at numerous other hospitals throughout the U.S., for
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`example, see the Clozaril Patient Management System (CPMS), Exhibit 1005.
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`The CPMS program provides for extensive counseling of patients, including
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`meetings with physicians, psychiatric research technicians and supportive group
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`therapy. Id. at S123.
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`7.
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`In my opinion, the Clozaril management systems in use in both the
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`VA and in numerous hospitals throughout the U.S. well before August 1998, is
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`very similar to the thalidomide monitoring and registration system set forth in
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`claim 1. The fact that the Clozaril is a potentially lethal drug as opposed to
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`teratogenic is not relevant. Regardless of whether a drug is lethal or teratogenic,
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`physicians, pharmacies, pharmaceutical and companies have a fundamental
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`obligation to protect patients that stretches back to the time of Hippocrates, “Do no
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`harm.” The means to protect patients from harm using a computer registration
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`system for pharmacies, patients and physicians was readily available in the 1990s.
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`8.
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`Powell provides guidelines for the clinical use and dispensing of
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`thalidomide. Exhibit 1006. Specifically, pregnancy should be excluded before
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`instituting therapy with thalidomide by a negative pregnancy test within 2 weeks
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`prior to starting therapy. Id. at 901. Patients should be specifically excluded from
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`treatment with thalidomide if: (i) they are unwilling to sign a consent form; (ii)
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`unable to understand the potential risk from taking the drug or are unable to
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`comply with prescribing instructions; (iii) the woman wishes to become pregnant;
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`and, (iv) are women of childbearing potential who have (a) not practiced a reliable
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`form of contraception for 1 year, (b) are unwilling to take reliable contraception or
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`(c) are not capable of complying with these requirements. Id. Patients undergoing
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`treatment with thalidomide should be monitored before, after and during treatment.
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`Id. Each patient being treated with thalidomide should be given an information
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`sheet and the physician writing the prescription must inform the patient of any
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`contraindications, warnings and precautions associated with use of the drug. Id.
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`9.
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`Powell clearly sets forth methods for delivering thalidomide to
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`patients in need of the drug while avoiding exposure of the foetus to the drug
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`(preamble). Dishman and Bastani disclose computerized programs for registering
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`prescribers such as physicians, pharmacies and patients, which in the case of the
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`VA ties the hospital’s laboratory database to the outpatient pharmacy dispensing
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`software and only allows clozapine prescriptions to be processed when certain
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`clinical criteria are met Exhibit 1004 at 900. Powell lays out explicit guidelines
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`for identification of women of childbearing potential. Exhibit 1006 at 901.
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`10. Dishman, Bastani and Powell all disclose the use of comprehensive
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`counseling to the patients both before, after and during treatment. Exhibits 1004-
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`1006. Powell provides specific guidelines for counseling patients concerning the
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`risks attendant to fetal exposure to said drug and states that before treatment the
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`patient must have a negative pregnancy test. Exhibit 1006 at 901.
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`11. The guidelines laid-out in Powell are very clear. No one wanted a
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`repeat of the horrors seen in the 1960s when thalidomide was introduced
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`Integrating the guidelines laid out in Powell with the clozapine computerized
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`management systems would have been obvious to everyone, physicians,
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`pharmacists, pharmaceutical companies and even patients. Based on the medical
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`literature which clearly showed a decrease in both mortality and morbidity when
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`such controls were implemented, the outcome of such an integration would not
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`only have been entirely predictable, but also highly desirable.
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`12. Finally, Dishman and Bastani disclose both registered pharmacies and
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`prescribers who require authorization in order to dispense the drug. Exhibit 1004
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`and 1005. Powell makes it clear that thalidomide should only be dispensed to a
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`patient who is not pregnant. Exhibit 1006.
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`13. The Clozaril systems establish computerized systems for controlling,
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`i.e., authorizing dispensing of the drug. Adding in a requirement that a patient
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`needs not to be pregnant before taking a teratogenic drug such as thalidomide
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`would be an absolute requirement. One does need even need a clear teaching of
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`this in the medical literature, but, nonetheless, Powell states the requirement
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`explicitly, in short, do not give thalidomide to someone who is pregnant.
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`14. As a physician, pharmacist and medical director of numerous
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`pharmaceutical companies, it would have been obvious to me to combine Dishman
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`and Bastani together with Powell to develop a computerized monitoring system to
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`provide a means to monitor and authorize distribution of contraindicated drugs,
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`including teratogenic drugs which could deny access, dispensing or prescriptions
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`oto patients, pharmacies or prescribers who fail to comply with certain, well
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`defined criteria. Exhibit 1007. Clearly, drugs such as clozapine, which have
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`potentially lethal side effects are contraindicated and administration must be tightly
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`controlled in order to avoid harming patients. Moreover, there would have been an
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`overwhelming motivation as well as a compelling need to create such a system
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`given the disaster with thalidomide in the early 1960s. Thus, for the reasons set
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`forth in the paragraphs above, the combination of the computerized monitoring
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`system drug monitoring and registration systems disclosed in Dishman and Bastani
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`together with the guidelines in Powell would have been entirely predictable.
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`15. With regards to claim 3, “[t]he method of claim 1 further comprising
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`including in said registering information concerning male patients who are capable
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`of impregnating females and including said males within said subpopulation”, it
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`would have been obvious to one of ordinary skill in the art to include male patients
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`who are capable of impregnating females in the registration.
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`16. Both physicians and pharmacists routinely limit the amounts of a drug
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`such as thalidomide that are prescribed. Accordingly, it would have been obvious
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`to one of ordinary skill in the art to limit prescriptions to 28 days (claim 7. “The
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`method of claim 1 wherein said prescriptions are filled for no more than about 28
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`days.”
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`17. Claim 10 states the “method of claim 1 further comprising: h.
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`providing to said patients who are capable of becoming pregnant a contraceptive
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`device or formulation.” Powell lists as criteria for exclusion, women of
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`childbearing potential who are not practicing reliable contraception, including,
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`contraceptive pill or an intrauterine device. Exhibit 1006 at 900. Both
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`contraceptive pills and intrauterine devices provide a means for practicing reliable
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`contraception. It is very common practice in the medical field to provide drug as
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`well as medical device samples to patients, when available. For example, 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. It would therefore have been obvious to one of
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`ordinary skill in the art to provide either a contraceptive device or formulation to a
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`patient in order to enable them to be eligible to receive thalidomide treatment.
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` 18. Isotretinoin, Accutane, is a vitamin A analogue that was introduced
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`into the U.S. to treat recalcitrant acne. Exhibit 1008 at 101. Based on animal
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`studies there was concern that the isotretinoin might be teratogenic in humans. Id.
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`These fears proved true and as many as 30% of the exposed fetuses had
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`devastating birth defects. Id. Instead of pulling the drug off the market, the
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`manufacturer of the drug proposed an aggressive program to reduce the risk of
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`pregnancy. Id. This program was implemented in 1988.
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`“The program was targeted at both prescribers and patients. In late 1988,
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`materials were distributed to every dermatologist and to all
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`nondermatologists identified as prescribers of isotretinoin in the United
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`States. The materials included guidelines for physicians (instructing them,
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`for example, to warn patients of risks, obtain negative pregnancy tests, and
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`delay therapy until the second or third day of the next normal menstrual
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`period). They also included a patient-qualification checklist, an information
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`brochure for patients, contraceptive information, information about and the
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`necessary forms for a contraception referral program (in which the
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`manufacturer would reimburse patients for a visit to another physician for
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`contraceptive counseling), and a consent form. In addition, in mid-1989 the
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`manufacturer replaced traditional medication bottles with a 10-capsule
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`blister pack that contained information directed specifically at women: the
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`package included warnings about the risks of becoming pregnant while
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`taking isotretinoin or during the month after treatment, an “avoid pregnancy”
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`icon behind each capsule, and line drawings of malformations associated
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`with isotretinoin. The program was reinforced by periodic communications
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`directed at prescribers and pharmacists.” Id.
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`19.
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`Honigfeld discloses the following information about the Clozapine
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`national registry, which was operating throughout the 1990s.
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`• “All data coming into the Clozapine national registry are entered into an
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`integrated, computerized database maintained by the manufacturer”.
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`• The national registry clears each potential candidate for clozapine therapy to
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`reduce the chances of reexposure to the medication by persons at increased
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`risk of developing agranulocytosis.”
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`• Clozapine national registry mandated blood testing (WBC) and only patients
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`with acceptable WBC could be treated. Patients must routinely have WBC
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`tested.
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`• The registry system outlines the responsibilities of physicians, pharmacies,
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`patients and distributors.
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`• Clozapine was made available only through registered treatment centers via
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`the Clozapine national registry.
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`• All patients must be cleared through the Clozapine national registry.
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`Pharmacists were cleared via the Clozapine national registry. Exhibit 1009.  
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`20. Mitchell clearly sets forth that with teratogenic drugs one needs to
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`develop or have in-place “a method for delivering a teratogenic drug to patients in
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`need of the drug while avoiding the delivery of said drug to a foetus” with regards
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`to isotretinoin. Exhibit 1008.
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`21. 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 thalidomide. Nowhere was this
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`fact made clearer than in meetings held in 1997 by the FDA and CDC. I found the
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`following statement from these meetings especially informative.
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`22. Dr. Bruce Williams, one of the named inventors, acknowledged that
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`the Clozaril management program could be used as a starting point. “Sandoz
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`developed a program that, from a practical perspective, ensures that patients have
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`had their white blood counts taken prior to the dispensing of their next
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`prescription, and that those white blood count numbers are in the appropriate
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`range.” (Exhibit 1010 (a) at 112).
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`23. Next, Dr. Bergfeld recommended the system (STEPS) “What I would
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`like to recommend is that registry for the physician include that they have signed
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`off on an informed consent that they have been informed about the information,
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`they have read it, and they agree to participate in that manner. ” Dr. Williams then
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`responded “That is reasonable.” (Exhibit 1010 (a) at 121).
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`24. 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 1010(a) at 220).
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`25. 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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`1010(b) at 159).
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`26. The CDC Meeting held in March clearly articulated that the FDA was
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`looking at other drug monitoring programs as guidance on how to manage
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`Thalidomide distribution. These programs, included: (i) restricted distribution
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`(Fentanyl, Oralet); (ii) limited quantity(Clozaril); (iii) consent (Accutane,
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`Felbatol); (iv) laboratory testing (Clozaril/ requiring a white blood count); (v)
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`registry (AZT, Acyclovir); and, (vi) patient/provider education (Accutane).
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`Further, the use of “informed consent form details the birth defects caused by
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`thalidomide, as well as other side effects of the drug…[describing] birth control
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`measures that should be used by men and women taking the drug” was also
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`discussed. Exhibit 1011 at 8.
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`27. Thus, claims 1-10 would have been obvious to me over Mitchell in
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`view of Honigfeld, the FDA Meeting, the CDC Meeting and Powell to develop a
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`computerized monitoring system to provide a means to monitor and authorize
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`distribution of contraindicated drugs, including teratogenic drugs which could deny
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`access, dispensing or prescriptions to patients, pharmacies or prescribers who fail
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`to comply with certain, well defined criteria. All of this information was readily
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`available to the medical community in the 1990s. The overwhelming clinical
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`importance for putting together a computerized registry to control distribution of
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`thalidomide was clearly articulated by the FDA, the CDC and the medical
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`literature. The need for development of a computerized registry for thalidomide
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`like what was done for clozapine in the 1990s was clear. The means to build such
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`a computerized registry were readily available in the 1990s. The combination of
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`the computerized registry, counseling and the identification of various at-risk
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`subpopulations, such as pregnant women would have been obvious to one of
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`ordinary skill in the art and the outcome of such a combination entirely predictable.
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`28.
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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 16 of 27
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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 17 of 27
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`Exhibit
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`RUSUME OF MATTEW W. DAVIS M.D. RHp.
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`Page 18 of 27
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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.
`
`Page 19 of 27
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`EMPLOYMENT HISTORY
`
`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 20 of 27
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`Director, Oncology Clinical Development
`Eisai Global Clinical Research
`
`
`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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`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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`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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`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.
`
`Page 26 of 27
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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 B