ODG’s development efforts benefit from collaboration with dedicated Scientific Advisors having expertise in various aspects of drug development. Serving generously on a pro bono basis, these advisors recommend approaches to scientific work, outlining studies that answer questions in an efficient manner, thus making the most cost-effective use of donor funds. Further, their advice shortens the time needed to develop oxfendazole for patients who are in need of its antiparasitic effects.
Timothy P. Coogan PhD, DABT is Founder and Principal of South Basin Associates (SBA), an independent consulting company focused on Nonclinical Drug Safety. Tim has expertise in building nonclinical safety assessment strategies for biologic and small molecule therapeutics in order to guide safe first in human use and continued clinical development through registration.
Prior to founding SBA, Tim worked for 26 years at Johnson & Johnson (J&J) within their pharmaceutical sector holding various positions with increasing responsibility. From 2013, he was Vice President and Head of the Biologics Toxicology group in Janssen Biotherapeutics, the former Centocor organization. In 2017, he became Global Head of Nonclinical Safety with overall responsibility for the nonclinical safety assessment of biologic and small molecule therapeutics in the Janssen R&D portfolio. During his career, Tim and his team have had responsibility for the development of many biologic and small molecule therapeutics, a number of which ultimately achieved global registration and approval. Additionally, Tim served as a member of the First-in-Human Early Development Committee evaluating potential therapeutics in the Janssen portfolio for safe administration in human. Tim earned a Ph.D. in Pharmacology from the University of the Sciences (formerly The Philadelphia College of Pharmacy & Science) and is Board Certified in Toxicology. He was a postdoctoral fellow at NYU Medical Center and came to J&J from the US National Cancer Institute in 1992. From 2006 to 2017, Tim was an Adjunct Assistant Professor in the School of Pharmacy at Temple University. (LinkedIn Profile: https://www.linkedin.com/in/timothy-coogan-a9937410)
Donald Heald, Ph.D., President, Tenacia CP BIO Consulting, LLC.
Dr. Heald has over 35 years of experience in clinical pharmacology (CP), translational science, medical affairs and global strategic marketing in the pharmaceutical & biotech industries. Over his career, he was directly responsible for the CP and Bioanalytical (BA) sections for 46 approved NDAs and global regulatory submissions. Prior to starting his own consulting company in 2020, Dr. Heald worked at Janssen Biotherapeutics (J&J) as Head of Discovery Translational Sciences and his group was responsible to help identify lead candidates and conduct experimental pharmacology studies in discovery. In addition, his group was responsible to determine the FIH starting and efficacious dose in early development for biologics across multiple therapeutic areas. Prior to Janssen Biotherapeutics, Don served as VP and Global Head of Clinical Pharmacokinetics at J&J Pharmaceutical Research and Development. Don’s group was responsible for conducting global CP Phase 1-4 studies for all drug candidates in all therapeutic areas and global regulatory submissions. Don led the CP group in Medical Affairs at Rhone Poulenc Rorer (RPR) and previously led the Clinical Drug Disposition group at RPR and was responsible for the Bioanalytical & CP departments supporting drug development and global regulatory filings. He was a Sr. Scientist at The Upjohn Company and served as a Clinical Pharmacologist for the Cardio/Renal Division at the FDA. Dr. Heald earned MS (pharmacology) and PhD (pharmaceutical sciences (PK/PD)) degrees from West Virginia University. He has over 65 publications, 70 poster presentations and invited speaker over 40 times and has received numerous awards. In addition, Don held numerous leadership positions in IQ Clinical Pharmacology Technical Group, Society of Nuclear Imaging in Drug Development, American Society of Clinical Pharmacology and Therapeutics (ASCPT) and is currently serving on the Board of Directors for ASCPT.
Norman D. Huebert, PhD, is a Pharmacokineticist with a background in Biochemistry and Biological Psychiatry. He has worked in the pharmaceutical industry in large pharma and biotech for 35+ years in the therapeutic areas of oncology, neuroscience, analgesia, respiratory, cardiovascular, enterology, metabolic diseases and inflammation. He has been involved in the discovery and development of 8 new chemical entities approved by regulatory agencies and has had 20+ enter clinical trials. His interests lie in de-risking discovery projects based on chemistry, biology, pharmaceutical and toxicological properties. He is currently consulting for various entities including biotech companies, Institutes and non-profit organizations.
John H. Krayer, MS. Nonclinical Toxicology Consultant and Principal at Krayer Consulting Services, LLC
John Krayer, MS, is Principal of Krayer Consulting Services, LLC, an independent nonclinical toxicology consulting company that he founded in 2021 following retirement from Janssen R&D, a Johnson & Johnson company. He has over 40-years’ experience in the field of toxicology, specializing in reproductive toxicology. Before retiring, John was Scientific Director in Nonclinical Safety at Janssen R&D where he managed a group of Study Toxicologists that monitored in-house and contracted toxicology studies, and worked closely with compound development team (CDT) toxicologists, CROs, and internal and external stakeholders to assure timely and accurate execution of toxicology studies. He also served as a nonclinical safety leader (NCSL) on pre- and post-new molecular entity (NME) CDTs. Additionally, he participated in the review of due diligence in-licensing opportunities, out-licensing of internal assets, and conducted and reported numerous health hazard/risk assessments. He has extensive experience in Health Authority interactions worldwide. Prior to rejoining Janssen R&D (Centocor R&D), John was a Study Director/Monitor in the GSK Safety Assessment group and was a Safety Assessment Project Representative. Prior to joining GSK, John was in the Full Development and Due Diligence group, Johnson & Johnson Pharmaceutical R&D. His career at J&J started in the Reproductive Toxicology group, Drug Safety Evaluation, McNeil Pharmaceutical following an introduction to developmental and reproductive toxicology as a Teratologist at Wyeth Laboratories. He participated on the HESI Developmental and Reproductive Toxicology (DART) Committee and is a member of the Society of Toxicology and Society for Birth Defects Research and Prevention. He additionally served as Treasurer and Councilor for the Middle Atlantic Reproduction and Teratology Association (MARTA). John was on a team that taught the Introduction to Toxicology course, Temple University School of Pharmacy, as well as a Janssen R&D team that taught Penn State, Hershey, PA graduate/medical students the Knowledge Sharing Seminar Series: Development of Biologics: From Bench to Patients. His expertise is in both large and small molecule drug development. John received his B.A. in Biology, and his M.S. in Cell and Developmental Biology, both at Rutgers University, New Jersey.
Daniel E. Schaufelberger, PhD, President Schaufelberger Consulting LLC, and VP Chemistry, Manufacturing and Controls (CMC) at NGT BioPharma Consultants, LLC
Dr. Schaufelberger has over 25 years of experience in pharmaceutical development, including pediatric products. Daniel retired from Janssen R&D LLC (Johnson & Johnson) as Sr. Scientific Director, CMC Leader, where he co-chaired the J&J internal Pediatric Formulation Network. He is an independent consultant in pediatric pharmaceutical development and general aspects of Chemistry, Manufacturing and Controls. He started his own consulting company in 2019, and more recently joined NGT BioPharma Consultants LLC as VP of CMC. Daniel holds a degree in Pharmacy (ETH Zurich) and a “Doctorat en Pharmacie” from the University of Lausanne, Switzerland. He did postdoctoral studies in the US and worked for Sandoz Pharma, Switzerland, before joining Johnson & Johnson and relocating to the US. Daniel has worked on a broad range of dosage forms across different therapeutic areas in global product development. His last accomplishment at Janssen was the development of a child-friendly, rapidly disintegrating chewable tablet of VERMOX (mebendazole) for the treatment/prevention of soil-transmitted helminth infections. The new formulation has been launched in 2019 in Peru and is now widely used in WHO sponsored distribution programs with supplies offered for free by J&J. Daniel is a member of the IQ Pediatric Working Group and has been appointed Formulation Expert for the pan-European “Conect4Children” initiative. Daniel is a founding member of the society of “Paediatric Medicines and Health Initiative”, based in Mumbai, India. He is a Scientific Advisor for the Swiss Tropical & Public Health Institute, University of Basel, Switzerland. In 2020, he joined Johns Hopkins University, School of Medicine, All Children’s Hospital in St. Petersburg, FL as adjunct assistant Professor, Neurology. Daniel has over thirty publications in peer-reviewed journals and is a frequent speaker and moderator at domestic and international conferences with a focus and passion for “developing better medicines for children”. linkedin.com/in/daniel-schaufelberger-phd-5aa10117