Monday, January 28, 2013

Drug discovery unable to attract big money! - Is innovation, rather the lack of it to blame?

Some interesting observations on early-stage funding for healthcare from the 2012 Venture Capital Activity Report published by CB Insights (report abstract at this link);

  • Healthcare gets a not-so-insignificant share of 23% of all venture capital in 2012, but the overall investment into healthcare is lower than 2011 numbers, inline with the overall decrease in VC funding from previous year
  • The year also saw overall deal-sizes within healthcare fall from 2011 levels,  again like in other industry segments
  • Within healthcare, medical device & equipment related investments took 40% of the total dollars distributed and this shift of money towards devices & equipment segment has gotten stronger in 2012
  • Within the remaining 60%, drug discovery, development & biotechnology seemed to have got ~35% share, of which chemistry based drug discovery/ development got ~20%
  • and finally, within the 35% share share towards drug development, a majority seemed to have gone towards late-phase funding (>60 %?)

Thus the funding received in 2012 by individual companies towards early stage (discovery pre-clinical et al) seems much lower than the 2011 average (while ~10mio USD seems to be the average deal-value for all phases included, ~2 million USD could be the average value for early phase funding) - I don’t see any reason to believe that 2013 will be any different and if this trend indeed continues, the introduction of new candidates into clinic will continue to lag as before and economizing the cost of discovery & early-development will continue to be a rational strategy to be employed by the small & virtual discoveries - not sure if that'd compromise on innovation further....

The tilt of VCs towards medical device/ equipment segment looks like a commonly employed de-risking strategy of most investors. It also simultaneously suggests a seemingly prevailing weak-sentiment in investor universe towards the quality of innovation happening in biotech & chemical drug development.

While innovation domain should go through its own disruptive innovation now...., any major positive swing from 2012 trend would happen only if GPs (& LPs of course....) innovate their conventional low-risk investment strategies resulting in a) significant increase in number of deals and b) an appropriately incremental average funding on each deal and both towards drug development. 

So when is the new paradigm shift in drug discovery happening & who is going to drive it?

Sunday, January 27, 2013

Generic Drug User Fee Act (GDUFA) - What will be the implications for the consumer & for the generic API manufacturers based outside NA & EU


20 August, 2011
Posted in Linkedin Answers by Murali Apparaju

For those who remember SOCMA & EFCG making a fervent pitch in 2006 for a level playing field for domestic (read: NA/ EU) and foreign (read India, China) API manufacturers, this is an announcement of their first success & how.....

Two days ago, GPhA, EFCG & SOCMA reached an agreement with US FDA on the proposed final form of the Generic Drug User Fee Act (GDUFA).

While at the conceptual level this act is for higher patient safety through a tighter regulation of Ingredient manufacturer, this also appears to be an apparent back-door strategy to wall-out "old-technology" (read: "No QbD/ PAT" also read: "Cheap") Indian & Chinese API manufacturers in favor of the more-regulated, domestic, safe & costlier? local manufacturers.
(the NY times brief in the above link is titled "A deal to get Cheaper & Safer drugs" - wonder how exactly was this deduced?!)

What do you think GDUFA will eventually achieve/ cause & do you think consumer is the real beneficiary?

Hoping to see some comments here.

Cheers,
Murali Apparaju


Saturday, January 26, 2013

NRAchists in gun-afflicted america....

December 2012

My comment on a LinkedIn article on need for Gun Control in USA, I only see the comments now, no article!!, still an interesting read...


As per the chart, USA has ~90 guns for every 100 people. Despite this startling fact, I still see many below demanding a more scientific & non-discriminatory analysis rather than brooding over the above fact. - know what, to hell with more stats.... it is probability! - the probability of a gun being used is directly proportional to the number of guns that are available for use........ stop kidding yourselves gents & ladies, face it instead & save the kids.

Caste, gender & slur - Quite an explosive cocktail!! :-)

01 March 2009

Wow, this repro' is a dinosaur, way back from 2009!!! - my comment below was on a real flamer of a topic that was originally posted in November 2007 & still going strong with 983 comments amounting to terabytes of sane words & insane rhetoric. I don't want to be another blogger to do the same mistake & hence have disabled comments on this - If you have a compulsive impulse to add to Uday's woes, post your comments on the original site below - cheers, V 

http://udayms.wordpress.com/2007/11/16/brahmin-guys-are-not-lovemarriage-material-says-brahmin-girl/


My observations on the original post (rather on the content of Brahmin Ponnu’s statements) – to keep it simple, I will assume she’s indeed a brahmin ponnu & the feelings indeed are true…

I)
“Familiarity breeds contempt – Over exposure to a certain kind makes one nauseated – the insider knowledge causing prejudice”
  •  Doesn’t this happen in your company, aren’t the insiders the last choice for the new post created & don’t outsiders look eminently more attractive than insiders to the management – this is a similar syndrome.

II)
“Choice of mate instincts keeps changing with age..”
  •  At college I’m sure the lure is of big talking, macho & adventurous guys – which an average brahmin male may not demonstrate owing to upbringing.. PHYSICAL & SOCIAL QUALITIES COUNT WHEN ONE IS LOOKING FOR A PRINCE ON THE WHITE HORSE TO TAKE YOU ON A DATE – SWEEP YOU AWAY?….FOREVER?….. THINK AGAIN…
  • 5 years down the line, I’m sure ponnu would settle for a Bay area techie in favour of the college stud who may not have settled as well & earning that well – MONEY COUNTS WHEN YOU ARE LOOKING TO MARRY


III)
“The lady’s comments are possibly reflecting the general liberation of minds in either sexes in this modern age…”
  •  Perhaps an indication of a growing & general reluctance to accept limitations in partners & aversion to compromise.
  • May be polygamy/ multiple partners is making a come-back… (check out the Axe Deo ad where mixing makes babes better….:-))
  • Perhaps, the ever increasing domination of “I” over anything else


IV)
“Brahmin men caught in a time-warp? – starting to live the stereotypes showcased by society, films??
  • Someone said this before, buck-up guys, change, work-out, change your attitude to looks, you have the basics in place, all you need to do is polish the stuff..
  • Forget about the simplicity your grandfather so believed in — he was in a different era… re-package your body, spirit, get attractive to the opposite sex…
  • I’m sure those who have done/ doing this already see the results, non-brahmin girls falling for them & yearning for them… (all the above applies still to these wide-eyed wonders, grass is greener on the other side of the fence)
  • finally it’s an appraisal, part-true, part-crap —- well…take some good out of it…. emerge better… don’t justify & get labelled more harshly…


all the best…





Friday, January 25, 2013

3200% premium for innovation!!

April 2012
Discussion posted on Pharmaceutical Discussion Group on Linkedin


PhRMA says price as trigger for compulsory license is not provided for in TRIPS - wonder if TRIPS provides for 3200% premium for innovation?

Reference article:


PhRMA’s Special 301 comments to the U.S. Trade Representative include a section on the compulsory licensing provisions in India’s Patents Act.  PhRMA recommends that “India should ensure that the CL provisions comply with TRIPS...

Why won't Gates spend a few more cents (per dose) on non-mercury biocides & shut-up the vaccine detractors?

April 2012
Discussion posted on Pharmaceutical Discussion Group on LI - by Murali Apparaju



I remember trying to promote ProClin (Supelco) as a viable safe non-mercury alternative to Thimerosal (Sigma), both Sigma-Aldrich products for the uninitiated - I've seen that despite obvious interest & some intention, vaccine manufacturers solely surviving from the bulk purchases by the likes of gates foundation continued to use Thimerosal owing to the cost-advantage it offers in a climate of 50% price fall each year… - 7 years hence, I’m wondering if all the noise on autism by Trump motivated Mr. Gates to at least encourage his supplier base to start looking at safer alternatives to Thimerosal albeit at a few cents higher per dose?... if not, why bill?



Reference video 


Thursday, January 24, 2013

Review of Mahendra Ramsinghani's "The Business of Venture Capital: Insights from Leading Practitioners on the Art of Raising a Fund, Deal Structuring, Value Creation, and Exit Strategies

21 Aug 2012

Review Posted on Amazon.com
http://www.amazon.com/review/R2Q6WI836ZOCJT/ref=cm_cr_pr_perm?ie=UTF8&ASIN=0470874449&linkCode=&nodeID=&tag=


5.0 out of 5 stars A 'must' for all those who fancy the bucket & probably the ocean too!August 21, 2012 By Vishrasayan

As someone aiming to venture into VC, and moving quite laterally at that, I was on lookout for a book that not only strengthens my basics but would also help me develop my own perspective of how the ecosystem behaves & how I could synergize and coexist with the same - `The Business of Venture Capital..' by Mahendra Ramsinghani fit the bill perfectly.

While essentially structured as a comprehensive guide to the VC process, the author took pains not to make the style pedagogic & peppered it liberally with quotes, case-studies and his own witty one-liners that helped the overall learning process while not getting your goat. Even as I persisted through all chapters, I did realize that the composition of each chapter allows one to skip a chapter or two & still make sense of the flow.

The book ends with a quote by David Ogilvy "Don't bunt. Aim out of the ballpark. Aim for the company of immortals". Interestingly (for me at least...), the epilogue starts with the sentence, "At its core, VC is truly an apprenticeship business" - This seeming contradiction/ irony is what defines the approach taken by the author Mahendra Ramsinghani in establishing that a true venture professional is essentially a lifelong apprentice who nonetheless perpetually aims to challenge the boundaries of a conventional success.

Highly recommended for aspiring & established VCs and anyone else who fancies the `bucket' in whichever way!