Bryan Branstetter, MS

OBJECTIVE

Experienced scientist pursuing a challenging career in pharmaceutical development, project management or CMC management within a dynamic company.

PROFESSIONAL EXPERIENCE

La Jolla Pharmaceuticals San Diego, CA 02/2018 - Present

Sr. Manager Pharmaceutical Operations

Manage external manufacturing partners to define, optimize, and scale GMP manufacturing processes

Review/approve CMO master batch records, executed batch records for drug substance, drug product and clinical packaging/labeling

Manage clinical supply chain and distribution activities

Author/review technical reports, SOP’s, validation protocols, and regulatory sections of cGMP related documents

Sherpa Clinical Packaging San Diego, CA 04/2017 – 02/2018

Project Manager focused on the design, and execution of a sponsor’s cGMP packaging, labeling and distribution needs for clinical studies focusing on quality and client communication.

Project Manager – Clinical Packaging, Labeling and Distribution

Create, execute and managed project timelines and budgets per client’s requests

Effectively managed the packaging, labeling, storage and distribution of Phase I-III CTMs

Simultaneously managed 8 or more clients/projects at any given time

Working knowledge of Enterprise Resource Planning (ERP) software

Strong understanding of GMP manufacturing and corresponding quality systems

Dart Neuroscience, LLC Poway, CA 11/2010 – 03/2017

Formulation Scientist focused on the development of specialized pharmaceuticals for the treatment of memory disorders with a strong background in synthetic chemistry.

Senior Associate Scientist – CMC/Formulations

Managed cGMP manufacturing of solid oral dosage forms at various CMO’s

Managed packaging, labeling and distribution of CTM’s for Phase I and II studies

Trained Pharmacy staff at clinic site on formulation preparation for Phase I clinical trials

Developed powder blends for the manufacture of capsules and tablets for Phase I and II studies

Prepared analyzed, and evaluated oral suspensions and solutions to support preclinical studies

Authored/Reviewed cGMP batch records, pharmacy manuals, and product development reports

Working knowledge of cGMP, ICH and FDA CMC guidelines

Associate Scientist – Medicinal Chemistry

Efficiently prepared, purified and characterized small molecules for CNS targets

Developed synthetic strategies for project specific targets

Negotiated purchase, oversaw installation and maintained DNS’s NMR lab

Preformed 2D and VT experiments to aid in structure elucidation for colleagues

Johnson and Johnson PRD La Jolla, CA 2005-2010

Medicinal chemist focused on the synthesis of small molecules for the potential treatment of Pain and CNS disorders

Research Associate/Associate Scientist

Efficiently prepared, purified and characterized possible drug candidates

Developed synthetic strategies for project specific targets

Interpreted SAR, in vitro and in vivo data generated from novel chemical series

Presented work at internal/external meetings and independently prepared quarterly reports

EDUCATION

2002-2005 University of Wisconsin-Milwaukee, Milwaukee, WI

Master’s in Organic Chemistry

Advisor: Dr. M. M. Hossain

Thesis: “Exploration of Acid Catalyzed Reactions of Ketones and, -Unsaturated Aldehydes in

the Presence of Ethyl Diazoacetate”

1997-2002University of Wisconsin-Madison, Madison, WI

Bachelor of Science in Chemistry

Undergraduate Research in the Lab of Dr. Hans Reich

TECHNOLOGY AND SKILLS

Business Strategy: Project management, patents, contract negotiations, and product development reports.

Clinical: Clinical packaging and labeling, pharmacy manual prep., batch record design, relationship building with clinical experts, Pre-IND writing. Competent in FDA, ICH and USP guidelines and regulations.

Lab/Science: Formulation design, single punch tablet press, encapsulation, blending, DSC, TGA, DVS, PXRD, solution/suspension preparation and analysis, and solubility. Proficient in 1D/2D NMR and normal and reverse phase chromatography including SFC.

Communication: Internal/External presentations, CMO training, CMO auditing and project management

Software: MS Project, Empower, Chemstation, MS Office, SciFinder, Reaxsys, ChemDraw, Vida, DS Viewer and Electronic Lab Notebook

AWARDS AND HONORS

“Kudos” Project Team Award, Dart NeuroScience 2016

Standards of Leadership Award, Johnson and Johnson 2006

TRAINING AND MEMBERSHIPS

ICH Q7 cGMP Guidance Training – Presented by Max Lazar, February 2017

Colorcon Coating School – Irvine, CA 2016

Colorcon Formulation School – Irvine, CA 2016

Postgraduate Course: “Hands on Tablet Technology” – University of Mississippi School of Pharmacy 2016.

Land O’ Lakes: “Practical Strategies for Developing Preclinical and Phase I Oral Drug Formulations” – UW-Madison School of Pharmacy 2015.

Johnson and Johnson In-House Course: "Properties of Heteroaromatic Compounds: Relevant Concepts and Trends for Drug Discovery Chemists" – Presented by John Kieth, September 2009.

Johnson and Johnson In-House Course: “Short Course in Medicinal Chemistry” – Presented by Mark Wetland, October 2007

Short Course: “Heterocyclic Chemistry-A Two Day Short Course” – Presented by Albert Padwa and Berry William Pearson, 2006

PUBLICATIONS, PATENTS, AND PRESENTATIONS

1.Branstetter, Bryan J.; Breitenbucher, James; Dyck, Brian; Gomez, Laurent; Hudson, Andrew Richard; Marrone, Tami Jo; Vickers, Troy; Peters, Marco. Substituted Thieno- and Furano-Fused Azolopyrimidin-5(6H)-one Compounds as PDE1 Inhibitors and their Preparation. PCT Int. Appl. (2013), WO 201-***-**** A1 20131227

2.Branstetter, Bryan J.; Allan, Amy; Dyck, Brian; Weinhouse, Michael I.; Gomez, Laurent; Marrone, Tami Jo.; Peters, Marco. Substituted Pyridine Azolopyrimidine-5(6H)-one Compounds as PDE1 Inhibitors and their Preparation. PCT Int. Appl. (2013), WO 201-***-**** A1 20131227.

3.Branstetter, Bryan J.; Allan, Amy; Breitenbucher, James; Dyck, Brian; Gharbaoui, Tawfik; Gomez, Laurent; Hudson, Andrew Richard; Marrone, Tami Jo; Vickers, Troy; Weinhouse, Michael I. Preparation of Therapeutic Thiophene-, Furan-, and Pyridine-Fused Azolopyrimidin-5-(6H)-ones. PCT Int. Appl. (2013), US 201******** A1 20131219.

4.Branstetter, Bryan J.; Letavic, Michael A.; Ly, Kiev S.; Rudolph, Dale A.; Savall, Brad M.; Shah, Chandravadan R.; Shireman, Brock T. Fused Heterocyclic Compounds as Orexin Receptor Modulators and their Preparation and use in the Treatment of Orexin Receptor-Mediated Disesases. PCT Int. Appl. (2010), WO 201******* A1 20110428

5.Berthelot, Didier jean-Claude; Henricus Jacobus Maria; Zaja, Mirko; Rech, Jason; Lebsack, Alec; Xiao, Wei; Breitenbucher, J. Guy; Branstetter, Bryan. Preparation of Heterocyclic Amides as Modulators of TRPA1. PCT Int. Appl. (2010), WO 20101209

6.Branstetter, Bryan J.; Lebsack, Alec D.; Rech, Jason C.; Hawryluk, Natalie A.; Merit, Jeffrey E.; Allison, Brett; Rynberg, Raymond; Buma, Johnathan; Rizzolio, Michele; Swanson, Nadia. 1,2-Diamino-ethane-substituted-6,7,8,9-tetrahydro-5H-pyrimido[4,5-d]azepines as TRPV1 Antagonists with Improved Properties. BOMCL (2010), 20(23), 7142-7146.

7.Branstetter, Bryan J.; Hawryluk, Natalie A.; Merit, Jeffrey E.; Lebsack, Alec D.; Hack, Michael D.; Swanson, Nadia; Ao, Hong; Maher, Michael P.; Bhattacharya, Anindya; Wang, Qi. Discovery and Syntheis of 6,7,8,9-Tetrahydro-5H-pyrimido[4,5-d]azepines as Novel TRPV1 Antagonists. BOMCL (2010), 20(23), 7137-7141.

8.Branstetter, Bryan J.; Lebsack, Alec D.; Hack, Michael D.; Xiao, Wei; Peterson, Mathew L.; Nasser, Nadia; Maher, Michael P.; Ao, Hong; Bhattacharya, Anindya; Kansagara, Mena. Identification and Synthesis of 2,7-diamino-thiazolo[5,4-d]pyrimidine Derivatives as TRPV1 Antagonists. BOMCL (2009), 19(1), 40-46.

9.Allison, Brett D.; Branstetter, Bryan James; Breitenbucher, James Guy; Hack, Michael D.; Hawryluk, Natalie A.; Lebsack, Alec D.; Mcclure, Kelly J.; Merit, Jeffrey E. Tetrahydro-pyrimidoazepines as modulators of trpv1. PCT Int. Appl. (2007), CODEN: PIXXD2 WO 200-***-**** A2 20070927 AN 2007:1086586

10.Branstetter, B.; Breitenbucher, J. G.; Lebsack, A. D.; Xiao, W. Thiazolopyrimidines modulators of TRPV1. US 0004253 A1, 2008

11.Branstetter, Bryan James; Breitenbucher, James Guy; Lebsack, Alec Donald; Liu, Jing; Rech, Jason Christopher; Xiao, Wei. Imidazolo-, oxazolo-, and thiazolopyrimidine comounds as modulators of trpv1. US 156599 A1, 2009

12.Branstetter, Bryan James; Breitenbucher, James Guy; Love, Christopher John; Leenaerts, Joseph Elisabeth; Cooymans, Ludwig Paul; Lebsack, Alec Donald; Rech, Jason Christopher; Gleason, Elizabeth Ann; Venable, Jennifer Diane; Wiener, Danielle; Smith, Deborah Margaret. Quinoline or isoquiinoline derivatives as P2X7 antagonists and their preparation, pharmaceutical compositions and use in the treatment of diseases. PCT Int. Appl. (2009), CODEN: PIXXD2 WO 200-***-**** A1, 2009

13.Dudley, M. E.; Morshed, M. M.; Brennan, C. L.; Islam, M. S.; Ahmad, M. S.; Atuu, M. R.; Branstetter, B.; Hossain, M. M. Acid-Catalyzed Reactions of Aromatic Aldehydes with Ethyl Diazoacetate: An Investigation on the Synthesis of 3-Hydroxy-2-arylacrylic Acid Ethyl Esters. Journal of Organic Chemistry (2004), 69, 7599-7608.

14.Branstetter, B.; Hossain, M. M. Acid-Catalyzed Reactions of Unsaturated Aldehydes and Ethyl Diazoacetate. Tetrahedron Letters (2005), 47, 221-223.

15.Identification and synthesis of 2,7-diamino-thiazolo[5,4-d]pyrimidine derivatives as TRPV1 antagonists. Lebsack, A. D.; Branstetter, B. J.; Xiao, W.; Peterson, M. L.; Hack, M. D.; Nasser, N.; Maher, M. P.; Ao, H.; Bhattacharya, A.; Kansagara, M.; Scott, B. P.; Luo, L.; Chaplan, S. R.; Wickenden, A. D.; Breitenbucher, J. G. Bioorg. Med. Chem. Lett. (2009), 19, 40-46.

16.Branstetter, Bryan; Hossain, M. Mahmun. An investigation of the formation of enol acrylates from the acid-catalyzed reactions of various ketones with ethyl diazoacetate. Abstracts of Papers, 228th ACS National Meeting, Philadelphia, PA, United States, August 22-26, 2004 (2004)

17.Branstetter, Bryan J.; Lebsack, Alec D.; Xiao, Wei; Hack, Michael D.; Nasser, Nadia; Maher, Michael P.; Ao, Hong; Bhattacharya, Anindya; Kansagara, Mena; Scott, Brian; Luo, Lin; Chaplan, Sandra R.; Wickenden, Alan D.; Breitenbucher, J. Guy. Structure-activity relationships of 2,7-diamino-thiazolo[5,4-d]pyrimidines as TRPV1 antagonists. Abstracts of Papers, 236th ACS National Meeting, Philadelphia, PA, United States, August 17-21, 2008 (2008)

REFERENCES

Prasad Gullapalli Mike Milner Matt Onaitis Luke Seikkula

Director - Formulations Director Pharm. Ops Chief Financial Officer VP Pharm. Ops

Dart Neuroscience La Jolla Pharmaceutical Mainstay Medical La Jolla Pharmaceutical

914-***-**** 858-***-**** 858-***-**** 858-***-****

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