October 2018 | Solutions Insider

Join Catalent at AAPS and Debate Latest Applied Development Approaches

We have the passion to unlock the potential of your small and large molecules. With expanded early development solutions, and the acquisition of Juniper Pharmaceuticals, Catalent has you covered from candidate selection to commercialization.   Visit booth 1727, Nov. 4 – 7, to debate, discover and learn more about new approaches, the latest technologies and best practice in drug development.

Four presentation seminars, workshops, and roundtables Six research posters In-booth networking reception on Monday, Nov. 5 from 3:30 p.m. Pharma consultant breakfast session on Tuesday, Nov. 6 at 7:45 a.m. Catalent experts available during AAPS community socials at the HUB.   Schedule a meeting with one of our experts during the event!

For full details click here to view the full agenda.

Pharma Consultant Breakfast Session During AAPS   Hear from experienced industry colleagues on the latest tips to help your clients avoid critical pitfalls in early development. Learn to better leverage CDMO experts to help manage and mitigate risks for your clients’ programs.   All this, and complimentary breakfast on Tuesday, Nov. 6 at 7:45 – 9:45 a.m., at the Henley Park Hotel, minutes away from the exhibit hall. Limited spots available, register today.

Catalent in the News

Catalent and Verastem Oncology Partner on Newly Launched, FDA-Approved COPIKTRA™ (duvelisib) Capsules Catalent welcomed the approval of Verastem Oncology’s COPIKTRA™ (duvelisib) capsules by the U.S. Food and Drug Administration (FDA). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies. Read more.   Catalent invests $7.3 Million at its Aprilia, Italy facility Catalent has completed the first phase of a $7.3 million investment to upgrade and expand its packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy. The first phase of investment, completed in August 2018, saw the expansion and upgrade of the facility’s integrated packaging capabilities, and the commissioning of the first of five new softgel encapsulation lines.Read more.    Catalent Selected to Provide Oral Delivery Systems for GB Sciences’ Proprietary Parkinson’s Disease Therapies GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences’ proprietary active pharmaceutical ingredients for its Parkinson’s disease therapies. Read more.

Additional Upcoming Events

Join us at SupplySide West Nov. 8-9 in Las Vegas, Nevada Hear expert sessions on Continuous Bioprocessing and Cell Line Development from Emily Shirmer and Greg Bleck during the Waterside Conference, Nov. 12 - 14 in Norfolk, Virginia Register to attend this complimentary event:  From Discovery to Clinic: Creating a comprehensive and efficient development operation, on Nov. 22, in Cambridge, U.K.

Top Expert Content

BIOLOGICS AND SPECIALTY DRUG DELIVERY Webinar:  Continuous Processing in Biomanufacturing – Watch this fascinating joint webinar between Codiak Biosciences and Catalent as they discuss new processes and technologies in biomanufacturing.

CLINICAL SUPPLY / CLINICAL SERVICES Webinar: How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk – Download this webinar and learn the appropriate level of detail to include in a study protocol to help avoid common sourcing issues later on, and why early input into a protocol design can potentially impact the costs, timelines, operational complexity, and overall risk incurred when sourcing comparators. White Paper:  Countdown to Brexit – Developed by a cross-functional team of Catalent experts, this white paper was written to help sponsors understand how the various Brexit outcome scenarios may specifically impact clinical supplies. In this paper, you will find more than 30 practical questions to evaluate how certain aspects of the clinical supply chain may be impacted by the U.K.’s departure from the European Union.  Case Study: Managing Risks to Time Critical Product Imports at Clinical Supply Depots – Read this compelling case study detailing how a Catalent customer arranged to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. Learn how common documentation errors can quickly jeopardize a study.

ORAL DRUG DELIVERY Q&A article: How Do I Streamline Early Drug Development While Planning for the Future? – Download this Q&A article which addresses the industry-wide need for R&D efficacy and the increasing emphasis on speed to clinic and cost savings. This approach may lead to a gap in the focus on chemistry, manufacturing and controls (CMC) between early and late phase development. This interview examines how companies should create a development strategy that bridges potential gaps earlier in the process to make the transition smoother. Webinar:  Venerated And Vital: Using Lipid Based Delivery For Fast And Efficient Early Phase Development– Learn about novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems. Find out how to use mechanistic studies and modeling to predict the impact of lipids on oral absorption.

CONSUMER HEALTH Webinar: 2018 Omega-3 Market Trends and New-to-Market Solutions – Download this webinar, which explores 2018 omega-3 market overview: sales, trends, and global consumer preferences. Learn how omega-3 solutions can address today’s leading health concerns.

Our Work Matters. Join us in Bringing Better Treatments to Patients Worldwide.

Join one of our rapidly growing teams in Bloomington, Madison, Morrisville, Kansas City or internationally in Eberbach, Schorndorf, Swindon and Strathroy. Discover the impact you could make with a career at Catalent.

Upcoming Expert Presentations, Webinars and Events

Additional Upcoming Events: AAPS Pharmsci 360 | Nov. 4 – 7, 2018 | Washington, DC | USA Bio Europe | Nov. 5 - 7, 2018 | Copenhagen, Denmark RESI Global Partnering Conference | Nov. 5, 2018 | New York, NY | USA Pharma Consultant Breakfast at AAPS | Nov. 6, 2018 | Washington, DC | USA Supply Side West | Nov. 8-9, 2018 | Las Vegas, Nevada | USA The Waterside Conference | Nov. 12-14, 2018 | Norfolk, Virginia | USA PBSS Workshop | Nov. 12, 2018 | San Diego, CA | USA Discovery to Clinic: Creating A Comprehensive and Efficient Development Operation | Nov. 22, 2018 | Cambridge, UK Partnerships in Clinical Trials | Nov. 27-29, 2018 | Barcelona, Spain PharmaVenue | Nov. 29 - 30, 2018 | Marbella, Spain

Recent Webinars: Now Available On-Demand! Venerated And Vital: Using Lipid Based Delivery For Fast And Efficient Early Phase Development 2018 Omega-3 Market Trends and New-to-Market Solutions Particle Size Reduction: Identifying the Potential & Benefits for Micronization Solutions How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk Continuous Processing in Biomanufacturing Jab to Tab: Invasive to Oral Conversion of Macromolecules