Oncology Therapeutic Development (OTD) Contract Research Organisation for the Early Development of Oncology Therapies

Oncology Therapeutic Development (OTD) is a contract research organisation specialising in the efficient creation and formulation of new therapies to treat and prevent cancerous tumours.

The company offers clinical consulting for venture capital (VC) groups or mid-size biotechnology companies to help optimise, launch, and execute plans for the clinical development of therapies. Its experienced medical staff provide strong support, making OTD a key partner.

OTD designs preclinical models to guide clinical development, as well as designing and implementing Phase I/II studies.

Consulting services for the development of oncology therapies

OTD aims to allow its partners to develop oncology therapies efficiently, cost-effectively, and in a timely manner. Its consulting services help establish a clinical development plan from study design to clinical trials.

The company’s detailled plans review proposed clinical studies, resources, and timelines to help ensure efficient trial conduct. OTD’s excellent due diligence helps ensure the precise collection of toxicology, regulatory affairs, pharmacology, and chemistry, manufacturing, and controls (CMC) data ready for preclinical and clinical development of novel drugs. The company provides key insights into the evolving patterns of cancer treatments to assist in this preparation and the development of strategies.

In addition, OTD helps design clinical and regulatory strategies to achieve expedited marketing approval and rapid adoption in the clinic. The company provides an on-site review of medical source data from clinical trials and compassionate-use programmes.

Management of clinical trials for oncology drugs

OTD’s team has vast experience in the management of oncology clinical trials, from conception to study report writing. The firm has previously assisted with more than 50 Phase I-II trials. These included many first-in-man molecules and featured therapies for all solid tumours and hematoplogic malignancies, including classic cytotoxins, targeted therapeutic agents, immunotherapies, and hormone therapies.

Many small biotechnology firms, mid and large-size companies, academic institutions, hospitals, and clinics have benefited from OTD’s collaboration.

Aspects of trials that OTD manages include:

  • Study design, target population definition, drug combination optimization
  • Protocol, amendment, and informed consent writing
  • Case report form (CRF) design emphasising clinically relevant data
  • Reglatory package preparation and submission to health authorities and ethics comitees or institutional review boards (IRB)
  • Patient eligibility verification
  • Project and site management
  • Monitoring
  • Serious adverse effect (SAE) medical safety monitoring
  • Pharmacokinetic and pharmacodynamics analysis
  • Data management with electronic case report forms (eCRF), randomisation using interactive voice response system (IVRS), and statistical analysis
  • Clinical study report (CSR) writing (for ICH E3 compliance), SAE narratives, posters, abstracts, and peer-reviewed manuscripts.
  • Pharmocovigilance: databases, SAE management, electronic transmission of serious unexpected serious adverse reactions (SUSAR) (Europeans Medication Agency certification / Eudravigilance)
  • Quality assurance

About OTD’s Management Team

OTD’s founder and head of consulting Esteban Cvitkovic is a medical oncologist, specialising in drug development. An important figure in the registration of many oncology drugs, he has lead therapeutic advances in genitourinary tumours and sarcomas, as well as head, neck, and gastrointestinal cancers.

With a portfolio of more than 200 peer-reviewed articles and 600 drug development abstracts, Cvitkovic has been appointed in instritutions such as Memorial Sloan Kettering Cancer Center and Columbia Presbyterian in New York, Instiuto Maria Negri in Milan, Institut Gustave Roussy and Hôpital Paul Brousse in Villejuif, and Hôpital Saint-Louis in Paris. His career began in Argentina after graduating at the age of 19. He co-founded the oncology-focused contract research organisation (CRO) Cvitkovic & Associates Consultants (CAC) in 1996.

OTD’s senior medical director Dr Mohamed Bekradda has 20 years of experience as a medical oncologist for the clinical development of anticancer drugs. With a focus on gastrointestinal and genitourinary cancers, he made a therapeutic evaluation of hormone-resistant prostate cancer and developed a cisplatin-containing chemotherapy regime for the treatment of germ cell tumours and an oxopilatin-containing regime of colorectal cancer and lung cancer. In addition, he has experience with anticancer agents such as immunotherapy, chermotherapy, and hormone therapy.

Dr Bekradda’s past appointments include at Institut Gustave Roussy in Villejuf, Centre Léon Bérard in Lyon, and the Center Hospitalier Sud Francilien in Essonnes. He also cofounded CAC with Professor Cvitkovic.

OTD’s senior project manager Fabrice Bourdel has both an MSc in cellular and molecular biology and an honours degree in biology and pharmacology of ageing. He worked at the CAC (subsequently AAIPharma) for more than ten years, focusing on clinical oncology research. He has extensive expertise in Phase I trials for cancer therapies and has managed more than 20 studies from Phase I to International Phase IV.

Make an enquiry

Follow this company

Follow the company to be always up to date with this company

Address
OTD Oncology Therapeutic Development

100 rue Martre

92110 Clichy

France

+33 1 47 15 01 01 +33 1 45 19 06 59 www.otd-oncology.com

Oncology Therapeutic Development (OTD) Images

Products and Services

Video

White Papers

Press Release

Regional Offices

OTD Oncology Therapeutic Development

100 rue Martre

92110 Clichy

France

+33 1 47 15 01 01 +33 1 45 19 06 59 www.otd-oncology.com

Contact company

I have read and accept the terms and conditions and privacy policy.
We'd like to keep you informed about relevant promotions, products and services, if you would like not to receive these, check this box.
If you would like to hear from carefully selected third party companies, check this box
Follow this company to receive notifications when they update.