ABOUT US

Background Statement

Today's competitive business climate requires that, at the earliest possible time, biotechnology, small pharmaceutical and medical device companies deliver to investors' evidence-based justification of their concepts. This requires proof-of-concept data, usually in man. Many biotech and small – midsize pharma/medical device companies capitalize on their strength - drug discovery - devoting most of their resources in this endeavor and leaving development of their lead inventions to others. This is fiscally sound if the lead candidates are initially channeled to a development team knowledgeable and skilled in the art of translational research with access to, or skills in, cutting edge development science, as well as clinical and global regulatory expertise yet maintaining their inventions within their Company. To do otherwise defocuses and devalues the company. For many small – midsize companies, it has proven disastrous to handle all development in-house because the skill set for development involves disciplines different from research, and it can be cost-prohibitive, and non-feasible to hire an entire complement of state-of-the-art development specialists. Further, the process of regulatory filing constitutes a specialty in its own right. To date, alternatives have been to partner early with big pharma, which then conducts the in-house studies, or to engage a large contract research organization (CRO). Neither has proven entirely satisfactory. In early partnering, there is a financial consequence because technology is de-valued due to its early development stage. Further, the technology suffers from lack of quality development because bench scientists required for good translational research are not part of the organization. Often this is further compromised by the not-invented-here syndrome. Similarly, the biotech/small – midsize pharma or medical device company looses control and quality when engaging a large CRO. Most large contract research companies have fixed, sizable overheads and therefore are quite costly and inefficient in servicing the early drug/device development phase. Further, near- and long-term drug/device approval strategies must be formed during early development. This requires considerable enlightened expertise in the various development disciplines and knowledge of the global regulatory climate. The emphasis here is on cerebral input rather than on the arms and legs in an organization such as a large CRO required during Phase III testing. Finally, during the proof-of-concept phase bench scientists involved with the invention and those preparing the Investigational New Drug (IND) filing and designing protocols for the PhaseI/IIA clinical trials must maintain a highly interactive environment. If the CRO remains intellectually and operationally distant from the client, precious time and vital insights may be lost.

An optimal partner for the development phase of a drug/device discovery company is one with cutting edge knowledge in the development sciences with sensitivity and skill in translational research, is cost efficient and where the locus of control and intellectual property remains in the discovery company.

About ViCroTM

ViCroTM has evolved into a full service medical product development company that provides pharmaceutical, biotechnology, and medical device companies, and/or academic research centers and non-profit organizations with a premier, affordable, efficient, and expeditious mechanism to reach market approval and reimbursement for innovative drugs, biologics, medical devices or foods.  The Company began providing drug discovery companies with clinical proof-of-concept expertise (the translational phase of drug development, which remains its flag ship operation.  Esteemed by its clients and at their behest, ViCroTM  added the services necessary for full market approval and reimbursement coding. 

ViCroTM in delivering quality and expeditious full lifecycle testing for your lead inventions becomes a team member with your group. In this alliance, ViCroTM assures that its client's internal discovery and development resources are maximized and that the company remains in control of its invention. ViCROTM assumes overall management for the regulatory strategy and strategic planning of the approval process including marketing.

The Process

ViCroTM begins by reviewing the lead candidacy status of your compound or device and identifying analyses and/or studies, if any, required for obtaining an IND/IDE, etc. It also provides a strategic plan for your global regulatory filing and a frank, competitive analysis of the potential product. If the early development plan is agreed upon, ViCroTM forms a development group within your company. A senior drug development professional from ViCroTM anchors the project. The development team draws first from the client company's staff, the scientists credited with the invention, and is augmented by specially selected ViCroTM professionals whose expertise completes the disciplines necessary for drug development. The ViCroTM portion of the team may include toxicologists, pharmacologists, formulation experts, clinical and pre-clinical researchers, statisticians, and marketers; all have a proven history in regulatory know-how. The ViCroTM team is selected from our consortium of drug development and regulatory specialists, all of whom are actively involved in cutting-edge science in their particular disciplines. Most are academicians or early pharma retirees with proven experience and knowledge of regulatory requirements. Many are current or former members of FDA's advisory councils or members of similar regulatory bodies. All are interested in advancing innovative health care inventions. The development team within the client company functions until it completes its mission. Your needs direct the ViCroTM mission. The team dissolves then leaving as its legacy a stronger, more experienced client company.

Advantages of ViCroTM for Full Service Development

CONTROL

In the development cycle the client company must remain in control of the regulatory process. Although all the know-how for development may not be within the company, the entity undergoing development is your invention, thus your risk capital. You must have the ability to daily monitor the development activities as you did the invention process and you must maintain your reputation for flexibility, speed, precision, and accountability. Working with ViCROTM assures this governance. The development entity resides technically and legally within your company.

DIALOGUE

The development cycle is the most critical stage for the approval of a pharmaceutical or device. This is a very unforgiving stage for any lead invention. Your invention needs the optimal platform to perform in man. If it fails during clinical trials, it doesn't matter why; it has lost the attention of investors and investigators that it may never recapture. Preventing this type of demise requires constant dialogue between the bench scientists and those individuals in the development disciplines (e.g. research clinicians, pharmacologists, toxicologists, statisticians, regulatory specialists, etc.). Working with ViCroTM assures this dialogue. No company spokesperson filters their interaction.

EXPERTISE

ViCroTM assumes you have assembled top-notch scientists who are responsible for discovery. ViCroTM matches their level of expertise. The small to midsize pharma, biotech or device company usually has neither the resources nor influence to recruit professionals of this caliber. ViCroTM, with its consortium of drug development and regulatory specialists, provides a pool of eminent professionals in the development disciplines upon which to draw on a project-by-project basis. All members are currently active and renowned in their own disciplines; all have a proven history in regulatory know-how. Thus ViCroTM provides a value-added component; it addresses the regulators' requirements in a fashion directly understandable to them. The intellectual and customer-oriented capacities of the ViCro team represent the competitive edge and the uniqueness of ViCroTM.

EFFICIENCY

Many small to midsize pharma/biotech and medical device companies have limited budgets directed toward discovery and cannot afford ViCroTM's broad expertise on a full time basis. In short, our client's typically need the optimal work product, in the most cost-efficient manner, in the shortest time frame. ViCROTM provides efficiency as it passes its economies to the client. It has low overhead costs, drawing its staff on a project-by- project basis from a consortium of individuals with impeccable credentials and regulatory experience. ViCroTM's consortium structure provides clients maximum flexibility. Further, because of the dedicated customer focus by a ViCroTM associate, we can maximize efficient implementation of activities in alignment with client objectives.

UNIFIED EFFORT

A team working together in real space, sharing a sense of oneness with a project enhances the quality of the work. Such is the case in ViCroTM projects. Since the project incorporates, under one roof, members from the client company with members from the ViCroTM consortium all interact regularly and share a sense of ownership of the invention being developed. This ensures an outcome of enhanced value.