The Academy of Pharmaceutical Sciences
'Promoting the pharmaceutical sciences'


Seattle Genetics unveils commercial and regulatory progress under ADCETRIS collaboration with Takeda.....           AstraZeneca CEO still interested in M&A but he is getting very picky.....           FDA shoots down Vertex's latest bid for Kalydeco expansion.....           Celltrion's biosimilar of J&J's Remicade reviewed favorably by FDA staffers.....           EMA: Faulty device didn't distort study findings for Bayer's Xarelto.....           FDA expands indication for Merck's Emend nausea and vomiting drug.....           Sigmoid Pharma agrees to acquire Freund Pharmatec.....           Bavarian Nordic enters research partnership to develop MRSA vaccine.....           AAI/CML unveil new offering for solid state chemistry and formulation development.....           Juventas enrolls first patient in phase 2 gene therapy clinical trial.....           Cancer Research UK starts phase 1/1b clinical trial of taladegib in combination with paclitaxel.....           US FDA advisory committee votes in favor for Takeda and Lundbeck's Brintellix.....           Patent losses looming, AZ fights back with Brilinta, diabetes and China.....           Blockbuster new launches coming from Intercept, Gilead and Merck: Reuters.....           Media-magnet hearing on Capitol Hill gets underway, with Valeant, Turing under spotlight.....           FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix.....           J&J chief shells out $9M for Manhattan condo.....           Valeant chief calls on Medicare to allow controversial copay help from pharma.....           Valeant, Turing slammed for price hikes during congressional hearing.....           FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse.....           Indian firm develops two Zika vaccines.....           Cytori Cell Therapy found safe in phase I erectile dysfunction trial.....           Fast Forward Pharmaceuticals starts phase II trials of FFP104 anti-CD40 monoclonal antibody.....           ViaCyte acquires rights to BetaLogics assets from Janssen.....           EC approves TAGRISSO to treat patients with EGFR T790M mutation-positive NSCLC.....           Arch Biopartners submits AB569 orphan drug application to EMA.....           Eisai, Esteve sign deal to co-promote anti-epilepsy drug Fycompa in Spain.....           Takeda secures rights to Mersana?s XMT-1522 outside US and Canada.....           Merck treads water in Q4 as Keytruda helps offset Remicade suffering.....           Valeant shells out $400K a month in hazard pay for interim CEO Schiller.....           Two hep C patients strike back at insurers for limiting coverage of pricey treatments.....           Novo Nordisk outstrips rivals with 8% growth, but lower profits target spooks investors.....           Hold your horses on an OTC spinoff, GSK chief tells breakup-happy analysts.....           Spotlight On... Can fast-growing Eliquis overtake J&J's Xarelto? Bristol-Myers' execs think so; Europe green-lights AZ lung cancer med; Takeda plots Japanese OTC spinoff; and more........           Can fast-growing Eliquis overtake J&J's Xarelto? Bristol's execs think so.....           Merck treads water in Q4 as Keytruda helps offset Remicade suffering.....           UK cancer drug developer Mission Therapeutics raises £60m in funding round.....           GSK, Adaptimmune Therapeutics expand cancer immunotherapy alliance.....           Cloud Pharmaceuticals completes 17 computational drug discovery projects.....           Teva and AbCellera sign deal to discover rare monoclonal antibodies.....           Ligand inks OmniAb platform license deal with Tizona Therapeutics.....           FDA grants fast track designation for Nimbus' NDI-010976 to treat NASH.....           FDA issues complete response letter to Telesta's BLA for MCNA.....           UPDATED: Gilead's hep C juggernaut continues in Q4, even as U.S. sales fall.....           Matinas gets FDA nod to start phase 1 study of MAT2501 to treat NTM infections.....           Alnylam completes enrollment in APOLLO phase 3 study with Patisiran in rare protein disorder.....           Eagle Pharmaceuticals wins FDA fast track designation for Ryanodex to treat exertional heat stroke.....           UPDATED: Sanofi sharpens job-cutting ax with 500-plus in France.....           Purdue loses a battle in war against OxyContin generics.....           UPDATED: Pfizer Q4 beats on Prevnar surge, but 2016 guidance disappoints.....           Big price hikes widespread in pharma, with dozens doubling last year: Bloomberg.....           Turing, Valeant hiked prices for max profits, then scrambled to quash the bad PR: Documents.....           Glaxo socks more cash into immunotherapy bet.....           Gilead's hep C juggernaut continues in Q4, even as U.S. sales fall.....           Ariad gets FDA nod to start clinical development of AP32788.....           Sanofi launches project to develop vaccine for Zika virus.....           UK regulator approves human gene-editing technique.....           EMA validates Gilead?s Type II variation application for Truvada.....           Panacea Pharmaceuticals selects Goodwin to develop anti-cancer monoclonal antibody.....           Bristol-Myers Squibb, Pfizer collaborate with Portola to develop andexanet alfa in Japan.....           Eisai acquires license from HUYA to develop HDAC inhibitor HBI-8000.....           Roche sees no 'short term' pricing pressure for company's cancer drugs: Reuters.....           Was Allergan's CEO simply touting a Texas plant expansion--or nudging watchdogs on Pfizer merger, too?.....           Novartis braces for multibillion-dollar generics hit as Gleevec copies launch.....           Don't blame industry trends for Sandoz's slide, analyst says. But biosimilars? Maybe.....           Gilead scheduling meet-up with Massachusetts AG over hep C pricing: Globe.....           New data boosts Novo against Sanofi in insulin-market fight.....           FDA to review Acadia's Nuplazid drug to treat Parkinson?s disease psychosis.....           FDA to review Acadia's Nuplazid drug to treat Parkinson?s disease psychosis.....           Allergan, AstraZeneca sign antibiotic development deal.....           Allergan, AstraZeneca sign antibiotic development deal.....           EMA recommends approval of Coagadex to treat rare bleeding disorder.....           EMA recommends approval of Coagadex to treat rare bleeding disorder.....           Oxford BioMedica starts second CART programme for undisclosed indication.....           Oxford BioMedica starts second CART programme for undisclosed indication.....           CHMP adopts positive opinion recommending Empliciti to treat multiple myeloma.....           CHMP adopts positive opinion recommending Empliciti to treat multiple myeloma.....           RegeneRx completes patient enrollment in phase 2b/3 US dry eye trial.....           Spectrum Pharmaceuticals starts registrational trial of SPI-2012 in breast cancer.....           Spectrum Pharmaceuticals starts registrational trial of SPI-2012 in breast cancer.....           CVMR, Central America Nickel form South American nickel partnership.....           Gilead Sciences' John Martin stepping out of CEO role after two decades, is replaced by John Milligan.....           Strong Q4 showings for AbbVie abroad offset Humira, Viekira stumbles at home.....           UPDATED: Amgen beats in Q4 as established drugs come through.....           Angered by Walgreens deal, Express Scripts blocks access to Valeant's Glumetza.....           Struggling Eisai gets FDA approval for cancer drug Halaven for liposarcoma.....           Merck sets $54K list price for hep C combo as it preps for battle with Gilead, AbbVie.....           WHO warns Zika virus could affect four million people.....           Sanofi plans to increase presence in Iran.....           Rigel completes patient enrollment in first phase 3 study of fostamatinib in ITP.....           Bristol-Myers Squibb's phase 3 Opdivo head and neck cancer study stopped early.....           FDA grants breakthrough therapy designation to Lynparza for prostate cancer.....           EIB lends EUR20m to French biopharmaceutical firm Transgene.....           AbbVie starts enrollment in phase 3 clinical study for elagolix in patients with uterine fibroids.....           RSS NEWSFEED....
Welcome to
The Academy of
Pharmaceutical Sciences
 
The Academy of Pharmaceutical Sciences (APS) is the UK-based professional membership body for Pharmaceutical Scientists.

We represent individuals and organisations from around the globe, throughout their development, in the delivery of excellence in the Pharmaceutical Science sector.
 
 
Recent meetings

APS 20th Anniversary International Pharmaceutical Photostability Conference 2015
5-7 October 2015 - Loughborough

In this International Year of Light 2015, the APS was particularly pleased to present this event, which was a one-day workshop and a two-day conference.
The course was suitable for those who are new to the topic of pharmaceutical photostability and photostability testing and also for those who wished to brush up on the basic concepts prior to the PPS’015 conference that followed it.

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6th APS International PharmSci Conference
7-9 September 2015 - Nottingham

The 6Th APS International PharmSci Conference - A summary from David Jones, Science Chair 2015

It has been my great pleasure and indeed honour to be the Chairman of this year’s APS conference. The excellent programme, involving both national and international contributors, was beautifully complemented by the wonderful energy and enthusiasm of all delegates. The scope of scientific disciplines was wide and encompassed many key themes of the pharmaceutical sciences including, drugs from natural sources, solid state pharmaceutics, formulation science, pharmaceutical analysis, pharmaceutical microbiology, nanosciences and material sciences, to name but a few.

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6th APS International PharmSci Conference
7-9 September 2015 - Nottingham

Exploring The 6Th APS International PharmSci Conference - A Hugh Success…

An overview from Bill Dawson, APS Chair

The flagship Academy conference was a huge success, building on its previous strengths on its return to the East Midlands Conference Centre in Nottingham. The balance between academia and industry was maintained and many young pharmaceutical scientists had their first opportunity to present either poster or podium presentation which is a major strength of PharmSci.

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Latest News
APS MANUFACTURING CLASSIFICATION SYSTEM (MCS)
MONDAY, 25 JANUARY 2016
‘A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms’, was the most downloaded article in Pharmaceutical Development & Technology, for 2015.. The APS is pleased to announce that), Dr Michael Leane (BMS), Dr Kendal Pitt (GSK) and Dr Gavin Reynolds (Astra Zeneca) have been congratulated by Charles Whalley - Managing Editor, Medicine & Health Science Journals that a paper resulting from, an ongoing successful joint APS focus group collaboration between the Material Science and Process Engineering and Product Formulation Focus Groups,entitled ‘A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms was the most downloaded article in the journal last year.. They were thanked for their contributing to the growing success of Pharmaceutical Development & Technology. Hoping to see more submissions from them in future!. Information about the APS MANUFACTURING CLASSIFICATION SYSTEM (MCS). The MCS, is a successful joint APS focus group collaboration between the Material Science and Process Engineering and Product Formulation Focus Groups, led by Michael Leane (BMS), Kendal Pitt (GSK) and Gavin Reynolds (Astra Zeneca). It began in June2013 after a joint meeting between the groups and has expanded internationally, enabling a wealth of discussion and knowledge to be captured. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. The proposed MCS could be used to develop a risk assessment for manufacturing and also indicate how robust a manufacturing process is likely to be. This resulted in a white paper, Pharm Dev Technology, 2015:20(1)12-21. The authors have presented at meetings to encourage active participation and discussion. For 2015, the following programme has been undertaken IFPAC, Washington DC 25th - 28th Jan 2015; APS Particle Engineering, Dublin April 2015; IPS-FIP/ANVISA; Brasilia, 22nd -23rd June2015APS PharmSci Conference Sept 2015 FIP;Dusseldorf, 28 Sept - 3rd Oct 2015. The next stage is to Issue a 2nd follow-up paper to extend to Hot Melt and Fluid Bed Granulation and Continuous manufacture.. Input is very much valued and can be either emailed to mcs@apsgb.org or input into a survey to include your comments. https://www.surveymonkey.com/s/57GGL8K.
APS PharmaFocus Day
FRIDAY, 22 JANUARY 2016
Pfizer, Discovery Park, Sandwich Wednesday 24th February 2016. The New Scientists Focus Group of the APS is pleased to offer students a unique opportunity to visit the Pfizer Research and Development site at Discovery Park in Sandwich.. During the visit, students will have a chance to tour the facilities, network with industrial pharmaceutical scientists and learn about career options in the pharmaceutical industry.. Registration for this is event is limited to 20 places so early booking is recommended.. Visit us online for more information: https://www.apsgb.co.uk/Events/20160224/. .
APS / JPAG: The use of in silico modelling in drug development
WEDNESDAY, 16 DECEMBER 2015
Thursday 17th March 2016 Royal Society of Chemistry, London . In silico tools can rapidly profile large data sets without the need for analytical testing. It is this predictivity, allied to the significant time and resource savings that make these tools so attractive within pharmaceutical research and development. Within discovery there has been significant effort to develop more drug-like molecules. This involves enhancing both the physiochemical and biopharmaceutical properties. In silico tools have been widely used to enhance solubility and permeability. PBPK modelling also supports formulation efforts to optimise in vivo exposure. Modelling has also been used to optimise the manufacturability of prototype formulations and their supporting processes. In silico tools can rapidly screen real and potential impurities and degradants for mutagenicity, as well as their purgability from the synthetic route. In silico tools are used to identify the degradation pathways and optimise the resultant shelf-life. This symposium brings leading experts to give solutions to the big issues, advice, best practice and current developments. This major symposium will provide essential information for all those involved in: • Formulating medicinal products • Developing manufacturing processes • Problem solving and root cause analysis • Quality control Registration at 9.30 a.m.; symposium starts at 10.00 a.m.. APS members can register at a special rate of £195 For more details and to register, please visit the JPAG website: http://www.jpag.org/?p=meetings&r=74 .
APS Developing new drugs for respiratory diseases
WEDNESDAY, 25 NOVEMBER 2015
APS Developing new drugs for respiratory diseases – how can clinical imaging of the lungs help?. GSK, Stevenage Thursday 21st and Friday 22nd January 2016. Purpose of meeting To review the state-of-the-art in respiratory imaging as applied to drug discovery and development. The focus will be on how imaging can be used to benefit all aspects of the drug discovery and development phases and which modalities may suit some aspects, but not others. The overall aim is to define the state of the art regarding clinical imaging of the lungs and how this can be applied to pharmaceutical discovery and medicines optimisation. Challenge At present there is little coordination of imaging with regard to its applications, strengths and weaknesses, best practice, key parameter. As an outline, here are some of the main challenges:. Is it satisfactory for everyone to be “doing their own thing”, or could some harmonisation be of real value? There appears to be a distinct lack of early investigative work on target engagement - is anybody working on this or is this something that needs to be addressed? What is the role/value of imaging in drug discovery for both early and late phase assets? Does imaging have a role in long term patient care? Are the benefits of imaging accepted and do they receive regulatory recognition. What are the practical issues (ethical concerns, IP constraints, developing and validating new techniques) that challenge further developments in imaging and wider application? Opportunities When developing new drugs for the inhaled route, what needs can be satisfied by imaging modalities – and which require further investment to make it a reality? From a Pharma perspective, imaging may have additive value in decision-making if it can:. Demonstrate pharmacological engagement of the target of interest in the lung (and if possible the distribution of the inhaled dose). Provide additional information that supports improvement of lung function beyond FEV1 to demonstrate efficacy, so Imaging modalities can demonstrate efficacy in their own right. Define new image based endpoints e.g. airway volume and correlate with existing endpoints. Show improved ventilation/perfusion, gas flow, oxygenation in patients post or during therapy that is sustained, so look at vascular performance, density and anatomy and correlate with physiological change. Can track inflammation (neutrophils, eosinophils, macrophages, T-Cells) or patterns of fibrotic change over time. Is able to also show deterioration of lung performance as disease progresses or potential detrimental side effects of long term drug use? So imaging can demonstrate both acute drug effects and chronic drug effects, and define how imaging endpoints change with drug action eg vascular MRI changes following administration of a pulmonary vascular vasodilator has not been looked at. Provide exposure to allow introduction in to clinical practice and hence further validation. Proposed outcomes By bringing clinical imaging groups together, it may be possible to recognise the opportunities in emerging imaging developments and apply these to areas of unmet need for the pharmaceutical industry. State of the art publication on how clinical imaging is used today and what it needs to do for the future. To bring imaging groups closer together and maybe develop a Respiratory Imaging subgroup? To identify the key gaps from a Pharma perspective and seek to resolve them. Start to define which imaging techniques are good for which endpoints and therefore which techniques can tackle different mechanisms of drug action. The possibility of seeking precompetitive funding (through IMI for example) to address gaps. A source of reference for justifying any particular imaging modality on future studies For more information on the programme, registration fees and to book your place, please visit us online here: https://www.apsgb.co.uk/Events/20160121/.
 
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Upcoming Events
APS PharmaFocus Day
24 February 2016
APS Industrial Insights 2016
11 - 12 April 2016
APS Board, Advisory Board & ELT Meeting
18 - 19 April 2016
Delivery of High Dose Inhaled Drugs
Spring 2016
Basic Biopharmaceutics Workshop
Spring 2016
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The Academy of Pharmaceutical Sciences
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