ThisAugust, Pharmaceutical Manufacturing and Packing Sourcer (PMPS) will publish an article by AsisChem scientists Guillermo Morales, Bryan Roland, and Emile Bellott, entitled: “Working With Synthesis” ( August, 2010, p70 ) Some of our findings and main points are summarized below:
For the past two decades, the industry buzz has been about ‘pipeline productivity’. The well-known graphic showing exponentially increasing drug R&D expenditures by the pharmaceutical industry, in parallel with level or declining new drug approvals, year-by-year, has been a popular talking point at industry meetings and conferences.
Against this backdrop, the pharma industry has evolved dramatically in response to competitive pressures.
|
|
1990's
|
2000's
|
|
Industry Competitive Environment
|
• Increasing globalization
• Emphasis on blockbusters
|
• Globalization
• Cost containment
• More emphasis on niche drugs
|
|
Pharma Business Model
|
In-house development
|
Partner or acquire majority of pipeline
|
|
Emerging Companies
|
Drive toward IPO
|
• Drive toward partnering event
• Lean operating model
• Emergence from academic research
|
|
Drug Discovery Paradigm
|
• Combichem and screen
• Structure-based design
|
Post genomics era - rationale – based discovery
|
|
Medicinal Chemistry
|
Emphasis on pharmacology
|
• Increasing emphasis on druggability and optimizing properties
|
|
Chemistry CRO's
|
Little competition
|
• Intense competition
• Continuing growth
• Emphasis on cost, skill, and intangibles
|
Drug prices face continued pressure, as the most visible out-of-pocket healthcare expense by most households. This will intensify the incentives driving the use of generic drugs and constrain pricing and use of innovative therapies.
One major area that will continue to be affected by the new sense of cost consciousness is discovery and development.
Diminished margins will only serve to accelerate the move by large pharma and biotech toward M&A and the consequent dismantling of redundant R&D operations. Analyst presentations by these large companies emphasize a goal of outsourcing more than half of the discovery pipeline through collaborations and deal-making with small innovator companies.
These small emerging companies, based on academic inventions and funded by venture capital typically emphasise a lean and flexible business model, using CROs and CMOs for all but their core scientific competencies.
As pricing constraints lead to business models that rein in cost, the use of CROs and CMOs will increase. A recent report predicts that the CRO market will more than double in the five years from 2009 to2014. At the same time, the center of gravity will continue to shift towards providers in the developing world, increasing use of manufacturing sources in emerging markets. The growth of this geographic shift in manufacturing sources will result in cost-saving potential, as well as an enhanced opportunity to penetrate high growth areas.
Our article concludes that this is a time of intense opportunity and growth for chemical synthesis outsourcing CRO's. As a consequence of the pool of talented scientists with former large pharma background, the best CRO's are positioned to become trusted collaborators who not only complete the technical aspects of the projects , but also help guide the program definition and development path.
Staying sharp and flexible, the successful CRO's bring solid infrastructure; highly skilled personnel; advanced knowledge in synthesis, medicinal chemistry, and computational methods; excellent problem solving; and project management skills. In addition, the leading CRO's bring additional services in ADME/Tox, and in vitro and in vivo biological assays.
Please use the "contact us" link in the AsisChem web site to request a reprint of the full article.
We look forward to meeting you at the fall 2010 ACS National Meeting, in Boston - August 23-26
Be the first to rate this post
- Currently 0/5 Stars.
- 1
- 2
- 3
- 4
- 5