DMPK Insights for Discovery and Development

The beauty and challenge of DMPK (Drug Metabolism & Pharmacokinetics) is that it spans the interface of multiple disciplines: biology, analytical chemistry, pharmacology, and modelling and simulation. DMPK spans the entire drug discovery and development continuum, from setting up ADME screening assays in lead identification to population PK in late development clinical trials. Adding to this complexity are DMPK topics specific to therapeutic areas and modalities as well as regulatory considerations. So, what’s a scientist outside the discipline to do? How do we eat an elephant?

My recommendation is to start with scientific fundamentals. 

1. Join a society and attend a meeting

The International Society for the Study of Xenobiotics (ISSX)  

An organization composed of preeminent scientists in the field who have laid the foundation  originally focused on small molecules but now expanded into peptides and biologics. ISSX provides different membership options, including a premier version that allows access to a library of webinars that you can watch on demand as well as ongoing virtual seminars.

The Gordon Conference on Drug Metabolism 

Think of this as a scientific summer boot camp where you’re immersed in the science under austere conditions. You’ll have no choice but to interact with others.

DMPK topics are often covered in adjacent/embedded discipline organizations like the Society of Toxicology (SoT) and the American Society of Clinical Pharmacology and Therapeutics (ASCPT).

2. Read the literature

DMPK Journals

Drug Metabolism and Disposition

Drug Metabolism Reviews

Xenobiotica

Books

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications

Essential, exhaustive, updated regularly with online options. If you haven’t read this, you’re not a real DMPK scientist.

Drug Metabolism and Pharmacokinetics Quick Guide, SC Khojasteh , H Wong , CECA Hop

Reasonably priced eBook from industry titans with helpful reference information

3. Dig into the data and how it’s generated

LC/MS: The cornerstone analytical technique leveraged in DMPK is mass spectrometry. ASMS, the American Society for Mass Spectrometry, offers a treasure trove of tutorial lectures available on demand to members, with one of the lowest annual membership fees available.

PK: The most popular tool to generate PK parameters is WinNonLin. Certara provides online resources for free to help you use it. 

PK-PD Data Analysis, Concepts and Applications ebook from Certara

These are all just suggestions to get you started, not a compendium. Let me know what you think and how you fare in your explorations!

For many of us, consulting is a blank spot on the map; an interesting idea to consider in retirement or if things had turned out differently in your career. You might even how best to leverage consultants in biopharmaceutical research and development. This includes not only large and small biopharmaceutical companies but the organizations they leverage including contract research organizations (CROs), vendors, and suppliers.

Scientific Consultants offer a plethora of advantages including:

· Expert guidance on strategy, tactics and operational aspects

· Independently generated high quality deliverables 

· An objective voice of experience 

· Access to a network of experts outside your organization 

· Flexible commitments in time and money spent

Why Should I Hire a Consultant and not a Full Time Employee?

There may not be enough work to support a full-time employee on an ongoing basis.  You may need a highly sought after skill set, or have challenges recruiting talent based on geography or competitors. Your environment may not have the luxury of training employees.  In many situations, there’s no substitute for experience, which could require years or even decades to acquire.

How Could I Best Leverage a Consultant?

Most scientists consider engaging consultants to answer particularly challenging questions after they’ve exhausted all other internal resources. Consultants are often used when getting a company, project or initiative off the ground to provide guidance and framework for people new to the area. For example, if you’re currently working in the cardiometabolic space and want to expand into ophthalmology, subject matter experts could help you navigate the complexities of this new domain. You may have confounding (and critical to decision making) data that is preventing your project from moving forward. A fresh set of eyes can make a huge difference and have you back on track quickly.

A consultant may be an embedded project team member who attends meetings, coordinates with external CROs, designs experiments, reviews and disseminates results internally. Consultants can aid in document preparation and regulatory submissions, and coach your team members through this important process.

How Do I Find a Consultant?

Your network is generally the best place to start. Cast a wide net: Ask for recommendations from co-workers, fellow students, collaborators from your academic training, mentors, friends. You can also find recruiting agencies specializing in consultants or consulting groups with hundreds of members. 

Why Would Anyone Want to Be a Consultant?

Consulting allows highly motivated experts to follow their passion for drug discovery and development, with increased autonomy and work-life balance. It also provides the opportunity to participate in diverse science with highly talented individuals across the globe.  In other words, to meet people like you!