Speakers: Matthew Rieke, MD, Principal, Quaker Bioventures, Inc., Philadelphia, Pennsylvania.

Harold Glass, PhD, Director, Pharmaceutical Business, University of the Sciences in Pennsylvania, Philadelphia, Pennsylvania.

George Tsetsekos, PhD, Dean, the Bennett S. LeBow College of Business, Drexel University, Philadelphia, Pennsylvania.

Dr. Rieke: The biotechnology industry has mushroomed since 1992; revenues increased from $8 billion in 1992 to $40 billion in 2002. There are 1,500 biotechnology companies in the U.S., and more than 340 of these are publicly held. The U.S. biotechnology industry spent $15.7 billion on R&D in 2001, and more than 155 biotechnology drugs and vaccines have been approved by the FDA. In the last six years, 70% of the biotechnology medications on the market were approved.

Venture capitalists are willing to invest in the highly risky, early-stage biotechnology companies because of the potential for profit. If potential profit is challenged, investors will move dollars out of the biotechnology industry. The environmental requirements for venture capitalists include (1) stable or increasing exit values, (2) stable or decreasing equity requirements, (3) stable or decreasing failure rates, and (4) stable or lower risk. Venture investing in medical devices was initially high, but over recent years, medical device companies have not been doing well. Reimbursement by the government for medical devices is not good, and less money is returning to venture capitalists. Development costs for FDA approval and reimbursement have also increased dramatically. The opportunity for reimbursement is critical. suhagra

Dr. Glass: Clinical investigators who use a biotechnology drug for 3, 6, and 18 months sustain a statistically significant (P < .05) higher product market share for the drug tested. Investigators have an impact on the success of the drug because they influence other physicians to prescribe the drug. However, investigators in contract research organization (CRO)-monitored clinical trials are less likely to prescribe the study drug after it reaches the market.

Most investigators are office-based. Peers are the most important source influencing a physician’s decision to prescribe a new drug for the first time. How often investigators prescribe a new drug is less important than what they say to other physicians, as reflected in their prescribing behavior vis-a-vis a new drug.

Company-prescribing loyalty is the single most important descriptive factor for early adopters of first-in-class new drugs. Loyalty toward a launch company is less favorable for a biotechnology company than for a regular “big pharma” company.

Dr. Tsetsekos: There is a need in the biotechnology industry to determine adequate pricing of products. Small companies enhance the marketplace, and their success is dependent on their location. Many biotechnology companies are found in the northeastern U.S. and in California, places with a high density of patients. Location can help the eventual success of a biotechnology agent.
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Improving the Quality and Lowering the Cost of Future Biologics

Speaker: Richard V. McCloskey, MD, Vice President, Medical Research, Johnson & Johnson Development Corporation, New Brunswick, New Jersey.

Biotechnology products such as monoclonal antibodies and fusion proteins offer an efficacy never attained before. Toxicity is low and controllable, and patients’ lives and medical practice have been transformed. The current methods of production of biotechnology products are expensive. The solution for decreasing the costs of antibodies is to improve potency and reduce doses, use parts of antibodies, develop new low-cost production methods, or find better antibodies.

The new methods and advantages in using transgenic plant systems for maintaining efficacy and safety of biological agents are as follows:

  • There are no human pathogens.
  • There are no mammalian contaminants.
  • Asepsis can begin later in production than is the case in current systems.
  • It might be possible to achieve lower production costs and lower purification costs.

However, some uncertainties remain:

  • Antibodies or proteins might be immunogenic.
  • There are regulatory concerns.
  • There is insufficient dialogue about transgenic plants, especially food crops, and misunderstandings abound.

Rabies vaccine and antibodies are being produced in potatoes. Vaccines have already been produced in alfalfa, tomatoes, and duckweed, and they are being studied in humans.

Health care professionals must support the research, understand the new systems, and use new products when they are approved. Industry must create platforms, and companies must make the antibodies and conduct the required biological and toxicological studies.

The Specialty Pharmacy Role in the Launch of a New Biotechnology Product: The Xolair™ Experience

Speaker: Russel Allinson, RPh, MS, Senior Vice President of Pharmacy, Priority Healthcare, Pittsburgh, Pennsylvania.

Omalizumab (Xolair™, Genentech, Novartis) is the prototypical biotechnology product that represents a new therapeutic area. This humanized monoclonal antibody is specifically designed to inhibit immunoglobulin E (IgE) and to prevent the allergic cascade of mast-cell degranulation in patients with asthma. The product must be administered sub-cutaneously according to the patient’s weight and IgE concentration once every four weeks.

A specialty pharmacy is required to administer Xolair™ to ensure better control over the product in the distribution channel, to meet managed care requirements, to foster better quality and reporting of data, to achieve consistent patient care, and to encourage optimal patient adherence.
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The specialty pharmacy’s role is to provide successful insurance coverage management with the use of Drug Fact Sheets, clinical management of injections through dose evaluation (using a nomogram), data capture and reporting, and patient support. The pharmacy makes sure that the drug is placed on the formulary to prevent the denial of payment, and it assists in the appeals process in case of denial of coverage or financial hardship. Specialty pharmacies have core competencies that are vital to the launching of injectable biotechnology products.

Venture capitalists are willing to invest in the highly risky, early-stage biotechnology companies because of the potential for profit. If potential profit is challenged, investors will move dollars out of the biotechnology industry. The environmental requirements for venture capitalists include (1) stable or increasing exit values, (2) stable or decreasing equity requirements, (3) stable or decreasing failure rates, and (4) stable or lower risk. Venture investing in medical devices was initially high, but over recent years, medical device companies have not been doing well. Reimbursement by the government for medical devices is not good, and less money is returning to venture capitalists. Development costs for FDA approval and reimbursement have also increased dramatically. The opportunity for reimbursement is critical.