"We engage Paracelsus at Aires (and did so at our previous company, Palkion) and have been very pleased with Dr. Furman’s knowledge, expertise, advice, timeliness, and work ethic. We are a virtual company, and so rely heavily on our consultants. Grace was, and is, a very valuable member of our team!"
"We chose Paracelsus to help us with our first IND application because of Grace Furman’s prominent reputation in the toxicology arena and her extensive experience shepherding small molecules through nonclinical safety and toxicology studies. In addition to developing our nonclinical development plan, Grace participated in strategic decisions of study design, review of data and writing of the IND application. She did an outstanding job. Grace displayed excellent knowledge, professionalism, insight and efficiency in getting the work done, and her superior writing and planning skills saved us time and money."
"We have had the great pleasure to work with Grace at Paracelsus on ENDECE’s lead oncolytic candidate, NDC-1308, and now consider her to be our “go to” person for toxicology. Grace guided our late pre-clinical toxicology strategies and developed our detailed animal safety study protocol for NDC-1308. In addition, she played a major role in our first pre-IND meeting with the FDA and was instrumental in ENDECE achieving a successful outcome. Grace is very professional, deeply knowledgeable and a pleasure to work with. ENDECE looks forward to continuing our relationship with Grace and Paracelsus."
"Families of Spinal Muscular Atrophy (FSMA), a non-profit organization with the mission of accelerating the identification of a treatment for SMA, began their relationship with Dr. Furman and Paracelsus in 2007. Dr. Furman and her colleagues at Paracelsus have been instrumental in helping FSMA reach multiple milestones for our internally owned small molecule drug program for Spinal Muscular Atrophy. These include receiving Orphan Designation from the FDA, preparing for a productive in-face pre-IND meeting with the FDA, out-licensing the compound to an industrial partner (Repligen Corporation), and recently receiving approval from the FDA to begin Phase I safety trials. Dr. Furman and her team of experts at Paracelus actively assisted us in all of these phases of the project, with specific activities ranging from designing GLP toxicology and pharmacology studies that formed the basis of our IND application, providing regulatory support when writing our application for orphan disease designation, and participating in out-licensing discussions with potential industry partners. Paracelsus provided us with valuable advice and guidance on our program, which has led to the very tangible results enumerated above. FSMA has been extremely pleased by the results of our association with Paracelsus and the stage to which our program has progressed to date with their help."
"“In 2007, Kalypsys took a chance by signing on as Grace’s first client as an independent consultant. Her work on that project immediately justified the risk taken, and we have engaged Grace for every subsequent program. Our track record of toxicology program acceptances by the FDA demonstrates that she has consistently delivered quality toxicology advice and services. Grace’s contributions have included outstanding strategic, tactical and operational support for programs in diverse therapeutic areas. I also appreciate that Grace brings a vitality and sense of humor that makes it truly a pleasure to have her as a project team member.” "
"Engaging Paracelsus, Inc. has been an extremely efficient route for Neuralstem’s drug development effort. Since 2009 starting from just proof-of-concept animal data to 2010 successful approval of IND, Paracelsus has provided nonclinical safety, pharmacokinetic and regulatory support. Paracelsus has provided on-the-mark, just enough, just-in-time, invaluable, advices for our very first drug candidate which successfully resulted in 30-day approval of IND by CDER for a psychiatric indication. Paracelsus continues to be an invaluable service provider as we are progressing our clinical development to Phase II."
Karl Johe PhD, Scientific Founder and Chairman, Neuralstem, Inc.
""It has been a pleasure to work with the experienced drug development team at Paracelsus, Inc. who have provided invaluable clear and concise critical path support to our programs at Selexagen Therapeutics, Inc.""
Selexagen Therapeutics, Inc., Patrick M. O'Connor, Ph.D., CSO
The CHRISTUS Stehlin Foundation for Cancer Research
"We used Paracelsus Consulting to formulate our toxicology strategy and to design a project plan and oversight of an IND submission. They are highly professional and after a brief explanation of our compound and background data assisted us in putting together a straightforward process to complete the IND application. Paracelsus also wrote all of the text for the modules in the IND pertaining to toxicology and assisted throughout the other modules. It’s also a plus that not only are they highly knowledgeable, but also very congenial and easy to work with. Our IND was approved by the FDA on our initial submission, which is proof of the expertise Paracelsus provided. Without hesitation I can enthusiastically recommend their services."
"TGen TD2 provides a broad range of regulatory expertise and services with integrated project management to ensure that client programs run seamlessly into clinical development. Our reputation of excellence in strategy, writing and submissions stems from our industry experienced team who are committed to the success of our clients. Paracelsus has been an indispensable member of this team since 2007 and is responsible for providing strategic and operational nonclinical safety support to TD2 client programs. TD2 and its clients have been overwhelmingly satisfied with the exceptional levels of professionalism and expertise provided by Paracelsus. We hope to continue our fruitful collaboration with Paracelsus for many years to come!"
Stephen Gately Ph.D, President & Chief Scientific Officer, TGen TD2
"Grace’s experience allowed us to challenge and think through the best strategy to help address the known FDA’s concerns on our early product plan. On repositioning our pre-clinical strategy we had our IND accepted within the 30 day review time with no requirement for additional pre-clinical and was allowed to enter phase 2 clinical studies."
Ian Clements, Co-founder, President & CEO, ViroXis