Contract Manufacturing / Packaging / Over-the-Counter / Small Molecule / QRM Process

Cultivating Better Contract Services

WellSpring Pharmaceutical Services wants to sew the seeds of its customer success

By Steven E. Kuehn, Editor in Chief

For the past decade and a half, WellSpring Pharmaceutical Corp. has been busy working to establish itself as a leading contract manufacturer in North America. With its primary facility located in Oakville, Ontario, Canada, WellSpring provides clinical and commercial manufacturing of solids, semi-solids, and non-sterile liquids as well as packaging in a variety of presentations. According to WellSpring, since 2001, the company has developed relationships with some 50 clients of whom 90 percent represent repeat business.

WellSpring is also a well-known, over-the-counter (OTC) drug manufacturer with a host of popular direct-to-consumer products for both Canadian and U.S. markets including Emetrol, Gelusil, Micatin, Glaxal Base, WELLSKIN Glaxal Base, WELLSKIN Barriere, and K-lyte. WellSpring’s prescription drug products include Dyrenium, a diuretic and Dibenzyline, an anti-hypertension therapy which are marketed in the U.S. These medicines provide treatment for diseases affecting niche groups of people and would not exist without WellSpring. According to one industry analyst, the company has made the development, marketing and sales of new and novel prescription and OTC drug products part of its overall strategic focus.

This ability, says WellSpring, provides the opportunity to manufacture medicines for other companies while ensuring the same ethical assembly methods are employed in the generation of any product. WellSpring’s qualified employees are committed to producing the best possible medicines for consumers. Able to seamlessly handle all pharmaceutical industry issues from documentation in support of compliance to on-time delivery in global markets, WellSpring’s Ontario plant produces tablets, liquids and semi-solids in a facility that benefits from consistent investment in capital improvements.

Founded by Dr. Robert Vukovich in 1999, WellSpring purchased its Oakville FDA- and HPB-regulated manufacturing facility in 2001. The 100,000-sq.-ft. facility, the company notes, has passed several inspections since its purchase, a successful “routine” associated with repeatedly winning new contracts for its capacity and the company’s related services.

Dr. Vukovich graduated with a Ph.D. in pathology and clinical pharmacology, after which he developed products for pharmaceutical companies including Warner Lambert, Bristol-Myers Squibb and the Revlon Health Care Group. In 1983 Vukovich founded and financed Roberts Pharmaceutical Corporation. In September of 1998, Shire Pharmaceuticals acquired the highly successful Roberts Pharmaceutical Corp. from Vukovich. The next year, he founded WellSpring and reviving his opportunity to serve patients more directly.

WellSpring added three over-the-counter products to its line in 2008, providing the opportunity to treat those suffering minor everyday afflictions, as well as those select groups in need of WellSpring’s prescription medications. The acquisition of Gelusil, Micatin and Emetrol broadened both WellSpring’s reach and its staff. WellSpring expanded to a larger Sarasota location in 2009, while maintaining its Canadian development and manufacturing presence.

WellSpring’s Oakville staffing is biased toward science, which it insists underpins operational excellence associated with its CMO operations and customer satisfaction, applying rigorous standards of quality control, product testing and validation.

Ancor Capital Partners announced its acquisition of WellSpring in November 2011. At the time, Ancor teamed with Sentinel Capital and Yukon Capital to complete the transaction and offered the industry this rationale: “WellSpring represents the 15th acquisition of a healthcare company for Ancor and combines our experience in contract manufacturing, pharmaceutical sales and OTC products. WellSpring is an innovator … well positioned to accelerate its growth …”

FRESH LEADERSHIP
David Mayers was named president of WellSpring Pharma Services in March. With 25 years of pharmaceutical manufacturing experience, most recently serving as vice president of manufacturing operations at Purdue Pharma, Mayers assumed immediate responsibility for all activities associated with the company’s CMO business unit overseeing Plant Operations, Business Development and Quality & Regulatory Affairs.

Wendy Shusko, president of WellSpring Pharmaceutical Corp. said, “The increasing complexity of the pharmaceutical environment, coupled with our desire to ensure continued growth and the appropriate positioning of WellSpring Pharma Services has necessitated recent decisions with this senior level role. David will provide the strategic and operational leadership to ensure the transformation and growth strategy of the Canadian operations, including creating a continuous improvement culture and optimizing organizational capability, allowing the organization to maximize growth opportunities and overall profitability.”

Over the last 11 years at Purdue, Mayers guided the expansion of the company’s facility, implementing a Lean environment and a corporate QMS supporting the Canadian facility’s global regulatory readiness while carving out a significant export and third party manufacturing presence. Known for his ability to provide strategic focus and leadership through times of growth and change, Mayers is set to bring his hard-won “operational wisdom” to bear for WellSpring and leverage experience that not only will serve WellSpring “well,” but its customers even more so. Soon thereafter Mayers was busy meeting customers and others at the Drug, Chemical & Associated Technologies Association (DCAT) Week 2015, the famous industry event celebrating its 125th year.

Mayers says he hears the industry loud and clear when it comes to injectable medications, the rise of biologics and niche compounds. “From a CMO perspective,” says Mayers, “we’re seeing a lot of smaller orphan drugs, and we are doing a lot of work in orphan drugs — IMS validated that … with data from earlier in the [DCAT Week] conference. We find it is becoming much more the norm. The concept of these smaller organizations taking up a few products — we’re seeing a lot of change too,” explains Mayers. So from the perspective of CMOs, he notes, the industry is seeing a surge in opportunity, because basically a number of companies are now either merging or switching and selling three or four of their products to somebody else. Mayers explains that companies are now coming to WellSpring seeking to do business with them because “It’s about [products] that they’re going to acquire.”

“The other thing that has really shaped [the industry of late], especially in North America has been this concept of reimbursement,” says Mayers. “Again, that’s more from a pharmaceutical company perspective. But something that I’ve seen just in the discussions I’ve had at DCAT, there’s been a change associated with the way costs are set up — GDUFA fees as an example — that’s a real issue and something I’ve experienced firsthand,” says Mayers. “Basically, we had a product that was produced in Europe. The compression and packaging was done in Canada. It was not a large-volume product.”

Mayers explains that his company was faced with paying fees in both Europe and Canada. “So you look at the profitability of that product, it changes dramatically,” says Mayers, noting that he’s received plenty of feedback from clients and potential customers: “How do you manage that? How do you handle that? Do we pass it on to our customers? When you have smaller volumes, it’s significant.” Mayers says it prompts a lot of organizations to walk away and that it creates more of an opportunity for other organizations to step up to the plate.

“It really has an impact, says Mayers: “GDUFA’s just a good example of it — are there fee-structure differences that didn’t exist perhaps five years ago that now are causing folks to have issues in their early phases? Because having to pay these fees right through Phase I, Phase II and well into commercialization is tough and without really having any money from commercialization.”

Fees and related costs associated with Generics is indeed an area for concerns because it can put companies into an awkward position financially. But from his perspective, Mayers sees that the Pharma industry is working through its own special issues, some self-generated. “I find — in the pharmaceutical industry — we talk about the concept of innovation. We are an interesting animal in that we are more innovative than almost any [other industry] and less innovative than anyone else. I think what we’re doing now is we [the industry] are recognizing that the innovation piece that existed from a molecule perspective — if anything, might be diminishing.” Mayers explains that while there might not be a new molecule — there are extensions of products like biosimilars or new dosage and delivery forms designed to extend their commercial life by boosting consumer demand by price or efficacy.

Considering operations and technologies, Mayers notes a shift in how companies are acquiring and applying new process and production technologies and how the factors that go into selecting and purchasing has shifted, perhaps towards the better. “Every organization has a different turnover of equipment. What I’ve found is that some of the newer equipment, especially design for things like containment or high potency can contribute more to the business than one might expect. I’ll give a good example: We’re looking at tri-layer compression equipment. The justification for that has more to do with efficiency than just replacing the old compression technology with new technology. It’s like going and buying a new car,” explains Mayers, likening it to buying a new car for its gas mileage but getting great value out of being able to connect your devices wirelessly and being able to drive those longer distances more comfortably because the seats and other ergonomics are designed so well. Mayers notes this trend will continue to be supported because enabling technologies are coming online that are not only more accessible because of price but also can be integrated more easily. “I think three or five years from now,” says Mayers, “we’re going to end up with processes that totally manage themselves — the concept of a ‘lights-out plant’ — and not solely because of efficiency gains. It’s because somebody said ‘wait a minute; I can kill five birds with one stone.’”