DORA L. VALLEJO-ARDILA, MBBS PhD

At the cutting edge of oncology practice, my role as a Medical Strategy & Business Development Consultant leverages strategic planning in clinical trial operations and medical affairs, implementing AI algorithms to enhance clinical trial recruitment and employing pre-screening clinician decision support systems to find the right trial for the right patient at the right time.

Passion

I am a highly qualified and skilled clinician-scientist with over ten years of academic and industry experience. I joined the Australian health industry sector as part of the Independent Global Talent program invited by the Australian government, and my capability to translate medical research into products and services that transform healthcare, promoting access and diversity to innovative cancer treatments.

Commitment

I have an internationally recognised record of outstanding achievements in my medical profession, research, and academia, including a PhD in surgical oncology and tumour immunology, a recognised trajectory in metabolic diseases, clinical oncology, Haematology and immunology clinical trials. This breadth of experience has proved valuable in my previous roles and equipped me well as a medical-scientific advisor and clinical trial consultant across the competitive drug development landscape in the US, Brazil, Germany, Australia, and China.

Integrity

In my role, I provide high-quality, evidence-driven medical, scientific, and strategic guidance for developing global clinical trials, Research & Development (R&D) pipelines, new strategies for investigational product launching to commercialisation, and project management of the pharmaceutical portfolio in diverse therapeutic areas, including oncology (solid tumours), haematology, and immune-oncology and precision oncology. I am implementing AI algorithms to enhance clinical trial recruitment in Australia.

Qualifications

Bachelor of Medicine and Bachelor of Surgery (MBBS PhD), Universidad Industrial de Santander, 2013 (Verified final Medical Degree Australian Medical Council). Active medical license (Colombia).
MD Thesis in the Institute of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, 2013.
PhD (Surgical Oncology and Cancer Therapeutics), Department of Surgery, University of Melbourne, 2021.
Advanced Physician Medical Monitor- Global Clinical Trials Certification, CCRPS International Accredited Certificate, 2022.
Advanced Clinical Trial Design Graduate Course, The University of Melbourne, 2019.

Consulting Services

Regulatory Advice (Medical Advisory)

We provide our clients with the support needed to ensure that all prospective clinical trial activities and related products and services comply with local regulations and ethical standards established by Therapeutics Good Administration Australia.

Patient Advocate Groups (PAG) Engagement

At feasibility and during active recruitment, we will increase awareness of patient participation in clinical trials by co-creating patient-centred materials that deeply resonate with patients' specific needs and concerns with our marketing and communications team.

Clinical Trial Support

We provide scientific and clinical evidence (publicly available or sponsored provided) of selected clinical trials to facilitate clinician referrals.

Knowledge Management

We stay abreast of industry literature, guidelines, competitive landscape, and best practices relevant to your clinical trials and related services.

Insights Gathering

We collect and analyse feedback from clinical trial sites, principal investigators and medical oncologists to inform and optimise strategy for individual trials and, more broadly, across Australia.

Cross-functional collaboration

We work with all departments of your team to achieve your recruitment goals.

Healthcare Professional (HCP) Engagement

At feasibility and during active recruitment, we build and maintain relationships with Clinical Research Sites and principal investigators strategically mapped, key opinion leaders (KOLs) in Medical Oncology and hematology and medical oncologists referring to your trials. Gaining insights from KOLs to estimate the burden of the disease (as perceived in the target population) and implementation of the protocols in Australia.

Strategic Advising

We provide strategic guidance and risk mitigation strategies for the execution of clinical trials and related services tailored to the local healthcare system and competitive treatment landscape by performing a Transportability analysis that assesses the feasibility of recruitment based on study eligibility in the target population in Australia to determine the “window of opportunity” for a clinical trial recommendation, for example, including assessment of protocol complexity, prevalence of reported of cancer type, lines of therapy approved in the Standard of Care (SoC) before trial recommendation.

Medical Monitoring

Providing medical oversight for globally sponsored clinical trials, acting as medical representative to provide input to the Clinical Monitoring and Safety Management.

The education and training that make me an expert in my field

PRICING

Hourly Rate

Best for: One-off or short-term consulting tasks where the scope of work is not well defined in advance

How it works: Consultants charge clients an hourly rate for the time spent working on the project. The total fee is calculated based on the number of hours worked.

Advantages: Flexibility for clients who may not need ongoing consulting services. Transparency, as clients pay for the actual time spent on their project.

Retainer Fee

Best for: Long-term consulting relationships or ongoing advisory services.

How it works: Clients pay a fixed monthly or quarterly fee to retain the services of a consultant for a specified number of hours of a set scope of work.

Advantages: Predictable and steady income for consultants. Clients have priority access to the consultant's expertise.

Project Basis

Best for: Well-defined projects with a clear scope of work and a specific deliverable or outcome.

How it works: Consultants charge a flat fee for the entire project, regardless of the time it takes to complete it.

Advantages: Clear pricing and expectations for both the consultant and the client. Clients know the total cost upfront.

Blogging

Medical-scientific Publications

What my team and colleagues say about the value I bring…

I would describe working with Dora as energising, though provoking and feeling supported. We worked together at Omico and within her role as a medical advisor/ lead she was an instrumental support to help develop and implement the BD strategy, develop robust value proposition and support in the development and implementation of Bd Processes. I commend Dora for her passion and in depth knowledge in precision oncology, she would be a great asset to any company playing in this field.

Karishma Jivani

Precision medicine l Commercial Executive l Partnerships l Business Development | Genetic Counselor

Dr. Ardila worked in my research group at the Institute of Immunology at the University of Duisburg-Essen from May 2016 to October 2016. During this period, she focused on working with the vaccine Candid#1. From the outset, Dr. Ardila showed great interest and quickly integrated into our team. She successfully established new methods and consistently worked diligently, reliably, and conscientiously and demonstrated the ability to work both innovatively and independently. She is productive, hardworking, and collaborative. Dr. Ardila has always supported her colleagues and contributed positively to the team. Dr. Ardila initiated a study on the Candid#1 vaccine in Argentina. She explored the potential role of Candid#1 in tumor patients and developed a protocol while establishing important contacts in Argentina for the study. This work is of significant importance to our laboratory. In summary, Dr. Ardila has proven herself capable of working independently with a clear vision and focus on the greater good. Her contributions have provided new insights and she has consistently demonstrated above-average commitment. Dr. Ardila is poised for continued success. Please feel free to contact me if you have any further questions.

Namir Shaabani

CSO and Co-Founder -Attentive Science Ltd

I am writing to recommend Dr. Dora Vallejo, with whom I have had the pleasure of working since around 2015. Thus, I am in an excellent position to write this recommendation. Since the first time we met, it was evident that Dora was a very talented individual. Indeed, during the years we have worked together, she showed great skills as a scientist and researcher. She is extremely hard working, intelligent and insightful besides being communicative and easy to work with. Our scientific collaborations started investigating regulators of genetic risk for the progression of non-alcoholic fatty liver disease to hepatocellular carcinoma, a project that culminated in a brilliant book chapter (https://doi.org/10.1007/16833_2022_40). We have also spent many hours working in other projects and ideas during her PhD. I sincerely believe that Dr. Vallejo is an outstanding researcher and professional. She has all the capabilities to propose bold, creative and interesting ideas to make an impact in her field of expertise.

Marco Antônio De Bastiani

Postdoctoral Researcher at Federal University of Rio Grande do Sul, PhD in Biochemistry (UFRGS)

I have known and had the opportunity to collaborate and work with Dora for several years. Dora has an innate ability to develop high-profile scientific projects, including coordinating clinical experiments and real-life studies. She also demonstrates an exquisite approach and is focused on productivity and achievements that she successfully achieves in various settings. Working with her and seeing her professional growth has been a pleasure.

Andrés Felipe Cardona Zorrilla

Head of Research, Science and Education “Luis Carlos Sarmiento Angulo" Cancer Treatment and Research Center (CTIC)

Collaborating with your team, we advanced the patient journey understanding and testing pathways, contributing to the development of transformative cancer treatments.