Hope for Devastating Small Bowel Syndrome Disease


Andre Bessette, CEO & Co-founder at Eclipse Regenesis talked about Short Bowel Syndrome at an event by Bio2DeviceGroup (www.bio2devicegroup.org) held at Wilson Sonsini (WSGR) in Palo Alto. Bessette shared information on prevalence of the disease, it’s impact, and the new technology that offers hope for restoration. 

Feel free to skip the short tutorial below and jump to SBS and the technology solutions for treatment of SBS

Movement of the food

Typically digestion begins in the mouth where chewing and saliva begin to break down the food. As it passes through the esophagus, the contractions in the esophagus moves the food forward towards the stomach. In the stomach, the food breaks down further into liquid or paste and is mixed with acids and enzymes. The stomach slowly empties the contents, called chyme, into the small intestine. 

Small Intestine
It is the tube shaped organ and is located between the stomach and large intestine. The small intestine is regarded as the workhorse of the digestive system. It is 20 FEET LONG and includes the duodenum, jejunum, and ileum. 

Duodenum is the first part of the small intestine where typically iron and other minerals are absorbed.
Jejunum is the middle section where cabs, proteins, fat and most vitamins are absorbed.
Ileum is the lower end of the small intestine where bile acids and vitamin B12 are absorbed.

From small intestine the food travels to the large intestine which is about 5 feet long in adults and helps in absorption of water and other remaining nutrients. It then changes waste from liquid to a solid matter called stool. 

Short Bowel Syndrome (SBS)

short gut. Before surgery and after surgery. Short bowel syndrome is a disorder caused by a lack of part of small intestine. Vector illustration for biology, scientific, and medical use.

Short Bowel Syndrome or SBS is a devastating condition where the small intestine is simply too short. The inadequate length of the small intestine leads to a whole host of problems primarily related to malabsorption of nutrients and depending on the degree of shortness, sometimes it drastically shortens lifespan. Typically SBS is diagnosed when people have at least half of their small intestine removed and sometimes all or part of their large intestine removed due to disease or injury and significant damage of the small intestine. Sometimes it is a congenital abnormality, where a baby is born with very short small intestine. Depending on the length, SBS may be mild, moderate or severe. 

Malabsorption

People with SBS cannot absorb enough water, vitamins, minerals, protein, fat, calories and other nutrients from food. Difficulty in absorbing nutrients depends upon the area of small intestine that is removed or non-existent. This inability to absorb nutrients and water causes severe and frequent diarrhea, weight loss and other symptoms related to loss of essential vitamins and minerals. 

Disease prevalence 

There are about 8 thousand new cases of SBS in the US, each year. About 65% of them are due to congenital or acquired defect. Typically pediatric patients die before they reach 3 years of age. Their short life is marked with TPN (Total Parenteral Nutrition) treatment where by nutrients are given directly into the bloodstream bypassing the gastrointestinal tract. Gattex (teduglutide) is a prescription medicine given through intravenous (IV) feeding or subcutaneous injection. Not only is it a costly treatment, averaging around 200-300K annually without much improvement but a baby would need to continuously be wearing or accompanying a backpack. Surgical treatment costs 150K to 400K and transplants cost over a million dollars and require life long care, possibility of rejection and infections and has about 5 year mortality for 50% of patients. NONE OF THE CURRENT TREATMENT OPTIONS RESTORE FULL BOWEL FUNCTION.

Eclipse Regenesis Solution

The Eclipse XL1 therapy is a restorative solution designed to grow a longer, healthy intestine rapidly in the course of 2-3 weeks. The solution is entirely mechanical and repeatable, without any harmful or toxic effects. Eclipse has devised a nitinol coil that is introduced into the small intestine via a stoma. Plication sutures are then applied outside the intestine to hold it in place. During the course of the therapy of 2-3 weeks, while the device is in place, nutrients continue to flow through the intestine. Over 2-3 weeks period, the coil gradually expands. As it expands, it gently pulls the small intestine, stimulating new tissue growth and lengthening the treated region 2 to 3 times. The solution is striking in its simplicity and beautiful uncomplicated. After expansion, the sutures dissolve, allowing the coil to move forward and finally get passed out naturally.

Besssette shared information on the team of co-founders with impressive credentials and answered various questions from the audience. Yes, the contractile function continues in the newly lengthened intestine, no the length sustains and does not snap back and the process is repeatable to produce clinical significant length of the intestine and all of these is indicated by the animal trials. 

Small Bowel Syndrome is an orphan disease and as such the Eclipse XL1 has received a HUD designation (which requires incidence rate of less than 8000 new cases a year, in the US). Eclipse is anticipating using the HDE regulatory pathway which requires safety and probable benefit data. Eclipse plans to commercialize in pediatric market, in the near future.  

 

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JOBS: September, 2019


Good deal. Close-up of two business people shaking hands while sitting at the working place

Please see some of my current opportunities below. All opportunities are for local (US based) candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

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The 39 Steps – Play Review


The 39 Steps is a theatrical spoof on the 1915 novel by John Buchan and the 1935 film by Alfred Hitchcock. Authors of the parody, Simon Corble and Nobby Dimon envisioned the theatrical spoof in 1996 and was later rewritten by Patrick Barlow, with four people playing many roles. At Theatreworks, Lance Gardner, Ron Campbell, Cassidy Brown, and Annie Abrams do a fabulous job of quick role changes as the fast paced spoof moves on, drawing the audience into the murder mystery, with a twist. 

Image result for the 39 steps, theatreworks

As the story evolves, Richard Hannay, a man with a boring humdrum life meets an exciting woman who confides in him that she is a spy and requests him to take her to his home. Soon she is mysteriously murdered at his home, leaving the bewildered and scared Hannay to go on the run, both from law enforcement and the people who murdered the spy woman. As Hannay expected, he is accused of murder. As he goes on the run in search of the murderers, Hannay has encounters with constables, spies, village farmers, traveling salesmen, inkeepers, newsboys and he crosses streams, assumes false identity, meets a blonde and even dangles from the bridge.  All this makes for lavishly theatrical and hugely hilarious production. 

Image result for the 39 steps, theatreworksImage result for the 39 steps, theatreworks

The 39 Steps at Theatreworks, mixes an engrossing masterpiece with juicy characters and hilarious role changes with exciting staging by Leslie Martinson, perfect scenic designs by David Lee Cuthbert, and all the excitement unfolds inside a fast paced whodunit murder mystery, brilliantly directed by Leslie Martinson. This play has been extended to run through September, 22 and tickets are available at www.theatreworks.org .

 

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Alaska – Land & Cruise — August, 2019


Alaska – via land — Wasilla, Palmer, Anchorage, Talkeetna, Healy, Fairbanks, Denali

IMG_20190807_161150440-1.jpgMy Alaskan adventure began in Wasilla and Palmer, Alaska. During 1930s, Great Depression, at a time when people had few sources of income, the Government invited Americans to settle in Alaska and do farming. After strict screening of applicants, 203 families were selected. Each family was allotted several thousand acres in Alaska and was given $3000 as starting incentive. They settled near Palmer. Today Palmer is a little town with a small but vibrant downtown with a little museum that celebrates the original inhabitants and their descendants. While I waited for my friend to arrive, I had a beautiful day visiting the shops and learning some history from chatty shop owners.  

IMG_20190811_105424848.jpgIMG_20190813_170931147.jpgWe stayed the night in Anchorage and began the 250 mile drive towards Healy. We were greeted by most amazing vistas with rolling snow capped mountains, glaciers and rivers interspersed with forests. In Alaska, you get all the nature your heart desires and it is teeming with wild life. We saw a hare, a black bear and a couple of hyenas. On the way we stopped at the beautiful town of Talkeetna and enjoyed its quaint shops, had fireweed ice cream and birch candy and then came across what we thought was a routine vista point. That was Mount Denali South viewpoint and the view was just breathtaking.

 

Denali, also known as Mount McKinley, with elevation of over 20,000 feet is the highest mountain in North America. It was a clear day and we could see the gorgeous mountain, in all its majestic beauty.

IMG_20190809_204306653.jpgFrom Healy we went to town of Denali and then visited Cheena hot springs in Fairbanks.  Besides being known for its sulphuric hot springs, Cheena is known for viewing of Aurora Borealis. Unfortunately, we did not get to see Aurora, except in a documentary, in a museum.  But we thoroughly and absolutely enjoyed soaking in the hot springs. Very reluctantly, I emerged out the relaxing waters.  We drove back to Anchorage enjoyed the day in Anchorage touring the downtown area, visited a little street fair and market and then proceeded on the beautiful drive South to the port of Seward. The drive was lovely. Seward is also a lovely little town and we enjoyed the walk through in the town before boarding the cruise at Holland America.

After we boarded the cruise…… 

 

Haines, AK – Absolute awesomeness of natural beauty in Alaska will make your soul sing happy tunes. A small five mile inlet called Glacier Bay exposes travelers to perhaps world’s most majestic wilderness area. It covers over 3.2 million acres of forest, inlet and shore with mountain peaks rising over 15,000 feet, towers of ice and many glaciers. Tidewater glaciers are rivers of ice that flow to the sea and from time to time large chunks of ice break free and flow into the ocean. There are seven such glaciers here. 

 

Margerie Glacier – Margerie glacier is truly Alaska’s spectacular gem of a glacier. The views were so amazing that on a sunny day, a boat load of people were watching on the deck, in stunned silence. And after rumbling sound followed by thunderous cracks, when large chunks of ice began to break off, the people erupted in oohs and aahs…

 

Juneau, Alaska & Mendenhall Glacier – This land keeps revealing more and more beauty and each new sight competes with the previous one for top spot. Mendenhall Glacier is about 13 miles long, located in Mendenhall Valley it is about 12 miles from downtown Juneau. The glacier terminates in Mendenhall lake where the views are stunning. We gazed upon the blue hues emanating from this spectacular glacier, then walked up to the visitor center and gawked upon more spectacular views from the top. Mendenhall Glacier is overflowing with beauty, with nature and wild life. While we didn’t see the bear, we saw a porcupine very up close.  Here’s a little joke we heard on the way. Why are Alaska state employees not allowed to look out of the window in the morning? So they could look out of the window in the afternoon. Actually life moves in a slow lane here and many residents take up to 4 month break and go away to the “lower 48” during winter, to work as a contractor or visit family. Small request: Regardless of your political affiliation, please take care of these gorgeous glaciers. Gunalcheesh (thank you) in Tinglits lingo. We also took Mount Roberts Tramway from right near the cruise ship dock for a short ride up 1,800 feet up the mountain. From there we got to see spectacular views of the city of Juneau and Gastineau Channel and did some shopping of gifts for friends. 

 

Kachikan, Alaska – Kachikan is a lovely city facing the Inside Passage and is known for its Native American totem poles. We did not get to visit Misty Fjords, a glacier carved wilderness with snow capped mountains and waterfalls and salmon spawning streams. Kachikan has a vibrant wild life with black bears, wolves and bald eagles. We visited Tongass National Forest which also has a salmon spawning stream. We were incredibly fortunate to see a bald eagle fly fairly up close with its completely majestic display of wings spread out. I could not get to my camera in time to capture the incredible flight but I will forever savor the sight. We also visited a bald eagles sanctuary. Injured or old eagles who cannot survive in the wild, are cared for there and they also work doing little shows for visitors.   We visited Totem Pole museum and then visited Creek Street, the former red-light district that is now turned into an arts and craft and museum area. 

 

Our Alaska journey ended in Vancouver, Canada but the incredible expansive beauty of  Alaska is seared forever in our memory. Alaska is truly the last most glamorous frontier that is easily accessible and offers spectacular awesomeoness in all its majestic glory for everyone to enjoy. It is up to each one of us, to do little some thing that we can do to preserve and protect this incredible and gorgeous land.

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Language Archive – Play Review


“What is death to a language.  There are 6900 languages in the world,  Every two weeks, a language dies. This statistic moves me more than any other.  It is death of imagination”. This dialog from Theatrework’s Tony Award-winning “Language Archive” is a celebration of the power of words. And the play itself is also a heart touching rendition of the limitation of language because after all, love transcends words.

Image result for language archive, theatreworks

Above everything else, playwright Julia Cho’s quirky sentimental comedy is a celebration of human spirit, with all its tenacity and vulnerabilities. Superbly directed by Jeffrey Lo, every dialog in the play is Muni-Muni (means makes on think deeply in Philippine language). The play centers around whimsical brilliant linguist George (Jomar Tagatac). George’s affirming love for the spoken word and his deep inner struggle to verbalize his innermost feelings are contradictions that point to a larger conundrum – what is more important and more fully defines humans, words or feelings. Even as George devotedly works to preserve and record dying languages of the world, internally he struggles to communicate his feelings to his beloved wife, Mary (Elena Wright). Mary on the other hand, lives in the world of feelings, wears her heart on her sleeve, composes and leaves littler verses for George to find, and cries at the drop of a hat. She is critical of George’s lack of emotions. When George insists that he feels and feels deeply and that his work is devoted to preserving languages and he also deeply mourns the death of a language, Mary counters, “You mourn ideas, not people”.  Mary, a woman of feelings, speaks some of the most memorable lines, including telling George, “There is a certain language, our language, and if you don’t come back, I can’t speak it any more,” and when George does go back, Mary indeed fails to understand him. Emma (Adrienne Kaori Walters) works with George and she understands George more deeply.  She also secretly loves George and pines for him.

Image result for language archive, theatreworks

Alta (Emily Kuroda) and Resten (Francis Jue) are endearing old couple who are amongst the last people to speak their native language. However, they only speak in their tongue when they are speaking with love. When they are fighting or sniping at each other, they choose to do that in English. George and Emma are keen to record their language but end up terribly frustrated as Alta and Resten are fighting and refuse to speak in their native tongue, as they snipe at each other in English.  In many ways, it makes intuitive sense that they speak in their native language only when they are communicating deep innermost feelings. After all, language of love is the language of the heart and it supercedes the language acquired through learning of words. Language of love is acquired in infancy, long before an infant learns words. The play beautifully weaves together the amazing power of love beyond words with the power inherent in words that give human feelings of love, longing, fear and vulnerabilities, meaning and substance and enables people engaged in a deep relationship an ability to create their own language.

This is a not-to-miss play of this theater season in the bay area and will be running till August 4 at Lucie Stern Theater in Palo Alto, CA.  Tickets are available at www.theatreworks.org .

Language Archive, Play, Review Julia Cho, Jeffrey Lo, Jomar Tagatac, Elena Wright, Adrienne Kaori Walters, Emily Kuroda, Francis Jue, Lucie Stern Theater, Palo Alto, www.theatreworks.org 

PS: World’s oldest continually operating library where lost languages have been found
archaeology-world.com/this-is-the-wo…

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Response to Tom Friedman (NY Times) – We need outrage, No that is not going to get Trump re-elected.


This is in response to Thomas Friedman’s column “Trump’s Going to Get Re-elected, Isn’t He? Voters have reason to worry”, published on July 16, 2019 in New York Times. .With all due respect “Sir, you are wrong”. With your prescribed cerebral approach to keeping the eye on the prize to winning elections, asking for money when Trump tweets, IS NOT GOING TO HELP DEMOCRATS WIN, not to mention it further corrodes the moral soul of the country.

No, we are not seeking revolution AND yes, we want to beat Trump at the polls. But expressing immense OUTRAGE isn’t exactly revolution. IF we don’t express outrage and let it be our new normal, IF we don’t stand steadfast with our black and brown people and with LGBTQ and with women, then what sir are we going to be able to do for the country? IF a 3 year old Sophie is going to be given a choice between her two parents and we simply collect money to beat these people at the polls, than what about our moral soul, how is our party different from the other party?

But since you want to focus on practicalities and not sentimentalities, then let us do that for a moment. 1) Just as Donald Trump is energizing his base with his relentless racist and sexist tweets, there is a whole Democrat base looking to have their opposition to blatant racism and sexim channled though a leader who can take Trump on. Money is a natural outcome of an energized base. 2) How large is Trump’s base? For the most part, his approval has hovered around 44% and disapproval has hovered around 51%. Do you want to sacrifice or water down the 51% of those looking to beat Trump in order to win a few swing voters? Well sir, those swing voters are right now few or non-existent. People have made up their minds and his base may get more obstinate but will never grow. The country is divided into people who feel morally outraged and those who are enchanted by moral liquidation coming from the highest office in our country. 

Right now, those of us who are outraged that such an individual who got there with outside help is allowed to use his office to incite racism and sexism, are banging our heads in frustration. No, perhaps #impeachment is not an answer because we need to go there only when we have certainty to win. But expressing our outrage in every other way, we ought to do; standing together with our citizens under attack, we ought to do. And even if we don’t take steps to impeach Trump, we need to get every one of his minions who have violated rules and regulations and hatch acts and plaster them all with criminal indictments. We need to blend our forward looking agenda about infrastructure, job creation, minimum pay raise, treating refugees with dignity, with hard issues of border protection, opioid flooding by big pharma and interference into our elections by foreign actors.  These are not simple issues, but to win, we will need to balance complex issues with both firmness and humanity.  No sir, don’t tell us that all we can do is send in money. All our frustrations cannot be culminated into sterile act of writing a check. We need outrage and a leader who will not stoop low to Trump’s level and yet will not balk at standing steadfast against everything wrong that is going on. Right now, we have 20+ awesome individuals who have taken on the challenge to beat Trump and as long as they are not afraid of taking on Trump and of being heard, we will win the election.

You are wrong, because sir, the way to beat Trump at polls is to not let him steal our voice.

 

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JOBS: July, 2019


Good deal. Close-up of two business people shaking hands while sitting at the working place

Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience. If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail or find me on Linkedin.

Clinical Trials Manager – San Jose, CA

There is an immediate opening for Clinical Trial Manager to join a high-performance team. The Clinical Trial Manager will be accountable for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more CROs. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Major Duties and Responsibilities

  • Manage the operational aspects of clinical trials
  • Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate
  • Prepare metrics and updates for management, as assigned
  • Proactively identify potential study issues/risks and recommends/implements solutions
  • Participate in and facilitate CRO/vendor selection process for outsourced activities
  • Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
  • May work with CRO to develop and revise the scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met
  • Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
  • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Serve as a liaison and resource for investigational sites
  • Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments

Skills

  • Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
  • Performs job duties with minimal guidance from supervisor
  • Organizes and prioritizes numerous tasks and completes them under time constraints.
  • Demonstrated success in problem solving.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Ability to constructively interact directly with clinical site personnel

Education and Experience

  • BA/BS or equivalent degree in scientific discipline.
  • Minimum 5 years of clinical trial management experience in biotech
  • Experience in managing outside vendors, e.g., CROs and other vendors
  • Experience with U.S. and Ex-U.S clinical trial management and Regulatory processes

Director of Regulatory Affairs – San Jose, CA

The position is responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions.

Major Responsibilities:

  • Develop and execute regulatory strategies for earliest possible approvals for development programs.
  • Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
  • Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA, 510(k) and other submission documents including meeting packages, briefing documents, responses, supplements etc.
  • Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
  • Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
  • Interface with international affiliates on regional regulatory strategy and implementation plans.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Skills

  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Ability to communicate and interact effectively across departments and on project team(s).
  • Results driven and team-orientated, with the ability to influence outcomes.

Education and Experience

  • Bachelor’s or Master’s degree in scientific discipline required.
  • 10-15 years’ experience in Regulatory Affairs in pharmaceutical, biotechnology or device industry.
  • Thorough knowledge of the drug, device and combination product development process with demonstrated experience in preparing global regulatory submissions.
  • Experience in multiple phases of development in various therapeutic areas.

Senior Quality Engineer – San Jose, CA

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.Responsibilities

  • Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • Support quality assurance activities, including, but not limited to: IQC, in-process and finished product testing and product release, Risk Management (FMEA, hazard analysis), internal and external audits and NCMRs and CAPAs
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
  • Provide QE support to production, purchasing and engineering
  • Support/lead test method validation activities
  • Conduct and support the development and validation of appropriate test methods for product and process performance
  • Develop and initiate sampling procedures and statistical process control methods
  • Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
  • Manage the Non-conforming Materials Review (NCMR) in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • Address systemic quality issues with suppliers or internal groups
  • Oversee calibration and preventive maintenance program
  • Oversee receiving inspection. Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods Identify and report nonconforming material
  • Perform/manage review of lot history records and disposition of product (subassembly and finished goods)
  • Work with engineering to develop adequate inspection criteria
  • Perform statistical analysis such as capability, gage R&R, and statistical process control
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • The position has supervisory responsibilities for a team of 5-8 direct reports
  • Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

  • A Minimum of 10 years quality assurance/engineering experience is Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is required
  • BS degree in Engineering is required
  • A Minimum of 3 years’ experience supervising employees
  • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience with non-conformances, CAPA, and Risk Management is required
  • Experience in performing test method validation and Gage R&Rs
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • CQE, CQA preferred

Skills and Specifications

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail
  • Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability

Manufacturing Engineer – San Jose, CA

Summary: Supports the manufacturing of high volume disposable device. Works with engineering and clinical to make sure device specifications conform to device requirements. Works with assemblers and technicians to make sure devices are built to desired specifications.

Responsibilities

  • Evaluate manufacturing processes by designing and conducting research; apply knowledge of product design, fabrication, assembly, tooling, and materials; solicit observations from operators.
  • Evaluate manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assure product and process quality by designing test methods; establishing standards; testing finished product and process capabilities.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Work with Development Engineers to effectively transfer new products to Manufacturing.
  • Maintain product and process data.
  • Complete design and development projects by training and guiding technicians and assemblers.

Requirements:

  • Proficient in process validations and its execution
  • Contribute to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor’s Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.
  • Ability to proactively identify and solve manufacturing issues.

Senior Manufacturing Equipment Engineer – San Jose, CA

Summary: Supports the manufacturing equipment and tooling used to manufacture company’s proprietary high volume disposable device. Works with Calibration and Preventive Maintenance personnel to ensure equipment is kept in optimal conditions. Works with equipment suppliers/vendors to purchase equipment/parts under our or equipment specifications.

Responsibilities

  • Assures that equipment integration projects are performed under the required timelines and budgets.
  • Develops manufacturing equipment by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators.
  • Identify Capacity and Quality Issues with Manufacturing Equipment. Recommend and Implement Solutions to revolve issue.
  • Provides support and oversees maintenance on Production Molding Machines
  • Design and fabricate of tools and fixtures with In house Machine Shop Equipment
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures.
  • Proficient in developing IQ/OQ/PQ documentation and its execution
  • Maintains product and company reputation by complying with government regulations.
  • Contributes to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry
  • Experience in plastic molding and material analysis

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies, and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.

Business AnalystPleasanton, CA

Requires 2+ years experience. Company offers 100% healthcare coverage & other benefits like 401K and there is potential for bonus.

Associate Scientist – Pleasanton, CA
Requires 10+ years pharma R&D experience with expertise in cell biology and should be able to translate it into business. Must know industry well and have a good network.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing. This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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Ashadh ka ek din (on Kalidasa): Naatak Play Review


Ashadh ka ek din (on Kalidas) : Naatak Play Review – June, 2019

Found on principles of bringing on stage intelligent and entertaining shows pertaining to East Asian literature and arts in San Francisco bay area, Naatak has consistently surpassed expectations from a demanding audience.

In Naatak’s 69th production, writer Mohan Rakesh’s “Ashadh ka ek din”, the focus is on young love, simple and lyrical as a poem, pure and unspoilt as nature, passionate and brimming with hope as the drop of first rain, in the month of ashadh. It depicts the story of Kalidasa, classical Sanskrit writer and poet who is presumed to have created his works in the 4th century, and was a royal poet during the reigns of kings Chandragupta II and Yasodharman. Kudos to Naatak for fantastic staging. How they manage it, despite low ticket prices is a mystery. 

It is as true today as it was then that stupendous achievements often come from heart-wrenching personal sacrifices. Kalidas (Anush Moorthy) was ahead of his times and his talents went unnoticed, in his little village. However the king in Ujjain was impressed by his work and sent him royal invitation to go to the capital, Ujjain and adorn the royal court as a national poet. Kalidas is reluctant to leave his beloved, Mallika (Preeti Bhat) who is the inspiration behind many of his works. But Mallika insists that he should not pass up this opportunity which will help bloom his talent.

Kalidas: nayi bhumi sukhi bhi to ho sakto hai

Mallika: koi bhumi aisi nahi jiske antar me komalta na ho, tumhari pratibha us komalta ka sparsh awashya pa legi.

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At the insistence of Mallika, Kalidas leaves his village, not to return for several years. With the force of royal sponsorship, Kalidas writes many epics like medghdootam, kumarsambhawa and raghuwans, all the while his beloved Mallika continues to be his muse. While Mallika pines for Kalidasa in the village. Mallika’s mother Ambika (Anshu Johri) curses Kalidasa and refuses to be drawn into the flow of emotions that have gripped her young daughter.  

Ambika: “ma ka jivan bhavna nahi, karm hai”.

Behind every successful man, there is a great sacrifice of a woman (of course, in the present times, opposite is also true). Produced by Alka Sippy and directed by brilliant, Manish Sabu, “ashadh ka ek din” is a story of love that is eternal, of time which stops for noone, and of sacrifice from which are born great works of art. One thing the play is not and I would have loved more of is Kalidasa’s work itself. The play does not focus as much on his poetry. Kalidasa had written Rutusamhara before he went to Ujjain. If the play included many lyrics from there which spoke of the beauty of the mountains, clouds and rains that appeared even more beautiful to the poet, in the company of his beloved, then it would have enhanced our joy. Nonetheless, it is a tender love story, with beautiful prose and heart-touching dialogues.

 

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JOBS: June, 2019


Image result for jobsPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail or find me on Linkedin.

Manufacturing Engineer – San Jose, CA

Summary: Supports the manufacturing of high volume disposable device. Works with engineering and clinical to make sure device specifications conform to device requirements. Works with assemblers and technicians to make sure devices are built to desired specifications.

Responsibilities

  • Evaluate manufacturing processes by designing and conducting research; apply knowledge of product design, fabrication, assembly, tooling, and materials; solicit observations from operators.
  • Evaluate manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assure product and process quality by designing test methods; establishing standards; testing finished product and process capabilities.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Work with Development Engineers to effectively transfer new products to Manufacturing.
  • Maintain product and process data.
  • Complete design and development projects by training and guiding technicians and assemblers.

Requirements:

  • Proficient in process validations and its execution
  • Contribute to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor’s Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.
  • Ability to proactively identify and solve manufacturing issues.

Senior Manufacturing Equipment Engineer – San Jose, CA

Summary: Supports the manufacturing equipment and tooling used to manufacture company’s proprietary high volume disposable device. Works with Calibration and Preventive Maintenance personnel to ensure equipment is kept in optimal conditions. Works with equipment suppliers/vendors to purchase equipment/parts under our or equipment specifications.

Responsibilities

  • Assures that equipment integration projects are performed under the required timelines and budgets.
  • Develops manufacturing equipment by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators.
  • Identify Capacity and Quality Issues with Manufacturing Equipment. Recommend and Implement Solutions to revolve issue.
  • Provides support and oversees maintenance on Production Molding Machines
  • Design and fabricate of tools and fixtures with In house Machine Shop Equipment
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures.
  • Proficient in developing IQ/OQ/PQ documentation and its execution
  • Maintains product and company reputation by complying with government regulations.
  • Contributes to team effort by accomplishing related results as needed.

Education and/or Job Experience

  • Bachelor Degree in Engineering Field or equivalent
  • Minimum 15 years in Medical Device Industry
  • Experience in plastic molding and material analysis

Skills and Specifications

  • A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
  • Capable of generating parts, assemblies, and drawings using Solidworks
  • Comfortable dealing with complexity and flexibility
  • Experience working under Change Control policies of FDA regulated devices and /or drugs.

 

Business Analyst – Pleasanton, CA
Requires 2+ years experience. Company offers 100% healthcare coverage & other benefits like 401K and there is potential for bonus.

Associate Scientist  – Pleasanton, CA
Requires 10+ years pharma R&D experience with 
expertise in cell biology and should be able to translate it into business. Must know industry well and have a good network. 

Regulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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De De Pyar De – Bollywood Movie Review


In Akiv Ali’s Bollywood film, “De De Pyar De”, finally we have a chick flick for men. Fret not; you will see the reason behind this oxymoron very soon.  Movie starts off as a romantic sex comedy between 50 something calm and confident alpha man, Ashish (Ajay Devgn) and about half his age hottie, Ayesha (Rakul Preet Singh). Ashish and Ayesha confidently flirt with each other, then fall in love, and then briefly discuss that gossipers in the community will judge that she is into him for his bottomless wealth (he is an investor in London) and he is into her for her youth and beauty (yes, she is hot) and thus the issue is put to rest.

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Lest we still become judgmental, their flirty tête-à-tête includes sweet caring (she makes dal for him, he says he does not like dal so as to not hurt her feelings) that indicates they are truly into each other and despite deciding to stay away from one another, they just could not. Singh is sexy but also expressive and caring. But that’s not where the film ends with 50 something guy romping with a young hottie. That is just the beginning. The movie wants us to give a stamp of moral approval on this relationship. And that is where the film takes a turn from romantic comedy to family drama. Ashish takes Ayesha from London to India to meet his ex wife and kids and parents.

The problem is —- ok there are many problems that can’t but make us feel a tad judgmental.  First of all, the problem is the girl. She drinks hard, parties hard, doesn’t blink an eye when she passes out and finds herself (undressed) in the morning, in a man’s house. In fact, she is incredulous (perhaps also mildly disappointed) that he passed up on rape and did not take advantage of her. While it is supposed to make the audience look with awe at Devgn’s character, one wonders about Singh’s character and her lack of readiness for a serious relationship with a man with a past. Then the problem is the boy. He does no planning and shows no confidence in any of his past or present relationship decisions and they are all marked by irresponsibility, half truths, hypocrisy and deceit. He takes a girl the age of his daughter to India, without adequately preparing everyone, embarrassing them all.

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The beauty of the movie that makes it all worthwhile emerges in the few short scenes with Tabu (Ashish’s ex-wife). I am sure her dialogs touch the heart of every woman, when she speaks of being tired of always having to be the responsible one and mend relationships. Tabu as a mature mom who listens to all sides and resolves key issues with her daughter’s in-laws, the glue that keeps the family together, admonishing her kids when they get bratty are all beautiful knockout scenes. But it is Tabu’s short speech to her family to stop being judgmental and take responsibility for their decisions, asking them to stop blaming her ex-husband, is phenomenal.  And finally, Tabu’s dialog with Ayesha, her rival for her ex’s attentions, is an absolute gem; although one wonders how realistic it is to expect a wife who is still into her husband, to be so very generous and understanding and go out of her way literally, to bring them together; especially a husband who has been so irresponsible and his girl-friend who is simply too young to grasp all the complexities of a blended family with children her age. But in this movie, after a few speeches, such familial complexities are quickly and conveniently resolved, so Ashish can have his cake and eat it too, without any repercussions. So here it is, finally a chick flick for guys.

De De Pyaar De reviews

If you are willing to ignore complex realities of stormy, messy relationships, simplistic moralizing, and long term lack of wisdom of the characters, overall the film is entertaining and fun.  Tabu and Singh both put on stellar acts. I rate the movie 3.2 on a scale of 1 to 5 (with 5 being excellent).

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