The Role of a Drug Development Consultancy

What are some common challenges facing the industry today?

As the drive to outsource across the entire drug development pathway continues to gain momentum, big pharma, smaller/mid-size biopharma and virtual organizations alike, are all looking for ways to progress assets and develop medicines quicker and with reduced cost. With traditional silo’s still very prevalent between each key subset of pharmaceutical development, e.g. drug substance manufacturing, formulation development, clinical drug product manufacturing, CRO services and commercial manufacturing… the effort to outsource across multiple vendors, manage complex logistics &supply chains, can make such savings in time and costs difficult to perceive and even harder to quantify.  

Where can drug development consultancy help? 

15 years ago in the CDMO space, it was quite rare for a prospective customer to come ‘armed’ with a third party consultant. As the frequency of consultant involvement increased over the years, it was often a complex three-way dialogue to navigate…who was the voice of our customer? To what extent should a service provider provide scientific recommendations?

Quotient Sciences has paved the way for effective relationships with our customers and their consultants in many ways. All of these, in my mind, reflect Quotient’s commitment to meeting customer needs by focusing on the molecule and sound science to guide the development strategy. Impressively, outside of our customer relationships we actively engage with a large network of consultants globally. We use these consultant relationships to help us understand market trends and customer needs through the eyes of this incredibly diverse, deeply knowledgeable group of industry experts. It may be as simple as bouncing off ideas for our next capability investment, our next acquisition or simply to understand where we are perceived to be either strong or weak as a service provider. Our team of internal drug development consultants (more on them later!) foster these relationships, which creates a strong platform of mutual respect and shared scientific expertise.

What support do customers need to ensure success of their formulation and their molecule? 

As a ‘service provider’, I believe that there are two things more important than anything else to position a drug development program for success – proactive communication and a strong scientific problem-solving ability. Both rather obvious, perhaps, but often a challenge within busy CDMOs focusing on operational delivery and ‘meeting milestones’. With outsourcing from big pharma and small to mid-biopharma often involving multiple vendors, it is imperative that there is a strong degree of coordination across all stakeholders. Too often delays result from poor cross-management of timelines and deliverables between external vendors. Challenges are not uncommon during development, but the ability to ensure smooth communication and coordination as well as scientific evaluation and actions means that a consultancy role can add value, save time and ultimately cost.

When you pair strong scientific thinking and great communication skills with the unique and proven ability to integrate drug product development with clinical dosing/testing – it is a differentiated and winning combination provided by Quotient!

Our clients are developing valuable assets to bring potentially life-saving medicines to patients – they should feel that this value and burden is understood and shared by those organizations supporting their development process.

Focusing on fundamentals – really understanding molecules from a physical and chemical perspective, means that our approach to working with customers is data-driven and scientifically robust. We allow science and customer needs to drive our approach and remain agnostic to the technologies used, pre-emptively addressing potential issues and trying to save our customers  both time and money.

What should customers look for when evaluating service providers? 

I have always found it incredibly rewarding to collaborate with a wide range of customers and get exposure to a broad range of compounds and dosage forms.. The variety and pace are not for everyone, but I would not have it any other way! I have often thought about how I would select a development and manufacturing provider (aka ‘vendor’) if I were on the other side of the fence. First, I would look for an organization that didn’t see themselves as, “just a vendor.” I would want to see that cared about my project , with an appropriate sense of urgency, and that they really understood my objectives and key milestones. I would also expect them to have a good depth of scientific expertise.  Maybe I am a small company planning to sell an asset and exit at the Proof-Of-Concept stage, or maybe I am big pharma with a wealth of in-house expertise that plans to take this all the way – does my development partner understand my compound and my goals? I would want a partner that is collaborative and prepared to ‘sit round the table’ brainstorming and sharing expertise on the best project plan – best both in terms of robust science and timeline. I want to see that the organization is nimble and has the autonomy to react to resources and capability needs and has a sense of proactive creativity. I also would want to connect with those that will actually ‘deliver’ my program….are they as committed and strong scientifically as those that ‘won’ my business…?

I do not envy those people that have to make these choices and select companies to which they will outsource significant and high value work. I do know that as an ‘outsider’ I was drawn to work for Quotient Sciences because I could see all these critical capabilities in play. I have no doubt that these attributes underpin our ability to design and deliver complex integrated programs of work globally and allow us to provide a really differentiated level of scientific service to our customers.

What consultancy support can Quotient provide?

Quotient Sciences has a global team of scientific experts, with a key objective to  ensure that we fully understand and support the wide range of molecules, customers, and customer needs that we encounter. Our Drug Development Consultants have a unique breadth and depth of scientific expertise, but are also very experienced in operating at the customer interface. The ability to combine these skillsets is often quite difficult to find, but in Quotient we excel!

Our other areas of expertise include:

·         Formulation Development

·         Clinical Trial Manufacturing

·         Clinical Pharmacology

·         Data Sciences

·         Drug Substance

·         Bioanalysis

·         Commercial Manufacturing

·         Drug Development Consulting