Our Experts

Carolyn Zele

Advisor, Solution Consulting

Expertise: Biosimilars, GLP-1s, Policy and Regulation, Oncology and Rare Disease, Real-World Data, Marketing and Promotion, Contracting, Reimbursement and Rebates, Industry Trends, Product Launch, Commercial Strategy, Payer Coverage and Restrictions, Payer Market Research, Patient/HCP Identification

As a solution consultant for MMIT, Carolyn Zele helps pharmaceutical manufacturers simplify market access and prepare for launch success. Prior to MMIT, Carolyn spent numerous years in the payer/PBM space managing formulary teams and technology across both regulated and non-regulated lines of business. She holds a Master of Science degree from Colorado State University.

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Insights by Carolyn Zele

On-Demand Webinar | November 14, 2025

Reducing Risk: 5 Steps for a Fearless Launch

In this webinar, we’ll discuss five of the largest risks associated with launch. Our experts will explain the concrete steps your team can take to mitigate those risks in advance—so you can launch your therapy without fear of failure.

Article | September 25, 2025

Cracking the Code of BIN/PCN/Group Data for Faster Benefit Verification

As patient access grows more complex, manufacturers need tools that reduce friction throughout the care journey. One valuable but frequently overlooked dataset is known as BIN/PCN/Group (BPG) data, which refers to a trio of identifiers used in pharmacy claims processing.

Article | September 4, 2025

How to Mitigate Payer Pushback on Fast-Tracked Therapies

For pharma manufacturers, securing expedited approval for a drug in development is typically seen as a win, which will result in faster patient access as well as faster revenue recognition.

Article | June 19, 2025

Starting with the End in Mind: How Pharma Can Build a Smarter Path to Commercialization

To chart a clear path to commercialization, a manufacturer must begin with the end in mind. Early market research helps pharma companies understand which clinical endpoints and differentiators an asset will need to succeed at launch.

On-Demand Webinar | June 10, 2025

Developing Your Commercial Strategy in Phases II-III

In this webinar, we’ll examine how pharma companies can use data and insights to make the most of this critical stage. We’ll discuss how targeted investments in Phase 2B/3 can provide an early look at access barriers throughout the patient journey.

Article | September 26, 2024

Acing Market Access: Six Steps to Take Before Launch

Our first post in this series discussed how early market access research, conducted in the 12-18 months before launch, helps pharma companies identify differentiators and establish accurate expectations.

On-Demand Webinar | September 17, 2024

Pre-Launch Market Access Preparation

Post-launch uptake depends on how well your team can define and communicate your brand’s clinical and economic value to payers, providers and patients. In this webinar, our experts explain how and when to initiate each market access step in the year before launch.

Article | August 8, 2024

Why Pharma Should Invest in Evidence-Based Physician Education

For years, many manufacturers have assumed that pre-market physician education was not strictly necessary unless their brand was the first to market or had a novel mechanism of action.

Article | May 16, 2024

Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers

Despite the rapid evolution of personalized medicine, access to genetic testing and next-generation sequencing (NGS) is a challenge—due in no small part to coverage confusion.

Article | March 14, 2024

Why Pharma Should Prioritize the Patient Journey: A Survivor’s Story

Many years ago, I became one of the first people to be diagnosed with an ultra-rare vasculitis syndrome, a dangerous inflammation of the small blood vessels. My disease is so rare that I had a much better chance of winning the lottery, but instead, I ended up sick.

Article | November 2, 2023

Payer Coverage of Fast-Tracked Therapies: A Cautionary Tale

When a pharma company secures expedited approval for a drug in development, everyone involved is usually thrilled. After all, a faster approval process means that patients in need will be able to access this critical treatment more quickly.

Article | October 12, 2023

Using Real-World Data to Improve Patient Access to Oncology Therapies

Many oncology manufacturers assume that a therapy’s inclusion on clinical pathways is more important than its coverage profile, but this isn’t always true.

Article | September 14, 2023

Uncovering the Patient Journey: Four Ways that Real-World Data Offers Value

For manufacturers, building a static commercialization strategy will only take you so far. But infusing that strategy with real-world data (RWD)—consisting of medical claims, lab testing and pharmacy data, and electronic health records—provides a more holistic view of the patient journey.

Article | June 29, 2023

Driving Market Access for Rare Disease Therapies

In the past, rare disease manufacturers often assumed that any therapy they launched would automatically be covered by most health plans. But the rising cost of many rare disease drugs has increased payer sensitivity to the expense of these therapies, even those with orphan drug designation.

Article | April 27, 2023

Market Access 101: Formulary and Medical Exceptions

In this final post, we’ll explore what it means to request a formulary exception or medical exception for a non-covered therapy. As we’ve said previously, payers and PBMs often place a mandatory six-month block on new therapies, to allow for review by the P&T committee as final coverage is determined.

Article | April 27, 2023

Market Access 101: Key Factors in Medical Benefit Contracting

In this post, we’ll dive deeper into the medical benefit, explaining how payer/PBM contracting works—and why it’s increasingly necessary.

Article | March 9, 2023

Market Access 101: Securing Coverage Under the Medical Benefit

In this post, we’ll discuss what manufacturers should know about drugs covered under the medical benefit. We’ll cover pre-certification requirements, components of a medical policy, and distribution methods, and address the importance of aligning clinical pathways and policies to smooth patient access.

Article | February 10, 2023

Market Access 101: Improving Your Drug’s Formulary Placement

In this post, we’ll address how to research and articulate your drug’s value proposition, how to overcome access barriers like prior authorization, and how to engage controllers during formulary decision-making.

Article | January 19, 2023

Market Access 101: Understanding the Basics

For many pharmaceutical companies, planning for commercialization only begins in earnest when a drug has been submitted for FDA approval—which is far too late.