Setting up your drug for clinical success: strategies and considerations from discovery to clinic

The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner to speed development.

This event will focus on key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase-appropriate formulation selection, and integration of product development and clinical supply.

When: 01. October 2019, 10:00 – 14:00
Where: Actelion Business Center, Hegenheimermattweg 95, 4123 Allschwil

 

Participation to the event is free of charge; however, your registration by 27th September 2019 is kindly required.


Program

09:30 Registration & Coffee
10:00

WELCOME FROM THE HOSTS

Leonildo Delgado, BaseLaunch
Andy Maitland, Account Director, Catalent

10:10

PART 1: PRECLINICAL STRATEGIES TO DERISK DEVELOPMENT

DRUG SUBSTANCE – FROM BENCH TO REACTORS
Giorgio Bertolini, PhD, Director of Research and Development, Olon SpA

Attrition rates and impact on development strategy
Long term developability assessment of the API

When is a route of synthesis not a route of synthesis? Evaluation of COGS, availability of starting material…
Importance of early evaluation of physicochemical characteristics

PHARMACOKINETICS
Jan Neelissen, PhD, Scientific Advisor, Catalent Pharma Solutions

Understand ADME deficiencies that can be improved through drug design or formulation
Set target pharmacokinetic profile and starting dose
Case studies

FORMULATION AND DRUG PRODUCT
Stephen Tindal, Director, Science & Technology, Catalent

Selecting an optimal formulation:

When advanced (solubility enhancing) technologies are required versus simplified approaches

Parallel formulation screening

11:40 Lunch & Networking
12:30

PART 2: ACHIEVING CLINICAL INFLECTION MILESTONES

DRUG SUBSTANCE
Chiara Magnone, VP, Quality Assurance Corporate, Olon SpA

Scale-up of API synthesis – non-cGMP to cGMP
Establishing control of critical quality attributes
Preparing for Process Performance Qualification (Validation)

FORMULATION AND DRUG PRODUCT AND CLINICAL SUPPLIES
Julien Meissonnier, Vice President, Science & Technology, Catalent Pharma Solutions

Phase-appropriate formulation
Selection of the optimal dosage form for commercialization
Efficient coordination of clinical supplies: clinical manufacturing, packaging, storage and distribution (manufacture at the clinics + integrated services)

PARTNERING, OUTSOURCING, WORKING WITH EXTERNAL PARTNERS
Katja Wosikowski, PhD, Nonclinical Drug Development Consultant, Wosikowski Consulting

Coordinate working with consultants, API manufacturers, CDMOs, CROs

14:00 Networking and 1:1 Private Consultancy Appointments

 

Following the meeting, all presenters and Catalent’s Science and Technology leaders will be available for private, no-obligation discussions on specific programs and challenges