Karma Oncology
Unravel the Complexities in Clinical Trials

A clinical trial can be a complex endeavour. Pharmaceutical and biotechnology sponsors may elect to outsource specific aspects of the clinical trial process to contract research organizations (CROs) to allow internal staff to focus on core scientific and business competencies as well as leveraging external expertise.

Karma Oncology is a focused oncology clinical development company that provides pharmaceutical and biotechnology firms with bespoke services including, but not limited to, clinical development planning and full-service clinical trial execution. Founded in 2012 by Dr. Karen J. Williams, Karma Oncology specialises in the preparation of clinical development plans along with the design, set-up, monitoring, management, and reporting of oncology clinical trials. Having worked in both the pharmaceutical and CRO industries during her career, Dr.Williams has 30 years of clinical research experience and has managed over 170 clinical trials in a variety of indications (with approximately 100 of those being oncology-specific). Drawing on her knowledge of the industry, Dr.Williams went on to establish Karma Oncology as a specialist provider of clinical development services.

Expert Clinical Development Planning

“Clients come to Karma for our expertise and experience with clinical development planning in oncology. Unlike traditional CROs that use inexperienced staff and development plans from generic document templates, we work with sponsor companies to develop focused product specific development plans and innovative clinical strategies. We can come in as early as lead-optimisation or early pre-clinical data and then partner with the sponsor to develop a practical strategic plan to go from first-in-human trials all the way through to regulatory approval” notes Dr.Williams, CEO of Karma Oncology. Taking into consideration various factors, such as tumour types, possible combination therapies, as well as tactical country and site selection, regulatory strategy, and an organisation’s ultimate aim (e.g. early exit, pharma-partnering, or autonomous full development), the team at Karma Oncology can map out the details of the phase I/II, II and III clinical trials required to ensure success. If different options are required based on business conditions (such as timelines, financial resources etc.), the Karma team can present multiple options, each with a timeline and budget, from which sponsors can make informed decisions with investors. More importantly, unlike other CROs, Karma Oncology engages a full team of internal experts (medical, statistical, regulatory and operations) in the clinical development planning process and, when appropriate or upon request, Karma can also reach out to its network of key opinion leaders for external perspectives and insight.

Going Global? Don’t Ignore Eastern Europe

Dr.Williams goes on to mention that one of the significant challenges in the clinical trial space is the ever-growing competition in trial centres for accessing patients, especially in the U.S. To this end, Karma Oncology supports sponsors with its services across the U.S. as well as Western and Eastern Europe.

One of our specialities is clinical development planning, and our plans are specifically customised to each particular company and the product they are developing

While sponsors can be hesitant to work in Eastern Europe, Dr.Williams has found that, in over 20-years of direct experience working in this region, data quality is of a high standard, and subject recruitment timelines can be substantially faster. Clinical Research Associates (CRAs) in the region maintain excellent relationships with investigators and study coordinators. These positive site interactions are facilitated by the fact that all Karma CRAs in Eastern Europe are MDs which, in turn, serves to further improve the quality and validity of the data collected. Dr.Williams and her team at Karma Oncology recommend that sponsors consider the addition of one or more Eastern European countries when rapid patient accrual is required.

Delivering upon Our Promises

When it comes to delivering projects on time, Karma Oncology strictly adheres to and achieves sponsor timelines through its business model and agility. “When I was a sponsor, one of my biggest frustrations was the constant over-promising and under-delivery by most CROs,” recalls Dr.Williams. Furthermore, many of the big CROs have lengthy inflexible internal timelines based on unnecessarily complicated systems and templates designed for non-oncology indications, all of which leads to delays, cost overruns and site/sponsor frustration. Karma Oncology is committed to being transparent with sponsors while setting a schedule for a study, even at the bidding stage. “We deliver on the promises we make” notes Dr. Williams, adding that “unlike some competitors, that sign the contract just to win the business and then fail to meet deliverable after deliverable, we would rather turn down the work and preserve our long-term relationship with a sponsor.” Reputation is paramount to Karma Oncology.
Karma Oncology has been called upon to ‘rescue’ a phase II program originally outsourced to a top-10 global CRO. When the trial fell behind schedule, the sponsor turned to Karma Oncology for support. With in-depth expertise, the Karma Oncology team organised the study, implemented the necessary changes, and ensured that the sponsor timelines were met.

Another issue that proves to be a point of tension between clinical research teams as well as the sponsor and vendor is “change orders.” “A change order indicates that we have missed out something in the bidding stage. Unless there is a material change in scope, the Karma Oncology team strives to stick to the budget through transparency and honesty,” emphasises Dr.Williams.

Steered by a High-Performance Team

A winning differentiator for Karma Oncology is its stable and mature team of experienced CRAs who are not looking for different career options or to move elsewhere.

While bigger CROs often bring in new college graduates as CRAs and train them on the job, Karma Oncology has a team of mature, experienced CRAs which ensures consistency throughout the study while saving sponsors the frustration of CRA turnover. “We do not constantly change CRAs, and even before initiating the study, our CRAs build a strong relationship with their sites because they will be involved in the submissions and contracting process. Thus, the site always has a single point of contact that is maintained for the duration of the trial. This further ensures consistency throughout the project as sponsors, and sites, do not have to invest time and resources in training people on the study—a win-win situation for everybody,” explains Dr.Williams. Karma Oncology’s uniqueness stems from its ability to deploy the same team from the beginning to the end of a project; there is no handover of the study from one team to another. The tight-knit group of experts is led by a project manager who serves as the key point of contact to sponsors and works in close collaboration with CRAs and all other team members.

"We do not constantly change CRAs, and even before initiating the study, our CRAs build a strong relationship with the sites because they will be involved in the submissions and contracting process. Thus, the site always has a single point of contact that is maintained for the duration of the trial"

To further boost the stability of its team, Karma Oncology is a strong proponent of maintaining a healthy work-life balance for employees and consultants. By offering both full-time and part-time positions along with the benefit of working from home, the company accommodates the personal life of employees and, in turn, fosters and retains a more mature team. The company has CRAs in 20 different countries and as close to the sites as possible, which saves sponsors significant travel expenses and ensures that they are well-acquainted with the native language and regulations. Further, Karma Oncology delivers its services through specialists in each area, quite contrary to what big CROs render under “one umbrella.” Above all, there are no layers of management for sponsors to go through; they can reach out to any senior-level executive in the company. This is important while working with emerging biotechnology companies that require instant access to personnel and data.

Holding the reins of the company, Dr.Williams takes pride in making herself available to sponsors at all times. Although Karma Oncology has grown exponentially over the last three years, Dr.Williams wishes to remain hands-on with the CROs’ day-to-day operations.

Moving ahead, Karma Oncology has expansion plans as the company recently hired a new VP for its office in North America to help develop the business further in that region. Working for pharmaceutical and biotechnology industries globally, Karma Oncology is indeed making a difference in the clinical trial space and will continue to empower sponsors with capabilities to efficiently conduct and manage clinical trials.