Explore Algorithme Pharma

Early PhaseA Full Service Early Phase Clinical Research Provider With Extensive Therapeutic Expertise

WHO WE AREWith over 20 years of experience in early stage clinical research, Algorithme Pharma leads the industry in quality, timelines and customer service.

Our company focus is to partner with our sponsors to progress their drugs through this critical early stage of drug development, as effectively and efficiently as possible. With an industry-best 98% recruiting and reporting performance, we are a full service early stage provider creating greater value for our sponsors.

We successfully complete more than 200 clinical trials annually and are recognized for our expertise in complex trials, adaptive designs and recruitment of special populations. Our in-house support services include small and large molecule Bioanalysis, Data Management, Biostatistics, Regulatory Support, Clinical Pharmacology and Project Management.

CONTENTS

1 Facilities

2 In-House Recruitment and Screening Management

3 Therapeutic Areas of Expertise

4 Direct Access to Special and Patient Populations

5 Extensive Experience with Study Designs

6 Our 3-Step Customized Study Planning Process

7 Local Partnerships

8 505(b)(2) Pathway

9 Regulatory Affairs Services

10 Quality Service

What does FULL SERVICE mean? Our In-House Support Services ensure on-time deliverables meet quality standards• Bioanalytical Sciences

(small and large molecule)• Biometrics • PK and PD Analysis • Protocol Development / Medical Writing

• Program Management• Regulatory Affairs• Scientific and Medical Writing• Study Design

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STRATEGICALLY LOCATED FACILITIES IN CANADA AND THE U.S.A.

Commitment to safety means continuous medical oversight and monitoring of all aspects of your project

• Feasibility Assessment Board evaluates safety, design and operational aspects for clinical trials. The board consists of medical, scientific and clinical experts

• Clinics equipped with defibrillators, crash-carts and the necessary materials for emergency procedures

• Patient monitoring system capable of monitoring 12 Lead ECGs, vital signs and SpO2 continuously with programmed alert protocols

• USP 797 Clean Room for Sterile Compounding

• Direct access to local hospitals in less than a 6-mile (~9.5 km) radius

Montreal, QC

Fargo, ND

Clinical Unit, MontrealClinical Unit, Fargo

• 200 beds are located in four fully equipped clinical units, including a dedicated long-stay unit

• Industry leadership by Dr. James Carlson

• Controlled Substance Studies with DEA/State Licensed Pharmacy

• 265 beds in 7 clinical units including 75 hospital beds with semi-intensive care units

• 15 physicians supported by registered nurses (ACLS certified) and more than 200 clinical staff

• Routinely accommodate long in-house mixed and single gender studies

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IN-HOUSE RECRUITMENT AND SCREENING MANAGEMENT ON-TIME DELIVERY OF FULL PANELS

Recruiting Best Practices• On-site participant advocate manages a continuous

feedback process to enhance the participant experience

• Participant Relationship Management (PRM) software for effective matching of study requirements and timelines, to population medical profiles and availabilities

How do we achieve 98% full and on-time recruitment? • Dedicated call center fielding ~1000

inbound and outbound calls daily • Database of over 120,000 participants,

40,000 active • Screening facility with direct access to public

transportation and medical specialists • Proactive and study-focused recruitment strategy

through multiple media channels

Self-Serve Participant PortalParticipants can: • Update their profiles • View studies suggested for them • Book appointments and view study calendars • Communicate with the recruitment team • Access study documents • Give live feedback

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THERAPEUTIC AREAS OF EXPERTISE RECOGNIZED EXPERIENCE FOR YOUR EARLY STAGE CLINICAL RESEARCH

Algorithme Pharma In Focus Case Study — Pharmacokinetic, Adhesion and Safety Evaluation of Transdermal Patches

Transdermal delivery offers a number of advantages over conventional routes of administration, which include providing a controlled release over an extended period. In a recent study, the pharmacokinetic, adhesion and safety profiles of a transdermal patch were compared under normal activities following single and multiple applications.

Experience with adaptive designs involving healthy

and patient cohorts

Multiple routes of administration

including parenteral, intra-articular injections and

inhalation

Hormonal Therapy

Direct access

to special and patient populations

The methodology used by Algorithme Pharma in transdermal delivery studies is critical in accurately assessing the pharmacokinetics, safety, effectiveness and tolerability of investigated drugs. This approach can also be applied to the development of a new drug product or for the determination of bioequivalence between two formulations.

Infectious Disease

Inflammatory Disease

Metabolic Disease Renal

DiabetesHepatic

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DIRECT ACCESS TO SPECIAL AND PATIENT POPULATIONS FOR EARLY DEVELOPMENT DATA AND ACCELERATED TIMELINES

Algorithme Pharma In FocusCase Study — Patient Population: Chronic Hepatitis B or C Virus InfectionAlgorithme Pharma has run multiple clinical trials involving patients with Chronic Hepatitis B or C Virus Infection, in both Treatment-Naïve and Virologically suppressed (i.e. currently on treatment) patients. With a carefully managed participant database, and our patient recruitment network, we have established direct access to an extensive, active panel of patients in this population, fulfilling the needs of over 10 Phase I/II patient studies. We were selected as one of the multi-sites participating in different drug programs to assess safety, tolerability, pharmacokinetics and efficacy at varying dose levels versus commercially available medication, following single and multiple dose administrations over a treatment period of up to 28 days. The ease of access to this population enabled us to be the lead site for active recruitment and enrollment.

Patient and Special PopulationsHypogonadism Osteoarthritis

Postmenopausal Hepatitis B and C InfectionObesity Impaired Hepatic Function

(Mild, Moderate and Severe)Cytochrome P450 PolymorphismUpper Respiratory Tract Infection (URTI) Impaired Renal Function

(Mild, Moderate and Severe)HyperlipidemiaElderly GI Inflammatory Diseases

Diabetes Type I and II Others available opon requestRheumatoid Arthritis

What do sponsors think about us?

“Algorithme Pharma has repeatedly demonstrated a willingness to explore new areas and incorporate tools and technologies to execute new study designs. For example, they have embraced complicated protocols including using insulin to induce hypoglycemia and have welcomed outside expertise to help them further develop internal capabilities.”

Hélène Dulude, B.Pharm., Ph.D.Director, Clinical DevelopmentLocemia Solutions ULC

Adaptive Integrated Design First-in-Human

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EXTENSIVE EXPERIENCE WITH STUDY DESIGNS ALLOWS SPONSORS TO LEVERAGE OUR EXPERIENCE AND DEVELOP THE OPTIMAL TRIAL

The Adaptive Design provides the benefit of investigating new dose levels in cohorts based on real-time results. To ensure participant safety, the start-stop criteria are developed and implemented prior to trial commencement. With the Adaptive Integrated Design, both the SAD and MAD phases are conducted simultaneously, allowing for accelerated clinical results and an earlier entry into Phase II.

To reduce Phase I clinical timelines by 3 to 5 months, we use an Adaptive Integrated Design which overlaps the SAD, MAD and Food Effect phases and allows the possibility of conducting a Proof-of-Concept (POC) arm in patients.

Algorithme Pharma In Focus Accelerating Early Stage Clinical Results — The Adaptive Integrated Design

• First-in-Human (FIH)

• Single Ascending Dose (SAD) and

Multiple Ascending Doses (MAD)

• Adaptive Integrated Designs

• Food Effect, Age Effect, Gender

Effect, PK/PD

• Drug-Drug Interaction Studies

• Efficacy / Proof-of-Concept Studies

• 505(b)(2)

• TQT Studies

• Comparative Bioavailability Studies

• Biologics / Biosimilars / NCEs

• Pharmacokinetics (PK) and

Pharmacodynamics (PD) in Patients

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OUR 3-STEP CUSTOMIZED STUDY PLANNING PROCESS ENSURES WE MEET SPONSOR ENDPOINTS AND TIMELINES

Study Design• Protocols, communication

plans and contributing ICH reports are all personalized to sponsor specifications

• Projects are tailored to each molecule based on preclinical and clinical data, as well as sponsor priorities

Study Team• Principal Investigator leads

a medical team of over 15 physicians

• Scientific Project Manager oversees complete program conduct and deliverables

• Clinical Study Manager coordinates activities at the screening and clinical sites

Sponsor Milestones• Accelerated reporting timelines

are available with customized software for scheduling and study milestone monitoring

• Monitoring of Key Performance Indicators (i.e. Recruitment, Study Conduct and Reporting) ensure timelines are met

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LOCAL PARTNERSHIPS WHICH EXPAND PATIENT ACCESS AND THERAPEUTIC AREA EXPERTISE

Centre hospitalier de l’Université de Montréal • Access to an extensive pool of over 450,000 patients. • New 520,000-sq.-ft. research facility for conducting complex

early stage clinical trials with access to diverse research groups with extensive clinical research experience in therapeutic areas including:

– Cardiovascular Diseases – Hepatic Diseases – Impaired Hepatic Function – Neurology – Oncology – Respiratory Disorders

Hôpital Maisonneuve-Rosemont • Clinical research team comprised of over 60 clinicians and

5,500 employees with access to over 700,000 patients. • Extensive network and patient access in key therapeutic areas

including: – Acute and Chronic Kidney Diseases – Impaired Renal Function – Hematologic Diseases – Metabolic Diseases – Neurology

Algorithme Pharma In Focus Case Study — Impaired Renal Function Clinical Trials Successful Enrollment Through Collaboration

We recently collaborated with Hôpital Maisonneuve-Rosemont (HMR) in a joint clinical trial in patients with impaired renal function. Patients with moderate and severe renal impairment were enrolled at the nephrology department at HMR, under the supervision of Dr. Vincent

Pichette, MD, PhD, nephrologist. In parallel, patients with mild renal impairment were enrolled at Algorithme Pharma with the matching of healthy subjects, under the supervision of Dr. Eric Sicard, MD, Principal Investigator.

Full enrollment was completed in 10 weeks (4 weeks ahead of schedule) and included 24 patients with mild, moderate and severely impaired renal function.

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THE 505(b)(2) PATHWAY ACCELERATED TIMELINES FOR A WIDE RANGE OF NEW DRUG APPLICATIONS

• Accelerated timelines for a wide range of new drug applications

• Conducted more than 60 clinical trials for multiple 505(b)(2) targeted filings, with several FDA approvals

• High quality 505(b)(2) trial conduct and individualized clinical program design

Algorithme Pharma in Focus Accelerated Sample Analysis Timelines

Accelerating clinical sample analysis data and report timelines allows for earlier decision making and regulatory submissions. We provide sponsors with accelerated lead-in, sample analysis, data and report timelines for over 350 developed and validated methods.

1 Project Start:3 Weeks After Con�rmation

3 Quality Assured Draft Report: 5 Days After Completion of Analysis

2 Quality Assured Data Timelines from Analysis StartIncluding Repeat Analysis and Incurred Sample Re-analysis (ISR)

1-1,000 Samples

1,001-4,000 Samples

4,001-6,000 Samples

4-6 days

6-10 days

10-13 days

Timelines may vary according to study speci�cations.

New indications

Route of administration

Formulation

New combination product including substitution of

an active ingredient

Strength

Prescription to over-the-counter

and vice-versa

DRUG MODIFICATIONS

Changesin

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REGULATORY AFFAIRS SERVICES TAILORED TO YOUR NEEDS

Algorithme Pharma In Focus Conducting Clinical Trials in Canada

We routinely manage the complete process for clients from IRB submission, Clinical Trial Application (CTA) submission, Clarifax responses and preparation of pre-CTA or pre-IND packages. Our Regulatory Affairs team maintains awareness of key guidance changes and produces high quality submissions, ensuring clinical trial milestones are met on time.

Due to the favorable regulatory environment, sponsors can conduct studies pre-IND, leverage Canada’s accelerated approval process (up to 30 calendar days for CTA approval), IRB approval system (2-5 working days from IRB meeting in parallel with the CTA submission) which enables a rapid study-start.

0

50

100

150

200

250

As ofMarch2015

Phase I Clinical Trials in CanadaA Growing Industry

No. o

f CTA

(TPD, Annual Performance, April - March 31)(Excluding Bioequivalence)

2010/’11 2011/’12 2012/’13 2013/’14 2014/’152009/’10

9 Clinical Trial Application (CTA) preparation and

submission

9 Coordination with regulatory agencies for

pre-CTA/IND meetings

9 IRB submission

9 Preparation of pre-CTA and pre-IND package

9 Clarifax responses

9 eCTD-compliant format

9 International experience of guidelines (TPD, FDA,

EMA, TGA, ANVISA)

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QUALITY SERVICE EVERY STEP OF THE WAYExperienced Quality Assurance Team• SOP management • Regulatory audits• Sponsor audits

• GCP/GLP data audits

• On-site inspections

• Process audits • Supplier audits • GLP Accredited

0

20

40

60

80

100

FDA Visits Without Citations(2011 - 2014)

0 - 3 4 - 6 7 - 10 7

Industry Average

No. of Visits

Perc

enta

ge (%

)

No FDACitations

AlgorithmePharma

What do sponsors think of our quality?

“The team members of Algorithme Pharma were responsive, hard-working and client oriented. It was easy to work with them and they were always willing to take the time to discuss any concerns and respond to questions.”

Marie-Françoise Temam Associate Director, Clinical OperationsIdenix

We have a stellar regulatory audit history. All studies are conducted at the highest level of safety and compliance. We regularly host successful regulatory inspections from agencies such as the FDA, Health Canada, ANVISA, ANSM, MHRA, AGES, AEMPS and SCC.

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“Partnering with our clients to get their drug through this critical early stage of drug development is our company focus. It is very rewarding to have these efforts recognized, as we work hard to treat every project with individualized attention, and to provide a personalized and customized service that surpasses our clients’ expectations. Our company is continuously looking for ways to improve our customer relationships and our range of services to create even greater value for our sponsors.”

Chris Perkin Chief Executive Officer Altasciences

Algorithme Pharma won the 2014 CRO Leadership Award in four categories and the 2015 CRO Leadership Award in the following five categories:

© Copyright Algorithme Pharma 2014

450 973-6077 contact@algopharm.com

888 267-7449 www.algopharm.com

For more information, please contact us.

575, boul. Armand-FrappierLaval (Québec)Canada H7V 4B3

4837, Amber Valley ParkwayFargo ND 58104U.S.A.