EXECUTIVE INTERVIEW - Avomeen: A Unique Approach to the Traditional Analytical CRO

Avomeen Analytical Services breaks the mold of a traditional CRO by bringing multidisciplinary experts from a range of industries together into a large state-of-the-art facility. This unique blend of talent allows the fast-growing laboratory to break away from just routine projects and allows them to effectively solve even the most complex problems that often times arise within the research and development stages of a pharmaceutical product. Headquartered in Ann Arbor, MI, the analytical testing laboratory has seen tremendous year-over-year growth due to its clients’ appreciation to the customization they receive, reliability of results, and exemplary customer service. Drug Development & Delivery recently caught up with Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services to discuss what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry, some of the laboratories non-routine service offerings, and how their unique approach has helped them to maintain the incredible year-over-year growth of the company.

Q: What makes Avomeen’s pharmaceutical development program unique?

A: Many CROs only work on projects within a limited scope in order to complete a high volume of routine tests with little to no customization to the individual client being served or the specific sample being analyzed. The caliber of our staff and our ability to solve both unusual and highly complex problems sets Avomeen apart from these types of laboratories. At Avomeen, more than 70% of our scientists are PhDs or Masters Level, which is a much higher percentage than you will find in companies geared toward high-volume routine work. Our model is geared toward customizing every project to meet the specific needs of the client. Our clients like that we are able to create definitive methods on complex products, such as an API that is difficult to solubilize or if they have an active ingredient to be analyzed that is not a small molecule but instead is something larger, such as what is found when testing an oatmeal based product what sets Avomeen’s analytical laboratory apart from other CRO’s that serve the pharmaceutical industry, some of the laboratories non-routine service offerings, and how their unique approach has helped them to maintain the incredible year-over-year growth of the company.

Q: Avomeen has about 35 current employees, what is the appeal of a laboratory your size?

A: We are a smaller CRO, this helps us to be nimble and react to our clients’ needs in a faster manner. When a new project comes onboard’ we put together a dedicated specialized team of scientists whose skillsets are tailored specifically to that type of work. We appeal to smaller and mid-sized companies as a better choice than going with a large CRO because they are primarily focused on multi-billion dollar pharma companies and often do not treat smaller companies with the same level of respect or attention as their more profitable clients; whereas for us, small to mid-sized pharmaceutical companies are our sweet spot. That is who we service most often, and as we are not a volume-based company, we are able to provide them a higher quality and more reliable service. When you have a molecule you are relying on for the future of your company, you want someone to take care of it and treat it as important as you would yourself, that is where is we come in. Conversely, there are also many very small CROs composed of just a few people. These laboratories don’t have the necessary sophistication, quality systems, or advanced state-of-the-art analytical instrumentation that we offer. So we are not among the monstrous organizations that only look for large billion-dollar clients, and we are also not one of the really small 3 to 5 person mom-and-pop-type laboratories.

Q: What does Avomeen offer when it comes to pharmaceutical development?

A: We provide preformulation and formulation development, a complete range of CMC analytical testing services, method development, validation, and transfer services, clinical trial manufacturing, stability, degradation, extractables/leachables analysis, and more. The focus of our testing is taking the API and getting it into the clinic as fast as possible. We are also unique in that we can assist pharmaceutical developers and researchers at any stage of their development process. Whether preclinical, clinical, or after market, we are able to support the clients’ individual needs and quickly jump into action.

Q: Do you offer any services or expertise that other CROs do not?

A: Many CROs have skilled pharmaceutical scientists, but most lack multidisciplinary scientists. They lack the polymer, material, and metallurgy experience that our staff possesses. Because Avomeen also services other commercial and industrial industries, we have a broad base of expertise that includes inorganic chemists, organic chemists, chemical engineers, pharmaceutical scientists, material scientists, polymer chemists, and more. Due to this, we are able to handle situations that land outside of the traditional drug molecule testing. For example, many extractables/leachables studies are performed on rubber stoppers and other items that are polymer based. So while many CROs do not have multidisciplinary expertise, we have the polymer specialists you will require in-house that work together with our pharmaceutical scientist to create a better E&L study for a rubber stopper and other unique items than a typical CRO could.

Q: In addition to your broad expertise, does Avomeen differ from typical CROs in any other ways?

A: Absolutely, one of the key differences is our size. As a midsized laboratory, we are neither too small nor too big. We are not so large as to only appeal to companies like Pfizer or Merck who often look for laboratories with high volume and narrow focus. Instead, we can cater to companies that require a customized approach from a laboratory that offers a range of services, this helps insure their drug product gets to market as quick as possible and at a lower cost.

Our customer contact is another thing that sets us apart; from the initial project discussion through the completion of your project, our clients are in communication directly with one of our technical directors and their dedicated team of chemists. One thing that our clients really appreciate is that even our internal business development team is composed of experienced PhD scientists; what this means for them is they get an experienced scientist helping them right from the start by offering advice and suggestions during a complementary initial consultation that helps to insure the project quoted and taken on will solve exactly what they are looking to complete. We have had a number of clients request a large package of services but unknowingly not include an item in their request list that would have left them with regulatory troubles and delays further on down the line had our staff not picked up on it. That’s the difference you get when you work with our sales staff who are experienced chemists versus most laboratories sales staff who are composed of individuals who aren’t as familiar with the industry and its regulatory requirements.

Q: What type of facilities and instrumentation do you have?

A: Avomeen has state-of-the-art facilities for our pharmaceutical development services, and we are constantly expanding on our growing capabilities. We have multiple ISO 7-Compliant clean rooms of various sizes spanning 1200 square feet of laboratory space. We have the equipment to perform both wet and dry granulation as well as tablet presses and capsule manufacturing capabilities in order to create and prepare clinical trial supplies. A few highlights of our tablet and capsule instrumentation are shown in the table.

Our laboratory is a 25,000-sq-ft facility consisting of segregated labs, including Clinical Trial Manufacturing (CTM) Suites, GLP/GMP Labs, Instrumental Analysis Labs, R&D Specialized Labs, Chromatography & Spectroscopy Labs, Formulation Suites, and more.

Q: Has your unique approach to CRO services proven beneficial?

A: We believe so; we have been a fast growing company, averaging 40% to 70% year- over-year growth for the first 3 years of the company. In the next 3 years, we expect to double our size once again. This impressive growth is due to how much mid-sized pharmaceutical companies appreciate our service offerings and technical expertise, with many of our clients coming back to us with additional larger projects after a successful timely completion of their project the first time around. Our model as a customized full-service CRO has proven to work, and as we continue to grow, so does our capacity to better serve the pharmaceutical marketplace. No one will ever question why you decided to use Avomeen, but they may question why you didn’t.