Clinetica Biosciences International, Inc.

The pharmaceutical regulatory climate post Vioxx

2008-02-14T08:47:00.000-08:00

In the past few years, the Food & Drug Administration (FDA) has been under pressure from a number of high profile safety concerns regarding FDA-approved drug products including Vioxx®, Tysabri®,Epogen®, Procrit® and Avandia®. In light of the increased scrutiny the FDA now faces, many industry critics have argued whether this has had any impact on the number of or time to drug approval of new medicines approved by the FDA.

Vioxx was voluntarily withdrawn from the market by Merck in September 2004 following the observation of an increased risk of serious adverse cardiovascular events compared to placebo in a long-term controlled clinical trial. Since then, a number of other high profile safety concerns of FDA-approved drugs have emerged. For example, Tysabri® was temporarily suspended, and additional warnings were added to the labels for Procrit®, Epogen® and Avandia®. There has been a strong public outcry against the FDA in response to these safety concerns, putting into question their competence in reviewing drug applications.

In the post-Vioxx era, statistics indicate that the FDA is becoming more cautious with the drug approvals process. Statistics indicate that the most significant change in the post-Vioxx era is a decrease in the number of New Molecular Entity (NME) approvals, albeit regulatory review times have not changed that much.

It is important to mention that a recent report by the Subcommittee on Science and Technology concluded that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. The report went on to say that the demands on the FDA have soared while the resources have not increased in proportion to the demands. With advances in medicine and healthcare, this places further demands on FDA staff to keep their knowledge current.

It seems plausible to conclude that if the current pressure on the FDA continues, regulatory review and approval timelines could lengthen and the number of approved drugs might decrease further in the years ahead.

References:

(1) Report of the Subcommittee on Science and Technology, FDA Science and Mission at Risk. Prepared for FDA Science Board. November 2007.

Clinetica announces introduction of pharmacy consulting services

2008-01-11T12:16:00.000-08:00

In 2001, the Canadian Medical Association published an article that reported the acute shortage of pharmacists in Canada (see link below).

http://www.cmaj.ca/cgi/content/full/165/6/809-a

Almost half a decade later, the pharmacist shortage in Canada sees no sign of abating! Last month the Globe & Mail reported that major pharmacy retailers are still busy poaching pharmacists from as far away as South Africa by luring them with incentives to come and practice pharmacy in Canada (see link below) while Ontario announced the introduction of a second school of pharmacy at the University of Waterloo to increase enrolment of pharmacy students.

http://www.canadapharmacynews.com/labels/pharmacist%20shortage.html

Many Canadian pharmacy owners are frustrated with the situation and the market for relief pharmacy services is looking better than ever as niche recruiting firms have positioned themselves to capitalize on this opportunity and offer pharmacy owners a viable alternative.

As a result, the Management Consulting division of Clinetica Biosciences International, Inc. is proud to announce the launch of value-added pharmacy consulting services for the Ontario market including customized pharmacy resourcing/ staffing solutions.

For more information or to request locum rates for your region, please call us toll-free at 1-877-BIO-PHARM (246-7476) or by e-mail at info@clinetica.com

Clinetica Management Consulting
Clinetica Biosciences International, Inc.
www.clinetica.com

Clinical trial industry in India - Status Report

2008-01-11T11:59:00.000-08:00

The expected growth of clinical research outsourcing industry in India is predicted to slow down, as the segment is facing an acute shortage of investigators or doctors trained with good clinical practice (GCP). According to industry sources, the clinical research industry in the country is expected to touch US$ 1 billion by 2010 and requires 3000 to 6000 GCP trained personnel by that time to meet the expected growth. Currently there are only less than 1000 doctors trained with GCP, which seems to be a major hurdle for the growth of the segment. Presently, the companies are left with two options, either to choose only doctors with GCP or to choose doctors without GCP and train them on GCP. It is learnt that with the rapid growth of the industry most of the companies are selecting doctors without GCP to meet the requirement and providing training to them. Several companies are selecting doctors without GCP and providing special training to the doctors before inducting them into the trials.The Indian CRO industry, which is expected to cover more than 15 per cent of the global clinical trials, has advantages like huge patient base, low cost advantage, completion of clinical trials on time and good infrastructure. All major pharmaceutical companies and CROs have already started their trials in India and it is expected to increase in future. However, industry sources pointed out that the government should take clear-cut steps and open more educational institutions to offer specialised courses to tackle the shortage of GCP trained doctors.

Source:
http://www.pharmabiz.com/article/detnews.asp?articleid=42459&sectionid=

Mohamed Jagani (CEO & President of Clinetica, Inc.) appointed to SED - Health Canada.

2007-10-24T17:13:00.000-07:00

On October 18th 2007, Mohamed Jagani, BPharm, RPh, MBA (CEO of Clinetica Biosciences, Inc.) was appointed to the Scientific Expert Database (SED) at the Therapeutic Products Directorate, Health Canada.

The SED is an inventory of qualified and dedicated scientists, researchers and other medical professionals who are looking to contribute their expertise and knowledge to Canada's regulatory review process for drugs and medical devices and/or sit as a participant on Health Canada's Scientific Advisory Panels or Committees. These processes are sometimes supported by external reviewers and experts, and the SED provides quick and easy access to scientific experts who can influence and/or make significant contributions to Canada's drug and medical device approvals policies and procedures.

Global Chinese Financial Forum - Toronto Conference 2007

2007-10-18T08:19:00.000-07:00

GCFF is the largest series of bilingual (Chinese/ English) financial functions in North America. GCFF fosters the development of North American and Asian financial industry by creating opportunities for companies, financial institutions, and investors to physically meet to truly benefit from each other.

This year the, conference in Toronto features:

Day 1: China Investment Symposium - (Oct. 19) Fairmont Royal York Hotel
Day 2: General Exhibition - (Oct. 20) Hilton Suites, Markham, ON

Representatives from Clinetica Biosciences International, Inc. including Mohamed Amin Jagani, BPharm, MBA (CEO & President) and Elton Lau, CFA, MBA (CFO) will be attendance.

Come see us at the Hilton Markham Suites Hotel on October 20th 2007!

For more information about the event, please visit the following URL:

http://www.gcff.ca/event/en_event_detail.asp?ie=30&ia=1

Consultations on the SR&ED Program

2007-10-16T17:34:00.000-07:00

On October 5, 2007, the Minister of Finance and the Minister of National Revenue announced the launch of consultations on the scientific research and experimental development (SR&ED) program. The government is seeking ideas on how to make the SR&ED tax incentive program more effective and efficient for Canadian business to foster a more competitive and prosperous Canadian economy.

The consultation documents ask for input on a number of areas, from how to design the program to make it more effective to how its administration can be improved to be even more efficient. Submissions are due by November 30, 2007. These consultations follow a commitment made by the federal government in its science and technology strategy document, Mobilizing Science and Technology to Canada’s Advantage, in which it was indicated that improvement opportunities exist both in policy and in administration of the program. Over the years, there have been a number of consultations on the program, each leading to further improvements in the program.

Canada’s SR&ED program is one of the most generous in the world. However, now over 30 countries offer such incentives and Canada’s previous advantage in this area has been seriously eroded. Other factors, such as the rising Canadian dollar, the decline of the North American auto industry and the rise of low-cost offshore alternatives have eroded Canadian industry’s ability to further invest in R&D, especially in the manufacturing industry.

The most important question is how can the program be structured to stimulate further Canadian investment in R&D in this country?

Previous suggestions have included improved refundability for the tax incentives within limits which would allow loss making corporations access to the credits; simplification of the current complex income tax rules which govern the program; and improved administration of the program. Changes to the program must balance improving private sector R&D investment through new cost-effective measures with maintaining the integrity of the tax system.

We recommend that all interested parties, from industry to industry associations, participate in the consultations. We would be pleased to assist you in this regard. Clinetica will also be making a submission to the government with recommendations and we appreciate input from industry and others impacted by the program. Please feel free to post your comments on this blogg.

New Scientific Experts Database launched by Health Canada

2007-10-15T11:02:00.000-07:00

The Enhanced Review Capacity Unit of the Office of Business Transformation proudly launched the Scientific Experts Database (SED) on June 19th. After a long 18 month development and testing period resulting in further enhancements to its functionality, the SED was ready to be demonstrated to TPD's internal clients - review bureau staff.
The SED is an inventory of qualified and dedicated scientists, researchers and other medical professionals who are looking to contribute their expertise and knowledge to Canada's regulatory review process for drugs and medical devices and/or sit as a participant on our Scientific Advisory Panels or Committees. These processes are sometimes supported by external reviewers and experts, and the SED provides quick and easy access to scientific experts who have applied on-line to become part of this inventory.
The launch included not only a demonstration of an on-line application and how it is imported and qualified, but also provided information on current contracting projections and the outreach strategy planned to keep the inventory growing. Next steps include desktop deployment to TPD users and the provision of a bilingual user manual for internal clients. This new way of doing business contributes to the goal of on-time reviews and helps us maintain our performance targets!
For more information on the SED visit:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/bulletin/tpd_dpt_bulletin03_2007_e.html