Bios - CRS 2021 Pediatric Drug Development & Delivery Meeting

Bjorn Knud Andersen, Director Front-End Innovation, Phillips-Medisize

Mr. Andersen is an industry expert with more than 20 years’ experience within medical device innovation and development, predominantly related to pharmaceutical drug delivery and state of the art patient self-administration solutions. Mr. Andersen has been heading the technical development focus for Phillips-Medisize’s Mini-tablet Dispenser and is currently acting as an internal specialist for its current core commercial applications as well as its continued technical evolution.

Louise Bracken, Co-Director Paediatric Medicines Research Unit, Alder Hey Children’s NHS Foundation Trust

Louise graduated from University College Dublin with a B.Sc. in Biochemistry in 2003. She went on to study Pharmacy at Liverpool John Moores University where she obtained a Master of Pharmacy in 2007. Louise joined Alder Hey in 2010 and completed a PhD at the University of Liverpool. The focus of her work was on the avoidability of adverse drug reactions (ADRs) in children and the development of an ADR assessment tool. Louise is a Senior Research Pharmacist and Co-Director of the Paediatric Medicines Research Unit at Alder Hey and works clinically in the area of neonates. Her research interests include drug safety, acceptability of medicines to children, paediatric formulations and medicines optimisation.

Stuart Charlton, Associate Scientific DirectorBristol Myers Squibb

Stuart works at Bristol Myers Squibb in the Drug Product Development group, having joined the company in 2005. His current role as Associate Scientific Director is focused on the development of oral solid dosage forms from the pre-clinical stage through to product registration. Stuart has a particular interest in paediatric drug product development and is an SME leading and supporting activities across the company and externally. Other research interests include mechanistic understanding and mini-piloting for roller compaction and film-coating. Stuart graduated from the University of Bath with a degree in Pharmacy, and was later awarded a PhD by the University of Nottingham in 2002.

David Clapham, B Pharm, Independent Pharmaceutical Consultant

David Clapham trained as a pharmacist and has over 40 years’ experience in various product development roles in the pharmaceutical industry.  He has experience in the formulation and product development of a wide range of dosage forms including medicines for children.

For the last 10 years of his career David was involved in the developability assessment and early stage clinical development of a wide range of assets.

Since retiring from GSK David has worked as an Independent Pharmaceutical Consultant. His main focus has been as a member of the EuPFI (European Paediatric Formulation Initiative).  He heads the EuPFI Taste Assessment and Taste masking workstream and is a member of several of the workstreams.

His research interests include presentation of medicines (taste, taste masking, sensory analysis           [both human and non human], appearance, colour, colour measurement), photostability, cyclodextrins and bioenhancement.

Helen Coope, European Medical Affairs Manager, Diurnal

Originally from academic immunology research, Helen spent her early career in biosciences in large pharma R&D, working from target validation through to Phase 2A clinical trials.  She later moved into medical affairs working with prescribers, patient groups and reimbursement organisations and supporting the use of medicines in a non-promotional capacity.  Helen now leads the European Medical Affairs team at specialty endocrinology company Diurnal.

Nikoletta Fotaki, Reader in BiopharmaceuticsUniversity of Bath

Dr Nikoletta Fotaki is a Reader in Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. Her expertise and research are focused on PBPK modeling, in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs and biowaivers. Her scholastic work includes more than 80 peer reviewed publications, one book, 5 book chapters, 86 published conference contributions and 2 patents. She is a Fellow of the AAPS, the vice chair of the OBAM Community of AAPS and she has been the chair of the IVRDT Focus Group of AAPS. She is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.

Gloria Garcia Palacios, Global Regulatory Affairs - EU Head I&I, Sanofi

A pharmacist by training, with a post-graduate degree in “International Development and Registration of Medicinal Products”. I have conducted most of my professional career in Industry, in the regulatory affairs department, where I have hold different regional and global positions across a broad range of therapeutic areas. I am currently working in sanofi as the Head of the EU Regulatory Affairs Immuno-Inflammation franchise. In addition, I am a subject matter expert for paediatric regulations in my company, co-chair of the sanofi pediatric network and, more importantly, a strong believer on the need to develop medicines for use in children and to facilitate this important activity with all stakeholders working together.

Olivier Giré, Chief Operating Officer Specialty Pharma, Crossject

A graduate of EDHEC Business School, Olivier Giré has been in the pharmaceutical industry since 1994, with international pharmaceutical management roles at IPSEN, ADVANZ, and EXELTIS before joining CROSSJECT in 2016. A member of the executive team, he leads pharmaceutical development and commercial operations.

Kevin Hughes, Regulatory Affairs and QA Manager, Colorcon Ltd.

Kevin has been with Colorcon for 17 years where he is the Regulatory Affairs and Quality Assurance Manager for Colorcon with responsibity for the EMEA region, providing regulatory support for both the pharmaceutical and food industries.

Kevin is on the board of IPEC, actively participates in the IPEC Quality and Regulatory Affairs committee. Kevin represents IPEC on the board of EUPFI (European Paediatrics Formulation Initiative).

Before Colorcon, Kevin spent 5 years at Boots Healthcare Development, where he was Team Leader developing solid oral dosage forms for Boots Pharmacies.

Kevin graduated with a BSc (Hons) in Food Science from Nottingham University.

Kingsley Iyoha, Director, Development, Pharmaceutical Sciences, Quotient Sciences

Kingsley has spent nearly 20 years developing products within the Pharmaceutical and Consumer Healthcare Industry.  His experience includes developing palatable, age-appropriate formulations within contract formulation development organizations. 

In his current role, Kingsley works closely with clients to agree product development approaches, leading a technical team that progresses programs through early-stage CMC development.  Kingsley also contributes to an internal pediatric workstream to share learnings and promote best practices across the organization.

Maria Kavallaris, Director Australian Centre for NanoMedicine UNSW Sydney and Head of Translational Cancer Nanomedicine, Children's Cancer Institute

Professor Maria Kavallaris AM is Founding Director of the Australian Centre for NanoMedicine at the University of New South Wales, Head of Translational Cancer NanoMedicine Theme at the Children’s Cancer Institute, Sydney Australia.  Maria is recognised for her innovation in driving interdisciplinary research in cancer nanomedicine. She is internationally recognised for her research in cancer biology and therapeutics in childhood and adult cancers. Her research has identified clinically important mechanisms of resistance to cancer therapies, with her discoveries leading to patents, industry and clinical linkages for the development of cancer therapeutics and devices.

Nicky Konstantopoulos, Associate Director, CMC, Medicines Development for Global Health

Dr. Nicky Konstantopoulos is a Drug Development Manager in Chemistry, Manufacturing and Controls (CMC) at Medicines Development for Global Health (MDGH), a not-for-profit biopharmaceutical company dedicated to the development of affordable medicines and vaccines for the people who need them most. In 2018, US FDA approved MDGH’s New Drug Application on moxidectin for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older, which is a leading global cause of preventable blindness. Prior to transitioning to the pharmaceutical industry, Dr Konstantopoulos is internationally recognised for her biochemistry and cell physiology research in diabetes and insulin resistance research. She has worked at Joslin Diabetes Centre (Boston), Mayo Clinic (Rochester), CSIRO (Melbourne) and biotech start-up, Verva Pharmaceuticals (Melbourne).

Fang Liu, Founder & Director, Fluid Pharma

Dr Fang Liu is the Founder & Director of Fluid Pharma Ltd, a UK bio-tech company specialised in age-appropriate medicines for children and older patients.  She is also an Associate Professor in the Department of Clinical Pharmaceutical and Biological Science at University of Hertfordshire, UK. She gained her PhD in Pharmaceutics at the School of Pharmacy University of London (now UCL School of Pharmacy) in 2008. Fang is the inventor of three patents and author/co-author of over 30 peer-reviewed scientific publications and book chapters in oral drug delivery, patient-centric medicines and biopharmaceutical analysis.   

Matthew Santangelo, Principal Scientist, Pfizer Inc.

Matt Santangelo is a Principal Scientist in the Drug Product Design group at Pfizer in Groton, CT. Matt has been with Pfizer for 17 years and has vast experience in drug product formulation and process development as well as analytical characterization. In his current role, Matt is primarily focused on the development of pediatric drug products to address the unique needs of this patient population. Matt also serves as a co-lead for the IQ Consortium Pediatric Working Group with the goal of collaboratively advancing pediatric formulation development and regulatory harmonization globally.

Ahad Rahim, Professor of Translational Neuroscience, University College London

Ahad Rahim is Professor of Translational Neuroscience at University College London and the Head of Research Department of Pharmacology at the UCL School of Pharmacy. His work focusses on developing new therapies for neurodegenerative diseases and moving these along the translational pathway for clinical application. These include gene, peptide, exosome and small molecule therapies. He works closely with clinicians at the UCL Great Ormond Street Hospital Institute of Child Health, UCL Queen’s Square Institute of Neurology and St Thomas’ Hospital, London. 

Ronald L. Smith, Principal, Pharmawyze LLC

Ronald L. Smith, Ph.D., was recently Scientific Associate Vice President of Pharmaceutical   Sciences at Merck Research Laboratories leading Exploratory Products & Technologies. Dr.   Smith joined Merck in 2008 as Executive Director of Pharmaceutical Research and was subsequently Head of Product Value Enhancement that translated technology-enabled concepts into differentiated medicines. Prior to Merck, Dr. Smith led Exploratory   Biopharmaceutics & Drug Delivery at Bristol- Myers Squibb Company. He began his career with the Procter & Gamble Company leading the research and product development of enabling technologies for intranasal, buccal, mucoadhesive and transdermal drug delivery. Dr. Smith is a Fellow of the American Association of Pharmaceutical Scientists and served as past-Chair of the Pharmaceutics & Drug Delivery Section of AAPS and the Board of Scientific Advisors for the Controlled Release Society. He has held Adjunct faculty appointments at the University of Cincinnati College of Pharmacy and the School of Pharmacy at West Virginia University and received his degrees in Chemistry from West Chester University (BS) and the University of Iowa (PhD).

Catherine Tuleu, Professor in Pediatric Pharmaceutics, University College London School of Pharmacy

Catherine TULEU, Docteur en Pharmacie, PhD, is Professor in Paediatric Pharmaceutics at UCL School of Pharmacy, UK. Her research is  inherently translational, ranges from formulation, process and methodology development to clinical implementation, integrating the following themes: children centric excipient research; reformulation and repurposing for better medicines for children; development of innovative age appropriate dosage forms (especially for under 5s); administration issues (co-administration with food/beverages) and devices; and sensory pharmaceuticsTM (acceptability and in vitro/in vivo taste assessment).. She is the founder and chairperson of the European Paediatric Formulation Initiative (EuPFI), a consortium working in a pre-competitive way on paediatric drug formulations. Her recently founded spin out company senCeuTics Ltd is focusing on preclinical taste evaluation [rat taste aversiveness (BATA) model; Biorelevant buccal drug release], paediatric formulation development [strategization; excipient risk assessment, acceptability/palatability study design  as well as Paediatric Investigational Plan (PIP) input and review].