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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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Accelerating Approval and Reducing Costs of Spray Dried Drugs through Development by Design (DbD)
Filipe Gaspar, Vice President, R&D and Márcio Temtem, Ph.D., Associate Director for Particle Design & Formulation at Hovione explain Development by Design (DbD).
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Achieving a High Level of Customer Service Through Lean Quality Management
Warren Horton, Executive Vice President Global Quality Assurance and Regulatory at Avara Pharmaceutical Services discusses the real foundation of customer service.
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Differentiating Generic SODFs with Hard Capsule Formulations
With lower development costs and greater flexibility, hard capsules are the best choice for the formulation of generic solid oral dosage pharmaceuticals, explains Jonathan Gilinski, Executive Director for CapsCanada.
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Innovating Equipment: Inline Buffer Dilution Technology
Nice Insight is in conversation with Kimo Sanderson, at Asahi Kasei Bioprocess America, to discuss the company’s “technology of the decade.”
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Implications of Serialization for the U.S. Pharma Industry
Lee Murtagh and Walter Hoberg III of Alcami explain the upcoming regulatory impact on the industry.
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Perspectives on Product Pricing Strategy and Practice
Getting pricing “right” is a tricky balancing act, but one that offers tremendous value for all.
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Elysium Health™ Announces Exclusive License for Use of Nicotinamide Riboside for the Slowing of Aging and Prevention of Age-Related Diseases from Mayo Clinic and Harvard
Aging is the single greatest risk factor for major debilitating and life-threatening conditions, including cancer, cardiovascular disease, and neurodegeneration.
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Patients with Rare Leukemia Disease Will Have New Treatment Option
US FDA approves AstraZeneca’s Lumoxiti (moxetumomab pasudotox) for the treatment of patients with hairy cell leukemia (HCL) who have undergone at least two prior therapies.
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New Genetic Understanding Could Lead to Brain Cancer Treatments
Researchers have identified the gene mutation that leads to the brain cancer glioblastoma
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Xeris Pharmaceuticals and OHSU Conducting Artificial Pancreas Clinical Trial Using Xeris’ Novel Ready-to-Use Liquid Glucagon
Patients enrolling in Phase 1 clinical trial using Xeris’ ready-to-use liquid glucagon formulation as part of a fully integrated, dual-hormone closed-loop system.
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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.
Nice Insight Awareness/Perception Scorecard
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Latest
View All LatestNew Genetic Understanding Could Lead to Brain Cancer Treatments
Sep 21, 2018 10:59:39 AM PAO-M09-18-NI-017Patients with Rare Leukemia Disease Will Have New Treatment Option
Sep 21, 2018 10:57:13 AM PAO-M09-18-NI-016Allergan Makes Neurotoxin Buy with Acquisition of Bonti Inc.
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-007
TOPICS
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Ziylo Acquired by Novo Nordisk in Deal That Could Exceed US$800m
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FDA approves first generic version of EpiPen
Sep 24, 2018 5:00:00 AM -
Veristat Congratulates Agios Pharmaceuticals on the FDA Approval of TIBSOVO®
Sep 21, 2018 5:00:00 AM
Nice Insight Industry Benchmark Reports 2017
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