Revving revenues

Conducting clinical trials and dispensing skincare products represent opportunities in an ever-changing landscape, according to Kenneth Beer, M.D., who spoke at The Cosmetic Bootcamp (CBC) in June.

For his practice, Dr. Beer told attendees that clinical trials provide an opportunity to collaborate in the development of new drugs and devices. He is a West Palm Beach, Florida-based dermatologist in private practice and a cofounder of CBC, as well as associate clinical professor of dermatology, University of Miami Miller School of Medicine; consulting associate, Department of Medicine, Duke University; and clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine.

Clinical trials also can provide a great opportunity for patients to get treatments before they are in the mainstream, he says. And if a practice provides satisfactory treatment for patients recruited for an acne or atopic dermatitis study, Dr. Beer says, these patients likely will choose to stay with the practice after the study concludes.

NEXT: Setting up a clinical trials program

Courting clinical trials

In setting up a clinical-trials program, it helps to have an interest in and affinity for this type of work, he says. In his case, "I love to publish, travel and work with drug companies on next-generation products."

Ideally, he says, a practice's clinical-study business should have a separate location, corporate structure and staff. Alternatively, "Once you have staff, you can hire other physician investigators to diversify" before embarking on a free-standing clinical-trials practice.

Whichever route a practice chooses, Dr. Beer says, "It's very important that you have one full-time study coordinator." Fortunately, he says, one of his nurses was able to become his study coordinator. "But I don't recommend that approach. It's really hard. Find somebody who's interested in clinical trials. They may not be highly experienced," but this person must be familiar with good clinical practice and open to learning the clinical-trial ropes. In these areas, he suggested using resources such as online tutorials available from the National Institutes of Health, as well as journals, organizations and meetings devoted to clinical trials.

Along with good clinical practice, Dr. Beer says that physicians and their staff also must be familiar with informed consent, recruitment, budgeting, negotiating, and space and staff requirements.

Ultimately, "You'll need to know a lot more. And you'll need more than one clinical-trial coordinator. If you're doing 12 studies, you'll probably need three coordinators."

Furthermore, "Sponsors will look to see if you're really serious about it" and have a dedicated location with its own staff. Conversely, "If your front desk girl does your clinical coordinating while running charts around and answering the phone, it doesn't look good," he adds.

Additionally, Dr. Beer says it's important to show sponsors that your staff is being continuously educated. "But at least up front, the educational requirements are manageable."

Often, he says, drug companies will initiate trials by approaching experienced investigators. If this happens, "You can pick and choose which ones you'll participate in. The downside is, you must toe the line. You can't create anything new" within the study protocol.

Travel to investigator meetings also is required, he says, as is hosting monitoring visits from sponsors and/or the Food and Drug Administration (FDA). "Sometimes the sponsors want face time. And every time a monitor comes in, even if it's for five minutes, you have to meet with them" and answer any questions they may have. "They open up your books; they want to see what you're doing."

Ultimately, "You have to figure out if it's worth the time and money."

NEXT: The process for investigator-initiated trials

Process for investigator-initiated trials

Investigator-initiated trials, on the other hand, require one to generate an idea, such as a new use for a neuromodulator, and propose it to a company or other potential sponsor, Dr. Beer says. This process is difficult, he adds, "because you must come up with 10 ideas for everyone that will be accepted."

Landing clinical trials of any type requires networking, he added. To get started, "If you have a friend in another state who is looking for additional sites for a trial that sounds interesting, let that friend know you're interested." If one publishes in a particular area such as acne, lasers, neuromodulators or fillers, Dr. Beer suggests opening the dialogue with a potential sponsor by communicating your interest to the appropriate sales representative.

"It's a very long, arduous procedure. Nobody hands you anything. It's something you really must invest in. There's one company we have invited to our site three times a year – they've come probably once a year. I've still never done a study with them."

Of greater concern, he says, is that sloppiness and dishonesty in clinical trials can bring trouble from the FDA. In one such case, "A physician's assistant was doing trials and patient care at the same time and was found to be making up data. The FDA shut the site down."

Additionally, "Recruiting can be difficult." If your practice lacks a strong patient base and/or staff and fails to recruit the patients required for a study, Dr. Beer says, the sponsoring company will be disappointed because it will have spent money initiating your study site.

Above all, "Don't just do clinical trials for money. However, if you're interested in practice diversity, and it's the type of thing that intellectually fascinates you, it can be a good direction to take."

Dispensing in-office products

Among product categories, he says that the acquisitions of NeoCutis and SkinMedica indicate that cosmeceuticals are booming and should remain a relatively stable source of growth. "To this day," he adds, "tretinoin and retinol are generally the most popular products that we deal with." Other basic cosmeceutical categories include acids, vitamins, antioxidants, growth factors and DNA repair products.

In dispensing such products, "Our goal as dermatologists is to add value and deliver products that are superior to what patients can get at department stores from somebody with a high school education."

When patients purchase products elsewhere, it's not just the $400 that they spend at Saks, he . Such patients also tend to seek other products – such as neuromodulator injections and laser treatments – from discount providers who frequently lack a dermatologist's education and experience, he said.

Dermatologists bear an obligation to educate patients about claims made on infomercials that certain products are better than FDA-approved prescription treatments, or that an over-the-counter or Internet product will take several years off the purchaser's appearance. "If a skincare product is saying it can take 10 years off, and the maker of Botox Cosmetic (onabotulinum toxin A, Allergan) is saying it can take five years off, which way are patients going to go? We should educate our patients about the right products for their skin type, medical conditions, geography, goals and budget. Then we can use private-label or brand-name products to individualize their treatment."

In the former area, Dr. Beer commonly gets calls from companies interested in developing stem-cell or cytokine-based beauty products. "I'm always interested, because I believe they hold a lot of potential." But thus far, he finds the data unconvincing. And whenever he has explored these opportunities, he says, they involve non-dermatologists mixing unapproved ingredients, usually bought online, in unapproved facilities.

Dr. Beer says he can live with the fact that the marketing of cytokines and stem cells has outstripped the science, and that the FDA is slow in approving such products. "But when you see these people literally mixing stuff in their offices, and you look at their pedigrees, they don't know anything about skincare or cytokines – but they are considered the gurus, and our patients are going to them."

Instead, he says that dermatologists interested in developing private-label products should stick to approved ingredients and reputable, properly insured laboratories. Taking these measures does not guarantee success, however. His practice offers a customized sun protection product, but it's difficult to compete against established manufacturers with great formulas, name recognition and substantial advertising budgets.

On the other hand, Dr. Beer says, if one chooses to dispense an off-the-shelf product, "A sales representative will come in, bring brochures, tell your staff what to do and supervise your sales, and you don't have to deal with it." Other forms of support offered by manufacturers include direct-to-consumer advertising, point-of-sale advertising and patient-loyalty programs, he notes. And if a product expires before it sells, "Manufacturers won't like it, but they'll take it back."

On the downside, the only factor that can distinguish your off-the-shelf products from those of competitors is pricing, he says. Additionally, physicians can't control manufacturers' pricing or ingredients, or customize the marketing materials that appear in their practices. "Many times," he adds, "a representative will give a trade-size sample to your front-desk employee, who then sells it on eBay. You find that you're bidding against yourself."

Along with clinical trials and product sales, he says, other ancillary revenue streams can include consulting – with established or startup companies, or in malpractice cases, to name a few possibilities.

"There are many opportunities for adding revenue to your practice. It depends on your personality, risk tolerance and goals. We live in very uncertain times. I recommend that you consider alternative income sources, to diversify and stay engaged," he says.

For more information:

www.cosmeticbootcamp.com

Disclosures:

Dr. Beer is the owner of ScientificRx Skincare. He has been a consultant and/or investigator for Allergan, Merz and Valeant, and virtually all makers of cosmeceuticals and in-office products. He also is a cofounder of The Cosmetic Bootcamp, which will begin offering a clinical trials boot camp for physicians of all specialties at a time and location to be determined in 2015.