A D V E R T I S E M E N T F E A T U R E

A D V E R T I S E R R E TA I N S S O L E R E S P O N S I B I L I T Y F O R C O N T E N T

Karma Oncology Limitedwww.karmaoncology.com

Karma Oncology:making clinical trials work for youKarma Oncology combines an agile and adaptable business model with expertise in oncology clinicaltrials to provide bespoke contract clinical research services for biotechnology companies globally.

No matter how promising a new therapy looksbased on in vitro and animal model studies, thereal test of efficacy and safety comes in clinicaltrials. So, choosing the most appropriate clinicaltrial design, recruiting the right patients and enroll-ing them into the best clinical trial sites is crucial.Making the wrong choices at this stage can torpedopotentially effective drugs and waste years of workand millions of dollars.

Karma Oncology, headquartered in Glasgow,Scotland, and with offices in The Netherlands andthe USA, and a remote team spanning Europe andNorth America, specializes in helping clients designand run clinical trials in oncology. Karma Oncologywas founded in 2012 by CEO Karen J. Williams,who after 30 years of experience in both pharmacompanies and contract research organizations(CROs) wanted to use her expertise to managemore efficient and effective clinical trials and setout to create a company that would achieve this.

When on the pharma side, Williams, who haspersonally managed more than 125 oncologytrials, found that CROs often imposed their ownconstraints on sponsors. “I felt that when outsourc-ing, the service I received was not what I would haveprovided a client, especially when we had to workaround CRO timelines rather than our own. Karmawas set up to offer the flexibility and adaptabilitysponsors require, and everything we do is structuredaround sponsors’ needs.”

Clinical development guidanceKarma’s services cover the full gamut of clinicaldevelopment and more. Unlike many other com-panies operating in this space, Karma works withbiotechs during late preclinical stages to help themput together clinical development plans. “We giveour clients multiple trial designs, each with its owntimeline and budget, so they can make informeddecisions,” said Williams.

Drawing on local knowledge and experience oftrial sites and investigators, Karma helps clientsselect the right country, and the right trial sites, fortheir clinical development program; provides adviceon which tumor types and comparator agents (ifappropriate) should be included in a given studydesign; and creates a roadmap for the most effi-cient route to market for a new drug, device ordiagnostic product.

The company also provides support in prepar-ing Investigational New Drug (IND) applications,including creating briefing packages for meetingswith regulatory agencies in Europe and the USA,as well as accompanying clients to meetings and

working on post-meeting follow-up. In manycases, success at this stage has helped Karma’sclients to secure the funding from investors thatis needed to drive their candidates into the clinicalphase of development.

With often limited resources, biotechs are keento run their trials as cost-effectively as possiblewithout sacrificing scientific rigor. Karma can helpwith such cost-saving, potentially saving millions ofdollars in clinical development costs, by designingtrials that, for example, combine different phases—such as phases 1 and 2, or phases 2 and 3—into asingle protocol, or by studying multiple tumor typesin a single study design.

Fully comprehensive teamAt the clinical operations level, Karma’s core teamof project managers, clinical research associates(CRAs), medical writers, clinical trial assistants andmedical monitors can perform complete clinicaltrials or any part of them. This science-led teamwork hard to stay at the forefront of oncology treat-ments and oncology trial design, and has experienceworking across many different solid tumors andhematological malignancies, as well as a wide rangeof therapeutic modalities from small molecules andbiologics to chimeric antigen receptor T (CAR-T)cell and autologous cell therapies.

The company also offers European legal repre-sentation and has a qualified and certified dataprotection officer who understands clinical trialsand the type of data that Karma processes.

The relatively small size of Karma not only allowsfor a friendly, family-like working environment butis the foundation of the company’s flexibility andadaptability. Clients can pick and choose whichaspects of clinical development they need thecompany’s help with to create a bespoke service,instead of paying for an off-the-shelf package thatmay include elements that the sponsor does notrequire. “All of our consulting, and the design andmanagement of clinical trials, are based on clientneeds, scientific excellence and cost-effectiveness,and our desire to ensure that our client’s require-ments are met,” said Williams.

Karen J. WilliamsFounder and CEOKarma Oncology LimitedGlasgow, UKTel: +44 1475 522156Email: karen.williams@

karmaoncology.com

CON

TACT

B30 | September 2020 | www.nature.com/biopharmdeal