The Origin of the Filipino Race

Si Malakas at Maganda (The Strong and the Beautiful)

Sometime in the early 1970's, I was invited as a guest speaker by the Lions Club in Kansas City, Missouri. They requested that I talked about The Filipino-American War (1898-1902) and also the Japanese-American War(I941-1945). My knowledge of the first war was from books that I have read. However, I have personal knowledge of the second war having written an article about my childhood memories of that War( see video at bottom of this page).

In my speech class in college, I was taught that in giving a speech, start with a joke to put your audience and you at ease. Preferably your joke should be related to your topic. So this is my joke. Do you know the origin of the Filipino Race?

Evidently, when God created mankind, he molded the human form using clays and an oven. The first time, he was doing this, God was so excited that he took what he was baking too soon. The human clay was under cooked or underdone. So it was pale and white. That was the origin of the White Race. God was not happy, so he started to bake another human form. This time he got a telephone call from Satan. God was upset he forgot about what he was doing and the baking over done, the human form was overcooked, and turned black. This was the origin of the Negro Race. God then told himself. This time It will be perfect. I will watch it very carefully and will not be distracted by any calls. His baking was perfect. The human form was golden brown, and perfectly cooked. This was the origin of the Filipino race.

The following video summarizes the Invasion Of the Philippines by the Japanese as well as the destruction of Manila. Do not forget to view the related videos in this set. This is a must see video for all history enthusiasts and students.


First Posted:2014

My Undergraduate College Years in UP, Diliman

This is my most widely read Chapter in my autobiography with over 12,000 page views. Enjoy!!

The Oblation Run* ( photo from paradise_philippines.com)

My first two years was in UPIC ( University of the Philippines, Iloilo College). At that time, it was only a two year institution. I started as Pre-Med as requested by my mother. My mom always dreamed of having a physician in the family. I made good grades, "A"s and "B"s (1.0 and 2.0) in all my subjects, and obtained college and university scholarships during my first year.

On my second year,I was awarded the Fernando Lopez Scholarship of free tuition fees for the whole year. The award was given to the student with the highest grade point average in the whole school. If there is a tie, the student with the most extracurricular activities wins the award. I was also elected President of the University of the Philippines Student Catholic Action( UPSCA), Iloilo Chapter. With this activity, I corresponded with the President of UPSCA Diliman, campus. At that time the president was Constantino Nieva, a law student from Marinduque. Later, he was ordained as a priest and studied in Rome, Italy for his Ph.D in Theology. Fr Nieva ( we call him Tito Tino, now) is the uncle of my wife, Macrine Nieva Jambalos Katague.

Life in UPIC went by very fast. In the Fall of 1953, I transferred to UP Diliman, College of Liberal Arts and decided to change my major to Chemistry. This change was inspired by my chemistry professor in UPIC. The fact that I hate the sight of blood, in my Zoology class dissecting frogs, made this change easy.

"There goes my mother's dream". ( Note: it was only about 5 years ago, when my niece, D'Wanie Katague Gregorio finished her MD degree, that my mother's dream was finally fulfilled)

In Diliman, I resumed my active participation with UPSCA, becoming a member of the UPSCA Student Council representing my college. Our spiritual adviser was the late Fr. John Delaney, a Jesuit priest. The rivalry between the UPSCANS and the FRATS /SORORITIES was the most published and talked topic during that time. This topic alone will consumed several pages in this article, so I am not discussing it. But this episode in my college life had been documented already in my college memoirs album. Needless to say, the UPSCANS dominated student politics for years and until the death of Fr. John Delaney.


A circular chapel( Chapel of the Holy Sacrifice) in the Diliman campus was one of Fr. Delaney's project. During the ground breaking for the chapel, the names of one thousand (1000) students, faculty members and their families who went to mass and communion everyday for one year were buried in the church foundation. What an honor that my name was one of the one thousand names included in the church foundation.

It was Fr. Tino who first introduced me to his niece, Macrine Nieva Jambalos. That year, I also joined the "Chemical Society". As a neophyte, one of my task was to look for Macrine. I was not able to do it. At the same time, one member of the Chemical Society who resided in the same dormitory with Macrine knew that she was also looking for me. So we were playing "HIDE and SEEK'. Finally, Macrine and I met in the sacristy of the old chapel and the rest is history. Our college romance is too long to be included in this article. Someday, I will write a short version of our story for the sake of our four children and six grandchildren.

In 1955, I graduated with my B.S.in Chemistry degree. I had written an article regarding my graduation( the 1 point I missed in the final examination, that change my outlook in life) in another posting.

The Oblation Run, UPLB( photo from photobucket.com)


The two pictures above are the "OBLATION RUN", an annual activity that had been attracting nationwide visitors and the press in UP. There was no Oblation Run during my college years. The photo is from the web, by photobucket.com (pinoyblogosphere).
The first photo was in the Diliman campus. The second photo was the run in the Los Banos Campus,in 2004.

* Historical Notes about the Oblation Run from Wikipedia

The Oblation Run is an annual tradition of the members of the Alpha Phi Omega, one of the prominent U.P. fraternities. Members of the fraternity run around the campus naked (a concept known as streaking) to protest their sentiments about a current political or economic situation. The run started in 1977 to protest the banning of the movie, “Hubad na Bayani,” which depicted human rights abuses in the martial law era.

Contrary to popular belief, neophytes are forbidden to run. "All those who run are full-fledged members who have volunteered" are allowed to run, explains Ojie Santillan, the fraternity's Auxiliary Chancellor. "There is a misconception that the Oblation Run is something our neophytes have to undergo as part of their initiation. That’s not true. We never allow our applicants to join.(the Oblation Run)" Today, the Oblation Run is held on or about December 16th, in honor of the international founding of Alpha Phi Omega.

"The Great Centennial Run"
Exactly, on UP's 100th anniversary day, and in the “UP Oblation Run," 100 UP-based Alpha Phi Omega (APO) Fraternity and several UP alumni on June 18, at 11:00 a.m., ran naked along the University of the Philippines (UP) campus to commemorate the centennial anniversary. They sprinted from the Vinzon’s Hall and stopped at Palma Hall, for short photo opportunity. Jejomar Binay, alumnus and former prime chancellor of APO fraternity led the event. Runners called "Scholars of the People" carried placards, "Serve the People," to petition for the state subsidies to their education.

The History of the Sculpture from Wikpedia:

The idea for the Oblation was first conceived during presidency of Rafael Palma, who was the one to commission Tolentino to make the sculpture. Palma requested that the statue would be based on the second verse of Jose Rizal's Mi Ultimo Adios;

"In fields of battle, deliriously fighting,
Others give you their lives, without doubt, without regret;
Where there’s cypress, laurel or lily,
On a plank or open field, in combat or cruel martyrdom,
If the home or country asks, it's all the same--it matters not".

The concrete sculpture painted to look like bronze, measures 3.5 meters in height, symbolizing the 350 years of Spanish rule in the Philippines. The sculpture is replete with references of selfless dedication and service to the nation, and as Tolentino himself describes it;

"The completely nude figure of a young man with outstretched arms and open hands, with tilted head, closed eyes and parted lips murmuring a prayer, with breast forward in the act of offering himself, is my interpretation of that sublime stanza. It symbolizes all the unknown heroes who fell during the night. The statue stands on a rustic base, a stylized rugged shape of the Philippine archipelago, lined with big and small hard rocks, each of which represents an island. The “katakataka” (wonder plant) whose roots are tightly implanted on Philippine soil, is the link that binds the symbolized figure to the allegorical Philippine Group. “Katakataka” is really a wonder plant. It is called siempre vivo (always alive) in Spanish. A leaf or a piece of it thrown anywhere will sprout into a young plant. Hence, it symbolizes the deep-rooted patriotism in the heart of our heroes. Such patriotism continually and forever grows anywhere in the Philippines".



Originally, the statue was completely naked, but, as morality was prevailing at that time, it was modified by former U.P. President Jorge Bocobo with the addition of a fig leaf to cover the genitals. The sculpture was funded by the UP students of 1935-1936, and was presided by Potenciano Illusorio and Jose B. Laurel, Jr., presidents of the student council during the first and second semester respectively and was dedicated on March 1939 at the University's Manila campus where it stayed until February 1949, when the main administrative offices of the university moved to the new Diliman campus in Quezon City.

The transfer of the Oblation to its new home served as the highlight of the move from Manila, which is historically referred to as the Exodus. The sculpture in front of the Quezon Hall at Diliman was installed facing west, purportedly a tribute to the American roots of the university. Today, that sculpture is only a bronze replica (which was recast from the original in Italy, in 1950, under the supervision of Tolentino himself) dedicated on UP's Golden Jubilee on November 29, 1958. The original sculpture is being kept at the Main Library (Gonzalez Hall), the former site of the UP College of Fine Arts, where Tolentino taught.

Several replicas of the Oblation were made for campuses of the University of the Philippines, some by national artist, Napoleon Abueva. 2005 national artist nominee Glenn Bautista,likewise, did his celebrated version of the Oblation in pen and ink as part of his school plates at the UP College of Fine Art under Professor Rebilion. The sculpture was registered at the Intellectual Property Office in the year 2004. Being the main symbol of the university, the Oblation is the centerpiece of many UP-related logos, like those of the Philippine Collegian and other student publications, the UP Cooperative, and the UP centennial emblem.

******************************************************************************
*EPILOGUE After 50 Years- Actually 55 years as of Today-October 4, 2010


The first circular church and first thin-shell concrete dome in the Philippines

The following article by Paulo Alcazaren( City Sense, STAR) written about five years ago brought pleasant memories of my college years and my first job as an Instructor in Chemistry at the University of the Philippines, Department of Chemistry ( 1952-1957).

December 20, 1955 ( also my 21st birthday) was the date when the first mass was held and the blessing of the chapel by Archbishop Rufino Santos. It was attended by an overflowing crowd of UP students and faculty members including most of the "1000" whose names were in the chapel foundation.

I am proud to remember, that my name is one of the 1000 names buried in the Foundation of the Chapel for completing the requirement of daily mass and communion for one year and pledging 5% of my student allowance to the building fund.

This article also reminded me of the war and struggle to control student government and campus life between the UPSCANS and the Fraternities/ Sororities. I was an UPSCAN then and one of the faithful apostles of Fr. John Patrick Delaney. Fr. John has a lot of influence on my life from that time and even today. His words of wisdom, charisma and encouragement still rings in my 76 years old body. I love you, Fr. John! May you rest in Peace eternally!

Here's an excerpt from Paulo Alcazaren article published in the Star dated December 21, 2005.

CHAPEL OF SACRIFICE

UP, DILIMAN, December 21, 2005 (STAR) CITY SENSE By Paulo Alcazaren - My first memory of the University of the Philippines was in 1965. My father had bought me a toy rocket ship and we launched it from one of the many open green spaces set within the lush campus landscape. I thought at the time that it was cool that we were the first to bring the space age to the UP. I was wrong. I found out later that it had come much earlier – in 1955 – with the completion of the Chapel of the Holy Sacrifice, affectionately known as Diliman’s "flying saucer."

Less than 10 years after that rocket launch, I found myself enrolled at the UP and painting that domed chapel in watercolor for a class in architectural rendering. That prompted my first visit and the experience was profound. I had never been in a circular church before and it felt strange to see the altar in the center. Nevertheless, I was drawn to it. Despite its small scale (only a hundred feet across), the space had an impact and a focus few structures here could match then, and that holds true even today.

The interior space was enhanced with artwork – a two-sided crucifix above showing the tortured, then the risen Lord, an abstracted river of life in a terrazzo-patterned floor below and 15 striking murals (Stations of the Cross) between the dome’s 32 columns – and added to the whole effect of embracing the visitor spatially and spiritually. The chapel was wonderfully open, blending the interior with the green outside. Finally, the setting – a simple, green lawn rising gently from the road – completed the postcard-pretty scene.

A Priest, Four Artists & Two Engineers

Fr. John Delaney, the controversial but charismatic Jesuit chaplain assigned to the campus, orchestrated the project. National Artist for Architecture Leandro Locsin cut his teeth designing it. Dean Alfredo Juinio of the UP College of Engineering came up with the innovative thin-shell approach which a young David Consunji implemented to perfection using the simplest of machinery and lots of guts.

Finally, three cutting-edge artists – Napoleon Abueva, Arturo Luz and Vincente Manansala – created the crucifix, floor and murals respectively, which started them on the road to national artist status. (Another national artist, in music this time, Jose Maceda, would premier his concert "Pagsamba" there in 1968 and repeat it regularly in the same venue.) One renowned religious leader, four national artists and two giants in Philippine engineering and construction make for a really special structure …and a compelling story of how it got built.

The UP transferred to Diliman in 1949. It was meant to do so in 1942 as part of a massive transfer of civic structures that included a new capitol complex at the elliptical circle. The war intervened. Immediately after, the future campus was commandeered by the American Armed Forces as their headquarters. The two Juan Arellano-designed structures built in 1941 meant for the colleges of law and education became military offices. Around it rose dozens of quonset huts and a chapel of wood, galvanized iron roofing, bamboo and sawali that had a distinctive vernacular-inspired roof (my suspicion is that it was also Arellano-designed because of some references in the literature to his experimentation in pitch-roofed silhouettes for the state university’s architecture).

Unstable Architecture And A Troubled Up

That chapel deteriorated into stables towards the end of the UP’s military term. It was in shambles when Fr. Delaney found it but he quickly went to work to clean it up, aided by an ever growing flock of students, faculty and residents. After the patch-up, the UP chapel became the religious center of the campus. In the early ‘50s it was shared with the Protestant and Aglipayan congregations reflecting the open spirit of community in UP then.

The growing population of students and residents in the 493-hectare campus, however, took its toll and Fr. Delaney, as well as the Protestant church leaders, finally decided it was time to build new and separate chapels. Under UP president Vidal Tan, the campus also accommodated requests and allocated parcels in the non-academic north section of the university for both.

Those were trying years for Delaney, president Tan and the university. Issues of academic freedom, the threat of sectarianism (fueled by Fr. Delany’s extremely pro-active involvement in campus life and the growing political clout of the Delaney-mentored UP Student Catholic Action organization), and fraternity and sorority violence (which the chaplain tried his best to solve) made for a more complicated narrative, whose total complexion colored the entire decade.

It was in the middle of this maelstrom that the idea for the "saucer" started. In May 1954 the Protestant chapel was first to start construction. The modern structure, by university architect Cesar Concio, was completed a year later. The Protestant Chapel of the Risen Lord was funded by donations from America. The Catholic congregation was not so lucky and had to scrounge and scrape, egged on by the tireless Fr. Delaney to "give till it hurt." Fr. Delaney also did not want to sell out to corporate sponsorship or be beholden to endowments from the rich. Almost all of the P150,000 it took (remember, the peso was 2:1 back then) was raised by the UP congregation. Students missed their lunches and faculty donated portions of their salary to the fund. No wonder the chapel was named The Chapel of the Holy Sacrifice!

Financially Contrite But Creative

It was more than sacrifice that added to the value of the chapel, it was the creative resource and risk Fr. Delaney took in the team that he selected to build it. He probably also felt the pressure to deliver to his flock a structure as modern as the neighboring Protestant Chapel. The saddle-shaped structure cut a handsome sight and his congregation would settle for no less.

During dinner one night at the home of the Abuevas, he met a 26-year-old architect whose only experience after college was to spend a year designing a radical circular chapel for a sugar magnate in Negros. It was supposed to be a gift to the Don Bosco fathers and meant to symbolize unity and openness. The chapel was never built but Fr. Delaney had almost identical requirements. The loss of the Bosconians (a congregation to which I belong) was UP’s gain.

Fr. Delaney wanted a simple but strong building that would be open to the light, air and space that UP had plenty of back then. He also wanted to maximize the potential of the site allocated by the university, an elevated platform rising slightly above and across the university infirmary and the Protestant chapel.

With the previous client’s permission, Locsin adapted the original design to fit the site. Fr. Delaney then roped in Dean Juinio for the structural design and Jose Segovia for the electrical design. The contractor was a young maverick named David Consunji, the founder of today’s construction powerhouse DMCI. The dean worked hard at fulfilling the requirements to create a dome to float above a thousand worshippers lightly and at the least cost. His answer: a thin shell nine inches at the base and diminishing to only three inches at the top.

When It Rained, They Poured

This type of roof had never been built in the country. It took the ingenuity of Consunji to construct it within the constraints of the meager budget and the lack of equipment needed to pour the shell within the 18-hour window Juinio set. The solution was ingenious and daring – four construction towers and a continuous ramp circling the structure allowed ordinary concrete mixers (churning out high-strength concrete) to supply a squad of workers in buggies rotating to pour the concrete.


The pour date was Aug. 25, 1955. It started to drizzle in the early morning and threatened to wreck the operation (the water would dilute the mix and weaken the concrete). But Fr. Delaney held a prayer vigil with UPSCANs taking turns asking for divine intervention. They got it as the site remained totally dry even as other parts of the large campus were drenched, even the University Theater, where the Nobel Prize winner for literature, William Faulkner, delivered a lecture.

With the dome completed, Locsin and Delaney sought the artists needed to furnish and embellish the structure. They were all given complete artistic freedom (so long as they stayed within the budget). Abueva hung his heavy wooden cross from the oculus (above which Locsin put the chapel’s bells). Luz integrated the symbolism of nature in the "river of life" into the terrazzo floor that connected the interior spaces with the circular lanai, which in turn was the smooth transition to the simple lawn outside. Manansala added color literally to the chapel with his murals of the Way of the Cross (with a 15th panel showing the Risen Lord – an attempt to relate to the neighboring Protestant chapel, perhaps?).

The Chapel And Up’s Current Malaise

At four in the morning on Dec. 20, 1955 the chapel was blessed by Archbishop Rufino J. Santos. Fr. Delaney said the first mass (also the first Christmas mass) to an overflowing crowd. In his sermon, he thanked all those who made sacrifices to see that the chapel would be completed. The mood of the congregation was joyous and it spilled over to January only to be dashed by the news of Delaney’s death from a stroke. The sacrifices and trials he faced in the last few years had taken its toll. His body was brought from the Ateneo to the new chapel for the requiem mass, starting a tradition of honoring those of UP who had made a difference.

The new chapel and the loss of their mentor only spurred UPSCANs to carry on their perceived mission of shaping campus life. In the years that followed they took political control of the student council stirring up a hornet’s nest of trouble that ended in the suspension of student political life in UP until a decision by the Supreme Court in the early ‘60s.

The story of the chapel and the university by then was moving at a breakneck speed towards more tumult from the left, right and center (literally). Martial law followed with the neutering of the university’s fustiness's. People Power followed and the UP’s gentle decline caused by financial woes, the indifference of government, physical deterioration of facilities and an inability to maximize its potential and pull itself out of the morass of internal strife and political issues that date back to those unresolved in the 1950s.

A Chapel Choked

I visited the chapel recently and was glad to see that the work of Locsin, Juinio, Consunji, Abueva, Luz and Manansala has stood the test of time. The ceiling is flaking a bit but most of the interiors, artwork and furnishing have stood up well despite five decades of service. The feeling inside is still magnificent and clearly the structure should be declared a national treasure.

I was appalled, however, at the condition of its gardens and the surrounding landscape. The chapel cannot now be appreciated as it was originally intended – a structure that was open and barrier-free. Gone are the visual connections to other buildings and the transparency and friendliness of the 1950s setting. The place has been eaten by the virus of horror vacuii – the fear of empty spaces that politicians with their city halls and parish priests with their churches perennially suffer from. Moreover the circulation of air is compromised because the structure is choked by so much extraneous material.

The chapel’s formerly simple and elegant grounds have been cut up into numerous odd-shaped parcels and "decorated" with themes, awkward fountains, "decorative" odds and ends (although the statuary isn’t bad) along with an over-busy landscaping that obviously cannot be constantly maintained.

I was told that a previous parish priest run amok and turned the grounds into a succession of follies that pushed the bounds of aesthetics and gives meaning to the word "ugly." I would gladly go on a starvation vigil to have all of it removed and the chapel given back its proper and distinguished setting, however humble it may be.

The rest of the campus’ balkanized landscape suffers similar fate. Colleges cage themselves in or surround their buildings with parking lots that are pedestrian-unfriendly. The architecture of new buildings seldom relate to their surroundings while lack of funds is evident in the lack of maintenance for almost every corner of the university. Gone are the days when UP Diliman carried an image of idyllic pursuit of scholarship. Today’s students pursue the next class across unsheltered narrow sidewalks and unsafe stretches of overgrown cogon.

The space age has come and gone for UP. Vestiges of its former glory are seen in structures like the chapel but just barely. The campus seems to have been sacrificed by the gods of macroeconomics at the altar of national belt-tightening. It may also be abandoned by Delaney’s God soon if we do not make the real sacrifices needed to ensure a rational, open-minded, non-sectarian, politics-free and aesthetically-abled future for the university.

Personal Note: In 2009, my wife and I attended mass in the chapel during our annual vacation to the Philippines from US. I was also shock of the appearance and landscaping of the sorounding area, I started to cry, hiding my tears from wife.

My wife and I have pleasant memories of our participation in the UPSCA choir for three years under the leadership of the Late Professor Antonio Molina. I first met my wife in the old UP Chapel, through her uncle Fr. Constantino Nieva, who was President of UPSCA in 1952. In 1957, we got married and the decoration of our wedding cake was a 1:1000 miniature scale of the Chapel.

Now for short article on UPSCA:

The UP Student Catholic Action (UPSCA) is a non-stock and non-profit student organization duly recognized by the University of the Philippines in Diliman, Quezon City. Primarily, as a religious organization, it provides individuals a formation rooted on the Catholic faith. It seeks to develop socially aware members who will become agents of social change. It aims to nurture a sense of family among members, encourage academic excellence, and direct collective energies towards active involvement in community and society.

UPSCA traces its roots to 1936, when Father Edward J. McCarthy of the Society of St. Columban organized a Student Catholic Action in UP as an offshoot of the Scholastic Philosophy Club. Since 1936, UPSCA has dared to respond to the different challenges in Philippine society and to stand by its principles, in the light of its vision of forming a truly Filipino Christian community. On the year 2011, UPSCA will be celebrating its 75th anniversary.

Here's the latest information on the Chapel of Holy Sacrifice from Wikipedia.

The Parish of the Holy Sacrifice, also the Church of the Holy Sacrifice, is the landmark Catholic chapel in the University of the Philippines, Diliman. It belongs to the Roman Catholic Diocese of Cubao and its present parish priest is Rev. Fr. Raymond Joseph Arre. Known for its architectural design, the church is recognized as a National Historical Landmark and a Cultural Treasure by the National Historical Institute and the National Museum respectively. It was designed by the late National Artist for Architecture, Leandro Locsin, which was only one of the five national artists who collaborated on the project. Alfredo Juinio served as the structural engineer for the project. The church is adjacent to the U.P. Health Service Building and the U.P. Shopping Center, and is serviced by all of the university's jeepney routes.

In 1955, then University of the Philippines, Diliman Catholic Chaplain, Fr. John Delaney, S.J. commissioned Locsin to design a chapel that is open and can easily accommodate 1,000 people. The Church of Holy Sacrifice is the first round chapel in the Philippines with the altar in the middle, and the first to have a thin shell concrete dome. The floor of the church was designed by Arturo Luz, the Stations of the Cross by Vicente Manansala and Ang Kiukok, and the double-sided crucifix and altar base by Napoleon Abueva, all of whom are now National Artists.

Being a pioneering building, it almost suffered a setback during the construction of the dome when the weather suddenly changed as the concrete was being poured. If it had rained, the concrete would have not settled, and the whole project would have been in jeopardy.

The first mass in the church was celebrated on December 20, 1955. Since then, there have been modifications to the church and its surroundings. The gigantic dome, which used to be white, is now green. The altar base was also changed from wood to marble, still by Napoleon Abueva. Perhaps the most significant change is that the church is now fenced off, and the once open grounds that surrounded the church are now landscaped.

On January 12, 2005, the church was recognized as a National Historical Landmark and a Cultural Treasure by the National Historical Institute and the National Museum, respectively. During the recognition ceremony, National Historical Institute Chairman Ambeth R. Ocampo lauded the church as a “masterpiece of Filipino artistry and ingenuity”. Currently, the parish is spearheading a project that aims to restore the dome of the historic church. This is the first circular church and the first thin-shell concrete dome in the Philippines.

Architecture

The dome of the church is supported by pillars located at the sides of the church, so that there are no supports to block the space inside. The unique design of the dome allows natural lighting and ventilation. At the middle of the dome is a circular skylight, which supports the triangular bell tower. The bell tower, then extends to the interior, supporting the crucifix. The arrangement of the interior of the church is concentric, with the altar in the middle.

Some Photos from a Recent Wedding at Chateau Du Mer

Photo by Rosette Pitero Sotta

On April 6, 2019, a wedding ceremony and reception was held at the Chateau Du Mer Conference Hall and Beach House. The following are some of the photographs taken by 6PM Photography Studio. Ms Rosette Pitero Sotta was the caterer of this memorable event in the life of Amiel and Ericka. Congratulations to the newly weds from the owners (Dave and Macrine Katague) of the Chateau Du Mer Beach House and Conference Hall.

The bride on the Bridge of Love -focal point in the landscaping design of the Beach House

https://www.facebook.com/sixpmstudio/videos/2359939200961414/

Chemistry, Manufacturing and Control Requirements for New Drug Application

In my previous posting, I discussed the general overview of new drug development in the US and FDA's role in the process. In this article I am focusing on the Chemistry portion of a New Drug Application (NDA) which was my expertise when I was still working for FDA. I worked for FDA from September, 1990 up to October, 2002. Twelve productive years of my professional career.

I am listing below a table of all Chemistry, Manufacturing and Control(CMC) guidance both in draft and final form. As a former Chemistry team leader in one of the divisions in the Center of New Drugs, I have some input on the contents of a few of these guidance. These guidance are available in the Internet for everyone.

Below is a table of Chemistry, Manufacturing and Controls (CMC) Guidance showing,
category, title status( draft or final) and date.

1. Chemistry, Manufacturing, and Controls (CMC) Analytical Procedures and Methods Validation (PDF - 91KB)1 Draft Guidance 08/30/00

2. Chemistry, Manufacturing, and Controls (CMC) Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161KB)2 Draft Guidance 12/04/09

3. Chemistry, Manufacturing, and Controls (CMC) Botanical Drug Products (PDF - 437KB)3 Final Guidance 06/01/04

Taken at My Retirement Party-FDA Colleagues-2002

4. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33KB)4 Final Guidance 07/01/97

5. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA (PDF - 108KB)5 Final Guidance 04/01/04

6. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB)6 Final Guidance 01/01/01

7. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 18KB)7 Final Guidance 11/19/04

8. Chemistry, Manufacturing, and Controls (CMC) CMC Postapproval Manufacturing Changes Reportable in Annual Reports (PDF - 78KB)8 Draft Guidance 06/24/10

9. Chemistry, Manufacturing, and Controls (CMC) Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)9 Draft Guidance 02/25/03

10. Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)10 Final Guidance 05/01/99

11.Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for
Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB)11 Final Guidance 05/01/02

12. Chemistry, Manufacturing, and Controls (CMC) Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products12 Final Guidance 04/01/96

13, Chemistry, Manufacturing, and Controls (CMC) Development of New Stereoisomeric Drugs13 Final Guidance 05/01/92

14. Chemistry, Manufacturing and Controls (CMC) Drug Master Files (DMFs)14 Additional Information regarding DMF's

Letter of Appreciation from the CEO and President of Bristol Myers-Sion Boney,1997

15. Chemistry, Manufacturing, and Controls (CMC) Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23KB)15 Final Guidance 11/01/99

16. Chemistry, Manufacturing, and Controls (CMC) Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB) Draft Guidance 09/11/02

17. Chemistry, Manufacturing, and Controls (CMC) Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)17 Final Guidance 07/01/98

18. Chemistry, Manufacturing, and Controls (CMC) Format and Content for the CMC Section of an Annual Report (PDF - 29KB)18 Final Guidance 09/01/94

19. Chemistry, Manufacturing, and Controls (CMC) Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79KB)19 Draft Guidance 07/14/09

20. Chemistry, Manufacturing, and Controls (CMC) INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 193KB)20 Final Guidance 05/20/03

21. Chemistry, Manufacturing, and Controls (CMC) IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)21 Final Guidance 05/01/01

Ceremony during my Equal Employment Opportunity Award(EE0)

22. Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)22

23. Chemistry, Manufacturing, and Controls (CMC) Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 45KB)23 Draft Guidance 08/21/02

24. Chemistry, Manufacturing, and Controls (CMC) Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29KB)24 Final Guidance 03/01/01

25. Chemistry, Manufacturing, and Controls (CMC) Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361KB)25 Draft Guidance 11/19/98

26. Chemistry, Manufacturing, and Controls (CMC) Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 116KB)26 Final Guidance 07/01/02

27. Chemistry, Manufacturing, and Controls (CMC) NDAs: Impurities in Drug Substances (PDF - 11KB)27 Final Guidance 02/01/00

28. Chemistry, Manufacturing, and Controls (CMC) Orally Disintegrating Tablets (PDF - 52KB)28 Final Guidance 12/17/08

29. Chemistry, Manufacturing, and Controls (CMC) PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76KB)29 Final Guidance 04/28/98

Some of My FDA Awards

30. Chemistry, Manufacturing, and Controls (CMC) Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB)30 Draft Guidance 08/02/10

31. Chemistry, Manufacturing, and Controls (CMC) Residual Solvents in Drug Products Marketed in the United States (PDF - 52KB)31 Final Guidance 11/24/09

32. Chemistry, Manufacturing, and Controls (CMC) Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703KB)32 Final Guidance 11/01/94

33. Chemistry, Manufacturing, and Controls (CMC) Size of Beads in Drug Products Labeled for Sprinkle (PDF - 43KB)33 Draft Guidance 01/18/11

34. Chemistry, Manufacturing, and Controls (CMC) Submitting Documentation for the Manufacturing of and Controls for Drug Products (PDF - 1048KB)34 Final Guidance 02/01/87

35. Chemistry, Manufacturing, and Controls (CMC) Guidelines for Submitting Samples and Analytical Data for Methods Validation Final Guidance 02/01/87

36. Chemistry, Manufacturing, and Controls (CMC) Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94KB)36 Final Guidance 02/01/87

37. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB)37 Final Guidance 11/01/95

38. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR Questions and Answers about SUPAC-IR Guidance38 Final Guidance 02/18/97

39. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117KB)39 Final Guidance 01/01/99

40. Chemistry, Manufacturing, and Controls (CMC) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF - 215KB)40 Final Guidance 10/06/97

41. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61KB)41 Draft Guidance 12/01/98

42. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)42 Final Guidance 05/01/97

43. Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use 09/01/97

My election to the United States Pharmacopeia Council of Experts is one of the highlight of my career with FDA

As a Chemistry Team Leader, you need to be familiar with contents of these 43 guidances, so when representatives from the Pharmaceutical firms ask you a question, you should be able to refer them to the guidance. If you can answer their question without referring to the guidance, the firm's representative look at you with high regard and respect. It is therefore imperative that you know most of the important requirements for an NDA submission as well as the post NDA requirements in the manufacture, chemistry and controls of an IND or NDA. A Guidance is not a Federal Regulation/Law. 21CFR (Code of Federal Regulation), gives FDA mandate to enforce drug and food laws in US. Source: www.fda.gov

My twelve years in FDA was the happiest and most productive years of my professional life. Macrine and my involvement with the Filipino-American community in the tristate area will also be memories that we will never forget.

Development of New Drugs in the United States

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Image from medscape.com

As a retired FDA employee involved in the development of new drugs in the Division of Anti-Infective Drug Products, Office of New Drug Chemistry, Center for New Drugs for over twelve years, I had often been asked by several of my blog readers to write a summary and an overview of new drug development in the US.

I had been postponing it, because I thought the subject is confidential, but when I started browsing in the WEB I found several articles on the subject. I even found a Chemistry manufacturing supplement that I had approved several years ago. The letter of approval and the chemist review was printed in the Internet. However, the specifics of the supplement was erased in the approval letter as well as in the chemist review. The patent of the drug discussed had expired, so it is open to generic companies, otherwise the chemist review and letter of approval will never be made public. I am getting out of the subject, but let me start on the subject right now.

Two of my colleagues in FDA-1995

New Chemical Entity (NCE) development

Broadly the process can be divided into pre-clinical and clinical work.

Pre-clinical.

New Chemical Entities (NCEs)(also known as New Molecular Entities (NMEs)) are compounds which emerge from the process of drug discovery. These will have promising activity against a particular biological target thought to be important in disease; however, little will be known about the safety, toxicity, pharmacokinetics and metabolism of this NCE in humans. It is the function of drug development to assess all of these parameters prior to human clinical trials. A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time an NCE is used in a human clinical trial ("first-in-man" (FIM) or First Human Dose (FHD)).

In addition, drug development is required to establish the physicochemical properties of the NCE: its chemical makeup, stability, solubility. The process by which the chemical is made will be optimized so that from being made at the bench on a milligram scale by a synthetic chemist, it can be manufactured on the kilogram and then on the ton scale. It will be further examined for its suitability to be made into capsules, tablets, aeresol, intramuscular injectable, subcuteneous injectable, or intravenous formulations. Together these processes are known in preclinical development as Chemistry, Manufacturing and Control (CMC).

Note: The CMC portion of was my primary function as the Team Chemistry Leader during my employment with FDA

Many aspects of drug development are focused on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in man. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs, brain, kidney, liver and digestive system), as well as effects on other parts of the body that might be affected by the drug (e.g. the skin if the new drug is to be delivered through the skin). While, increasingly, these tests can be made using in vitro methods (e.g. with isolated cells), many tests can only be made by using experimental animals, since it is only in an intact organism that the complex interplay of metabolism and drug exposure on toxicity can be examined.

The information gathered from this pre-clinical testing, as well as information on CMC, and is submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug application or IND. If the IND is approved, development moves to the clinical phase.

Clinical phase.

Clinical trials involves three steps: Phase I trials, usually in healthy patients, determine safety and dosing Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of sick patients Phase III trials a large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients

The process of drug development does not stop once an NCE begins human clinical trials. In addition to the tests required to move a novel drug into the clinic for the first time it is also important to ensure that long-term or chronic toxicities are determined, as well as effects on systems not previously monitored (fertility, reproduction, immune system, etc.). The compound will also be tested for its capability to cause cancer (carcinogenicity testing).

If a compound emerges from these tests with an acceptable toxicity and safety profile, and it can further be demonstrated to have the desired effect in clinical trials, then it can be submitted for marketing approval in the various countries where it will be sold. In the US, this process is called a New Drug Application or NDA. Most NCEs, however, fail during drug development, either because they have some unacceptable toxicity, or because they simply do not work in clinical trials.

As this drug discovery process becomes more expensive it is becoming important to look at new ways to bring forward NCEs. One approach to improve efficiency is to recognize that there are many steps requiring different levels of experimentation. The early phase of drug discovery actually has components of real innovation, components of experimentation and components that involve set routines. This model of Innovation, Experimentation, and Commoditization ensures that new ways to do work are adopted continually. This model also allows the discipline to use appropriate internal and external resources for the right work.

Cost

Studies published by diMasi et al in 2003 report an average pre-tax cost of approximately $800 million to bring a new drug (i.e. a drug with a new chemical entity) to market. A study published in 2006 estimates that costs vary from around $500 million to $2 billion depending on the therapy or the developing firm. A study published in 2010 in the journal Health Economics, including an author from the US Federal Trade Commission, was critical of the methods used by diMasi et al but came up with a higher estimate of ~$1.2B. Critic Marcia Angell, M.D., a former editor of the New England Journal of Medicine, has called that number grossly inflated, and estimates that the total is closer to $100 million. A 2011 study also critical of the diMasi methods, puts average costs at $55 million.

Success rate

Candidates for a new drug to treat a disease might theoretically include from 5,000 to 10,000 chemical compounds. On average about 250 of these will show sufficient promise for further evaluation using laboratory tests, mice and other test animals. Typically, about ten of these will qualify for tests on humans. A study conducted by the Tufts Center for the Study of Drug Development covering the 1980s and 1990s found that only 21.5 percent of drugs that start phase I trials are eventually approved for marketing. Now you know why the drugs you purchased in the pharmacy is very expensive ( except the generic drugs). Most Americans will not be able to afford new drugs if they do not have insurance.

The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act20 is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.Code of Federal Regulations (CFR)

Code Of Federal Regulations (CFR)21. The final regulations published in the Federal Register22 (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the The Federal Food, Drug, and Cosmetic Act23 and related statutes. Section 21 of the CFR24 contains most regulations pertaining to food and drugs.

Note: I hope you found the above posting informative. My next posting on this subject will be on the Chemistry, Manufacturing and Control(CMC) Requirements for IND's and NDA's. If you find this posting either boring or interesting, let me know via comments. Thank You.

First Posting: 2011

Pleasant Memories of My Gardens at Chateau Du Mer

The following photos I took from my gardens at Chateau Du Mer, Amoingon, Boac, Marinduque, Philippines in 2011.










I hope you enjoy the above pictures! I had fun taking them! Good Day to All!

Life is Short, So Enjoy it to the Fullest

It is spring time here in Northern California. It is time for some inspiration readings!

LIFE IS SHORT... ENJOY & LIVE LIFE TO THE FULLEST!!!
🔹Love God and others More!✔
🔹Take time to PRAY and Read the Word of God! ✔
🔹Drink Plenty of water. ✔
🔹EAT:
Breakfast like a KING,
Lunch like a Prince &
Dinner like a pauper. ✔
🔹Live with the 3 E's--
Energy,
Enthusiasm &
Empathy.✔
🔹Play good games.✔
🔹Read more books than you did in 2018.✔
🔹Sit in silence for at least 10 minutes each day.✔
🔹Sleep for 7 hours.✔
🔹Take a 10-30 minutes walk daily And while you walk...😊 Smile.✔
🔹Don't over do. Keep your limits.✔
🔹Don't take yourself so seriously. No one else does.✔
🔹Don't waste your precious energy on gossip.✔
🔹Dream more while you are awake.✔
🔹Envy is a waste of time. You already have all you need.✔
🔹Forget issues of the past. Don't remind your partner with his/her mistakes of the past. That will ruin your present Happiness.✔
🔹Life is too short to waste time hating anyone. Don't hate others.✔
🔹Make peace with your past so it won't spoil the present.✔
🔹No one is in charge of your happiness except you.✔
🔹Smile and Laugh More.✔
🔹You don't have to win every argument, Agree to disagree. ✔
🔹Call your family often.✔
🔹Each day give something good to others.✔
🔹Forgive everyone for everything.✔
🔹Spend time with people over the age of 70 & under the age of 6.✔
🔹Try to make at least three people smile each day.✔
🔹What other people think of you is none of your business.✔
🔹Do the right thing!✔
🔹GOD heals everything.✔
🔹However good or bad a situation is, it will change.✔
🔹No matter how you feel, Get up, Dress up and Show up. The best is yet to come.✔
🔹When awake in the morning Thank GOD for it.✔
🔹Your Inner most is always happy...
So, be Happy. ✔
ABOVE IS A REPOST
FROM:Jone Jingco Haimer

Building this beach house is one of our life's fullest enjoyment!

Video Memories of Macrine's 80th Birthday

Last week, we celebrated Macrine's 83rd birthday with a very simple party. About 90% of the guests were also present when we celebrated her 80th birthday. A few of the guests were inquiring where is the videographer who took an excellent and unforgettable video now. I told them he is back in Australia. He is my nephew and namesake.

The video is one of the many pleasant memories of my nephew's visit three years ago. Three Years ago, Macrine could still swim and walk. Today she is wheel-chaired bound due a double hip surgery, that was not too successful.

The following video was taken by my nephew and Namesake from Australia three years ago.

My Auntie Macrine's 80th | "It's been a long time!" from Dave Katague on Vimeo.

For more videos of Dave Katague:https://www.youtube.com/watch?v=aFALi2TsbbI