Dr Said Dermime graduated with BSc. Degree in Biological Sciences from the University of Constantine, Algeria in 1985. He then received his MSc and PhD degrees in immunology from Salford University, Manchester, UK in 1987 and 1992 respectively. After that, he joined the National Cancer Institute, Milan, Italy for a period of 2 years as postdoctoral fellow and the NHLBI, NIH, Bethesda, USA, for another 2 years fellowship under an NIH Fogarty International Award. To gain industrial experience, he worked at PPL Therapeutics Limited, London, UK, and COBRA Therapeutics Ltd., UK for a period of 2 years. Dr Dermime was appointed in 1998 at the Paterson Institute for Cancer Research, Manchester, UK, as a lymphoma-cancer-vaccine Team Leader for 4 years. Subsequently, he established and led the Tumor Immunology Section at King Faisal Specialist Hospital & Research Centre, Riyadh, KSA, for a period of 6 years as a senior scientist. Dr Dermime joined after that the Dasman Diabetes Institute in Kuwait in 2008 to establish and lead the department of Biomedical Research and to head the Immunology & Innovative Cell Therapy Unit. In December 2012, he joined King Fahad Specialist Hospital in Dammam, Saudi Arabia to establish the Biomedical Research Facility and to head the Immunology & Innovative Cell therapy Program. Recently, he was recruited by the National Centre for Cancer Care and Research (NCCCR), Hamad Medical Corporation to establish and Lead the Translational Cancer Research Facility.
Robert Hawkins is Cancer Research UK Professor at the University of Manchester and Christie Hospital. In addition to clinical training he was an MRC Research Fellow with Dr Greg Winter and Dr Cesar Milstein at the MRC laboratory of Molecular Biology in Cambridge. His PhD was in antibody engineering and as a Cancer Research UK Senior Clinical Fellow he developed translational research interests in antibody based gene therapy. He was first appointed as a consultant in Cambridge in 1995 and then became Professor of Oncology at the University of Bristol in 1996. In 1998 he moved to the Christie Hospital to become Professor and Director of Medical Oncology. Clinically, He heads a clinical research group undertaking trials renal cancers and also a range of early phase clinical trials of biological agents. He also leads a group undertaking translational research into immunotherapy of cancer with a focus on adoptive cell therapy. In addition, to pre-clinical research he has developed a GMP cell therapy unit to provide clinical grade cell manufacturing – this is now a commercial spinout company (Cellular Therapeutics Ltd). He is/has been the coordinator of several major European Union consortia in this field including the on-going clinical trials project (www.ATTACK-cancer.eu). He has published widely in scientific and clinical journals.
Professor Hussain graduated from Dow Medical College Karachi in 1994. He completed his general medical professional training in UK. He did his Doctorate in Oncology from University of Birmingham. He then completed his Medical oncology training in Birmingham, United Kingdom and received his certification and specialist registration in Medical oncology.
He is Professor/ Chair and Consultant in Oncology at the University of Plymouth and Plymouth University Hospitals. His major areas of interest are management of urological cancers, clinical trials, early drug development and translational medicine. He has set up a large number of clinical trials from early phase to late phase studies during his career thus providing early access to novel drugs for patients within the region and receives patient referrals from far and wide.
His work on organ preservation in bladder cancer moved all the way from an early phase I study (Hussain et al Annals of Oncology 2001), to phase II efficacy study (Hussain et al BJC 2004) that led to a Cancer Research UK funded study BC2001 trial that was reported in New England Journal of Medicine (James, Hussain, Hall et al April 2012). This study has now changed the standard of care for patients with muscle invasive bladder cancer opting for organ preservation treatment. His work on split dose cisplatin in bladder cancer has extended the spectrum of patients receiving cisplatin based chemotherapy (Hussain et al BJC 2004). Dr Hussain is principal investigator of a number of studies in bladder, prostate and kidney cancers. He is a chief investigator of a national randomised placebo-controlled phase II neo-adjuvant study in muscle invasive bladder cancer. He served as chief investigator of various early phase, and translational studies. Dr Hussain received prestigious ASCO merit award for two consecutive years.
Dr Hussain has authored 77 peer-reviewed publications including 4 book chapters in textbooks of oncology. Dr Hussain has been an invited speaker to international and national meetings. Dr Hussain has secured funding of over 3.6 million pounds from national funding bodies.
Michael Streit, MD, MBA joined Janssen on 24 June 2013 as Clinical Leader, Early Development to support the Hematology and Prostate Cancer early-development activities.
Michael has a strong and diverse background in biomedical sciences. He received his medical training in Hematology/Oncology from the Free University in Berlin. Michael went on to complete a three-year post‐doctoral research fellowship at the Cutaneous Biology Research Center at the Massachusetts General Hospital where he also served as research instructor at Harvard Medical School.
His first industry assignment was to work as a laboratory‐based Oncology Discovery scientist at Berlex Biosciences the US-subsidiary of Schering AG (now part of Bayer). He subsequently received an MBA from Golden Gate University and joined Boehringer‐Ingelheim to conduct early and late clinical trials in lymphoma, pancreatic and lung cancer patients. In 2008, he moved to Bristol‐Myers Squibb (BMS) and led several global Phase 3 trials in hepatocellular carcinoma for the antiangiogenic agent, brivanib. In addition, Michael was also the co‐leader of their Biomarker Working Group focused on preclinical and clinical translational research. In 2010, he joined GlaxoSmithKline (GSK) Oncology to work on the MEK inhibitor trametinib and the BRAF-inhibitor dabrafenib. Michael was the physician leader of the US and EU filing of trametinib and co-leader of the US-filing of the first combination therapy of two targeted small molecule inhibitors (i.e. trametinib and dabrafenib). Both new medicines were approved by the FDA in May 2013.
Since Joining Janssen, Michael has worked on a number of first-time-in-human programs such as the listeria-based immunotherapies (ADU-214 and ADU-741) and the first –T-cell re-direction antibody (i.e. MGD-011). Currently, Michael is the medical lead of the agonistic anti-CD40 antibody program and primarily supports the activities of the Prostate DAS.
Jordi Rodón Ahnert, MD, PhD specializes in early drug development, biomarker discovery, personalized cancer medicine, and neuro-oncology. He is now at MD Anderson’s Investigational Cancer Therapeutics department after moving from Barcelona, where he has been the director and clinical head of the Research Unit for Molecular Therapy of Cancer at the Vall d’Hebron University Hospital in Barcelona, Spain. Within this unit, he served as clinical head of the Early Clinical Drug Development Group, which aims to develop best-in-class targeted therapies, determine patient populations most likely to benefit using personalized molecular characterization, and identify biomarkers of response. At Vall d’Hebron University Hospital he was also in charge of the Neuroncology program, building it in collaboration with the Phase I Unit, the multidisciplinary clinic and the Gene Expression and Cancer Laboratory leaded by Joan Seoane.
Dr JP Armand focuses his cancer research in the field of new mechanism of oncogenese and early drug development.
Jean-Pierre Armand MD, MSc, is certified in Medical Oncology (University of Toulouse III and Paris XI)
He was recently General Director of the Institut Claudius Regaud in Toulouse (2007 -2012) . Over the last five years he has been in charge of the construction of a new cancer center, in a European research hub created in the Toulouse cancer campus (Institut Universitaire du Cancer).
After a position as research fellow in Columbia University New York, Dr Armand has joined Institut Claudius Regaud in Toulouse, he was head of Medical oncology until 1984. In the next 23 years, at Institut Gustave Roussy (IGR) in Paris, he was successively CEO of the Hospital IGR3, head of the Department of Medical oncology at IGR2 and finally CMO of IGR&D, Dept of Innovation and Development at IGR.
Although expert in breast, head & neck, and neuro-oncology, the first field of Dr Armand was very early drug development in phase 1 and 2. He has been the founder of the IGR Phase I Unit (Ditep) in the early 80s. He did the first in human phase I in the world at IGR of numerous drugs, including classicals cytotoxics, Irinotecan, Oxaliplatin, Taxotere, Navelbine, Vinflunine, and more recently targeted therapies, Sutent, Sorafenib, Temsirolismus…
Dr Armand is active in the International Cancer community.
He served as :
• President of the European Society for Medical Oncology (ESMO),
• Medical Director of the Federation of European Cancer Societies (FECS/ECCO),
• President of the French Cancer Society (SFC)
• Chairman of the Protocol Review Committee of European Organization of Research and Treament of Cancer (EORTC)
• Chairman of Oncology at French EMEA (AFSSAPS)
• Member of International Boards of the American Association for Cancer Research (AACR)
• Member of scientific committee of the American Society of Clinical Oncology (ASCO) and AACR
• Member of the board of clinical trials at Institut National du Cancer (INCa)
• chairman of the president nominating committee of ESMO
He has (co)authored over 300 medical and scientific peer-reviewed articles and he is/was member of the Editorial Boards of Annals of Oncology, the European Journal of Cancer, Journal of Clinical Oncology, Investigational New Drugs, Anticancer Research, Clinical Cancer Research.,CISCO journal
DR Armand he received
– In 2008 (Stockholm) the ESMO Award as “the European oncologist of the year”
– In 2013 the Targeted Anticancer Therapy (TAT) honorary award in recognition of his
contribution to new drug discovery in cancer
– In 2013, decoration of Chevalier of Legion d’ honneur of France
– In 2014 the European Lung cancer award
After a 5 years as CEO of Institut Claudius Regaud in Toulouse, he is now (2016) back in Paris as：
1)senior clinical and reseache consultant in the drug development department (DITEP) at GUSTAVE ROUSSY cancer campus Grand Paris University Hospital;
2)vice-president of education at IFSBM (Institut de formation superieur biomedical-university Paris-sud);
3) Vice president /CMO at Campus Cancer-Paris.
Thierry Vandamme obtained his PhD in Pharmaceutical Sciences in 1994 at the catholic University of Louvain in Belgium. After its PhD thesis, he carried out two post-doctoral training courses, the first one at the University of Stanford in California (01.01.1995 – 31.12.1995) in the Laboratory of Dr. Jorge Heller (Laboratory of synthesis of biodegradable polymers) and the second one at the School of Pharmacy in London (01.01.1996 – 31.08.1996) in the research team of Professor Ruth Duncan (Laboratory of therapeutic polymers). In 1996, he became lecturer at the University Louis Pasteur of Strasbourg and was promoted Professor in Biogalenics in February 2005 on an employment “Fillon”. His research activities are undertaken within the Department of Bioorganic Chemistry (UMR7199) and the main aim of this research activities are based on the developments of new systems of delivery of drugs. His research activities and his laboratory are located in the Faculty of Pharmacy of the University of Strasbourg. He is also the Vice-Dean in charge of research in the Faculty of Pharmacy.
Dr. Abdelilah Gounni is a Professor in the Department of Immunology, Max Rady college of Medicine at the University of Manitoba. He is a member of the Biology of Breathing Group and a senior scientist of the Children Hospital Research Institute of Manitoba.
Professor Gounni received his Ph.D. from Pasteur Institute, University of Lille, France, and then underwent training as a National Swiss Foundation Research fellow at the University of Basel, and as a postdoctoral fellow at the Meakins Christie Labs at McGill University, Montreal, Canada.
His research program investigates the molecular mechanisms of immune regulation in airway chronic inflammation, and is continuously supported by funding agencies including the Canadian Institutes of Health Research (CIHR), Research Manitoba and National Sciences and Engineering Research of Canada among others.
Dr. Gounni is well established investigator with an outstanding publication record, 85 in total and 28 in the last 5 years, with a Scopus H Index of 31 and more than 2700 citations. He is a recipient of many prestigious awards including Swiss National Foundation fellowship, CIHR postdoctoral Fellowship, CIHR New Investigator and Manitoba Research Chair among others. Over his career, he has mentored more than 30 post-doc medical fellows and graduate students. He served on many international and national granting agencies committee and Editorial Board of respected journals.
- Seventeen (17) years of management experience in all facets of biologics development & manufacturing in leadership positions that include Vaccine
- Extensive expertise in cell line development, media development, purification development, analytical development & formulation development, clinical manufacturing and commercial manufacturing.
- Directly responsible for the successful transfer of late phase III manufacturing processes for BDS at CMO and its implementation and production at 2500L scale.
- Completed and demonstrated the comparability of BDS produced at XOMA and at CMO
- Member of CMO selection committee for manufacturing of phase III antibodies
- Extensive experience in process development and manufacturing of antibodies using CHO-K1 & E.coli.
- Directed process characterization of multiple antibodies based on QRM, DOE and QbD processes for upstream and downstream processes.
- Reviewed and approved process validation protocols and reports for PPQ BDS batches
- Provided technical support to CMOs in resolving and closing the process deviations.
- Planned and implemented stage III Continued Process Verification (CPV) protocols for trending and monitoring CPP, CQA,APRs & Product Quality Reviews(PQRs)
- Scaled up Pertussis combo vaccine commercial process to 2000L; significantly contributed to the approval PLA for combo commercial vaccine.
- Develop and maintained knowledge management systems for commercial processes in the form of TDRS and TTRs
- Involved in writing of CMC sections of INDs (phase I, II, III), PLA and BLA for proteins, vaccines and antibody products.
- Worked collaboratively within matrix organization structures with Preclinical, Clinical, Regulatory, Quality and Supply chain to support clinical and commercial manufacturing.
Ability to coach and develop the technical skills required by process development and manufacturing personnel with focus on right priorities, good project management skills, and negotiation skills
Dr Rana Rais, Ph.D. is an Assistant Professor at the Johns Hopkins School of Medicine, and Director of the drug metabolism and pharmacokinetics group of Johns Hopkins Drug Discovery. Prior to joining Johns Hopkins Drug Discovery Program, Dr. Rais was granted a Research Science Regulatory (RSR) fellowship at US FDA to evaluate the biopharmaceutic properties of new molecular entities from new drug applications. Dr. Rais received her Ph.D. in Pharmaceutical Sciences with substantial experience in biopharmaceutics, drug transport, metabolism, pharmacokinetics, and drug delivery. Specifically, Dr. Rais has developed and implemented methods to study the in vitro and in vivo and pharmacokinetics of novel chemical entities. Also a major focus of her lab has been evaluating drug delivery strategies specifically prodrug approaches for compounds with poor physicochemical properties such as poor solubility and poor permeability. Examples of such compounds include anticancer agents as well as hydrophilic molecules with multiple charges which show poor penetration to biological membranes. Lastly, she and her lab are highly skilled in conducting bioanalysis of challenging molecules in different biological matrices especially those that cannot be analyzed by simple reverse phase chromatography.