Leadership and Senior Consultants
The leadership of BioTechLogic is comprised of three former Searle/Pharmacia/Pfizer BioPharma colleagues: Peter Dellva, Patrick Giljum and Tracy TreDenick
The Biopharma group that these founders supported was responsible for the management of a virtual supply chain that assures biopharmaceutical supplies, managed third-party contract manufacturers, negotiated contracts, and provided technical and submission support to develop the manufacturing and regulatory documents that would support global drug submission and approval.
When Pfizer closed the former Seale Chicago Site in 2003, these colleagues saw an opportunity to provide a valuable service. Many of BioTechLogic’s employees share this same history.
Collectively, they offer more than 50 years of experience in the biopharmaceutical industry—and they lead a staff of experienced experts in the field. They work as a team to help clients overcome regulatory and submission hurdles and achieve commercialization success.
Peter Dellva – Head of Business and Finance
Peter Dellva joined BioTechLogic in 2004 as the Head of Business and Finance. He has over 27 years of experience in the biopharmaceutical industry. He currently oversees all financial and administrative aspects of BioTechLogic’s business.
Prior to joining BioTechLogic, Mr. Dellva led a team of 13 professionals that provided manufacturing strategy, sourcing strategies, contract manufacturing development and management, process validation, and supply chain management for clinical and commercial proteins within Pfizer’s (previously Pharmacia’s) biopharma organization.
He was responsible for the development of Pharmacia’s Biotechnology Manufacturing Strategy to support current and future protein products, including the successful startup, validation, and commercialization of Somavert® API. He negotiated and managed clinical and commercial supply agreements with a total value in excess of $200 million with major biotech industry CMOs in the U.S. and Europe as well as developing financial systems to manage virtual (all external) manufacturing supply chains.
From 1993-1999, he provided on-site management of commercial and clinical protein production at multiple sites for G.D. Searle, a division of Monsanto.
He holds a B.S. in Chemical Engineering from Iowa State University, an M.M. in Finance and International Business and an M.S. in Biotechnology, both from Northwestern University.
Patrick Giljum – Head of Operations and Senior Consultant
Patrick Giljum joined BioTechLogic in 2004 as the Head of Operations. He has over 27 years of experience in biopharmaceutical process development and cGMP manufacturing of clinical and commercial supplies, supporting multiple Drug Substance and Drug Product technologies. Most recently, he supported the process validation, registration, and commercialization of an adjuvanted vaccine filed in both the US and Europe.
Prior to joining BioTechLogic, Mr. Giljum directed the manufacturing operations for clinical supply, registration, and ongoing commercial supply of biopharmaceutical products within Pfizer (and the former Pharmacia Corporation), including the process validation, registration, and commercialization of Somavert®.
From 1993-1999, Mr. Giljum was involved in the development of multiple Cytokine protein products for G.D. Searle, a division of Monsanto, including molecular biology, synthesis and purification, technology relocation, process validation, and the production of clinical and launch supplies.
From 1991 to 1993, Mr. Giljum supported the molecular biology and fermentation technology for the commercialization of Posilac®, Bovine Somatotropin, with Monsanto, Animal Science Division.
Mr. Giljum received his B.A. in Biology/Microbiology and completed graduate studies in Medical Physiology and Molecular Biology at St. Louis University.
Tracy TreDenick – Head of Regulatory and Quality, and Senior Consultant
Tracy TreDenick joined BioTechLogic in 2004 as the Head of Quality and Regulatory. She has over 28 years of experience in Pharmaceutical Quality, Manufacturing and Regulatory.
Most recently she has performed multi-product facility audits with additional pre and post-viral clearance requirements, global commercialization and submission readiness assessments, and prepared several U.S. and Europe Chemistry, Manufacturing, and Control sections in the CTD format for an adjuvanted vaccine, combination product, and biosimilar. This responsibility included the preparation of documents that spanned the course of process development, clinical and commercial-scale manufacturing for both the Drug Substance and Drug Product. This experience enabled a full understanding of the expectations for development, manufacturing, and analytical characterization of the product to obtain global product approval.
Prior to joining BioTechLogic, Ms. TreDenick directed the validation and pre-approval readiness programs for biopharmaceutical products within Pfizer (formerly Pharmacia Corporation), including the process validation, registration, and commercialization of Somavert®, a well-characterized recombinant protein product.
From 2000 to 2002, Ms. TreDenick was Manager – Global Quality and Compliance for G.D. Searle, a division of Monsanto. During this time she was involved in the quality and regulatory review of women’s health care products. Prior to joining G.D. Searle, Ms. TreDenick had roles with increasing Quality Assurance responsibility for SoloPak Pharmaceuticals and Baxter Health Care that supported drug product Aseptic filling operations.
Ms. TreDenick received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She also completed graduate study courses in Business Management at Keller Graduate School of Management.