EXECUTIVE INTERVIEW – HERMES PHARMA: Reducing Risk, Speeding Development – A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS – In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP – The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
CLINICAL TRIALS – 2023 & Beyond: How Technology is Changing the Face of Clinical Trials
Betsy Wagner and Marie E. Lamont explain how before anyone can take full advantage of this opportunity, education about the technology and the practical benefits, viewed through the lens of understanding historical lessons learned, will be the critical next step.
NATURAL LANGUAGE PROCESSING – Mandatory IDMP Compliance is Almost Here – How NLP Can Help
Simon Johns says with the US scheduled to implement IDMP this year and the EU in the process of implementation, IDMP is no longer just a distant requirement. It is happening now, and all organizations should be prepared for mandatory use this year.
DEVICE DEVELOPMENT – Connected Auto-Injector Development: How to Leverage Human Factors Engineering
Finola Austin examines the human factors process for such devices, including a detailed look at the recent development of the UniSafe® 1 mL auto-injector.
CELL & GENE THERAPY – Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success
Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.
SPECIAL FEATURE – Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance
Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.
EXECUTIVE INTERVIEW – Sever Pharma Solutions: Development & Manufacturing of High Potent Polymer-Based Dosage Forms
Tony Listro, Vice President of Technology and Site Lead for SPS’s North American site in Putnam, CT, discusses the company’s recent focus areas as well as current plans for expansion.
SUPPLY CHAIN SOLUTIONS – Steady Supply in Turbulent Times: The Importance of Secure Supply Chains & Drug Packaging Integrity
Peter Belden offers unique insight into strategies that can be applied to weather the turbulent times ahead and ensure a reliable supply of critical drug products to patients, and explores how sustainability and integrity can be attained with the right packaging and supply chain solutions.
THERAPEUTIC FOCUS – Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients With Parkinson’s Disease
Joseph M. Palumbo, MD, says addressing Parkinson’s via the inflammatory pathway offers a unique perspective that was virtually unheard of only 10 years ago.
MEDICAL DEVICE TESTING – Breathing Component Biocompatibility: The Practical Application of ISO 18562
Luminita Moraru, MSc, explains how the medical devices industry has grown and is expanding daily and presents the key steps that need consideration when assessing breathing devices.
EXECUTIVE INTERVIEW – Tarsus Pharmaceuticals: A Journey to Establishing a New Disease Category in Eyecare & Transforming Treatment for Patients With Serious Diseases
Sesha Neervannan, PhD, Chief Operating Officer of Tarsus, discusses the company’s innovative approach to creating a new treatment category for eyelid disease and their strategic focus on advancing other treatments in their pipeline.
2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry
In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.
2023 Respiratory Drug Development eBook – Inhalers Trend Toward Sustainability & Targeted Control
In this fourth annual Respiratory e-book, learn more about Porex and Nemera and their contributions to inhalation drug delivery and device design.
EXCLUSIVE WHITEPAPERS
WHITEPAPER – Streamline Early-Stage Development to Reach the Clinic Faster
It can be easy to overlook the importance of early-stage pharmaceutical product development, viewing it as a series of checklist tasks slowing progression toward clinical trials. Rather, early-stage development is critical to establish a solid foundation for those trials…..
WHITEPAPER – Accelerate Preclinical Developments & Improve Oral Bioavailability With Lipid-Based Formulation & Encapsulation Technology Combination
This paper covers the benefits of the LBF and capsules combination in dosage form developments, an efficient technology platform to bring efficient and differentiated products to the market.
WHITEPAPER – Improving API Solubility by Salt & Cocrystal Formation
Ensuring sufficient solubility is critical to the success of small molecule drugs. An active pharmaceutical ingredient (API) must be absorbed by the body and enter the systemic circulation to deliver the desired therapeutic effect. Many APIs,….
WHITEPAPER – Effect of Excipient Choices on Topical Formulations & Manufacturing Processes
In this whitepaper, we review the effect of excipient choice on the process of manufacturing topical products. The effect of the following excipient types will be discussed: surface active agents, preservatives, polymer choice and….
WHITEPAPER – Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
EXCLUSIVE WEBINARS
WEBINAR – Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
WEBINAR – Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
ON-DEMAND WEBINAR – Solve Common Design Challenges in Inhalation Devices With Porous Polymers
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
WEBINAR – Step Into the Future of Therapeutic Antibody Discovery
Join us to hear about our new biotherapeutic antibody discovery service — the Pioneer Platform, and how it can help you find your next lead candidate.
ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
EXCLUSIVE ONLINE CONTENT
Evonik Strengthens Portfolio of Nanoparticle Technologies & Services for Parenteral Drug Delivery
Evonik is strengthening its platform of parenteral drug delivery solutions with three new standard PLA-PEG di-block copolymers and a new nanoparticle formulation service using….
Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 From Ongoing MYCHELANGELO I Trial
Omega Therapeutics, Inc. recently announced encouraging preliminary safety, tolerability, pharmacokinetic, and translational data from the initial two dose level cohorts (n=8) from Part 1 of its ongoing Phase 1/2 MYCHELANGELO I study evaluating….
SOHM Announces Acquisition of ABBIE, a World-Class Gene-Editing Platform That Can Deliver Genetic Payloads Using Non-Viral Vectors
With this acquisition, SOHM is well-positioned as a competitive player in the $5.3 billion gene-editing market in 2023. The gene-editing market is expected to grow….
MilliporeSigma to Become First Provider to Offer Fully Integrated mRNA Services
MilliporeSigma is the first CTDMO to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and….
Bora Collaborates With Sunway Biotech to Launch Global Nutraceuticals Offering
Bora Health, a global design, development and distribution partner of pharmaceuticals and health foods and part of the Bora group, recently announced its merged with Sunway Biotech, a leading ingredients manufacturer and….
Vir Biotechnology Announces First Participant Dosed in New Phase 1 Trial Evaluating Investigational T Cell Vaccine for the Prevention of HIV
Vir Biotechnology, Inc. recently announced the first participant has been dosed in a Phase 1 trial evaluating the safety, reactogenicity, and immunogenicity of VIR-1388, an investigational novel T cell vaccine for….
LIXTE Biotechnology Announces a Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, Plus GSK’s Immunotherapy in Clear-Cell Ovarian Cancer
The Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival to Immunotherapy When Genetically Deficient in PP2A….
Samsung Biologics Announces Expanded Strategic Agreement With Bristol Myers Squibb
Samsung Biologics recently announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a Bristol Myers Squibb commercial antibody cancer drug….
BioNTech & CEPI Announce Partnership to Advance mRNA Mpox Vaccine Development & Support CEPI’s 100 Days Mission
BioNTech SE and the Coalition for Epidemic Preparedness Innovations (CEPI) recently announced a strategic partnership to advance mRNA-based vaccine candidates with the development of….
New Collaboration With Stevanato Group to Elevate mRNA Production With Nfinity Platform
Quantoom Biosciences recently announced a new collaboration with Stevanato Group, a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life science industries, with the goal of….
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