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Building a Biologics Business from the Ground Up
Building a biologics business from the ground up provides tremendous flexibility but requires the right business strategy.
PAP-Q2-18-CL-008 -
Leveraging Hot Melt Extrusion for Solubility and Continuous Manufacturing
Hot melt extrusion (HME) technology leads to enhanced solubility.
PAP-Q2-18-CL-007 -
Inside Mergers & Acquisitions
Innovation and efficiency are both key to successful drug development and commercialization.
PAP-Q2-18-CL-001 -
Changes in the Biopharma Industry: from Minor to Major Evolution
The biopharmaceutical industry continues to grow rapidly. Targeted biologics are helping treat previously untreatable diseases.
PAP-Q2-18-NI-002 -
Supporting Patient-Centric Clinical Trials from Point-of-Origin through the Last Mile
The clinical trial paradigm has shifted.
PAP-Q2-18-CL-002 -
Taking Middle-Market CROs and CDMOs to the Next Level
Smaller outsourcing organizations often need assistance moving to the next level.
PAP-Q2-18-CL-003 -
Addressing Development Challenges for Complex Biologic Drug Candidates
Biotherapeutics identified as potential drug candidates are increasingly complex.
PAP-Q2-18-CL-004 -
Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence
Next-generation viral vector and gene therapy manufacturing facilities must be flexible.
PAP-Q2-18-CL-005 -
Meeting Biopharma Contract Manufacturing Needs with a Flexible Global Network
As biologic drugs become more complex and sophisticated, biopharmaceutical companies increasingly need the support of contract development and manufacturing organizations (CDMOs) with advanced capabilities and technology platforms that are consistently implemented across scales and geographies.
PAP-Q2-18-CL-006 -
Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility
Manufacturing in multi-product facilities affords numerous advantages- and challenges.
PAP-Q2-18-CL-009 -
State-of-the-Art Biologics Manufacturing in an Unexpected Location
Biotechpharma UAB, located in Vilnius, is exporting biologic drug substances worldwide.
PAP-Q2-18-CL-010 -
Overcoming Raw Material and Supply Chain Challenges in Viral Vector Manufacturing
Viral vector manufacturers involved in all stages of clinical-trial-material and commercial product production rely on single-use (SU) technologies.
PAP-Q2-18-CL-011 -
Modern OSD Facility Design Considerations for Operational Efficiency and Regulatory Compliance
Oral solid dosage (OSD) remains the preferred dosage delivery form for the formulation of many of today’s drug products.
PAP-Q2-18-CL-012 -
Strengthening the Outsource Service Offering through Integration
Controlling costs and increasing efficiencies are two fundamental drivers for outsourcing of pharmaceutical manufacturing.
PAP-Q2-18-CL-013 -
Corporate Social Responsibility as a Driver for Improved Sustainability
The pharmaceutical industry must respond to growing expectations regarding the environmental impact of medicinal products and manufacturing.
PAP-Q2-18-CL-014 -
Challenges for Next-Generation Biological Therapeutics Discovery and Development
In the last three and half decades, the focus of drug discovery and development has gradually shifted to large, complex molecular entities — therapeutic biologics.
PAP-Q2-18-FA-001 -
Thinking a Generation Ahead: Biologics-Based Therapy
Whether dealing with stem cells, CRISPR Cas-9 technology or antibody-drug conjugates, there is no shortage of innovation - the challenge is scaling up.
PAP-Q2-18-FA-002 -
Finishing Touches – The Future of Fill-Finish and Pharma Packaging
Fill-finish has remained relatively stable in spite of myriad developments in the industry over the last decade.
PAP-Q2-18-FA-003 -
Maximizing ROI through Equipment Liquidation
Cost pressures are significant drivers for pharmaceutical manufacturers seeking to eliminate redundancies and increase productivity and efficiency.
PAP-Q2-18-CL-015 -
Experience Meets Flexibility
Advances in rapid synthesis technologies are leading to the preparation of new classes of compounds with attractive therapeutic properties.
PAP-Q2-18-CL-016 -
Scientific Expertise Facilitates Oral Peptide Product Development and Manufacturing
Most often developed as injectable formulations, a few “oral peptide” drugs have been approved in recent years.
PAP-Q2-18-CL-017 -
Achieving Controlled Nucleation During Aseptic Lyophilization
Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency.
PAP-Q2-18-CL-018 -
BioPharma CDMO Success Requires Technical Leadership and Problem-Solving Capabilities
Since their introduction, biologic drugs have shown great potential to treat diseases not possible to remedy with traditional small-molecule drugs.
PAP-Q2-18-CL-019 -
Providing Flexible Capabilities to Meet Market Demand for Sterile Fill-Finish Services
The fill-finish step in the manufacturing of drugs is the last step completed before a product is packaged and delivered to the patient.
PAP-Q2-18-CL-020 -
DOPING – Famous Cases, Substances and Values in Sports
Doping remains a constant threat to the ethics and values in professional sports, as well as on the amateur level.
PAP-Q2-18-NI-003
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Meeting the Changing Demands for Sterile-Fill Finish Operations
Justin Kadis, Business Development for Federal Equipment Company, discusses optimized and error-free fill-finish operations.
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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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Uniting the Industry for the Prevention of “Pharmageddon”
Tim Tyson Chairman and CEO of Avara Pharmaceutical Services explains Pharmageddon and how to prevent it.
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With Respect to Supplier-Partner Relationships, What is Your Preferred Collaboration Model?
Experts weigh in on our Roundtable question.
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Reducing Time to Market with Targeted Regulatory Affairs Support
Regulatory affairs activities are essential components of any drug development and commercialization program, explains Maryse Phan, Head of Regulatory Affairs for API Manufacturing, Servier.
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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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Allergan Makes Neurotoxin Buy with Acquisition of Bonti Inc.
Purchase gives Allergan entry into the market for neurotoxin with cosmetic and medical uses.
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J&J Anticipates Growth
Launches and label extensions are anticipated to drive profits.
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Biohaven Reports Positive Results From Double-Blind, Placebo-Controlled, Investigator Initiated, Proof Of Concept Trial Of BHV-0223 For Anxiety
The company announced positive results from the trial, evaluating the effect of BHV-0223 in patients diagnosed with social anxiety disorder and public speaking anxiety while performing an anxiety-provoking speech task.
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Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.
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Transforming with an Equipment Partner: Preparing the Industry for Serialization
Justin Kadis, Business Development for Federal Equipment Company explains the link between the serialization mandate and pharma equipment.
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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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Experience Meets Flexibility
Terry Novak, Chief Operating Officer for Tedor Pharma discusses how to meet demands of an increasingly complex global OSD market
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Scientific Expertise Facilitates Oral Peptide Product Development and Manufacturing
Ariana Nagel, Director of Product Development, R&D and and Matthew Ferrell, Director of Analytical Development at UPM Pharmaceuticals explain the benefits and challenges of peptide therapies.
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Investing for Successful Advancement of Viral Vector Manufacturing
Mark Bamforth, CEO and Cofounder and Richard Synder, CSO at Brammer Bio, explain their approach to the latest in gene therapy.
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Achieving Successful Treatment Outcomes Through the Delivery of Manufacturing Services
Janice Graff, Director of Finished Product Sales & Business Development and KaShauna G. Rohlehr PMP, Program Manager at GSK Contract Manufacturing explain the company’s commitment and expertise in the development and commercialization of novel biotherapies.
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Preparing for Hurricane Florence in Pharma
The industry has taken steps to ensure safety in spite of the natural disaster.
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Latest Apple Watch Gets FDA Approval as a Class II Device
The new version of Apple Watch includes an electrocardiogram feature
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BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza
BioNTech will receive $120 million in upfront, equity and near-term research payments from Pfizer and will be eligible to receive up to $305 million in potential development, regulatory and commercial milestone payments and up to double-digit royalties.
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Sun Pharma Announces U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease
CEQUA (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye treatment to combine cyclosporine A with nanomicellar technology.
Nice Insight Awareness/Perception Scorecard
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Latest
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Sep 19, 2018 4:15:43 PM PAO-M09-18-NI-015Transforming with an Equipment Partner: Preparing the Industry for Serialization
Sep 17, 2018 6:00:00 AM PAO-M09-18-CL-001Ophthalmic Drug Developer Kodiak BioSciences Files for IPO
Sep 14, 2018 1:15:11 PM PAO-M09-18-NI-010EU Gives Nod to KEYTRUDA and Chemotherapy Combination Treatment
Sep 14, 2018 1:12:10 PM PAO-M09-18-NI-009Sanofi-Aventis Collaborates with Dyadic International on Cl Gene Expression
Sep 13, 2018 2:34:36 PM PAO-M09-18-NI-007Incorrect Dosing Cup Leads to Recall of Children’s Advil Suspension
Sep 6, 2018 2:31:17 PM PAO-M09-18-NI-005Funding Raised for Development of Drug to Treat Symptoms of Menopause
Sep 6, 2018 2:26:11 PM PAO-M09-18-NI-004
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Stratford Pharmaceuticals, LLC Acquired by Eli Global
Sep 19, 2018 5:00:00 AM
Nice Insight Industry Benchmark Reports 2017
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