Operation Warp Speed leadership and Catalent recently reviewed the company’s readiness to ship hundreds of millions of COVID-19 vaccine doses for its partner Moderna as soon as possible once authorized by the FDA.

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Visitors to Catalent’s facility in Bloomington, Indiana, included Vice President Pence, HHS Secretary Azar, Indiana Governor Holcomb and CDC Director Dr. Redfield, as well as leaders from Moderna and Catalent. During a roundtable session, the group discussed Catalent’s efforts to accomplish this feat including accelerating the construction of a brand-new building, installing and validating new equipment, and hiring over 1,000 new employees for its great team in Indiana.

Watch the Roundtable.

At Catalent Cell & Gene Therapy in Maryland, manufacturing operations have commenced to support adeno-associated virus (AAV) production for Passage Bio’s lead gene therapy product candidates for the treatment of rare monogenic disorders of the central nervous system. Also, Catalent announced that it has signed a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib). GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 

Dr. Mhashilkar is a Lead Scientist at Catalent’s St. Petersburg, Florida facility. She earned her MD at Grant Medical College, a Master of Public Health and doctorate at the University of South Florida and completed her MBA at Florida Southern College. Dr. Mhashilkar specializes in lipid-based softgel formulation for immediate and extended release. She also works on process development and regulatory CMC support. Find out what drives Dr. Mhashilkar’s passion for softgel formulation - read her published works, which include five peer-reviewed articles.

Biologics

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• Webinar: “Supply Chain Contingencies to Avoid Upheaval” - This session at the 2020 BIO Investor Forum features Catalent’s Karen Flynn, President of Biologics and Chief Commercial Officer, explaining the challenges and opportunities changing how biomedical supply chains must plan and innovate to continue to serve patients and build resilience. 
• Article: “Control Strategies for Perfusion Cell Culture” - Claudia Berdugo-Davis, Director of Process Development, Catalent Biologics, discusses perfusion in a recent BioPharm International article.
• Webinar: “Advancing Your Biologics Drug Product: Strategies for Successful Formulation, Tech Transfer and Delivery System” - Learn about formulation development with a focus on stability and aggregation, strategies to accelerate drug product technical transfers, and the trends and usability insights in injection delivery systems. 
• Article: “How COVID-19 is Bending the Curve on Vaccine & Therapeutic Manufacturing Norms” - Bernie Clark, Vice President of Marketing and Strategy, Catalent Biologics, discusses the collaboration and innovation necessary to help combat coronavirus.

Cell & Gene Therapy

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• Webinar: “CPhI Festival of Pharma Roundtable: Cell & Gene Technology” - Panelists, including Thomas VanCott, Ph.D., Global Head of Product Development, Catalent Cell & Gene Therapy, discuss innovative technologies and their adoption for cell and gene therapies. The panelists consider strategies to improve efficiency and standardization in cell and gene production. 
• Article: “Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™” - Catalent and LumaCyte experts compare AAV production with three different transfection reagents using both LumaCyte’s Laser Force Cytology (LFC) instrument, Radiance®, and a digital droplet PCR (ddPCR) based viral genome titer assay. 
• Webinar: “How to Commercially Scale T-Cell Allogeneic Therapies” - Jesse Trekker, Ph.D., Business Development Director at Catalent Cell & Gene Therapy, discusses an innovative manufacturing methodology and fill/finish approaches to accelerate T-cell therapies to the commercial readiness phase.

Clinical Supply Services

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• Webinar: “Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain” - Explore strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges. 
• Webinar: “Discover the Latest Funding, Drug Development and Clinical Solutions Strategies” - Specifically designed for pharmaceutical and biotech consultants, and early-stage development partners, experts present their insights and techniques to help your clients get their molecules from preclinical to Phase 1. 
• Webinar: “Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges and Solutions” - Learn what challenges can occur in Phase 3 and how to address them in advance to limit potential setbacks, as well as the ways solution providers can lend their expertise in clinical trial supply management to help prepare for Phase 3. 

Oral Drug Delivery

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• Webinar: “De-risking Orphan Drug Programs in 2020 and Beyond” - In this Endpoints webinar, four orphan drug developers share what they have learnt during the pandemic and how they plan to fortify their programs. 
• Article: “Principles of Raman Spectroscopy and Application to Pharmaceutical Development” - Learn the Basic principles of Raman spectroscopy and how it is used to analyze the structure of a chemical compound. 
• Webinar: “Setting Up Your Small Molecule for Success: Formulation, PBPK Modeling and Regulatory Strategies in Early Clinical Trials” - Topics include the technological aspects of drug development, PBPK modeling, and the regulatory requirements for early clinical research. 

Consumer Health

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• Article: “Plant-Based Delivery Systems Continue Their Rise in Dietary Supplements” - Dan Peizer, Vice President of Global Strategy and Marketing, Catalent Consumer Health, discusses the benefits of plant-based supplements in a recent Nutritional Outlook article.
• Webinar: “Innovations in Nutritional Supplements: Catalent’s Newest Delivery Technology, OptiGel^® DR” - Catalent introduces its latest innovation: OptiGel^® DR delayed release softgel technology. This new technology is applicable to a wide range of ingredients and formulations. 
• Infographic: “How OTC Monograph Reform Affects You” - Learn about how changes in OTC monograph reform are driving new product opportunities. 

Catalent ignites the development of their future leaders by continuously investing in our employees and creating an innovative environment to advance their potential. We are growing rapidly across sites in Bloomington, Indiana, Madison, Wisconsin, Winchester, Kentucky, and more.

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Visit www.catalent.com/careers for more information.