Speakers

Kreshnik Hoxha works as Director of CMC and Clinical Supply Chain at Grey Wolf Therapeutics and leads the company’s CMC small molecule development activities in immuno-oncology. As part of his 13-year international experience with small molecules, Dr Hoxha has led the development of 20+ drug products for delivery to clinics worldwide. He holds a PhD in crystallography and crystal engineering (co-crystals and salts) from the University of Hull, United Kingdom.

Kreshnik’s experience transcends all sides of the drug development model: in-house development, virtual biotechs and CDMOs. Previously, Dr Hoxha led the CMC operations at Healx, a Cambridge-based AI biotech company and was responsible for API and pharmaceutical development activities and clinical supply chain. He was also engaged in commercial manufacturing and technology transfers as part of Consilient Health, a London-based virtual pharma.

Aside from his sponsor experience, he has also worked in the CDMO space as part of Patheon Thermo Fisher Scientific, where he provided technical leadership in formulation development and scale-up - partnering with biotech partners in the UK, Europe and North America. Kreshnik has also worked in a semi-virtual model with partial in-house development as part of Indivior developing solid oral dosage forms and nasal sprays.

Presentation Title: Development of Phase Appropriate Drug Products and Management of the CMC Minefield in an Outsourced Environment

Abstract: The interface between a biotech sponsor and the CDMO is a focal point where the CMC success or challenge takes place. In his talk, Kreshnik will be elaborating on the fine balancing act between developing phase appropriate formulations that ensure speed to clinic versus excessive development endeavours that lose sight of the overall objective.
He will be speaking in a dual capacity: as someone who has worked within a CDMO with biotech clients, but also as a biotech Head of CMC, who drives drug development in an outsourced environment.
Case studies highlighting technical challenges will be presented alongside practical solutions that delivered IMP to the clinic in a timely manner.

View company profile