By Louis Garguilo, Chief Editor, Outsourced Pharma
We’ve been investigating the importance of consultants for outsourcing assistance.
It’s time to get personal.
How much value-added can one individual bring to your operations?
How much more can they possibly know than you do (or your team can learn) about working with CDMOs, supply chains, quality systems and regulations, and the like?
You ask yourself, before devoting funds and critical time and energy to finding and hiring a consultant: "Exactly who are these exalted and sought after characters?"
Readers, I present exhibit one: Antkisha Joshi.
Been There … And There
She was born in India, raised in Nigeria, then moved back to India for an MS in Microbiology (more degrees and certificates to follow), and to start her career – at a manufacturer making gelatin for gel capsules. Steady throughout her ensuing career, she’s been a quality management specialist.
“That first job in India was my initial exposure to quality systems,” she tells me recently from her home office in Australia. (We’ll catch up to that location soon.)
“When I joined, they were just going after certification for company wide ISO 9000. I had the opportunity to be heavily involved in everything around acquiring that certification, writing procedures, then learning to be an auditor and taking on other quality experiences.
“Today, I feel I owe most everything I know about quality, or my subsequent learning and practical application of which, based on that initial ISO 9000 implementation.”
Why was that so meaningful?
“It’s a much more practical system for all industries, compared to the isolated pharma quality system, and if applied well, adds valuable understanding tof the pharma regulations and quality.”
Joshi next moved to the UK, where she worked at a CDMO (Cobra Biologics, now a part of Charles River Laboratories). She would come to enjoy the variability of projects, and working with different kinds of customers, a feeling that never left her, and ultimately led her to become a fulltime quality-systems management consultant.
But before that, she found herself back in India, in Vadodara, in 2008, working at another CDMO in a fully sterile facility (Astral Pharmaceutical Industries) making beta-lactam injectables.
“At the time we were collaborating with a U.S. pharma company to supply six different sterile injectable products, each having six strengths. This gave me exposure to the world of writing ANDA dossiers, preparing for pre-approval inspections, and facing FDA inspectors."
This is also where she got exposure to the training side of the quality business, assisting with preparation and training of the CDMO for the audits and running the process.
“During those entire pre-approval audits, the company was given only two minor 483’s,” she says proudly.
And those two, she says, only added to her experience and enthusiasm for learning and teaching about quality.
Teach More, Learn More
Next up was a move to generics maker Strides Arcolabs, this time in Bengaluru, India.
The company had a vacancy in the training department, where they were looking to implement electronic learning systems. “It was still new at the time,” she says, "but I went there for another challenge."
“People were using electronic quality management systems, but this system was exclusively for training. It was just me and my boss. We got it established across five sites – a great challenge at a company with a workforce in the thousands."
She was happy to again be located in the manufacturing space.
“I really wanted to be involved in that project execution, and also change the perceptions about how training should be delivered, how to make it interesting and more engaging."
Yet another inter-India move placed her back in her hometown in 2012, where she established her first consulting operations.
Her main client, though – the original gelatin manufacturer where she started her career – asked her to rejoin them.
“Over the years they had received multiple certifications – ISO14001, HACCP in addition to ISO9001 – and they wanted someone to try to integrate and simplify across the enterprise, and work effectively with the FDA.”
Mission accomplished. Next up? Brisbane, Australia.
“My husband got transferred for his work. The plan was to stay for two years,” she laughs, “but we liked it. We've been here now for nine years.”
Her job? At another CDMO, this time the emerging Luina Bio.
“They were beginning to expand into the microbiome space," she explains, "and get into more of the life science contract manufacturing. So I started with the quality assurance department, and in general, all the quality aspects and requirements around every project that came through."
Over time, she became their head of QA.
I Am Consultant
But Joshi needed one final move to bring us to the consultant we put on exhibit today, and present her as a prime example of the type of professionals who are available to assist you and your operation on the development and manufacturing journey.
Just shy of six years at Luina Bio, she knew what she wanted to do next. This position may last a lifetime. She opened her own consultancy in Brisbane in October, 2022. Now, so to speak, she can move from challenge to challenge without having to move.
“The consultant industry has grown in importance,” she says. “Along with other reasons, today this has also been affected by venture capitalists or private equity firms supporting the start up or the small virtual-pharma companies that rely on consultants and outsourcing.”
“But what I want to point out before we end our conversation is that each company needs to ask this first: For what purpose are we hiring a consultant?”
It’s important, because every consultant is unique, has his or her particular specialty and background, career and life experiences, personality, cost structure and contract desires, location, as well as other factors."
Luckily, the trajectory of the drug industry over the decades, including booms and busts, innovations and dead ends, start-ups and evolving models of operation, M&A (both on the sponsor and CDMO side) … has produced for you an abundant consultancy pot of gold.
In fact, if you select carefully, gold may be the answer to how much a consultant is worth today.
Create A Quality-System Plan Before Outsourcing
Your Consultants, Your Destiny