January 21 Joseph Priestly Society Program: "Drug Development: From Chemicals to Biologics"

The January 21 Joseph Priestly Society Meeting at the Chemical Heritage Foundation featured a panel discussing the subject “Drug Development: From Chemicals to Biologics.” Moderated by Maria Maccecchini, CEO and founder of QR Pharma, the panelists were Robert Garbaccio, Sr. Principal Scientist at Merck, Ganesh Kaundinya, a founders of Momenta Pharmaceuticals and Susan Dillon, Global Therapeutic Head for Immunology for the Janssen R&D Division of Johnson & Johnson.

 The panelists addressed the difficulty in choosing between small molecule and biologic approaches to address therapeutic challenges. The choice is driven by the biochemistry of the target, its location in the body and the desire for long or short duration therapeutic effects. This is a key choice as it strongly effects the chance of success for the therapy.

 Also noted was the need to have robust preclinical screening methodologies to identify attractive candidates.  The group all noted that most drug developers have the full range of modalities in their toolbox to address disease challenges. In addition to developing relevant in-vitro methods to do the initial assessment, preclinical candidates should be screened for multiple therapeutic indications.

 The strong growth of biologics was discussed. In 2013, 86% of the therapies on the market were small molecules yet 7 of the top 10 sellers were biologics. This is a result of a better understanding of underlying disease biology, the number of diseases lacking effective small molecule therapies and the reduced side effects of biologics. There have also been great advances in manufacturing “humanized antibodies.” Small molecules, on the other hand, benefit from being easily administered by oral dosage.

 While it was originally postulated that “generic” biologics would never appear, the recent global introduction of biosimilar drugs has proven this assumption wrong. The panelist discussed the difference between generic small molecules, which are required to be chemically and biologically equivalent and biologics where the metric is bioequivalency. The regulatory differences between different regions of the world were reviewed.

The factors influencing new drug cost were considered. Material costs are not significant compared to the cost of development, which includes the amortized cost of unsuccessful candidate therapies. There was consensus that improving the efficiency of early stage screening is the biggest opportunity for cost improvement. It was pointed out, however, that the value to the patient drives pricing.

 The audio track for the panel discussion and audience questions will be posted shortly.

 On February 11, Roger Nielsen, President of Abbey Color, speaks about “Abbey Color: Entrepreneurship in a 150 Year-Old Industry.” For more information about JPS programs and to register, see  http://www.chemheritage.org/visit/events/public-events/2016-02-11-jps.aspx.