Firm Profile

WHAT WE DO

We facilitate your ability to assess the potential clinical efficacy of your invention; provide a sound but aggressive regulatory strategy consistent with your business strategy; facilitate your development process; compile/file regulatory documents and assure a smooth regulatory approval process; translate the potential of your invention to investors.

WHO WE ARE

We are a Company that draws upon our Consortium of experts in preclinical, clinical, manufacturing and regulatory matters to develop and implement strategies that bring your invention expeditiously and economically to the marketplace in a manner consistent with international regulatory standards.

Members of our Consortium come from academia and industry; all have in-depth experience in the regulatory process. Collectively, we have mastery of the regulatory process both in the US and abroad.

WHY ViCro?

Our proven preeminent expertise in the drug/biologics/medical device/dietary supplement development disciplines along with our understanding and appreciation of regulatory philosophy and concerns provides a value-added product not otherwise available or affordable to a small/mid-size health care enterprise or academic medical center.

HOW WE WORK

In concert with you, we custom design a contract research organization within your company. We augment and fully integrate the available expertise for product development from your staff with expertise necessary for regulatory approval from our Consortium. Together we divide the project into sequential steps. You authorize ViCro (the virtual CRO) to perform some or all of these steps. Upon completion of the project, the virtual company dissolves leaving you in complete control of your product.

ADVANTAGES

DIALOGUE:

Communication between Research and Development scientists is critical to success during product development. ViCro structure integrates your inventors with Consortium members to provide an environment that facilitates open unfettered dialogue among the team.

EXPERTISE:

ViCro Consortium of eminent professionals in the development disciplines provides you a level of expertise that complements the creativity of your inventors. Our proven track record in the regulatory process provides a value-added component to the work product.

EFFICIENCY:

ViCro, as a virtual company, combines low overhead with high caliber experts, providing you economical, unparalleled work.

CONTROL:

All our activities occur within a substructure of your Company.

ILLUSTRATIVE EXAMPLE

Company X, a small biotech company, owned a broad spectrum protein, licensing one indication to big pharma, and retaining the second indication; the focus of this discussion. The Company conducted discovery activities of the second indication in-house through research grants and company funds. It had already conducted some in vitro and in vivo proof-of-principle testing prior to bringing Dr. Ann Rose, the Founder of ViCRO, onboard to lead development efforts. Limited in house development expertise was available. Company X's goal was two pronged: take the molecule through clinical proof-of-concept testing and partner it.

After a thorough review of the available data, Dr. Rose determined that the team for this project would include the molecular biologists involved in the indication, the bench scientists involved in the in vitro assay development work, and the animal modeling team. Complementing the in house group, she brought on board a toxicologist, a pharmacologist, a statistician, clinical researchers and a compound manufacturer. She and the team determined that they needed additional pharmacokinetics, statistics, and toxicology to prepare an IND. Further, in conjunction with off-line meetings with regulatory bodies, it was determined that two non-drug clinical trials would enhance the IND. Dr. Rose initiated and successfully completed these trials.

Only eleven months elapsed from the date of the Founder's involvement to completion of the IND application. At that point, the Company's partner for the first indication was so impressed with the data assembled for this second indication that they partnered forthwith to become the holder of the successful IND. Profiling this molecule accurately and completely, in record time, enhanced its worth and culminated in an attractive partnership.

FOUNDER & PRINCIPAL

Ann H. Rose is the founder and a principal in ViCro founded in 1998. She earned her doctorate in epidemiology and public health from the University of Texas in 1980. Shortly thereafter, she joined the Congress of the U.S. as a health technology analyst. After this assignment, she assumed a position in the Secretary & Assistant Secretary of Health's office (DHHS) in which she had oversight and liaison responsibility for the FDA. She was a principal in several key pieces of legislation affecting the PHS. Specifically, she was a point person in the agency's contribution to the Orphan Products Act of 1983 and the Technology Transfer Act of 1986. She wrote the initial implementation guidelines for each piece of legislation and worked closely with the NIH, FDA, and CDC in their implementation. She was instrumental in licensing the first AIDS invention from a laboratory at the NIH.

Following several corporate positions in big pharma and the biotech industry, she entered private practice as a health, technology advisor to industry, academia, and foundations. She believes that her most important professional contribution yet will be assisting small/mid-size health product development companies and /or academic medical centers bring their novel ideas to the marketplace expeditiously and economically.

RECENT ACCOMPLISHMENTS

We consistently outperform agency timelines (U.S. or foreign) for responses on submissions be they IND’s, NDA’s IDE’s, BLA’s. orphan product designations, etc. These accomplishments are the result of excellent submission applications, know-how in working with FDA, HC or EMEA and focus on the project.

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