Quotient Sciences

Oncology drugs dominate today’s pharma industry pipeline with more than 5500 molecules in development in 2019 alone. With this number of molecules, the stakes are high, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the challenges associated with developing oncology drug products to accelerate to proof-of-concept and toward a successful commercial launch.

Key development considerations include the following:

What dosage form is needed for proof-of-concept studies and what will the final commercial product look like?

Does the molecule chemistry present additional challenges?

Can the risk of a poor formulation delaying or terminating the program be reduced?

Will the molecule begin clinical evaluation in patients or healthy subjects?

What is the target patient population and will a pediatric formulation also be required?

Are there clinical supply chain challenges to overcome for oncology patient trials?

How can manufacturing processes be optimized and scaled-up for commercial launch?

In a market segment where concerns over development time and cost are even more accentuated, the need to manage R&D budgets while not compromising speed to market is crucial. This presentation, given by experts from a contract development and manufacturing organization and a biotechnology company, will outline development challenges and share case studies.

Review drug substance and biopharmaceutics considerations

Understand the regulatory frameworks for NCEs and existing marketed drugs (e.g., 505b2)

Develop the right dosage form for each stage of clinical development

Review patient-centric and age-appropriate formulations

Discuss flexible and adaptive manufacturing and supply chains for oncology trials

Develop methods to scale up processes in readiness for commercial launch

Dr. Asma Patel, Executive Director of Product Development, Pharmaceutical Sciences, Quotient Sciences Nottingham

John Zucaro, PE Senior Vice President, CMC

: Tuesday, November 17, 2020 at 11am EDT| 8am PDT| 4pm GMT| 5pm CET

On demand available after final airing until Nov. 17, 2021

Webcasts

***Live: Tuesday, November 17, 2020 at 11am EDT| 8am PDT| 4pm GMT| 5pm CET***Oncology drugs dominate today’s industry pipeline, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the development challenges that come with oncology drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch. *** On demand available after final airing until Nov. 17, 2021.***


Advancing the CMC Development of Oncology Medicines 

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

With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry. Despite improvements in regulatory support and commercial rewards for developing orphan drugs, difficulties remain for drug developers in bringing these medicines to market quickly; including limited R&D budgets, an ever-evolving regulatory framework, low anticipated returns from small volume product revenues, challenging product development and clinical recruitment.

These challenges present unique pressures on pharmaceutical scientists to achieve their goal of accelerating the availability of new therapeutic options for patients with rare diseases. But does the focus on speed mean sacrifices have to be made elsewhere in the development plan for orphan drugs?

Key questions and development considerations include:

What are some of the timeline challenges associated with developing orphan drugs?

What dosage form do we need for initial clinical studies and what do we want as the final commercial product?

How do we manage the product supply chain to ensure drug product reaches clinical sites and patients at the right time?

What is the target patient population and will different product formats be required for adult and pediatric patients?

In a market segment, where concerns over development time and cost are even more accentuated, the need to manage R&D budgets while not compromising speed to market is crucial. This webinar will outline some of the development challenges for orphan drugs and share case studies from BioCryst Pharmaceuticals on how they have successfully advanced molecules through the drug development process.

How to accelerate to initial patient data (proof-of-concept) with a suitable dosage form

How to develop a formulation strategy for age-appropriate, patient-centric formulations, including pediatric dosage forms

How to tailor the manufacturing and supply chain for small volume products to ensure clinical trial materials reach patients at the right time

Scaling-up product manufacturing to shorten the time to market and enable a successful commercial

Peter Scholes, Chief Scientific Officer, Quotient Sciences

Paul Sabo, Executive Director, Drug Product Development, BioCryst Pharmaceuticals

: Wednesday, October 28, 2020 at 11am EDT| 8am PDT| 3pm GMT| 4pm CET

***Live: Wednesday, October 28, 2020 at 11am EDT| 8am PDT| 3pm GMT| 4pm CET*** With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry. But does the focus on speed mean sacrifices have to be made elsewhere in the development plan for orphan drugs?  ***On demand available after final airing until Oct. 28, 2021***



Advancing the Pharmaceutical Development of Orphan Drugs for Rare Diseases

Articles

This whitepaper will cover five areas for consideration by oncology drug developers & the potential solutions in development, manufacturing & supply that are emerging.

Accelerating the Development of Oncology Medicines

This white paper addresses the principal CMC challenges for the developers of orphan drugs and highlights the potential solutions which are emerging.
