Fishing for Ideas at Informex USA 2012

Mar 1, 2012 | Contact Author | By: Rachel L. Grabenhofer
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Title: Fishing for Ideas at Informex USA 2012
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At first, this cosmetics R&D trade journal editor felt like a fish out of water at the Informex USA specialty chemicals exhibition, held Feb. 14–17, 2012, in New Orleans. Most booths lured attendees with new active pharmaceutical ingredients (APIs), specialty polymers, greener synthesis processes, catalysts, coatings, amino acids, outsourcing services and more; but not especially for cosmetic applications. However, this is what one might expect when exploring lesser-known industries and by casting a wider net, this editor encountered a few novel nibbles and scored a few big catches for personal care.

For starters, it was interesting to note the themes, concerns and strategies in these peripheral markets. They ranged from eco-friendly materials and processes, strategic partnerships between divisions/ companies, outsourcing, regulatory concerns and financial constraints, to supply chain issues, speed to market, consumer demand, delivery of materials, safety and more. Some of these concepts seemed all-too familiar, although a few were notedly different and potentially telling of what could come.

Themes

Green chemistry: The push for green chemistry, the related life cycle management of materials, and the development of biocatalysts via fermentation processes were notable and familiar topics at the event. The Feb. 15, Informex show daily reported an increase in the biopharmaceuticals field, i.e., pharmaceuticals from biological sources and produced by biotechnology. In relation, “white biotechnology” was referenced in conference presentations. This branch of biotechnology relates to the search for methods to replace petroleum-based synthetics.1 Unlike personal care however, the word natural was not prominent, save for one exhibitor whose sister division develops traditional Chinese medicine.

Specialty alliances, partnerships: Collaborations, whether between departments or companies, were also a common strategy within specialty chemical manufacturers—also not unfamiliar to the cosmetics industry. As panel members during the Tuesday morning outsourcing session explained, specialists that complement one another must make alliances because competition is fierce, although one should be careful not to risk the direction of a company’s portfolio or its intellectual property application. As owner of the intellectual property, the company should do a thorough job of training, including bringing in analytical folks to teach people how to use its IP. During the Q&A session, however, one attendee countered, “This business functions on secrets.” Again, not unheard of in the personal care industry.

The same speaker panel furthered that the ultimate goal is to build relationships through these collaborations so that companies are not here today, gone tomorrow. They explained that “three- to five-year investments are typical for this industry’s products but there’s a lot of turnover.” Strong connections can be made by taking the time to develop the project. This may also be the case, even more so, in the personal care industry, where product cycles are much shorter than in the specialty chemical and pharmaceutical industry, and speed to market is a much faster process.

Customization: Like some personal care products and ingredients, specialty chemicals are becoming more complex, especially as precisely targeted therapies are developed, which makes them more difficult to synthesize and navigate the related “mine field” of intellectual property. In response to this, some companies have emerged that specialize in the development of these chiral chemicals. In other cases, companies have expanded to accommodate customized requests. As Todd Aplin, R&D advisor at Albemarle Fine Chemistry said, “We need to really understand what the customers want and be customer driven vs. market driven.”

Considering the complexities of customization, companies are focused on streamlining the process for example, by integrating earlier-stage drug development activities such as computer modeling. In his presentation on designing practical catalysts, Jerry Spivey, PhD, of Louisiana State University, discussed how computer computational methods can be used to develop a gold catalyst by modeling its effects at an atomic level—a daunting task. “Au 38 was chosen because it can be synthesized reasonably but managed computationally,” he said, furthering that his research was based on gold supported on titanium since this material was highly referenced, therefore affording him a reference point.

Considering the entire commercialization process, Joseph Barendt, PhD, COO of Chiral Technologies, discussed two aspects; one focused on pre-clinical trials and the other on clinical trials through launch. With pre-clinical trials, one can expect a high attrition rate without concern for pricing. In pre-clinical trials, technologies are not yet vetted and speed is the driver rather than cost. According to Barendt, “The current trend is to produce racemic molecules and purify faster.” He added, “There is increased outsourcing at this stage for such techniques as high-performance liquid chromatography, supercritical fluid chromatography and vibrational circular dichroism,” and that during these early stages, the process is about creating chemicals that are “good enough.”

In the second aspect of commercialization, i.e., clinical trials through launch, according to Barendt, scaleability and cost are major drivers as well as the efficiency and robustness of the process. This aspect is more about defining and refining with further improvements and optimizations. For this aspect, Barendt recommended to “let the experts handle it,” and to use stage-appropriate technologies to improve efficacy. All in all, according to Barendt, key to the commercialization process are “juggling time and cost constraints; never assuming—especially with complex structures—they will work the same as before; using all the tools available; and being sure the process is scaleable.”

Concerns

Not surprisingly, like personal care, the specialty chemicals industry deals with issues of public perception, regulations and product safety. Specifically, as Adrian Hanrahan, managing director of Robinson Brothers Ltd., wrote in the February 17 Informex show daily, “the European Chemicals Agency continues changing guidelines to push chemical manufacturers to using totally enclosed systems, yet continuous processes are not always viable and batch processing is preferable.” He added, “The people setting the rules do not understand the industry.” Certainly the personal care industry has heard this cry before.

In relation, one attendee during a Q&A session noted that the constraints of REACh must be made applicable and workable in the “real” world. In relation, several presentations noted concerns for a more streamlined approach to regulatory oversight. Imagine if the personal care industry were regulated so stringently. Other concerns in specialty chemicals ranged from supply chain issues of global vs. regional sourcing; weaknesses such as marketplace exploitation, intentional adulteration and substandard manufacturing—buzzwords presented by the nonprofit industry watchdog group Rx-360; and supply shortages, which open the window for counterfeiters to exploit. This is one reason that supplier auditing is important and strong communication is crucial.

Strategies

All in all, as Andy Harris, CEO of Syrgis wrote in the February 15 Informex show daily, “Innovation needs to be at the heart of what we do.” He added that peer-reviewed science and rational assessments must be a key part of the process, especially when there is a push to create solutions and accelerate them through clinical development. Practical approaches to innovation may include improved understanding of disease etiology, or developing value-added products and more aggressively launching cost-effective treatments. Like the personal care industry, however, financial constraints on innovation can be a roadblock—which is both a concern and a strategy. While there are many ideas and programs within academia, there is a lack of investment, which has given rise to consolidations and add-on acquisitions, resulting in fewer players having larger portfolios and worldwide reach.

In effort to lessen financial constraints, drug discovery, screening methods and modeling, as previously mentioned, are employed to streamline the commercialization process. For example, pharmacodynamic and companion biomarkers are used to provide an early indication of efficacy as well as potential challenges during product development. In relation, according to Thomas Speace, president and CEO of Neuland Technologies, at the February 17 life cycle breakfast briefing, life cycle management can help to maximize revenue potential—and once a new drug is developed and approved, “the competition is on,” he said, “then company must look for ways to cut the budget to pass that on to consumers.”

Another strategy to reduce financial constraints is the development of virtual pharmaceutical companies or companies that rely on outsourcing for almost all their activities that require physical assets or infrastructure. According to one such company,2 these entities are knowledge-based and typically consist of a CEO, CFO, legal counsel and a host of business development and project management specialists. Since these companies do not incur high infrastructure costs, they promise a lower total cost of pharmaceutical development. Typically, a fully virtual pharmaceutical company in-licenses an active pharmaceutical ingredient that is approaching or entering clinical trials and will contract out each stage of future clinical development, including the preparation of the new drug application (NDA). However, as the panel discussion on outsourcing reminded attendees, the products created from outsourcing must be of the same quality, as the outsourced products are an offshoot and represent the parent company.

Setting financial constraints aside, an interesting "case study" on innovation was presented by Victoria Scarborough, PhD, external technology program manager for Sherwin-Williams (SW). She described a "Creative R&D Lab Environment," aka “Cradle,” that the company developed to drive innovation. According to Scarborough, “the Cradle consists mostly of start-up companies from universities that do not have to pay SW to innovate there; the company simply is given the first rights of refusal for the technologies developed.”

Within SW, "communities of practice" have been established whereby experts focused on areas such as titanium dioxide, color and polymers voluntarily join communities to share ideas very casually through and intranet devoted to their community of practice topic. Besides infrastructures built for collaboration, SW tracks its internal product development processes in a database to know what step each project is in; for instance, if a project is in the proof of concept lab. Finally, Scarborough recommended sources to support innovation, such as the Product Development Managers' Association (PDMA), Industrial Research Institute for technology scouts, creating communities within companies based on areas of interest, and even coursework such as that offered by the University of California at Berkeley, which is focused simply on open innovation.

Crossing Over

Perhaps the most obvious connection between the cosmetics and personal care industry and the specialty chemicals industries is within the realm of active topical ingredients, which is why the organizers added cosmeceuticals to the breakfast briefing panels. Interestingly, in a discussion on the way to the event, the CEO of one API told me, “This show is mostly focused on APIs, and with these companies being so tied up in regulatory tape, you’ll be lucky to get a word in with them edgewise.” To which I countered that while stringent regulations tie the hands of product developers and slow the speed to market, several topical pharma product developers are turning toward the cosmetics industry. He thought this was an interesting observation; in fact, he attended the cosmeceuticals session the next day.

The cosmeceuticals session was moderated by myself, Rachel Grabenhofer, editor of Cosmetics & Toiletries, and featured John Gordon of Alion Science and Technology, Romesh Kumar of Clariant, Robert Lochhead of the University of Southern Mississippi, and Marc Cornell of ChemAid Labs. Gordon presented an assay for the detection of endocrine disruptors, which are especially a concern in sunscreens, whereas Kumar discussed pigments, in the sense of their durability and stability in household paints, although pigments obviously can apply in color cosmetics.

The headlines in the Feb. 16 Informex show daily covering this session read, “Cosmetics Morphing to Pharmaceuticals?”—a frightening proclamation to most cosmetic manufacturers. However, as Lochhead stated during his presentation, “Consumers are now demanding cosmetics that also physically change the body.” He added that while such products must be marketed carefully, they do in fact act on a topical pharmaceutical level.

Lochhead’s presentation covered innovations on the horizon based on today’s capabilities to tailor-make molecules, noting techniques including atom transfer radical polymerization (ATRP) and reversible addition−fragmentation chain transfer (RAFT) polymerization, gene therapy to treat skin, dendrimer technologies, nanoparticles and “click” chemistry. According to Lochhead, click chemistry is “a very old chemistry using safe, reproducible chemical reactions to ‘click’ molecules onto things, including each other.” Considering the application of this technology with cysteine SS crosslinks, he proposed “a conditioner of the future that could click onto hair,” which could be developed within as soon as ten years.

Lochhead ended the discussion with the statement that nano-engineering is what industry is now doing, thus new experts are needed in this area. “We need a new breed of formulating scientists who can molecular engineer,” he said, which means educating them, the government, politicians and the public about the great potential of these technologies. Responding to this concept of the drug/cosmetic interface and regulation, he added “[Cosmetics and personal care is] one of the fastest moving industries on the earth and FDA regulation would slow us down. We need to do things faster, which can be accomplished through combinatorial approaches and high throughput formulation.”

Marc Cornell of ChemAid also discussed how new application devices bridge pharmaceuticals and cosmetics—especially since such devices can increase the efficacy and penetration of products. He explained how medical devices are regulated by the FDA, and how more safety and efficacy testing is necessary; in relation, observing “I believe we will eventually standardize anti-aging test methods.” Cornell presented devices such as power lasers and other energy-emitting devices including those based on sound phoresis, iontophoresis and photodynamics to activate topical products. He concluded, “There’s a growth opportunity at the device/product interface.”

Conclusions

While several technologies presented at the show sparked ideas for the future of personal care, a few were practically ready for application today. These included concepts such as a soluble phosphate polymer technology for controlled, sustained release; milling technologies to improve pigment effects; increased penetration and efficacy of personal care products via devices; plasticizers for fragrance and more. These “big catches” for personal care Cosmetics & Toiletries expects to reel in as technical articles later this year. Stay tuned.

References
1.  www.nature.com/embor/journal/v4/n9/full/embor928.html
2. http://potentcompoundsafety.com/2010/08/virtual-pharmaceutical-companies-and-ehs-responsibilities.html 

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Informex USA 2012

The Informex USA specialty chemicals exhibition, held Feb. 14-17, 2012, was held in New Orleans. While exhibitors lured attendees with technologies not especially intended for cosmetic applications, some novel nibbles and a few big catches were made there for personal care R&D.

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