Pharmaceutical Discussion Group - Latest & Highlighted Discussions

What will be the effect of the Global financial meltdown on; a. Innovation in Pharmaceutical Industry? (linkedIn PhDG Group discussion topic)

Viswanatha — Thu, 09 Oct 2008 09:09:40 GMT

Discussion Initiated by Nehal Vora on PhDG @ Linkedin

Why are clinical trial registers not considered trial advertising? (LinkedIn-PhDG Question)

Viswanatha — Wed, 03 Sep 2008 08:59:46 GMT

Question Posed by Janelle Bowden @ http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&gid=38263&discussionID=24467

----------------------------------------------------------------------------------------------------

All trial advertising to consumers usually required ethics approval. However, the information on the publicly accessible, online, clinical trial registers is not subject to ethical scrutiny? Why is that? Why should there be so much scrutiny therefore over clinical trial ads?

Please let me know what you think here, or at my blog post on the same topic... https://www.accesscr.com.au/blog/index.php/2008/09/02/i-have-a-question-about-clinical-trial-advertising-and-clinical-trial-registers/

Non-Aseptic Processing and cGMP - What is the scope of non-aseptic processing under cGMP? Where do you draw the line.....(LinkedIn-PhDG Discussion)

Viswanatha — Thu, 04 Sep 2008 11:56:51 GMT

Topic created by Jignesh Padia on LinkedIn PhDG discussion forum...

----------------------------------------------------------------------------------------------------Do we need a clean room for cGMP even if we are non-aspetic manufacturer. What if you make the bulk drug substance / injectables going for final fill. Can you operate non-aseptically? I don't know the answers... I do have many more questions on this grey area of biopharmaceuticals......

Hope to get your comments.

Regulatory Oversight on Synthetic Analogues of 'Natural' Nutraceuticals

Viswanatha — Sat, 30 Aug 2008 09:41:13 GMT

Is the Regulatory oversight (particularly in US & EU & w.r.t. the marketing approval, processing therapeutic claims etc.) process on 'Synthetic Analogues of Natural (extracted) Nutraceuticals any different (from the approval process for 'natural' nutraceuticals)?

Preformulated Coatings v/s Drug Delivery (development?) Technology (LinkedIn Question)

Viswanatha — Wed, 10 Sep 2008 13:44:16 GMT

Question on LinkedIn by Brian Clancy

Are "excipients" e.g. formulated coatings disrupting mature "drug delivery technologies," e.g. sustained release? Further, how would you order drug delivery functionalities from most mature to least mature / incubation stage?

I would like to test the hypothesis: "Coating and matrix forming excipient providers (e.g. Evonik Degussa - Eudragit, Colorcon - Surelease, Dow - Methocel, etc.), along with their product-centric business model ($/Kg. monetization, not royalty) are moving into territory once associated with drug delivery technology, namely sustained and enteric release oral solid dosage forms (OSDFs)."

Furthermore, I would like to test the hypothesis: "The following are correctly ordered from most to least mature:"

Established / Mature:
1. sustained release (oral),
2. passive transdermal,
3. fast dissolve (oral dissolving tablet),
4. sustained release depot injection (small molecule),
5. transmucosal

Emerging:
6. PEGylation,
7. Enhanced Drug Solubilisation,
8. Pulmonary,
9. Sustained Release Depot Injection (Large Molecule),

Incubation:
10. Oral Protein & Peptide

Which functional categories would you add? Would you change the order?

PhDG Groupsite on CollectiveX will still be the primary discussions hangout!

Viswanatha — Mon, 01 Sep 2008 07:39:03 GMT

Dear Colleagues;

Many of you may have noticed that the Linked-In Groups now allow discussions! - however, it still doesn't provide many features that are very possible here... viz., Individual Forums, News Feeds, Member Objectives, Key Connections, Polls & other widgets, File uploads etc..

I wish to reiterate that DESPITE the enhanced features on LinkedIn, PhDG Groupsite will still be primary hangout for all discussions & request you to make this ‘The Hub' for all action.

Regards,

Viswanatha Apparaju

PS: CollectiveX is releasing a Version 2. for Groupsites, apparently with lot more ‘usability' engineered in... - When this goes online during first week of September, you may notice a lot of anarchy on the PhDG Groupsite - I assure you that all this will be sorted out in a week..... Rock On...

Data Integration: Dream or Reality?

Barbara — Thu, 21 Aug 2008 16:38:15 GMT

Within one company, if you have a horizontal view across all trials, you will notice that data is stored in various formats, including diverse relational databases, text files, XML files, spreadsheets and certainly proprietary storage formats. There is no unique way of collecting, organizing and analyzing data.
The problem is to utilize of this critical data to assess the trial's or program's performance.

What you need to efficiently measure the performance of your program is a unique type of storage that you could then query in a very efficient and time saving way: the metrics will be assessed on this unique model, generate homogeneous reports and ease decision-making.
That is where data integration takes all its meaning: the different sources will be combined in order to provide you with a unified view of your critical data.

Data integration solutions will be able to "connect" to your different source data (EDC output, IVRS, Safety data, Lab data, etc.). Once the data is integrated in this model, the metrics will be measured on it, and reports will be generated - standardized reports regardless the original output!

Think of the gain on time and professionalism: you could run reports for all studies, one dashboard similar to the next, in a couple of minutes, instead of spending days to manually create your report.

It appears that this dream is coming closer to reality! Thanks to services or applications that become a real interface between you, your providers and you performance management tool for example.

This kind of solution will use a standardized format, into which your providers will provide the data, and from which you and other tools, like indeed the performance management tool, will retrieve the critical data to assess the performance.

Data integration systems already exist for other domains like finance. Over the past decade it appears that it is possible in this domain. Now it is up to us to make it happen in the clinical area.

Our goal is to create a workgroup with some, if not all, of you. Together in the workgroup we will discuss first of all the needs, establish some specifications and standardized interfaces - which you might have encountered in other domains -, so that clinical data integration becomes reality!

Would Advanced Analysis Tools (What-if scenario, prediction...) be benefic to manage your clinical trial?

Barbara — Fri, 15 Aug 2008 12:03:18 GMT

Based on your experience in Clinical Trials, can you share with us what needs to be predictable? What kind of data should be analysed in order to be able to answer to the big question : "What if... ?"
What will make your performance improve ?

Thanks,

Barbara

Clinical trial performance survey

Barbara — Fri, 15 Aug 2008 18:53:29 GMT

In your opinion, and based on your experience, which of the following root causes is curbing good clinical trial performance:

Disparate and dispersed data, making difficult to have an integrated report at a glance
Isolated teams, creating painful communication loops and useless delays
Lack of methodology to assess metrics of performance, discontinuing the enhancement of informed decision
Other, please explain

This survey is also available on our website (http://www.evidence-performance.com/blog) ; all your answers will be merged together and we will display the most chosen root causes on our website - check it out!

Take care

Barbara

This time I seek a C F O

Nick — Mon, 18 Aug 2008 09:12:23 GMT

For a biotech.

An expereinced CFO with success in raising funds (next round will be c$20Million) in either Europe or the USA.

To find out more please contact either sara.otty@theRSAgroup.com or laura.stockman@theRSAgroup.com

Nick

Consultant needed

David — Tue, 12 Aug 2008 20:24:10 GMT

I am looking for a consultant who has experience as an operating room scrub nurse in orthopedics to help us review the preparation of our product. We are located in the Rockville, MD area and would prefer someone local as first choice.

Please send any contact informaion or referrals to me at: dmarkowitz@biosetinc.com

Thanks

David Markowitz

Director, Clinical Operations

Looking for a Biotech Job

Ankush — Mon, 11 Aug 2008 20:21:02 GMT

All,

I am a medicinal chemist with 11+ years of experience in directing (and also hands-on) a small molecule drug discovery and development in the areas of immunology, oncology, cardiovascular and virology. I enjoy learning and handling multiple responsibilities to benefit organization. I am looking for an appropriate job opportunity with start-up or a small biotech involved in a small molecule drug discovery and development.

I would appreciate if any of you could help me to spot an appropriate start-up or biotech in US, especially on the west coast. I will be glad to forward my resume and happy to discuss, if there is any information needed.

Thanks in advance.

Ankush Argade, Ph.D. (medchem)

Risk of 'undeclared Cytotoxicity'!

Viswanatha — Thu, 14 Aug 2008 17:11:10 GMT

Is there a practice among Pharmaceutical Services Organizations/ Contract Research Organizations to screen for potential Cytotoxicity while handling synthesis of Library Scaffolds & Pharmacophores? - The assumption is that unlike for INDs & late-stage NCEs, the cytotoxic evaluation wouldn't happen for these & hence not declared?

If such a practice does exist in a few organizations, how is the screening done? will it be merely structural screening or is there any other way?

Establishing limits for Topical Dosages

D.V. — Mon, 01 Sep 2008 22:38:20 GMT

Dear All,

For establishing limits of Related Substances in oral dosage forms of New drug products we have Q3B (R2) as guidance.

How we can establish limits of related substances in Topical dosages such as creams, gels, oils and other products ????? Do we have any guidance ??????????? pl help me out......

Subba Rao.D.V.

What constitutes 'Medicinal Chemistry'?

Viswanatha — Sat, 09 Aug 2008 17:25:58 GMT

The scope of "Medicinal Chemistry Services" seems to vary widely across Industry! - What all services/ solutions you feel should be offered under the title 'Med-Chem Services?"

Talent Management & Career Progression Planning

John — Thu, 07 Aug 2008 09:43:26 GMT

As a Business Executive, Hiring authority or HR Professional have you ever asked one or more of these questions:

* How can we retain our top people better than we do? * What are the most effective strategies to gain new talent? * How can we benchmark our Talent Management processes with other companies and other industries? * How do other companies develop their top people? * Where are our business leaders of tomorrow going to come from? * Where can I find the information I need, or discuss the issues with other like minded professionals?

Or as an ambitious professional have you ever wondered:

* How have the business leaders of today got where they are? * How can I best achieve by personal and career goals? * What new skills do I need and where can I get them?

We and our clients have been pondering the same questions for years and never yet found a single source which is simple, reliable and impartial - so we've set up a new facility instead. Aimed at bringing together the leaders of today and tomorrow with HR professionals, consultants and the top executive recruiters there is now a new global forum linked to sector-related Talent Management Groups (Including a Life Science Talent group). Please join us and participate in the worldwide Executive Careers Network http://CNAExecutiveCareers.ning.com

Please feel free to contact me at john.jebb@cnaint.com if you want further information

I look forward to meeting and engaging with you there

Regards John Jebb

Heard about Clinical Trial Performance Spot

Barbara — Sat, 02 Aug 2008 14:56:30 GMT

Hey there !

Since you and I are both in connection to the Clinical trial area, I thought that you might be interested to know about the Clinical Trial Performance Spot.

The blog has been created together with a couple of other experts in that field in order to discuss their key experiences in measuring and enhancing clinical trial performance and productivity.

With your experience and expertise in the clinical trial, you will be able to share lots of information with our other members. Most likely you will be feeling concerned about the topics we deal with in the blog.

I'm sure you already faced the ‘Monday morning' situation when you have to send the trial status to your manager - but oh no! no real integrated reports are available, you will have to look up the database, online or offline, and compile yourself the reports so that the managers get a nice overview about how good the trial does...
Oh the trial does not look that good according to plan? Then you will probably have to explain why you are not on schedule... but do you know? Where is the shoe pinching? You see... you need to diagnose why the performance of the trial is not as high as expected!! But how can you do this? Using some metrics, as standard as possible, is best to make this assessment.
As you can see each question brings you to another question, but also brings you closer to a solution.
This is a typical example of the topics that the blog will go through.

We need you to participate to the topics developed in the spot. All together, we will be able to make the difference and to improve on the quality of the next clinical trials!

http://www.evidence-performance.com/blog

The blog is led by you; invite your colleagues and friends that could be interested!
I am looking forward to reading your first comment on the Clinical Trial Performance Spot!

Happy reading!
Barbara

Photodynamic Therapy

Viswanatha — Sat, 16 Aug 2008 04:41:00 GMT

Hi,

What is your outlook on the future for Photodynamic Therapy NCEs?

Do you know of any Photodynamic Therapy Drug Candidate (NCE) that have made it beyond the Clincal Phase II trials?

Service Suppliers - Inspection and Certification

Byron — Mon, 07 Jul 2008 10:27:03 GMT

Dear all,

We are doing a general search for criteria, guidelines, papers and documents related to inspection of service suppliers for pharmaceutical manufacturers.

Also we appreciate if official regulatory affairs from different countries could be supplied.

Thanks in advance,

Byron Silva

www.vetaffairs.com.br

Manufacturing of cephalosporin

rajesh — Tue, 12 Aug 2008 16:22:01 GMT

Can some body help me on the following points with respect to manufacturing of Cephalosporin and Quinolones.

During manufacturing of which Cephalosporin and Quinolones the use of Boron Trifluoride Gas and complex are use
Do United states has also INPUT OUTPUT Norms as we have in India, if yes can some one guide me the website for details

Were else we use of Boron Trifluoride gas and complex in the manufacturing sector of pharmaceuticals

Table of All Studies

Wanda — Sun, 13 Jul 2008 22:25:20 GMT

Can someone here provide some feedback on how these are created specifically and what software program is normally used? Just wanting an idea of how they are supposed to look precisely.

Thanks!

Evidence based Herbal (Traditional) Medicine – Your Experience!!

Viswanatha — Mon, 14 Jul 2008 18:29:07 GMT

Since we have many here that are into Clinical Pharmacology, I am encouraged to ask;

Drawing from your experience;

What is your take on "Evidence Based Herbal Medicine"?
On what aspects/ parameters do the Herbal Products differ or compare favorably with Synthetic Drug Candidates?
Are the therapeutic claims of Herbal Product, in general, any less justifiable than those of the Synthetic Drug Products?

hope I could convey my intention & provoke a few!

I look forward to some lively discussion here..

LinkedIn Question: Do you think the pharmaceutical industry is focusing too much on "quality of life" drugs and not enough on therapeutic cures?

Viswanatha — Thu, 31 Jul 2008 15:09:50 GMT

Hi,

The above question was placed on LinkedIn and received some very interesting viewpoints..

http://www.linkedin.com/answers/technology/biotech/TCH_BIO/262996-13692006

any more input here?

Is there a threat to Pharma-Outsourcing Industry given the recent focus on M&A by Pharma majors?

Viswanatha — Fri, 12 Sep 2008 05:06:05 GMT

I've been wondering...

Looking at the recent M&A activity in India, I too am a little concerned on the opportunities available for pure pharmaceutical services organizations (both CRO & CRAMS offering services ranging from discovery, formulation development, manufacture, clinical scale synthesis & contract manufacture of APIs & dosages etc)

The trend indicates that more and more innovator pharma majors are looking to invest in their own off-site discovery, development & manufacturing sites utilizing the options available in low-cost centers such as India & China... (mostly through acquisition & some through building up) - will this not make the concept of pure pharmaceutical service organizations redundant over a period of time...?

It's always been said that pharma-outsourcing hasn't matured yet & when the signs of maturity started to emerge..., it seems the big-daddies are on a backward & forward integration spree again...will pharma-outsourcing ever reach the same level of maturity shown by the IT industry?

Under this context, what do you foresee as the future of Pharmaceutical Services Organizations (CRO/ CRAMS) in India and as such world-over?

Vice President/General Manager Biologic Manufacturing Operations

TOM — Thu, 10 Jul 2008 10:31:42 GMT

I'm searching for a VP/GM Operations. MUST have biological manufacturing experience.

This position has P&L responsibility. Reports to COO. Northeast location.

Send resume to: transpacific@comcast.net

Transpacific Group, Inc. Executive Search

PhDG Membership: Basic Demographic – As on 03 Jul 2008

Viswanatha — Fri, 04 Jul 2008 13:22:27 GMT

GEOGRAPHICAL INFORMATION:

The PhDG membership spans 51 Countries, the top 10 countries being United States, India, United Kingdom, Belgium, Italy, Netherlands, France, Canada, Australia & Switzerland. Top 10 Countries account for 91% of the total membership. Out of which, the region Split up is as follows;

North America - 48% (USA:46.5% & Canada:1.5%)

Europe - 23% (UK: 9.8%, Belgium:4.5%, Italy: 3.5%, Netherlands:2.5%, France:2.3%, Switzerland: 0.8%)

Asia - 18.8% (India: 18.8%)

Australia - 0.8%

AGE & GENDER:

Female, Male Ratio - 27:73

Average age - 40yr

The professional profiles cannot be accurate as many chose not to share the details - which is perfectly fine.

However, the recently updated Group Question requires new members to update their interest among all the forums - while this information is starting to come in for the new members, the old ones aren't updated - thereby not allowing any kind of analysis at this time. In hindsight, I understand this information should've been requested from the very start...... no wonder QbD is considered so very crucial...

I again request members (you see one request at the very top of the PhDG homepage) to visit their settings and quickly update the information of their forums of interest.

best

Viswanatha Apparaju

CPhI Worldwide 2008, Frankfurt - will you be there?

Viswanatha — Wed, 02 Jul 2008 20:29:40 GMT

CPhI Worldwide 2008 @ Frankfurt : 30 Sep 2008 - 02 Oct 2008

I request all, if willing, to confirm Yes/No etc & also provide the stand number if attending as an exhibitor...

Thank you

Vis

Coverage of diagnostic technics and management of food intolerance

Arnaud — Wed, 02 Jul 2008 15:18:01 GMT

Hi,

I'm currently working on the management and the coverage of pathology such as food intolerance e.g. coeliac disease, lactose intolerance, pernicious anemia. Does anybody know if the diagnostic technics and the management of such pathologies are covered in Europe and the US? Any source where I can find this information?

Many thanks,

Arnaud

Should we expand the definition of pharmacovigilance--and how we do it?

Tom — Thu, 03 Jul 2008 16:21:29 GMT

Wikipedia's definition of pharmacovigilance (PV), stolen shamelessly by me and condensed, is "the science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long and short term effects of medicines." The question I would like to raise is the following: why do we limit our efforts to just the "adverse" effects?

If our PV efforts determine that disproportionately many patients using treatment X develop blood clots, for example, we regard that as good science, and we might even require X's manufacturer to warn their customers, etc. If we could expand our scope, however, and collect information on all sorts of things that happen to patients, not just those we call "adverse," we might learn that an unusual number of patients using X (a) get elected to public office for the first time, or (b) get a promotion at work, or (c) are able to stop taking their morning ibuprofen, or (d, included to be provocative) even win the lottery. Like the list of possible adverse outcomes, the list of possible beneficial outcomes could go on and on.

I think the quality of the inferences we could make would be the same for the beneficial events as for the adverse. Suppose we observe 25 blood clots in 1000 patients, and, comparing that with some control, conclude that is more than would be expected by chance. Would we not reach the same conclusion if, rather than blood clots, the outcome is success in marriage? Either judgment might be in error, of course. (And if we noticed patients winning the lottery too often, we would almost certainly believe it to be an error.) But it appears to me that the quality of the inference is the same whether the outcome being counted is adverse or beneficial (and sometimes it's hard to say what's good and what's bad).

Let me be clear: what we DO with our conclusion (put a warning on X's label, for instance) is a decision that is distinct from the judgment that X raises the risk of blood clots (or the "risk" of success at work). They are related, of course; we add the warning to the label because we believe the conclusion is sufficiently reliable that patients should consider the possibility before taking X. If we were to conclude that X raises the chances of financial success, we might choose to require the manufacturer to undertake confirmatory studies. Or we might permit manufacturers to distribute reprints of the articles reporting the finding. There are other choices we might make. But why should we not even give ourselves a chance to discover the beneficial effects?

Obviously, this would require a wholesale change in the way we do PV. We would need to drop the "adverse" terminology, so that we don't unduly influence those who report the information. We would have to find clever ways to ask "what has happened to the patient since he took X?" We would have to change the whole mindset of the PV community.

But why not?

Pharmaceutical Advertising in India

Viswanatha — Thu, 26 Jun 2008 18:47:08 GMT

Assume for a moment...

India decides to allow Pharmaceutical Advertising vide all channels of Media!

What do you foresee as the potential impact/ Implications: short-term & long-term?