2About QPS Bio -Kinetic

ABOUT QPS BIO-KINETIC

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QPS Bio-Kinetic is your link to trouble-free trials

QPS Bio-Kinetic is an early-phase clinical research facility headquartered in Springfield, Missouri. Established as Bio-Kinetic Clinical Applications in 1994 by Dale Bourg and David Koenigsfeld, QPS Bio-Kinetic began operations in a small 12-bed facility with only a few key team members. Today, we offer clients a 240-bed state-of-the-art clinical research facility, an extensive database of healthy volunteers in a rich recruiting environment, and a highly-skilled and experienced staff using disciplined processes to give you the highest accuracy and data integrity.

QPS Bio-Kinetic is a division of QPS, a global GLP/GCP-compliant contract laboratory supporting drug discovery and development for pharmaceutical and biotechnology clients worldwide since 1995. QPS offers a full range of integrated services including:

>>> Drug metabolism and pharmacokinetics (DMPK)

>>> Bioanalysis (LC/MS/MS, LBA, Hybridization-LBA)

>>> Early clinical research

>>> Translational medicine (protein markers, genomic markers, and immunogenicity/neutralizing antibodies)

The unification of QPS and Bio-Kinetic Clinical Applications in 2008 provided a seamless transfer of compound knowledge from discovery through preclinical and into early-phase clinical research.

3 >>> About QPS Bio -Kinetic

About QPS

Personalized service

QPS provides GLP/GCP-compliant preclinical and clinical research services to pharmaceutical and biotechnology clients worldwide in the areas of bioanalysis, preclinical DMPK, translational medicine research, and early-phase clinical research. Our regional laboratories are located at Newark, Delaware; Springfield, Missouri; and Taipei, Taiwan.

To ensure the best possible communication, we assign a study management team specifically for every project. The study management team works closely with you to develop source documents, menus, time and event schedules, and study-specific logs. You will also receive accurate, detailed updates from the team throughout each trial in the form of emails and logs. This tactic of straightforward and regular communication allows us to specialize in extremely intensive trials where no detail is too miniscule.

4About QPS Bio -Kinetic >>>

At QPS Bio-Kinetic, our experienced team of investigators, nurses, physician and research coordinators, phlebotomists, and technicians, as well as proven processes and systems, ensure that samples are collected per protocol every time. In addition, QPS Bio-Kinetic is composed of five separate clinical units, each with its own collection, processing and freezer areas. This assures the preservation of the integrity of your study by isolating the subjects and samples for your study, never allowing them to intermingle with other studies. Wherever possible, QPS Bio-Kinetic will assign the same phlebotomist to collect and process samples for every time point on a given study.

Sample integrity is also maintained during storage, reconciliation and shipment. QPS Bio-Kinetic has temperature monitors in every refrigerator, as well as its -20 and -70 degree Celsius freezers to ensure samples are maintained at the protocol-specified temperatures. Shipping is completed by at least two IATA-certified QPS Bio-Kinetic staff. Each sample is physically examined during packaging, with the entire process overseen by the Director of Clinical Operations. With over 15 years of experience in proper sample handling and a 100 percent sample reconciliation process, you can be assured QPS Bio-Kinetic will do everything possible to avoid sample loss or delay in analysis.

Study integrity

6Services

SERVICES

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Subjects

Services

>>> Healthy, normal males

>>> Healthy, normal females

>>> Healthy, normal, hormonal birth control naïve females

>>> Healthy, postmenopausal women

>>> Healthy, geriatric males and females

>>> Other, select populations

>>> Clinical pharmacology, Phase I-IV

>>> Safety and tolerability studies

>>> Bioequivalence/bioavailability

>>> Pharmacokinetic/pharmacodynamic

>>> Drug/drug interaction

>>> Food effect

>>> TQTc/cardiac safety

>>> Rising dose tolerance

7 >>> Services

Routes of drug administration

>>> Intravenous

>>> Intramuscular

>>> Subcutaneous

>>> Oral

>>> Buccal

>>> Transdermal — cream, gel, patch

>>> Vaginal — cream, gel, suppository

>>> Suppository

>>> Intranasal

>>> Intrauterine

8Services >>>

Types of studies

QPS Bio-Kinetic has completed over 800 Phase I-IV studies in the last 15 years. Some examples of completed studies include:

>>> Vaccine studies (i.e., hepatitis B, Japanese encephalitis, yellow fever, West Nile, dengue fever, small pox, and influenza)

>>> Postmenopausal studies

>>> Geriatric studies

>>> Contraception studies

>>> Cardiac safety studies

10Faci l i ty >>>

FACIlITy

The advantages of the QPS Bio-Kinetic facility

QPS Bio-Kinetic’s recently expanded facility was specifically designed for conducting clinical trials. Among its features:

>>> 240 beds with five clinical units

>>> Separate secure pharmacy, retention area, examination rooms, dosing and phlebotomy stations

>>> 24-hour security systems

>>> Fully-equipped ECG and vital sign monitoring

>>> A local clinical laboratory for prompt turnaround of clinical results with electronic lab transfer capabilities

>>> Menus prepared to protocol specifications

>>> Comprehensive SOPs with appropriate training records

>>> Independent clinics with the ability to run concurrent studies

>>> Calibration and maintenance logs for equipment

>>> Back-up generators

>>> Secure archive/document storage

>>> Wireless internet access

>>> 11 Faci l i ty

>>> Advanced refrigerated centrifuges

>>> High-speed micro centrifuges

>>> Self-interpreting electrocardiographs

>>> Laminar flow hoods

>>> NIST-calibrated temperature recording devices in refrigerators and freezers

>>> -70˚ C freezers

>>> -20˚ C freezers

>>> AEDs

>>> Electronic vital sign machines

>>> IV pumps

Calibrated equipment

14Staf f/Experience >>>

STAFF/ExPERIENCE

Our staff has the skill and experience you need – and we love a challenge

Our clinical research team members and senior staff have significant knowledge and experience in the CRO industry and in conducting clinical trials. In aggregate, our leadership team has worked in the research industry for more than 167 years.

We also have an enviable record of retaining employees – our average tenure is six years, with a turnover of less than 10 percent. This means that the people working on your study today will likely be the same people you work with on your next study.

QPS Bio-Kinetic has undergone over 100 successful FDA, sponsor and third-party audits. We also love a challenge. QPS Bio-Kinetic has recently exceeded sponsors’ expectations as demonstrated in the following examples:

>>> A 1200-person study with subjects ages 40 to 90-plus, where 80 percent of the subjects had to be 60-plus years old and all had to be recruited and started within four weeks. Over 16,000 samples were collected.

>>> A four-way crossover involving 90 postmenopausal women where one of the four confinement periods fell over a holiday weekend. QPS Bio-Kinetic recruited and completed the study in less than eight weeks.

>>> Seven studies were completed on the same compound in which subjects were required to be compound-naïve. Each study required between 116 and 140 subjects, approximate equal numbers male and female, as well as a multi-period in-house confinement, and required returns over the next three months.

16Recruiting Database

RECRUITINg DATABASE

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Our database and methods make recruiting and starting a study easy

QPS Bio-Kinetic recruiters operate with a proven, multi-layered technique that taps into both existing, qualified study participants and new candidates from the greater Springfield, Missouri area. Since 1994, this has allowed QPS Bio-Kinetic to start over 97 percent of client studies on-time and full.

The Springfield metropolitan area has a population of over 500,000, including a college population of over 40,000 students. The nature of the curriculum at many area colleges, as well as the generally temperate Midwestern character of the Springfield population, provides us with very high quality, reliable and substance-free participants.

Careful pre-screening and volunteer assessment have created an extensive database of active subjects. Furthermore, our strategy of continuous marketing provides us with new, study-naïve volunteers daily. Our database is comprised of approximately 20,000 potential study participants who are accessible by phone, email or letter, allowing us to fill 80 percent of our studies from our database alone. Because of the reliability of repeat participants and participant referrals, 96 percent of QPS Bio-Kinetic’s subjects that enter a trial will follow through until study completion.

In addition, we continually update our volunteers’ medical histories so our clients receive the cleanest data possible. These medical histories go through a strict QC process, again ensuring quality data.

>>> 17 Recruiting Database

QPS Bio-Kinetic is especially proud of our unusually large pool of female volunteers including:

>>> Postmenopausal

>>> Surgically postmenopausal

>>> Surgically sterile

>>> Hormonal birth control naïve

>>> Women of childbearing potential

Facts about Springfield

>>> The population of Springfield is approximately 150,797

>>> The population of the metropolitan area is approximately 500,000

>>> Springfield is listed by Where to Retire Magazine as a “Top Place to Retire”

>>> America’s Promise Alliance rates Springfield as one of their “100 Best Communities for Young People”

>>> Springfield is listed by National Geographic as a “Top 50 Adventure Town”

>>> Just minutes from some of the best show caves in the US, including Fantastic Caverns, America’s only ride-through cave

18Recruiting Database >>>

>>> Verispan indicates that Springfield is home to two “Top 100 Hospitals in the US”

>>> Springfield is recognized by Forbes as one of the “Top 25 Metro Areas” for the low cost of doing business

>>> A short, 45-minute drive from our office is the vacation town of Branson, Missouri. Branson is an incredible value with more than 50 live performance theaters, three pristine lakes, twelve championship golf courses, an international award-winning theme park, dozens of attractions and museums, shopping galore, and a full range of dining options

Integrated clinical study services

>>> Protocol design and preparation

>>> Case report form design and preparation

>>> Clinical studies conducted to final approved protocol specifications

>>> Bioanalysis

>>> Clinical PK or PK/PD data analysis

>>> Clinical PK report preparation

>>> Clinical data management and biostatistics of safety data

>>> Preparation of clinical study report

>>> 19 Recruiting Database

Bioanalysis technology platforms

QPS offers four bioanalysis technology platforms: LC/MS/MS for small molecules, oligonucleotides, and polypeptides; LBA for proteins, antibodies, and vaccines; hybridization-LBA for oligonucleotides; and LC/RFD for animal and human mass balance/excretion studies. We work with sponsors to develop and validate robust assays using the most appropriate technology platform in accordance with FDA guidelines.

QPS also provides LBA for quantitation of biologics, as well as immunogenicity and neutralizing antibodies testing. For LBA, we use colorimetric, fluorescence, chemiluminescence, and electrochemiluminescence (MSD® platform) detections.

QPS bioanalysis groups support the whole spectrum of drug development from early discovery, to IND-enabling studies, to clinical studies. Our staff has had significant experience with the conventional matrices (plasma, serum, whole-blood, urine, bile, and feces), as well as various animal and human tissues, including liver, brain, CSF, myocardium, coronary arterial tissue, arterial tissues, skin, spleen, prostate, small intestine, kidney, lung, bronchial alveolar fluid (BAL), retina, vitreous humor, aqueous humor, tumor tissue, plasma/culture media, plasma extracts, human serum albumin (HSA), alpha-acid glycoprotein (AAG), red blood cells, peripheral blood mononuclear cell (PBMC), microsomes, S9, hepatocytes, and cDNA.

20Recruiting Database >>>

Clinical PK/PD

Bioanalysis facilities and equipment

As part of Phase I integrated services or a stand-alone service, QPS provides clinical PK or PK/PD data analysis with either non-compartmental PK methods using WinNonlin and SAS software applications, or population PK or PK/PD modeling using NONMEM, SAS and other associated software applications.

QPS has a total of 30 LC/MS/MS systems and can support your development studies either in our QPS-US facility or QPS-Taiwan facility. The QPS-Taiwan location shares the same SOPs, laboratory procedures, systems, and processes as QPS-US, providing our sponsors with a truly US-established and “field-tested” Asia-Pacific CRO option to support global studies.

QPS’s bioanalysis function has over 90 technical personnel, plus another 20 direct supporting staff in project management, data management, sample coordination, report writing, and metrology to ensure that drug quantitation studies meet sponsor requirements and timelines.

TESTImONIAlS

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“Our company has placed studies at [QPS] Bio-Kinetic for over 10 years, including the key pharmacokinetic study assessing Drug X components, as well as many of our postmenopausal women, Drug Y pilot bioavailability studies, and all of our pivotal bioequivalence studies.

One wouldn’t normally think of Springfield, Missouri, as a major CRO site, but the types of subjects they continually enroll are just solid, middle-class citizens with excellent retention for a clinical study.

For our pivotal Drug Y BE studies, we routinely enroll over 70 postmenopausal women subjects and no other site in this country or EU can enroll and dose them in one day, as can be done at [QPS] Bio-Kinetic. [QPS] Bio-Kinetic is planned as a site for all future Drug Y BE studies. Having served on the Drug Y team and been involved in many management presentations, there is simply no way we can make our timelines and meet our project objectives without using this site.”

Phil M., Assistant VP of Clinical Pharmacology

“[QPS] Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically experts but also understand the importance of your study. They have the equation for guaranteed success. I always recommend [QPS] Bio-Kinetic to my colleagues.”

Rick S., CEO

Testimonials

People are talking about QPS Bio-Kinetic

22Testimonials >>>

“When we look for clinical research sites, we prefer smaller organizations that understand the unique pressures of optimizing speed, quality and price we face as a small company. We demand they be trustworthy, can perform the protocol as directed, are able to communicate study progress and are focused on client service.

I have worked with [QPS] Bio-Kinetic for many years, in particular for BE/BA, DDI and cardiac safety studies. Because of their experienced staff, training and detailed processes, I am confident I can count on qualified study participants, quality data and PK samples to be drawn on time.

I trust [QPS] Bio-Kinetic to tell me when they don’t have the capacity to perform my study according to my specifications or timeline. Based on their history of meeting my expectations and my trust in the [QPS] Bio-Kinetic staff, [QPS] Bio-Kinetic has become my first choice as a clinical site.”

Jim M., Senior Director, Clinical Development

“At [QPS] Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. [QPS] Bio-Kinetic employs dedicated and experienced people to perform your studies.”

Sheela M., Associate Director, QA

“I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program.”

Nicholas Di P., MD, PhD, Associate Director, Early Development

>>> 23 Testimonials

In pharmaceutical development, you need a clinical trials partner that you can trust to perform quickly and accurately. To accomplish this, we provide:

QPS Bio-Kinetic is where advanced facilities, skilled professionals and proven processes meet

>>> Studies that start on-time and full

>>> Subjects that meet all study criteria

>>> Professional study management staff

>>> Excellent client communications

>>> A full range of services

>>> Modern, fully-equipped facilities

>>> Meticulous execution of study procedures

>>> Accurate and thorough data reporting

In the US, that partner is QPS Bio-Kinetic.

NOTES

Bio-Kinetic Clinical Applications, LLC1816 W. Mt. Vernon

Springfield, MO, 65802

WeB www.qps-usa.comTeL (417) 831-0456FAx (417) 831-0778