RALEIGH-DURHAM, NC--(Marketwired - Sep 22, 2016) - Tergus Pharma (www.terguspharma.com) CEO, Vijendra Nalamothu, PhD, will speak at the 5th annual Innovations in Dermatological Sciences conference. The two-day event, which has put together a stellar lineup of industry experts, will be held September 29-30, 2016 at the Marriott Renaissance Woodbridge hotel in Iselin, New Jersey. Dr. Nalamothu will discuss, "Semi-Solid Drug Product Characterization using Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs). Linking Innovation and Clinical De-Risking using Appropriate Critical Quality Attributes (CQAs)."
With the FDA emphasizing incorporation of Quality by Design (QbD) principles very early on in drug product development, it is critical to approach formulation in a strategic way, using Critical Material Attributes (CMAs) with defined Critical Quality Attributes (CQAs) of the drug product. In this session, discussion will be focused on strategic development of topically administered dosage forms with a focus on Clinical De-Risking using innovative approaches to improve functional efficacy and achieve desired skin delivery profiles at the target site (skin/nail layers).
Various de-risking strategies to develop topical semisolid formulations targeting desired permeation/drug delivery profiles will be discussed from both a vehicle composition point of view and using tools such as CQAs. The session will include an overview of ways to screen formulations for these attributes and will discuss the importance of incorporating these screening tools early on as a stage gate approach to formulation development. Case studies will be presented to discuss the impact of specific excipients on permeation/release profiles and CQAs.
"I am honored to be invited to speak at the Innovations in Dermatological Sciences conference," said Vijendra Nalamothu, PhD, CEO and co-founder of Tergus. "The organizers have put together an august panel of speakers and I am pleased to be part of the program."
The company will also be participating in CPhI Worldwide conference in Barcelona, Spain. The conference will be on October 4th - 6th at the Fira de Barcelona Gran Via.
Tergus is the industry leader in topical pharmaceutical development, skin biology & IVRT testing and Phase I - III cGMP clinical supply manufacturing. Pioneers in Quality by Design for semi-solids, the company was honored by Inc. Magazine as one of the 500 fastest growing privately held companies in 2016. Tergus is one of the top 20 health and life sciences companies on that list.
Tergus has enjoyed strong growth for the past few years and has attracted top talent in topical formulation, development, testing, analysis and manufacturing. It continues to grow its footprint, recently expanding to a more than 28,000 square-foot facility that includes top-of-the-line R&D labs, GMP manufacturing suite and the largest capability in the industry for IVRT and skin permeation studies. Tergus pioneered QbD for topical pharmaceuticals and continues to innovate and develop strategies that result in greater success for its clients.
Tergus offers complete topical pharmaceutical consulting services, development, formulation, analytical R&D, In Vitro Release Testing (IVRT), skin biology and cGMP clinical supplies manufacturing. The company has capability to produce clinical supplies up to 150kg using their state of the art manufacturing equipment. The company's motto is "Think Topical, Think Tergus."
Tergus (www.terguspharma.com) is the market leader in full-service topical pharmaceutical research, development, testing, analysis and manufacturing. The company has more than 20 years in business located in a state-of-the-art laboratory facility in Durham, North Carolina. The company has a long and stellar reputation for delivering quality and results for clients from formulation through manufacturing. Tergus pioneered Quality by Design (QbD) protocols for semi-solid delivery forms and has the largest bank of In Vitro Release Testing (IVRT) Franz Diffusion cells. The company's motto is "Think Topical. Think Tergus."