Services

Dr. Bawa’s broad experience in the Lifesciences industry over several decades provides him with an extensive network of contacts. These span drug, device and biotech companies ranging from start-ups, to mid-size companies and multinationals. Dr. Bawa’s personal relationships with C-Suite executives, research scientists and functional & project managers in diverse areas of business, regulatory compliance and R&D is an invaluable asset you can draw upon to facilitate your access to these resources.

With nearly 4 decades of experience and a proven track record of multiple drugs, devices and drug/device combinations on the market, Dr. Bawa’s experience in addressing knotty product design issues by devising novel solutions can help you to resolve product design challenges in an efficient manner.

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Some representative examples are below:

At Alcon, developed a unique environmentally responsive gel platform for antiglaucoma drugs and anti-infectives. Intensive efforts resulted in the rapid progression of strategic formulations through  ANDA & NDA targets and subsequent successful marketing under Alcon’s branded generic Falcon line.

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• Developed unique formulations improving the solubilization of poorly soluble drugs (such as prostaglandins, (such as latanoprost) using innovative ingredients to enable expeditious global regulatory approval (especially Japan & Europe) and subsequent worldwide marketing. 

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• Developed novel topical formulations (NSAID, antiglaucoma) directly targeting leading competitors and bypassing their patents (diclofenac sodium, Timolol maleate).

Representative Patents:

"Gelling Ophthalmic Compositions Containing Xanthan Gum” 

USP #6,261,547 (2001), R. Bawa, R. Hall, B. Kabra, J. Teague, G. Cagle, K. Markwardt and M. Shah

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"Storage-Stable Prostaglandin Compositions”

                        USP #6,011,062 (2000), W. Schneider, R. Bawa and A. Weiner

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At Bausch & Lomb Conceptualized a revolutionary family of sterile and versatile ocular drug delivery systems (both bioerodible as well as nonerodible) for antinfectives and lubricants.

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•  Led a diverse project team addressing formulation, characterization, analytical, clinical and regulatory aspects through successful development of the minidisc containing an anti-infective biomolecule.

 Representative Patents:

"Ophthalmic Article" (Minidisc Patent)

                        USP #5,137,728 (1992), R. Bawa

The key to successful product launch is to avoid the pitfalls of designing processes that are not scalable from the bench scale to reproducible ease of manufacture.

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New products often involve conceiving and developing innovative process solutions. You can collaborate with Dr. Bawa to customize processes to address product needs and successfully take product concepts from the laboratory through the pilot scale to robust manufacturing processes. 

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• At Bausch & Lomb, attacked a critical manufacturing problem.  Identified cause, developed and implemented solution leading to cycle reduction from seven months to 3 days.  Success led to development and marketing of second lens following same developmental model.

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• Invented and developed innovative lens production processes based on supercritical fluid technology that allowed development and successful marketing of  cutting edge new products for the global marketplace.

• At Atrix Labs, developed innovative processes for powder filling of drugs as well as lyophilization of injectable polypeptides in plastic syringes. This enabled the development of commercial scale production of leuprolide acetate currently marketed as ELIGARD®

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• Conceived and implemented development and regulatory strategies resulting in the rapid approval and marketing of unique injectable, in-situ gelling formulations for the treatment of prostate cancer. Resulted in a multi-million dollar contract with European partner Indivior, PLC for extended release buprenorphine (for treatment of opioid induced addiction) marketed as SUBLOCADE®

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​Representative  Patents:

"Treatment Of Contact lenses With Supercritical Fluid”

USP #6,071,439 (2000), R. Bawa, F. Tasber and  D. Hahn

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“Method for Lyophilizing an Active Agent”, USP#7,467,482 (2015), C.L. Yarborough, D.G. Madril and R. Bawa

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“System for Use in Lyophilization Comprising Delivery Containers and a Cover Plate”, USP#6,610,252, (2003) D.G. Madril, C.L. Yarborough and R. Bawa

As President of Colorado Histo-Prep and CEO/CSO of CARE Research, LLC and past President of the Rocky Mountain Chapter of the International Society of Quality Assurance, Dr. Bawa can help you to comply with FDA and USDA requirements and audits. Additionally, based on nearly four decades of successful product and process research experience Dr. Bawa can help you to identify optimal regulatory pathways at minimal expense.