Barbara A. Berglund

Chief Executive Officer

Barbara Berglund has been working in the pharmaceutical industry for over twenty years. She has worked directly with liquid and lyophilized sterile parenterals, ophthalmic solutions, solid dosages, suspensions, microencapsulated products, transdermal presentations, and nasal presentations for approval in the US, Canada, Europe, Australia, Britain, Brazil and Japan. Her experience spans quality and operations, including strategic leadership roles in quality control, quality assurance, project management, and clinical trial manufacturing.

In her operations, laboratory, and quality roles, Barbara has worked directly with drugs from innovation, through clinical trials, through registration, and to commercialization, and has directly supported the CMC process; this includes pre-IND documentation, FDA interactions, and creation and editing of the submission documents for CTD e-filing. She has worked with innovator drugs, generics, and commercial products with orphan indications; for these products, knowledge management and Quality by Design approach are critical to success. The products range from diluents to small molecules, peptides, proteins,
encapsulated DNA and adjuvated vaccines. She has worked with solid and liquid active and excipient ingredients, purified drug substances and formulated drug products.

Barbara has had direct quality oversight of four generic (ANDA) submissions; all 4 drugs were sterile parenterals, and 2 of them were lyophilized products. All four ANDAs were submitted to FDA using eCTD. She has created and/or edited CMC sections for 27 INDs and 2 NDAs; these include liquid sterile parenteral, lyophilized sterile parenteral, liquid ophthalmic, ophthalmic implant, solid dosage, and transdermal products. The support has included drug substance, drug product, and pre-clinical sections. In her roles in operations, Barbara supported two PAI audits and in her role in quality control, she supported three PAI audits. She has performed two mock-PAI audits as a consultant. All five inspections were for pre-approval of sterile parenteral products, and three of them were for lyophilized products.

She has managed programs for organizations responding to pre-approval audits to assure success, and has managed remediation programs for organizations working on compliance issues. She provides strategic and tactical leadership for small and virtual pharmaceutical organizations.

Barbara has a deep understanding of quality systems, having managed various initiatives to certify organizations to CLIA, ISO 9001 and ISO 13485, and to gain ISO 17025 accreditation. She has performed gap assessments for safety initiatives such as GHS labeling and REACH, and has implemented quality management systems in pharma, medical devices, and services organizations.

Barbara has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and in Pharmacological & Physiological Science. She received her Project Management Professional certification in 2007, her Six Sigma Green Belt in 2008, and her Certified Manager of Quality/Operational Excellence and Certified Quality Auditor from the American Society for Quality in 2015.

Extended Biography

Education

  • Saint Louis University, Department of Pharmacological and Physiological Science
  • UM-St Louis, Department of Chemistry
  • Gonzaga University, Emerging Leaders Program

Memberships and Certifications

  • 10/07 – present PMP, Project Management Professional
  • 03/15 – present CQM/OE, ASQ Certified Quality Manager / Organizational Excellence
  • 12/15 – present CQA, ASQ Certified Quality Auditor
  • 11/08 – present Green Belt, Lean Manufacturing
  • 08/07 – present PMI, Project Management Institute
  • 06/04 – present PDA, Parenteral Drug Association
  • 01/13 – present ASQ, American Society for Quality

Special accomplishments

  • Focused formulation and analytical development for sterile ophthalmic products
  • Built and integrated QC and QA systems in support of a startup pharma manufacturing facility.
  • Brought multiple labs completely into ISO 17025 accreditation.
  • 15 years experience in quality and operations in liquid and lyophilized sterile parenteral (aseptic) pharmaceutical and device manufacturing facilities.
  • Designed the infrastructure for an all-new department within QC and microbiological QC. This included job descriptions, hours required to meet the projected needs of the business, number of employees needed (including additional supervision) and core reporting relationships.
  • Designed and implemented a tiered promotion system for the QC lab. This included job description development, title development, and structural department changes.
  • Designed and implemented an all-new training program for the QC lab. This included a paradigm shift from linear “read and understood” training to a practical, modular approach. This included core curriculum as well as job specific training tasks.
  • Designed, developed, and implemented training programs for cGMP, project management, basic lyophilization training, and QC compliance. These include lecture, workshop, and web-based training.
  • Designed and implemented a streamlined and generic batch record for the CTM manufacturing facility. This allowed for ease of technical transfers, increased consistency batch-to-batch and a dramatic decrease in deviations.
  • Designed and implemented an all-new training program for the CTM manufacturing facility. This included a requirement to walk through a process in advance of finalizing manufacturing documents and hands-on training in advance of task performance.
  • Presented at PDA, PMI, Compliance-Online, and other in-person and web-based conferences.

Training programs

  • Berglund BA (2008). Lyophilization Training. HS offsite training course, 7/08, Spokane.
  • Berglund BA (2009). Lyophilization Training for QC. HS training course, 1/09, Spokane.
  • Berglund BA (2010). Project Management of Lean or Fast-Turnaround Projects.  Workshop presented in June, July, and August, 2010 at HS.
  • Berglund BA (2010). Analytical Method Transfer Strategies for a Contract Manufacturing Organization. Webinar presentation for the PDA June
    22, 2010.
  • Berglund BA and Allen W (2010). Initiation of Short-Term and Process Improvement Projects. Webinar presented for PMI 8/28/10 and 8/29/10.
  • Berglund BA (2010). Planning Phase of Short-Term and Process Improvement Projects. Webinar presented for PMI 12/13/10.
  • Berglund BA (2011). Does Your Pharmaceutical Lab Have GMP and non-GMP Functions? Web training presented via ComplianceOnline 1/19/11, repeated on 9/9/11, 2/10/12, 7/13, 6/14, 5/16 and 5/17.
  • Berglund BA (2011). How to Transfer QC Procedures for Commercial Products in Pharma Industry – ICH and USP Guidelines. Web training presented via ComplianceOnline 2/03/11, repeated on 9/29/11,  7/13, 7/15 and 4/17.
  • Berglund BA (2011). Designing appropriate product specifications for lyophilized parenteral products. Web training presented via ComplianceOnline 4/21/11, repeated 10/20/11.
  • Berglund BA and Bossert KA (2011). Validation of Lyophilization. 2-day training course presented on 6/23/11 – 6/24/11 via the PDA TRI Courseprogram, Bethesda, MD; repeated 3/12; 10/13; 12/14; 5/15; 12/16; 5/17.
  • Berglund BA (2011). Scientifically Sound Approach to Transfer of Analytical Procedures. Part of a 2-day course offered via IPA Canada, 10/4/11 –10/5/11.
  • Berglund BA (2011). Approaching unknown cause laboratory investigations for pharmaceutical tools using lean tools. Web training via
    Compliance-Online 10/06/11; repeated 6/12; 6/13.

Oral and Poster Presentations

  • Howlett AC, Berglund B, Cantrell C, Evans D, Wilken G, Pinto J, Boring D, and Rice K (1994). The pharmacology of endogenous compounds that interact with the cannabinoid receptor in the brain. International Cannabinoid Research Society, 7/94, Montreal.
  • Tong W, Collantes ER, Welsh W, Howlett AC, Berglund BA (1996). A low energy arachidonlyethanolamide conformer that exhibits pharmacophoric similarities to 9-nor-9-hydroxy hexahydrocannabinol. International Cannabinoid Research Society, 6/96, Cape Cod.
  • Howlett AC, Song C, Wilken GH, Pigg JJ, Berglund BA (1996). Characterization of the rat brain cannabinoid receptor using receptor peptide fragments and site-directed antibodies. International Cannabinoid Research Society, 6/96, Cape Cod.
  • Berglund BA, Boring DL, Howlett AC (1996). Cerebrodiene, arachidonyl ethanolamide and hybrid structures: potential for interaction with brain cannabinoid receptors. Frontiers in Bioactive Lipids, 5/96, Washington DC.
  • Fleming P, Berglund B, Howlett AC, Rice KC (1997). Synthesis and biological evaluation of anandamide analogs. CPDD, 4/97.
  • Berglund B, Fleming P, Rice K, Boring D, Howlett A (1997). Investigation of structural analogs of arachidonylethanolamide for binding and activation of cannabinoid receptors. International Cannabinoid Research Society, 6/97, Atlanta.
  • Berglund B, Cartier E, Fleming P, Rice K, Boring D, Howlett A (1997). Investigation of structural analogs of anandamide for binding and activation of peripheral cannabinoid receptors. Eicosanoids and other Bioactive Lipids in Cancer, Inflammation and Related Disease, 9/97, LaJolla.
  • Berglund BA, Fleming PR, Rice KR, Howlett AC (1998). Characterization of structural requirements of ligand binding to the CB1 and CB2 cannabinoid receptors. IUPhAR, 7/98, Munich.
  • Shim J-Y, Welsh WJ, Berglund BA, Howlett AC, Fleming PF, Rice K (1999).  Prediction of the bioactive conformation of arachidonyl ethanolamide using the distance constrained systematic search. ACS, 4/99.
  • Berglund BA (2008). Validation Requirements for Lyophilized Products in a Parenteral Manufacturing Facility: Focus on Aseptic Processing, Clinical Trial, and Commercial Scale Lyophilization. PharmaED’s Lyophilization, 9/08, Philadelphia.
  • Berglund BA (2010). Analytical Method Transfer Strategies for a Contract Manufacturing Organization. Podium presentation for the PDA 2010 Annual Meeting, 3/15/2010.
  • Berglund BA (2010). Knowledge Management: Application of Project Management and Program Management Best Practices to Lean Manufacturing and Lean Laboratory Projects. Podium presentation for the PDA 2010 Annual Meeting, 3/16/2010.
  • Berglund BA (2011). Increasing Success of Lean and Short-Term Projects Using the Initiation Phase. Podium presentation at the PMI Pharmaceutical Community of Practice, Durham, NC, 3/08/11.
  • Berglund BA & Allen WF (2011). The Application of PMBOK Guide Practices at Your Pharmaceutical Manufacturing Organization. Podium presentation at the PMI North America Congress, Dallas, TX, 10/23/11.

Publications

  • Metheny N, Reed L, Berglund B, Wehrle MA (1994). Visual characterization of aspirates from feeding tubes as a method for predicting tube location. Nursing Res. 43:282-287.
  • Howlett AC, Berglund BA, Melvin LS (1995). Cannabinoid receptor agonists and antagonists. Current Pharm. Des. 1,343-54.
  • Boring DL, Berglund BA, Howlett AC (1996). Cerebrodiene, arachidonyl-ethanolamide, and hybrid structures: potential for interaction with brain cannabinoid receptors. Prostaglandins Leukot Essent Fatty Acids. 55(3):207-10.
  • Tong W, Collantes ER, Welsh WJ, Berglund B, Howlett AC (1998). Derivation of a pharmacophore model for anandamide using constrained conformational searching and comparative molecular field analysis. J Med Chem. 41(22):4207-15.
  • Howlett AC, Song C, Berglund BA, Wilken GH, Pigg JJ (1998). Characterization of CB1 cannabinoid receptors using receptor peptide fragments and site-directed antibodies. Mol. Pharmacol. 53(3):504-10.
  • Berglund BA, Boring DL, Wilken GH, Makriyannis A, Howlett AC, Lin S (1998). Structural requirements for arachidonylethanolamide interaction with CB1 and CB2 cannabinoid receptors: pharmacology of the carbonyl and ethanolamide groups. Prostaglandins Leukot Essent Fatty Acids. 59(2):111-8.
  • Berglund BA, Boring DL, Howlett AC (1999). Investigation of structural analogs of prostaglandin amides for binding to and activation of CB1 and CB2 cannabinoid receptors in rat brain and human tonsils. Adv Exp Med Biol. 469:527-33.
  • Berglund BA, Fleming PR, Rice KC, Shim J-Y, Welsh WJ, Howlett AC (2000). Development of a novel class of monocyclic and bicyclic alkyl amides that exhibit CB1 and CB2 cannabinoid receptor affinity and receptor activation. Drug Des. Discov. 16(4): 281-94.