ONCOLOGY DEVELOPMENT
Expertise. Experience, Efficiency.
I work with clients, providing exceptional consulting services that are catered specifically to their needs. Take a look below at the services I offer and get in touch to achieve immediate results.
CLINICAL STUDY DESIGN
I work collaboratively throughout the entire process and guarantee measurable results. As a medical oncologist/hematologist consultant and a biostatistician, and with an extensive experience both at the bedside and in pharmaceutical development, I can design a consistent set of clincal studies, adapted for each product stage.
DEVELOPMENT STRATEGY
Since founding my business, I’ve provided my clients with a wide range of consulting services such as providing a development strategy, from pre-clinical, IND to NDA and post-marketing. My own company licenced out drug IP within a two-year time by focusing on strategic elements.
HANDS ON
My clients are my number one priority, and my services prove just how committed I am to their success. There are no small tasks, from investigator selection to protocol writting or CRF checking.
CONNECTED
With investigators, universities, colleague with various skills, the biotech/pharma industry.
We will find the solution!
Experience
Oncology-hematology, Pharmacology, Biostatistics
Skill set
Clinical development plan
Protocol outlines
Protocol development
Investigator brochure
Clinical studies I, II, III , IV
Pharmacology, Phamacokinetics
CRF development, CRF Design, CSR
Data validation and analysis
Biostatistics, Multivariate analysis
Phase IV strategic plan
Retrospective analysis
Pharmacovigilance studies
Safety clustering for concise labeling
Developped thetrapies & Methods
Chemotherapy
Targeted therapies
Phototherapy
Immunooncology
Adoptive immunotherapy
Antisense
Antibody-Drug-Conjugates
Large molecules
Liposomes
Antibodies
Growth factors
Compagnon diagnostics.
Biomarkers
Experiences
FDA, EMA, European countries agencies
Pre-IND, End of Phase II meeting
FDA briefing documents
Cooperative groups
Study implementation
Medical monitoring
Testimonials
“ I have been working quite extensively with Erard - he knows very well oncology and is a clear and straightforward thinker in terms of indication, clinical design, path to registration. Erard is one of the few clinical development strategists I trust from A to Z. I love his passion for oncology and would be happy to serve as reference should you need to”
JP Bizarri, 32 years experience
Former VP clinical development Sanofi-Aventis, EVP Celgene
Erard worked with me at Immunomedics on a Urothelial Cancer study and multiple other studies. He provided medical expertise in design, implementation, investigator selection, steering committee, statistics and CRF design. He advised on investigator initiated studies also. He was a valuable contributor to the program. It was a pleasure to work with Erard.
Peggy Siemon-Hryczyk
Pharmaceutical Executive
Breakthrough Life Sciences retained Dr Gilles to support a high-level strategy review for a key U.S. client. The company’s board asked for an independent/outside opinion on the viability of implementing a multiplex, blood based screening test for colon cancer in Europe. Our work included challenging client assumptions about the market landscape and key scientific and clinical elements of the test itself. Erard’s insights as an oncologist and technical skills on the statistical side proved to be invaluable throughout the project. We relied heavily on his expertise which added credibility to our conclusions and recommendations. I would gladly work with Erard again.
Breakthrough Life Science
About
Oncology Consulting
Hello, my name is Erard Gilles, and I am looking forward to bringing my strengths to your team! With over a decade of results-oriented experience, you will find me to be a highly valuable consulting asset to your organization. I have a proven ability of serving as the face of the company to stakeholders, as well as natural talent and passion for doing so. Additionally, I am highly accomplished in oncology and the pharmaceutical companies. I am looking to apply my expertise towards the positive progress of a new company. Please read on for more about me, and the array of talents I can and will bring to the table.