Ophthalmology

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Translation From Ophthalmic Research to Ophthalmic Products

Am J Ophthalmol. 2025 Aug Novack GD, Brock WJ, Schupp AR

CMCTKS has worked with ophthalmology products that are eye drop solutions/suspensions, intravitreal injection solutions/suspensions, ocular implants, combination drug/device, and ocular films. CMCTKS has worked with both CDER and CBER divisions for ophthalmology. Furthermore, CMCTKS has extensive experience with drug/device combination products, including special delivery systems, spray bottles, multi-use dropper bottles (including preservative-free), blow-fill-seal bottles, and pre-filled syringes.

CMCTKS has manufacturing, analytical, and regulatory experience with injectable (intravenous, intravitreal, and subcutaneous) protein and peptide formulations, including synthetic peptides, proteins derived from natural products, and proteins produced in cells. This includes biologics which are used in cell therapy. CMCTKS has developed relationships with reputable industry partners for formulation and process development, aseptic manufacturing, test procedure development and validation, and clinical packaging.

Audrey Schupp, Chief Executive Officer

Ms. Audrey Schupp has been in the pharmaceutical industry for 25+ years. She began her career in the Quality Control Microbiology department of a life sciences company under consent decree. Within a year of her employment, she was chosen to be a team member of a newly created Quality Assurance department dedicated to working closely with Operations to elevate company Quality standards and extract the company from the consent decree. Within six months of working within this new group, she was promoted to Group Lead for a team of ten Quality Assurance supervisors operating in the compounding, filling, and lyophilization areas. This unique opportunity allowed her to witness how Quality and Operations could be structured to affect real change and allowed her to participate in the development of Quality Systems aimed at building Quality principles into the manufacturing and facility operations. Harmonizing Quality and Manufacturing has been her guiding principle throughout her career.

Ms. Schupp believes that in order to compile a robust CMC submission, Operations, Quality Assurance, and Regulatory Affairs must work closely and in harmony. She has held both Quality and Operations roles; however, she understands that strong knowledge of regulatory guidance documents (FDA, ICH, EU GMPs, Canadian GMPs, Japanese GMPs, ISO) is critical to ensure that quality is built into the process, to ensure that good decisions are being made, and to ensure the CMC portions of the submissions are complete and accurate.

Ms. Schupp is a skilled CMC technical transfer expert and submission technical writer (IND, NDA, ANDA, BLA, PAS, CBE-30, CBE-0). She has been responsible for leading the technical writing of the CMC sections for more than thirty regulatory filings, including complete CMC sections for NDA, BLA, and drug-device submissions. She has been responsible for technical transfers requiring a complete overhaul of the CMC sections, numerous technical transfers requiring minor to moderate revisions to the existing filing, and has served as the subject matter expert for FDA Prior Approval Inspections.

Ms. Schupp has been in Quality and Manufacturing roles in both traditional and virtual pharmaceutical companies. Her strengths are managing vendor relationships, pre-IND and early phase IND submissions, technical transfers, and highly challenging routine production environments. She has worked directly in technical roles as the Subject Matter Expert for liquid, powder, ointment, ampoule, pre-filled syringe, and lyophilized sterile/aseptic products; ophthalmic products; nasal sprays; transdermal and topical products; solid dosage forms; medical devices; and combination products. She has led inter-disciplinary project teams through complicated technical transfer programs, Quality Systems remediation programs, and Quality by Design product strategies. She has extensive expertise in due diligence audits, quality audits, suppler qualification, and vendor sourcing.

In 2014, Audrey Schupp began her own consulting business aimed at assisting pharmaceutical, biotechnology, and medical device companies in achieving their submission goals. CMC Turnkey Solutions works with small, virtual, niche innovative companies to provide regulatory strategy support, submission preparation, CMC Quality and Operations oversight, and supply chain management to ensure product is developed and manufactured under Quality First principles.

Adriana Stihi, CMC Scientific Advisor

Mrs. Adriana Stihi graduated from the most prestigious engineering and technology university in Romania, her homeland, with a Masters degree in Biochemistry. After working for more than 10 years on several biotechnology and biomedical research projects, Adriana moved with her family to the United States and started her new career in the pharmaceutical industry.

For 30+ years, Adriana has held positions of increasing responsibility in R&D, QC and QA within branded and generic, traditional and virtual pharmaceutical companies. Adriana began her career in the analytical chemistry field. As one of the first users of the Waters Alliance HPLC system launched in 1996, she worked with field engineers on improving the end-user experience. Only a couple of years into her career, Adriana was recognized for her keen expertise and attention to detail, being selected for an interdepartmental team for audit of data generated for regulatory submissions. This unique opportunity allowed her to gain a strong understanding of quality and risk management systems.

Over the years, Adriana had the opportunity to work on all stages of drug product’s lifecycle: pharmaceutical development, product launch, technology transfer, commercial manufacturing, and post-approval commitments. She has been responsible and successfully completed analytical laboratory setups, technology transfers, development and validation activities, internal and external quality audits, applying her extensive knowledge of Quality Management System and LEAN strategies. As quality manager for development and commercial activities at contract manufacturing sites in US, Canada and EU, Adriana lead technical and compliance activities, and authored key CMC sections for numerous regulatory submissions.

As a culmination of her career, Adriana served as Quality Director of a start-up dietary supplements manufacturing company that developed and patented the design and technology for a novel 2-in-1 capsule product. In this role, she created and maintained quality standards and policies, product quality documentation, supplier qualification programs, quality agreements and contracts, to support batch release and final product commercialization in compliance with GMP and FDA regulations.

In 2019, Adriana established her own consulting business providing regulatory submission support for small pharmaceutical companies, and began her productive collaboration with CMC Turnkey Solutions as Subject Matter Expert (SME) for all its analytical programs.

David Kosinski, CMC & Supply Chain Consultant

David Kosinski is a strategic technology and regulatory operations Senior Project Manager and advisor with more than two decades of experience leading enterprise portfolios across the Pharmaceutical, Clinical Research, Telecommunications, and Compliance sectors. As a Senior Project Manager, Consultant and transformation leader, he specializes in aligning technology modernization with operational execution, regulatory expectations, and executive business priorities—guiding organizations through complex change, integration, and risk landscapes with precision and measurable outcomes.

David has delivered high-impact advisory support for global sponsors including AbbVie, Merck, Johnson & Johnson, Regeneron, Astellas, and Bristol Myers Squibb, shaping delivery models across Clinical Development, Pharmacovigilance, Regulatory Affairs, Market Access, and Quality systems. He is frequently sought after for his ability to simplify complexity, translate regulatory and data needs into actionable technology plans, and shepherd organizations through readiness for inspection, audit, submission, and commercialization.

With proven expertise in M&A integration, portfolio rationalization, data governance, AI risk modeling, and ERP modernization, David supports executive teams in making informed investment decisions and establishing future-state operating frameworks. His work on high-profile integrations—including AbbVie–Allergan and BMS–Celgene—delivered organizational harmonization, cross-system alignment, and unified governance models that accelerated time-to-value and reduced operational friction.

Earlier in his career, David led enterprise technology portfolios at Verizon Wireless, directing budgets exceeding $100 million and managing global teams of 200+ resources. His tenure included implementation of mission-critical Application Performance Management, cloud modernization, disaster recovery frameworks, and cybersecurity programs that strengthened organizational resilience and 24/7 system integrity.

As a Senior Project Manager, consultant and executive advisor, David partners with C-suite leaders, PMOs, and regulatory stakeholders to drive portfolio investment strategy, risk mitigation, enterprise transformation, and compliance maturity. His hallmark approach blends business clarity, technical rigor, and regulatory foresight—ensuring clients achieve operational stability, inspection readiness, technology adoption, and sustained competitive advantage.