Accelerating the development of medications that improve the quality of life is in everyone’s interest, especially when they are the first available treatment or have advantages over existing treatments. Conducting early phase clinical trials with Algorithme Pharma benefits pharmaceutical and biotechnology companies by accelerating the study-start timelines by over 40%. This advantage over North American industry standards is made possible through the combination of efficient processes at Algorithme Pharma and the favorable Canadian clinical research environment.

ACCELERATED TIMELINES WITH ALGORITHME PHARMAWhen considering placement of early phase clinical trials in Canada, a clear understanding of the submissions needed for the study-start process can allow companies to benefit from Canadian clinical trial timelines. To fully leverage these timelines, Algorithme Pharma routinely manages the complete process for our clients.

In planning a First-In-Human (FIH) trial of a New Chemical Entity (NCE) in Canada, a Clinical Trial Application (CTA) must be submitted to the Therapeutics Products Directorate (TPD) at Health Canada. There are minor differences in submission requirements in addition to the advantageous timelines when comparing the Canadian CTA to the U.S. Investigational New Drug (IND) application (see Table 1).

With the accelerated internal processes available at Algorithme Pharma, plus the more favorable regulatory envi-ronment, our data shows a CTA mean approval timeline of 21 days, versus a 30-day approval timeline for INDs (Clinical Phase I Trials).

IND SubmissionRecruitment / Screening

Recruitment / Screening

CTA SubmissionInstitutional Review Board

US Standard (Series Schedule)

Algorithme Pharma(Parallel Schedule)

Total Pre-Study Timeline

Clinical Phase 1 Pre-Study Timelines (days) US CRO & Algorithme Pharma

Another significant advantage to conducting clinical trials with Algorithme Pharma in Canada over a U.S. CRO is that the participant recruitment and screening can be performed while waiting for approval of the CTA. When this efficiency is added to the CTA submission timeline, the total study-start acceleration is up to 25 days resulting in a timeline reduction of over 40% (as illustrated in the chart above).

Clinical Trials in Canada: The Algorithme Pharma Advantage

CLINICAL RESEARCH QUALITY IN CANADACanada is home to many reputable clinical research teams expe-rienced in managing complex, international studies. This research community is supported by common health research networks and strong information-management systems. Combined, this platform has developed Canada’s reputation for exceeding industry standards in meeting recruitment targets and generating high-quality results to meet the requirements of international regulatory agencies.

Algorithme Pharma has an exemplary regulatory history with successful inspections by Health Canada, USA’s FDA, Brazil’s ANVISA, France’s ANSM, United Kingdom’s MHRA, Austria’s AGES, Spain’s AEMPS, Standards Council of Canada, and the Ministry of Public Health in Thailand. This proven track record has led Algorithme Pharma to earn a reputation in the industry for high-quality and reliable results.

Table 1: Outline of Regulatory Submission Differences between CTA and IND for First-In-Human Trial

Canadian CTA United States IND

1. Administrative information (country specific information such as submission forms)

2. CTD summaries (includes manufacturing summaries & nonclinical data)

4. Nonclinical reports

5. Clinical reports & Publications

Health Canada Forms

Investigator’s Brochure

Protocol Synopsis (PSEAT-CTA)

Protocol and Informed Consent Form

Quality Overall Summary (QOS)

Not Required (summaries only)

Not Required

FDA Forms

Investigator’s Brochure

General Investigational Plan

Some Sponsors will include QOS, though Module 3 (full manufacturing data) is preferred.

Nonclinical summary

3. Quality (full manufacturing data)

Not Required Required

Required

Required (if any)

Protocol and Informed Consent submitted in Module 5 (Clinical reports and publications)

Source: Biotechnology Focus – April 2012

Module

Partnering with Algorithme Pharma has benefited many pharmaceutical and biotechnology companies in accelerating their clinical trial timelines. The effective combination of the Canadian clinical research environment and Algorithme Pharma’s efficient operational procedures, delivers a measurable advantage over industry standards.

To request more information, please contact us at contact@algopharm.com

THERAPEUTIC AREA PATIENT POPULATIONSEach therapeutic area presents its own unique challenges for early stage clinical trials. Algorithme Pharma’s integrated network of scientific and regulatory experts have in-depth experience in designing optimized study protocols and accessing patient populations to enable quicker “go/no-go” decisions.

Oncology 41%

Infectious Disease 9%

Other 14%

Diabetes 7%

In�ammation 2%

Immunology 2%

Cardiovascular Disease 13%

Central Nervous Disease 12%

Clinical Trials in Canada by Therapeutic Area

Source: clincaltrials.gov

UNIVERSAL HEALTH CARE: DELIVERING EARLY PHASE CLINICAL TRIAL ADVANTAGES

Health care in Canada is delivered through a publicly funded Medicare system, which is administered universally and free at the point of use. This initiative is supported by the Government of Canada and managed by each province individually. The intent is to assure a “continuum of care” across the country. This healthcare management philosophy has allowed pharma-ceutical and biotechno logy communities to leverage the high quality of participant health for pivotal early phase clinical trials. The continuum of care means patient health is properly managed and makes recruiting for trials more efficient. Com-bined with Algorithme Pharma’s active participant list of over 40,000 healthy participants, recruitment levels and timelines far exceed industry standards and ensure on time study-starts.

Algorithme Pharma’s 2012 average recruitment performance was 98% with almost 7,000 participants enrolled.

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Founded in 1992, Algorithme Pharma is an established early stage clinical contract research organization (CRO) providing multiple research services for pharmaceutical, biotechnology and generic drug industries.

Algorithme Pharma’s facilities include a 6-unit clinic with 224 beds and a 20,000 square foot Bioanalytical laboratory.

With over 20 years’ experience in clinical research, Algorithme Pharma successfully completes over 200 clinical trials annually in Phase I/IIa and Bioequivalence. Combined with Algorithme Pharma’s active participant list of over 40,000 healthy participants, recruitment levels and timelines far exceed industry standards and ensure on-time study starts. In addition, our network of specialized clinicians and relationships with local hospitals provides access to a wide range of patient populations.

Furthermore, Algorithme Pharma performs large and small molecule bioanalysis on samples from Preclinical to Phase IV studies. The organization is comprised of almost 500 professionals from the medical and scientific fields who work together to provide quality input into study design, conduct and reporting in a wide range of therapeutic areas.

Bioanalytical Support Specialities:

Global Access to Patient Populations

- Chronic heart disease

- Asthma

- Chronic obstructive pulmonary disease (COPD)

- Diabetes mellitus (type I & type II)

- Preclinical

- Clinical Phase I – IV

- Bioequivalence

- CNS Diseases

- Hypertension

- Dermatological diseases

- Thyroid

- Renal failure

- Biomarker quantification

- Dried Blood Spot Analysis

- Drug-Drug Interactions

- Endogenous compounds

- Large Molecule Quantification by LC- MS/MS

- Ophthalmic diseases

- Rheumatoid Arthritis

- Hepatitis

- Gastrointestinal Disease

- Ligand Binding Assays

- Metabolite ID

- Protein Binding

- Tissue Analysis

ALTASCIENCES COMPANY Inc.

www.altasciences.com

ALGORITHME PHARMATel.: (450) 973-6077Toll free: 1-888-267-7449contact@algopharm.com