Rho: 'The hurdles are high when you have a drug that the world doesn’t need'

By Melissa Fassbender contact

- Last updated on GMT

Related tags: Rho, Quality by design, Regulations, Patient recruitment

Rho experts speak to the challenges facing drug development, meeting unmet needs, quality by design, and advances in technology, among other topics, during a sit-down at the CRO’s headquarters.

Today, it’s more difficult to develop a new medication that meets an unmet need, as products are more effective and safer than in the past, explained Jack Modell, MD, vice president and senior medical officer, Rho.

“It gets difficult with drug development because there are still a lot of unmet needs, a lot of opportunities, but they are harder to find, and the hurdles are higher because we’ve got better medications,”​ said Modell. “Therefore, the trials tend to be longer, larger, more expensive, and the regulatory hurdles even higher as well.”

The industry also struggles with clinical trial recruitment and ‘not getting the right patients,’ he said, noting the presence of ‘professional patients,’ among other challenges.

As one way to address this, Modell suggested the use of computerized assessments, such as interactive voice response. “For some things, computers are better than people,”​ he said during a discussion with Outsourcing-Pharma and colleague, Matt Healy, Rho vice president of clinical operations, at the company’s headquarters in Durham, NC.

“We’re at a point in time now where things are progressing faster than they ever have before,”​ said Healy, who cited the advent of technology and changes in guidances as key to this acceleration.

“The hurdles are high when you have a drug that the world doesn’t need,”​ added Modell. “But when you have a drug that the world needs and is waiting for … FDA and everybody else will do what they can to help get that drug approved.”

For the full conversation, watch the video above.

Related news

Show more

Related products

show more

Using SDTM, ADaM, and SEND

Using SDTM, ADaM, and SEND

Formedix | 09-Nov-2022 | Technical / White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...

How to design an effective CRF

How to design an effective CRF

Formedix | 10-Oct-2022 | Technical / White Paper

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical...

The Complexities of Ophthalmic Drug Development

The Complexities of Ophthalmic Drug Development

Altasciences | 04-Oct-2022 | Technical / White Paper

Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...

Because When It's On the Line... Capability Matters.

Because When It's On the Line... Capability Matters.

Baxter BioPharma Solutions | 01-Oct-2022 | Product Brochure

Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise,...

Related suppliers

Follow us

Products

View more

Webinars