João Paulo Lima Email and Phone Number

Embodied by OrphanDC mission, I provide support to our foreign clients who noticed that running highly demanding trials in Brazil and South America is not only feasible but very doable. We keep the highest standards of data quality and patient protection in all our trials. We seek to partnering all studies to the most suitable trial sites. We assess every single trial we support to identify which is the best strategy. While developing any strategy, I liase with KOL and different sites in Brazil receiving and offering inputs on the trial market, competitors, and features that may hasten the trial enrollment and conduction. A sizeable portion of my work revolves around training and identifying opportunities for trials around Brazil.Thence I work in very close collaboration with trial sites, sponsors, and PIs; building a network based on mutual trust and excellent knowledge of clinical research in Brazil.

As part of my personal quest of fostering clinical research in Brazil, I've been providing expert input to clinical trial sites in Brazil since 2020. From site inception to revamp and satellite creation, from private clinics, not-for-profit, and public hospitals, there is always an opportunity to bring excellence in oncologic and non-oncologic care to nearly all patients.From assessing viability, reason and motives to start a research unit, to develop the team, training staff (regulatory, coordination, medical affairs, PIship) and there is a good way to make the trial unit shine in a very competitive market.I conducted investigator-initiated studies (IIS), with pharma and academic support. From protocol drafting through budgeting, statistical analysis plan, granting application, day-to-day practice and publishing, our team has strong experience on all steps of IIS.

The mission of the hospital aligns to my personal view of cancer management: provide outstanding service for private and public patients, combining clinical and translational research with passionate human care on a daily basis.

Medical Lead of the Clinical Research Support Center (CAPEC) AC Camargo.Responsible for the capture and follow-up of Clinical Studies of Internship (Phase II-IV) and Data Science.Following the Cancer Center project, the AC Camargo Clinical Research enters a new phase with the possibility of conducting interventional studies with immunotherapy, CAR-Ts, Phase I dose escalation, and combined surgical treatment.We maintain the focus on the patient, thus we seek to guarantee full security to the subject of research and data quality control according to the best clinical practices.

I had a close contact with key scientists in the field of drug discovery at our state-of-art facilities of ICR-RMH. This granted me the opportunity to have full exposure to all aspects of drug development, from the clinics to finding a target, drug design and testing in patients, and then iterative translational studies.I took active role in decision pertaining dose escalation, cohort expansion, patient selection, PK/PD interpretation in some of our 44 early trials.Excellent patient care and absolute GCP compliance were at the forefront our routine. On a daily basis, I assessed the suitability of cancer patients for our early phase trials through the clinical perspective and by the biologic rational when we offered to our patients the participation in a trial of our ever-growing portfolio. The intense collaboration with leading drug developers was a very exciting facet of the job and involves either our in-site partner ICR or several Biopharma and biotech companies. In the drug development process I liaised with sponsors, regulatory bodies and patient associations, having a very unique opportunity to enhance my understanding and experience in experimental therapeutics from different angles.I had the opportunity to confirm challenging task must be dealt by a passionate, cooperative, and outstanding team! Gratefully DDU has one.

In the Gynae Renal Melanoma unit I had the unique opportunity of interacting with world key physician-scientists in a cutting edge environment; this broadened my understanding of medical oncology, clinical research and science production.The day-to-day medical and research duties - with the valuable advice of excellent clinical mentors - contributed enormously to my development as a doctor and clinical researcher.I was the medical port of call for study monitors in the top UK recruiting Gynaecology oncology unit led by Dr Susana Banerjee. On my stint as research fellow, we manage to nearly double our inclusion of patients in Gynae clinical trials, which now has more than 20 trials open to recruitment. At the renal and melanoma unit, I was directly involved with immunotherapy and targeted-therapy trials at this extremely active unit led by Prof Martin Gore and Dr James Larkin. At the same, we kept an excellent data record and GCP compliance.During my stint, I was heavily involved with clinical audit and also with clinical and translational studies, which enhanced further my abilities of scientific production.

I worked as medical consultant in the breast and gynaecology unit of Barretos Cancer hospital, the largest cancer center of South America. During the four years in this position, I became the deputy senior consultant of the unit, liaising on a daily basis with sponsors, regulatory bodies, aiming to enhance the care of our patients through better trial options and improvement of standards of care.We managed to be Brazilian top recruiters in some breast cancer trials and, more importantly, national reference in good research practice. As a sign of our achievements, our hospital was selected as preferred partner by some pharma companies, as BMS, Roche, and Novartis. We also provide clinical research training for our fellows, introducing them to reality that cancer care must encompass clinical trials and GCP.

Attending Physician assigned at the Breast and Gyn Tumors Unit

As a volunteer, I had a most amazing "off the walls" experience in the care of cancer patients. It was really rewarding and intense to share cancer experiences with young patients outside the consultation room.