2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM – Age-Appropriate Pediatric Formulation Development
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
PLATFORM TECHNOLOGY – Overcoming the Challenges of Drug Brain Delivery With a Novel Brain Delivery Vector
Mei Mei Tian, PhD, explains how the xB3 platform has the potential to support development of treatments for CNS diseases that can treat thousands of patients in the years ahead.
POLYMERIC DELIVERY SYSTEM – Next-Generation Long-Acting Implantables Using Surface-Eroding Elastomers
Stephanie Reed, PhD, Carissa Smoot, and Dennis Shull describe how PGSU ultimately offers many advantages over other polymers for long-acting implantables, particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry.
VACCINE DEVELOPMENT – COVID-19 Vaccine Focusing on T Cells to Protect the Most Vulnerable
Jeffrey Wolf, MBA, JD, says while most vaccines in development are targeted to protect healthy people, few are focusing on those who are most at risk – seniors and those with co-morbidities like heart failure, obesity, or type 2 diabetes.
EXECUTIVE INTERVIEW – Yourway: Supporting COVID-19 Studies & Vaccine Distribution
Leandro Moreira, Senior Vice President, Marketing and Business Development, Yourway, discusses what role the company will play in globally transporting COVID-19 vaccine(s), how Yourway is gearing up for this project, and the challenges of this extraordinary task.
PLATFORM TECHNOLOGY – Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders
Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.
FORMULATION FORUM – Parenteral Sustained Delivery of ASD-005 Liposomal Formulation: A Case Study in Applications of Lipid-Based Nanoparticle Carriers
Jim Huang, PhD, presents an investigation aimed at studying the administration of a liposomal form of a third-generation β-blocker, ASD-005, by injectable route of administration to efficiently manage emergency hypertension and congestive heart failure.
ASSAY DEVELOPMENT – Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
PEGYLATION – PEGylation – Three Decades of Product Approvals & Technology Development
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
CDMO CASE STUDY – AJILITY: Streamlining Drug Product Manufacturing
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
DRUG DELIVERY – Recognizing the Patient Potential for Transdermal Drug Delivery
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
EXECUTIVE INTERVIEW – Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
DEVICE DEVELOPMENT – Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES – Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
EXCLUSIVE ONLINE CONTENT
BioNTech & InstaDeep Announce Strategic Collaboration & Form AI Innovation Lab to Develop Novel Immunotherapies
BioNTech SE and InstaDeep Ltd recently announced a multi-year strategic collaboration aimed at applying the latest advances in artificial intelligence (AI) and machine learning (ML) technology to develop….
Foster Corporation Enters Marketing Partnership With Aran Biomedical
Foster Corporation recently announce a new business relationship with Aran Biomedical, a global leader in biomaterial product solutions for implantable medical devices…..
Recipharm Announces Signature of Letter of Intent for Aseptic Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Recipharm, a leading contract development and manufacturing organization (CDMO), recently announced that it has signed a letter of intent with Moderna, a US-based biotech company, to formulate, fill, and….
Evaluation Kit for Sensirion’s Single-Use Liquid Flow Sensor LD20-2600B is Now Available for Distribution
The LD20-2600B single-use liquid flow sensor for fast, precise and reliable measurements of the lowest flow rates in biomedical applications was successfully launched….
Samsung Biologics Announces Strategic Manufacturing Partnership With Lilly to Accelerate Delivery of COVID-19 Antibody Treatments
Samsung Biologics’ partnership with Eli Lilly and Company is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement….
Assembly Biosciences & Door Pharmaceuticals Sign Collaboration & Option Agreement
Assembly Biosciences, Inc. and Door Pharmaceuticals, LLC recently announced the companies have signed an exclusive, 2-year collaboration and option agreement focused on the development of….
XOMA Earns $2-Million Milestone From Takeda
XOMA Corporation recently announced it has earned a $2-million milestone payment from Takeda Pharmaceutical Company Limited as the first patient has been dosed….
Aeterna Zentaris Amends License Agreement With Novo Nordisk
Aeterna Zentaris Inc. recently announced that, through a wholly owned subsdiary, it has entered into an amendment of its existing License Agreement with Novo Nordisk Biopharm….
WHITE PAPER ALERT – Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation
Despite the relative simplicity of over-encapsulation, proper planning, and careful execution are still fundamental to success — full consideration must be given to every detail from capsule color and size selection to having a well-trained team dedicated to the process…..
Benefits of Small-Scale Drug Development
Kieran Coffey, Technical Lead at Pfizer CentreOne’s Newbridge facility, discusses the benefits of small-scale processing for process development of tablet products.
AUDIO SPOTLIGHT
