FROM THE EDITOR

  • Biopharma Outsourcing Shall Be Revealed
    Biopharma Outsourcing Shall Be Revealed

    Pharmaceutical and biotechnology (biopharma) outsourcing is an unknown quantity to the global healthcare consumer. This will change and the biopharma industry ought to get in front of it.

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INDUSTRY NEWS

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OUTSOURCING INSIGHTS

  • The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing
    The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing

    The biotechnology market sector has experienced stellar performance in recent years, outperforming the S&P 500 and most other market segments. In just under three years, the NASDAQ Biotechnology Index (BMI) has risen over 180 percent, climbing 32 percent, 65 percent, and 34 percent (as of Dec 1, 2014) in 2012, 2013, and 2014 respectively. First quarter 2014 kicked off with 23 Biotech IPOs, the strongest first quarter performance since 2000. With such strong market demand for new biotech companies with innovative assets, most analysts believe the outlook for the sector remains quite promising. This would potentially seem like good news for contract manufacturing organizations (CMOs) as market enthusiasm and gains would be expected to stimulate investment in new biotechnology startup companies.

  • A New Approach To Laboratory Efficiency: On-site Instrument Concierge Service
    A New Approach To Laboratory Efficiency: On-site Instrument Concierge Service

    Scientists are spending an enormous amount of their time and effort simply getting instrumentation to the point that it can be used,” the NRC reports. “This wasted time can be used more productively when a well-functioning repair and maintenance system is in place.

  • Keeping The Right Chemistry In Compound Procurement
    Keeping The Right Chemistry In Compound Procurement

    What happens when virtual screening libraries meet the real world?

    Virtual screening libraries can be brilliantly designed to deliver the best range of chemistry for your wet screen, but when the virtual meets the real, things get more complicated. Including computational chemistry in the procurement process means that you can move from virtual screening to plated compounds and still keep the best of both worlds.

    Delivering a plated library of screening compounds is a more complex process than first meets the eye and involves a series of sometimes conflicting requirements. First and foremost, the compounds must include the right chemistry. Virtual screening is an excellent way to design an optimum set of compounds, but the complexities of the procurement process often means that the best compounds cannot be obtained on time and within budget. Offsetting pricing, availability and shipping overheads from multiple vendors is a major logistical challenge and often leads to compromises in the chemical diversity of the final purchased set.

  • Preparing Sales, Marketing And Technology Teams To Win Today’s Customer
    Preparing Sales, Marketing And Technology Teams To Win Today’s Customer

    As today’s information-craving customers force the life sciences industry to change their sales and marketing model, innovative customer engagement models are sought as a revenue-generation lever. Message reach and frequency no longer equate to sales. Now it’s about building and sustaining customer loyalty by delivering value. Top-line and market share growth are perpetuated by the quality of customer engagements. 

    Moving from brand message to customer needs requires sales, marketing and technology teams to revise their strategies. To implement this new communication approach, life sciences companies will face some key challenges. Understanding these core challenges is the first step toward customer communication transformation, a journey that leads to growth, cost reductions and enhanced technology value. 

  • Retake Control, Shorten Cycle Times, and Cut Costs With Insourcing
    Retake Control, Shorten Cycle Times, and Cut Costs With Insourcing

    While many companies enjoy unproblematic outsourcing relationships, there are others that are still struggling to make the benefits outweigh the costs. Stuck between an in-house approach that was ineffective in the past and an outsourced model that is burdensome today, an interest in insourcing continues to expand.

  • Biomarkers In Preclinical Drug Development: Current And Future States
    Biomarkers In Preclinical Drug Development: Current And Future States

    Biomarkers are commonly used in clinical trials to identify organ injury before it becomes clinically evident. While they add value in early discovery work and in human trials to identify major safety issues, their potential has not yet been fully reached in preclinical development in animals. This paper explores the current state of biomarker use in preclinical development and examines possible steps for future use.

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OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency

    When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.

  • The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing

    The biotechnology market sector has experienced stellar performance in recent years, outperforming the S&P 500 and most other market segments. In just under three years, the NASDAQ Biotechnology Index (BMI) has risen over 180 percent, climbing 32 percent, 65 percent, and 34 percent (as of Dec 1, 2014) in 2012, 2013, and 2014 respectively. First quarter 2014 kicked off with 23 Biotech IPOs, the strongest first quarter performance since 2000. With such strong market demand for new biotech companies with innovative assets, most analysts believe the outlook for the sector remains quite promising. This would potentially seem like good news for contract manufacturing organizations (CMOs) as market enthusiasm and gains would be expected to stimulate investment in new biotechnology startup companies.

  • WIB Profile: Nektar Therapeutics Develops Drug Candidates with Improved Patient Benefits

    As a Scientist II at Nektar Therapeutics, Vidula Dixit-Duarte has a wide range of responsibilities from laboratory scientist to project team lead to new product concept analyst. Nektar has a robust pipeline of products based on its advanced polymer conjugate technology. The company also partners with top pharma and biopharmaceutical companies to help bring new products and product advancements to market. The company’s technology and drug expertise has resulted in nine approved products in the United States or Europe through partnerships with leading biopharmaceutical companies. For those reasons and more, we chose to feature Vidula Dixit-Duarte in this installment of our Women in Bio profile.  

  • Getting The Right Drug To The Right Patient At The Right Time

    It’s no secret that there are patients across the globe with a high degree of unmet medical needs. These patients are desperate for access to new and innovative medicines that are either still in clinical development or not available commercially in their country. “The primary way for them to access those medicines is via a clinical trial,” says Mark Corbett, SVP of Clinigen Group’s Global Access Program. “Unfortunately, if they are in a situation where they don’t live near a clinical trial site, or the trial is not available in their country, there are mechanisms that exist outside of clinical trials to allow patients with a high unmet medical need to access these medicines. We work within these mechanisms to provide global access programs on behalf of pharma and biotech companies, providing access to their innovative new medicines to patients in dire need.”

  • FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent

    While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.

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FEATURED SUPPLIERS

  • Patheon Inc.
    Patheon Inc.

    Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.

  • 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.

  • Cook Pharmica
    Cook Pharmica

    Cook Pharmica is an integrated contract development and manufacturing organization that simplifies the supply chain needs of its customers. By offering a unique solution of providing support from drug substance through drug product and packaging all under one roof with one management team and one quality system, Cook Pharmica helps pharmaceutical companies mitigate their risk and avoid complicated technical transfers. Cook Pharmica also operates as a strategic partner with customers, freeing them up to focus on their core competencies, which typically include research and development of new products. By taking advantage of Cook Pharmica’s one source, one location model, pharmaceutical these companies can better leverage their budgets, simplify their supply chain needs, and achieve greater speed to market.

  • DPT Laboratories
    DPT Laboratories

    DPT is the contract development and manufacturing organization (CDMO) that specializes in semi-solid, liquid and sterile dosage forms. With unmatched technical expertise and fully integrated drug development and manufacturing services for sterile and non-sterile dosage forms, we can help you successfully develop and commercialize your next product.

  • Norwich Pharma Services
    Norwich Pharma Services

    Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries. We combine comprehensive services, exceptional customer focus, and the highly-respected resources and reputation of Norwich to offer a complete range of Clinical Services.

  • CoreRX, Inc.
    CoreRX, Inc.

    CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx offers customized formulation development & clinical material manufacturing solutions. Our solutions maximize client investments, shorten development time, and reduce overall costs. From First-in-Man drug development, to full CMC support, CoreRx combines 200+ years of pharmaceutical development experience and expertise to produce safe, effective, and innovative drug products, on time, and on budget.

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 UPCOMING TRAINING COURSES

Identifying and Closing the Training Gap in Clinical Research

January 6, 2015
1pm-2:30pm EST, Online Training

Building Accountability on Your Clinical Teams

January 8, 2015
1pm-2:30pm EST, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
1pm-2:30pm EST, Online Training

Aseptic Processing: Preparing Staff and Programs For Compliance

January 13, 2015
1pm-2:30pm EST, Online Training

Introduction to Biostatistics: 2-Sample Tests and ANOVA

January 14, 2015
1pm-3pm EST, Online Training
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OUTSOURCING EVENTS

Identifying and Closing the Training Gap in Clinical Research

January 6, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Building Accountability on Your Clinical Teams

January 8, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Aseptic Processing: Preparing Staff and Programs For Compliance

January 13, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Introduction to Biostatistics: 2-Sample Tests and ANOVA

January 14, 2015
1pm-3pm EST, Online Training
Price:  $349 - Introductory Rate
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ABOUT US

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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Outsourced Pharma is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute.