Newsletter | May 3, 2021

05.03.21 -- Manufacturing Therapeutics In Hospitals: Reenvisioning The Bioprocessing Paradigm

 
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Oral Solid Dose Regulatory Hurdles And How To Approach Them

In your quest to meet the regulatory requirements for your oral solids project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this blog experts discuss common regulatory challenges and how to approach them.

How Scale-Up Benefits A Clinical Program To Get Results

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market, a competitive advantage for gaining market share.

Cut It Out: The Role Of Gene-Editing Technologies In Combating HIV

Despite the public attention and large population impacted by HIV, developing a cure has been particularly difficult. Will gene-editing techniques, such as the CRISPR-Cas9 system, change the paradigm?

How To Attract Investors: Funding Advice For Biotechs From VC Experts

How do you find the initial capital and attract new investors to hit your milestones and stay solvent? Experts share their experiences and offer advice for companies on the path toward bringing potentially life-changing therapies to patients.

Six Principles For Getting Pharma Development Right From The Start

This paper highlights six keys that pharma and biotech companies should keep in mind when selecting a partner to synthesize an API to ensure the development process tracks toward success.

Eliminate Drug Discovery Errors Before They Happen: Why Picking The Correct Binding Technology Is Critical To Success
Starting with the right tool is crucial in saving you time and money in the drug development process. This binding technologies toolbox covers temperature related intensity change (TRIC), surface plasmon resonance (SPR), differential scanning fluorimetry (DSF), and isothermal titration calorimetry (ITC).
Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry
A global top-ten pharmaceutical company was sponsoring a complex, eight-year Phase 3 trial across 43 countries. The sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it were outsourced.
Keys To A Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients the better. With additional novel drug products planned for approval over the next few years, along with new and emerging modalities, it is imperative that companies invest adequate time and resources in strategic planning and preparation activities to ensure the best chances for a successful commercial launch.

Local Delivery For Treatment Of Lung Cancer: Manufacturing Formulations For Dry Powder Inhaler By Spray Drying

Explore two case studies where lung cancer therapies were delivered to the lung by dry powder inhaler in a rat model and evaluated for efficacy. The results confirmed that local delivery is a promising route to treat lung cancer.

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You're A Virtual Biotech? Think Again.
 

If you claim you are a “virtual organization” fully utilizing an “outsourced model,” you may be headed for an identity crisis — one that’s beneficial.