FROM THE EDITOR

  • Unifying Theory Of Outsourcing From Pharmatek President
    Unifying Theory Of Outsourcing From Pharmatek President

    Timothy Scott, co-founder and president of Pharmatek Laboratories, a CDMO focusing on services for small molecules of peptides, has put it all together. Not quite Einstein's quest for a theory of everything, but his synthesis of the outsourcing industry is alluring. Here’s why.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • A Witness To The History of Outsourcing
    A Witness To The History of Outsourcing

    Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry. 

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INDUSTRY NEWS

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OUTSOURCING INSIGHTS

  • Electronic Drug Accountability Systems: Ensuring Compliance, Safety, And Data Integrity In Clinical Trials

    By Stefan Duerr, Associate Director Of Project Management, Cenduit

    Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits.1,2 A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability.2,3 Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.

  • Clinical Endpoints:  What Do Payers And Regulators Want?
    Clinical Endpoints: What Do Payers And Regulators Want?

    In 1962, the Federal Food, Drug, and Cosmetic Act added an amendment that requires new drugs to show substantial evidence of effectiveness and specifies that this evidence must be derived from adequate and well-controlled clinical investigations.  Clinical benefits that have supported drug approval in the past include important clinical outcomes – for example, increased survival or symptomatic improvement, as well as effects on established surrogate endpoints – e.g., blood pressure, tumor markers, and serum cholesterol. 

  • Reflections On The Placebo Response
    Reflections On The Placebo Response

    Since the 1960s, much medical research has been conducted on placebo, an inert agent that does not contain any active therapeutic substances. It looks like a real medicine, but it is not; and it is used to diminish the suffering of the patient through expectation rather than through the exertion of a specific medical effect.

  • Patient Reported Outcomes For Registries: Should The Treating Physician See The Data, And If So, When?
    Patient Reported Outcomes For Registries: Should The Treating Physician See The Data, And If So, When?

     

    The application of electronic patient reported outcome (ePRO) data collection and direct-to-patient reporting has enabled patients participating in registries to report their symptom or treatment experiences between physician visits, with minimal patient burden. These independent reporting approaches – described in Chapter 5 of the Agency for Healthcare Research and Quality’s ‘Registries for Evaluating Patient Outcomes: A User’s Guide’[i] – are often applied in real world research not only to collect data directly from the patients outside of an office visit, but also to support patient retention over long follow-up periods.

     

  • Optimization Of Design Space And Throughput Conditions For Scale Up Of A Low- Dose Roller Compacted Product

    Roller compaction of low dose active pharmaceutical ingredients into solid dosages forms is quite challenging. Ribbon porosity, tensile strength, mean granule size and surface area are key quality attributes that can affect downstream processing and final product performance. By Prasad.VN Challapalli, Manaud de Raspide, Satish Kamath, and Ram Kasina

  • A World Of Opportunities: Your Focused Field Guide For Specialty Transport To Emerging Markets
    A World Of Opportunities: Your Focused Field Guide For Specialty Transport To Emerging Markets

    What documentation and steps are required to clear a product shipment for entry into China? What is the ability for major airports in Brazil to store refrigerated products while they are awaiting customs clearance?

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OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • What Can Be Learned From Catalent’s Move To The Big Board

    When I was invited to attend the New York Stock Exchange (NYSE) closing bell ceremony as a guest of the Catalent (CTLT) executive leadership team, I had a lot of questions. For example, why pick being listed on the big board as opposed to NASDAQ? After all, despite the NYSE winning the IPOs of technology juggernauts like Twitter (TWTR) and Alibaba (BABA), as well as having the biggest of all the biotechs, Novo Nordisk (NVO), listed on its exchange, the NASDAQ is considered the traditional bastion of both the bio as well as the tech.  Though some may think the decision to list on one exchange versus another may seem like a minor detail, John Chiminski, Catalent’s president and CEO, seems to know that when it comes to creating brand equity, it is the attention to executing on the little things which often has the biggest impact.

  • Tools for the Design of Vaccines to Help Reduce Clinical Failure

    If you are involved in the pharma industry, then you are interested in saving lives. In the area of preventative medicine, therapeutic vaccines have proven to have a tremendous impact on the ability to save millions of lives. Similar to pharmaceuticals, vaccine development can take over 10 years and less than 10 percent of candidates reach commercialization. Reducing the cost of failure and increasing the chances of clinical success for vaccines is beneficial to both the pharma industry and those being treated for or protected from disease.

  • Are Regulators Providing The Right Quality Incentives?

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.

  • Novartis’ Heart Failure Medicine Cuts Cardiovascular Deaths by 20% In Landmark PARADIGM-HF Trial

    At the European Society of Cardiology congress held this past weekend in Barcelona (and published simultaneously in the New England Journal of Medicine) Novartis revealed its investigational heart failure medicine LCZ696 was superior to ACE-inhibitor enalapril on key endpoints. The findings were the result of PARADIGM-HF, the largest heart failure study ever conducted. Findings showed patients with heart failure with reduced ejection fraction (HF-REF) who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril on top of current best treatment.

  • Is Life Sciences Media Helping Or Hurting The Industry?

    If you’re like me, keeping up with news in the life sciences industry is an integral part of your day. I am especially interested in news relating to the pharma companies and their partners, and every day I get emails updating me on the latest news pertaining to drug discovery. But lately I have noticed a disturbing trend in many of those emails. It seems some media outlets are doing their best to promote all the bad news they can find. As a result, I am beginning to wonder why they seem to be lining up against the industry they are intended to cover.

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FEATURED SUPPLIERS

  • Baxter BioPharma Solutions
    Baxter BioPharma Solutions

    BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.

  • BASi (Bioanalytical Systems Inc)
    BASi (Bioanalytical Systems Inc)

    BASi provides world-class research to the pharmaceutical industry worldwide. We offer an extensive array of contract laboratory services and manufacture more than 30 different scientific instruments.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

  • PPD
    PPD
  • That’s Nice LLC
    That’s Nice LLC

    That’s Nice is a full-service agency providing research-driven brand management and marketing that enable businesses to achieve their goals. Our integrated services reflect 18 years of knowledge in life science and materials science markets, a passion for strategic thinking, and a comprehensive approach that meets the needs of global companies.

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

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OUTSOURCING EVENTS

Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel

September 18, 2014
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CRA Oversight - A Risk-based Approach

September 23, 2014
1pm-2:30pm EDT, Online Training
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It's Ten O'Clock. Do You Know Where Your Trial Master File Is?

September 24, 2014
1pm-2:30pm EDT, Online Training
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Partnership Strategies with CRO/Vendors: Create Relationships that Create Results

September 25, 2014
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Qualifying Your Trainers – What Do They Need For Your Training To Be Effective?

September 30, 2014
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Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services. With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

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