About Belas Consulting, Inc.
Mission Statement
Provide critical consulting expertise to clients that require practical solutions for formidable bioanalytical and outsourcing needs to enable expeditious drug development.
Vision Statement
Create an internationally recognized corporation that provides clients, and thus ultimately patients, with support solutions required for bringing innovative medicines to the global marketplace.
About Dr. Frank J. Belas, Jr., President of Belas Consulting, Inc.
Dr. Frank J. Belas, Jr. is President of Belas Consulting, Inc., which specializes in providing clients with practical solutions for formidable bioanalytical and outsourcing needs. Dr. Belas has 25 years of experience in GLP and non-GLP bioanalytical science, 20 of which have been as a bioanalytical/outsourcing leader in Big Pharma, holding several area/cross-functional leadership positions of increasing responsibility, including Sr. Advisor, Chief Operating Officer and Strategy.
Over his career, Dr. Belas has repeatedly demonstrated a proven ability to appropriately leverage scientific expertise, logistical skill, and industry-specific business acumen in support of drug development efforts. In short, his strategic and tactical bioanalytical leadership has been critical to the advancement of medicines.
This includes both small molecules, and biologics, across the therapeutic areas of psychiatry, neurology, pain, immunology, diabetes, and oncology. The resulting bioanalytical data generated through his leadership has been utilized repeatedly to support regulatory filings of novel pharmaceutical report submissions.
Prior to Forming Belas Consulting, Inc.
Dr. Belas previously held scientific, leadership, and/or senior management/advisor positions in both Academia and Big Pharma. During his career at Eli Lilly and Co., Dr. Belas assumed several Director positions where, in addition to obtaining extensive and ongoing expertise in small molecule bioanalytical and outsourcing strategy/management, he acquired a broad array of additional scientific experiences in the areas of in vivo/in vitro Metabolism, Screening, Isotopic Chemistry, New Technology, Core Lab Support, and Drug Development.
As a Sr. Advisor-Chief Operating Officer and Strategy, Laboratory for Experimental Medicine, he was the single point of accountability for the validation, implementation, and overall portfolio management of immunogenicity assays, and novel biomarkers required to facilitate the development and registration approval of new molecular entities.
Prior to his career at Lilly, Dr. Belas spent five years at Vanderbilt University Medical Center, Division of Clinical Pharmacology, again assuming positions of increasing leadership in bioanalytical science. Dr. Belas has authored/co-authored 1 book chapter, 12 publications, and 21 published abstracts/oral presentations. He has also been an invited speaker/lecturer at the Samuel Curtis Johnson Graduate School of Management at Cornell University on the topic of Execution in the Business Environment.
Education and Training
NIH Postdoctoral Research Fellow in Clinical Pharmacology. Vanderbilt University School of Medicine, Division of Clinical Pharmacology.
June 1992-May 1995. Research Focus: Drug metabolism and bioanalytical assay development.
Ph.D. degree in Biochemical and Biophysical Sciences. The University of Houston.
August 1988–May 1992. Dissertation title: “Abieta‑8,11,13‑trien‑11‑ol: Isolation and Identification of an Inhibitor of Cell Growth and Analysis of Structure/Activity Relationships of Analogs”.
M.S. degree in Biological Sciences. The University of New Orleans.
January 1986-August 1988. Thesis title: “Interactions in metabolism of calcium, magnesium, and sodium in the freshwater sponge Ephydatia fluviatilis“.
B.A. degree in Biological Sciences. The University of New Orleans.
August 1981–December 1985.
EMPLOYMENT
Belas Consulting, Inc. – President-Belas Consulting, Inc.; Jan. 2018-Present.
Focus/Expertise: Providing clients with practical solutions for formidable bioanalytical and outsourcing needs.
Eli Lily and Company – Retirement from Eli Lilly and Company; Jan. 1, 2018.
Sr. Advisor-Chief Operating Officer and Strategy, Laboratory for Experimental Medicine (LEM); Eli Lilly and Company; Nov. 2016-Dec. 2017.
Focus/Responsibilities: Single point of accountability for the validation, implementation, and overall portfolio management of immunogenicity assays, and novel biomarkers, required to facilitate the development and registration approval of new molecular entities; accountable for staff management/leadership, including staffing strategies, talent recruitment, personnel development, and employee retention; CRO strategy and management; implemented a robust Quality Management System; provided strong fiscal and operational (portfolio) management support for the complete immunogenicity “book of work”.
Director, Drug Disposition (DD)-Outsourcing, Scientific & Logistical Oversight Team (SLOT); Eli Lilly and Company; Aug. 2011-Oct. 2016.
Focus/Responsibilities: Primary management representative responsible for the scientific and logistical oversight of all internal and external sourcing efforts within DD; major contributor to both strategic and tactical efforts involving key business outsourcing efforts; principal management relationship representative for interactions with strategic outsourcing partners; responsible for internal/external capacity metrics, forecasting projections, Quality trends, and financials; primary Authority to Spend (ATS) approver for DD, ensuring all spend was appropriately allocated and within compliance guidelines; leader of Quality/Compliance efforts.
Director, Drug Disposition-LO Metabolism, Screening, Bioanalytical/Scientific Outsourcing, Isotopic Chemistry; Eli Lilly and Company; Dec. 2008-Jul. 2011.
Focus/Responsibilities: Oversaw internal and external support for bioanalytical (pre-clinical/clinical), discovery metabolism, and analytical biomarker organizations; direct (formal) responsibility for all external bioanalytical and Drug Disposition biomarker support as well as enabling external support for other areas within DD; directed the scientific, logistical, and financial aspects of a multi-million dollar (internal) analytical facility; responsibility for Operating Expense, Capital, Direct-Cost (outsourcing), Travel, and Supplies/Materials Budgets; devised/implemented strategy and set overall vision for the Bioanalytical, LO Metabolism, Biomarkers, & Scientific Outsourcing/Oversight groups; directed, advised, and conducted on-site evaluations for global bioanalytical operations and advised executive-level management regarding global bioanalytical strategies; responsible for expanding global bioanalytical partnerships and funding strategies across different geographies; integrated functional goals with overarching component and corporate objectives.
Director, ADME-Structure ID/BioA Core (SID/BAC) Labs, Biomarkers, New Technology, Investigative MS, Outsourcing Oversight; Eli Lilly and Company; Apr. 2004-Nov. 2008.
Focus/Responsibilities: responsible for LC/MS/MS, NMR, and Biosynthetic metabolism support for drug discovery and development efforts; biomarker, internal/external GLP bioanalytical support efforts in support of pre-clinical and clinical studies; directed the scientific, logistical, and financial aspects of a multi-million dollar analytical facility; devised/implemented strategy and set overall vision for the groups; oversaw select global operations; integrated functional goals with overarching department objectives; provided “bridge” between upper/executive management and scientific/business drug development personnel; served as an expert bioanalytical (BA) advisor to all DD therapeutic area personnel; played major role in the hiring/recruiting of personnel; served as Sponsor/Advisor/team member for Six Sigma efforts; Chair of Technology Committee.
Group Leader & Global Bioanalytical (BA) Coordinator, ADME; Eli Lilly and Company; Jan. 1998-Mar. 2004.
- Group Leader (GLP Bioanalytical (BA) Unit/Integrated BA Organization) Jan., 1998-Mar., 2004
- Research Scientist (Jan., 2001-Mar., 2004)
- Global Bioanalytical Coordinator, June 2000-Mar., 2004
- Senior Bioanalytical Chemist (Jan., 1998-Jan., 2001)
Focus/Responsibilities: LC/MS/MS bioanalytical assay development, validation, and sample analysis in support of drug discovery and development (Tox/ADME/PK) studies; directed the scientific, logistical, and (select) financial aspects of a multi-million dollar facility; key player in devising and implementing strategy and overall vision for the group; responsible for setting priorities and ensuring deadlines are met; served as key “point-person” for internal and external interactions with all bioanalytical partners/business contacts; major role in the hiring/recruiting of global bioanalytical personnel; Chair of Bioanalytical Resource Advisory Group.
Vanderbilt University Medical Center – Director and Research Assistant Professor, Vanderbilt University Medical Center Mass Spectrometry (VUMC MS) Resource, February 1997-January 1998.
Research Focus: drug metabolism and bioanalytical assay development.
Responsibilities: responsible for the scientific, managerial, and financial aspects of a multi-million-dollar core facility; personnel included Ph.D.-level Senior Scientists, Research Assistants, a Mass Spectrometry Engineer, and an Administrative Assistant. The Resource provided bioanalytical support for eight major Centers as well as individual investigators within the Medical Center.
Assistant Director/Research Instructor, Vanderbilt University School of Medicine, Department of Pharmacology, January 1996-January 1997.
Research Focus: drug metabolism and bioanalytical assay development.
Responsibilities: supervised all aspects of projects on a daily basis; directly supervised 7 individuals; was responsible for interacting with all laboratory personnel to facilitate productivity and efficiency of the Resource; involved in the hiring of postdoctoral fellows and research assistants; was a member of the committee for the evaluation and purchase of new triple quadrupole mass spectrometers; reviewed original manuscripts and book chapters.
Assistant Director/Research Associate, Vanderbilt University Medical Center Bioanalytical Resource, Department of Pharmacology, Division of Clinical Pharmacology, May 1995‑December 1995.
Research Focus and Responsibilities: essentially same as above.