NEWS: Our Blog

Australia Advantage – Consider Conducting Clinical Trials in Australia

Mar 16, 2023 11:33:42 AM / by Alliance Pharma posted in Pharmaceuticals, Immunoassay, bioanalytical, laboratory, Quality, Large Molecule, Bioanalysis, DMPK, Australia

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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!

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ICT Autumn 2022: How To Build a Comprehensive Response to Client Needs as a CRO

Nov 28, 2022 12:45:23 PM / by Alliance Pharma posted in Pharmaceuticals, Leadership, Philadelphia, bioanalytical, Quality, Drug Transporter, Bioanalysis, DMPK, AMS

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As a CRO, meeting client expectations can be an ongoing challenge. What can organisations do to make sure their research is as effective and efficient as possible?

In the Autumn 2022 issue of European Pharmaceutical Contractor magazine, the leadership team from Alliance Pharma reviews what CRO organisations can do to make sure their research is as effective and efficient as possible while meeting the ongoing challenge of their customer's expectations.



Patrick Bennett, Jean Pierre Boutrand, and Vito Saccente at Alliance Pharma

Serving clients is the core of a contract research organisation’s (CRO) business. The more comprehensive a CRO’s service offerings, the more likely it is to attract and retain clients. Recent events – like the COVID-19 pandemic – have set in motion industry shifts. Such shifts demand CROs adapt so that they can continue meeting their clients’ evolving needs . . .

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> Building Stronger Collaborative Partnerships with Cutting-Edge Instruments

Oct 23, 2018 4:36:17 PM / by Karen Pryor posted in Pharmaceuticals, Philadelphia, bioanalytical, laboratory, Bioanalysis, Growth, 6545XT, QTOF, AdvanceBio

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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.

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> Alliance Pharma New Hire

Oct 9, 2018 10:19:28 AM / by Karen Pryor posted in Pharmaceuticals, Leadership, Philadelphia, bioanalytical, laboratory, Employee engagement, Bioanalysis, Growth, New Hire

 

 

Dr. RyanKleinAlliance 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/

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> Alliance Pharma Bioanalytical Team Adds New Instrumentation to Expand Large Molecule Bioanalysis Capability

Sep 21, 2018 4:41:17 PM / by Colin Barry, Ph.D. & Scott Ugrin, Ph.D. posted in Pharmaceuticals, bioanalytical, Large Molecule, Bioanalysis

Colin Barry, Ph.D. & Scott Ugrin, Ph.D.

Alliance Pharma’s bioanalytical team provides comprehensive services for both small and large molecules using a variety of platforms from mass spectrometry to ligand binding assays using an assortment of specialized instrumentation. Our analytical laboratories boast thirteen LC-MS/MS systems from three different manufacturers and include various platforms. Nine systems from AB Sciex are each coupled to Shimadzu UHPLC systems, including two API4000 QTRAP systems, two API4000 triple quad systems, three 5500 triple quad systems, and two 6500 triple quad systems. Each system is designed for high sensitivity quantitative analysis of small molecules generated from either in vitro or in vivo studies and in various matrices.

Alliance Pharma’s small molecule mass-spec based bioanalytical team specializes in:

  • Development, optimization, and transfer of bioanalytical assays
  • Method Validation
  • Sample analysis to support clinical (GLP) and non-clinical studies
  • Plasma, serum, whole blood, and all tissue types
  • Biomarker assay development, validation and sample analysis
  • High throughput screening from in vitro ADME assays
  • Metabolite identification

 

The newest additions to the bioanalytical lab include two Agilent 6545 XT Q-ToF high resolution mass spectrometers coupled to Agilent 1290 Infinity II UHPLC systems with PDA and FL detectors. These new systems add additional capacity to our existing high-resolution accurate-mass (HRAM) systems: 1) a Dionex RSLCnano, 2-D nano/micro/cap UHPLC system coupled to a Q Exactive Plus, and 2) an Orbitrap XL from Thermo Scientific. The newest HRAM systems are ideally suited for analysis of proteins and peptides and will allow generation of highly detailed information for intact proteins and antibodies, confirmation of sequence at the peptide level, and sophisticated analysis of both simple and comprehensive post-translational modifications.

The combination of mass accuracy (> 1 ppm) and high resolution (up to 280,000 at m/z 200) allow for increased specificity and sensitivity in extremely complex matrices. The additional capabilities position Alliance Pharma to continue to expand our large molecule qualitative and quantitative analysis capabilities.

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Determination of Venlafaxine and Five Metabolites in Rat Plasma.

Jun 12, 2018 6:36:43 PM / by Karen Pryor posted in Pharmaceuticals, bioanalytical, laboratory

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.

VEN Publication with JCB - Rat Plasma 6-4-18

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

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Bioanalytical Jobs for New Graduates

Feb 24, 2017 11:56:06 AM / by Jeannette Bezinque posted in bioanalytical

As we approach graduation season, many college seniors are beginning their bioanalytical job search on campus, online, and by networking. Entry-level jobs offered at Alliance Pharma are suitable for students with a Bachelor's or higher in the sciences such as Chemistry, Biochemistry, or Biology. New scientists thrive in this environment, where they have direct access to Ph.D. level mentors in their day-to-day lab operations. Our company also has several career paths with two stages for Analysts and two stages for Scientists and opportunities for advancement. 

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Reasons to apply for bioanalytical jobs at Alliance Pharma:

  • Rapid Growth - Dr. Feng Li, President, is a two-time winner of the Smart CEO Future50 award
  • Career Support - Working in a small pharmaceutical company setting gives novice researchers access to more complex and challenging assignments.
  • Mentorship - Alliance Pharma prides itself on the ability to hire young talent and nurture them through the initial stages of lab work. 

 

In the video below, Kale Drost (Ursinus '15) and Anna Fiorella (Ursinus '16) share their post-college career experience. They offer anecdotes of working in the bioanalytical laboratory and demonstrate a few scientific study processes. Be sure to listen as to what you can expect in the real world in the words of two Alliance Pharma employees. 

“Enjoy the time you have left in school because you will miss it.” -Anna

 

Here are 5 tips to make a GREAT Impression with your job resume

  1. Check for typos or misspellings.
  2. Include any relevant volunteer work and honors.
  3. Use the keywords scientific researchers seek in new hires- LC-MS/MS, mass spectrometry, sample extraction, instrument maintenance, etc.
  4. Don't over-exaggerate your lab experience.
  5. Keep it to one page, especially if you are an entry-level candidate with a Bachelor's degree.

 

Get to know Alliance by following our LinkedIn page for career postings and frequent updates. We also post job openings directly on our site. 

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