Our Ecosystem of Strategic Advisors

At Advanced Clinical, our people and their capabilities are what drive clinical trial results. Within our “One Team” approach, in addition to our consultants and the AC team, is our strong ecosystem of strategic advisors across functions. They are integral to our business operating model, providing extensive knowledge, credentials and capabilities that augment client results along all of our services. They have the type of leadership ability, phase and therapeutic area expertise as well as technical skills that drive our industry leading capabilities and strategic solutions to create a new standard in the industry.

All of our advisors are highly sought after for their brilliant contributions as members of leadership; ability to strategize; ability to deal with strong regulatory situations; rescue work for clinical trials; and because they’re just good people!  We are very proud to be working with all of them.

Our ecosystem of advisors have the following capabilities:

Strategic Advisory:

We are proud to represent the key members of our ecosystem:

James C. Oliver

James serves as a drug and protocol due diligence advisor, with 28+ years of global clinical research experience in academia and the pharmaceutical industry. He brings a wealth of leadership experience, primarily in principal investigator and director roles across therapeutic areas, in bringing INDs to market. Currently he is president and CEO of Peptagen, Inc. Learn More.

James has a PhD and a Bachelor of Science in pharmacy, both from Mercer University, School of Pharmacy.

Other Aspects of James’ Background:

• Extensive experience in FDA and regulatory strategy for U.S., Asia Pacific and European companies
• Experience with 14 of 18 review divisions in the Office of New Drugs and interacted with 10 FDA supportive divisions
• Published in 43 publications/abstracts

Gil Price, MD

Gil has more than 20 years of experience in Drug Safety and Efficacy, with expertise in strategic and tactical management within clinical research. He is recognized for his work in medical and regulatory services for Phase III/IV clinical trials in several therapeutic areas. Currently he is the CEO and CMO of Drug Safety Solutions. Learn More.

Gil earned his MD from the University of Santiago and a Bachelor of Science degree from the University of Rio Grande as well as a degree in political science and economics from the University of Cambridge. He completed a residency in internal medicine at Northeastern Ohio University College of Medicine, Aultman Hospital.

Other Aspects of Gil’s background:

• Comprehensive Board experience (public, private, non-profit and community charities)
• Founding executive of three financially successful businesses
• Considered to be a “key opinion leader” in pharmacovigilance

Carol Ann Olson, MD, PhD

Carol Ann has 15 years of pharmaceutical experience, across all phases of clinical development, regulatory submissions and support for the commercial success of marketed products. She provides expert consultation and clinical oversight for all aspects of clinical pharmaceutical development, as well as representation at regulatory authority meetings and clinical strategic planning and regulatory review. She is currently a consultant at Sapphire Oak Consultants, LLC. Learn More.

Carol earned her MD with Honors from the Pritzker School of Medicine; a PhD in biochemistry from The University of Chicago; a Master of Science in chemistry from North Dakota State University; and a Bachelor of Arts in biology from Concordia College, She completed a residency in internal medicine at The University of Chicago, and a fellowship in infectious diseases at the University of Minnesota.

Other Aspects of Carol’s background:

• Led initiatives to gain multiple orphan drug designations and grants
• Served as subinvestigator for the AIDS Clinical Trial Unit at the University of Minnesota and led a pharmaceutical development team for a New Chemical Entity for African sleeping sickness
• Authored or co-authored more than 75 publications in basic and clinical research (papers, chapters, abstracts and invited lectures)

Bernice Welles, MD, MBA

Bernice brings years of leadership within the pharmaceutical industry, heading several teams in clinical development and commercial efforts across therapeutic areas. She has also served in leadership roles in clinical operations and regulatory affairs, as well as multiple positions within academia. Her accomplishments span from leading the portfolio strategy for Genentech as Vice President of Product Development to currently holding executive positions as CEO of Alquest Therapeutics Inc. and vice president, clinical and regulatory, of Enject Inc., both “cutting edge” biotechnology startup companies.

Bernice earned her MD, Alpha Omega Alpha, from Albany Medical College; an MBA in finance from The Wharton School of Business, University of Pennsylvania; a Master of Science in urban and environmental policy/public health from Tufts University; and a Bachelor of Arts in music, with honors, cum laude, from Brandeis University. She completed a residency in internal medicine at Beth Israel Hospital and fellowships at both the University of California and University Hospital in Boston.

Other Aspects of Bernice’s background:

• Currently working on the development of a novel pen device to administer glucagon for emergency hypoglycemia
• Awards, honors and grants include: NIH, Clinical Investigator Development Award; Endocrine Fellows Foundation Grant; ARCS Scholarship; NIH, National Research Service Award; National Health Service Corps Scholarship; Mosby Book Award
• Appeared in 28 publications/abstracts

Larry W. Hancock, PhD

Larry has considerable experience in medical writing, with expertise in organizing, developing, recruiting, and training global regulatory medical writing teams. His academic (over 19 years) and pharmaceutical leadership backgrounds extend across multiple technical and therapeutic areas. Currently he is a medical writing and pharmaceutical development consultant and organizer of Sapphire Oak Consultants, LLC. Learn More.

Larry earned his PhD in biochemistry from the University of Kentucky and his Bachelor of Arts in chemistry from the University of Evansville. Following a postdoctoral fellowship in the Dept. of Pediatrics at The University of Chicago, he held academic appointments at The University of Chicago, the University of Minnesota, and Chicago Medical School.

Other Aspects of Larry’s background:

• Has been directly responsible for the preparation of all regulatory documents supporting Phase 1-4 pharmaceutical development as well as the preparation of peer-reviewed publications
• Led development of transatlantic medical writing function, and was responsible for all aspects of personnel recruitment and training, development of infrastructure and processes, and integration and implementation of technology supporting regulatory submissions from IND through NDA/MAA
• Authored or co-authored more than 60 academic publications (papers, chapters, and abstracts) and has provided medical writing support for clinical research publications in multiple therapeutic areas

Marvin R. Garovoy, MD

Marvin serves as a biotechnology and pharmaceutical industry consultant, with 15+ years of drug development experience with biological and small molecule drugs across the biotechnology industry. He brings a wealth of leadership experience in all stages of clinical development across therapeutic areas. Currently he is a clinical consultant, oncology and immunology, at Peregrine Pharmaceuticals, Inc.

Marvin earned his MD, cum laude, from State University of New York Downstate Medical Center and a Bachelor of Arts in biology from New York University. He completed a residency in medicine at New York University Medical Center, Bellevue Hospital, and a fellowship in transplantation immunology and nephrology at Harvard Medical School, Peter Bent Brigham Hospital. He held academic appointments at Harvard Medical School, the University of California, San Francisco, and the Mayo Clinic.

Other Aspects of Marvin’s Background:

• Currently developing Clinical strategy, Monitor Safety and support FDA interactions for early stage trials in oncology (lung, pancreatic, breast, prostate)
• Awarded two patents, for creating universal donor cells and treating Psoriasis, and two patents currently filed, for creating universal donor cells and generating in vivo oligonucleotides
• Authored or co-authored more than 178 peer reviewed papers, 45 chapters, and 2 books

Patricia Ann Walicke, MD, PhD

Patricia brings years of leadership experience across several areas of clinical research, including clinical trial design and direction across multiple phases, regulatory submissions and interactions, as well as medical monitoring and safety. Currently she is an independent consultant for clinical development programs.

Patricia earned her MD from Harvard Medical School; a PhD in neurobiology from Harvard University; and a Bachelor of Science in life sciences from the Massachusetts Institute of Technology. She held academic appointments at University of California, San Francisco, Mercer University, and Emory University.

Other Aspects of Patricia’s Background:

• Current assists clients with clinical development programs for various diseases
• Holds one patent and two patent applications across multiple areas of research
• Served as investigator or sub-investigator for 10 clinical trials for drugs in such areas as Alzheimer’s disease and epilepsy

In addition to the clinical trials we have conducted, our ecosystem has extensive expertise across the following therapeutic areas:

Allergy & Respiratory
Analgeisa/Pain
Anesthesia
Arrhythmias
Blood Screening
Cardiology/Cardiovascular/Vascular Diseases
Cardiovascular - Cardiovascular Devices Unit
Cardiovascular/Metabolic Diseases
Clinical Nutrition
Coronary Artery Disease
Critical Care
Dermatology/Plastic Surgery
Diabetes
Diabetes Management
Endocrinology
Gastroenterology
Gastrointestinal & Hepatology
General Surgery
Genitourinary
Healthy Patient Studies
Chronic Heart Failure
Hematology
Hemophilia
Immunoglobulin
Immunology/Infectious Diseases/Inflammation Medicine
Implants
Infectious Disease
Infectious Diseases (Antibacterials)
Infectious Diseases (Antivirals), Inflammation
Metabolic Bone Disease
Musculoskeletal
Nephrology
Nephrology/Urology
Neurological Disease/Neurology
Neuroscience
Obstetrics/Gynecology
Oncology/Cancer
Ophthalmology
Orthopaedics
Osteoarthritis
Otolaryngology
Pediatrics
Peripheral Vascular and Obstructive Disease
Pharmaceuticals – Solutions and Drug Delivery
Pharmacology/Toxicology
Plastic Surgery
Psychiatry/Psychology
Pulmonary Medicine
Pulmonary/Respiratory Diseases
Pulmonology
Radio Frequency Therapy for BPH
Renal
Respiratory
Rheumatology
Spinal/Bone Therapies
Stents (Heart)
Transplant Medicine
Trauma/Emergency Medicine
Urology
Vaccines
Women’s Health