References - Travel and Leisure

Introduction

Yosemite National Park is one of the most visited parks in the U.S.A. It is here where Ansel Adams shot his most famous photographs after he fell in love with the awe inspiring landscape, the steep cliffs and the magnificent waterfalls. While most of the over 4 million visitors only see Yosemite Valley, the park has mu

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ch more to offer. Mountain Climbers try their skills on the 3593 foot (about 1100m) vertical granite wall of El Capitan and Rafters ride the wild waters of the Merced River. The park draws a large crowd of professional and hobby nature and wildlife photographers.

Location

The park is located about 200miles (3 hours) east of San Fr

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ancisco (Airport Code: SFO) in the heart of the High Sierras. From San Francisco take I-580 east, I-205 East, I-5 North (2.2mi), CA-120 east. Follow CA-120 into the park. From the west, take CA-120 to enter Yosemite National Park. If you are coming from L.A. you will most likely enter the Park on CA-140. CA-140 meets CA-120 in Yosem

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ite Valley. From the east, you can enter on CA-120. You have to cross Tioga Pass, which is not always open (see below). The park entrance fee is $20/car. If you plan to visit at least 2 other parks within a year, you should consider buying a National Park Pass for $50. It does not include State Parks.

Yosemite Valley

Yosemite Vall

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ey is unquestionably the most visited part of the park. During the summer month of June, July, August and maybe September the valley is full of visitors. Traffic jams are a common occurrence. Don't let this discourage you from visiting the Valley. If you take a short hike along the many trails you can avoid the crowds easily. If you

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

have only one day to visit Yosemite, this is definitely the place to go. It is also the only place in Yosemite where you can buy food. Free shuttle busses are available to get around. The bus stations are marked in the Newspaper that you will get at the entrance station. The best time to visit the Valley is February through late Ma

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

y. In February the roads may not always be open due to snow. Call 209-372-0200 for current conditions (209-372-4726 for recorded information). Most likely you will not be allowed access without carrying snow chains.

Glacier Point Road and Mariposa Grove

Glacier Point Road

Glacier Point Road usually opens in late May (later in yea

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

rs of heavy snow fall) and closes in November. It is a 32-mile drive from the visitor center to Glacier Point itself (the end of the road). Plan for many stops and hikes though, as you will have some of the most spectacular views from up here. You could also hike up here, on the four-mile trail. Believe me, you don't want to try thi

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

s. The elevation is not to be underestimated. If you don't have wings, you should be here by car anyways and if the road is not open so be it, but don't take my word for it.

Mariposa Grove

Mariposa Grove is Yosemite's largest grove of giant sequoias. In winter it is not easy to reach, as the 2-mile road into the grove is closed. Y

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ou have to hike on the snow. Mariposa Grove is divided into upper and lower Grove. The largest tree (Grizzly Giant) is about 1800 years old and has seen the rise and fall of empires. If you ever wanted to feel like an insect standing next to a tree, this is the place to go.

Tioga Pass

If you visit Yosemite in June or July, you sho

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

uld consider coming up here. Actually this area should be referred to as the backcountry. CA-120 crosses Yosemite from East to West and leads over Tioga Pass. The Road usually opens in late May and closes in October, but there are years when the Road is closed until July. Massive amounts of Snow make this area inaccessible in winter

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

. If you come here in June or July you could experience the blooming of the Wildflowers, making the Meadows a wonderful patch of colors. Tioga pass itself is 9945 feet (3031m) high and offers some of the most spectacular views of the park. If you drive through the park from East to west, take CA-120 towards Tioga Pass instead of dri

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ving towards Yosemite Valley at the intersection near Crane Flat. Immediately after the Intersection, you will come to Tuolumne Grove, another place to see giant sequoias. Even though it is not as big and magnificent as Mariposa Grove, it is still well worth the visit.

Tips

If you are all by yourself in the backcountry, consider t

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

hat help may not be close. A large population of Black Bears lives in Yosemite. Bears have been known to break open cars to get food. Always wrap your food and pack it in such a way, that the bears cannot smell it. If you are camping and leaving open food containers around, that's just asking for trouble. Remember, Bears can run fas

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ter then you and climb trees. If you see a mother with cups, don't approach them. Mountain lions are scared of anything really big. If you have children, pick them up and put them on your shoulders to prevent them from being attacked. Bring enough film or memory cards. More than once have I seen people asking desperately around to b

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

uy them when all of a sudden the beautiful setting sun bathes the cliffs in red light and they ran out. On better days I shot a few hundred exposures. Gas up. The park is big and gasoline is not available everywhere. If you come from San Francisco, get gas in Oakdale. There are still opportunities later if you don't mind spending mo

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

re money.

Accomodation

As usual, traveling during the weekend has its price. If you can afford to come here during the week you will get better deals, as less people will compete for the same room. I have been able to get some good deals in El Portal (on CA-140 just outside the park). There are a bunch of Hotels on CA-120, but the

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

y are much farther away from the park. If you can bankroll a stay in the Park, it is obviously the better choice.

Hotels on the east side

If you exit Yosemite on the East towards Mono Lake you will get to the city of Lee Vining. The only Hotel I would stay in here is the Best Western. If you have no reservation, well good luck. If

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

you go south for about 40 minutes you will get to the town of Mammoth Lakes, offering plenty of Hotels. Alternatively you can go north towards Bridgeport.

Restaurants

The Restaurant that belongs to the Yosemite View Lodge is pretty good, but you have to wait to get a seat. They also have a Pizzeria if you cannot wait. Next to the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

Visitor Center in Yosemite Valley there is a small Burger place and a Sandwich place. Both are not very good, but I bet after a day of hiking you wont care much and a nasty burger will sound just as good as Filet Mignon. Much more information about Yosemite National Park can be found in my article http://www.opentravelinfo.com/ynp.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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