Drug Discovery Whitepaper and Articles
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Pharma Might Learn About M&A Integration From The CMO World
6/9/2014
The urge to merge in the pharmaceutical industry has been strong in 2014. However, the ability to get a deal done and successfully integrate those that transpire is far from guaranteed. This might ring true particularly with the kind of high-profile deals we are seeing recently. Pharma might benefit from some insight into one such deal from the provider side of the business.
This spring Jim Mullen became CEO of DPx Holdings B.V., formed in a $2.65 billion transaction combining JLL Partners’ assets Patheon and Banner Life Sciences, with Royal DSM’s Pharmaceuticals Products business. Mullen previously held the title of CEO of Patheon. This was a large deal in the service provider sector. In a recent interview with Outsourced Pharma, Mullen walked us through some of the key elements that allowed the deal to transpire.
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What If Pfizer Didn’t Exist In The U.S.?
5/22/2014
The most significant intellectual activity available to human beings is asking questions. A study of the creative but unfortunately under-utilized critical skill of questioning is documented in a new book by Warren Berget titled, “A More Beautiful Question: The Power of Inquiry to Spark Breakthrough Ideas,” published by Bloomsbury.
According to Berget and a variety of CEOs, researchers and other experts in this field, fundamental questioning can benefit start-ups and multi-nationals alike, including assisting in the discovery (or rediscovery) of the core reason for being in business.
Unfortunately, after what seems like a natural ability and inclination to ask literally thousands of questions when we are children, our schools and workplaces end up discouraging the use of questions. As a result, employees don’t bring the benefits of this skill to our organizations.
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Building Pipelines From The Outside: Pharma Seeks Good Science And Sound Operations
5/20/2014
Large pharmaceutical companies are increasingly looking outside their organizations to shore up their portfolios and bring products to market faster and more efficiently than internal R&D functions. In particular, niche pharma has become an attractive target for the industry giants—either for funding, licensing or acquisitions. What is driving this, and what does it mean?
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The Language Of Our Industry
4/21/2014
True character and the quality of our thoughts are revealed in the way we talk about ourselves and the events in which we participate. We may purposely affect certain patterns of language, but the real thing is sooner or later uncovered.
Or something like that. We also know we have to walk the talk, as the more succinct saying puts it. Considering specifically the language of the contract drug discovery, development and manufacturing industry, in a recent outsourcing survey conducted by contractpharma.com, 75% of respondents said that they would use the word “partnership” to describe their relationship with their contract service providers. That has to be good news for both pharma sponsors and the CROs/CMOs around the world, and points to an improvement in level of service delivered by the latter.
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Pharma Research & Development Analysis: CPhI Annual Report
4/7/2014
CPhI, The world's leading pharamceutical networking evernt, with over 100,000 attendees globally - is now using its collective resourced to create Pharma Insight Reports, analyzing individual parts fo the pharma industry, as well as, creating the well respected and eagerly anticipated Annual Report featuring a global panel of experts. This CPhI Pharma Insights Report examines the current trends in evaluation, adoption and partnering solutions that have been implemented across the industry to drive greater innovations and cost efficiencies.
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The Emergence Of Prodrugs: A Proficient Pathway To New Drug Development Through The 505(b)(2) Pathway
4/4/2014
For decades, scientists have sought the “magic bullet” for optimum drug delivery to combat and cure disease. Numerous agents have given rise to anticipation that a solution had been found, including antibody-specific binding with antigen; liposomal delivery of drugs; and nanotechnology with the use of carbon nanotubes and nanoparticulate agents. These agents bear promise of overcoming membrane permeability concerns, drug solubility, drug stability, toxicity and site-specific delivery. However, one of the most encouraging vehicles for optimum drug delivery is the use of prodrugs, whose physical and chemical properties are able to overcome the barriers that limit the delivery of an active drug.
Prodrugs employ various physical and chemical modifications to improve features of the active drug. Prodrugs can be viewed as pharmacologically inactive pre-drug functional groups that undergo a chemical transformation or enzymatic cleavage to liberate the active parent drug and produce the desired effect in the body.
Prodrugs work by optimizing the properties of absorption, distribution, metabolism and excretion (ADME) that the parent drug may not possess. These characteristics, when lacking in the parent drug molecule, can render the molecule ineffective and even inactive.
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Communicating R&D Innovations Early And Carefully
3/5/2014
You would expect a room full of communications, marketing and public relations professionals to be exuberant in their discussion of how to deliver the company message across platforms and generally boast about their brands. While some of that did take place at the 3rd Annual Life Science Brand Reputation and Communications Conference in Atlanta (February 20-21), a lot of the discussion focused on FDA regulations and SEC concerns, and the checks and balances applied to patient, media and investor communications by internal legal and investor relations departments.
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Quality by Design: A CMO’s Perspective On Gaining Knowledge Faster And Better
11/26/2013
Although the phrase “QbD” has been thought of as a new or borrowed concept and discussed in terms of feasibility, many CMOs have been using these con-cepts, albeit perhaps not in a well-planned, cohesive manner.
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Poster: CMC For 505(b)(2) Applications
4/7/2010
The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
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How Biogen Integrated PAT With End-To-End Supply Chain Transparency
To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.