Srping break : NYC

After the bus driving through the Lincoln Tunnel, we cross the boundary between of New York and New Jersey. My memorable spring break began.  

Day 1: March 16^th Monday.

In the afternoon, my best friend, Chen qi, show me the Cathedral of St. John the Divine which is one block away from his apartment. It is magnificent cathedral. The outer construction style is the same as other cathedral I visited. The inside space is extremely large. I guess it is capable of containing two thousands Christian. Chen qi told me the Cathedral caught fire in 1980s. Its towers were burn down completely. I can see some stones are still black and reconstruction work has not been finished.  We happened to hear organ playing at that time.

Left the Church, we walked to campus of Columbia University. I found the legendary owl hidden in Alma Mater statue in front of the Low Memorial library. People said the first student in freshmen class who find the owl hidden in the statue will be valedictorian.

In the Low memorial library, I happened to find two many Chinese antique which are donated by Columbia alumni. The antique are very old.  Recumbent Feline is of Dynasty  Attendant to Kuan-yin (赵匡胤) is of Ming dynasty. This Gilded Bronze is ordered for palace by the emperor of the Ming dynasty.

Day 2:

I planned to spend a half day on Liberty Island and Ellis Island, but the trip took a whole day! Much time were used to get security check, just like what we do in the airport, and even more strict.

Since 9.11, tourists are not allowed to go up to the face level of Statue of Liberty. But, I was still glad that I could stand there and took as many pictures I can. After all, the statue is a landmark of U.S. with symbolic meaning.

The Ellis Island, which was a gate for hope and expectation, is an amazing museum of American immigrant history.  All today’s procedure I experienced could be found its original shape such as I-94 form, medical exam, financial verification, English ability testing (….original TOEFL testing… ) and so on.

Aboard the ferry back to Manhattan, it was 5 o’clock already. We headed to the Wall Street. Taking pictures in front of NYSE, Charging bull (the Wall Street Bull) which is actually on the Broadway not Wall Street.  

Day 3:

I love to spend time in museum, where is full of history and human wisdom. The Metropolitan Museum of Art is my day 3 destiny. There are two part of collections impress me. The first one is Armor collection. The museum preserves thousands of Armors from Europe through Asia.  Western style armor is quite different from Eastern style. European armor is made of iron and bronze; barely see fabric and leather, while Asian armor is opposite. The other part attracted me is Impressionism art. My preference to impressionism pictures started from a art appreciation class at junior high school. The Sunrise of Claude Monet makes me love impressionism from that time.     

Day 4

The United Nation tour is not fun at all. It turned to world peace education by our tour guide. But, at least, I stand in The General Assembly Hall.

Leaving the United Nation building, I went to downtown Manhattan for WTC site. 9.11 has passed for 8 years, I could still feel sorrowful atmosphere around WTC site.

At night, Shu and Chen took me to a Broadway show, Little Mermaid. I think it is the most exciting event I had in the NYC. The stage is glamorous. The mermaid actress is a cute little girl. I enjoyed the show quite much. After the show, I met Jimmy, my cousin not meet for 27 years. Huh Huh. He is a cool guy doing a cool job. We decided to hang out next day.

Day 5

It is my last day in NYC. Chinatown and Brooklyn Bridge are in my plan. I had a lunch in New land cafeteria (新世界茶餐厅), a Cantonese style restaurant. It may be one of the oldest Chinese restaurants in Chinatown (Not sure…), their waiters are old….

Labor up and down the Brooklyn Bride is a tiring job. But, I did it and will not try again….  

In the evening, I hanged out with jimmy. We went to a JP style BBQ restaurant called Yakitori Taisho. The small restaurant is packed. We have to wait on hour for seat… Jimmy told me it is one of several affordable places in downtown Manhattan.  

Tips for successful career

After having a meaningful conversation with Dr. Rossi, the career advisor of our program, and recalling other conversations about career topic before, I think I need to summarize how to walk on a successful career.

1. Contribution:
Capitalist is not philanthropist. An organization open one position because they want one people could do the job. If a worker does not give contribution, layoff is closing to him/her.

Tips: Actively creating job is a skill to make contribution.

2. Attitude:
Interviewer, employer, or colleague, will judge a candidate by “would I like him/her?” So, possessing a positive, energetic, collaborative attitude is critical element for someone wants a successful career.

No job is done totally independently. Good interaction between people increase working efficiency. Employer appreciates team worker. Showing this attitude and making employer like you.

3. Communication
Keep communication open. There are hundreds and thousands of Chinese working in large company, but barely see Chinese working in senior management level. I think they are not communicative enough. “Talking 10 times more than what had been done” is also applicable in capitalism society.

Tips: Tell your boss your opinion, but always with evidence. In a better situation, make something before speaking out.

4. People skill
Keep a good relationship with boss and colleague. Effect of good people skill will embody when you leave. Good mouthing and bad mouthing lie on relation. It may change everything

Tips: Ask for someone’s business cards all the time. At appropriate time point, ask them if they are willing to be a reference.

5. Knowledge
A thirty minutes interview is not long enough for interview make a full assessment, but they could see candidate’s potential by judging:
- Knowledge on the whole industry. How much does he know about what is happening?
- Knowledge on the company, including its mission. Where is the job coming from and where is it going to?

These tips make a good employee. How to make a good boss? to be continued!

Film: An American Crime

I just watched this film, An American Crime and had a heavy heart. The film is adapted from real crime case occurred in Indiana in 1965. It tells true story of Sylvia Linken's misery and death.

Sylvia's parents were carnival workers. They went on tour all the time and have to leave Sylvia and her sister, Jenny to Ms. Gertrude Baniszewski to take care of them. Ms. Baniszewski, will get 20 dollars every week as return. She whipped sylvia first time because the check from Sylvia's parents did not arrive on time. Later, she begin to torture her for no clear reasons and scared Jenny not to tell the truth to their parents. Gertrude abet her kids to torture Sylvia, too. Finally, Sylvia died at one night.

The neighbors listened what happened, but they did not even try to stop it. Sylvia's parent left their kids to a stranger for living. Jenny did not call their parents, becasue she was afraid of getting the same treatment. How stoniness are these people!

09 Spring Career Fair

The embodiment of deepening economic downturn is packed career fair. Last Wednesday, I headed to Homewood Campus at Baltimore to participate in my first job fair in the U.S.

I got there at 1 P.M., which normally is see-you time in a career fair. There was still many students walking arround in the Rec. Center for their job hunting. Not to my surprise, positions of many big companies are fopen or U.S. citizen or Green Card holder only. Even internship application is not easy. Take Accenture as an example, they do not recurit foreign students in their intern program.

What I did on that day is submit my CV to FDA for summer intern application. But, they did not come back to me until now... I may go HW again on March 3, to meet FDA representative and follow up my intern opportunity.

It is a experience anyway. Nothing to win or loose.

02/04/09 BLA - Dyax Corp.-ecallantide for the treatment of acute attacks of hereditary angioedema

Disease:
Hereditary Angioedema (HAE) is a rare disease. Approximately 10,000 individual suffers. Less than 50% properly diagnosed. The major symptom is edema (swelling) in various body parts including hands, face, feet and airway. It is a potentially life-threatening disease when HAE attack laryngeal. The reason of HAE is deficiency in C1 esterase inhibitor activity, which are believed to block Kallikrein (血管舒缓素) Synthesis and decrease Bradykinin (血管舒缓激肽).

Medicine:
FDA approved several medicines for short and long term prophylaxis like Androgens, but no for acute attack. (Androgens have SAEs).
Dyax use recombinant technology to produce a protein, called Ecallantide, to specifically inhabit Kallikrein and suppress Bradykinin. Then physiological symptom, Edema, disappear. According to stability study, Ecallantide injection can be stored at 2-8 C for two years and at room temperature for 2 weeks.

Clinical studies:
Due to it is a rare disease, 219 HAE patients (4% of patients seeking treatment) were enrolled in the studies. The 219 HAE patients received 609 doses totally.

Design:
Phase 1 and Phase 2:
4 studies in Healthy subjects: DB, placebo-controlled, IV, PK, dose escalation
EDEMA0 / EDEMA1: single IV dose, 1 open-label, 1 placebo-controlled
EDEMA 2: Multi-dose, IV or Sbq, OL.
Phase 3:
EDEMA 3: DB, single dose, 30mg subq, placebo-controlled
EDEMA 3: RD, 30mg subq, open label
EDEMA 4: DB, Single-dose, 30mg subq, placebo-controlled
Ongoing continuation study: RD, OL

Efficacy measurement tool: Patient-Reported Outcome (PRO) assessment
Refer to FDA guideline: Patient-reported outcome measures.
Tool 1:Mean Symptom Complex Severity (MSCS): Point-in-time assessment of symptom severity
Tool 2:Treatment Outcome Score (TOS): Assessment of response to treatment.

Safety: Ecallantide is a foreign protein. So, the main concern is anaphylaxis and hyperandsensitivity caused by ecallantide.
Adverse events/physical exams/vital signs/routine clinical lab test and urinanalysis/ECG/Serial antibody testing

Sponsor conclusion:
No exception, the data sponsor present are “substantial” and “convincing” evidence of studies.

FDA conclusion:
FDA point out several issues about studies:
1) In EDEMA3: Dose administration error.
2) In EDEMA4: sample size increased from 52 to 96. It leads to the decrease of P value.
3) Pediatric data is limited.
Efficacy:
- EDEMA3 results not statistically significant by the pre-specified analysis
- EDEMA4 results of questionable robustness
- Pediatric data is limited
Safety
- Significant risk of anaphylaxis
- Limited data in pediatric patients.

Advisory committee
Voting (5 questions)
Question 4: Do the safety and efficacy data provide substantial and convincing evidence to support the approval of ecallantide for the treatment of acute attacks of hereditary angioedema?
Yes: 6 No: 5 Abstain: 2

Comments:
data is inadequate.
Rechallenge study is crude. It put patients in extremely dangerous situation.
If approved, post-marketing study is necessary.

My comments:
Apparently, the clinical data is inadequate, especially, pediatric data. In addition, sponsor changed the sample size of EDEMA 4 (add 44 patients) in order to get statistically significant results. Considering it is an orphan drug, advisory committee member may lower their standard of judgment.

First exprience of meeting of FDA Adviosry Committee

I began to plan my 1st meeting of FDA Advisory Committee participation since last september, when my first semester started. The convience of regulatory meeting participation is my preliminary reason for choosing Johns Hopkins.

The meeting was hold at Hilton hotel, Gaithersburg. The meeting location is close to where I live -- Approximately, 15 minutes by bus. But, it takes me 20 minutes to walk to nearest No. 54 bus stop...

I arrived at Hilton several minutes later than I thought becasue the bus is later against schedule. Sign in, meeting material pick up and sneak into the salon. I felt awkward when I found that most of participants dressed formally. The cold weather and long-distance walking discouraged me from wearing suit and leather shoes.

The meeting was open to public from beginning to end. The arrangement was very good. Agenda, sponsor/FDA presentation slides, and other meeting handouts were free and easily accessible.

The whole meeting is not boring as I thought. I did not take out and read my Biostatistics textbook, which was going to kill extra time. Although language is still an obstacle, I could understand what they talked about. It would be helpful, if I reviewed the meeting briefing package before meeting.

Generally speaking, the meeting worth participation. I will detail the meeting later.

Unknown name plant

I don't exactly have a green thumb.

(To be continued...when I know the name of my plant...)