Meet Dr. Amanda Goldrick, MBBS, Hematology & Oncology
Medpace is pleased to announce the addition of new Oncology expert, Dr. Amanda Goldrick, to the Medical Leadership team.
Dr. Amanda Goldrick is an Oncologist with over ten years of experience in clinical practice, academia, and clinical research. As Research Medical Director at AMGEN Inc, where she led a Phase III trial in multiple myeloma, a Phase 1 trial of a bispecific T-cell engager in small cell lung cancer, designed late phase trials including a first line Phase III registrational clinical trial and delivered the pediatric strategy for that asset. Dr Goldrick has maintained her license to practice in Australia and during leave in the COVID-19 pandemic, took care of patients as medical oncologist and a palliative medicine specialist at two rural centers in Australia. Dr. Goldrick is also a member of American Society of Clinical Oncology (ASCO).
In our latest interview session, gain insights into Dr. Goldrick’s background, expertise, and her views on current trends in oncology clinical research.
Tell us about your background in Oncology clinical development.
From very early on in medical school I found myself intrigued by the science of malignancy, both solid tumor and hematology. This interest only deepened when exposed to patients with these conditions first as a medical student and later during Internal medicine training. I experienced the depth of their illnesses, and the confronting challenges they faced. It was patients who motivated me. I was fortunate to experience ways of working in Hematology & Oncology teams where I truly felt there was something very special about the humanity of the doctor-patient/nurse -patient interactions, an unswerving commitment to patient care, a focus on quality of life and improving outcomes and a dedication to do that through science. I found my home in the multi-disciplinary team involved in the care of patients and their families, the evidenced based approach to treatment decisions, and a commitment to generating high quality evidence through clinical trial to drive treatment decisions… I could also see that Oncology was a discipline that would explode with knowledge, evolve throughout my career, providing a never-ending source of learning and deep satisfaction both scientific and personal.
After basic training and examinations in Internal Medicine, I completed a four-year fellowship training program in Medical Oncology which included 6 months rotations through Radiation Oncology and 6 more months of Hematology making a year in total. This was, followed by specialist training in Palliative Medicine. After obtaining specialist qualifications, I devoted my work to the care of patients in clinical practice, mostly in public academic hospitals in Sydney, Australia where I held conjoint University appointments and was a principal investigator or co-investigator on multiple clinical trials in breast, lung, gynecologic and head and neck cancers. My broad clinical experience includes work in the British Columbia Cancer Agency and in city and rural private practice in Australia. I have led the Palliative Medicine teams in providing consultative services in an acute city hospital and community and hospice settings. I was a busy clinician investigator, active in clinical trials both industries sponsored, and cooperative group led studies and was fortunate enough to enroll patients in several practice changing trials in breast, gynecologic, head and neck, lung, and colorectal cancers.
Following full time practice, I shifted my research focus from patients in my own practice to research and development in the biotechnology industry where I have spent the last 10 years. I first gained experience by leading a local medical team and working on medical strategy, regulatory approval and access, commercialization and clinical operations before moving to the United States to join the global organization where I focused on clinical development designing and executing Phase 1- III trials in hematology and oncology. I have maintained my medical license and continue to treat patients from time to time, which I find both humbling and inspirational. I will never cease to be amazed by the altruism of patients willing to participate in clinical trials uncertain whether they themselves will benefit but buoyed by the opportunity to help others.
What motivates you and your interest in clinical research – specifically in Oncology?
The practice of clinical medicine is a privilege that has driven me to work for better outcomes for patients and to do this through scientific research that is well designed and executed with excellence. Whether the challenge is what treatment to recommend for an early cancer with a high risk of recurrence to reduce that risk while at the same time minimizing the risks of serious treatment toxicity or, in the case of patients with advanced metastatic cancer, how to best meet the patient’s treatment goals be it more time and time well spent or, a huge turn for the better and find a cure. During the 10 years in the biotechnology industry, I have sought to transform the lives of people with grievous illnesses. I have focused my efforts on delivering medicines to patients underpinned by data derived from exceptional science, extensive pre-clinical evaluation, and high-quality clinical trials.
What challenges, considerations, or risks are specific to Oncology clinical development?
There is an understandable urgency for cancer patients where the condition is incurable, and they are facing a treatment cliff and time is running out. A clinical trial may be the only way to access novel treatment. Also, Oncology is a very dynamic area. The competitive landscape is fierce. Companies must be both methodical and meticulous in their execution with assiduous attention to safety and biology. At the same time, they must be nimble, fast, and decisive, prepared to take some calculated risks. It is a treacherous line for drug developers. New data, new understandings and learnings require companies to be agile and learn of success or failure as soon as possible able to pause and to pivot. For patients, learning of a new medicine being explored is exciting but daunting – will it be in time for them? For those patients with early-stage cancers who might benefit from early intervention (adjuvant treatment) after curative surgery, the questions are around what refinements could be made that deliver the same or better efficacy but with less toxicity, both acute and long term.
How does your prior experience translate into the work you do at Medpace?
I am fortunate to have had the experience in the biotechnology industry where I gained an understanding of the end-to-end process of clinical development from discovery to Ph 1- III trials, and of the next steps of approval, access and adoption through which medicines reach patients. Before that, there was the practice of clinical medicine a privilege that has driven me to work for better outcomes for patients.
What is the biggest hot spot or trend in the field of Oncology clinical research at present?
We are blessed with a richness of novel targets and platforms along with technological innovations that are shaving time off and optimizing new molecules. The resurgence of interest in drug antibody conjugates with a series of acquisitions by large companies of new agents from small biotech and refinements in the constructs that are improving efficacy (increasing payload to drug ratio, novel payloads, and protein drug conjugates for improved tumor tissue penetration) and safety (specificity of the antibody to tumor antigen to reduce off target effects). We are seeing both RNA oncolytic viral treatments, non- viral vector-based gene therapies, considerable advances in cell therapy, and novel monoclonal antibodies beyond bispecific antibodies. There are also hot button issues is dose optimization. The FDA expects drug development companies to no longer just seek the maximum tolerated dose (MTD) but to identify the lowest possible effective dose. This can require testing multiple dose cohorts and go back again to add additional subjects which can increase both time and cost and still, end up with the company finding it difficult to select the RP2D and proceeding to randomize in a Ph 2. On the upside, this not only requires companies to sharpen their thinking but to use more sophisticated (and interesting) dose escalation methodologies with our colleagues in biostatistics. There is also increasing focus on industry being more accountable for the cost of medicines and the value proposition. There is also increasing importance of including patient-reported outcomes as endpoints and “the patient voice” in the design of clinical trials.
What is your vision for clinical trials in Oncology in the next 10-20 years?
In pre-clinical evaluation, there will likely be less reliance on animal data and more data from organoids as well as the use of various forms of artificial intelligence and machine learning in drug discovery and molecule optimization that will accelerate timelines, identify failures early and allow resources to flow to other ideas. Patients will have a greater say in trial design and endpoints through sophisticated patient advocacy groups which we see already. There may be increasing focus on modelling, virtual trials within databases, remote monitoring, and use of AI in data monitoring. Also, more precision and personalized studies based on biomarker expression and mutation analysis, trials of de-intensification where patients with low risk undergo less intense treatment.
Medpace Hematology & Oncology CRO
At Medpace, our in-depth clinical experience combined with our comprehensive research experience translates into our ability to successfully design and execute your Oncology clinical trials in the most efficient and effective way possible.