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Join our rare disease and orphan drug experts at World Orphan Drug Congress Europe.

Our therapeutically aligned A-Team has comprehensive experience in rare disease and orphan drug research, including the facilitation of over 200 clinical studies across 60 countries. Schedule a meeting and visit us at booth #48 to learn more.

Panel Topic - Breaking Barriers: Addressing Clinical Development Challenges in Medicines for Children with Rare Diseases

3:10pm - Wednesday, November 1st

  • Innovative clinical trial solutions, including modern statistical methodology approaches, modelling, simulation and extrapolation
  • Working with patient advocacy groups, patient’s families, and the application of patient centric trial principles
  • Regulatory stakeholder collaboration
  • Optimization of clinical assessments

Panelists: 

Speaker Session - Consistent Subjectivity: How to quantify subjective endpoints in rare diseases

10:10am - Thursday, November 2nd

  • Considerations when no adequate rating scale is available for your clinical trial
  • Best practices in ensuring subjectivity is standardised
  • Leveraging technology to streamline the collection, quantification, and analysis of subjective data

Speaker:

  • Milan Marinkov - Executive Medical Director, Therapeutic Area Medical Lead, Rare Diseases

Fill out the form to schedule a meeting.
Richard Vesely (3)

Richard Vesely

Vice President, Regulatory Strategy

With over 12 years of experience at the European Medicines Agency as Pediatric Coordinator and Head of Office for Rheumatology, Immunology, Gastroenterology, and Respiratory Diseases, Richard is an expert in regulatory procedures in the European Union. He led the team in evaluating marketing authorizations, scientific advice, and pediatric and orphan designation procedures. With 30 years of clinical and research experience as a pediatrician, pediatric immunologist, and rheumatologist, Richard has expertise in the development of paediatric investigation plans and initial pediatric study plans.

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Maria-Cruz Morillo

Global Therapeutic Operations Lead, Rare Diseases

Maria-Cruz Morillo, M.S. Pharmacy, has deep knowledge in drug development after 27 years of experience in Project Management and Strategy and IMP Supply in both biotech and CROs. Her strategic mindset and demonstrated ability to design and implement effective study protocols has contributed significantly to the achievement of market authorizations for numerous rare endocrinology and hematology autoimmune programs. Maria-Cruz is currently working as the head of Allucent’s team of Rare Disease experts, integrating our cross functional expertise to provide strategic solutions that foster successful outcomes in rare disease clinical trials and ensure excellence in delivery.

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Jessica K. Roberts

Director, Pharmacometrics

Jessica has worked in modeling and simulation for over 10 years with an emphasis on pediatric patients. With experience from the NICU and PICU at Primary Children’s Hospital and oncology protocols at St. Jude Children’s Research Hospital before becoming a consultant, Jessica has had the opportunity to contribute to studies in neonates, infants, and pediatric patients for the treatment of infectious diseases, pain management, oncology, and respiratory illnesses, to name a few.  Her experience has focused on optimal sampling in pediatric patients for clinical trials as well as selection of the best dose for treatment in various pediatric age groups. During her career, Jessica has published over 35 research articles, invited editorials, invited reviews, and invited book chapters, and given many oral and poster presentations that have focused on drug development in neonate, infant, and pediatric patients.  

Milan Marinkov Headshot

Milan Marinkov

Executive Medical Director, TA Medical Lead

Milan is a seasoned medic with over 15 years of extensive experience in the fields of clinical research and drug development. Throughout his career, he has made significant contributions to the successful introduction of multiple pharmaceutical products into the market. Milan's professional background encompasses roles in both CRO and the pharmaceutical industry, providing him with a comprehensive perspective on drug development. Specializing in rare and neuroscience diseases, Milan has played a pivotal role in the design and refinement of study protocols to optimize clinical research methodologies. His expertise extends to overseeing and presiding over steering committees, as well as evaluating safety signals and risk-benefit ratios. Milan has also served as the medical team leader in numerous complex clinical trials. Currently, Milan holds the position of Executive Medical Director at Allucent, where he leads a team of medics dedicated to advancing research in rare diseases. Prior to venturing into the realm of clinical research, Milan pursued a career as a medical doctor and earned diplomas in clinical pharmacology and neurology.