From The Editor | April 24, 2023

Your Consultants, Your Destiny


By Louis Garguilo, Chief Editor, Outsourced Pharma


I’ve been doggedly pursuing this hypothesis with biopharma professionals:

Consultants have become more important than ever.

The resulting correspondences have been illuminating, shedding light not only on the role of consultants themselves, but where we are as a drug development and manufacturing outsourcing community.

Based on that feedback, we’ll host an Outsourced Pharma Live webinar devoted to this subject on April 22nd. (Join us; it’s free to do so, and we’ll field your questions as well.)

Recently, I altered the hypothesis to a question (Are consultants more important than ever?), and presented it to our advisory board via email. Here are two of the replies.

The answer to your premise question is a strong, ‘No.’ Finding the RIGHT consultants is more important than ever. 

“I recently spoke to an executive about her bad experience at a CDMO, and it appears her advisor had limited experience, stayed in his comfort bubble, and the result was a poor vendor ID process, and abject project failure. Actually, I can’t tell you how many times other consultants are called in to clean up messes that the original ones created.

“Smaller companies particularly rely on and continue to need the right consultants. For example, if your consultants don’t have the relationships to leverage the larger CDMOs you believe are the best fit for you, you may have the wrong consultants.”

-- Brian James, Chief Operating Officer, Rondaxe Pharma LLC


“I think you might want to alter the question to: “In What Areas Are Consultants More Important?

Our business-management model is one of internal and external expertise (consultants) working in tandem as our leadership team. As a small, clinical-stage company, we rely heavily upon our external relationships (e.g., CROs, CDMO, etc.) and the consultants we engage to manage such relationships successfully.

Progress with our programs – getting to relevant milestones (e.g., data points) – is critical for small, publicly-traded biotech companies. We utilize consultants and contractual relationships to meet timelines, and ensure the quality necessary to support continued, further progress on behalf of the Company.”

-- David A. Dodd, Chairman, President & CEO, GeoVax Labs, Inc.


Also, in a recent editorial, “Create A Quality-System Plan Before Outsourcing,” we received advice from Antiksha Joshi, Director, Urmi Quality Management Consulting Pty Ltd. Joshi is an experienced quality management systems professional who formerly worked at a number of service providers before turning to serving sponsors as a consultant.

Here’s what she had to say about my hypothesized ascendency of consultants.

We will detail Joshi’s deep international experiences prior to becoming a full time consultant in a following editorial, but her comments below specifically on our question of consultant ascendency will make it clear she is securely comfortable in outsourcing around the world.

Globally Ascendent

Due in large measure to the worldwide outsourcing our development and manufacturing community performs, Joshi begins her thoughts unequivocally by responding, “Yes, consultants have become more important than ever.”

She says this is a coefficient of logistical globalization. She means that in most all developed countries, there's a vibrant energy, and human and financial resources being spent on bringing research and development products, programs, and platforms forward to potential commercialization.

This, she says, is made manifest in the increase in start-ups and other companies who look at biopharma as a new technology in an age of technology-driven markets.

This global world of bio-technology requires ingenuity, and innovative and cost effective means to scale up and push programs through development stages. Bio-technology (in this usage we can also include small molecules) has become an opportunity for private investors and venture capital to take part in growth narratives with defined exit strategies (e.g. asset or company sale to bigger pharma), or the opportunity for returns with eventual commercialization.

“All this search for new technology has driven early-phase activity across the drug development board,” says Joshi. Which is driving contract research, development and manufacturing, and a search for external partners across the planet.

This global zeitgeist despite the recent troubles between nations (e.g., war in Europe; China belligerency), and leading to a current focus on shortening supply chains.

“You simply do not always find the most appropriate external partners where you are,” says Joshi. “So you outsource to different continents.”

Sponsors – even inexperienced ones – find “it’s relatively easy to do so, and manage the intercontinental relationships – because of the role of consultants.”

“Frankly,” she adds, “logistically and financially, I believe many times it's advantageous to have consultants based around the globe to access this global energy and these worldwide opportunities to work with external partners – as well as access external funding.

Person In Place

We’ve grown accustomed with the outsourcing term “person-in-plant,” or PIP. That’s having one of your own employees embedded at a CDMO (to the degree and length allowed by the CDMO) to oversee your project as it is being executed there.

But Joshi alludes to a different version of PIP – this time its “person in place” – referring to having trusted consultants on the ground in otherwise might feel like far-flung locations, providing oversight on your behalf.

These roles take on spectacular responsibility (as David Dodd mentions above.)

“This international consultant, in a sense, also serves the CDMO to collaborate with various sponsors. That's one way the consultant industry has grown in importance to both sides of the outsourcing equation.”

But a word to the wise as we finish up.

“I would also point out that companies need to know why specifically they are hiring a consultant, and who the right consultants are for that area where you need assistance (which sends us to our opening comments from Brian James).

“I’m not suggesting the consultant will solve all your problems,” says Joshi. “He or she comes with various expertise, but ultimately, you are responsible for success or failure. That means ultimate product quality and safety, understanding regulations and working with regulatory bodies.”

In other words, no matter how important consultants have become, they don't take over your ultimate responsibilities or decision-making.