CURABLE CONSULTING SERVICES

Support functions for internal teams at biotech & pharmaceutical companies and healthcare systems

RESEARCH & SCIENTIFIC ANALYSIS

  • Scientific literature review, summary, interpretation, and application to preclinical and clinical programs
  • Collaboration structuring, relevant patient sample procurement, in vitro design
  • Research support for the internal team
  • Document and data review and analysis
  • Technical writing for multiple audiences
  • Translation of technical writing for lay audiences

 

PRECLINICAL DESIGN & INTERPRETATION

  • Assistance with identifying and understanding relevant preclinical models
  • Expert recommendations regarding model selection, collaborating investigators, experimental design, and interpretation of results
  • Assistance with documentation of findings

 

CLINICAL DEVELOPMENT STRATEGY & TRIAL DESIGN

With an emphasis on safety and clear, realistic execution, our consultants support clients crafting a clinical development strategy oriented to FDA requirements and commercial success.

  • Trial Design
  • Expert recommendations regarding cost and duration
  • Insight into patient considerations for therapeutic design and testing
  • CRO selection and support alongside CRO, including site selection
  • KOL and investigator recommendations
  • Enrollment and enrichment strategies
  • Regulatory strategy, including guidance on evolving endpoints
  • Commercial strategy

 

AREAS OF EXPERT KNOWLEDGE

  • Rare and Complex Disease
  • Fibrotic Disease
  • Liver and Lung Indications
  • GI Disease
  • Autoimmunity
  • Transplant Medicine
  • Immunology
  • Imaging Biomarkers
  • Laboratory Biomarkers
  • PRO Instruments
  • Patient Engagement
  • Combination Trials
  • Innovative Trial Design
  • Health Policy
  • Medical Toxicology
  • Clinical Pharmacology
  • Antibody Technologies
  • Medical Devices
  • Cell Therapies
  • Targeting Technologies
  • Genetic Modification

RAMONA DOYLE, MD

Dr. Doyle is a physician with academic, government and biotech experience and a deep commitment to patient care and science-driven ethical drug development and impactful clinical research. She brings to client engagements deep experience in medicine, patient care, product development science, endowments and tech-academic partnerships. She has a track record of driving excellence for patient populations with unmet needs in often-challenging settings with high-target performance requirements. She has extensive experience in clinical trial design and execution, as well as regulatory and commercial strategy, including leadership of clinical development strategy and execution at the CMO level. She has served as Vice President of Therapeutics at the California Institute of Regenerative Medicine (CIRM), where she helped to design and launch a strategic overhaul of this California state agency tasked with disbursing $3 billion research dollars. Previously, she served as Senior Group Medical Director for Respiratory Product Development at Genentech, leading an international team of scientists and clinicians developing programs in five different disease areas. In 2014, Dr. Doyle was the Roche R&D lead for the acquisition of InterMune, Inc., and its drug Esbriet® (pirfenidone) for idiopathic pulmonary fibrosis (IPF). Prior to her tenure at Genentech, she served as Director of Medical Affairs at Gilead, where she led the respiratory and cardiovascular disease franchise. Dr. Doyle is also a clinical professor of medicine at UCSF. She was on the faculty at Stanford University School of Medicine for 12 years, during which time she served as the Medical Director of the Lung and Heart-Lung Transplantation Program and founded a program in pulmonary hypertension. Dr. Doyle continues to maintain clinical skills and see patients regularly in voluntary faculty positions at UCSF. Based in San Francisco, Dr. Doyle received her BA degree from the University of the South (Sewanee), BA and M.Sc. degrees from Oxford University in England and her MD degree from Emory University in Atlanta, after which she completed her training in internal medicine, as well as a fellowship in pulmonary and critical care medicine, at the University of California at San Francisco (UCSF) Medical Center.

SAM JACKSON, MD, MBA

Sam is a board-certified physician executive with a track record of value creation. He has extensive expertise in translational medicine and in all phases of drug-development.  After graduating from Stanford University with a BA in English Sam moved to UCSF where he worked in the pharmaceutical chemistry laboratory of Charles Craik specializing in the structure and function of proteins. Sam then attended the University of Pennsylvania for his MD and MBA degrees where he received a full scholarship. He went on to complete residency training in Emergency Medicine at the UC Davis Medical Center in Sacramento and fellowship training in Medical Toxicology at the Banner Good Samaritan hospital in Phoenix Arizona, the foremost in-patient medical toxicology center in the US. At Banner he served as an investigator on a clinical trial for a treatment against scorpion envenomation.  Sam’s tenure in industry began at Amgen where he joined the Early Development Safety Group. There he was involved in several programs at the pre-clinical and first-in-human stages of drug development. Later he was promoted to the position of Global Safety Officer for Prolia™ Amgen’s recently launched drug for osteoporosis. In this role he traveled to several regulatory agencies across the globe answering questions and discussing clinical data for label negotiations. Sam took on his next challenge at Genentech working as a Project Team Leader in the early development organization leading drug-development teams in various therapeutic areas such as immunology, ophthalmology, infectious and gastro-intestinal disease with programs in the pre-IND and first-human stages. After Genentech, Sam worked at Dynavax as the Executive Medical Director in charge of development for Heplisav™, a vaccine against Hepatitis B that uses an innovative adjuvant that stimulates the innate immune system. There he led the pivotal phase 3 trial and the extensive analysis of clinical trial data that led to the approval of this important new vaccine for the prevention of Hepatitis B. After Dynavax Sam served as the Chief Medical Officer of Alkahest, a private biotechnology company using plasma-derived therapeutics to treat age-related diseases. He is currently working as a consultant Chief Medical Officer at Excision Biotherapeutics, an innovative biotechnology firm using CRISPR to cure viral infectious disease.  Sam enjoys working as a consultant helping teams solve practical problems in drug development and translational medicine. He also enjoys spending time with his two daughters as they discover new ways to negotiate for more screen time.

LISA BOYETTE, MD, PhD

Dr. Boyette is a biomedical engineer, physician, and classically trained immunologist who specializes in translational approaches to complex disease pathogenesis and target identification, as well as therapeutic development and testing in rare and complex patient populations. In 2014 she co-founded the non-profit SAVE JON, later renamed Curable, in an effort to blueprint a new strategy for bringing the very best technical and clinical resources into present application for patients, namely patients suffering from Primary Sclerosing Cholangitis and related disorders.  During her tenure as CEO of Curable, Dr. Boyette started and oversaw all active research and medical support programs, including the International PSC Genome Project, a collaborative initiative with the Regeneron Genetics Center, Mayo Clinic, Kiel University, and others; Unravel PSC, a multi-omics systems biology program in collaboration with NIDDK, Indiana University, and industry partners; and several triage and referral initiatives for PSC patients, including a clinical trials listing and a trial matching service.  In response to demand from pharmaceutical and biotech partners, Curable formed a subsidiary in 2018 called Curable Consulting to deliver guidance and implementation services to companies working in the rare liver disease space.  Dr. Boyette serves as a consultant at Curable Consulting and chairs the Curable Executive Board.  Prior to founding Curable, Dr. Boyette performed clinical research to understand the role of the innate immune system in solid organ transplant rejection and tolerance. Based in Pittsburgh, she continues to investigate these topics as an adjunct assistant professor in the Starzl Transplantation Institute at the University of Pittsburgh School of Medicine. She is also an expert in the area of adult and pluripotent stem cells, regenerative medicine, and genetic engineering. She was a policy fellow at the Institute of Medicine of the National Academies of Science. She trained as a fellow at the Starzl Transplantation Institute and the National Institutes of Health, received her M.D. and Ph.D. from the University of Virginia, and received a B.S. in Biomedical Engineering from Virginia Commonwealth University.