Featured Articles From The Current Issue
BIODEGRADABLE FIBERS - Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.


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Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
Leon Grother, MS, and Mathias Bayru, MS, MBA, indicate recent developments in ODT technology have widened the range of actives that can be formulated and product types that are possible. In particular, the promise of formulating biologics and ODT vaccines is hugely exciting.
Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.
Michael D. Hooven, MSME, believes in the challenge to deliver innovative therapies that address unmet patient needs while delivering profitable growth, and the industry is responding by embracing disruptive technology that can concurrently help on both fronts and also speed time to market for pharmaceutical products and services.
T.R. Shantha, MD, PhD, FACA, explores and explains how therapeutic and non- therapeutic agents can reach the brain, bypassing through the formidable BBB based on the unique microanatomic and physiologic characteristics of the nasal olfactory mucosal route and its CNS connections that allow transportation directly into the CNS.
Harry A. Arena, MBA, President & CEO of TDT, Chris Kim, President & General Counsel, Viral Gene, Inc., and Dr. Scott Waldman, Professor & Chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, discuss the unique characteristics of the vaccine, the patients who will benefit the most, and how a research team captured the attention of investors.
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
Patrick Walsh, CEO of Avista Pharma Solutions, talks about his company’s range of capabilities and what is driving growth in this dynamic industry.
Cai Xuan, PhD, and Volkan Gunduz, PhD, GlobalData Analysts, estimate that by the end of the forecast period in 2025, NSCLC sales will rise to $26.8B in the 8MM, at a moderate CAGR of 15.7%.
Mirco Junker, PhD, GlobalData Analyst, says high cure rates exceeding 90% are now achievable for most patients suffering from chronic hepatitis C, and as a result, the industry is reaching a new phase in the fight against this deadly infectious disease.
Michela J. McMullan, PhD, GlobalData Analyst, reports that although the ACS market is set to grow at a CAGR of 4.6%, reaching $12.1B by 2025, the potential for the market to be even more lucrative exists, especially in the sizable lipid-targeting arena.
Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.
Exclusive Online Content
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & ExcipientsElemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients
The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for elemental impurities in December 2014.1 Regulators are now implementing the requirements worldwide, with some start dates already in place as of June 2016.

Avomeen Recapitalizes to Achieve Next Growth Plan Objective Avomeen Recapitalizes to Achieve Next Growth Plan Objective
In an effort to foster growth and reinforce its infrastructure, Avomeen Analytical Services, a fast growing full-service independent analytical and chemical testing laboratory based in Ann Arbor, MI, recently announced a recapitalization with High Street Capital, a Chicago-based provider of flexible capital and operating expertise to middle market businesses.

Gerresheimer Introduces Metal-Free Syringe Gerresheimer Introduces Metal-Free Syringe
Biopharmaceuticals demonstrate a series of special features. They are often highly viscous and in individual cases tend to interact with silicone oil or, for example, tungsten residue from syringe production..........

PCI Clinical Services & Suvoda Announce Strategic PartnershipPCI Clinical Services & Suvoda Announce Strategic Partnership
PCI Clinical Services recently announced a partnership with Suvoda LLC that will benefit clinical trials, delivering Suvoda’s cutting-edge IRT/IWRS technology for subject randomization and trial supply management integrated with PCI’s comprehensive packaging and logistical services for clinical trial supplies.

Nemus Bioscience Announces Licensing Agreement for a Cannabinoid-Based Anti-Infective Platform Directed Against Drug-Resistant OrganismsNemus Bioscience Announces Licensing Agreement for a Cannabinoid-Based Anti-Infective Platform Directed Against Drug-Resistant Organisms
NEMUS Bioscience, Inc. (NMUS) announced that the company had signed a licensing agreement with the University of Mississippi (UM) for a platform of cannabinoid-based molecules (UM5070) for potential anti-infective use against bacteria, viruses, and fungi.

Catalent to Develop Softgel Capsules for JOT's Leading Orphan Disease CandidatesCatalent to Develop Softgel Capsules for JOT's Leading Orphan Disease Candidates
Catalent Pharma Solutions recently announced that it is to evaluate Jupiter Orphan Therapeutics, Inc.’s (JOT) novel formulation of resveratrol, JOTROL, for delivery using Catalent’s R.P. Scherer softgel technology.

Cartridge Filling: Combination Features That Can Help Gain a Competitive EdgeCartridge Filling: Combination Features That Can Help Gain a Competitive Edge
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.

Leading Developer of Multi-Layer Oral Thin Film Completes Going Public TransactionLeading Developer of Multi-Layer Oral Thin Film Completes Going Public Transaction
CURE Pharmaceutical, a pre-eminent developer and manufacturer of advanced oral thin film for use in pharmaceutical, veterinary, and buccal and dermal over-the-counter applications, recently announced the completion of a going public transaction and the issuance of its new stock symbol - CURR.

Dalton Enters Into Agreement With USAMMDA in Support of US Army’s Drug Development ProgramDalton Enters Into Agreement With USAMMDA in Support of US Army’s Drug Development Program
Dalton Pharma Services, a privately owned pharmaceutical services provider, recently announced that it has entered into a contract service agreement with the United States Army Medical Materiel Development Activity (USAMMDA) in support of the US Army’s product development program for the treatment of severe or complicated malaria due to Plasmodium falciparum.

Lonza to Acquire Capsugel to Create Leading Integrated Solutions Provider to the Global Pharma & Consumer Healthcare Industries Lonza to Acquire Capsugel to Create Leading Integrated Solutions Provider to the Global Pharma & Consumer Healthcare Industries
Lonza Group AG, KKR, and Capsugel S.A. recently announced they have entered into a definitive agreement under which Lonza will acquire Capsugel from KKR for $5.5 billion in cash, including refinancing of existing Capsugel debt of approximately $2 billion, through a transaction that has been approved by the Boards of Directors of both Lonza and Capsugel.
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Palm Beach Gardens, FL

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March 21-23
New York, NY

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April 3-5
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October 24-26
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November 7-8
Nienna, Austria

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November 12-17
San Diego, CA

 



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