Gerald L. Klein, MD and Peter C. Johnson, MD

EXPERIENCE: There is a shortage of experienced skilled medical professionals in the biopharmaceutical profession. Despite their skills, these sought-after physicians cannot as individuals have all of the skills that are often required by the industry. In addition, they are expensive employees, who must keep up with not only medical science, but also new technology, regulations, compliance, ethics, safety and pharmacovigilance. In addition, they need to possess the commercial and communication skills that is frequently lacking in physicians. Hiring a chief medical officer and senior doctors, therefore, may not be an efficient use of funding. What is needed is a mechanism that allows a company to obtain a Medical Officer skill set that is uniquely suited to its needs. This will often require combinations of persons having the needed skills. Not only does this avoid all the employee expenses associated with these permanent roles, you obtain the benefit of an experienced medical officer, as needed along with the experience and know how of the “Virtual Medical Department”. The latter is a network of experienced skilled physicians and other health care providers, all of whom have complementary skill sets and the ability to consult for your company through the designated VMO.

MEDICAL MONITORING: Our VMO model provides a much greater knowledge base than any one person could possibly possess. The importance of a large knowledge base is illustrated by the increased use of combinations of diagnostics and therapeutics. These frequently require expertise not only in the biopharmaceutical product but also in the ability to oversee having a diagnostic approved along with its therapeutic counterpart. Rare diseases products, complicated diagnostics, and biomarkers, therapeutic products that require complicated Risk Evaluation and Mitigation Strategy (REMS) programs, and combination products are other examples of programs that may require difficult to find medical expertise.

FUNDRAISING: The VMO may be a key component of a startup that is attempting
to raise funding for their development program. Angel and Venture Capitol Investors want to ensure that their companies have the proper scientific and development experts on board before they commit capital to a new venture. Yet the startup frequently cannot afford to hire an experienced Chief Medical Officer. Even if it did have the funding, it is unlikely that any one CMO would have all the skills needed by a rapidly changing development company. The VMO can serve this role as a dedicated part of the startup’s team in a cost effective manner. The use of the virtual team may help assure the potential funder that the start up is diligent in the preservation of capital.

OBJECTIVE EVALUATION: The VMO has obvious advantages for start up
and small companies. However, they also provide great benefit to midsize and large companies. These larger companies may not have the exact medical expertise or experience needed to solve specific problems or to prevent them. When spending millions of dollars and substantial staff time on a clinical trials program or medical liaison strategy, it is imperative to have an outside objective medical evaluation of your program. This can be a trial, campaign, pharmacovigilance plan, protocol, articles, posters, etc. It does not matter what type of program it is as long as it is important to the company. This outside evaluation provides another way of evaluating your program free from the company’s own or hired contractors’ preconceptions, conflicts of interest and internal politics. This can save time, effort, financial costs, and may help prevent precipitous stock decline.

SAFETY AND PHARMACOVIGILANCE: A sensitive area where a VMO can provide critical advice which may be crucial to the company’s well being is in safety and pharmacovigilance. This is an area where Truthfulness, Transparency, and Trust are Tantamount to preventing patient harm, legal entanglements, and large fines, loss of revenue, and other unforeseen consequences. The VCMO should audit safety data and pharmacovigilance plans. Companies need an objective evaluation of this information. Next, the sensitive communication of this data must be presented in a timely, accurate and scientific manner. It will help enhance the biopharmaceutical company’s image and reputation. Hence, having an outside-unrelated third party is critical in reviewing this crucial data.

Unfortunately, both public and regulatory agencies believe that many pharmaceutical and device manufacturers are not forthcoming enough in presenting honest data about the safety and efficacy of their products. The VMO, since he/she is unrelated to the company and its CRO, can be more believable. This will help prevent preconceived concepts that there is a cover up some major safety problems. If there is indeed a safety problem, the VMO may be able to suggest ways to mitigate its impact. For example a detailed analysis may uncover a specific genetic trait that causes one population to be more vulnerable for increased adverse events to a drug and thereby making other populations more appropriate for this product. This is a complicated message that must be judiciously presented to patients, health care providers (HCP) and payers. Experienced medical affairs skills are needed to simplify such a technical message and capably present it to health care providers to answer questions as to why and when they should use this product that may have a complicated REMS program. Conveying that the product’s benefits for specific patient populations outweigh the administrative burden that the health care provider must address is an important medical communication skill. These communications with the medical affairs program are frequently critical to the product’s success.

MEDICAL AFFAIRS AND MARKETING: The VMO can be a driving forces in establishing a vibrant, successful medical affairs and marketing program. These programs have to be directed at both academic and community physicians. They must be also tailored to all other prescription writers, including nurse practitioners and physician assistants. Additional messages should be developed for pharmacists, nurses, nurses’ aides, and other medical staff. Your medical team has to be able to effectively communicate with all these groups. Focus groups and advisory panels have been the standard ways that companies gain marketing information about diagnostic and therapeutic needs, product understanding and other key marketing parameters. We have developed our INfocus Group where extended amount of physician-to-physician time with very select health care providers is spent. These individuals have been identified as realistic representatives of the medical practice market. This is coupled with our larger more diverse meetings with other health care providers to validate INfocus Group findings, as well as to add additional secondary data to the analysis.

LICENSING: Many small companies do not have the internal expertise to fully vet potential new products for in licensing and technology transfer. Large companies may lack the ability to have their key individuals provide an impartial evaluation or devote the necessary time and resources needed to render a proper judgment. These evaluations must provide the scientific, medical, developmental and commercial potential and potential complications of products under evaluation. A VMO can provide this important appraisal of the potential to transfer new technology, be it a device, drug, biological or combination product.

CONCLUSION: The use of the VMO will provide a valuable, experienced, customizable, cost-effective asset to any biopharmaceutical company.