Join us in Copenhagen for a half-day seminar to examine the decisions that define early oral drug product success. This seminar brings together scientific, development, and investment leaders to examine the decisions that define early oral drug product success and long-term fundability for complex molecules.
The program starts with material characterization, process modeling and Quality by Design. Speakers show how early understanding of critical material attributes and process parameters reduces scale-up risk and builds a robust formulation strategy.
Sessions then move into practical approaches for early risk identification. Learn how PBPK modeling supports better prediction of ADME and bioavailability, and how scientific design choices shape development pathways. The agenda also highlights enabling oral technologies that expand delivery options for both small molecules and emerging macromolecules.
The event concludes with a focused discussion on fundability. A panel of experts explores how investors assess early-stage programs, which technical and strategic signals build credibility, and how development decisions directly impact investment outcomes.
Participants will gain practical tools to de-risk development, strengthen decision-making, and communicate program value with greater confidence. The seminar closes with an open networking reception for continued discussion with peers, experts, and investors.
Key learning objectives:
– Understand how early scientific and modeling approaches reduce development risk and improve decision quality
– Identify when advanced oral technologies can address bioavailability challenges and support progression to first-in-human studies
– Recognize how development strategy and technical execution influence credibility, investor confidence, and program fundability
Who Should Attend
Professionals in Preclinical & Formulation Development, Reasearch & Development, CMC, Product Development, Project Management, Manufacturing & Operations, Supply Chain Management, and Pharma Consultants seeking a CDMO partner for developing and manufacturing oral dosage forms.
Date: Thursday, 24 September 2026
Time: 8:30 – 13:45
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Opening remarks Ines Andres Bustos, Account Director, Rx Early Phase, Catalent |
| 9:10 | Explore how PBPK modeling supports smarter, faster decisions in early development by predicting how a compound’s absorption and disposition may respond to different formulation approaches Jan Neelissen, Associate Director, DMPK Advisory Services |
| 9:35 | Begin with the End in Mind: Design Principles for Oral Drug Product Development How sound scientific choices, clear planning, and disciplined governance build asset value and strengthen program reliability and regulatory acceptance. Stephen Tindal, Senior Director, Scientific Advisory, Oral Small Molecules, Europe, Catalent |
| 10:05 | Material Characterization, Process Modelling and QbD in Formulation Development Highlights how deep material insight and predictive process modeling reduce scale-up risk. Diogo Gomes Lopes, PD Scientific Team Leader, Catalent |
| 10:30 | Coffee Break & Networking |
| 10:45 | Expanding Oral Drug Delivery Options for Small and Macromolecules using Innovative Technologies Explains when lipid-based softgels and Zydis® ODTs enable oral delivery for challenging small molecules and macromolecules, reduce early bioavailability risk and support a clearer path to clinical supply. Karunakar Sukur, Global VP, Pharma Product Development & Head Scientific Advisory, Catalent |
| 11:30 | Fundability by Design: How Early Development Strategy Wins Investor Confidence Explores how early development strategy shapes investor perception of risk and fundability. Highlights how key decisions generate credibility signals, shape investor confidence and determine which programs attract capital. Speaker: To be confirmed |
| 12:00 | Panel Discussion: Scientific and Strategic Drivers of Early-Stage Fundability |
| 12:45 | Light Lunch/refresments & Mingle |
| 13:45 | End of Boost Seminar |
Speakers
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Inés de Andrés, Account Director, Catalent Inés de Andrés is an Account Director at Catalent, responsible for the Nordic region. With over 20 years of experience in the pharmaceutical industry, she has held key roles across CDMOs in Switzerland, Germany, and Belgium. In her current role, she supports pharmaceutical clients from preclinical through Phase 2 development, delivering tailored solutions across formulation, manufacturing, and clinical supply. With a strong customer focus, Inés brings expertise in sales, business strategy, project management, and customer service. Inés holds a degree in Pharmacy from the Universidad Complutense de Madrid. |
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Jan Neelissen, Associate Director, DMPK Advisory Services
Jan Neelissen, Ph.D., serves as the associate director of DMPK advisory services. He has over 25 years of pharmaceutical industry experience in the field of DMPK. In his current role, he advises drug innovators in developing new therapeutics and designing tailored formulation, delivery, and manufacturing solutions. Neelissen is a trained biologist and holds a doctorate in pharmaceutical sciences from Leiden University. |
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Stephen Tindal, Senior Director, Scientific Advisory, Oral Small Molecules, Europe, Catalent
Stephen Tindal is the Director of Science and Technology at Catalent. His work is largely focused on preclinical to phase 1 development and is based on assessing preclinical data to help define any challenges to dosage form development. Tindal has more than 36 years’ experience at Catalent, where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and supporting business development. He holds a bachelor’s degree in Chemistry and Analytical Science from Loughborough University, Loughborough, U.K. |
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Karunakar Sukur, Global VP, Pharma Product Development & Head Scientific Advisory, Catalent
Dr. Karunakar (Karu) Sukuru is a global pharmaceutical R&D leader with over 30 years of experience in drug product development and advanced oral delivery technologies. As Global Vice President of Pharma Product Development and Head of Scientific Advisory at Catalent, he leads nearly 1,000 scientists across 14 international sites, driving innovation in oral delivery of small, mid and large molecule therapeutics. A recognized expert in controlled release softgel and enabling technologies, Dr. Sukuru holds eight issued patents and more than 20 pending across lyophilized biologics, nanoparticle systems, ASDs and capsule shell and fill formulation science. He previously held leadership roles at Endo Pharmaceuticals and Banner Pharmacaps. He is a frequent speaker at AAPS, CRS, FDA and IPC forums and has served as an expert committee member at USP setting standards. Dr. Sukuru obtained his Masters and Ph.D. from IIT-BHU, India and B.Pharm., Gulburga University, India He is also a Licensed Pharmacist. |
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Diogo Gomes Lopes, PD Scientific Team Leader, Catalent
Diogo Gomes Lopes is PD Scientific Team Leader at Catalent in Schorndorf, Germany. He leads multidisciplinary scientific teams responsible for formulation and process development of oral solid dosage forms, as well as the implementation of bulk manufacturing and packaging processes from development through commercial launch. His work focuses on integrating material characterization, process modeling, and Quality by Design principles to reduce development risk, accelerate scale-up, and establish robust manufacturing strategies. |
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