Our advanced scientific infrastructure and world-class experts attract trials from across the globe and meet their needs with the highest standards and efficient regulatory requirements.

Explore the extensive benefits of Australia’s clinical research ecosystem below.

1. GLOBALLY ACCEPTED DATA
   Alliance Pharma has a world-class reputation for quality data, following the highest level of GCP and ICH standards. Data from clinical trials conducted in Australia is widely accepted by all regulatory authorities including FDA and EMA.
   
   
2. EXTEND YOUR BUDGET BY 43.5%
    includes bioanalytics services
    almost halve your clinical trial costs
   
   You can claim R&D cash refund with the Australian Government clinical trial rebate program. As an example, if you spend $200k on eligible R&D, you can receive $87k (43.5%) back from the Australian Tax Office (ATO). This effectively means you could turn $1million dollars into $1.7 million dollars of research spend in just three years.
   
   
3. RAPID START-UP & APPROVAL
    The Australian Regulatory Framework is the fastest in the world for undertaking early phase clinical research trials
    Trials can start in 4-8 weeks compared to 10 months in the US.
    No IND required for clinical trials. Save up to a year in regulatory timelines and considerable costs.
   
   
4. INDUSTRY-LEADING TECHNOLOGY
   Clinical trials are resource-intensive processes requiring the availability of state-of-the-art equipment and facilities for testing and analysis. We have invested heavily in the industry-leading technology platforms to support speed, communications, and regulatory compliance.
   
   
5. GLOBAL CAPABILITIES
   Local relationships, global execution As a global contract research organization – with sites in USA and UK – we can provide internal assay transfer and validation protocols among our global sites.
   
   Harmonized SOPs, policies, and IT systems to facilitate transfer of methods, data, and information enable you to reduce time, risk, and cost.
   
   
6. SEASONAL DIFFERENCES
   Seasonal differences to Europe and US, and time differences (our Australia lab works while you sleep)Seasonal differences between Australia and Europe or the US allow for yearlong participant recruitment for trials involving seasonal illnesses such as flu or allergies and allows researchers to cover seasonal variations in patient recruitment.
   
   
7. HEALTHCARE ENVIRONMENT
   Australian clinical practices and some aspects of its health care system are similar to the United States, United Kingdom and most of Europe.
   
   
8. DIVERSE PARTICIPANT RECRUITMENT
   The willingness of potential participants and their knowledge of clinical trials is another attractive option for sponsors to conduct trials in Australia.
   
   A mixed population of Caucasians and Asian adds diversity to the participant pool and enables ethnicity differences in treatment response to be studied.
   
   

Need Support to Conduct Clinical Trials in Australia?  Contact Alliance!

          An enzyme-linked immunosorbent assay (ELISA) is a chemical test to detect the presence of proteins or other molecules. The enzyme-labeled antibody binds to antigens leading to a color change that is used to quantify antigen-antibody interactions. Quantification of these concentrations requires measuring the intensity of the color change, which indicates the concentration of antigen bound to the antibody. ELISA’s include four variants: direct, indirect, sandwich, and competitive, which all have their respective advantages and disadvantages.

Benefits of an ELISA

High Sensitivity: The concentration of both antibody and antigen can be quantified on the nanogram scale. This means that scientists can use a smaller amount of enzyme, which still produces a large scale catalytic reaction.

High Specificity: Antibodies are very specific to their targets due to their spatial configuration and chemical structure. They can easily recognize and bind to antigens similar to how a key unlocks a specific door.

Versatility: Indirect ELISA’s allow for multiple primary antibodies created in one species with the same labeled secondary antibody used for detection. Also, it’s easy to wash off any unbound antibodies by applying a detergent solution to the plate.

Clinically approved ELISA tests for diseases like HIV, Lyme disease, and tuberculosis are proving their efficacy and value to the Pharmaceutical industry.

Alliance Pharma is dedicated to bringing comprehensive solutions to our collaborative partnerships.  We understand the importance of efficiency and our team of scientists strive to provide the highest analytical services for your project. 

Our recent purchase of multiple Agilent 6545XT AdvanceBio QTOFs – which is specifically designed with biopharmaceutical characterization in mind - provides high resolution and sensitivity for qualitative and quantitative analyses of biomolecules ranging from peptides to intact monoclonal antibodies. The iterative peptide mapping workflow allows us to dig deep into samples with a wide range of analyte concentrations (i.e. host cell proteins and sequence variants). The Agilent 6545XT AdvanceBio QTOF maximizes our uptime by performing thousands of protein injections without degradation of performance with mass accuracies within 10 ppm for glycosylated intact proteins. 

At Alliance Pharma we believe keeping up with the latest technology helps us to provide the best services for our clients.  The 1290 Infinity II LC system when coupled with the 6545XT, represents the next generation LC for ultrahigh-performance liquid chromatography with superior reliability, offering efficient and reproducible separations of biomolecules for detection by MS or integrated UV and FLD modules. 

By using instruments that complement our scientist’s knowledge and experience we meet analytical objectives, increase productivity, and are cost-effective.  Contact us to see how our recent instrument purchase will help keep your project on track.  Call or email Ryan at 919-801-3146 or  rklein@alliancepharmaco.com for more information.

Alliance Pharma has hired Dr. Ryan Klein as Director of Business Development. Dr. Klein has more than 20 years of experience in the pharmaceutical industry developing both oral and topical dosage forms for a range of indications. Dr. Klein began his career at GlaxoSmithKline, where he was an integral component of their drug discovery organization providing drug metabolism and pharmacokinetic expertise to project teams. He was instrumental in the development and implementation of a number of in vitro and in situ ADME models to assess drug absorption, metabolism, and disposition.

After leaving GSK, Dr. Klein joined Tergus Pharma, a CRO providing topical R&D services to the pharmaceutical industry. At Tergus, Ryan filled various roles including leadership positions as the Head of Research & Development and Head of In Vitro Sciences, as the company grew from five employees to approximately seventy five over a seven year period.

Dr. Klein’s areas of expertise include drug permeability, absorption and metabolism in the gastrointestinal tract, liver and skin, intestinal drug transporters, and the anatomy, physiology, and pharmacology of the skin and GI tract. He also has a strong analytical background with extensive experience developing and validating in vitro release testing methods for semi-solid dosage forms, as well as developing and validating HPLC assay and impurities methods.

Leveraging Dr. Klein’s experience on the client side allows Alliance Pharma to collaborate on a higher level with Sponsors, using his in-depth knowledge and vast experience to align the best team of scientists to support each project.

Ryan earned his bachelor’s degree in Chemistry from Wake Forest University in Winston-Salem, North Carolina, and earned his doctoral degree in Pharmaceutical Sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill. Ryan has authored & co-authored numerous scientific publications and patents, and serves as a member of several pharmaceutical research focus and discussion groups.

To read more or to connect with Ryan, view his LinkedIn profile https://www.linkedin.com/in/ryanrklein/

This method was validated by following the US FDA guidance for bioanalytical method validation. To read more about the Validation of an LC-MS/MS method for simultaneous quantification of venlafaxine and its five metabolites in rat plasma and its application in a pharmacokinetic study click here.

Guodong Gua,⁎, Michelle Blacka, Colt Cooksona, Anna Fiorellaa, Yinghe Lib, Steven H. Gormanc, Ray Bakhtiarc

a Alliance Pharma, Inc., Malvern, PA, United States

b GlaxoSmilthKline (GSK), Collegeville, PA, United States

c Teva Branded Pharmaceutical Products R&D, West Chester, PA, United States

Journal of Chromatography B 1087–1088 (2018) 29–35

In 2016, Alliance Pharma had many notable achievements. One of the reasons that we continue to see growth year after year is the strong leadership of Dr. Feng (Frank) Li. For a second year in a row, Alliance Pharma was recognized with SmartCEO Future 50 award as Philadelphia region’s fastest growing mid-sized companies for 2017. From an increase in laboratory space and personnel to a host of new instruments, Alliance Pharma’s expansion facilitates an agile and adaptive environment to meet the specialty research needs of our clients—some of the world's best pharmaceutical companies.

By opening the laboratory animal facility in April 2016, Alliance began to offer in-life dosing studies and created three vivarium technician jobs. We also added critical research space for light-sensitive compounds. Nearby, a new temperature and humidity control unit upgraded our archive room storage capabilities. A few months ago, a crane arrived to deliver an AC unit for the new large-molecule mass spectrometry laboratory. In addition to space enhancements, we also added several new pieces of equipment.

Brand New Equipment Purchased in 2016

• Thermo Scientific Q Exactive Plus High-Resolution Mass Spectrometer
• Another Hamilton Robotics Automated Liquid Handling System
• Another Meso Sector Imager S600 Microplate Reader  
• Three additional High-Performance Liquid Chromatography (HPLC) systems
• Five additional laboratory freezers
• Beckman Coulter AU480 Chemistry Analyzer

System Formalization

As part of our commitment to continuous improvement in service, we updated our quality manual and disaster recovery plan. 

A new software system was implemented to facilitate project management for each department. We also implemented a secure, digital sample management system to easily track data about storage and shipments. Laboratory operations has made improvements in the instrument inventory system, chemical and solvent inventory system, reagent inventory system, and HPLC column tracking system. Also, we have partnered with excellent providers to streamline our accounting and human resources systems.

Finally, a Training Coordinator was appointed to improve our on-boarding process for new employees and to identify areas for staff training and development. Since our company grew by over 50%, this was a much-needed organizational structure.

New Hire Spotlights

Our workforce grew to a total employee count of 63 in 2016. You can check out some of our staff announcements on our LinkedIn page. Our leadership team additions this year include Dr. Weiqing Chen, Dr. Wei Lu, and Dr. Colin Barry.

Notable Achievements in Social Media

On December 29th, we relaunched our site with Hubspot to deliver innovative and helpful content about the pharmaceutical research industry.

We gained our 100th Twitter follower on December 15. Thank you @ArcturusRX!

Eight team members worked together to create our first social media video, the #mannequinchallenge.

Over 1000 people saw our October 19 LinkedIn update.

Check us out on LinkedIn, Twitter, Facebook, or on our blog to read more about this year’s highlights. 

Future Direction

Our promise for 2017 is to continue to strengthen our specialties. We will continue to emphasize quality, compliance, and skill training. It is important for us to continue to improve our operational efficiency.  We plan to achieve new levels of productivity by further standardizing and harmonizing processes, and automating procedures, wherever possible. As always, we seek to deliver the highest quality data and in the most timely expectations.