dermatology pharmaceutical examination

About Spear Pharmaceuticals

For more than 25 years, Spear Pharmaceuticals has been committed to making FDA-approved bioequivalent and branded products accessible to the public.

 

The Spear doctrine for bioequivalent drugs is to utilize the same active and inactive ingredients, as well as the same texture, look and consistency, as the branded product.

 

Our commitment to quality has resulted in FDA approval of eleven first-to-market bioequivalent dermatological products, with several more in the pipeline.

History of Spear Pharmaceuticals

Spear Pharmaceuticals, founded by K.L. Spear, M.D., in 1993, is a company that develops specialty dermatological products to fulfill market needs. Dr. Spear started the firm after 20 years working with patients, and seeing firsthand the improvement he could effect in their skin, and how that change for the better could enhance their lives.

Dr. Spear’s mission was formed when he realized there was no generic bioequivalent for one of dermatology’s biggest products. He knew from his everyday medical practice the kind of positive impact he could provide to his patients, and believed from his clinical trial experience at the Mayo clinic that it would be possible to develop an affordable alternative to Retin-A®.

That was the genesis of the DERMIDENTICAL™ process, which designs and develops bioequivalent drugs that have the same active and inactive ingredients, the same texture, look and consistency as the branded product. The Spear doctrine is to produce quality bioequivalent products with characteristics that meet a dermatologist’s demanding specifications. We prefer the term bioequivalent over generic because it better explains our process.

Spear has extensive experience with dermatologic compounds from both the clinical and technical perspectives. Tretinoin is one such compound, for which Spear introduced the first FDA-approved generic bioequivalent versions of Retin-A®, Renova®, Retin-A Micro®, and Atralin®. Since 2001, pharmacies around the country have dispensed over a million prescriptions containing Spear’s tretinoin. The Spear generic to Renova® was converted to Refissa® and is now sold by ZO Skin Health, Inc.

Working with seasoned drug industry professionals covering the disciplines of research and development, quality, manufacturing, regulatory, sales and marketing, Dr. Spear has fulfilled his vision of making FDA-approved bioequivalent drugs accessible to the public. In 1998 after only 5 years, Spear obtained its first approvals, becoming the smallest pharmaceutical company ever to receive an FDA approval. To date, Spear has earned FDA approval for 11 first-to-market bioequivalent dermatologicals, and has several more in the pipeline.

Spear Pharmaceuticals is responsible for all technical aspects of the corporation, including manufacturing, regulatory, quality control, and research and development.

Spear Dermatology Products is the sales, marketing, and distribution arm of Spear Pharmaceuticals.

Experience

K.L. Spear, M.D.

President & Dermatologist

K.L. Spear, M.D., founded Spear Pharmaceuticals after more than 20 years of work in the field of dermatology. His experience led him to believe that by helping people improve the condition of their skin, he could also have a positive impact on their lives. And by understanding the pharmaceutical market, he knew that he could provide that kind of help to thousands of patients around the country.

 

Dr. Spear attended the University of Illinois as an undergraduate and attended Medical School there as well. He graduated from the prestigious Mayo Clinic as a Dermatologist in 1983 and he practiced Dermatology in Florida for 18 years until 2001.

 

In 1993 he founded Spear Pharmaceuticals with this mission: To develop Bioequivalent Dermatologic Drugs that are off patent, giving patients identical, affordable alternatives through the patented DERMIDENTICAL™ process.

Bob Sarrio

Sr. VP Scientific & Quality Affairs

Bob Sarrio joined Spear in 1998 as the lead scientist and quality expert. Prior to joining Spear Pharmaceuticals, Bob headed the pharmaceuticals division for a regulatory consulting firm overseeing and assisting the regulatory, CGMP compliance, and analytical/product development/technical/scientific functions for client firms involved in radiopharmaceuticals, medical devices, biotechnologically derived products, sterile manufacturing and purification of genetically altered cell lines, as well as small molecule drug products.

 

Bob’s formal studies include a full doctoral education (all but dissertation) in physical chemistry. Thesis work was done at Oak Ridge National Laboratory in the facility’s Transuranium Research Lab (TRL) studying the chemistry and physics of the man-made elements.

David Christ

Sr. VP Regulatory

David Christ joined the Spear team in February 2003 to support the company’s growing number of ANDA approvals and R&D pipeline.

 

For over 25 years David has worked in the pharmaceutical industry in various capacities, including manufacturing, quality, formulations, project leader, and primarily in Regulatory Affairs. As both a consultant and within private industry, he has worked alongside a number of FDA officials, developing an understanding of the FDA perspective.

 

Much of that work has involved management of drug applications for topical products and semisolid formulations, especially in generics. His formal education includes a B.S. in Chemistry (Fairfield University) and an MBA (Hofstra University).

Rachel Phillips, PharmD, MS

VP New Product Development

Rachel Phillips joined the Spear Pharmaceuticals team in January 2013 to support management of new product development. Prior to joining Spear, Rachel worked at Xcenda developing managed market strategy.

 

Rachel completed a fellowship in health outcomes and managed markets at Xcenda. During her fellowship, she obtained a Masters of Science in Applied Pharmacoeconomics from the University of Florida.

 

Rachel received her Doctor of Pharmacy degree from the University of Florida, and her Bachelor of Science from the University of Richmond.

Contact Us

If you have a question on new product development, contact Rachel Phillips at phillips@spearpharma.com.

 

If you would like to contact our sister manufacturing site, Rockledge Pharmaceutical Manufacturing, contact Lorri Renaud at renaud@rpmrx.com 

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