e-journal

Recent trends in specialty pharma business model

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The recent rise of specialty pharma is attributed to its flexible, versatile, and open business model while the traditional big pharma is facing a challenging time with patent cliff, generic threat, and low research and development (R&D) productivity. These multinational pharmaceuticalcompanies,facinga,havebeensystematicallyexternalizingR&Dand
some even establish their own corporate venture capital so as to diversify withmore shots on goal, with the hope of achieving a higher success rate in their compound pipeline. Biologics and clinical Phase II proof-of-concept (POC) compounds are the preferred licensing and collaboration targets. Biologics enjoys a high success rate with a low generic biosimilar threat,while theneedis highfor clinical Phase IIPOCcompounds,dueto itshighattrition/lowsuccess
rate.Repurposingof big pharmaleftovercompoundsis apopular strategy butwith limitations.Most old compounds come with baggage either in lackluster clinical performance or short in patent life. Orphan drugs is another area which has gained popularity in recent years. The shorter and less costly regulatory pathway provides incentives, especially for smaller specialty pharma. However, clinical studies on orphan drugs require a large network of clinical
operations in many countries in order to recruit enough patients. Big pharma is also working on orphan drugs starting with a small indication, with the hope of expanding the indication into a blockbuster status. Specialtymedicine, including orphan drugs, has becomethe growth engine in the pharmaceutical industry worldwide. Big pharma is also keen on in-licensing technology or projects from specialty pharma to extend product life cycles, in order to protect
their blockbuster drug franchises. Ample opportunities exist for smaller players, even in the emerging countries, to collaborate with multinational pharmaceutical companies provided that the technology platforms or specialty medicinal products are what the big pharma wants.Theunderstanding of intellectual propertiesandinternational drug regulationsare the key for specialty pharma to have a workable strategy for product registration worldwide.

Keywords:
corporate venture intellectual property open innovation orphan drug specialty pharma

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Ketersediaan

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Informasi Detail

Judul Seri

j ournal of food and drug anal ys i s

No. Panggil

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Penerbit

: Elsevier Taiwan., 2015

Deskripsi Fisik

j ournal of food and drug anal ys i s 2 3 ( 2 0 1 5 ) 5 9 5 e6 0 8

Bahasa

English

ISBN/ISSN

-

Klasifikasi

-

Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

-

Subjek

Food And Health

Info Detail Spesifik

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Pernyataan Tanggungjawab

Wati/Agus

Versi lain/terkait

Lampiran Berkas

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