Expert Details

Expert in Hepatology Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) Liver Disease, Pharmacovigilance, Drug Development- Drug-Induced Liver Injury Hepatotoxicity

Expert ID: 735622 New York, USA

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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


Expert may consult nationally and internationally, and is also local to the following cities: east coast - but willing to travel

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Education

Year Degree Subject Institution
Year: 1985 Degree: MD Subject: Hepatology Institution: Mount Sinai

Work History

Years Employer Title Department Responsibilities
Years: 2019 to Present Employer: Undisclosed Title: CEO/ Consultant Department: Responsibilities: Consultant on liver-related issues such as clinical trial design, Drug-induced liver disease, clinical development program, expert witnessing etc.
Years: 2019 to Present Employer: Undisclosed Title: Head of Liver Disease Development Clinical Sciences Department: Responsibilities:
Years: 2015 to 2019 Employer: Shire Pharmaceuticals Title: Department: Responsibilities:
Years: 2017 to 2019 Employer: Takeda Title: Various Department: Responsibilities:  Chair Liver Safety Drug-induced Liver Injury working group
Oct 2017-Jan 2019 ( when acquired by Takeda)

 Global Development Lead Hepatology
Dec 2016-Takeda takeover

 Global Development Lead Nonalcoholic Steatohepatitis (NASH)
Shire Pharmaceuticals Lexington, Mass
Dec 2016-June 2018

 Global Clinical Development Lead- (NASH)
Shire Pharmaceuticals Lexington, Mass
May 2015- June 2018
Years: 2012 to 2015 Employer: Kadmon Pharmaceuticals Title: Various Department: Responsibilities:  Global Head of Hepatology Kadmon Corporation LLC
 Senior Vice President of Pharmacovigilance Kadmon
 Senior Vice President Clinical Research Kadmon
New York, NY August 1 2013- May 2015
 Senior Vice President of Clinical Research and Head of Hepatology Kadmon Corporation LLC, New York, NY July 2012-August 2013
Years: 2012 to 2012 Employer: Self Employed Title: Independent Hepatology Consultant Department: Responsibilities: Provided clear, unbiased views on biopharma company developments, including clinical data, regulatory events, and product launches, for healthcare investors, investment banks, and venture capital firms. Provide Business Development, R&D Strategy and Corporate Services for biotech and pharma companies. Identified and evaluated products for licensing, assess the market opportunity and competitive landscape, and assess valuation.
Years: 2009 to 2011 Employer: NYU Langone Medical Center Title: Director Of Hepatology Department: Responsibilities:
Years: 2006 to 2009 Employer: Solo Practice Hepatology Title: Department: Responsibilities:
Years: 1991 to 2006 Employer: Solo Practice Hepatology and Gastroenterology Title: Department: Responsibilities:
Years: 2009 to 2018 Employer: New York University Langone Medical Center Title: Clinical Professor Of Medicine Department: Responsibilities:

Government Experience

Years Agency Role Description
Years: 2018 to Present Agency: FDA Role: Published guidelines with colleagues from FDA in liver disease Description: Published guidelines with colleagues from FDA in liver disease

International Experience

Years Country / Region Summary
Years: 2012 to Present Country / Region: England, Spain, Vienna Summary: Presentations/ Lectures

Career Accomplishments

Associations / Societies
AASLD- american association study liver disease - Fellow
American Liver Foundation- board member NY

Society Memberships

American Medical Association – 1986
American College of Physicians – 1986
American Association for the Study of Liver Disease – 1991 - present
American Gastroenterological Association – 1991-present
Medical Society of New York – 1991
Nassau and Suffolk County Medical Society – 1991
International Association for the Study of Liver Disease – 1991 Mount Sinai School of Medicine Class of 1985 Alumni Committee
International Liver Transplant Society 2008
Medical Advisory Board Primary Biliary Cirrhosis Foundation 1999-present
Medical Advisory Board Latino Organization for Liver Awareness (LOLA) 2005-present
Medical Advisory Board Hepatitis C Multicultural Organization 2005- present
Guest lecturer Hepatitis B Foundation June 2007
Medical Advisory Board Primary Sclerosing Cholangitis Foundation 2007-present



Committees:
1. Publications Review Committee
2. Promotional Review Committee
3. Labeling Review
4. Compliance

Licenses / Certifications
board certified Hepatology and Gastroenterology

Board Certified Internal Medicine
Board Certified Gastroenterology/Hepatology
Board re-Certified Gastroenterology/Hepatology
Fellow of American Association for the Study of Liver Disease (AASLD)
New York State Medical License

Professional Appointments
Former Clinical Professor NYU Langone
Awards / Recognition
Numerous
Medical / Professional
HOSPITAL AFFILIATIONS
NorthShore University Hospital Plainview, New York
New York University Langone Medical Center

UNDERGRADUATE
Columbia University New York, NY – 1980, B.A.
Biology Honor Society
President, Women in Health Careers Society


MEDICAL SCHOOL
Mount Sinai School of Medicine, New York, NY 1985, M.D.

INTERNSHIP Internal Medicine
Beth Israel Medical Center – July 1985 – June 1986
First Ave., 17th Street, New York, NY

RESIDENCY Internal Medicine
Beth Israel Medical Center – July 1986 – June 1988
First Ave., 17th Street, New York, NY

FELLOWSHIPS
1. Hepatology Mount Sinai Medical Center, July 1988 – June 1989
2. Gastroenterology State University Hospital at Stony Brook, July 1989 – July 1991
Publications and Patents Summary
Publications: 43
Research Studies: 24
Books: 4
Book Chapters: 15
Media/ Television: 17
Media/ Magazines, Newspapers, Radio: 46
Media/ Videos, CDs: 15

Fields of Expertise

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