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  4.  » Formulating the Future: Accelerating Oral Drug Development and Manufacturing

Formulating the Future: Accelerating Oral Drug Development and Manufacturing

Date: Tuesday, May 31, 2022 – 9:00-17:00 hrs
Location: Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA, United Kingdom

In collaboration with One Nucleus

 

FEATURED SPEAKERS

 

Prof. Johannes Khinast, Ph.D.
Head, Institute for Process and Particle Engineering at the Graz University of Technology & CEO, Research Center Pharmaceutical Engineering

 

Prof.  Johannes G. Khinast is the head of the Institute for Process and Particle Engineering (http://ippt.tugraz.at/) at the Graz University of Technology and the scientific director of the Research Center Pharmaceutical Engineering (http://www.rcpe.at/). He received his Ph.D. in the area of particle technology in 1995 from the Graz University of Technology in 1995. He was then a post-doctoral fellow at the University of Houston with Prof. Dan Luss. In 1998 Prof. Khinast joined Rutgers University (New Jersey, USA) as an assistant professor, where he was granted early tenure in 2003. During his period at Rutgers University Prof. Khinast received several important awards, including the Bristol-Myers Squibb Young Faculty Development Award (1999), the DuPont Young Professor Award (2000), the North American Mixing Forum Award (2000) and finally in 2001 the prestigious NSF CAREER Award. In 2005 Prof. Khinast was selected as a Marie Curie Chair of the EU, and in 2006 he was offered a professorship at the Graz University of Technology. Prof. Khinast has received significant funding for his work in process simulation, pharmaceutical process engineering and particle technology in the order of more than 80 million Euros from various sources. He also has worked with a large number of pharmaceutical and equipment companies and serves an advisor for the implementation of novel technology. He has supervised more than 40 Ph.D. students and PostDocs and his publication record encompasses over 300 peer-reviewed publications and 8 book chapters. He also holds 11 patents in the area of pharmaceutical manufacturing.

Session Title: A Fast-Track Roadmap from Concept to Clinical Batch of HME-Based Drug Products

 

Karunakar (Karu) Sukuru, R.Ph., Ph.D.
Vice President, Rx Product Development, Catalent, Somerset

 

Karu Sukuru, who holds doctorate in Pharmaceutics and Drug Design, joined Catalent in 2016 as Vice President-Product Development for Softgel and Oral Technologies. He has developed innovative controlled release platform technologies in softgel/liquid filled hard capsules dosage forms leading to two patents and has over half a dozen pending patent applications. Sukuru received his doctorate from the Banaras Hindu University, Banaras, India.

Session Title: Recent Advances in Softgel Dosage Form as a Delivery System

 

Nick Hodgson, Ph.D.
Head of Development & Spray Drying, EUROAPI

 

Nick Hodgson is a Chemical and Process Engineer with over 20 years’ experience in the pharmaceutical manufacturing industry. He has worked with industrial spray dryers for much of that time in a variety of roles such as engineering projects, environment, health and safety as well as development and manufacturing operations. Throughout his career, Mr. Hodgson has responded to and overcome many challenges associated with large scale spray drying. He currently leads a cross functional team delivering spray drying services to clients from the Haverhill site of EUROAPI. The service includes process transfer and scale up capabilities for clinical trial support as well as commercial manufacturing. Mr. Hodgson holds a master’s in chemical and process engineering from the University of Sheffield, Sheffield, UK.

Session Title: Transfer and Scale Up Process Steps for Spray Drying

 

David Elder, Ph.D.
Principal Consultant, David P Elder Consultancy

 

David Elder has nearly 40 years of service within the pharmaceutical industry at Sterling, Syntext and GlaxoSmithKline. He is now an independent GMC consultant. He is a visiting professor at King’s College, London and is a member of the British Pharmacopoeia. He is a member of the Joint Pharmaceutical Analysis Group (JPAG) and the Analytical Division Council of the Royal Society of Chemistry.

Session Title: Sustaining Accelerated Product Development

 

Jan Neelissen, Ph.D.
Associate Director, Science & Technology, Catalent

 

Dr. Jan Neelissen, Associate Director of DMPK Advisory Services, has over 25 years of pharmaceutical industry experience in the field of DMPK. In his current role, he advises drug innovators in developing new therapeutics and designing tailored formulation, delivery and manufacturing solutions. Prior to joining Catalent in 2017, Dr. Neelissen spent 17 years at AstraZeneca where he held various leadership positions including Associate Director in vitro DMPK and Associate Director Modelling and Simulation. Dr. Neelissen is a biologist by training and holds a doctorate in Pharmaceutical Sciences from Leiden University, Leiden, Netherlands.

Session Title: Physiologically based Pharmacokinetic Modelling to Support Drug Development

 

Stephen Tindal
Associate Director, Science & Technology, Catalent

 

Stephen Tindal is Director of Science and Technology at Catalent, where he plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years’ experience at Catalent where he has held roles of increasing responsibility, and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in Chemistry and Analytical Science from Loughborough University, Loughborough, U.K.

Session Title: Small-Molecule Manufacturing Options for Expedited Programs

 

Dejan Lamesic, Ph.D.
PD Scientific Team Leader, Product Development, Catalent, Schorndorf

 

Dejan Lamesic is a Product Development Scientific Team Leader at Catalent’s Shorndorf, Germany facility. He attended the University of Ljubljana, Faculty of Pharmacy in Slovenia, obtaining his Master of Pharmacy degree and then a Ph.D. degree focusing on Quality by Design aspects of pharmaceutical excipients for development and manufacturing of solid dosage forms. His strong expertise in particle engineering and compaction process includes tableting and dry granulation.

Session Title: Small-Molecule Manufacturing Options for Expedited Programs

 

Susan Banbury
Head of Formulation, Catalent

 

Graduated in Pharmacy from University of Bath, UK and awarded PhD from University of Nottingham, UK following research on intranasal peptide absorption. Worked in Formulation Development for Cyanamid / Lederle Labs and subsequently at Catalent for over 20 years with roles in Formulation Development (softgel & Zydis), project management & commercial operations and as Head for Formulation for the past ~3 years.

Session Title: Improving Clinical & Patient Adherence Outcomes with Orally Disintegrating Tablets (ODTs)