Who We Are

The experts at IBTS have expertise in a broad spectrum of the product development world.  Some of our experts are profiled here


 Steve Pondell

 Steve Pondell is a Principal at Integrated BioTech Solutions.  He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production.  As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider.  He has experience at working with small biotech companies as well as multi-national pharmaceutical companies.  He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager.  His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.

Steve earned his Chemical Engineering degree from the University of Michigan and his MBA from the Lake Forest Graduate School of Management.


Robin G. LaBelle

Robin LaBelle is a Principal with Integrated BioTech Solutions. He has over 30 years of experience in the pharmaceutical/biotechnology industries with a global focus for the past 20 years. He has experience with many types of drug products (e.g., tablets, capsules, liquids, creams, ointments, sterile products, and fermentation products), and has had extensive interaction with FDA/DEA and other agencies, both foreign and domestic (e.g., OIG, EMA, MHRA, and Health Canada).  

Previously, Robin was the Director of Global Quality Assurance and Regulatory Compliance for Encysive Pharmaceuticals in Houston.  At Encysive, he established and managed the Regulatory Compliance function for the company, including the establishment of a Compliance Committee to meet OIG Guidance.  Robin was involved with the Pre-Approval Inspections (PAIs), which lead to Thelin approval in Europe, and Canada.

Prior to Encysive, Robin held a number of Regulatory Affairs/Compliance and Quality Control/Assurance positions with such companies as Ayerst Laboratories (Wyeth), Marion Laboratories (Marion Merrell Dow/Hoechst Marion Roussel) and Medeva Pharmaceuticals (MD Pharmaceuticals CA). 


Jerry Brandewie

Jerry Brandewie is a professional in Pharmaceutical Manufacturing, who has held the titles of General Manager, Responsible Head, Director of Production, and VP of Operations during over 30 years of experience in the biopharmaceutical and small molecule industries including manufacturing, validation, quality control and quality assurance.  Focused in manufacturing, Jerry has helped develop as well as streamline production processes, managed large groups and facilities, and written regulatory submissions to FDA and EMA.  His strong quality and compliance skills have been integral in managing manufacturing projects at contract sites domestic and international.  Jerry’s international collaborations have included working with facilities in Denmark, Spain, Italy, India, China, and Sweden.

With a background in chemistry and biochemistry, Jerry has worked with varied products including; allergy, recombinant protein, NCE and ATMPs, including viral-based gene therapy and plasmid-based DNA products.  His accomplishments include facility design and operation, authoring CMC sections of BLA and MAA submissions, PAI preparation, and commercial facility approval by FDA.  His hands-on experience includes cell banks, fermentation, cell culture, purification, formulation, and final product filling.  Jerry has worked with products produced from natural sources, E. coli, various mammalian cell lines, Aspergillus, and chemical synthesis.  Jerry is experienced in all phases of process validation with extensive knowledge in validation of sterilization, aseptic filling, environmental monitoring, and media simulations.


Rob Kaster

Rob Kaster brings more than 30 years of pharmaceutical experience from both small and large organizations (including Wyeth and DuPont).  His background includes CMC drug product formulation development/manufacturing, GXP Quality Assurance and CMC Regulatory Affairs  

His Drug Product formulation/manufacturing and analytical development background includes most dosage forms from many major therapeutic areas from the pre-clinical phase through clinical, process validation, and commercial manufacturing.    

Rob’s QA/Compliance experience includes quality oversight, program design/implementation, CAPA assessment, quality agreements, extensive QA/QC document auditing including IND/ANDA/NDA/IMPD, assessment of data.  In addition, he has experience with numerous validations, protocols, SOPs, site qualifications, PAI-readiness inspections and training.  Rob has conducted hundreds of audit as an American Society for Quality (ASQ) Certified Quality Auditor (CQA).   

Rob is an expert in CMC Regulatory Affairs, including submission preparations (IND, NDA, ANDA, 510K, IMPD, etc.), in both older traditional format and the currently accepted eCTD format.  Regulatory affairs activities also include FDA onsite meetings, telecoms, strategy design, with an intimate knowledge of applicable U.S. and international regulations.  

Rob is a graduate of The Philadelphia College of Pharmacy and Science (now University of the Sciences in Philadelphia) with a degree in Pharmacy. 


Judy Smith, RN

Judy Smith is an expert consultant in Clinical Project Management and FDA, ICH/GCP regulations.  She brings over thirty years of experience in the Healthcare and Pharmaceutical/Biotech/Device Development both domestically and internationally. She has experience in Phase I through Phase IV development. Ms. Smith spent her first 15 years in the industry as Clinical Project Manager in the International Division of Abbott Laboratories and has participated in the filing of drug applications in multiple countries including, Europe, Asia, and Central and South America.  As a senior clinical project manager she has managed Contract Research Organization (CRO) personnel, trained Clinical Research Associates (CRA), both domestically and internationally, managed budgets and contract negotiations, study timelines and patient enrollment, data preparation, and clinical summary reports. She has experience in NDA filing preparation and coordinated preparation and logistics for FDA Advisory Committee.  She has worked as an independent auditor to review investigational sites, vender qualification audits and provided sites with FDA site audit training. 

Ms. Smith’s other pharmaceutical industry experience includes positions as Research Nurse, Project Manager for CRO’s working with pharmaceutical drugs and devices, Senior Clinical Research Manager Consultant to various small biotech companies and Clinical Studies Regulatory Auditor.