Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 1 of 68 PageID #: 13551
`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 1 of 68 PagelD #: 13551
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`EXHIBIT 14
`EXHIBIT 14
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`

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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 2 of 68 PageID #: 13552
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 22-252-MSG
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Counterclaim-Plaintiffs,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`
`
`)
`)
`)
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`DECLARATION OF PROFESSOR STEPHEN BYRN
`
`1.
`
`I, Professor Stephen Byrn, hereby declare as follows:
`
`I.
`
`INTRODUCTION
`
`2.
`
`3.
`
`I am the Charles B. Jordan Professor of Medicinal Chemistry at Purdue University.
`
`I have been retained by Defendants Moderna, Inc. and ModernaTX, Inc.
`
`(collectively, “Moderna”) in connection with the above-captioned lawsuit.
`
`II.
`
`BACKGROUND AND ASSIGNMENT
`A.
`
`The Suit
`
`4.
`
`I have been advised by counsel for Moderna that Arbutus Biopharma Corp. and
`
`Genevant Sciences GmbH (collectively, “Plaintiffs”) have asserted patents including U.S. Patent
`
`Nos. 8,058,069 (the “’069 Patent”), 8,492,359 (the “’359 Patent”), 8,822,668 (the “’668 Patent”),
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`
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`

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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 3 of 68 PageID #: 13553
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`
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`9,364,435 (the “’435 Patent”), and 11,141,378 (the “’378 Patent”) (collectively, the “Molar Ratio
`
`Patents”) against Moderna. I have reviewed and analyzed the Molar Ratio Patents in connection
`
`with the opinions I express herein.
`
`B. Moderna’s COVID-19 Vaccine
`
`5.
`
`Moderna’s COVID-19 Vaccine, “mRNA-1273,” is an FDA-approved drug
`
`product.1 mRNA-1273 contains four lipids: SM-102, polyethylene glycol [PEG] 2000 dimyristoyl
`
`glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC].2
`
`C.
`
`6.
`
`The Discovery Dispute
`
`I understand that Plaintiffs have requested drug product samples from all batches
`
`of drug product of Moderna’s COVID-19 Vaccine, and specifically samples of drug product that
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`contain 100 milligrams of lipid content per batch.
`
`7.
`
`I have been advised by counsel that Moderna assigns “part numbers” to
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`differentiate between formulations and processes used to make the drug product. For example,
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`Moderna’s drug product with part number
`
` is manufactured as a
`
` mL vial with a
`
`specification that requires lipid content of
`
` MRNA-GEN-00456568 (Exhibit #A). One
`
`drug product vial of part number
`
` would comprise
`
` mg total lipid content.
`
`8.
`
`I have been further advised by counsel for Moderna that, in response to Plaintiffs’
`
`sample request, Moderna has offered to produce 3 drug product samples for each part number that
`
`
`1 https://purplebooksearch.fda.gov/productdetails?query=125752.
`2 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f96b315c-fa57-4876-a7e5-
`a9b584d8e6e6
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`2
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`

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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 4 of 68 PageID #: 13554
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`has been manufactured in the U.S.3 and has objected to the production of the volume of samples
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`requested by Plaintiffs on the grounds of relevance and disproportionality to the needs of the case.
`
`9.
`
`I have been further advised by counsel for Moderna that Plaintiffs have filed an
`
`application to the Court in this case seeking an order compelling Moderna to produce samples
`
`from all batches of drug product of Moderna’s COVID-19 Vaccine in response to Plaintiffs’ RFP
`
`seeking “50 vials of the Accused Product from each lot referenced in Biologics License
`
`Application 125752 or that has otherwise been manufactured by or on behalf of Moderna.” I
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`understand that Plaintiffs have requested sufficient vials to comprise “100 mg of lipid” for each
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`lot.
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`D.
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`10.
`
`Assignment
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`I have been asked by counsel for Moderna to consider (1) whether “100 mg of lipid”
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`for each batch is necessary to conduct testing for lipid content (2) whether Plaintiffs’ justification
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`that they need samples in order to determine the lipid content in individual LNPs is scientifically
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`sound.
`
`11.
`
`To answer these questions, I have considered the materials identified herein, and
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`rely on my education, professional training, and expertise in medicinal chemistry as well as my
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`general knowledge of chemistry, which I have developed in over 50 years of experience as a
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`professor of medicinal chemistry.
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`12.
`
`I am being compensated for my time spent working on this matter at a rate of $850
`
`per hour. I have no financial interest in the outcome of this case.
`
`
`3 I have been informed that Moderna transitioned from drug product vials to single-dose
`syringes and that for such batches Moderna would provide an equivalent number of syringe
`samples.
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`
`
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`3
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`

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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 5 of 68 PageID #: 13555
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`
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`III.
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`PROFESSIONAL BACKGROUND & TESTIMONY
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`13.
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`I received a Ph.D. in Chemistry from the University of Illinois in 1970 and was a
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`post-doctoral fellow at UCLA from 1970 to 1972. In 1972, I became a professor in the Medicinal
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`Chemistry and Pharmacognosy Department at Purdue University. I was Head of the Department
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`of Medicinal Chemistry and Pharmacognosy at Purdue University in the School of Pharmacy and
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`Pharmaceutical Sciences from 1988-1994. I was the Director of the Center for AIDS Research at
`
`Purdue form 1988 until 1998, and I was the Head of the Department of Industrial and Physical
`
`Pharmacy from 1994 to 2009. I became the Charles B. Jordan Professor of Medicinal Chemistry
`
`in 1992.
`
`14.
`
`I am an author of over 225 peer-reviewed publications in technical journals on
`
`topics relating to solid-state chemistry, analysis, formulation, X-ray crystallography, stability,
`
`medicinal chemistry, chemistry, and the like. I am also co-author of the three leading books in the
`
`field of solid-state chemistry of pharmaceuticals. My most recent book was published by Wiley in
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`2017 and is entitled “Solid State Properties of Pharmaceutical Materials.” Under my supervision,
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`over 50 students and post-doctoral associates have published numerous papers and theses on many
`
`different compounds and formulations.
`
`15.
`
`I have taught numerous courses as outlined in my Curriculum Vitae, attached as
`
`Exhibit B. At Purdue I co-authored a book entitled Quantitative Pharmaceutical Chemistry and
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`lectured on HPLC. I have continued to lecture and work with HPLC since then. I have also taught
`
`at the federal Food and Drug Administration and have given I have also given over 270 invited
`
`lectures and symposium talks and presentations on solid-state chemistry, analysis, polymorphs,
`
`and similar topics.
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`
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`4
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 6 of 68 PageID #: 13556
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`16.
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`I have used a wide range of analytical methods to characterize pharmaceuticals
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`including HPLC, X-ray diffraction, NMR spectroscopy, environmental scanning electron
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`microscopy, differential scanning calorimetry, thermal gravimetric analysis, IR spectroscopy,
`
`Raman spectroscopy, moisture sorption analysis, thermal microscopy, and dissolution.
`
`17.
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`I am the past Chair of the Pharmaceutical Sciences Advisory Committee at the
`
`FDA. The role of that Committee is to advise the FDA on polymorphism issues, biopharmaceutical
`
`issues, as well as general chemical manufacturing control issues, including formulation,
`
`dissolution, and hydrates. I am the former Chair of the Drug Substances Technical Committee of
`
`the Product Quality Research Institute (PQRI) where, to improve drug quality, we discussed three
`
`main areas: (1) specifications, (2) particle size, and (3) chemical impurities.
`
`18.
`
`I am also past Chair of the Chemistry 5 Expert Committee at the USP (United States
`
`Pharmacopeia), and a past member of the Council of Experts at the USP. As part of my work on
`
`the Chemistry 5 Committee, I advised on over 500 monographs of the USP many of which
`
`included HPLC analyses.
`
`19.
`
`In my laboratory, we are currently making lipid nanoparticles utilizing cationic
`
`lipids to encapsulate small molecule drugs. We routinely utilize HPLC and mass spectrometry to
`
`analyze these lipid nanoparticles.
`
`20. My prior testimony is attached in Exhibit #C.
`
`IV.
`
`SUMMARY OF OPINIONS AND CONCLUSIONS
`
`21.
`
`Based on my review of the materials cited in this declaration, it is my opinion that
`
`Moderna’s use of an HPLC/UHPLC procedure to measure lipid content of each batch of its
`
`COVID-19 vaccine is reliable, standard method to determine lipid content. Genevant and the
`
`named inventors similarly use an HPLC/UHPLC method to measure lipid content.
`
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`5
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 7 of 68 PageID #: 13557
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`22.
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`I am not aware of any method for determining the lipid content of an isolated single
`
`LNP in Moderna’s COVID-19 vaccine, let alone a method that would generate reliable or
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`scientifically sound results.
`
`23.
`
`It is also my opinion that Plaintiffs’ request for 100 mg of lipid for each drug
`
`product batch is excessive and far more than what is needed to measure lipid content. I am not
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`aware of any analytical techniques for determining lipid content that would require such large
`
`amounts of sample.
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`24.
`
`It is also my opinion that 3 drug product samples for each part number is more than
`
`an adequate amount of lipid for Plaintiffs to analyze lipid content.
`
`V.
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`OPINIONS
`A.
`
`Scientific Background Information
`1.
`
`Lipid Nanoparticles
`
`25.
`
`Lipid nanoparticles (“LNPs”) are drug delivery vehicles comprising lipids—fatty
`
`compounds that are generally insoluble in water. The LNPs at issue here comprise four separate
`
`lipid components: a PEG lipid, cholesterol, a phospholipid, and an ionizable (referred to here as a
`
`cationic) lipid.
`
`26.
`
`LNPs vary in size but are generally around 50-150 nanometers, which is thousands
`
`of times smaller than a grain of sand.
`
`2.
`
`Analytical Methods
`
`27.
`
`Various analytical chemistry techniques are referred to in this declaration and in
`
`the case materials I have considered for purposes of my analysis. These analytical chemistry
`
`techniques include HPLC, UHPLC, and mass spectrometry among others.
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`6
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 8 of 68 PageID #: 13558
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`28.
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`I have been advised by counsel for Moderna that Plaintiffs have not identified what
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`analytical method for lipid quantification that they will rely on in this case, if any, and have not
`
`identified any method that justifies the amount and quantity of samples they are seeking.
`
`a.
`
`HPLC and UHPLC
`
`29.
`
`High performance liquid chromatography (“HPLC”) and ultrahigh performance
`
`liquid chromatography (“UHPLC” or “UPLC”) are techniques used to separate compounds in
`
`mixtures while in solution. HPLC and UHPLC/UPLC operate on the same principles. For both,
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`separations occur on a stationary phase (usually silica or chemically derivatized silica) that is
`
`packed into a column. Solvent (called the mobile phase) is pumped through the column, and a
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`compound mixture is injected into the flowing solvent and onto the column. Due to differences in
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`interactions between the stationary phase and the compounds in the mixture such as adsorption,
`
`the compound mixture can be separated as it flows through the column such that each compound
`
`elutes (is washed out or removed) at a different time.
`
`30.
`
` Using standard equipment and methodology, you cannot inject 100 mg of lipids
`
`into an HPLC/UHPLC column.
`
`31.
`
`HPLC/UHPLC is generally considered a standard method for measuring lipid
`
`content.
`
`32.
`
`In Plaintiffs’ expert David H. Thompson’s Markman declaration concerning the
`
`Molar Ratio Patents, he cites articles showing that HPLC is a preferred method for measuring lipid
`
`content. See D.I 181, J.A. 29 (Thompson Decl.) at ¶ 56 citing P. Tam et al., Stabilized plasmid-
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`lipid particles for systemic gene therapy, Gene Therapy, vol. 7, pp. 1867-74 (2000) (“Tam 2000”)
`
`and J. Heyes et al., Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates
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`
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`7
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 9 of 68 PageID #: 13559
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`suitable for use in drug delivery, Journal of Controlled Release, vol. 112, pp. 280-90 (2006)
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`(“Heyes 2006”).
`
`33.
`
`HPLC/UHPLC cannot be used to determine the lipid content of an isolated single
`
`LNP.
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`b.
`
`Mass spectrometry
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`34.
`
`Liquid chromatography-mass spectrometry and LC-tandem mass spectrometry
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`involve the interfacing of HPLC or UHPLC to a mass spectrometer or a mass spectrometer capable
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`of analyzing the sample using the MS/MS technique. Mass spectrometers convert molecules to gas
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`phase ions that are then separated and analyzed in an electromagnetic field according to their mass-
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`to-charge properties. High resolution mass spectrometers can analyze ions with such accuracy that
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`the elemental compositions of the ions can be determined. Tandem mass spectrometers provide a
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`second dimension of ion characterization by selecting a specific precursor ion, fragmenting it
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`(usually using a gas phase process called collision-induced dissociation) and then recording all or
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`specific fragment ions that provide structural information about the precursor ion.
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`35. Mass spectrometry cannot be used to determine the lipid content of an isolated
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`single LNP.
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`B. Molar Ratio Patents
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`36.
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`The Molar Ratio Patents do not refer to any analytical method for measuring lipid
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`content in the specification or the claims.
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`37.
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`Dr. Kieu Lam, named co-inventor of the Molar Ratio Patents, used HPLC to
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`analyze lipid content,
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`8
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 10 of 68 PageID #: 13560
`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 10 of 68 PagelD #: 13560
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`Cc.
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`38.
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`Genevant Uses HPLC/UHPLC to Measure Lipid Content
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`I understand that Genevant has stated in a discovery response that “lipid content
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`and/orlipid molarratio of a lipid composition may be determined using liquid chromatography,
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`such as high-performance liquid chromatography (“HPLC”) or reverse phase HPLC (“RP-
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`HPLC”), coupled to a suitable detector, such as an evaporative light scattering detector (““ELSD”)
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`or a charged aerosol detector (“CAD”). Other methods such as mass spectrometry may also be
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`used.” Genevant Responses to Moderna’s Third Set of Interrogatories at 6-7 (Interrogatory No.
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`13).
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`39.|Genevant developed a method usingls
`
`[ ‘
`
`0 ie7
`[oT
`ee
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`o
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`4
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`1 milligram (mg) is 1000 micrograms(1g).
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 11 of 68 PageID #: 13561
`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 11 of 68 PagelD #: 13561
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`||Nan&Oo
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`E.
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`48.
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`Other Analytical Methods
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`Tamnot aware of any procedure for determining lipid content of an LNP that would
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`require more than 100 pg oflipid content.
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`F.
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`49.
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`Lipid Content Testing for Individual LNPs
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`There are likely millions if not trillions of individual LNPs in a given dose of
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`Moderna’s COVID-19 vaccine. As stated above, LNPs vary in size but are generally around 50-
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`150 nanometers, which is thousands of tumes smaller than a grainof sand.
`10
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 12 of 68 PageID #: 13562
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`50.
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`Plaintiffs’ Motion indicates that they seek to perform testing to measure the lipid
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`content in individual lipid particles (“that testing measures the aggregate concentrations of lipids
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`in a batch; it does not measure the lipid ratio of LNPs amongst the trillions of particles in each
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`batch.”). Applying Plaintiffs’ interpretation of the Molar Ratio Patent claims, I am not aware of
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`any method for isolating a single LNP. Similarly, I am not aware of any method for determining
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`the lipid content of an isolated single LNP. As stated above, HPLC/UHPLC cannot be used to
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`determine the lipid content of an isolated single LNP.
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`51.
`
`The Molar Ratio Patents do not describe any method for isolating a single LNP or
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`any method for determining the lipid content of an isolated single LNP. As stated above at ¶ 39,
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`the named inventors’ notebooks that Plaintiffs have identified as underlying those patents show
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`that the inventors used HPLC and measured aggregate concentrations (though those measurements
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`and the method are not reported in the Molar Ratio Patents).
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`*
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`*
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`*
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`I declare under penalty of perjury under the laws of the United States of America that the
`
`foregoing is true and correct to the best of my knowledge.
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`
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`Executed on this January 5, 2024
`
`Stephen Byrn
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`11
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 13 of 68 PageID #: 13563
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`EXHIBIT (cid:36)
`EXHIBIT A
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`EXHIBIT (cid:37)
`EXHIBIT B
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`Professional Title:
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`Home Address:
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`Marital Status:
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`Education:
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`Professional Experience:
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 22 of 68 PageID #: 13572
`CURRICULUM VITAE - DR. STEPHEN R. BYRN
`Charles B. Jordan Professor of Medicinal Chemistry; School of Pharmacy
`and Pharmaceutical Sciences, Department of Industrial and Physical
`Pharmacy, Purdue University, West Lafayette, Indiana 47907
`824 Barlow Street, West Lafayette, Indiana 47906
`Married, ten children
`DePauw University, Greencastle, Indiana, B.A.,
`1962-1966, Chemistry
`University of Illinois, Urbana, Illinois, Ph.D.,
`1966-1970, Organic and Physical Chemistry
`University of California, Los Angeles, California, Postdoctoral, 1970-1972,
`Physical Chemistry
`Assistant Professor of Medicinal Chemistry, Department of Medicinal
`Chemistry and Pharmacognosy, School of Pharmacy and Pharmacal
`Sciences, Purdue University, West Lafayette, Indiana, July 1, 1972 to June
`30, 1976
`Associate Professor of Medicinal Chemistry, Department of Medicinal
`Chemistry and Pharmacognosy, School of Pharmacy and Pharmacal
`Sciences, Purdue University, West Lafayette, Indiana, July 1, 1976 to June
`30, 1981
`Professor of Medicinal Chemistry, Department of Medicinal Chemistry and
`Pharmacognosy, School of Pharmacy and Pharmacal Sciences, Purdue
`University, West Lafayette, Indiana, July 1, 1981 to present
`Associate Department Head of Medicinal Chemistry, Department of
`Medicinal Chemistry and Pharmacognosy, School of Pharmacy and
`Pharmacal Sciences, Purdue University, West Lafayette, Indiana, 1979 to
`1988
`Assistant Dean of the Graduate School, Purdue University, West Lafayette,
`Indiana, 1984 to 1988
`Head, Department of Medicinal Chemistry and Pharmacognosy, School of
`Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette,
`Indiana, l988 to 1994
`Founder and Director, Purdue University Center for AIDS Research,
`September 30, l988 to March 1, 1998
`Head, Department of Industrial and Physical Pharmacy, School of
`Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette,
`Indiana, September 1, 1994 to June 30, 2009
`Charles B. Jordan Professor of Medicinal Chemistry, 1992 to present.
`Co-Director, Center for Biotechnology Innovation and Regulatory Science,
`Discovery Park and Agricultural and Biochemical Engineering Department,
`2014-present
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`1
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`Case 1:22-cv-00252-MSG Document 195-20 Filed 01/16/24 Page 23 of 68 PageID #: 13573
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`Director, NIPTE Center of Excellence for Abuse Deterrent Formulations,
`March, 2017-present
`
`
`
`
`
`
`
`Memberships:
`
`
`Phi Eta Sigma, Rho Chi, Phi Lambda Upsilon, Phi Kappa Phi, Sigma Xi
`American Chemical Society
`American Crystallographic Association
`American Association of Pharmaceutical Scientists
`
`Awards, Honors:
`
`
`Rector Scholar, DePauw University, 1962-1966
`Sinclair Oil Company Fellow, University of Illinois, 1967-1968
`National Science Foundation Graduate Fellow, University of Illinois, 1968-1971
`National Institutes of Health Postdoctoral Fellow, University of California, 1971-1972
`Elected Fellow, American Association of Pharmaceutical Scientists, 1989
`Elected Member, United States Pharmacopeia Revision Committee, 1990-1995 & 1995-2000 & 2000-2005.
`Council of Experts 2000-2005, Member of several subcommittees including chemistry, dissolution,
`excipients and PAT.
`Purdue University Representative to the USP, 2000, 2005, 2010.
`Alumni Citation, DePauw University, 1991
`Thomas W. Binford Memorial Award for Outstanding Contributions to Entrepreneurial Development, World of
`Difference Award, State of Indiana, 2000
`FDA Advisory Committee Service Award, October 31, 2001
`AAPS Outstanding Paper Award, 2008, APQ Section (With L. Taylor)
`Purdue University, Outstanding Faculty Commercialization Award, 2008-09
`AAPS David Grant Research Achievement Award in Physical Pharmacy, 2009
`Special Issue (September 2010) of the Journal of Pharmaceutical Sciences was dedicated to Stephen R. Byrn,
`based on his contributions to the field of solid state pharmaceutics.
`FDA Honor Award. Stephen Byrn as Member of FDA/Kilimanjaro School of Pharmacy Regulatory
`Collaboration, 2013
`AAPS Dale Wurster Award In Pharmaceutics, November 16, 2016.
`LSAMP Faculty Mentor of the Year Award, Purdue University, 2018
`Pharmaceutical Sciences Teacher of the Year Award, Purdue University, 2018
`Purdue University Morrill Award, Most Outstanding Faculty Member, 2018
`AAPS Pharmaceutical Global Health Award, November 2018
`
`Memberships, Editorial Boards and Major Committees:
`
`Journal of Pharmaceutical Sciences Editorial Advisory Board - 1994-present.
`AAPS Pharm. Sci. Tech. Editorial Advisory Board – 2007 – present.
`Pharmaceutics Editorial Advisory Board - 2009 – 2014
`Journal of Validation Technology, Editorial Advisory board – 2010 – 2012
`Crystal Growth and Design Editorial Advisory Board – 2002 to 2007
`Journal of Drug Targeting, 1993-1995.
`Journal of Pharmaceutical and Biomedical Analysis, 1998-2002
`Pharmaceutical Sciences Advisory Committee, FDA 1997-2001, Chair 2000-2001
`Controlled Substances Advisory Committee, State of Indiana 1982-1998 (Chair 1995-8)
`Drug Substance Technical Committee, FDA-PQRI, 1997-present (Chair 1997-2001)
`National Academies of Sciences, Engineering, and Medicine, Topical Pain Creams, March 1, 2019 - present
`
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`Professional Service:
`
`
`American Chemical Society, Secretary-Treasurer, Vice-Chairman and Chairman Purdue Section, 1976-1982
`
`Controlled Substances Advisory Committee, l982-1998, Secretary, 1987-1994, Chair, 1994-1998
`
`American Society of Pharmacognosy, Program Committee, 1977
`
`Symposium Organizer American Chemical Society, Division of Medicinal Chemistry, 1987
`
`Organizer, First and Third Midwest Organic Solid State Chemistry Symposia, 1988 (University of Illinois), 1990
`(Purdue University), 2005 (Purdue University, with Ken Morris). Co-organizer, 2016 (Purdue University)
`
`Organizer of a Short Course, entitled "Polymorphs and Solvates of Drugs," 1988 (Bradford, England), 1990
`(Purdue University), 1992 (Bradford, England)
`
`Reviewer numerous journals including JACS, J. Org. Chem., Acc. Chem. Res., J. Pharm. Sci., Pharm. Res.,
`Crystal Growth and Design
`
`Chair, NIPTE Abuse Deterrent Center of Excellence 2017 - present
`
`University Committees:
`
`
`Athletic Affairs Committee, 1979-1984
`Computer Center Policy Committee, 1983-1988
`Commencement Committee, 1984-l989
`Development Committee, 1991-2
`Vision (Long Range Planning) Committee, 1993
`University Promotions Committee 1995-1998.
`Purdue University Faculty Senate 2007-2010 and 2012-2016.
`Global Academic Committee, 2018-Present
`
`Departmental Committees:
`
`
`As Chair of two departments I have served on numerous departmental committees.
`
`Graduate School Committees:
`
`
`M.D.-Ph.D., 1984-1988
`Area Committee, 1984-1988
`Computer Committee, 1984-1988
`Residency Review Committee, 1984-1988
`David Ross Fellowship Committee, 1984
`
`Teaching Effort:
`
`
`Courses Taught – Pharmacy and Doctor of Pharmacy Curriculum
`
`
`Pharmaceutical Solids, 1998-2001.
`
` Regulatory Affairs, 1998-present.
`
` MDCH 310 - Analytical Medicinal Chemistry, l972-1997
`
` MDCH 418 - Computers in Pharmacy, l978-1988
`
` IPPH 471 – Sterile Products – Instructor in Charge 2004-05, 2014
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`
` IPPH 363 – Industrial Pharmacy - 2008-2012 (Instructor in charge, 2010)
`
` PHRM 898 – Dosage Forms I – Solid state, Tablets, Capsules – 2012-present, course coordinator 2017
`
` PHRM 461 – Drug Discovery and Development II –Course coordinator or co-coordinator, 2014-present
`
`Courses Taught - Graduate Curriculum
`
` MDCH 614 - Advanced Medicinal Analysis, l972-1997
`
`
`IPPH 590/587 - Pharmaceutical Solids 2004 – 2018
`
` MDCH 698, 699 - Directed research for M.S. and Ph.D. graduate students and post-doctoral associates. 1972
`- Present
`
`IPPH 521– Drug Development 2004 - 2014
`
`
`
`IPPH 522 – Good Regulatory Practices 2004 – 2014
`
`
`IPPH 562 – Pharmaceutical Manufacturing 2010
`
`
`PHRM 46100 – Drug Discovery and Development II, 2013-present
`
` ABE 52100 – Drug Development 2015 - present
`
` ABE 52200 – Good Regulatory Practices, 2015-present
`
`
`IT 50800 - Quality and Productivity in Industry and Technology
`
`
`IT 57100 Project Management in Industry and Technology
`
`
`Teaching Programs Co-Founded – MS Degree in Biotechnology Innovation and Regulatory Sciences in the
`US and Africa (Joint with Professor Kari Clase, Ph. D.) originally Program in Regulatory and
`Quality Compliance, cofounded jointly with M. Schmidt, Ph. D.:
`
`
`
`This new area of specialization in the Agricultural and Biochemical Engineering Department focuses on creating
`leaders in biotechnology innovation and regulatory science, especially relating to pharmaceuticals. The curricula
`also addresses topics of innovation and integrates emerging technologies.
`The program consists of 10 courses and a special project for a total of 30 credit hours. The array of courses will
`provide:
`
`• an understanding of all aspects of quality
`• an understanding of biotechnology innovation and regulatory science
`in-depth knowledge related to biotechnology and pharma
`•
`• knowledge on how to lead and manage operations within the industry
`
`The degree format is tailored to student needs:
`
`• Traditional, on-campus degree program in West Lafayette
`• Blended online and weekend program
`
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`In Africa in collaboration with Kilimanjaro School of Pharmacy, Moshi, Tanzania and Nelson Mandela,
`African Institute of Science and Technology, Arusha, Tanzania
`
`
`
`
`
`Sustainable Medicines in Africa (Joint with Sr. Zita Ekeocha, M.S. and Professor Kari Clase)
`
`The sustainable medicine program in Africa is aimed at addressing the problem of lack of access to high quality
`medicines in Africa. This program consists of: (1) Master’s degree in Biotechnology Innovation and Regulatory
`Science (Sr. Zita Ekeocha)); (2) an actual GMP-level pharmaceutical manufacturing facility (2008 – 2020), and
`(3) a quality medicines laboratory equipped with HPLCs. The educational programs are aimed at providing
`source of well-trained manufacturing scientists for pharmaceutical industry in Tanzania and Africa. The GMP-
`level facility and GMP courses are used to teach manufacturing under strict quality control. The GMP facility
`served as a model for other such facilities throughout Sub-Saharan Africa. The feasibility of establishing a
`sustainable medicine program in Tanzania is supported by the experience of the former Infusion Units Project in
`Tanzania, now known as Saint Luke Foundation (SLF). This program has manufactured and distributed infusion
`solutions throughout Tanzania since 1983. Additionally, the availability of trained personnel and a model facility
`will combat several current problems especially those related to counterfeited/poor quality medicines.
`
`This Master’s degree in Biotechnology Innovation and Regulatory Science is supported by Bill and Melinda
`Gates Foundation as an ANDi (African National Drug Innovation) Center for Pharmaceutical Manufacturing and
`Regulatory Training. This center is one of less than 50 centers in Africa.
`
`Graduate Students and Postdoctoral Associates:
`
`M.S. (thesis) - E. Kreutzer (1976), S. VanEss (1977), B. Stewart (1978), G. Migliaccio (1979), G. Gibson-Clay
`(1979), J. Gomes (1979), P. Hoyos (1982), L. Morales (1991), H. Tat (1998), R. Alajlouni
`
`Ph.D. - G. Dolch (1976), M.D. Tsai (1978), R. Clay (1979), J. Gomes (1981), H. Martinez (1983), I. Lassalle
`(1984), P. Sutton (1984), P. Toren (1985), J. Chaber (l986), D. Kessler (l986), P. Hoyos (l986), E.
`Kolodziej (l986), D. Carlson (l989), C. Chan (1990), P. Saindon (1991), K. Ray (1992), N. Sipahimalani
`(1992), Wu-Po Ma (1993), D. Nugyen (1993), P. Toma (1993), G. Stephenson (1994), M. Wahle (1997), W.
`Xu (1997), T. Borchardt (1997), V. Joshi (1998), X. He (1999), R. Te (2000), X. Chen (2000), Y. Hu (2000),
`Zhihui Qui (2001); Hui Li (2002); T. Davis (2003), A Gupta (2005), Chen Mao (2007), Faraj Atassi (2007),
`EunHee Lee (2007), Yuerong Hu (With L. Taylor) (2008); Niraj Trasi (2011), Ziyang Su (2011); Sumana
`Penumetcha (2011); Xin Chen (2012); Y. Song (2015), H. Nie (2017); Salma Salem (2019)
`
`Postdoctoral Associates - P.Y. Siew (1976), C.T. Lin (1980), P. Perrier (1981), J. Stowell (1984), B. Tobias
`(l988), C. Chan (1990), C. Cox (1990), Kin-shan Huang (1995), R. Schlam (1999); N. Poendaev (2001-
`2003), D. Smith (2003-2006), Eun Hee Lee (2007-2010), Salma Salem 2020 - present
`
`Current Graduate Students - None
`
`Current Senior Research Associate – Daniel Smith, Ph. D.
`
`
`Undergraduate Student Activities:
`
`Counselor for Pharmacy Students, 1978-1996.
`Faculty Fellow (Shreve Hall & Hillenbrand Hall), 1982-1997.
`Senior Faculty Fellow (Shreve Hall), 1986-1990.
`Senior Faculty Fellow (Hillenbrand Hall) 1993-1995
`Adopt a Student Program, College of Pharmacy, 2009-10
`
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`Research Interests:
`
`
`Solid State Chemistry of Drugs/Pharmaceutical Solids
`
`
`Investigators: S. Byrn, Amrinder Singh
`
`The overall goal of our research is to develop the field of Solid State Chemistry of Drugs so that all of the
`principles and factors governing solid state chemistry are understood. This knowledge is then used to predict and
`analyze all behaviors of solids observed during the drug development process and in formulations. Thus, the solid
`state chemistry of drugs is being studied to improve knowledge of the f