Medelis Publishes "Adaptive Trial Design in Phase I / Phase II Studies"
Cytel CEO Ranganath Nayak, PhD discusses how adaptive trial design benefits sponsors in phase I and phase II studies.
Phoenix AZ —February 2, 2010 — Medelis, Inc., a full-service oncology contract research organization (CRO) providing drug development services in the US and Europe, has published a free new issue of Peer Perspectives in Oncology, "Adaptive Trial Design in Phase I / Phase II Studies." In this interview, Cytel CEO Ranganath Nayak, PhD discusses the benefits, opportunities, and challenges presented by adaptive trial design in Phase I and Phase II studies.
"Cytel has designed more adaptive trials for industry sponsors than any other service provider and in virtually every therapeutic area," explains Medelis CEO Bob Bosserman."We are pleased to work with them to implement adaptive trials for our clients and to publish this interview for our Insider Abstracts series."
Oncology thought-leaders Dr. Alan Sandler and Dr. James Cassidy join Medelis’ Medical Advisory Board
Advisors provide cutting-edge expertise and assistance in the development and advancement of personalized therapies and further strengthen Medelis' relationship with the clinical research community.
Phoenix AZ —September 29, 2009 — Medelis, Inc., a full-service oncology contract research organization (CRO) providing services in the US and Europe, today announced the addition of two respected oncology thought-leaders, Dr. Alan Sandler of Portland, Oregon and Dr. James Cassidy of Glasgow, Scotland, to its medical advisory board.
Medelis Expands CRO Services to Devices, Appoints Dr. Inder Makin as VP
Medelis to support device manufacturers throughout the product life cycle including early design and prototyping, simulation, preclinical and phase I-III clinical studies.
Phoenix AZ — September 22, 2009 — Today, Medelis announced that the company is expanding its services to support medical devices under the guidance of Inder Makin, M.D., Ph.D., who joins the company as Vice President, Devices & Radiological Health.
Dr. Makin has more than 20 years of experience developing "concept to clinic" healthcare technologies in both academia and industry. He has developed medical ultrasound-based research programs at various institutes, taking concepts (including catheter-based devices for intravascular thrombolysis transdermal drug delivery devices and non-invasive and intracorporeal tissue ablation devices) through feasibility and launch.
Cancer Researcher Dan Von Hoff, M.D. Advocates for “Context of Vulnerability,” A Powerful New Paradigm for Targeted Drug Development
Renowned cancer researcher Dr. Daniel Von Hoff and his team at TGen are fervent believers in a new approach to developing novel therapies for patients with pancreatic cancer. They are guided by a rationale dubbed the "context of vulnerability." Dr. Von Hoff provides case studies and explains how this powerful paradigm has already led to promising discoveries and is changing the future of oncology drug development.
Phoenix AZ —February 17, 2009 — Today, Medelis has published a free new downloadable abstract, "Context of Vulnerability: A Powerful New Paradigm for Targeted Drug Development." In this extensive interview, renowned oncology investigator Daniel D. Von Hoff, M.D., a founder of Medelis and a member the National Cancer Advisory Board, advocates for powerful new drug development paradigm that is generating impressive results in the war on pancreatic cancer, the most deadly of all cancers.
Medelis Publishes "The Lost Opportunity in Phase I Oncology Trials"
While most biotechnology companies use the phase I to evaluate a drug’s toxicity and tolerability, Medelis' Dr. Dan Von Hoff advocates that it can also provide valuable efficacy data and a compelling rationale for further study and investment, which ultimately leads to improved patient care.
Phoenix AZ — December 22, 2008 — Cancer drug developers traditionally use the phase I trial solely to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug. Today, Medelis has published a free new downloadable abstract, "The Lost Opportunity in Phase I Oncology Trials," an interview with renowned oncology investigator Daniel D. Von Hoff, M.D. In the abstract, he advocates for a phase I approach that looks beyond toxicity and gleans meaningful efficacy data, creating a more compelling rationale for further investment and improved patient care.
Medelis Expands Worldwide CRO Services with New European Division Led by Deirdre Tessman, Ph.D.
Medelis Europe offers complete oncology drug development services from preclinical through phase III
Phoenix AZ — October 7, 2008 — Medelis, Inc. today announced the formation of Medelis Europe and the appointment of Deirdre Tessman, Ph.D. as its Managing Director. Formerly of Tessman Technology Ltd. and ILEX Pharmaceuticals, Dr. Tessman brings more than 30 years of worldwide drug development and regulatory experience to the Medelis organization. She has directed all phases of pharmaceutical development from research through drug approval and marketing with additional expertise in the startup and turnaround of pharmaceutical companies.
Medelis Hires VP Preclinical Studies, Adds Oncology Preclinical Research Services to CRO Portfolio
September 9, 2008 — Medelis today announced that Mike McGarry, Ph.D. has joined the company as Vice President of Preclinical Studies. Dr. McGarry, a preclinical research scientist with over 35 years of experience generating animal-based data, will lead a new service offering to provide preclinical program design, management and execution on behalf of Medelis’ biotech clients around the world.
Medelis Publishes 'Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster'
September 4, 2008 — Medelis has published a free new downloadable abstract, "Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster," an interview with Mike McGarry, Ph.D.
Dr. McGarry is a preclinical research scientist with 35 years of experience generating high quality animal-based data. In the interview, he describes a nuanced preclinical process that can help a Chief Medical Officer (CMO) get into the clinic faster. This approach hinges on a strategic, well-defined rodent model, quality data, and ongoing integration between the pre-clinical, regulatory and clinical teams.
Medelis Publishes Interview with Renowned Oncology Investigator Dan Von Hoff
July 9, 2008 — Medelis has published a free new downloadable abstract, "The Complete Phase Ib: An Approach for Getting to Phase II Faster," an interview with renowned oncology investigator Daniel D. Von Hoff, M.D.
In the abstract, the second in Medelis' Peer Perspectives in Oncology series, Dr. Von Hoff discusses "the complete phase Ib," a trial design that streamlines phase I by testing various drug combinations in one trial with multiple arms running in parallel. This structure creates rapid accrual rates, substantial economies of scale and significant time savings for sponsors versus the traditional sequential approach. It also garners enthusiasm from investigators and patients, who ultimately gain greater potential for improved therapeutic benefits and care.
Medelis launches "Peer Perspectives in Oncology"
March 25, 2008: Medelis today announced the launch of Peer Perspectives in Oncology, a Q&A series that brings together some of the industry’s most respected researchers to talk about the issues facing Chief Medical Officers today: Rising costs. Optimum patient accrual. Targeted therapeutics. Patient safety. FDA regulations. Efficacy. Budgets. Timelines.
