Yesterday Parexel’s principle consultant Ravi Harapanhalli told Outsourcing-Pharma he had been approached by the US-based specialty healthcare solutions company’s toxicology associate director E.Priya Eddy at the AAPS annual meeting in Washington D.C., US.
If the deal comes to fruition, Harapanhalli – an advocate of developing both drugs and delivery devices in conjunction with one another – will lead the analysis of the study's management, which is believed to be focussed on a lidocaine-based product.
He told Outsourcing-Pharma: “Ms Eddy came to me and asked if we’d help in the development of this product.
“Because it will be a combination product [drug and patch] Endo want our expertise on double pronged development.
“If all goes as planned we’ll be providing a consulting service beginning by looking over their programme, and what they have done so far.
“I’ll do a gap analysis where I will look at the type of product, the drug, the dosage form, and after that I will have a meeting with them to discuss where the critical gaps are and how they could develop the product more efficiently while going through the regulatory maze.”
New business
If the partnership goes ahead, Harapanhalli believes it could open up new doors for Parexel in the field of drug and delivery device combination consultancy.
He added: “Maybe people only know Parexel as a contract research organisation (CRO) or consulting firm, but not necessarily what new grounds we are covering.
“For us this could mean more consulting work in different areas like clinical and none clinical toxicology, and clinical pharmacology, and it may also mean something for clinical phase changes if we have to look at proof of concept ect.”
As for the type of company bio pharmaceutical services organization Parexel is now looking to provide its consultancy service to he added: “Basically we look to any company which has a good fit with what we can do for them, with our expertise areas and skill set.
“Any one from start-up companies, to well established pharma firms, or in situations like this where a company has a combination product.”