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Expert has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology. During that time she served as a consultant to > 15 industry -associated companies as an expert on all aspects of liver disease from drug development to commercialization. Expert left NYU to become Senior Vice President of Clinical Research and Head of Hepatology at Kadmon Corporation. After 1 year Expert was promoted to Global Head of Hepatology, and became Senior Vice President of Pharmacovigilance in addition to SVP of Clinical Research.

Expert left Kadmon in 2015 to join Shire as the Global Clinical Development Lead - Hepatology, to be the clinical lead on their NASH program, as well as to consult on other liver-related issues within the company, such as cholestatic liver disease and liver-related safety issues. After a year and a half she was promoted to interim Global Development Lead - Hepatolgy.
She remains a Clinical Professor of Medicine.

Expert graduated from Columbia University with a B.A. and was trained in hepatology (as well as medical school) at the Mount Sinai School of Medicine in New York City. She has authored numerous medical and lay-public book and book chapters and contributed to three encyclopedias on various liver-related topics. Her scientific publications in the field of Hepatology have appeared in such peer-reviewed journals as Hepatology, Gastroenterology, Seminars of Liver Disease, Transplantation and she is a contributing editor of several peer-reviewed journals.

Specialties: Hepatology Nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) Liver Disease, Clinical Research, Pharmacovigilance, Drug Development- drug-induced liver injury hepatotoxicity

Quick Summary:
 Previous - Head of Liver Disease Development Takeda/Shire Pharmaceuticals
 Hepatologist for 30 years (KOL)
 Promoted to Global Head of Hepatology/ Senior Vice President of Clinical Research and Senior Vice President of Pharmacovigilance within one year of working in Biotech Industry ( Kadmon)
 Promoted to Global Development Lead from Global Clinical Development lead, in one and one half year of working at Shire Pharmaceuticals
 ~ 25 years’ experience as a consultant with numerous biotech/pharmaceutical companies related to liver disease lifecycle development- drug development phase 1-4 /clinical trial design, due diligence, valuations, regulatory interactions, marketing and sales
 Unique experience and skill set in liver disease including all aspects of the biotech/pharmaceutical arena related to liver disease drug lifecycle from translational science, preclinical and clinical research and development ( phase 1-4), to business development strategy, to marketing and sales, labeling, product launch medical affairs, regulatory strategy, and pharmacovigilance
 Close working relationships with regulatory agencies including publications
 Member of the Liver Forum – a collaborative group comprised of members from the FDA, EMA, Industry and AASLD tasked with developing guidance on diagnostic and therapeutic modalities for liver fibrosis, definitions, and trial endpoints in NASH
 International expert on Drug-Induced Liver Injury (DILI)
 Proven ability to manage multiple projects and products simultaneously to ensure timely, on-target and within budget accomplishment of tasks
 Extensive experience in public speaking and medical writing (over 30 years to both lay and medical community), medical consulting on drug development and trial design, as well as market opportunities and due diligence and valuation of new products, pharmacovigilance and drug safety monitoring, IND/NDA/ANDA/ Fast track/505(b)2 preparation and submission, medical monitoring of clinical trials, and medical illustration and medical editing.
 Built largest solo –practice devoted to liver disease in the United States from 1991-2011(when Expert left practice to join biotech)
 Extensive scientific research and numerous peer-review publications in the field of hepatitis and liver disease
 Wrote best-selling book on hepatitis and liver disease

Skill Summary – Executive level role in the following:
Research and Drug Development
1. Design and implementation of Phase 1-4 Clinical Trials
2. Recruitment of clinical trials ( both investigative sites and subject) in liver disease
3. Pharmacokinetic and BE/BA trial design and implementation
4. Medical monitor
5. Medical writing including abstract, manuscript writing and publication, and FDA, EMA correspondence
6. Investigator initiated trial evaluation
7. More than 30 years of clinical research experience in all areas of liver disease including but not limited to: Primary Biliary Cholangitis (PBC), nonalcoholic fatty liver disease (NAFLD), hepatitis C (HCV), Hepatitis B (HBV), Primary Sclerosing Cholangitis (PSC), Wilson’s Disease (WD)
8. Interfaced with preclinical scientists
9. Experience in clinical development in other fibrotic disease such Idiopathic Pulmonary Fibrosis (IPF)

Medical Affairs/ Commercial/Marketing/Sales
1. Interacted closely with members of the commercial and business development teams
2. Provided strategic and clinical guidance to Medical Affairs, marketing and sales.
3. Close interaction with medical science liasons
4. Development and execution of the medical strategy for the HCV, and WD portfolio
5. Commercial asset evaluation
6. Provide medical perspective on market related unmet needs to support product focused Core Scientific Communication needs and to identify evidence gaps.
7. Medical writing for promotional and nonpromotional material
8. Medical Representative on the Promotional and Nonpromotional Review Committee
9. Target product profile formulation
10. Participated in sales representative training overall and at national sales meeting
11. Familiarity commercialization processes including understanding of outcomes research / payor access issues
12. Over a period of over 30 years developed and built close working relationships with almost every KOL in the field of liver disease. – For example this had enabled me to successfully recruit 25 KOL sites to a clinical phase 2 trial within 48 hours
13. Developed and maintained relationships with key internal and external stakeholders, as well as liver disease thought leaders, advocacy and disease organizations

Regulatory
1. Worked in conjunction with Regulatory to prepare NDAs/ANDAs/ INDs/ Fast Track Designation/PIP/ 505(b)2 and to interact with FDA
2. Development of Product Insert/label
3. Ensured compliance with medical, regulatory, legal and ethical standards.

Pharmacovigilance – SVP Pharmacovigilance –Kadmon
Pioneered Liver Safety Drug-induced Liver Injury (DILI) working group at Shire
1. Supervised pharmaceutical product safety, regulatory reporting requirements of individual study, literature and spontaneous reports of adverse events.
2. Responsible for ensuring complete and timely reporting of individual case safety reports to regulatory authorities in the U.S. and globally.
3. Responsible for ensuring adherence to global/local/SOP Requirements.
4. Responsible for Training/guiding sites, investigators and monitoring team on safety reporting procedures as per protocol, ICH (International Conference on Harmonisation)/GCP (Good Clinical Practices) and SOPs.
5. Chair of the Liver Safety Drug-induced Liver Injury (DILI) Working Group
6. Member of IQ DILI