All posts by Administrator

02Nov/06

Understanding Your Patent Portfolio, Reducing Risk Through Due Diligence

by Leslie Gladstone Restaino

The explosion of Life sciences innovation and the globalization of the marketplace have heightened the importance of intel1ectual property (IP) in biotech business transactions. More than 70% of the total-market value of Standard and Poor’s 500 companies derive from intangible assets. The success of Life sciences companies depends not only on continuing innovation and business acumen, but also on the strength of their corporate portfolio of intellectual property rights. Any party acquiring an interest in intel1ectual property rights (whether by license, strategic alliance, or as an investor in or acquirer of life sciences entities), should conduct a due diligence analysis to ensure that the technology underlying the transaction in fact has its purported value and is properly protected. This is particularly critical because IP assets can have a significant affect on predicted cash flow, product development, and income. Any assessment of the transaction is insufficient without proper IP consideration. Often, IP is considered late in the game and in only a cursory manner, leading to significant negative results.

The purpose of a due diligence analysis involves assessment of potential risks and benefits related to the transaction, including identifying risks that may undermine the value of the technology and developing strategies for overcoming such risks. The analysis must confirm that a purported technology owner actually owns the intellectual property rights to the technology, has the right to transfer it, can use the technology without substantial risk of treading on third-party intellectual property rights, and that intellectual property rights are valid and enforceable.

Read The Complete Article

About the Author:

Leslie Gladstone Restaino is a Member of the Firm of Sills Cummis Epstein & Gross, P.C in the Intellectual Property and Corporate Practice Groups. She concentrates her practice on the special business and legal needs of public and private life sciences companies. Ms. Restaino represents established pharmaceutical companies and start-ups in the life sciences industry throughout all phases of their life cycle and understands the business concerns of growing and established companies.

20Oct/06

Can Microsoft Accelerate the Pace of Drug Discovery and Development?

Source: Microsoft Corp.

Yesterday, at Microsoft’s biotechnology Executive Forum, Microsoft announced the initiation of the BioIT Alliance’s second proof of concept, called the Biomarkers Project, along with an update on the Alliance’s first proof of concept, the Collaborative Molecular Environment.

The BioIT Alliance is a cross-industry group working to integrate science and technology to accelerate the pace of drug discovery and realize the potential of personalized medicine. The early focus of the Alliance has been to address the data-capture and data-integration challenges that face the industry.

“The life sciences offer one of the best opportunities for information technology to accelerate the pace of drug discovery and development,” said Craig Mundie, chief research and strategy officer at Microsoft. “Our collaboration in the Alliance will help the life science industry move discoveries from the lab to the clinic much faster.”

The Biomarkers Project: Initiation of Second Proof of Concept 

“One of the most important fields of research today is in gaining an understanding of the relationship between genetic traits and clinical outcomes,” said Dr. Michael Hanley, vice president of Discovery Research at Amylin Pharmaceuticals Inc. “The research and pharmaceutical community is hindered by the lack of integration among the software tools that are used to gain this insight.”

To address these challenges of software integration, the BioIT Alliance is collaborating on its second proof of concept, the Biomarkers Project. This undertaking will simplify the process for identifying and validating genomic biomarkers — the characteristics that indicate the presence of a disease or the likely efficacy of a drug.

09Oct/06

It’s Time to Deepen the Gene Pool

By Daniel R. Matlis

In my “Final Word” column, published in Pharmaceutical Formulation and Quality, I discussed the need to deepen our industry’s gene pool. 

Johnson and Johnson has taken a huge leap to diversify the industries’ gene pool.  J&J recently announced the appointment of LaVerne H. Council to the position of vice president and chief information officer.

Council comes to J&J from Dell Inc.  She brings to the position a wealth of global experience in information technology, supply chain management and business operations. During her tenure at Dell, Council was responsible for infrastructure engineering, networking, security, and enterprise application interfaces and was the global supply chain technology leader for Dell’s core operations.

Skeptics might ask how her experience at a major computer maker qualifies her for the position at one of the most prestigious life-science companies? After all, what do PCs and healthcare have in common? Well, more than you think.

Read the complete column in Pharmaceutical Formulation and Quality.

30Sep/06

FDA Issues Final cGMP Guidance

By Daniel R. Matlis
                            
Yesterday, on the heels of the release of a critical Institute of Medicine Report, the FDA issued a Final Guidance for Industry on a Quality Systems Approach to Pharmaceutical CGMP Regulations. The guidance covers the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA).

This new guidance appears to be an interim step on the long awaited rewrite of the 1978 GMPs, known as the “GMPs for the 21st Century Initiative”.
According to the FDA, this guidance aims to address the following issues:

  • A quality system addresses the public and private sectors’ mutual goal of providing a high-quality drug product to patients and prescribers. 
  • A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace. 
  • It is important that the CGMP regulations are harmonized to the extent possible with other widely used quality management systems, including ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDA’s own medical device quality system regulations.  This guidance serves as a first step to highlight common elements between the CGMP regulations and Quality Management Systems.  With the globalization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-device combination products, the convergence of quality management principles across different regions and among various product types is very desirable.
  •  The FDA has concluded that modern quality systems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions. Manufacturers with a robust quality system and appropriate process knowledge can implement many types of improvements.   In addition, an effective quality system, by lowering the risk of manufacturing problems, may result in shorter and fewer FDA inspections.
  • A quality system can provide the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product’s life cycle), continual improvement, and risk management in the drug manufacturing process.  A quality system adopted by a manufacturer can be tailored to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.

This announcement is a step in the right direction. However, as stated in every guidance document it “does not create or confer any rights for or on any person and does not operate to bind FDA or the public”.

Let’s see what the “GMPs for the 21st Century” brings.

28Sep/06

FDA Drug Safety System Needs Fixing, IOM Report Says

By Daniel R. Matlis 

According to a report issued by the Institute of Medicine (IOM), the FDA suffers from a lack of clear regulatory authority, chronic under funding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits.  

The report, entitled The Future of Drug Safety: Promoting and Protecting the Health of the Public”, was commissioned by the FDA and the Department of Health and Human Services in response to the growing public concern with health risks posed by approved drugs. The Agency asked the IOM to convene a committee to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs. 

“FDA has an enormous and complex mission — both to make innovative new drugs available to patients as quickly as possible and to assess the long-term risks and benefits of these products once they are on the market,” said Sheila Burke, chair of the committee that wrote the report.  “We found an imbalance in the regulatory attention and resources available before and after approval.  Staff and resources devoted to pre-approval functions are substantially greater.  Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market.  Few high-quality studies are conducted after approval, and the data are generally quite limited.  Many of the report’s recommendations are intended to bring the strengths of the pre-approval process to the post-approval process, to ensure ongoing attention to medications’ risks and benefits for as long as the products are in use.” 

During its research, the committee found that

  1. There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
  2. Most stakeholders–the agency, the industry, consumer organizations, Congress, professional societies, health care entities–appear to  agree on the need for certain improvements in the system.
  3. The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
  4. FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion. 

To address these issues, the report offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.  
These recommendations include:

  • Labeling requirements and advertising limits for new medications
  • Clarified authority and additional enforcement tools for the agency
  • Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits 
  •  Mandatory registration of clinical trial results to facilitate public access to drug safety information
  • An increased role for FDA’s drug safety staff
  • A large boost in funding and staffing for the agency

“We have already called for making sure the FDA has adequate resources to perform its critical drug review, surveillance and monitoring functions: said Caroline Loew, Senior Vice President of the Pharmaceutical Research and Manufacturers of America (PhRMA), “Additionally, PhRMA supports recommendations for modernizing the post-market surveillance system for drugs, including more efficient use of the adverse reaction reporting system; maximizing use of large health care data bases; and building more expertise around epidemiological studies.”

I agree that the FDA and Industry need to do a better job monitoring medications’ risk-benefit profiles after approval. They must also improve communications to healthcare providers and patients on the uncertainties and potential risks associated with newly introduced drugs. 

However, as patients, we must recognize that there are no “risk free medicines”. Each patient must work with their healthcare provider to evaluate the risk-benefit profile associated with each recommended therapy and make an informed decision based on the facts available at that time. We must also remain vigilant and be ready to reassess those choices when new post approval data becomes available.

After all, our health is our responsibility.