Dr. Ravi Kiran Kaja, Ph.D., FRSC
Senior Principal Scientist, Complex Generics - Pharmaceutical Science, General Chapters U.S. Pharmacopeia (USP), Rockville, MD 20852
Dr. Ravi Kiran Kaja is a distinguished scientific leader with over 20 years of experience in analytical chemistry and pharmaceutical R&D, specializing in formulation analytical sciences for sterile and complex drug products. With a Ph.D. in Analytical Chemistry, he is recognised for combining deep technical rigor with strategic vision to advance high‑quality medicines.
In his role at USP, Dr. Kaja leads scientific strategy for complex generics and drives the development of impactful USP–NF documentary standards, including general chapters on pharmaceutical packaging and complex drug products—strengthening global quality frameworks and supporting patient safety worldwide.
Dr. Kaja’s expertise spans sterile formulation analytics, complex formulation characterisation, Extractables & Leachables, manufacturing sciences, MS&T, and technology transfer. Known for his collaborative leadership, he actively promotes the sharing of scientific knowledge to elevate pharmaceutical quality across the industry.
Ron Brown
Toxicologist at Risk Science Consortium, former FDA
Ron Brown is a board-certified toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organisations.
At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Alberto Bresciani
Founder and Principal, Tycho Science and Tech
Alberto Bresciani is an Owner and CEO at Tycho s.r.l. since 2025. He has years of hands-on experience applying AI in drug discovery within the pharmaceutical and life sciences sector. His expertise includes utilizing AI models in biology, chemistry, and large language models (LLMs). More recently, he served as the Director of Project Biology at Recursion (2024 to date) and Exscientia (2022 to 2024). From 2010 to 2022, he held a significant operational role at IRBM S.p.A. as the Director - High Throughput Biology and Screening, where he was responsible for managing a team of over 50 people in discovery sciences. He has published over 50 scientific articles in peer-reviewed international journals.
Marco Ceccolini
Product Analytical Development Scientist, Angelini Pharma, AFI Member
Marco Ceccolini is an experienced Analytical Scientist specializing in product development from early-stage new chemical entities to the lifecycle of marketed projects. Currently Senior Scientist at Angelini Pharma since 2020, he leads analytical method development, impurity control strategies, statistical analysis, and coordinates team activities with external partners for early-stage projects. He holds a Bachelor and Master's degree in Pharmaceutical Chemistry and Technology from the Università di Bologna. Marco has contributed to numerous scientific publications and presented at international conferences on topics such as Analytical Quality by Design, E&L, and forced degradation studies, serving as a university lecturer for pharmaceutical stability and impurity management.
Paolo Pescio
Managing Director, Eurofins Regulatory and Consultancy Services Italy
Paolo Pescio is a Strategic Regulatory Leader and Compliance Expert with extensive experience in medical devices and pharmaceuticals, currently serving as Managing Director within Eurofins Regulatory & Consultancy Services Europe. With a strong background in regulatory strategy, quality systems and compliance, Paolo has supported numerous companies in navigating complex regulatory frameworks across EU and international markets, including medical devices, combination products and pharmaceutical products. His expertise spans regulatory pathways, risk-based approaches, authority interactions and compliance strategy, with a particular focus on translating regulatory requirements into practical, implementable solutions.
Paolo holds an MBA and is an ERT-certified expert, combining strategic vision with hands-on regulatory experience. He is frequently involved in high-level advisory projects and acts as a trusted partner for companies facing evolving regulatory expectations.
Simone Carrara
E&L Business Unit Manager & Senior Scientific Director, Eurofins BioPharma Product Testing Italy
Simone Carrara is the E&L and Packaging Testing Business Unit Manager at Eurofins Biolab, with over 15 years of experience in Extractables & Leachables, packaging testing and pharmaceutical project management within highly regulated environments. He currently leads the E&L and Packaging Testing activities at Eurofins Biolab, combining scientific expertise, operational leadership and client-facing responsibilities. Over the years, Simone has covered key roles including E&L Senior Scientific Director, Extractables & Leachables Laboratory Manager, and Pharma Project Leader, gaining deep hands-on experience across the full lifecycle of E&L studies — from study design and execution to data interpretation and regulatory support. His background also includes strong expertise in bioanalytical sciences, LC/MS analysis, and quality-controlled laboratory environments, supported by an Executive MBA from Politecnico di Milano and a degree in Industrial Biotechnology.
As Chairperson and Moderator of the Eurofins E&L Summit, Simone will guide discussions across technical and regulatory sessions, ensuring focused dialogue, scientific rigor and practical relevance, and facilitating effective exchange between industry, regulators and experts.
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