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Anapharmwww.anapharm.com

Teamwork and close project management help Anapharm

apply its resources in ways that ensure that its client’s studies are carefully planned and executed in

a timely and cost-efficient way

Science,service

Anapharm

With its headquarters in Quebec City and clinics in Toronto and Montreal, Anapharm performs early-phase drug development for its clients in the pharmaceutical, biotechnology and generic drug industries. The private company offers various

bioanalytical laboratory services, as well as Phase 1 clinical development and bioequivalence services. It also has access to a global network of resources for Phase 1 to Phase 4 consulting and clinical drug development through its parent company, New Jersey–based PharmaNet Development Group, Inc.

Dr. Robert Massé heads Anapharm’s Bioanalytical Division as vice president at its Quebec City and Montreal sites. Beyond managing that division and being responsible for its profitability, his primary responsibilities are to establish strong working relationships with clients to ensure that the bioanalytical aspects of their drug development programs are met both from quality and timeline standpoints; maintaining and improving

Teamwork and close project management help Anapharm

apply its resources in ways that ensure that its client’s studies are carefully planned and executed in

a timely and cost-efficient way

Science,service

customizationand

http://www.gamma-dynacare.com

Anapharm

Gamma-Dynacare has a history of performing

both central and local clinical trial laboratory

testing for pharmaceutical companies, CRO’s and

physicians across Canada. It has developed and

utilizes sophisticated instrumentation systems

and protocols for collection, transportation,

testing and reporting of results customized to suit

the sponsor needs. Gamma-Dynacare and its

affiliate LabCorp of the US are able to perform

international clinical trials.

Gamma-Dynacare

Anapharm’s leadership position in bioanalysis by fostering the implementation and use of innovative technology platforms to achieve the company’s business development initiatives; and establishing close business relationships with suppliers, “because some of them, for example, work at developing new technologies that could meet our specific needs and those of our clients,” he says.

“Essentially, we support our clients in the early stages of the development process of their candidate drugs,” Massé continues, “where the tolerance and safety of the drug at rising doses in healthy volunteers is assessed to understand the factors controlling systemic exposure in humans [pharmacokinetics] and to prove in a patient population that the drug works as planned. In that context, we provide services such as clinical research and bioanalytical services to bring our client’s drugs to their next stage, which means helping sponsors to bring their molecule from preclinical development, to early clinical development, to full clinical development and ultimately approval to market.”

It may be inappropriate for some drug candidates to be tested in healthy volunteers (for example, cytotoxic or radiopharmaceuticals used in chemotherapy), and such clinical testing would therefore begin in a carefully selected target population.

Anapharm performs clinical research services in most therapeutic areas of drug development,

namely cancer, cardiovascular diseases, endocrinology, CNS and immune diseases in which small synthetic molecules, biological molecules and vaccines can be investigated.

Client categories include pharmaceutical start-ups, all sizes of established biotech companies, large pharmaceutical companies, generic companies and biosimilar companies, “which develop a similar copy of biological molecules that are already on the market. That’s an emerging area of the pharma industry that we’re seeing increased interest in these days,” Massé says. If you’re a drug company, he notes, and the development of your drug is critical to the financial well-being of your company, you will choose an

early-stage clinical developer that will provide the quality you expect within the time frame you need, “since quality and time are of the essence in the pharmaceutical business. The first company to file for a given new generic drug or a unique new chemical entity or biological compound might capture a significant share of the market in the therapeutic application of interest.”

Developing a drug in the early-phase stages is a complex process. First, in vivo efficacy has to be demonstrated in animal models or target cellular organisms if it is an antibiotic or antiviral compound. By providing bioanalytical support in preclinical pharmacokinetic and toxicokinetic studies, Anapharm contributes to the assessment of the “druggability” of drug candidates. In that context, Anapharm provides its clients with bioanalytical data that helps them determine whether their drug is developable. Although preclinical studies may prove that a drug candidate displays therapeutic efficacy in disease animal models while showing an adequate safety profile, an Investigational New Drug (IND) application must be filed if the drug is to be marketed in the US. The IND requires further data concerning metabolism, bioavailability, systemic exposure, pharmacokinetics, predicted pharmacological doses in humans, toxicity in rodents and non-rodents, etc.

Depending on the therapeutic application of a given drug, a cost-benefit evaluation may be

“If there’s no challenge in life, there’s no spark that makes you wake up in the morning with the craving to achieve better every day”

Anapharm

communicating with clients. “Although all clients are demanding, we have a preferred relationship with each of them because we adapt our management and communication processes to their specific needs. Some will actively participate in the resolution of scientific issues, so we don’t just perform the service; we involve the client in every aspect of our research service activities. In such an operational environment, confidentiality is crucial. In fact, it’s an ethical concept that is deeply embedded in all business relationships Anapharm has with its clients and suppliers.”

Some bioanalysis challenges are obviously more difficult than others. “For example, some drugs have a complex metabolism or specific physicochemical features that pose a unique challenge to our bioanalytical scientists. So we investigate those drugs prior to conducting internal studies to make sure all the biological and scientific aspects related to these drugs are mastered, so there are no surprises when the subjects are dosed and the samples are analyzed.”

Project management services are customized for each client, so that all project-related activities are managed by a dedicated project manager. Therefore, the team is configured to facilitate communications, acquire timely scientific and regulatory advice, coordinate project meetings and teleconferences with key scientists, ensure that all key discussions are documented and, if asked, represent the project on behalf of the client to outside interests, such as investors, the US Food and Drug Administration (FDA) and the sponsor’s management team.

“By focusing on science, service and customization,” Massé concludes, “our resources are applied in ways that ensure our sponsor’s studies are wisely planned and executed in a timely and cost-efficient manner.” www.anapharm.com

required to accelerate both clinical development and regulatory acceptance. “In the area of oncology, for example, a drug that displays some toxic effects may also bring a significant benefit to patients,” says Massé. “Therefore, it would not be investigated in healthy volunteers in the clinical development phases but in patients. Anapharm has developed expertise in Phase 1/First-in-human studies, which are conducted under very strict medical supervision. In addition to clinical services, Anapharm also provides ancillary services such as pharmacokinetics, regulatory affairs, statistical analysis and clinical biochemistry services.”

Massé looks forward to the challenges his job brings daily. “If there’s no challenge in life, there’s no spark that makes you wake up in the morning with the craving to achieve better every day.

“There are scientific challenges that need to be addressed, so we work as a team within Anapharm. Teamwork is essential,” Massé explains. “You need to work closely with your team members and empower them, so that they make proper and timely decisions when required. Each member of the team has a complementary role and is expected to be both proactive in anticipating client needs and expectations and responsive during the execution of a project. It’s important that the team concept also includes the client’s representatives. This shows clients that they’re not just dealing with one or two company executives or managers, but that they are active members of the whole team, which is working for them to achieve their goals. And our team, together with the client’s team, can accomplish a lot.”

Massé relies on a combination of scientific methodologies developed as per Good Laboratory Practices (GLP), compliance with related regulatory guidance, and a creative approach to

Anapharmwww.anapharm.com