SMALL GROUP VIRTUAL SERIES: Early Development Strategies – Setting up for Success

The path to take a drug candidate from discovery through to commercial success is long, expensive and has many challenges. Pharmaceutical companies need to get the right balance of speed, cost, quality and risk, so having the appropriate strategy from the beginning of the drug development journey will maximise the chances of success.

In this series of small group virtual meetings, experts in solid state chemistry, material sciences and pharmaceutical development will discuss scientific considerations and drug development strategies that will get you to your first in human studies quickly and economically, whilst ensuring quality is not compromised. During the meetings, you will be invited to ask questions and discuss the strategies being presented.


Solid State Properties and Crystallization – The Interface Between Active Pharmaceutical Ingredient and Drug Product

London (United Kingdom – England) Wednesday, June 3, 2020 at 1:00:00 pm

Abstract: The physical properties of a solid active pharmaceutical ingredient (API) largely determine the crystallization process used for isolation, purification and form control, and also guide the development of an effective formulation. Understanding of the relevant solid-state properties and solid-liquid equilibria are therefore central to both chemical process and product development. In addition, it is essential to understand interactions between the API and excipients used in a formulation in order to capture any incompatibilities early in development and mitigate for these.

During this session, learn more:

  • Determining relevant physical properties of an API in development
  • Chemical process and formulation development

Speaker Information:

Dr. Gordon Hutton, Materials Science Lead

Gordon has over 25 years experience in the pharmaceutical industry, initially as a process development chemist honing an interest and skills in crystallisation, before developing as a pharmaceutical Materials Scientist over the last 15years with GSK. He now works across API, Drug Product and Consumer Health divisions and currently leads a team and runs a lab at Thermo Fisher Scientific Cork working across boundaries on API’s, Drug Product Intermediates and Drug Products. Gordon holds a PhD in organic chemistry.

Dr.-Ing. habil. Matthew J. Jones, Senior Manager Crystallization.

Matthew has over 25 years of experience in crystallization process development and solid state chemistry and has worked in pharmaceutical development since 2008. He joined Patheon in 2016 and has since established a crystallization process development laboratory with a group of specialists at the Linz manufacturing site and is leading the modernization of the solid state lab at the Florence, South Carolina manufacturing facility. Matthew holds a PhD in physical chemistry and a higher doctorate (habilitation) in chemical engineering.


Solve API Solubility Issues With Focused Formulation Approaches

London (United Kingdom – England) Wednesday, June 10, 2020 at 1:00:00 pm

Abstract: Molecules that exhibit poor aqueous solubility, typically Developability Classification System (DCS) class II and IV compounds, can result in formulations that show low PK exposure and low bioavailability. While various technologies are available to increase PK exposure via solubilisation enhancement, choosing the best one or two approaches can be a costly and inefficient process. This discussion will provide an overview of the proprietary Quadrant2® computational service—built on a diverse knowledge set for selecting the technology based on API information and the intended clinical dose. The formulation components and composition most likely to increase solubility and PK exposure before the first screening experiment is conducted are then recommended. Case studies will be shown that illustrate how Quadrant 2® guides the development of spray-dried dispersion and lipidic formulations for such molecules.

Speaker Information:

Kevin Kane, PhD, Global SME

Kevin provides technical consulting for early formulation development programs and spray drying services, with expertise in finding solutions that align with a client’s clinical study design for small molecules with biopharmaceutic and physicochemical challenges. Kevin brings more than 25 years of industrial experience in synthesis, formulation and solubilization technologies, and adaptive clinical studies, having worked as an independent consultant and as a scientist at various CDMOs including Bend Research and Quotient Sciences in addition to his 8 years at Patheon Thermo Fisher. Kevin has a PhD Inorganic Chemistry (Ohio University), MS Polymer Chemistry and BS Chemistry (Texas State University)

Helen Danagher BSc (hons) Technical Specialist UK

Helen provides technical expertise and guidance to the early product development teams at the Milton Park Site in the UK. Helen has extensive CMC experience in the formulation development of oral solid dose, parenteral and inhalation products taking them from concept design, clinical trial manufacture, scale up and regulatory approval through to commercialisation. Helen has over 25 years experience in the pharmaceutical industry gained within innovative Pharma at GSK, and the Mundipharma group of associated companies in the product development, quality and project management areas. Helen has a degree in Pharmaceutical and Cosmetic Science from De Montfort University, Leicester.

Kreshnik Hoxha, PhD, Technical Project Lead

Kreshnik provides technical leadership in CMC drug development, clinical manufacture, scale up and technology transfer at Milton Park UK. Kreshnik has 7 years of industrial experience working in formulation development of immediate and sustained release oral solid dosage products, semi solids and nasal sprays. Kreshnik has previously worked for Indivior, innovative pharma in addiction treatment, where he partnered with CDMOs across UK and US. Prior to that he worked for Reckitt Benckiser, FMCG in over-the-counter medicines. Kreshnik has a PhD in Crystallography and Crystal Engineering and MChem in Chemistry with Nanotechnology (University of Hull, UK).


Getting Phase 1 Clinic Delivery in 14 weeks

London (United Kingdom – England) Wednesday, June 17, 2020 at 1:00:00 pm

Abstract: The translation of a new molecule from preclinical stage to a first-in-human (FIH) trial often has some associated risk for emerging biopharma sponsors or in cases where a rare disease treatment is being developed. Striking a balance between the administering the critical first dose and meeting the clinical objectives can be a challenge when selecting a phase-appropriate dosage form.

During this discussion, learn more:

  • Common FIH study requirements
  • Outline of simple solid oral dosage forms
  • Illustrate how they can be formulated, manufactured, labelled, packed and delivered to the clinic in as few as 14 weeks
  • Cases studies and scientific considerations will be part of the seminar.

Speaker Information:

Kevin Kane, PhD, Global SME

Kevin provides technical consulting for early formulation development programs and spray drying services, with expertise in finding solutions that align with a client’s clinical study design for small molecules with biopharmaceutic and physicochemical challenges. Kevin brings more than 25 years of industrial experience in synthesis, formulation and solubilization technologies, and adaptive clinical studies, having worked as an independent consultant and as a scientist at various CDMOs including Bend Research and Quotient Sciences in addition to his 8 years at Patheon Thermo Fisher. Kevin has a PhD Inorganic Chemistry (Ohio University), MS Polymer Chemistry and BS Chemistry (Texas State University)

Helen Danagher BSc (hons) Technical Specialist UK

Helen provides technical expertise and guidance to the early product development teams at the Milton Park Site in the UK. Helen has extensive CMC experience in the formulation development of oral solid dose, parenteral and inhalation products taking them from concept design, clinical trial manufacture, scale up and regulatory approval through to commercialisation. Helen has over 25 years experience in the pharmaceutical industry gained within innovative Pharma at GSK, and the Mundipharma group of associated companies in the product development, quality and project management areas. Helen has a degree in Pharmaceutical and Cosmetic Science from De Montfort University, Leicester.