In the 4th episode of Talk is Biotech!, I talk with the CSO of CARE Research Rajan Bawa to learn about his scientific and entrepreneurial career, hear his unique insights on the preclinical CRO (contract research organization) business, and understand his perspective on the pharma and biotech industry.
Making of a bio entrepreneur
Rajan was born and raised in Mumbai, which was called Bombay at the time. He went to BITS Pilani, a reputed college in the state of Rajasthan in India, to pursue an undergraduate degree in chemical engineering. He later moved to the US to get a graduate degree at MIT, where his focus was on biopolymers for controlled drug release. His first job was at Hoffmann-La Roche in New Jersey. He joined their pharma R&D department, but Roche was risk-averse and did not like taking chances on innovative projects. While working on his Ph.D., Rajan eventually went to Bausch and Lomb in Rochester, New York where he began working on polymers and contact lenses. With an engineering background and a keen interest in drug development, he started putting drugs in biopolymer matrices and designing a controlled release system.
Since then, he has worked for numerous companies such as Alcon Laboratories (in charge of the drug delivery department) and Atrix Laboratories (worked on systems for the controlled release).
Growing weary of big pharma politics, he decided to take a leap of faith and start his entrepreneurial journey. He bought a small histology service company and then expanded its offerings to histopathology, clinical chemistry, and hematology. Rajan later acquired one of their clients; a preclinical CRO called CARE Research. He still serves as the Chief Scientific Officer at the company.
Things to keep in mind when you start a preclinical CRO business
Rajan shares some of the common challenges in starting and scaling a preclinical CRO business and what it takes to stay in the game.
1. Pay attention to regulatory requirements
The animals have to be managed in compliance with USDA affiliation. This business also often requires extra accreditation to win its customers' trust, such as AALAS (American Association for Laboratory Animal Science) or AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care).
"When you're working with the animals, you have to make sure that the animals are properly taken care of and that you comply with all the USDA regulations. "And then if you want to go further and get more credibility, you get accredited by AALAS or AAALAC," said Rajan.
Rajan also touched upon the importance of an independent IACUC (institutional animal care and use committee) in this line of business. IACUC is required by federal regulations for most institutions that use animals in research, teaching, and testing. The IACUC has a crucial oversight role, including the review and approval of animal use activities and animal facilities inspection. IACUC is the counterpart of the IRP for clinical studies.
"At CARE Research, the protocol for every single project that we do has to be approved by the IACUC. It is required to have a mix of people there, most of them can be technical people, but one has to be a community member. The community member also has to weigh in and give their approval for the projects that we do. So we do all of these projects using animals in a very humane way," said Rajan.
"We get inspected by the USDA frequently, so we always have to be prepared and maintain our high level of animal care.."
2. Offer competitive pricing and outstanding customer service
Preclinical CRO is a crowded business. There are thousands of CROs offering animal testing services worldwide. To stay ahead, companies have to offer competitive pricing and outstanding customer service.
The emergence of animal alternative for drug testing
Rajan underscores the importance of using whole animals over in silico model & 3D printing technologies.
"In vitro models cannot mimic the whole body experience."
He is correct about it as 2D and 3D cell culture models are still not mature enough to completely recapitulate human physiology. Even the FDA doesn't accept the data from "cloned systems" just yet. Animal alternatives are still used as supportive tools, and it will take some time to use them as animal alternatives.
I do, however, believe that we will ultimately make drug testing animal- and cruelty-free as we continue to develop technologies such as bioprinting, organoids, organ-on-chips, and in silico models. Some of the pioneers making waves in the animal alternative space include Poietis, Emulate, Inc., CELLINK, CTIBiotech, OcellO, MIMETAS, Visikol, InSphero, Epithelix, MatTek Corporation, zPREDICTA, PhenoVista Biosciences, NanoBiotec, CurioChips, myriamed GmbH, STEMCELL Technologies, IMMUNE 3D, and AxoSim.
Culprits of the slow drug drug R&D cycle
The drug R&D cycle is painfully slow. Many culprits are responsible for slower processes and poor scalability—chief among them: lack of quality data in the cloud and instant access to resources in the digital environment. Some other problems include poor predictability of preclinical models and research irreproducibility.
"It’s excellent if you have got a promising drug candidate, but you will have to jump through all kinds of hoops before it hits the market. Drug developers face challenges on every level from formulation, manufacturing, scalability, storage, distribution, and so on.
In vitro and ex vivo models as screening tools
"It’s fantastic if you use ex-vivo or in-vitro techniques to screen compounds as a screening tool, but when you ultimately come up with a good drug candidate, that's when you are going to have to use the whole animal. The FDA loves this approach as this allows you to reduce the number of animals used. And the sponsor loves that too because animal studies are much more expensive to do than in-vitro or ex vivo studies. So as far as the screening tool is concerned, it's worth its weight in gold."
Animal alternatives in the cosmetics industry
The cosmetics industry used to do animal testing, mainly on rabbits, to determine the safety and biocompatibility of cosmetics products. Many countries have outlawed the use of animals as test subjects for beauty products, so this industry now relies on innovative alternatives like 3D printed models. Unsurprisingly, cosmetics giants like Loreal are investing heavily in 3D printing technologies and additive biomanufacturing to create skin models for product testing .
Reasons for pharma’s productivity decline
Big pharma's decline in productivity has been well documented. The returns on R&D investment of big pharma is only 1.9% compared to 9.3% of smaller biotech, and the majority of new drugs approved are developed by smaller yet more efficient and productive companies. Rajan believes internal politics, bureaucratic processes, and short-term gains are the primary reasons for the fall in productivity we’re seeing in big pharma.
Is big pharma hurting drug R&D?
"What happens often is that big companies see these promising startups as threats, so they buy them simply to shelf their drug candidates,"
Rajan says. Another problem is that the bureaucratic structure of big pharma affects the small companies that they acquire, making their R&D processes slower and less efficient as a result.
Big pharma as an innovation portfolio manager
It is not profitable for more prominent companies to perform R&D as the return on research investment is low. On the other hand, small life science companies can work in digital networks, perform R&D, bring new products to market faster, and eventually replace big pharma when it comes to innovating and bringing new products to the market. However, with the level of resources the big pharma companies have, they can support the smaller companies and act more like innovation portfolio managers.
Advice for bioentrepreneurs to buy an existing business
When buying a business, it is important to focus on whether you can scale the existing business instead of focusing solely on its technology and revenue forecast. It doesn't matter how strong the company is if you don't know what to do with it and are not passionate about it. "You don't want to buy what that person has done so far. You want to buy it based on what you can do with it. How can you make it grow? You need to have a passion for it and be willing to devote 150% of you to make it thrive."
Final words for bioentrepreneurs
I agree with Rajan that persistence and passion are crucial to success for any entrepreneur. A startup is likely to fail if the passion they once harnessed to create it extinguishes.
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