Team
Principal Consultants
Meade Medaugh, P.E.Founding Member || Principal Consultant, Processes Development & CMC
Meade Medaugh, P.E., is the Founder and Process Lead at DES Pharma, bringing 15 years of dedicated experience in the biopharmaceutical industry. As a leader in bioprocess innovation, Meade holds degrees in both biochemistry and chemical engineering and specializes in bioprocess design, scale-up, and manufacturing.
He has successfully supported over 25 products from pre-clinical optimization to post-commercial launch. This extensive experience inspired him to found DES with a vision to bring crucial knowledge and efficiency to the commercialization of desperately needed therapies.
Prior to founding DES, Meade held several leadership positions in both startups and late-stage commercial companies across all biologics modalities. He is driven by a scientific rigor to produce safe, high-quality drug products that enable wider patient access by lowering manufacturing costs—the core principle upon which DES was founded.
Isaac G. JeganathanFounding Member || Principal Consultant, Supply Chain & Procurement
Isaac brings more than 25 years of experience in bio-pharmaceutical manufacturing, holding leadership roles with industry giants Pfizer, GSK and Moderna. Isaac has extensive experience building high-performing teams, transforming operations, negotiating contracts and implementing ERP systems worldwide.
Isaac has successfully launched multiple billion dollar blockbuster drugs, flawlessly executed over 30 technology transfers of globally commercialized products, and generated billions of dollars of bottom-line savings by implementing network optimization strategies.
Isaac received his MBA from Fordham University and a B.S. in Chemical Engineering from Columbia University.
Jeannine LarrieuxPrincipal Consultant, Analytical Development & QC
Jeannine Larrieux is a pharmaceutical consultant with over 30 years of experience specializing in Quality, Compliance, and Analytical CMC for Small Molecules, Biologics (ADCs, mAbs, Biosimilars), and advanced Gene Therapies (CAR-T, AAV, LVV).
She has led QC and Analytical strategy, regulatory submissions (IND, CTA, BLA, NDA), and technical transfers across clinical and commercial phases. Her expertise includes developing and executing remediation plans in response to FDA 483s, building robust quality systems, and implementing stability and raw material programs that drive regulatory confidence.
Jeannine is known for her integrity, scientific rigor, and commitment to patient safety, helping organizations uphold compliance while accelerating innovation.
Today, Jeannine works with biopharma organizations to strengthen compliance frameworks, ensure data integrity, and support analytical lifecycle management under global regulations. She is RAPS-certified in pharmaceuticals, biologics, and medical devices.
Gladys Joa, Pharm.D.Principal Consultant
Gladys brings 20 years of in-depth pharmacovigilance and medical safety experience from pre-market through post-market settings.
Gladys has completed effective integration of safety-related data from non-clinical, clinical pharmacology, clinical, literature, epidemiology, post-market, and quality, for comprehensive signal detection, trend analyses, and phase appropriate risk mitigation strategies. She is well-versed in medical safety regulatory requirements, including signal detection and management, aggregate reports, risk management plans, global and regional initial and supplemental regulatory submissions for marketing authorizations, literature review, case processing, safety systems, clinical study protocols, investigator’s brochures, and prescribing labels.
She has also led and built high-performing medical safety scientist teams, where she successfully partnered informatics, biostatisticians, non-clinical, clinical pharmacology, clinical, operations, regulatory, quality, manufacturing, vendors, business partners, and regulatory authorities to achieve safety-related goals for pre-marketed and post-marketed products.
Gladys has developed and implemented best practices for global medical safety from first-in-human studies through regulatory submissions for marketing authorizations, resulting in successful marketing authorizations with minimal safety-related questions from regulatory authorities.
Senior Consultants
Matthew Pontrelli, M.S. Senior Consultant, Process Development & CMC
Matthew brings over a decade of specialized expertise in PD and CMC, with deep technical knowledge spanning early-stage innovation through late-stage commercialization of biologics products. His approach integrates Quality by Design principles with advanced statistical methods, leveraging Design of Experiments (DOE) and multivariate analysis to develop robust, commercially viable processes. Matthew has extensive experience in late-stage process characterization, including scale-down model qualification, parameter classification, and in-process attribute limit determination, with direct support of PPQ readiness activities and validation protocol development.
His technical leadership encompasses both upstream and downstream unit operations, with particular depth in chromatography, tangential flow filtration, and viral clearance validation. A skilled technical writer, Matthew has authored comprehensive process descriptions, regulatory documentation, risk assessments, and technology transfer packages that have successfully navigated programs through critical regulatory milestones. Matthew accelerates biologics programs from development through commercial manufacturing.
Anulfo Valdez, MSc Senior Consultant, Analytical Development
Anulfo Valdez is an experienced consultant with more than 30 years of experience with strong background in pharmaceutical and biotechnology analytical development. Anulfo brings deep expertise in chromatographic techniques, LC-MS, biologics and peptide analysis, and biophysical characterization. He provides scientific and strategic support across the full product lifecycle, from early research and development through commercialization. He brings extensive experience developing, optimizing, and validating chromatography-based methods, for small molecules, biologics, and peptides, supporting applications such as structural characterization, impurity profiling, forced degradation and stability studies, biosimilars, and quality control. Anulfo also delivers analytical methods that are robust, reproducible, and compliant with ICH, FDA, and GMP regulatory requirements.
His background includes Design of Experiments (DoE) and statistical methodologies to enhance method robustness, identify critical analytical and process parameters, reduce variability, and accelerate development timelines. He is known for translating complex analytical and characterization data into clear, actionable insights for cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs.
Lei Zhu, PhD.Senior Consultant, Analytical Development
Lei Zhu is a nonclinical consultant with over 15 years of experience in multiple disease research fields and more than six years directing preclinical and translational gene therapy programs for rare diseases. He has led IND-enabling GLP and non-GLP studies, achieving FDA IND approval for first-in-class AAV gene therapy programs, and brings strong expertise in in vivo pharmacology, safety pharmacology, PK/PD modeling, and biomarker discovery.
Lei has extensive experience managing CROs and vivarium operations, integrating cross-functional efforts across clinical, manufacturing, and regulatory teams, and leveraging computational approaches to drive data interpretation and decision-making. He is a prolific scientific contributor with multiple first-author publications and patents.
Today, Lei works with biopharma organizations to advance innovative therapeutics from discovery through clinical development, providing strategic leadership in translational science, regulatory-ready preclinical design, and data-driven program execution.
Connect With Our Team TodayAdvance Your Drug Program
with Confidence
Start building reliable, high-quality drug development programs today.