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The Evolution of Pharma Depends on Data Integration and Application
The potential applications for this vast quantity and variety of data are nearly endless.
PAP-Q4-18-NI-001 -
The Coming of Age of Amorphous Solid Dispersions
Numerous drugs formulated as amorphous solid dispersions have been successfully commercialized.
PAP-Q4-18-CL-004 -
From Proof of Concept to Commercialization
Brammer’s vision is to be the leading CDMO for viral vector supply to cell and gene therapy innovators.
PAP-Q4-18-CL-003 -
Knowledge and Experience Equal Successful Technology Transfer
Technology transfer should result in the transfer of product and process knowledge into a new phase of the life cycle.
PAP-Q4-18-CL-008 -
A Turnkey Solution: Sourcing Equipment and Empowering Operators
We offer a turnkey solution by sourcing equipment that meets production line requirements.
PAP-Q4-18-CL-007 -
Designing Effective Facilities to Meet the Growing Demand for Oligonucleotide Drugs
An oligo drug manufacturing facility incorporates aspects of small-molecule and biologic drug facilities.
PAP-Q4-18-CL-002 -
Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate
The FDA issued new guidances regarding enforcement of the DSCSA's track and trace mandate.
PAP-Q4-18-NI-011 -
Big Data in Drug Development and Discovery
Companies that apply the data will have a competitive advantage in drug discovery and development.
PAP-Q4-18-NI-006 -
Big Data in Drug Manufacturing
To achieve cohesive data integration in drug manufacturing, systems must be aligned.
PAP-Q4-18-NI-005 -
Big Data in Drug Packaging and Distribution
The emphasis on serialization is a tangible move toward making post-market data mining more robust.
PAP-Q4-18-NI-004 -
Preparing Clinical Trial Logistics for a No-Deal Brexit
Pharmaceutical companies should prepare for Brexit by mitigating their supply chain risks.
PAP-Q4-18-CL-006 -
Drug Repositioning: Facilitating Drug Repositioning with Artificial Intelligence
Computer-based approaches are essential to enable systematic drug repositioning efforts.
PAP-Q4-18-NI-009 -
The Value of Complementary Specialized Capabilities
Continued investment in innovations that address the needs of current and next-generation therapies is essential.
PAP-Q4-18-CL-001 -
Risk Minimization with an Integrated Global Network
Collaborating with an embedded organization with an integrated, global network can facilitate access to growing markets.
PAP-Q4-18-CL-005 -
Preparative Chromatography
Servier’s InnoPreP™ technology offering appeals to mid-size pharmas who need to quickly move their project into clinical studies .
PAP-Q4-18-NI-002 -
New Drug News: Regulatory Approval Brings siRNA into the Rare Disease Toolbox
siRNA joins the other nucleic acid–based drugs entering the marketplace for the treatment of rare diseases.
PAP-Q4-18-NI-010 -
Foreign Investment: Chinese Capital Backs U.S. Biotech
Given the amount of Chinese capital and the growing interest in the segment, the market feels unlimited.
PAP-Q4-18-NI-008 -
Q: What Innovative Technologies Had the Greatest Impact on your Company this Year? What Were the Impacts?
Industry leaders discuss recent technological innovations.
PAP-Q4-18-NI-007 -
Q: Looking Forward, What New Technologies/Paradigms Do You Anticipate Having the Greatest Impact Next Year (Digitalization and Industry 4.0, Serialization, etc.)?
Industry leaders discuss forthcoming technological innovations.
PAP-Q4-18-NI-003
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Supporting Patient-Centric Clinical Trials from Point-of-Origin through the Last Mile
Wes Wheeler, CEO of Marken explains how Direct-to-Patient (DTP) clinical trials are becoming an industry standard.
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Taking Middle-Market CROs and CDMOs to the Next Level
Pharmaceutical development is a very attractive area for both strategic and financial investors, says Jeffrey Marlough, Managing Director at Castleford Capital.
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Leveraging Hot Melt Extrusion for Solubility and Continuous Manufacturing
Hot melt extrusion (HME) technology has become a key solution to adding absorption for enhanced solubility, says Tony Listro, Vice President, Technical Business Development at Foster Delivery Science.
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Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence
Next-generation viral vector and gene therapy manufacturing facilities must be flexible, says Thomas Page, Ph.D., Vice President of Engineering and Asset Development for Fujifilm Diosynth Biotechnologies.
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Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility
Peter Boeddeker, Director of Quality Management at Baxter BioPharma Solutions describes the challenges and advantages of multi-product facilities.
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State-of-the-Art Biologics Manufacturing in an Unexpected Location
Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board for Biotechpharma comments on how the company, located in Lithuania is exporting biologic drug substances worldwide.
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Unilever’s Indian Subsidiary to Acquire GSK’s Consumer Nutrition Brands in India
The deal represents India’s largest consumer goods transaction.
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FDA Gives Novartis Gene Replacement Therapy Application Priority Review
Zolgensma (AVXS-101, onasemnogene abeparvovec) is designed to address the genetic cause of spinal muscular atrophy.
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Statement from FDA Commissioner Scott Gottlieb, M.D., on New Actions Advancing the Agency's Biosimilars Policy Framework
Timely and efficient regulatory processes ensure that the U.S. remains a driving force in global biomedical innovation.
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Roche to Develop Companion Diagnostic Test to Help Identify Patients Eligible for Anti-PD-1 Therapy Based on Biomarker Expression, Not Location, of Solid Tumors
Roche will seek FDA approval for biomarker panel expected to provide a standardized predictive testing option for dMMR.
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Speeding Development and Reducing Costs with Analytical Quality by Design
António Ramos, Analytical Chemistry Group Leader, Process Chemistry Development and Rui Loureiro, Director of the R&D Process Chemistry at Hovione outline Quality by Design (QbD) in analytical method development.
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Leveraging Offsite Fabrication in the Pharma Industry
Offsite fabrication of facility components and equipment can help drug manufacturers achieve their goals, says Dennis Kearney, Pharmaceutical Core Team Leader at CRB USA.
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Terminal Sterilization for Parenteral Drugs: Finding the Right CDMO Partner
Lluis Twose, Managing Director for Grifols, discusses terminal sterilization options for parenteral drugs.
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Hard-Shell Capsule Solutions for Sensitive Compounds: A Focus on Probiotics
Eli Elias, Director of Business Development for CapsCanada explains why hard-shell capsules designed to degrade under specific conditions are a better option for probiotics.
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Seven Trends Impacting Chemical Process Development
While greater efficiency and productivity will always be goals in manufacturing, there is currently increased demand to optimize processes in chemical manufacturing, says Justin Kadis, Business Development for Federal Equipment Company.
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Facilitating Implementation and Customer Service with Offline Serialization
Tyler Ewald, Associate Director, Manufacturing and Joseph Quales, Supervisor, Label Control at UPM Pharmaceuticals explain the company’s offline serialization system.
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Clinical Study Explores the Efficacy of Numerous Ebola Therapies
The safety and efficacy of investigational Ebola medicines in multiple countries experiencing outbreaks will be evaluated internationally.
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Mallinckrodt Spins off its Generics Business
The company will split into two divisions.
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FDA Approves Roche's Tecentriq in Combination with Avastin and Chemotherapy for the Initial Treatment of People with a Specific Type of Metastatic Lung Cancer
This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer.
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NYCEDC Grants $1M To Quentis Therapeutics For Expansion of LifeSci Space in West Harlem
This is the first grant to be distributed from $10M LifeSci NYC Expansion Fund.
Nice Insight Awareness/Perception Scorecard
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Latest
View All LatestHard-Shell Capsule Solutions for Sensitive Compounds: A Focus on Probiotics
Dec 6, 2018 2:24:02 PM PAO-M12-18-CL-002FDA Gives Novartis Gene Replacement Therapy Application Priority Review
Dec 5, 2018 12:07:21 PM PAO-M12-18-NI-003Unilever’s Indian Subsidiary to Acquire GSK’s Consumer Nutrition Brands in India
Dec 5, 2018 11:58:17 AM PAO-M12-18-NI-002Regeneron’s Bispecific Antibody Candidate Shows Positive Results in Early Clinical Studies
Dec 5, 2018 11:56:33 AM PAO-M12-18-NI-007Cilag GmbH to Collaborate with argenx on New Treatment for AML, MDS
Dec 5, 2018 11:55:49 AM PAO-M12-18-NI-005Pfizer’s Rituximab Biosimilar Achieves Positive Study Results
Dec 5, 2018 11:54:25 AM PAO-M12-18-NI-001Steps Ahead: Planning for Future Equipment Surpluses from the Point of Procurement
Dec 5, 2018 10:58:20 AM PAO-M12-18-CL-001
TOPICS
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Therapix Biosciences Provides Update Regarding FSD Acquisition
Dec 14, 2018 5:00:00 AM -
Abbott to Present at J.P. Morgan Healthcare Conference
Dec 14, 2018 5:00:00 AM -
BiomX Appoints Sailaja Puttagunta as Chief Medical Officer
Dec 14, 2018 5:00:00 AM -
XOSPATA® (gilteritinib) Available at Biologics by McKesson
Dec 13, 2018 5:00:00 AM -
Tenax Therapeutics Announces Pricing of $10 Million Underwritten Offering
Dec 13, 2018 5:00:00 AM
Nice Insight Industry Benchmark Reports 2017
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