Accelerating drug product development from early phase to scale up and commercialisation
Sponsored by: Quotient Sciences
- Product Development
- Drug Development
- Clinical Manufacture
Date: 24 April
Days to go: 32
Time: 4PM London/11AM New York
A case study with Druggability Technologies: advancing the development of DRGT-46
To improve R&D productivity and bring new molecules to market as quickly as possible, drug companies are continuously seeking new ways of streamlining drug development using alternative outsourcing models. One such approach is to focus on smarter R&D by adopting a highly integrated model, like Quotient Sciences’ Translational Pharmaceutics® platform, in which a single outsourcing partner coordinates and adapts the drug product manufacturing requirements (“make”) with the specific needs of the clinical development plan (“test”), creating significant time efficiencies and cost savings.
This webinar will cover a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT. The case study will give examples of how clinical data can be used to drive formulation selection in “real-time” and demonstrate how Quotient’s tight integration of formulation, manufacturing and clinical research activities has enabled DRGT to execute an efficient development plan with a single outsourcing partner and, most importantly, reduce the time from early development to confirming the commercial formulation.
The speakers will describe the use fit-for-phase drug product strategies in drug development, to manage costs, time and risks, even where solublization strategies are required for poorly soluble molecules. The case study will show how early phase products can be developed initially at small-scale with low costs and high degrees of flexibility and then subsequently be quickly scaled to support Phase II/III requirements, where a more robust drug product and manufacturing process is required. Most importantly we will illustrate how by effective program integration and management, drug companies can maintain a continuous supply of the drug product into patient trials and progress towards registration batches and commercialization all with a single development partner, avoiding the need for costly and time consuming transfers of manufacturing processes or analytical methods.
CEO, Druggability Technologies
Gábor Heltovics is the CEO of Druggability Technologies (DRGT). Headquartered in Malta, DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value pharmaceutical products based on the Company’s Super-API Technology. Gábor holds Master's degrees in biology and chemistry, and he is an MBA. He is a seasoned entrepreneurial senior executive with extensive drug development , R&D and general management experience in the pharma and FMCG industries in the US, UK, and EU. He has a successful track record of innovation management and technology platform development in major multinational corporations such as Procter & Gamble and Coca-Cola, as well as SME Bio-pharmaceutical companies.
Vice President, CDMO Services, Quotient Sciences
Nikki is the VP of CDMO Services and is responsible for building Quotient’s global formulation and manufacturing capabilities across all of Quotient’s sites. Nikki possesses 23 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase spray-dried inhaled and topical products intended for both European and U.S. markets. In a previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product.
Key Learning Objectives
- Understand how an integrated “make-test” model can generate clinical data to drive formulation selection
- Assess the benefits of phase-appropriate development of solubility challenged molecules and learn how manufacturing processes can be effectively scaled up for late stage development and commercialisation
- Evaluate the advantages to a small biotech/pharma of working with a fully integrated drug development outsourcing partner
- Manager of Pharmaceutical Development
- Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director of Pharmaceutical Development
- Director of Formulation Development
- Director of Manufacturing
- Director of Clinical Manufacturing
- Director or Vice President of R&D
- Vice President of Pharmaceutical Development
- Heads of Outsourcing
- Chief Scientific Officer