How Complete is Your Regulatory Knowledge?

regulatory_imgA thorough knowledge of regulatory issues is vital. Having a solid grasp of the regulatory environment is critically important. Companies face an ever changing regulatory environment, increasing regulatory requirements, increasing development costs and times.

How deep of your regulatory knowledge? Test yourself now:

 https://docs.google.com/forms/d/e/1FAIpQLSfJYHWzc93lyk-SBuBKPeIhq6nC_xKEFXJKBwJYqDFPHi5THA/viewform?c=0&w=1

Comment on this post to let us know how you did!

Tergus Hires for Key Positions

We just announced the addition of several new positions and the hiring of James Varner as a Senior Manager of Analytical R&D and Lance Rogers as Project Management Leader. Varner will lead late-stage development and optimization, method validation, Quality Control release and stability testing and scale up protocols. Rogers will grow and set the direction for the project management department. The hiring of Mr. Varner and Mr. Rogers, as well as a number of other key hires, will further the company’s growth and expansion.

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Tergus CEO to Lead Boot Camp Session at Dermatology Entrepreneur Conference

Vijendra Photo small

Tergus CEO, Vijendra Nalamothu, will be co-leading the Entrepreneur Boot Camp at the 2nd annual Dermatology Entrepreneur Conference, March 3, 2016. Tergus is also a sponsor of the event and will have a booth in the exhibition hall in the Ronald Reagan Building International Trade Center, Washington, D. C.

The 2nd Annual Dermatology Entrepreneurship conference will focus on fostering the early development of innovative products and services by physicians and entrepreneurs for dermatologic health. Held the day prior to the start of the annual American Academy of Dermatology meeting, the conference will serve to inspire and educate physicians and entrepreneurs in the skills and steps necessary to bring forward their ideas and inventions. It will simultaneously function as a networking event for cultivating an entrepreneurial ecosystem that includes physicians, researchers, entrepreneurs, investors, strategic corporate partners, service providers and other stakeholders.

Dr. Nalamothu will present a session titled, Preclinical Activities on the Critical Path, which will focus on the considerations and strategies needed to successfully bring a topical dermatological product to market. Dr. Nalamothu, whose deep expertise in topical pharmaceuticals makes him uniquely qualified to lead the session, will educate entrepreneurs on how to bring a topical pharmaceutical to market. Some of the specific subjects that will be covered include: preclinical aspects leading to entry into humans, including CMC and formulation/delivery strategies for pharmacology, toxicology, etc.

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One Key Factor to Avoid Clinical Trial Failure with Topicals

Having the right formulation is critical for topical pharmaceuticals. One of the most important factors is avoiding symptom relief factors in the formulation.

Most skin conditions have physical symptoms that can be addressed to some extent using a cosmetic approach. For example, psoriasis has plaques—unsightly, itchy and inflamed patches of skin. Products that include moisturizing ingredients, like lotion, can relieve some symptoms. They don’t however, address the underlying issues.

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Tergus Hires Michele Nathan Borek

The following release just went over the newswire. We are very pleased the Michele Nathan Borek has joined Tergus!

Tergus Hires Leading Sales and Marketing Executive
Michele Nathan Borek has more than 20 years of experience in creating growth for life science companies

Research Triangle Park, North Carolina – December 10, 2015 – Tergus (www.terguspharma.com), the industry leader in topical pharmaceutical development, skin biology & IVRT testing and Phase I – III cGMP clinical supply manufacturing, has hired Michele Nathan Borek to head the company’s sales and marketing efforts. Tergus continues to attract top talent with the hire of Ms. Borek, who has more than 20 years of experience in implementing successful marketing and sales efforts for life science companies.

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How Tergus Leads the Industry with In Vitro Release Testing (IVRT)

Some of you may know that Tergus co-founder, Kailas Thakker, was involved in the development of in Vitro Release Testing (IVRT), recognized as an essential testing protocol for semi-solid dosage forms. Her work led to the development of the SUPAC-SS guidance document that the pharmaceutical industry follows. She is a member of the USP’s Advisory Panel and helped draft chapters 3 and 1724. She is also a member of USP’s Expert Committee on Dosage forms for the current revision cycle.

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Topical Drug Delivery Considerations for Biologics

Vijendra Nalamothu. PhD ,

According to the analyst firm Global Information, the demand for biologics and biosimilars is estimated to grow to more than $100 billion in 2015, continuing the double-digit growth rate seen in the last decade. As the industry continues to grow, alternative delivery methods are of increasing interest—particularly the topical delivery of large molecules. Formulation for any topical pharmaceutical is a top priority since the efficacy of the molecule can be affected by any misstep. Biologics also have the additional consideration of achieving the right penetration to the target.

Topical Drug Delivery Considerations for Biologics

Vijendra Nalamothu. PhD
Marc Hens PhD.
Tergus Pharma

According to the analyst firm Global Information, the demand for biologics and biosimilars is estimated to grow to more than $100 billion in 2015, continuing the double-digit growth rate seen in the last decade. As the industry continues to grow, alternative delivery methods are of increasing interest—particularly the topical delivery of large molecules. Formulation for any topical pharmaceutical is a top priority since the efficacy of the molecule can be affected by any misstep. Biologics also have the additional consideration of achieving the right penetration to the target.

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IVRT Method Development – Simply Put (Part 1)

Ryan Klein, Director R&D at Tergus

We have previously touched on the dramatic increase in the use and application of in vitro release testing (IVRT) during the development of topical products (See the September 23, 2014 blog post). As a follow up in an upcoming blog series, we’ll consider the technical aspects of IVRT, briefly introduce the most common apparatus used to perform the experiment, and review a basic strategy for developing robust and reproducible methods while reviewing the major assumptions and most basic considerations underlying the technique.

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