| | Catalent Announces Plan for Alessandro Maselli to Become New CEO Effective July 1, 2022 |
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| Earlier this month, Catalent announced that its Board of Directors had appointed Alessandro Maselli, currently President and Chief Operating Officer, as the company’s next President and Chief Executive Officer, effective July 1, 2022. Maselli will also join the company’s Board of Directors upon assuming his new role. Current Chair and Chief Executive Officer John Chiminski will remain in his present role until July 1, 2022, when he will assume the position of Executive Chair of the Board. “I am grateful and humbled to have had the opportunity to lead Catalent over the past 12 years, and I’m pleased to congratulate Alessandro, an experienced leader who has been critical to Catalent’s success,” said John Chiminski, Chair and Chief Executive Officer. |
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| | | John Chiminski speaks at STAT’s
"A Look Ahead at Biotech in 2022" |
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| | | In December, John Chiminski featured on the expert panel of this leading industry event, which focused on the ongoing battle against the SARS-CoV-2 virus, and explored what might be in store for the biotech industry in the years to come.
After the event John Chiminski commented, “I’m grateful to have had the opportunity to explain how Catalent is powering a new era of biopharma innovation at STAT’s "Look Ahead at Biotech in 2022" event. I feel energized about the future of our industry”.
Click below to watch his interview at the event with STAT's co-founder and executive editor Rick Berke. | | Watch Video |
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| BrainStorm Cell Therapeutics and Catalent Announce Completion of Technology Transfer for NurOwn® Manufacturing |
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| BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced that the technology transfer for NurOwn manufacturing at Catalent’s facility has been finalized. NurOwn® is BrainStorm’s autologous cellular therapy being developed for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases.
Catalent had entered a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate’s potential regulatory approval. NurOwn will be manufactured at Catalent’s world-class 32,000 square-foot cell therapy manufacturing facility in Houston, Texas.
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| | | Edenbridge Pharmaceuticals Announces U.S. FDA Approval of DARTISLA ODT (Glycopyrrolate) Orally Disintegrating Tablets |
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| Edenbridge Pharmaceuticals, LLC announced that it has received approval from the U.S. Food and Drug Administration on its 505(b)(2) New Drug Application (NDA) for DARTISLA ODT (glycopyrrolate) orally disintegrating tablets. DARTISLA ODT is indicated for adults as an adjunctive therapy in the treatment of patients with peptic ulcer. Edenbridge will launch this product to the market in early 2022 as its first branded specialty prescription product
DARTISLA ODT is manufactured using Catalent’s proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.
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| | | | | Developing optimized formulations with minimal drug substance Advances in in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterized using multiple material-sparing assays, allowing the most promising formulation candidates to move on to in vivo studies, reports Lisa Caralli, Science and Technology Director, Pharmaceutics, Catalent. Optimizing API usage for in vivo studies often requires preliminary understanding of the metabolism profile and absorption potential of the compound. In silico modelling that can predict absorption, distribution, metabolism and excretion (ADME) parameters using the compound’s molecular structure is a good starting point, and models can be enhanced and refined by the inclusion of data from in vitro studies. | | Read more on Manufacturing Chemist.com |
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| | | Idiopathic pulmonary fibrosis: An opportunity for inhaled therapies Idiopathic pulmonary fibrosis (IPF) is the most common of the interstitial lung diseases, primarily occurring in older adults, predominantly in their 60s and 70s. Unlike oral or intravenous therapies, inhaled therapies deliver drugs directly to the airways. For diseases of the lung, this is the therapeutic site of action providing high pulmonary drug levels and rapid onset of action. In this article Catalent’s Carolyn Berg discusses significant opportunities for pharmaceutical developers to pursue inhaled formulations of drugs, especially to counteract the urgent need for disease-modifying therapies for IPF patients and other rare lung diseases and thereby provide safer, more tolerable and more efficacious products. | | Read the Article in Inhalation |
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| | | Biologic Fierce JPM Week 2022 | Virtual | January 18-20, 2022 Join Alessandro Maselli, Catalent’s President & COO, for this exclusive one on one executive interview and a panel discussion on ‘The Post-COVID Supply Chain’ during Fierce JPM Week 2022. Schedule a Meeting with Catalent at this event.
DCAT Week | New York | March 21 - 25, 2022 The DCAT organization welcomes member companies back to New York City in 2022.
CASSS WCBP | Washington, D.C. - Hybrid | January 25 - 27, 2022
Meet with Catalent Biologics experts at Booth 22 to discuss your biologics analytical challenges. Hear about the latest investments we have made in our network to increase our biologics analytical capabilities and capacity. Schedule a meeting with Catalent at this event.
Cell and Gene Therapy
Phacilitate – Advanced Therapies Week | Miami, Florida | January 25 - 28, 2022 Meet our team of experts at Booth 324 to learn more about our integrated cell & gene therapy portfolio including plasmid DNA, viral vectors, and autologous and allogeneic cell therapies. Join Catalent’s George Buchman on January 27 at 11:20 – 11:35 for an in-person presentation discussing strategies to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials.
Accelerating Manufacturing for Next Generation hiPSC-Based Clinical Therapies | Virtual | January 27, 2022 In this webinar, presenters including experts from Catalent will share their experiences of the development and manufacturing of Human induced pluripotent stem cells (hiPSCs). The expert panel will highlight key considerations for driving clinical and commercial success with hiPSCs as starting materials, including aspects such as their derivation, expansion, and differentiation. Register today!
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Oral & Specialty Delivery
Inhalation & Respiratory Drug Delivery (IRDD) Congress | San Diego, California | February 1 - 2, 2022 Meet with Catalent during IRDD Congress to learn how we can partner to help expedite your inhaled therapy from concept to commercialization. On Tuesday, February 1 from 10:15-10:45 a.m., our inhalation expert, Patrick Goncalves, will share a presentation titled ‘Utilizing a Quality by Design Approach for Dry Powder Inhalation Product Development’, and will discuss the best practices for the successful development of capsule-based inhaled drug products from formulation development, through clinical and commercial scale manufacturing.
RDD2022: Respiratory Drug Delivery | Orlando, Florida| May 1-5, 2022 Meet with Catalent’s experts in applied drug delivery experts in Florida and discover how we can support your respiratory drug delivery needs. Click here to schedule a meeting with our team at the event.
Consumer Health
MakeUp in Los Angeles | Los Angeles, California | February 23 - 24, 2022 Meet our Catalent beauty experts and explore how we can partner to help bring your next product from concept to market. Schedule a meeting with our experts today!
Natural Products Expo West 2022 | Anaheim, California | March 9 – 12, 2022 Visit Catalent’s consumer health team at Booth #4381 to find out how together, we can bring nutritional supplement products to life! Register today and schedule a meeting with our experts.
In-Cosmetics Global 2022 | Paris, France | April 5 – 7, 2022 In-Cosmetics is all about the beauty of collaboration - connecting producers and suppliers of raw materials, fragrances, lab equipment, testing and regulatory solutions with researchers and buyers from personal care brands. We invite you to join in. Click here to schedule a meeting with Catalent at this event today!
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| A Catalyst in Drug Development |
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| Todd Stone, Ph.D. Director, Analytical Development |
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| Dr. Stone is Director, Analytical Development at Catalent’s Bloomington, Indiana, facility. He and his team focus on developing statistically rigorous analytical methods and high throughput formulation strategies using the principles of Quality by Design (QbD). Dr. Stone leads the scientific direction of the analytical and formulation groups ensuring Catalent provides clients with the highest quality data characterizing the critical quality attributes of their molecules. Access his works including eight peer-reviewed articles and scientific posters below. |
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| | Biologics Webinar: " Developing the next big vaccine technologies" - The rapid development of safe and efficacious mRNA vaccines was a triumph for biopharma that has propelled the entire vaccine field straight into a first-class concern for investors and dealmakers. In this panel discussion, Endpoints News publisher Arsalan Arif convenes some of the field's top experts to discuss the techniques and technologies they are working on including self-amplifying RNA, virus-like particles, “pan-viral vaccines” and scaling up mRNA. Article: " What’s Next for mRNA? From COVID to Cancer & Beyond" – Interest in mRNA as a therapeutic modality has exploded with the approval of mRNA-based COVID-19 vaccines.Join this webinar as Catalent experts discuss the challenges of mRNA development and manufacturing, potential solutions and where the industry may go next with mRNA-based therapies. Summary: " The Path to Self-Administration: Considerations for Moving from a Pre-Filled Syringe to an Auto-Injector" - With patient care increasingly moving into outpatient facilities and even the home, auto-injectors are an increasingly viable option for enabling patients and their caregivers to self-administer therapies. Catalent Biologics offers advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection. Webinar: " Leveraging Proven Technology to Speed Path to First-In-Human Studies with GPEx® Lightning"– Introducing GPEx Lightning, Catalent’s latest technology for a fast, flexible way to shorten the path to production of phase 1 material. Tune in as Greg Bleck, Vice President, R&D, Biologics at Catalent shares the latest data leveraging GPEx Lightning to generate highly stable, highly productive cell pools and discuss how the GPEx suite of technologies can be tailored to the specific needs of each individual program on its path to clinical trials.
Webinar: " Exploring New and Improved Analytical Methods for Traditional and Unique Modalities" - Biophysical characterization is critical to the understanding the make-up and behaviors of biologic therapies and vaccines, both early in development and throughout the manufacturing scale-up process. With the increase in complexity of biologics, there is a need to develop new and improved analytical methods to characterize the biologic products. Join this presentation to explore the latest challenges in biophysical characterization as the experts present their solutions to overcome these challenges. |
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| Cell & Gene Therapy
Webinar: " Accelerating Advances in Cell and Gene Therapy Production" – The field of cell and gene therapy is revolutionizing the way in which rare and previously untreatable genetic diseases are managed. Production processes for advanced therapies such as viral vectors, autologous and allogeneic cell therapies are still in the early years of development, with numerous advanced approaches under evaluation to improve yield, and help assure quality, function, and safety of these life-transforming medicines. Join this session to review the progress in several areas of advanced development and their impact on readiness for large scale manufacturing. Video: “ Plasmid DNA: Integrated Solutions for Cell and Gene Therapies" - Plasmid DNA is a critical raw material for cell and gene therapies. Discover the importance of having an integrated partner like Catalent Cell & Gene Therapy, and how we can keep clients’ development and manufacturing needs on track. |
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Clinical Supply Services
Webinar: " Running Decentralized Trials at Scale" - The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele-visits, digital consent, new monitoring sensors, and direct-to-patient supply are virtual tools that existed before the pandemic. But now there’s a swift adoption of these methods because they’ve been proven to help launch and complete trials more effectively. This Endpoints News webinar assembles a panel of clinical experts who are already running the trials of tomorrow. Video: " Clinical Supplies for Japan Studies" - Catalent’s clinical supply packaging facility in Shiga, Japan, is strategically located between Tokyo and Osaka. One of largest clinical supply sites in Japan, the 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service throughout Japan. |
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| Oral Drug Delivery " Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology" - Micronization is a proven and widely used technology to address the bioavailability and manufacturability challenges faced by highly potent oral drugs. Development of HPAPIs presents unique challenges for product containment, and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and shares recommendations for safe product handling, from clinical manufacturing to commercialization. The speaker will also share the key advantages of using micronization technology for the development and manufacture of HPAPIs. Fact Sheet: " Micronization Technology Solutions From Early Phase Development to Commercial Scale Manufacturing" – Micronization is an established formulation technology for improving the bioavailability and performance of small molecules. The micronization process can be used to generate a more consistent particle-size distribution, thereby enhancing pharmaceutical formulations. Catalent is a global leader in pharmaceutical air jet milling micronization and has more than 30 years’ experience delivering micronization technology solutions from development to commercial scale. Webinars: " Concept to Dosing-Challenges in New Orphan Drugs "– Some Orphan drugs programs have become the most consequential new medicines approved in the past five years, and with a slate of new innovative biopharmas entering the clinic with promising therapies for patients who have no good alternatives, orphan programs will remain a feature of the development pipeline.There’s an urgency to develop these drugs as fast as possible while maintaining a program that will withstand regulatory scrutiny. In this Endpoints Webinar, a group of experienced cancer drug developers discuss key strategies in managing an orphan drug program. Webinar: " A Guide to Drug Development of Challenging Molecules"- Presented in partnership with Medicon Valley Alliance, the crucible of Scandinavian life sciences, presenters addressed key considerations of early drug development, molecule developability assessment, drug bioavailability and discussed the relationship between intracellular and transcellular permeability of beyond the Rule of Five drugs. |
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| Consumer Health Webinar: " The Shift to “Experiential” in the Supplement Market" - In recent years, many more consumers have focused on the holistic experience of the products they buy and use. This trend has made its mark in the nutritional supplement space. Learn more about how this trend will influence the growth of the supplement market today and for years to come. Webinar: " How Unit Dose Beauty Is Reshaping the Beauty Market"- How fresh are the beauty products you use? When it comes to certain ingredients and types of beauty products, conserving their potency is key to maintaining their full potential. With key features such as ensuring that products remain fresh and effective, unit dose is a key staple to the beauty market today. So, what’s preventing your brand from offering a unit dose solution? |
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| | | Biologics Development and Manufacturing In this 360° Virtual Tour at Catalent’s facility in Bloomington, Indiana, explore our North American Center of Excellence for early-phase clinical biologics formulation development and drug product fill/finish. Explore the world-class late-stage and commercial manufacturing for vial fill/finish and secondary packaging of biologics and sterile products in this 360° virtual tour of Catalent’s facility in Anagni, Italy. | Cell and Gene Therapies Catalent has a network of cell therapy clinical and commercial manufacturing facilities in the U.S. and Europe. Discover its capabilities for the development and manufacturing of allogeneic and autologous immuno- and stem-cell therapies. Learn about the company’s expertise in both early and late-stage manufacturing as you get a glimpse inside our cell therapy facility in Gosselies, Belgium. In this 360° virtual tour, explore Catalent’s Harmans/BWI-1 clinical and commercial manufacturing facility for gene therapies in Baltimore, Maryland. At approximately 200,000 sq. ft., this state-of-the-art, FDA-licensed facility houses 10 CGMP manufacturing suites including fill/finish, and contains central services labs, testing labs, and acts as a central warehouse and supply chain hub for Catalent’s gene therapy solutions. |
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| Oral Development and Manufacturing In this 360° virtual tour, explore Strathroy, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. Catalent’s Boston, Massachusetts, facility provides manufacturing and development services for inhaled powders. The site features a top-tier vendor set for capsule filling and blister packaging lines as well as spray dryers up to PSD-7 scale, the largest size for CGMP pharmaceutical use in North America. With expertise in commercial launch and scale-up, the Boston site is a center-of-excellence for tech transfer projects. |
| We are the Catalyst for your success. Join us! |
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| Catalent ignites the development of their future leaders by continuously investing in their employees and creating an innovative environment to advance their potential. We are growing rapidly across sites in Bloomington, Indiana; Madison, Wisconsin; Harmans, Maryland; Kansas City, Missouri; and more.
Visit www.catalent.com/careers for more information.
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Every brand has a challenge. We have a solution.
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| | | or call +1 877 891 9609 to speak with one of our experts today! |
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To unsubscribe or manage your subscriptions, please click here. For more information call +1-866-720-3148 or in Europe 00800 88 55 6178, email us at [email protected], or visit our website www.catalent.com. And to learn more about Career opportunities across our global network, visit www.catalent.com/careers. Catalent Pharma Solutions respects your privacy. Links to third party sites are provided as a convenience only. Catalent makes no representation or warranty about the technology, security or any content available at these sites. Links are not intended to imply Catalent's affiliation or endorsement of the website, its owner(s) or the content. © 2021, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
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