The Academy of Pharmaceutical Sciences
'Promoting the pharmaceutical sciences'


Novartis reports positive results for LCZ696 drug to treat chronic heart disease.....           NIAID funds BioCryst's non-human primate trial of BCX4430 to treat Ebola disease.....           FDA approves InnoPharma's decitabine for injection to treat myelodysplastic syndromes.....           Dezima releases positive Phase IIb TA-8995 trial results for dyslipidemia treatment.....           Takeda and Lilly remain on the hook for $9B Actos award.....           Bloomberg: Sale of OTC specialist Omega could top $5.3B with bids from Bayer, Sanofi.....           Boehringer Ingelheim still being dogged by Ben Venue plant.....           Rumor mill churning as possible Pfizer/AstraZeneca Round 2 approaches.....           Are specialty pharma CEOs worth their salt?.....           Pfizer gets FDA fast track status for C. difficile vaccine candidate.....           Innovus and DanaLife ink marketing, distribution deal for Zestra in alternative markets.....           FDA approves TWi Pharma's generic megestrol acetate 125mg/ml oral suspension.....           FDA approves Pfizer and Protalix's Elelyso to treat type 1 Gaucher Disease.....           DPx Holdings agrees to acquire Gallus BioPharmaceuticals.....           iBio secures European patent allowances for protein expression technology.....           Immunotech completes Phase I and Phase II field trials of patented treatment of HIV/AIDS and hepatitis C viruses.....           China Food and Drug Administration approves SciClone and BTG's DC Bead.....           Amgen reports positive top-line results from Phase III trial of evolocumab combination.....           Momenta's ANDA for generic Copaxone accepted for review by FDA.....           FDA says Aegerion has satisfied its demands over chatty CEO.....           Ayasdi introduces care application for healthcare providers to develop precise clinical pathways.....           USPTO issues notice of allowance for claims in Alnylam's Tuschl patent application.....           Synexus acquires research centre in South Africa.....           Merck's EMD Millipore opens biomanufacturing sciences and training center in Japan.....           Amgen's NDA for heart failure drug ivabradine gets FDA priority review status.....           Biothera gets NIH funding to further develop fungal vaccine.....           U.K.'s cancer drugs fund gets £160M--and power to push for lower prices.....           Valeant, Ackman score a chance to force Allergan to an earlier showdown.....           Cost watchdogs bar Boehringer, Lilly's diabetes med Jardiance--for now.....           Novartis takes a cue from GSK, Biogen with wide-open spaces in new Aussie HQ.....           Mylan, Momenta, Sandoz join assault on Teva's new-and-improved Copaxone.....           FDA clears Glaxo Ebola vaccine for speedy human trials.....           Bristol-Myers's hepatitis C infection combination therapy gets European approval.....           Vifor Pharma's hyperphosphatemia drug Velphoro gets marketing authorisation in Europe.....           Amerigen, Menovo partner to develop generic pharmaceuticals for US market.....           Acura gets NIH grant to fund new Limitx abuse deterrent technology.....           Repros Therapeutics reports top line results of Androxal from first of two pivotal studies.....           Madison Vaccines' MVI-816 to be used in clinical trial of a new combination to treat metastatic prostate cancer.....           Anavex selects Alfred Hospital as lead site for Phase IIa Alzheimer's trial.....           Sorrento secures NIH Grant to advance immunotherapy for IPF treatment.....           FDA grants approval to MediciNova to begin MN-166 trial to treat ALS.....           Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C.....           Who's worried about the drug-pricing debate? Regeneron's CEO, for one.....           Black box warning for antidepressants spelled the death of litigation.....           Allergan sets date for special meeting but vows to keep fighting Valeant buyout.....           Study sounds alarm on sleep-aid ingredient zolpidem.....           Sanofi brings Japan exec to U.S. to fill empty pharma chief's shoes.....           PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready.....           FDA approves GlaxoSmithKline's anaemia drug Promacta.....           AccentHealth releases OTC white paper on Physician's role in OTC recommendations, purchasing decisions.....           Ipsen to start second resupply of Increlex in the US in September.....           Bavarian Nordic secures order to supply IMVAMUNE smallpox vaccine in Canada.....           AB SCIEX, Dalton Pharma partner to advance antibody-drug conjugate analysis.....           Recipharm, Isofol Medical collaborate to manufacture Modufolin.....           Concert Pharma secures $2m payment for new drug product AVP-786.....           FDA approves Fresenius Kabi's Kabiven and Perikabiven for parenteral nutrition.....           Boehringer and Lilly launch type 2 diabetes drug Jardiance in US with prescription.....           Janssen's Cilag International acquires biopharmaceutical firm Covagen.....           Cardiome, Eurolab ink deal to commercialize Brinavess in Argentina.....           FDA grants orphan drug status for Insys? CBD to treat glioblastoma multiforme.....           Roche's Spring Bioscience introduces PD-L1 IHC antibody for immunotherapy research.....           Civitas Therapeutics gets $55m series C financing.....           Alkermes submits NDA to FDA for schizophrenia drug aripiprazole lauroxil.....           Non-synthetic growth hormone supplements provide OTC alternative to HGH injections.....           NEOMED secures $12m from Canadian government.....           Lifestyle Nutrition Labs to unveil drinkable prenatal vitamin Mommy Water.....           Galena says goodbye to ex-CEO, no severance pay included.....           China's Luye Pharma founder soars into pharma's billionaire echelon.....           Apotex fails to block FDA import ban with NAFTA; Iroko nabs osteoarthritis approval for Zorvolex;.....           Valeant's deal show goes on with $25M dermatology buy.....           Looking for a Xalkori boost, Pfizer adds targeted med to Merck IO pact.....           It's official: The Pfizer-AstraZeneca deal talk can resume.....           Novartis CEO Jimenez shrugs off biosimilars in the short term.....           Alexion starts eculizumab trail for post-kidney replacement DGF prevention.....           FDA approves Iroko's ZORVOLEX for osteoarthritis pain management.....           Cilag International acquires biopharmaceutical firm Covagen.....           MultiCell gets US patent covering therapeutics which fight virus infection and cancer.....           VIVUS acquires topiramate-related patents from Janssen Pharmaceuticals.....           Mylan introduces first generic Klor-Con extended-release tablets for hypokalemia treatment.....           Actavis seeks FDA approval to market Rotigotine Extended-release Transdermal Film.....           EMA accepts to review Cubist's MAA for ceftolozane/tazobactam.....           FDA approves ViiV Healthcare's Triumeq to treat HIV-1 infection.....           Glaxo's ViiV venture adds $5B combo pill to its HIV-fighting armory.....           Valeant one-ups Allergan with lawsuit to thwart defensive M&A.....           Jumping into global M&A mix key to India growing its pharma industry.....           Mad at NICE's cancer drug rejections? Look to drugmakers, agency chief says.....           Celebrity pitch-folks may not be worth the money, study finds.....           Roche agrees to acquire InterMune for $8.3bn.....           New clinical study evaluates Masimo RAM technology for tracking changes in respiratory rate in anesthetized patients.....           Aldea Pharmaceuticals closes $24m series B financing.....           Baxter reports positive top-line results from Phase III trial of BAX 855.....           BreedIT, Seach form KanaboSeed to develop new medical cannabis varieties.....           Roche ready to roll on InterMune's lung drug with $8.6B buyout deal.....           Advaxis, Merck collaborate for new immune therapies for prostate cancer treatment.....           RSS NEWSFEED....
Welcome to
The Academy of
Pharmaceutical Sciences
 
The Academy of Pharmaceutical Sciences is the professional body for the Pharmaceutical Sciences in United Kingdom. A Pharmaceutical Scientist is an individual who contributes to bringing a new drug from concept through to a medicinal product. This includes, but is not exclusive to, individuals in academia, industry, regulation, clinical research and manufacturing.

The mission of the Academy of Pharmaceutical Sciences is to champion innovation and opportunity in Pharmaceutical Sciences for the delivery of medicines.

In order to achieve this mission, our aims are to:

  • Promote the Pharmaceutical Sciences to stakeholders to facilitate understanding and achieve engagement
  • Share learning, drive collaboration, partnership and innovation
  • Deliver insights into industry and academic roles for aspiring scientists
Latest News
Join the New Regulatory Focus Group session on Tuesday 9th September, 2014, from 14.15 to 15.50 at the APS Pharm Sci conference 2014
WEDNESDAY, 27 AUGUST 2014
The Regulatory Focus Group was formed earlier this year to bridge the gap between the science and regulation of medicines and to facilitate discussion and consideration of regulatory aspects relevant to the development of new and improved medicines. The Focus Group is pleased to present this session under the title ‘Process validation and continuous process verification – expectations and experiences’.. The session will include presentations from three key speakers who have extensive experience in this subject area and who have been influential in creating the current environment for regulatory and industrial practice relating to process validation. The session will be opened by Dr Catherine McHugh who will present the EU dossier requirements for process validation: The revised guideline. Until recently, Catherine was an Executive Pharmaceutical Assessor at the Irish Medicines Board and was the rapporteur for the new EU guideline. She is now Principal Consultant at PAREXEL Consulting. Catherine will describe the revision of the EU guideline and the current requirements to support marketing authorisation applications. She will compare approaches in the EU with those in the USA, and cover both the traditional approach to process validation and continuous process verification. Penny Butterell, Contract Operations QA, Pfizer, will describe A lifecycle approach to process validation. Penny has much experience in applying QbD practices particularly around the control strategy for process validation and continuous process verification. Penny is involved with training and development activities on the principles of ICH Q8-10 delivered on behalf of the International Society for Pharmaceutical Engineering (ISPE). The third speaker is Des Makohon who will provide A GMP inspector’s view on successful validation practice. Des is a Senior GMP Inspector at the MHRA. Des is a member of the EMA team on Process Analytical Technologies (PAT) and he has spoken widely at conferences on aspects of process validation and contributed to the establishment of the EU position on process validation. The Regulatory Focus Group (http://www.apsgb.co.uk/focus_groups/overview.asp?TeamCode=RE27) aims to:. Provide a forum for discussion of regulatory issues that are of interest to the APS membership Facilitate discussion on new product development approaches, manufacturing technologies or drug delivery approaches that have a regulatory impact Promote pharmaceutical science and innovation Provide training and education on regulatory topics for the benefit of members. A small Steering Committee has been formed to identify and prioritise the main areas of interest of this Focus Group with a view to organising an ongoing programme of 1-2 day meetings.. . If you are interested in joining the Regulatory Focus Group or if you have suggestions for topics which you would like the Steering Committee to consider, please contact Malcolm Dash at malcolm.dash@mhra.gsi.gov.uk.
Join the New Scientist Focus Group session on Tuesday 9th September, 2014, from 10.35 to 12.05 at the APS Pharm Sci conference 2014
THURSDAY, 31 JULY 2014
Join the New Scientist Focus Group session on Tuesday 9th September, 2014, from 10.35 to 12.05 at the APS Pharm Sci conference 2014.  The session will include presentations from established and emerging scientists and will be chaired by Neda Yavari from AstraZeneca and Mei Wong from Pfizer. The session will be opened by Dr Claire Thompson who will talk on Translating Innovation into Medicine Claire is a Co-founder and Director at NanoScientium. NanoScientium fast-tracks nanotechnologies into products and profits, with a focus on the healthcare space. It provides business intelligence to investors, academic and industrial nanotechnology developers and large corporations to enable their investment, development and acquisition strategies. Prior to this Claire was Head of Research and Development with Oxford Pharmascience,  where she developed cutting edge technologies to enable medicines to be safer and easier to take.. Following Claire, is Dr Nikoletta Fotaki who is a senior lecturer in pharmaceutical sciences  from the University of Bath, who will talk on Predicting Performance in Paediatric Population; a Biopharmaceutics Perspective.  Nikoletta’s research and activities are focused on the development of in vitro screening tools and associated software for predicting oral absorption, the assessment of the impact of changes in drug substance properties and changes in the formulation process on bioavailability, animal models for predicting absorption, and in vitro-in vivo correlations/ in vitro-in vivo relations.. The third speaker is Dr Michael Cook from the University of Reading who will talk on Glycopolymer Hydrogels as Mucosa-Mimetic Materials. Michael is a teaching fellow, in the chemistry and pharmacy departments. His responsibilities include the overseeing of tutorials, workshops and lab classes. His research interests lie primarily in the development of pharmaceutical materials containing living cells or other bioactives.. Jay Poorna Reddy who is a Research Scientist at Bristol-Myers Squibb will complete the session with a talk on On-line Raman Spectroscopy for Monitoring Form Changes During High Shear Wet Granulation: Effect of Process Parameters and Binder Solutions Containing Polymeric Excipients. . The New Scientist Focus Group (http://www.apsgb.co.uk/focus_groups/overview.asp?TeamCode=NE15) aims to highlight the wide range of opportunities available to new scientists within the pharmaceutical arena providing advice on potential career paths and supporting their development.. Each year they organise Industrial Insights, a two day event for undergraduate and postgraduate students exploring opportunities in the pharmaceutical industry.  Please join them in March/April 2015 when Industrial Insights will be hosted by Pfizer at their pharmaceutical sciences facilities in Kent. For more information please see:  http://www.apsgb.co.uk/blog2/default.asp. .
APS Blog - Brendan Gilmore 'Is the tide really turning on antibiotic research stagnation?'
WEDNESDAY, 9 JULY 2014
. Last week, British Prime Minister David Cameron announced the launch of a Commission on Antimicrobial Resistance, the first global leader to declare the need for immediate global action to halt the rise of antibiotic resistance, promote public engagement, education and stewardship to arrest the global over-use of antibiotics and examine the economic and market barriers to global antibiotic research and development which have seen the last three decades of the ‘antibiotic era’ characterized by a dearth of research into new chemical diversity in the antibiotic arsenal, as major Big Pharma players exited the field and no new classes of antibiotics marketed for a quarter of a century. The Commission will be chaired by the world-renowned economist, Dr Jim O’Neill (former Chief Economist at Goldman Sachs and creator of the BRIC acronym to represent the four major developing economies Brazil, Russia, India and China which symbolize the decentralization of global economic power away from the G7 countries). The commission, hosted and funded by the Wellcome Trust, will produce a major international review, examining the broader issues of incentivizing the antibiotic drug pipeline, the economic issues surrounding antimicrobial resistance and improved use and stewardship of our existing antimicrobial agents. Quoting from the Wellcome Trust, the commission is tasked with examining the following themes:. the development, use and regulatory environment of antimicrobials, especially antibiotics, and explore how to make investments in new antibiotics more attractive to pharmaceutical companies and other funding bodies. the balance between effective and sustainable incentives for investment, and the need to conserve antimicrobial drugs so they can remain effective for as long as possible how governments and other funders can stimulate investment in new antimicrobials, and timeframes and mechanisms for implementation. increasing international cooperation and support for action by the international community, including much closer working with low- and middle-income countries on the issue”. Although the announcement has received a widespread welcome in the UK and beyond, the Prime Minister has received some criticism for appointing an economist (rather than a scientist, presumably) to chair the commission. However, the acknowledgement that the stagnation of antibiotic innovation on a scale which is failing to meet the demands of global antibiotic use in the face of mushrooming antibiotic resistance is primarily due to economic barriers is a critical one. Furthermore, as developing economies flourish, the rise in demand for antibiotics soars, supporting fledgling healthcare systems, agriculture-based economies and ageing populations. A commission chair with expert knowledge of BRIC and other emerging economies, themselves major global consumers of antibiotics and key targets for public educational and antimicrobial stewardship programmes, may yet prove a significant move. The commission commences its activities in the autumn, initially for a period of one year.. This establishment of the commission comes hot on the heels of the announcement that antibiotics, has been chosen as the challenge theme (as voted for by the British public) for the £10m Longitude Prize 2014. The challenge set for the Longitude Prize is to develop a cost-effective, accurate, rapid and easy-to-use test for bacterial infections to enable healthcare professionals across the globe to select and administer the right antibiotic for a particular infection, at the right time. Such point-of-care diagnostics will form the basis of strategies to curb the inappropriate use of antibiotic agents, protecting the limited arsenal of antimicrobial agents available against emerging antibiotic resistance. The challenge is open, as in the spirit of the original prize, to both amateur scientists and the professional scientific community to put forward ideas on how to solve it. The Longitude Prize, a £20,000 (today c. £2m) challenge established by an Act of Parliament, to find a practical solution that could find longitude accurate to half a degree (equivalent to 2 minutes), was awarded 300 years ago to John Harrison for his invention of the marine chronometer. John Harrison was a joiner and clockmaker with little formal education, whose invention allowed accurate global positioning and ensured Britain’s position as a naval super power. In parallel, John Hadley and Tobias Mayer perfected the apparatus and astronomical tables, which allowed longitudinal measurements via the lunar distance method. It can only be hoped that the prize will again give rise to more than one approach to solve the intractable problem of antimicrobial resistance. The Longitude Committee, led by Astronomer Royal Lord Martin Rees, are now finalizing the criteria for award of the £10 million prize, with proposals accepted from this autumn.. In May 2014, the Biotechnology and Biological Sciences Research Council (BBSRC) announced that combating antimicrobial resistance would become a key strategic priority, in line with the UK Department of Health Five Year Antimicrobial Resistance Strategy (2013-2018), calling for improved knowledge and understanding of antimicrobial resistance, conservation and stewardship of the efficacy of existing treatments and stimulation of the development of new antibiotics (and their alternatives), diagnostics and novel therapies. Also, in May 2014, the Royal Pharmaceutical Society’s Pharmaceutical Sciences Expert Advisory Panel (PS-EAP) published ‘New medicines, Better Medicines, Better Use of Medicines – A Guide to the Science Underpinning Pharmaceutical Practice’, highlighting the major challenges and opportunities faced when creating new medicines, improving existing medicines or ensuring better, safer use of medicines. In addition, the document makes seven recommendations for action arising from the challenges highlighted. Recommendation two of the guide is “stimulating new antimicrobial development and improving antimicrobial stewardship”.. So, clearly the political, societal and scientific will is behind the development of new antimicrobial drugs, education and stewardship for protection of those we have available and development of new therapies for infectious diseases. The crisis of antimicrobial resistance, leads to significant opportunities for the UK science and technology sector in leading the world in new antimicrobial agents and therapies and technologies aimed at point-of-care diagnosis of infection to facilitate appropriate, judicious use of antibiotics and other antimicrobial agents.. The APS microbiology and anti-infectives focus group seeks to be at the forefront of underpinning the importance of microbiology in the pharmaceutical sciences, public engagement on antimicrobial stewardship and providing a forum for the scientific discussion of cutting edge antimicrobials research and development in these exciting times for antimicrobial chemotherapy..
Contribute to a Round Table discussion on the development of a Manufacturing Classification System with speaker and contributors from Astra Zeneca, BMS and GSK.
FRIDAY, 4 JULY 2014
. On Tuesday 9th September 2014; 16:20 to 17:50 at the APS Pharm Sci Conference 2014. Speaker: Gavin Reynolds (AZ). Co-chairs: Michael Leane (BMS), Kendal Pitt (GSK).. This roundtable session will introduce the concept of a drug product Manufacturing Classification System (MCS) based on processing route and seeks feedback from the wider pharmaceutical science community on the best way to apply it to practice. 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 Active Pharmaceutical Ingredient (API) and the needs of the formulation. The proposed MCS could be used to develop a risk assessment for manufacturing based on “ideal” ranges for API physical properties and therefore indicate how robust a manufacturing process is likely to be in relation to those properties.. The four classes proposed are:. Class I: Direct Compression Class II: Dry Granulation Class III: Wet Granulation Class IV: Other Technologies. Input from interested parties is needed to develop this concept. In particular, feedback is sought on what API properties are important when selecting or modifying materials to enable an efficient pharmaceutical manufacturing process.
 
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