Here is a really useful link for the FDA’s Training and Continuing Education Courses.  This is the web page for educational tutorials offered by the Center for Drug Evaluation and Research. CDER’s primary mission is to make certain that safe and effective drugs are available to the American people:

http://www.fda.gov/Training/ForHealthProfessionals/default.htm

There are many factors affecting small biotech companies today; however, liquidity takes the first place.  There are two main reasons why this is so: firstly, initial public offering (IPO) has been discarded as an exit way for investors, and secondly, available capital is decreasing fast because investors are not able to comply with commitments to existing venture capital funds, and the funds that are available are frozen into existing investments which for various reasons can’t be left behind.  The outcome of these is obvious, serious liquidity issues.

It has been established that 25% of the 370 public biotech companies in the United States possess less than six months worth of cash, and private companies are probably in worse shape, making it urgent to find money and credit lines in new ways.  But, how?

1.    When a firm requires short-term liquidity it should look for the help of existing private investors who already have gambled on a company’s future.  Doing this during an economic crisis means existing investors will be very affected in terms of dilution of equity, thus, they will be very interested in giving bridge loans and other kinds of money contributions to offer managers the necessary time to get back on their feet and reposition their companies.

2.    Small biotech companies could monetize some of their assets.  Some specialized financial firms offer financing against future royalty payments or against existing or future revenues linked to specific clinical development programs.  Some other firms that specialize in giving loans to pharmaceutical companies may help the small biotech firm access credit lines to buy equipment.

3.    Reverse mergers have become very popular among biotech companies that need to better their liquidity.  Biotech firms with strong pipelines are joining forces with publicly traded firms with lots of money reserves but fewer than desirable pipelines.

4.    Biotech firms should go out and take advantage of the many funding opportunities available right now outside the commercial arena.  Funding from the government or charity organizations will definitely reinforce their money capabilities as well as their credibility in the market, and as if this is not enough, it also does not dilute equity.  Public funding has expanded importantly in fields like stem cell research, regenerative medicine, and cancer research, while non-profits are very supportive of areas like the therapeutic field, which is completely neglected by the big pharmaceutical companies.  There are also the organizations dedicated to a specific disease that are very interested in funding promising research directed towards their field of concern.

The future prospects for the biotech industry are positive.  The consumers are still spending money on its products, and the interest of big pharma companies in the new technologies developed by biotech firms is very strong.  Life sciences consulting companies agree that the firms that make it through this crisis will enjoy less competition in the future, but first, they have to work their way through the storm, and it will only be achieved if they acknowledge the challenges and adjust their finances and strategy accordingly.

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The promise for the future is the delivery of high profile and high-value biosimilar products, which if realized will result in the industry reaching its full potential in relation to the availability of biopharmaceutical products. To achieve this the US will need to define an appropriate regulatory strategy which so far is absent.

The biosimilar area has become increasingly appealing and controversial.  Almost all generic manufacturers are actively involved in developing such products, be it directly or indirectly; however, success will only be found by  those who are patient and have the resources and money to invest right away in lieu of future profits.

Indeed, the future of the pharmaceutical industry is in biotechnology.  Biotech drugs currently conform around 10 to 15% of the pharma market, and the biotech area as a whole is the fastest growing; however, the market must be re-alined if it wants to take full advantage of the large numbers of products that are losing their patents in the next few years.  To date,  the progress has been  slow, with a great vdeal of attention centered on three crucial concerns that will probably determine the future of the whole pharmaceutical market:

1.    A regulatory deal is almost certain
To date,  the nonstop backbiting between the FDA, Congress and interested parties, along with the lack of a regulatory trail for biosimilars in the United States, has contributed to an overwhelming market expansion inside and outside the US.

Although it looks like some tyoe of regulatory deal may be struck this year, no one knows how supportive it will be to the development of biosimilars in the United States in an economically meaningful way.

2.    More valuable product variety is on its way
The Biosimilar products currently on the market are fairly inexpensive; nevertheless, the new ones, including monoclonal antibodies for the treatment of cancer and CNS, should prove to be more appealing and profitable for manufacturers.

3.    Acceptance from physicians
Biological drugs are a complex and an expensive way of treating serious diseases; in some cases this may result in physicians being reluctant to prescribe and use biosimilars as generic drugs.  Some countries, like France and Japanhave already expressed concerns about bioequivalence and are more reluctant than others, making it more difficult for biosimilars to be accepted.

The hope of biosimilar manufacturers is that the market will see biosimilars as therapeutically equivalent and thus, safe to prescribe in place of other drugs.

For branded manufacturers the opposite case is true. Here they hope is that the regulators will name these drugs as completely different drugs that cannot be replaced, thus protecting their branded monopoly.

As a result of these different financial  interests, there is considerable dialog on-going about  INN naming, because products with different INN names are more likely to be considered different and not interchangeable.

In countries where generic products are widely used and physicians know how to prescribe based on INN, biosimilars are expected to have a good acceptance.  The key is to ensure physicians are certain about the safety and efficacy of the drug so that they are willing to change; however, it is likely that an economic incentive will be required to bring this about.

The reason why physicians prescribe generics is to save money, and it is still not certain if biosimilars will generate enough savings..

In regards to patients, they will accept the properly approved biosimilars without a problem; however, they will prefer the newest drug available if it is within their means.

A crucial point in the biosimilar debate is the interchangeability and substitutability, of the products in the different regulated markets.  The legislation before Congress deals with specific provisions that permit the applicants to try to show interchangeability, but the FDA does not like the idea.  In Europe, biosimilars are labeled as having a ‘therapeutic similarity’, but until now, there are no serious efforts to deal with this concern.  Substitutability, which would enable, for example, a pharmacist to offer a biosimilar drug when the physician has prescribed the original, is very unlikely to be accepted.

Life sciences consulting firms are working with their clients to prepare them for the changes ahead and ensure their survival and development of their full potential in agreement with the new perspective in the industry.

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