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`CHRISTOPHER J. SOARES, Ph.D.
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`2
`es
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`Home:
`Cell:
`Ennai:
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`Leadership ~ Drug Discovery & Development ~ Expert Witness
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`Researchscientist adeptat utilizing experience within the biotech/pharmaceutical industry to
`successfully advance research and development objectives in diverse therapeutic areas. Proven
`ability to analyze scientific information and lead research programs.
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`¢ Biotech professional with extensive drug discovery and development expertise.
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`e Experienced with small molecule and macromolecular drugs (proteins and peptides) in
`multiple therapeutic areas. Extensive experience in peptide therapeutics based on the
`calcitonin and GLP-1 hormoneswith novelclinical candidates developed from both peptide
`families. This included dual acting analogues at both receptors and analogs with extended
`duration of action.
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`Program leader for multidisciplinary teams (research, clinical, regulatory and development
`groups) who worked on projects aimed at advancing moleculesto the clinic.
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`¢ Evaluated and implemented diverse technologies to enhance the delivery of drug candidates
`by various modes(nasal, oral, systemic, topical, etc).
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`¢ Currently advancing a peptide therapeutic for the treatment of neuropathic pain both as an
`acute therapeutic and an extended-release formulation for dosing as a once-weekly or
`oncemonthly treatment.
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`¢ Expert witness in a patent dispute between a pharmaceutical company and generic
`manufacturer. Case wassettled the day preceding trial (May 2018 - March 2019).
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`Scientific expert for the filing of an IPR of a GLP-1 agonist patent (2019)
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`¢ Expert witness for a generic pharmaceutical company challenging patents related to a peptide
`therapeutic used to treat symptoms ofirritable bowel syndrome with constipation or chronic
`constipation (2021)
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`MPI EXHIBIT 1023 PAGE1
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`MPI EXHIBIT 1023 PAGE 1
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`PROFESSIONAL POSITIONS
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`2013-present AcheRx LLC, Seattle, Washington. A peptide therapeutics company investigating
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`diseases linked to the perception and transmission of neuropathic pain.
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`Scientific Founder – Discovered a novel series of peptide CGRP antagonists.
` Accomplished proof-of-concept studies resulting in the identification of a clinical
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`candidate for the acute treatment of migraine. Patents obtained covering lead
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` compound series and for novel methods-of-use. Received an SBIR grant to
`develop slow-release formulations of the peptide lead (August 2021)
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`2010-2013 Avryll Therapeutics Inc., San Diego, California. A biotechnology company
`focused on the science of cartilage repair and biologic drug delivery.
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`Consulting R&D Director – Accomplished synthesis of drug substance and
`preclinical studies (in vitro and in vivo) towards the advancement of a clinical
`candidate. The budget was managed to reduce costs by over 40 % of initial
`estimates. Supervise collaborations, licensing agreements and intellectual property
`portfolio with external legal counsel.
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`2002-2010 Amylin Pharmaceuticals, Inc., San Diego, California. A biotechnology
`company focused on discovering first-in-class medicines for metabolic disorders
`including diabetes and obesity.
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`Associate Director - Research (2005-2010)
`• Managed groups of chemists in determining structure activity relationships
`and lead finding.
`• Project co-leader for the identification and development of peptide candidates
`with increased duration of action (once-weekly) and oral bioavailability.
`Managed the design, evaluation (in vitro/in vivo) and nomination of
`candidates for clinical development.
`• Evaluated novel compounds/biology for initiating therapeutic-area programs.
`• As a team member helped to successfully:
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`− Identify a clinical candidate for depression (Psylin Neurosciences Team).
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`− Identify lead candidates for inflammation (BioSeek Collaboration).
`− Design moieties for synergistic weight loss (Phybrids for Obesity Team).
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`Sr. Scientific Investigator - Research Chemistry (2003-2005)
`• Project co-leader for the identification and development of novel GLP-1
`peptide candidates for the treatment of congestive heart failure. Peptides were
`designed to improve pharmaceutical properties vs. potency resulting in a
`pharmaceutically superior candidate chosen for clinical development.
`Initiated an effort to determine the synthetic feasibility of Phybrid peptides to
`incorporate dual pharmacologically active agents in a single moiety.
`Identified and advanced to clinical development a novel peptide that activated
`both the amylin and GLP-1 receptor
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`MPI EXHIBIT 1023 PAGE 2
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`Scientific Investigator - Research Chemistry (2002-2003)
`Project co-leader for the identification and development of peptide candidates for
`the treatment of obesity. Peptides were designed to have increased efficacy and
`duration of action over the lead compound and resulted in the nomination of a
`clinical candidate currently in Phase II development.
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`1998-2002 CombiChem Inc. /DuPont Pharmaceuticals Inc. San Diego, California. A
`pharmaceutical company focused on developing computationally designed small
`molecule libraries and tools for high throughput synthesis and purification.
`CombiChem was later acquired by DuPont Pharmaceuticals Inc.
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`Senior Research Scientist - Medicinal Chemistry
`Designed and synthesized novel compound libraries for partnership SAR project
`collaborations
`in Alzheimer’s, cardiovascular,
`inflammation and obesity
`programs. Worked closely with computational groups to design and analyze
`library diversity.
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`1992-1998 Amylin Pharmaceuticals, Inc., San Diego, California. A biotechnology
`company focused on discovering new medicines for metabolic disorders including
`diabetes and obesity.
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`Chemical modification of recombinantly produced peptides and accomplishing
`their stable formulation. Designed, synthesized and optimized leads of novel
`peptides, peptide mimetics and small molecule compounds for diabetes and
`obesity programs. Optimized both potency and synthetic procedures of several
`compound classes.
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`Senior Staff Scientist - Research Chemistry (1996-1998)
`Staff Scientist - Research Chemistry (1993-1996)
`Senior Research Associate - Process Chemistry (1992-1993)
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`1989-1992 The Scripps Research Institute, La Jolla, California. Postdoctoral Research
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`Fellow in the laboratory of Prof. Reza Ghadiri, Department of Chemistry.
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`EDUCATION
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`Ph.D. Chemistry
`University of California, Davis
`Advisor: Dr. Mark J. Kurth
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`M.S. Chemistry
`Hampton University, Virginia
`Advisor: Dr. Charles M. Bump
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`B.Sc. Chemistry (Honours)
`University of Bombay, India.
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`MPI EXHIBIT 1023 PAGE 3
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`PATENTS
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`1. Soares, C. J. “Use of CGRP receptor antagonists in neuroprotection and neurological
` disorders”. US11390654B2. Filed: 08/30/2017, Granted: July 2022
`2. Soares, C. J. “CGRP agonist peptides”. US9951115B2. Filed: July 2014, Granted:
`April 2018.
`3. Soares, C. J. “Peptide antagonists of the calcitonin/CGRP family of peptide hormones and
`their use”. US9193776B2 Filed: Jan. 2013, Granted: Nov. 2015
`4. Forood, B. B.; Ghosh, S.; Trevaskis, J. L.; Sun, C.; Levy, O. E.; D'Souza, L. J.; Soares, C. J.
`“Polypeptide Conjugate”. U.S. Pat. App. No. 13/511/201, accepted May 22, 2012.
`5. Samant, M. P.; D'Souza, L. J.; Levy, O. E.; Ghosh, S.; Soares, C. J. “Site-Specific
`Enzymatic Modification of Exendins and Analogs Thereof”. U.S. Pat. App. No. 61/637,393,
`accepted April 24, 2012.
`6. Alfaro-Lopez, J.; Soares, C. J.; Coates, E.; Sharma, A.; Ghosh, S. S. “GLP-1 Receptor
`agonist compounds having stabilized regions”. PCT/US2011/045614, published July 27,
`2011.
`7. Ghosh, S. S.; Josue Alfaro-Lopez, J.; D'Souza, L. J.; Levy, O. E.; Lin, Q.; Soares, C. J.
`“Peptide-peptidase inhibitor conjugates and methods of making and using same”. U.S. Pat.
`App. No. 2008077955, published February 4, 2008.
`8. Levy, O. E.; Baron, A. D.; D'Souza, L. J.; Erickson, M.; Ghosh, S. S.; Hanley, M. R.;
`Janssen, S.; Jodka, C. M.; Lewis, D. Y.; Mack, C. M.; Parkes, D. G.; Pitner, R. A.; Soares, C.
`J.; Srivastava, V.; Young, A. A.; Thao, L. DPP-IV Resistant GIP hybrid polypeptides with
`selectable properties” WO 2008/021560 published February 2, 2008.
`9. Ghosh, S. S.; Lewis, D. Y.; Janssen, S.; Srivastava, V.; Liu, Q.; Jodka, C. M.; Soares, C. J.;
`Lin, Q. “Composition and methods for treatment of congestive heart failure”. International
`Pat. App. No. WO 2007/139941, published June 12, 2007.
`10. Soares, C. J.; Hanley, M. R.; Lewis, D. Y.; Parkes, D. G.; Jodka, C. M.; Prickett, K. S.;
`Ghosh, S. S.; Mack, C. M.; Lin, Q. “Amylin family peptides and methods for making and
`using them”. International Pat. App. No. WO 2006/083254 A1, published August 10, 2006.
`11. Levy, O. E.; Hanley, M. R.; Jodka, C. M.; Lewis, D. Y.; Soares, C. J.; Ghosh, S. S.;
`D'Souza, L. J.; Parkes, D. G.; Mack, C. M. “Hybrid polypeptides with selectable properties”.
`U.S. Pat. App. No. 20060094652, published May 4, 2006.
`12. Levy, O. E.; Hanley, M. R.; Jodka, C. M.; Lewis, D. Y.; Soares, C. J.; Ghosh, S. S.;
`D'Souza, L. J.; Parkes, D. G.; Mack, C. M.; Srivastava, V.; Janssen, S.; Baron, A. D.; Young,
`A. A.; Pittner, R. A.; Erickson, M. “GIP analog and hybrid polypeptides with selectable
`properties”. International Pat. App. No. WO 2006/086769 A2, published Feb.10, 2006.
`13. Konradi, A.; Plies, M.A.; Thorsett, G.D.; Ashwell, S.; Sarantakis, D.; Welmaker, G.S.; Kreft,
`A.; Semko, C.; Sullivan, R.W.; Soares, C.J.; Ly, K.S.; Tarby, C.M. "Compounds which
`inhibit leukocyte adhesion mediated by VLA-4". U.S. Pat. App. No. 20050261293, published
`Nov. 24, 2005.
`14. Konradi, A.; Plies, M.A.; Thorsett, G.D.; Ashwell, S.; Sarantakis, D.; Welmaker, G.S.; Kreft,
`A.; Semko, C.; Sullivan, R.W.; Soares, C.J.; Ly, K.S.; Tarby, C.M. " Compounds which
`inhibit leukocyte adhesion mediated by VLA-4". U.S. Pat. No. 6,903,088, issued June 7,
`2005.
`15. Konradi, A.; Plies, M.A.; Thorsett, G.D.; Ashwell, S.; Sarantakis, D.; Welmaker, G.S.; Kreft,
`A.; Semko, C.; Sullivan, R.W.; Soares, C.J.; Ly, K.S.; Tarby, C.M. " Compounds which
`inhibit leukocyte adhesion mediated by VLA-4". U.S. Pat. No. 6,479,492, issued Nov. 12,
`2002.
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`PUBLICATIONS
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`1. Levy, O.E.; Jodka, C.M.; Ren, S.S.; Mamedova, L.; Sharma, A.; Samant, M.; D'Souza, L.J.;
`Soares, C.J.; Yuskin, D.R.; Jin, L.J.; Parkes, D.G.; Tatarkiewicz, K.; Ghosh, S.S. Novel
`exenatide analogs with peptidic albumin binding domains: potent anti-diabetic agents with
`extended duration of action. PLoS One, 2014, 9, 0087704
`2. Soares, C.; Mack, C.; Ghosh, S.; Lewis, D.; Lin, Q.; Lwin, A.; Herich, J.; Pittner, R.; Wilson,
`J.; Roan, J.; Alvarado, L.; DeConzo, K.; Jodka, C.; Guss, S.; Laugero, L.; Gedulin,
`S.; Smith, P.; Hanley M.; Parkes D. “Davalintide (AC2307), a Novel Amylin Mimetic
`Peptide: Enhanced Pharmacological Properties Over Native Amylin to Reduce Food Intake
`and Body Weight”. Int. Journal of Obesity, 2010, 34, 385.
`3. Alfaro-Lopez, J.; Soares, C. J.; Ghosh, S. S.; Kravchuk, A.; Coates, E.; Jodka, C. M.;
`Carroll, A; and Lin, Q “Peptide-Lisinopril Conjugates: Design, Synthesis and Biological
`Activities”. Advances in Experimental Medicine and Biology, 2009, 611, 535.
`4. Roth, J. D.; Mack, C. M.; Soares, C. J.; Ghosh, S. S.; Parkes, D. G. Amylin-Based
`Pharmacotherapy – Past, Present and Future. Immun. Endoc. & Metab. Agents in Med.
`Chem., 2008, 8, 317-324.
`5. Saiah, E.; Soares, C. “Small molecule coagulation cascade inhibitors in the clinic”. Curr.
`Top. Med. Chem. 2005, 5, 1677-95.
`6. Prickett, K.S.; Albrecht, E.; Soares, C.J.; Lumpkin, R.H.; Gaeta, L. S. L.; Moore, C.X.;
`Young, A. A.; Beeley, N.R.A.; Beaumont, K. 1995. "Design of receptor selective peptides
`that antagonise the action of amylin in vivo". Proceedings of The Fourteenth American
`Peptide Symposium.
`7. Ghadiri, M.R.; Soares, C.J.; Choi, C. "Design of an artificial four-helix bundle
`metalloprotein via a novel Ru(II)-assisted self-assembly process". J. Am. Chem. Soc. 1992,
`114, 4000.
`8. Ghadiri, M.R.; Soares, C.J.; Choi, C. "A convergent approach to protein design. Metal ion
`assisted spontaneous self-assembly of a polypeptide into a triple helix bundle protein". J.
`Am. Chem. Soc. 1992, 114, 825.
`9. Reddy, G.N.; Soares, C.J.; Kurth, M.J.; Segall, H.J. "Use of 2-Dimethylaminopyridine in
`tritium and deuterium exchange reactions". J. Labeled Cmpds and Radiopharm. 1991, 29,
`1257.
`10. Kurth, M.J.; Soares, C.J. "Asymmetric aza-Claisen Rearrangement: Synthesis of
`(+)dihydropallescensin-2[(+)-penlanpallescensin]". Tetrahedron Lett. 1987, 28, 1031.
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