The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

Managing Relationships: Identifying and Engaging Thought Leaders in Pharma and Biotech
29 March 2018
Managing Relationships: Identifying and Engaging Thought Leaders in Pharma and Biotech

Key Opinion Leaders (KOLs) are physicians and scientific experts that have an independent voice or strong impact earned from an established reputation in their field. Read more

Demand for Experts When the Stakes are High – The Added Value of KOLs
26 March 2018
Demand for Experts When the Stakes are High – The Added Value of KOLs

A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community. Read more

Unverified Science-Based Claims in the Media – Another Example Why the “Ingelfinger Rule” is so Important
19 March 2018
Unverified Science-Based Claims in the Media – Another Example Why the “Ingelfinger Rule” is so Important

It’s likely that most readers of this blog, let alone most members of the public, have little idea of what the Ingelfinger Rule is and less about why it is so important. Read more

FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®
14 March 2018
FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®

On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application. Read more

FDA Advisory Committee Supports New Ulcerative Colitis Indication for Xeljanz (Tofacitinib)
13 March 2018
FDA Advisory Committee Supports New Ulcerative Colitis Indication for Xeljanz (Tofacitinib)

On March 8th, 2018 the FDA Gastrointestinal Drugs Advisory Committee (GDAC) discussed the supplemental new drug application (sNDA) Read more

How to Find the Right Regulatory Experts for Your Case or Controversy
13 March 2018
How to Find the Right Regulatory Experts for Your Case or Controversy

Whether you are outside counsel retained in a pharmaceutical product liability case or in-house counsel responsible for a chemical manufacturer in a high-profile government investigation, having the right regulatory expert can be the difference between remarkable success and high stakes failure. Read more

The Importance of Genetics Experts in Pharmaceutical Litigation
06 March 2018
The Importance of Genetics Experts in Pharmaceutical Litigation

A recent defense verdict in the testosterone litigation highlights the importance of genetics in pharmaceutical litigation. Read more

FDA Advisory Committee Denies Charleston Laboratories’ Hydexor
20 February 2018
FDA Advisory Committee Denies Charleston Laboratories’ Hydexor

On February 14th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Read more

Protein-based adverse drug reactions (ADRs): Using proteomics to assess drug safety
20 February 2018
Protein-based adverse drug reactions (ADRs): Using proteomics to assess drug safety

Each year, adverse drug events cost millions of dollars in hospital admissions, injuries to patients, and malpractice. Read more

Do You Have the Right Scientific and Technical Support  To Succeed In Biopharmaceutical Patent Litigation?
09 February 2018
Do You Have the Right Scientific and Technical Support To Succeed In Biopharmaceutical Patent Litigation?

This post was authored by David H. Schwartz, a principle at Innovative Science Solutions and Paul Fehlner, JD, PhD, founder of Life Sciences Innovation. Paul is a life sciences lawyer and biopharmaceutical consultant with a strong intellectual property focus who partners with research institutes, startups, and Fortune 500’s to help them transform basic scientific discoveries into life-changing products and services around the world. Read more

Using Big Data Tools To Help Build Great Expert Teams
30 January 2018
Using Big Data Tools To Help Build Great Expert Teams

As a litigator specializing in product liability, toxic torts, government actions and other civil litigation, identifying the right experts and recruiting a team of experts perfectly suited to your case can be critical to your success, especially when that case involves complex scientific issues. Read more

FDA Panel Denies Aradigm the Opportunity to Market Inhaled Antibiotic Treatment for Non-Cystic Fibrosis Bronchiectasis Patients
29 January 2018
FDA Panel Denies Aradigm the Opportunity to Market Inhaled Antibiotic Treatment for Non-Cystic Fibrosis Bronchiectasis Patients

The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. Read more

FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes
26 January 2018
FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes

The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP). Read more

Human-Organs-on-Chips: Will They Revolutionize Courtroom Toxicology Testimony?
25 January 2018
Human-Organs-on-Chips: Will They Revolutionize Courtroom Toxicology Testimony?

Human-Organs-on-Chips are microfluidic cell culture microchips lined with living human cells that simulate the functions of human organs, including the lung, intestine, kidney, skin, bone marrow and blood-brain barrier. Read more

FDA Panel Denies Clarus and Lipocine a Run at the First Oral Testosterone Replacement Therapy
16 January 2018
FDA Panel Denies Clarus and Lipocine a Run at the First Oral Testosterone Replacement Therapy

The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations. Read more

Mitigating the Risk of Adverse Drug Reactions in Pharmacogenomic-Inspired Litigation
11 January 2018
Mitigating the Risk of Adverse Drug Reactions in Pharmacogenomic-Inspired Litigation

This post was drafted by Innovative Science Solutions and Wendell S. Fortson, founder of Fortson Strategies, LLC.  Fortson Strategies is a national cancer litigation strategy firm for corporations. Read more

Toxicology in the 21st Century – 5 Tips for Litigators
03 January 2018
Toxicology in the 21st Century – 5 Tips for Litigators

Chemicals are part of everyday life. They are found in common household and workplace products including food, packaging, paint and dyes, cleaning supplies, medicines, among many other categories of products. Read more

3 Steps to Recruiting the Ideal Expert Witness
06 December 2017
3 Steps to Recruiting the Ideal Expert Witness

This article was authored by Ted Dunkelberger, who provides expertise in litigation strategy and expert recruitment at ISS. Read more