Catalent

https://www.pharmtech.com/pt_w/planning_ahead

While clinical studies are in Phase 2, it is important for sponsors to be prepared for any Phase 3 challenges that might arise. Understanding what resources are available is key to being ready for Phase 3 before it even begins.

What are some possible challenges sponsors might encounter during Phase 3? In what ways can sponsors enhance their study protocols and improve supply chain efficiencies? How can sponsors mitigate risk to help ensure smooth study execution and accurate data collection?

Discover what challenges can occur in Phase 3 and how to address them in advance to limit potential setbacks.

Understand how solutions providers can lend their expertise in clinical trial supply management to help prepare for Phase 3.

Learn how consulting with a comparator sourcing specialist early and incorporating the strategy into the protocol can help reduce cost, timelines, and risk.

 Keith Krenitsky, Director, Global Clinical and Ancillary Supplies, Catalent

James Cowley, Senior Clinical Supply Manager, Catalent

: Monday, Oct. 26, 2020 at 9am EDT| 1pm GMT| 2pm CET

Monday, Oct. 26, 2020 at 2pm EDT| 1pm CDT| 11am PDT

On demand available after final airing until Oct. 26, 2021

Webcasts

*** Live: Monday, Oct. 26, 2020, 11am EDT| 8am PDT| 3pm GMT| 4pm CET *** What are typical challenges sponsors encounter during Phase 3 clinical trials?  How can advance preparation during Phase 2 help mitigate risks? Learn effective strategies to avoid surprises and problems in late-stage trials from experience clinical trial and supply experts. ***On demand available after final airing until Oct. 26, 2021***

Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges & Solutions

https://www.pharmtech.com/pt_w/strategies_to_accelerate

Development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines are exhibiting a trend toward higher lipophilicity and molecular weight, which can lead to poor solubility and bioavailability.

During this webcast, industry experts will introduce a fast and efficient development process that can help deliver the right clinical candidate, best formulation strategy, and an optimal dosage form to Phase 1. The presentation will also review details of some established data-driven approaches, including physiologically based pharmacokinetic (PBPK) modeling, parallel formulation screening, API sparing techniques, and optimal early dosing strategies that will help avoid development pitfalls and de-risk a molecule’s path to clinic.

Learn about how to utilize PBPK modeling in candidate and formulation selection

Review scalable formulation technologies for poorly soluble compounds

Understand API sparing techniques for selecting the best formulation approach

Learn about optimal dosing strategies in early development

Hear real-world successful case studies that utilize these data-driven approaches

Katarina Vulic, Principal Scientist, Novartis Institutes for BioMedical Research

Lisa Caralli, Science and Technology Director, Pharmaceutics at Catalent Pharma Solutions

 Wednesday, Sept. 23, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

	On demand available after final airing until Sept. 23, 2021

Review how data-driven approaches, including physiologically based pharmacokinetic (PBPK) modeling, parallel formulation screening, API sparing techniques, and optimal early dosing strategies can help avoid development pitfalls for small-molecule drug candidates on the path to clinic. 

Live: Wednesday, Sept. 23, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing until Sept. 23, 2021

From Candidate to Clinic: Strategies to Accelerate Your Molecule’s Development Path

Articles

Catalent Cell & Gene Therapy, the Journey


	This webcast will provide a solid understanding of the Over the Counter (OTC) market performance before the novel coronavirus outbreak occurred, what the CARES Act is and how OTC Monograph Reform affects the industry, and what the innovation trends and opportunities are looking forward.  This will ensure that key lessons and opportunities are remembered amid extraordinary consumer buying trends driven by the outbreak, providing a solid baseline for future planning.

Nicholas Hall, Chairman & CEO, The Nicholas Hall Group of Companies

	John Punzi, Ph.D., Senior Director Quality Assurance & Technical Affairs, Consumer Healthcare Products Association (CHPA)

	Cornell Stamoran, Ph.D., Vice President Strategy & Government Affairs, Catalent

	Mark Gardella, R..Ph., Vice President Product Development, Consumer Health, Catalent

Tuesday, May 5, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until May 5, 2021

Catalent, Consumer Healthcare Products Association (CHPA), The Nicholas Hall Group

Gain insight from Nicholas Hall, the Consumer Healthcare Products Association, and Catalent into the performance of the OTC market, some of the innovation trends and opportunities that are emerging, and the impact of OTC monograph reform on future developments.
Live: Tuesday, May 5, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after airing until May 5, 2021 
Register free


OTC Trends, Monograph Reform, and Innovation

Drug formulators are often tasked with trying to increase the bioavailability of poorly water-soluble drugs. This Pharmaceutical Technology eBook takes an in-depth look at one approach: Spray Drying for Bioavailability Enhancement.
